Delivery system with dose dispenser

Abstract

A delivery system includes a syringe having a chamber for containing a medicament and an outlet through which the medicament may be expelled. The plunger rod is movable relative to the syringe and is configured to cause the medicament to be expelled from the syringe when the medicament is within the syringe and the plunger rod is moved. When the delivery system is in the first configuration, the tray allows the plunger rod to move relative to the syringe over a first range of motion to expel a first dose of medicament and blocks the plunger rod from moving relative to the syringe over a subsequent range of motion to expel further medicament. The tray or plunger rod is rotatable to place the delivery system in a second configuration in which the plunger rod is free to move relative to the syringe over a subsequent range of motion to expel further medicament.

Description

Technical Field

[0001] This disclosure relates to a drug delivery system configured to facilitate the delivery of drugs in separate doses. Background Technology

[0002] Respiratory syncytial virus (RSV) is a leading cause of severe acute lower respiratory tract illness (LRI) in infants and children worldwide, and a common cause of severe pneumonia requiring hospitalization in children. Globally, RSV is estimated to have caused approximately 33 million cases of LRI in children under 5 years of age and resulted in approximately 118,000 deaths in 2015. It is estimated that in low- and middle-income countries, more than 80% of all RSV-related LRIs (RSV-LRI) and more than 50% of RSV-related deaths occur in infants ≥ 6 months of age.

[0003] A typical pharmaceutical delivery device may include a pharmaceutical syringe with an outlet through which the pharmaceutical agent can be discharged as the plunger rod moves through the syringe.

[0004] Some medications are designed to be delivered in two or more doses from a single syringe. In this case, the user may need to manipulate the plunger in a first range of motion to dispense the first dose, and then manipulate the plunger in one or more subsequent ranges of motion to dispense subsequent doses. Some patients may have difficulty manipulating the plunger to accurately dispense multiple intended individual doses of medication, ensuring that each dose contains the intended amount of medication. Alternatively, patients may accidentally dispense an unintended amount of medication or dispense the entire dose at once due to lack of experience with the device or misunderstanding of the device's instructions. Summary of the Invention

[0005] In a first aspect of this disclosure, a delivery system is provided, the delivery system comprising:

[0006] A syringe comprising a chamber for containing a drug and an outlet through which the drug may be discharged from the chamber;

[0007] A plunger rod, movable relative to the syringe and configured to cause the medication to be expelled from the syringe when the medication is inside the syringe and the plunger rod is moved; and

[0008] The disc, when the device is in the first configuration, allows the plunger rod to move relative to the syringe within a first range of motion to dispense a first dose of medication, and prevents the plunger rod from moving relative to the syringe within a subsequent range of motion to dispense further medication;

[0009] In this configuration, the disc or plunger rod can be rotated to place the device in a second configuration in which the plunger rod moves freely relative to the syringe in a subsequent range of motion to dispense further medication.

[0010] Therefore, the plunger rod is easy to manipulate to accurately dispense the intended individual dose with the expected amount of medication in each dose. Furthermore, it prevents patients or other device operators from accidentally dispensing unintended amounts of medication, or dispensing all medication at once.

[0011] In some embodiments, the disc is configured to rotate relative to the syringe to position the delivery system in a second configuration.

[0012] In some embodiments, the plunger rod includes a first region and a second region.

[0013] In some embodiments, the first region and the second region are formed integrally.

[0014] In some embodiments, the first region and the second region together form an elongated member of the plunger rod.

[0015] The disc may have an opening through which a plunger rod is displaced to dispense medication, wherein the plunger rod has a first region that is configured to allow the first region to pass through the opening in the disc to dispense a first dose of medication when the plunger rod or disc is in a first rotational orientation about the longitudinal axis of the device, and wherein the plunger rod has a second region proximal to the first region that is configured to prevent the second region from passing through the opening when the plunger rod or disc is in the first rotational orientation.

[0016] The second region can be configured to allow the second region to pass through an opening in the disc when the plunger rod or disc is in a second rotational orientation around the longitudinal axis of the device, in order to dispense a second dose of the drug.

[0017] The drug delivery device can be further configured to deliver more than two doses of drug, wherein the plunger rod includes additional regions in addition to the first and second regions, each additional region being formed to pass through an opening in the disk only when the plunger rod or the disk is in a predetermined rotational orientation about a longitudinal axis associated with the additional region.

[0018] The disc can be releasably attached to the finger flange of the syringe.

[0019] Therefore, if the syringes are to be discarded, the tray can be reused.

[0020] The disc can be configured to rotate about the longitudinal axis of the device between a first position and a second position, in which the disc allows the plunger rod to move in a first range of motion and blocks the plunger rod from moving in a subsequent range of motion, and in the second position, the plunger rod is free to move relative to the syringe in a subsequent range of motion to dispense further medication.

[0021] The device may further include a guide element having an opening through which a plunger rod is movable to dispense medication, the opening being configured to prevent the plunger rod from rotating about the longitudinal axis of the device.

[0022] The disc may include an opening that overlaps with an opening of a guide element, and wherein, when the disc is in a first position, a plunger rod is permitted to move through the opening of the disc and the opening of the guide element in a first range of motion, but is blocked from moving in a subsequent range of motion; and wherein, when the disc is in a second position, the plunger rod is permitted to move through the opening of the disc and the opening of the guide element in a subsequent range of motion to dispense further medication.

[0023] The plunger rod may include a first region at the distal end of the plunger rod and a second region at the proximal end of the plunger rod, wherein the first region and the second region have identical cross-sectional profiles and exhibit n-order rotational symmetry, where n is an integer; and wherein the cross-sectional profiles of the first region and the second region are offset by an angle α about the longitudinal axis of the plunger rod. Optionally, .

[0024] Therefore, the disc or plunger can be rotated to move from the first configuration to the second configuration.

[0025] The plunger rod may include a first region at the distal end of the plunger rod and a second region at the proximal end of the plunger rod, wherein the first region includes a first cross-sectional profile and the second region includes a second cross-sectional profile different from the first cross-sectional profile.

[0026] The shape of the opening in the guide element can be determined as the superposition of the offset cross-sectional profiles of the first and second regions of the plunger rod.

[0027] The shape of the opening in the disc can be determined to match the cross-sectional profile of the first and second regions of the plunger rod.

[0028] The shape of the opening in the guide element can be determined as the superposition of the first and second cross-sectional profiles of the plunger rod.

[0029] The shape of the opening in the pan can be determined as the superposition of the first and second cross-sectional profiles of the plunger rod.

[0030] The plunger rod may include a third region disposed between the first region and the second region, wherein the shape of the cross-sectional profile of the third region is determined such that the disk can rotate freely when the third region is located within the opening of the disk.

[0031] Therefore, the delivery device is configured to constrain the plunger rod over its entire range of motion, and the device moves from a first configuration to a second configuration by rotating the disc.

[0032] The plunger rod can be configured to rotate about the longitudinal axis of the device between a first position and a second position. In the first position, the disc allows the plunger rod to move in a first range of motion and blocks the plunger rod from moving in a subsequent range of motion. In the second position, the plunger rod is free to move relative to the syringe in a subsequent range of motion to expel further medication.

[0033] The plunger rod may include an elongated element that can slide linearly over its range of motion.

[0034] The plunger rod may include a plunger configured to compress a drug reservoir.

[0035] The plunger rod may include a piston rod that can slide linearly into the syringe.

[0036] A syringe may include a barrel and an outlet at the distal end of the barrel.

[0037] The syringe may include a piston that is in sealed contact with the barrel wall and can slide within the barrel by movement of the plunger rod to discharge the drug from the outlet.

[0038] The plunger rod can be configured such that when the plunger rod moves in a first range of motion, substantially half of the agent in the chamber is expelled, and when the plunger rod moves in a second range of motion, substantially half of the agent in the chamber is expelled.

[0039] The medication delivery device may further include a stopper at the outlet of the device to facilitate insertion of the stopper and the outlet into the orifice of the patient to be delivered medication.

[0040] The stopper and / or outlet may include a Luer lock to seal the stopper to the outlet.

[0041] Therefore, the device is configured to administer medication, such as a vaccine, via the nose.

[0042] The stopper can be configured to atomize the liquid agent as it is discharged through the outlet and the agent passage in the stopper.

[0043] The medication can be contained within the chamber of the syringe.

[0044] The syringe may be provided with the medication.

[0045] The medication can be a vaccine suitable for nasal administration, and the vaccine can be an RSV vaccine.

[0046] The device can be an intranasal atomized delivery device.

[0047] The device can be configured to deliver approximately half the dose to each nostril.

[0048] The device can be configured to deliver approximately 0.2 mL, with approximately 0.1 mL delivered to each nostril.

[0049] This intranasal nebulizer can deliver droplets with an average droplet size of approximately 10-120 µm. v50 .

[0050] Intranasal nebulizers can deliver droplets of average size D. v50 The average droplet size delivered to each nostril can be approximately 10-120 µm, approximately 30-110 µm, approximately 50-110 µm, approximately 70-110 µm, or approximately 80-110 µm.

[0051] The intranasal atomization delivery device can be configured such that the average injection volume to each nostril is between about 85 µL and about 120 µL, about 90 µL and about 115 µL, or about 95 µL and about 115 µL.

[0052] In a second aspect of this disclosure, an apparatus is provided including a finger flange attachment and a plunger rod for use with a syringe, the finger flange attachment including a disc that, when attached to the finger flange of the syringe, can be configured to allow the plunger rod to move relative to the syringe in a first range of motion to dispense a first dose of medication, and to prevent the plunger rod from moving relative to the syringe in a subsequent range of motion to dispense further medication.

[0053] Therefore, the syringe can be easily adapted to provide the advantages of this disclosure.

[0054] The disc can be rotatable to a second configuration in which the plunger rod is allowed to move relative to the syringe in a subsequent range of motion to dispense further medication.

[0055] In some embodiments, the disc is configured to rotate relative to the syringe to position the delivery system in a second configuration.

[0056] In a third aspect of this disclosure, a method for operating the delivery system as described above is provided, the method comprising:

[0057] Insert the outlet into the patient's first nostril;

[0058] The plunger rod is moved relative to the syringe within a first range of motion to expel a first dose of the drug.

[0059] The device is placed in the second configuration;

[0060] Insert the outlet into the patient's second nostril; and

[0061] This moves the plunger relative to the syringe within a subsequent range of motion to expel a further dose of the drug.

[0062] In some embodiments, placing the device in the second configuration includes rotating the disc relative to the syringe.

[0063] This method may include administering an RSV vaccine.

[0064] Delivery systems may include intranasal nebulizers.

[0065] The RSV vaccine can be delivered intranasally, with approximately half the dose delivered to each nostril.

[0066] An intranasal dose of RSV vaccine can be delivered in approximately 0.2 mL, with approximately 0.1 mL delivered to each nostril.

[0067] This intranasal nebulizer can deliver droplets with an average droplet size of approximately 10-120 µm. v50 .

[0068] Intranasal nebulizers can deliver droplets of average size D. v50 The average droplet size delivered to each nostril can be approximately 10-120 µm, approximately 30-110 µm, approximately 50-110 µm, approximately 70-110 µm, or approximately 80-110 µm.

[0069] The intranasal atomization delivery device can be configured such that the average injection volume to each nostril is between about 85 µL and about 120 µL, about 90 µL and about 115 µL, or about 95 µL and about 115 µL.

[0070] According to this disclosure, a delivery system is also provided, comprising: a syringe including a chamber for receiving a drug and an outlet through which the drug may be discharged from the chamber; a plunger rod movable relative to the syringe and configured to cause the drug to be discharged from the syringe when the drug is within the syringe and the plunger rod is moved; and a disc, which, when the delivery system is in a first configuration, allows the plunger rod to move relative to the syringe in a first range of motion to discharge a first dose of the drug and prevents the plunger rod from moving relative to the syringe in a subsequent range of motion to discharge further drug; wherein the disc is rotatable relative to the syringe to position the delivery system in a second configuration in which the plunger rod is free to move relative to the syringe in a subsequent range of motion to discharge further drug.

[0071] In some embodiments, the plunger rod includes a first region and a second region, and wherein the disc has an opening through which the plunger rod is displaced to dispense a drug, wherein the first region of the plunger rod is configured to allow the first region to pass through the opening in the disc to dispense a first dose of drug when the disc is in a first rotational orientation about the longitudinal axis of the device, and wherein the second region of the plunger rod is proximal to the first region, the second region being configured to prevent the second region from passing through the opening when the disc is in the first rotational orientation, and wherein the second region is configured to allow the second region to pass through the opening in the disc to dispense a second dose of drug when the disc is in a second rotational orientation about the longitudinal axis of the device.

[0072] These and other aspects of this disclosure will become clear and explained with reference to the embodiments described below. Attached Figure Description

[0073] The embodiments will now be described by way of example only and with reference to the accompanying drawings, in which:

[0074] Figure 1 This is a perspective view of a drug delivery device as an example of the present disclosure, which is shown in an initial position;

[0075] Figure 2 yes Figure 1 A side view of the device;

[0076] Figure 3 yes Figure 1 A side view of the device after the plunger rod has moved within its first range of motion;

[0077] Figure 4 yes Figure 1 The device is viewed from the side after the plunger rod has moved within its second range of motion.

[0078] Figure 5 This is a perspective view of the plunger rod used in the example of this disclosure;

[0079] Figure 6 This is a detailed view of the disc and finger gripper used in the examples in this disclosure;

[0080] Figure 7 This is a detailed view of the disc and finger gripper used in the examples in this disclosure;

[0081] Figure 8 This is a detailed view of the disc and finger gripper used in the examples in this disclosure;

[0082] Figure 9 This is a perspective view of the plunger rod used in the example of this disclosure;

[0083] Figure 10 This is a detailed view of the disc and finger gripper used in the examples in this disclosure;

[0084] Figure 11 This is a detailed view of the disc and finger gripper used in the examples in this disclosure;

[0085] Figure 12 This is a detailed view of the disc and finger gripper used in the examples in this disclosure;

[0086] Figure 13 This is a perspective view of the plunger rod used in the example of this disclosure;

[0087] Figure 14 This is a detailed view of the disc and finger gripper used in the examples in this disclosure;

[0088] Figure 15 This is a detailed view of the disc and finger gripper used in the examples in this disclosure;

[0089] Figure 16 This is a detailed view of the disc and finger gripper used in the examples in this disclosure;

[0090] Figure 17a shows a finger flange attachment used in an example of this disclosure;

[0091] Figure 17b shows a syringe and plunger rod for use with the finger flange attachment of Figure 17a; and

[0092] Figure 17c illustrates an example of drug delivery according to this disclosure, the drug delivery device being assembled from the finger flange attachment of Figure 17a and the syringe and plunger rod of Figure 17b. Detailed Implementation

[0093] This article describes systems, devices, components, and methods that can be associated with the use of intranasal nebulization delivery devices to deliver respiratory syncytial virus (RSV) vaccines.

[0094] As used herein, “RSV ΔNS2 / Δ1313 / I1314L” refers to RSV ΔNS2 / Δ1313 / I1314L (NIH) or RSV ΔNS2 / Δ1313 / I1314L (Sanofi). Each of ΔNS2 / Δ1313 / I1314L (National Institutes of Health (NIH)) and RSV ΔNS2 / Δ1313 / I1314L (Sanofi) contains an attenuated live RSV having (i) a 523-nucleotide (nt) deletion in the NS2 gene (ΔNS2), (ii) an amino acid deletion in the L protein, and (iii) a genetically stable mutation in the L gene. The attenuated live RSV ΔNS2 / Δ1313 / I1314L (Sanofi) also contains a nucleotide modification at position 14456, which represents a change from thymine (T) to adenine (A) in the non-coding region.

[0095] As used herein, “RSV ΔNS2 / Δ1313 / I1314L vaccine” refers to either “RSV ΔNS2 / Δ1313 / I1314L (NIH) vaccine” or “RSV ΔNS2 / Δ1313 / I1314L (Sanofi) vaccine”. The RSV ΔNS2 / Δ1313 / I1314L (NIH) vaccine contains an effective amount of RSV ΔNS2 / Δ1313 / I1314L (NIH). The RSV ΔNS2 / Δ1313 / I1314L (Sanofi) vaccine contains an effective amount of RSV ΔNS2 / Δ1313 / I1314L (Sanofi).

[0096] Exemplary methods and uses

[0097] In some embodiments, a method is provided for delivering a dose of RSV vaccine using an intranasal nebulizer delivery device.

[0098] In some embodiments, a method of administering a dose of an RSV vaccine containing attenuated live RSV uses an intranasal nebulizer delivery device. In some embodiments, a method is provided for administering a dose of an RSV vaccine using an intranasal nebulizer delivery device, the RSV vaccine comprising: an effective amount of attenuated live RSV having (i) a 523-nucleotide (nt) deletion in the NS2 gene (ΔNS2), (ii) an amino acid deletion in the L protein, and (iii) a genetically stable mutation in the L gene (RSVΔNS2 / Δ1313 / I1314L (NIH) vaccine); or further comprising a nucleotide-modified RSVΔNS2 / Δ1313 / I1314L (Sanofi) vaccine, the nucleotide modification being in a non-coding region representing a change from thymine (T) to adenine (A). In some embodiments, the codon encoding serine at position 1313 of the L protein is deleted, resulting in an amino acid deletion (Δ1313) in the L protein. In some embodiments, the substitution of leucine for isoleucine at position 1314 causes a genetically stable mutation (I1314L) in the L gene.

[0099] In some embodiments, a method is provided for administering a dose of RSV vaccine using an intranasal nebulizer. In some embodiments, the pediatric subjects may be 6 to 18 months old.

[0100] In some embodiments, an intranasal nebulizer is used to deliver the RSV vaccine intranasally to deliver approximately half a dose to each nostril. In some embodiments, the RSV vaccine is delivered intranasally to deliver the entire dose to one nostril. In some embodiments, the RSV vaccine is delivered intranasally in a manner where half a dose is delivered to one nostril, and an additional half dose is delivered to the same nostril after the first half dose has been absorbed. In some embodiments, the RSV vaccine is delivered intranasally using an intranasal nebulizer to deliver unequal doses to one or both nostrils.

[0101] In some embodiments, the RSV vaccine is delivered intranasally as a liquid formulation using an intranasal nebulizer. In some embodiments, the RSV vaccine dose is delivered intranasally at approximately 0.2 mL using an intranasal nebulizer. In some embodiments, the 0.2 mL dose is delivered intranasally, with approximately 0.1 mL delivered to each nostril. In some embodiments, the RSV vaccine dose is delivered intranasally at approximately 0.01 mL, 0.02 mL, 0.05 mL, 0.1 mL, 0.2 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL, 1.4 mL, or 1.5 mL using an intranasal nebulizer. As described above, the dose may be evenly distributed between the two nostrils, unevenly distributed between the two nostrils, or delivered entirely to one nostril in one or more deliveries.

[0102] In some embodiments, methods are provided for administering a first dose of RSV vaccine using an intranasal nebulizer and for administering a second dose of RSV vaccine using an intranasal nebulizer.

[0103] In some embodiments, a method is provided for administering a first dose of RSV vaccine using an intranasal nebulizer delivery device, wherein the intranasal nebulizer delivery device includes a spray nozzle to atomize the RSV vaccine and guide a spray plume toward the top of the nasal passage into the nasal cavity. In some embodiments, a method is provided for administering a dose of RSV vaccine using an intranasal nebulizer delivery device, wherein the intranasal nebulizer delivery device includes a spray nozzle to atomize the RSV vaccine and guide a spray plume toward the top of the nasal passage into the nasal cavity. In some embodiments, the intranasal nebulizer delivery device includes: a cylinder operatively connected to a spray nozzle, and a plunger movable within the cylinder to advance the RSV vaccine through the spray nozzle. In some embodiments, the intranasal nebulizer delivery device further includes a dose dispenser for dividing the dose of RSV vaccine into two or more deliveries. In some embodiments, the dose dispenser may divide the dose of RSV vaccine into approximately half the volume to be delivered to the subject. In some embodiments, the dose dispenser is used to deliver ½ dose to each nostril of the subject.

[0104] In some embodiments, the intranasal nebulizer delivers droplets of average size D10-120 µm. v50 In some embodiments, the intranasal nebulizer delivers droplets of average size D of 10-120 µm, about 30-110 µm, about 50-110 µm, about 70-110 µm, or about 80-110 µm. v50In some embodiments, the intranasal nebulizer delivers an average injection weight between about 95 mg and about 135 mg, between about 100 mg and about 130 mg, or between about 100 mg and about 130 mg, or between about 105 mg and about 130 mg. In some embodiments, the intranasal nebulizer delivers an average injection volume of about 85 µL to about 120 µL, about 90 µL to about 115 µL, or about 95 µL to about 115 µL.

[0105] In some embodiments, the intranasal nebulizer delivery device described herein is provided for administering a dose of an RSV vaccine to a subject, wherein the RSV vaccine comprises an effective amount of live attenuated RSV. In some embodiments, the use includes live attenuated RSV having (i) a 523-nucleotide (nt) deletion in the NS2 gene (ΔNS2), (ii) an amino acid deletion in the L protein, and (iii) a genetically stable mutation in the L gene (RSVΔNS2 / Δ1313 / I1314L (NIH) vaccine; or further comprising a nucleotide-modified RSVΔNS2 / Δ1313 / I1314L (Sanofi) vaccine, the nucleotide modification being in a non-coding region representing a change from thymine (T) to adenine (A).

[0106] Immunogenicity

[0107] Compared to 61% and 47% of RSV-naïve participants in the low-dose and high-dose groups, respectively, after one dose of the vaccine, approximately 70% (70%) of vaccine recipients in both the low-dose and high-dose groups achieved a 4-fold response in neutralizing antibody titers after a second dose. This increase in the percentage of participants achieving a 4-fold response after the second administration supports the use of a second dose in this population. A 70% increase in this fold after the second administration is consistent with the candidate vaccine's expected clinical efficacy target of 70%. After one or two vaccinations, 75% of people experienced a 4-fold increase in serum neutralizing antibody titers. The percentage of RSV-naïve participants who also achieved a 4-fold response in neutralizing antibody titers after one vaccination (36% in the low-dose group and 22% in the high-dose group) suggests a potential benefit for this subgroup as well. It must be noted that this is from an interim analysis of a moderate sample of participants at this time (n = 20 out of 97 vaccine recipients).

[0108] In summary, these data strongly support the use of the RSV ΔNS2 / Δ1313 / I1314L (Sanofi) vaccine in operational range studies against the candidate, including at doses of 5.6 log PFU / dose and 6.2 log PFU / dose.

[0109] Vaccine virus shedding and infectivity

[0110] Following each vaccination, vaccine virus shedding was considered as a factor of vaccine infectivity, in addition to a fold increase in neutralizing antibody titers or serum IgG. High levels of vaccine infectivity (over 80% and 70% of RSV-uninfected participants, respectively, after the first and second vaccinations) support promising vaccine candidates associated with good vaccination efficacy. When infectivity was considered after either vaccination, evidence of infection was found in over 90% of participants. Relatively high infectivity was observed in a small cohort of RSV-experienced participants (80% and 33.3% in low- and high-dose recipients after a single vaccination, and 60% and 50% after a second vaccination), suggesting promising efficacy for this group. Furthermore, the significant decrease in the percentage of vaccine virus shedding (approximately 20%) in RSV-uninfected participants after the second vaccination, compared to over 70% after the first vaccination (as previously documented with other effective attenuated live mucosal virus vaccines), is characteristic of subsequent “challenges” in the form of a second vaccine dose, which are characterized by a significant reduction in vaccine virus shedding. It is worth noting that the available shedding data for this cohort comes from data at a single time point (seven days post-vaccination) after each vaccination. While this is consistent with the peak viral shedding points documented in other RSV live attenuated vaccine (LAV) trials, it may have missed some shedding. This limitation in available shedding data makes the results particularly encouraging.

[0111] Overall Conclusion

[0112] Interim analysis results showed that the RSV ΔNS2 / Δ1313 / I1314L (Sanofi) candidate vaccine had good safety, immunogenicity and infectivity.

[0113] No safety issues were found after administration of one or two doses of the investigational RSV ΔNS2 / Δ1313 / I1314L (Sanofi) vaccine at any dose level or based on baseline serological status.

[0114] Immunogenicity conclusions based on vaccine viral shedding and IgA serological status at baseline demonstrated significant vaccination at both dose levels, and in RSV-naïve participants, 70% of RSV-naïve vaccine recipients achieved a 4-fold response in serological neutralizing antibody response after the second dose at both dose levels.

[0115] Figures 1 to 4A drug delivery device 10 (hereinafter “device 10”) according to a first embodiment is shown. Device 10 has a proximal end P and a distal end D, and is generally elongated with a central axis XX. Device 10 includes a drug container 11 (hereinafter referred to as “container 11”), a plunger rod 12, and a finger gripper 13 attached to the proximal end of container 11. In the embodiment described herein, container 11 is a syringe 11, and finger gripper 13 is a finger flange 13 of syringe 11. The terms “syringe 11” and “container 11” are used interchangeably herein. Container 11 is elongated and includes an outer wall 14 defining a drug chamber 15. Container 11 is open at the proximal end P and includes an outlet 16 at the distal end D opposite to the proximal end of container 11. The term “distal” refers to a location relatively closer to the outlet 16 and from which the drug is delivered in use, and the term “proximal” refers to a location relatively farther from the outlet 16. The distal region of the plunger rod 12 received within the container 11 is in sealing contact with the inner wall of the container 11. The proximal end of the plunger rod 12 includes an end surface 20 on which the user presses their thumb during use to dispense medication (described in more detail below).

[0116] The outlet 16 includes a constricted portion of the container that gradually narrows into a nozzle. A stopper 17 is disposed on the outlet 16. The stopper 17 and / or the outlet 16 may include a Luer lock to seal the stopper 17 to the outlet 16. In some embodiments, the stopper 17 may be configured to facilitate insertion of the outlet into an orifice into which a drug is to be delivered. Optionally, the stopper 17 may be configured with a drug passage that is configured to atomize liquid drug exiting through the outlet 16 and the stopper 17.

[0117] exist Figures 1 to 4 In the exemplary embodiment shown, the device 10 is generally in the form of a syringe, wherein the container 11 includes a syringe barrel, and the plunger rod 12 is received within the syringe barrel. In some embodiments, the piston 18 may be disposed within the drug chamber 15, in sealing contact with the inner wall of the container 11. In this arrangement, the piston 18 may be attached to the distal end of the plunger rod 12 (see [link to original document]). Figure 9 And the plunger rod 12 therefore does not need to be in sealed contact with the inner wall of the container 11.

[0118] In use, the agent 19 is supplied within the agent chamber 15 and is retained within the chamber 15 due to the sealing of the plunger rod 12 and / or piston 18 at the proximal end of the chamber 15 and the narrow outlet 16 at the distal end of the chamber 15 (which may be provided with a cap, valve, temporary breakable seal, or other closure). Alternatively, the narrow outlet 16 alone can prevent the agent 19 from escaping from the distal end of the chamber 15. The agent 19 can be discharged from the chamber 15 in one or more doses by linearly moving the plunger rod 12 distally into the chamber 15 to reduce the volume of the chamber and force the agent 19 out of the outlet 16.

[0119] Device 10 includes a disc 21, which functions as a "dose dispenser" during use of the device. The disc or dose dispenser 21 (hereinafter referred to as "disc") is... Figure 6 It is shown in more detail in the figure and includes a body 22 having an opening 23 extending through the body 22.

[0120] Piston rod 12 in Figure 5 The image is shown in more detail below and includes an elongated rod having a piston 18 or alternatively a piston, thus the plunger rod 12 serves as a piston rod or plunger rod for moving the piston 18 within the container 11. In various embodiments, the piston 18 may be integrally formed with the plunger rod 12, or may be mechanically or otherwise attached to the plunger rod 12 (e.g., by adhesive bonding), or the plunger rod 12 may abut against the piston 18. The plunger rod 12 includes a first region 30 at the distal end of the plunger rod 12 and a second region 31 at the proximal end of the plunger rod 12. The first and second regions of the plunger rod 12 include a square cross-sectional profile. The cross-sectional profiles of the first region 30 and the second region 31 are offset from each other by 45 degrees about the longitudinal axis YY of the plunger rod 12.

[0121] The plunger rod 12 is arranged to slide through an opening 23 in the disc 21. The opening 23 is aligned with the axis XX of the orifice in the pharmaceutical chamber 15, thus the plunger rod 12 extends through the opening 23 and into the container 11. It should be understood that when the device is assembled, the axes XX and YY of the device 10 and the plunger rod 12 are collinear, that is, the plunger rod 12 is aligned with the longitudinal axis XX of the device. The shape of the opening 23 in the disc 21 is determined to match the cross-sectional profile of the first and second regions of the plunger rod 12, but is slightly larger in each dimension to allow the plunger rod 12 to slide freely through the opening 23.

[0122] In the initial position, the first region 30 of the plunger rod is disposed in the opening 23 of the disk 21. Because the cross-sectional profiles of the first segment 30 and the second segment 31 of the plunger rod 12 are offset about the longitudinal axis YY of the plunger rod 12, the plunger rod 12 or the disk 21 needs to be rotated about the longitudinal axis YY of the plunger rod before the second region 31 of the plunger rod can pass through the opening 23 of the disk 21. With the disk 21 fixed, the plunger rod 12 can be rotated. For example, the disk 21 can be fixed to the finger gripper 13. In such an example (not shown), the disk 21 can be integrally formed with the finger gripper 13, and the opening 23 is provided in the finger gripper 13.

[0123] Alternatively, and as Figures 6 to 8 As shown, the disk 21 is rotatable and provides a guide element 24 to prevent the plunger rod 12 from rotating. The guide element 24 includes an opening 25 that overlaps with an opening in the disk 21, such as... Figure 8 As shown. Therefore, the plunger rod extends through both the opening 23 of the disc 21 and the opening 25 of the guide element 23. The shape of the opening 25 of the guide element 24 is defined as the superposition of the offset cross-sectional profiles of the first region 30 and the second region 31 of the plunger rod 12. This means that regardless of whether the first region 30 or the second region 31 of the plunger rod is located within the guide element 24, the plunger rod 12 is prevented from rotating about its axis YY due to the interference between the plunger rod 12 and the opening 25 of the guide element 24. The plunger rod 12 remains constrained by the guide element 24 throughout its entire range of motion. That is, regardless of the position of the plunger rod 12, either the first region 30 or the second region 31 of the plunger rod is located within the opening 25 of the guide element 24. Figures 6 to 8 As shown, the guide element 24 can be integrated with the finger gripper 13, and the opening 25 of the guide element 24 is the same as the opening 25 in the finger gripper 13. In such an example, the disc 21 includes a disc-shaped body 22 located in a correspondingly shaped recess in the finger gripper 13 to allow the disc 21 to rotate.

[0124] The plunger rod 12 further includes a third region 29 between the first region 30 and the second region 31. At the intermediate position of the plunger rod 12 (e.g., Figure 3 As shown), the third region 29 of the plunger rod 12 is disposed within the opening 23 of the disk 21. The shape of the third region is determined to not interfere with the opening 23 in the disk 21, so as to allow the plunger rod 12 or the disk 21 to rotate as needed.

[0125] The operation of the device 10 described in the above embodiment will now be described. The operation of the device 10 will be described in the context of its use as an intranasal drug delivery device 10 (i.e., a device for delivering a drug into a patient's nostrils). However, this concept is not intended to be limited to intranasal devices, and can be equally applied to various other forms of drug delivery devices intended to deliver a drug in two or more individual doses. In the context of intranasal devices, it is generally necessary to deliver a volume of drug (e.g., a vaccine) from the device 10 into each nostril, typically dividing the drug volume equally into doses for each nostril. When using such a device, the device 10... Figure 2 The device begins in the initial position shown. At this point, the plunger rod 12 is in its initial position, and no agent 19 is discharged from the chamber 15. Also in this initial position, the first region 30 of the plunger rod 12 is disposed within the opening 23 of the disk 21. In this position, the disk 21 and the plunger rod 12 are referred to as being in the "first position," and the device 10 is in the "first configuration."

[0126] The user (if administering the medication themselves, this could be the patient, or if administered by a third party, this could be a healthcare professional or other user) inserts the plug 17 into the first nostril. The user then presses the end surface 20 with their thumb while placing their index and middle fingers on the finger grip 13, causing the plunger rod 12 to move axially in the distal direction D. This pushes the piston 18 distally within the chamber 15 and expels the medication 19 from the outlet 16 through the medication passage of the plug 17, nebulizing the medication for the patient to inhale. The user continues to move the plunger rod 12 distally within this first range of motion until the distal side 27 of the second region 31 abuts against the proximal side 26 of the disc 21 and the plunger rod 12 can no longer move further distally. At this point, the plunger rod 12 is in the intermediate position, and the first dose of medication 19 has been delivered to the patient. In other words, the plunger rod 12 is in an intermediate position after having moved within the first range of motion, but some medication 19 remains in the chamber 15 for subsequent dose delivery. Also at this time, the first region 30 of the plunger rod 12 has moved into the container 11, and the third region 29 of the plunger rod 12 is now positioned within the opening 23 of the disc 21. Since the shape of the third region 29 is determined not to interfere with the opening 23 in the disc 21, either the plunger rod 12 or the disc 21 can now rotate. With the guide element 24 provided, the plunger rod 12 is prevented from rotating, and alternatively, the disc 21 is rotatable.

[0127] The user then removes the device 10 from the first nostril and rotates the disc 21 or plunger rod 12 to the second position, thereby placing the device 10 in the second configuration. In the second configuration, the opening 23 in the disc 21 is aligned with the second region 31 of the plunger rod 12 so as not to impede further movement of the plunger rod 12. In other words, the distal side 27 of the second region 31 and the proximal side 26 of the disc 21 are disengaged. The user then inserts the plug 17 into the other nostril. Since the disc 21 or plunger rod 12 has been rotated, it no longer prevents further axial movement of the plunger rod 12 in the distal direction. The user then presses the end surface 20 again to move the plunger rod 12 axially in the distal direction D, which pushes the piston 18 distally within the chamber 15 and expels the remaining medication 19 from the outlet 16 and through the medication passage of the plug 17 to nebulize the medication for the patient to inhale. The user continues to move the plunger rod 12 distally within this second range of motion until the distal side 28 of the end surface 20 abuts against the proximal side 26 of the disc 21, or the piston 18 abuts against the distal end of the chamber 15 and therefore cannot move further distally. At this point, the plunger rod 12 is in the end position, and the remaining medication 19 has been expelled as the second and final dose delivered to the patient.

[0128] The aforementioned device 10 provides a simple and effective way to ensure that the user can divide the medication delivery process into two separate doses, and the disc 21 provides an effective way to ensure that the medication 19 is divided as intended and that the user does not accidentally deliver too much / all of the medication in the first dose. Furthermore, since the disc 21 cannot be removed from the finger gripper 13, it cannot be pried open. This further helps to ensure that the medication is delivered in the intended dose volume in each dose.

[0129] As from Figure 2 It can be seen that the distance between the proximal side 26 of the disc 21 and the distal side 27 of the second region 31 of the plunger rod 12 has a length dimension L1 in the axial direction. In the exemplary embodiment shown, this length L1 also corresponds to the axial length L2 of the second region 31 of the plunger rod 12. It should be understood that the volume of the drug 19 delivered in the first dose is determined by the plunger rod 12 from the initial position ( Figure 2 (as shown) to the middle position ( Figure 3 The distance that the plunger rod 12 can move (as shown) is determined by when the second region 31 of the plunger rod 12 abuts against the disc 21. That is, the volume of the first dose is determined by the distance L1 that the plunger rod 12 moves within its first range of motion. It should also be understood that the volume of the second dose delivered is determined by the distance L1 that the plunger rod 12 moves from its intermediate position (as shown). Figure 3 (as shown) to the end position ( Figure 4The remaining distance that the plunger rod 12 can move (as shown) is determined by when the end surface 20 abuts against the disc 21, which can also coincide with the time when the piston 18 abuts against the distal end of the chamber 15. That is, the volume of this second dose of the drug is determined by the distance L2 that the plunger rod 12 moves within the second range of motion.

[0130] In view of the above, the ratio of the volume of the first and second doses of the drug to be delivered can be controlled by controlling the first and second ranges of motion of the plunger rod 12 (which can be controlled by selecting the dimensions L1 and L2 of the device 10 as needed). In embodiments where the first and second doses are to be equal, it should be understood that dimensions L1 and L2 can be made the same.

[0131] Although the above references are basically as follows Figure 5 The plunger rod 12 shown illustrates the operation of the device 10, but it should be understood that other plunger rods 12 with different cross-sectional profiles of the first region 30 and the second region 31 can be provided. The cross-sectional profiles of the first region 30 and the second region 31 can be any suitable shape, when offset about the longitudinal axis YY of the plunger rod 12, such that the distal side 27 of the second region 31 of the plunger rod 12 abuts against the proximal side 26 of the disc 21 as the plunger rod 12 moves from its initial position to its intermediate position. Therefore, any shape including n-order rotational symmetry (where n is an integer) may be suitable. The cross-sectional profiles of the first region 30 and the second region 31 must be offset about the longitudinal axis of the plunger rod 12 by an angle α, where... .

[0132] Figure 13 An alternative plunger rod 12 is shown, in which the same features retain the same reference numerals. Figure 13 The plunger rod differs from the plunger rod 12 described above only in that the plunger rod 12 comprises a cylindrical cross-section having a constant diameter along all three regions: the first region 30, the second region 31, and the third region 29. The cross-sections of the first region 30 and the second region 31 each further include portions 37 and 37' extending beyond the cylindrical cross-section. These portions are referred to herein as the first key 37 and the second key 37'. The first key 37 is offset from the second key 37' by an angle not equal to 360 degrees around the longitudinal axis YY of the plunger rod. Therefore, including the keys 37 and 37', the first region 30 and the second region 31 comprise the same cross-sectional area, but are offset along the longitudinal axis YY.

[0133] Figures 14 to 16 The text shows the relationship with... Figure 13 The plunger rod 12 is used in conjunction with a disc 21 and a guide element 24. An opening 23 in the disc 21 includes a keyway 38 that allows the keys 37, 37' of the first region 30 and the second region 31 to pass through only when aligned with them. Therefore, as described above... Figures 5 to 8 As described, the shape of the opening 23 in the disc 21 is determined to match the cross-sectional profile of the first region 30 and the second region 31 of the plunger rod 12. Similarly, as described above, the shape of the opening 25 in the guide element 24 is determined to be a superposition of offset cross-sectional profiles of the first region 30 and the second region 31 of the plunger rod 12. Therefore, it should be understood that the guide element 24 and the disc 21 are substantially as combined... Figures 5 to 8 It functions as described. That is, when the device 10 is in the first configuration, the disc 21 allows the plunger rod 12 to move within a first range of motion to dispense a first dose of medication and prevents the plunger rod 12 from moving within a subsequent range of motion; the disc 21 can rotate about a third region 29 of the plunger rod 12 to place the device 10 in a second configuration, in which the plunger rod 12 moves freely within a subsequent range of motion to dispense further medication. As described above, the guide element 24 always prevents the plunger rod 12 from rotating.

[0134] It should be understood that Figure 13 The constant-diameter cross-section of the plunger rod 12 provides better stress distribution than other plunger rod designs, and therefore offers better lifespan. This is because stress tends to concentrate in areas where the cross-section changes, which may reduce the number of operating cycles that can be achieved before fatigue failure. It should also be understood that by "constant-diameter cross-section," the plunger rod 12 is not necessarily limited to a circular cross-section, but can be any constant cross-sectional shape that can move unimpeded through the openings 23, 25 of the guide element 24 and the disk 21. Clearly, the constant cross-sectional area does not include the keys 37, 37', which provide the necessary interference fit with the disk 21. Equally important, the constant cross-sectional shape does not impede the rotation of the disk when the third region 29 is positioned within the disk 21.

[0135] Figure 9 Another alternative plunger rod 12 is shown, in which the same features retain the same reference numerals. Figure 9 The plunger rod differs from the plunger rod 12 described above only in that the cross-sectional profiles of the first region 30 and the second region 31 of the plunger rod are different. That is, the first region 30 includes a first cross-sectional profile that differs from the cross-sectional profile of the second region 31. Figure 12 In the first region 30, the cross-sectional profile is square, while the cross-sectional profile of the second region 31 includes a portion 34 that extends beyond the first cross-sectional profile when projected along the axis YY. Figures 10 to 12 The text shows the relationship with... Figure 9A disc 21 and a guide element 24 are used together with the plunger rod 12. The shape of the opening 23 in the disc 21 is determined to match the cross-sectional profile of the second region 31 of the plunger rod, and therefore includes a region 35 corresponding to the portion 34 of the second cross-sectional profile. As previously described, the opening 23 is slightly larger in each dimension to allow the plunger rod 12 to slide freely through the opening 23. The guide element 24 is also optional, but when included, the shape of the opening 25 of the guide element is determined to match the cross-sectional profile of the second region 31 of the plunger rod 12.

[0136] For the second region 31 of the plunger rod 12 to pass through the opening 23 in the disk 21, a portion 34 of the second region 31 must be aligned with a region 35 of the opening 23 in the disk 21. In the initial position, the region 35 of the opening 23 in the disk 21 is not aligned with a portion 34 of the second region 31 of the plunger rod 12. Therefore, as previously stated, before the second region 31 of the plunger rod can pass through the opening 23 in the disk 21, the plunger rod 12 or the disk 21 needs to be rotated about the longitudinal axis YY of the plunger rod 12. With the disk 21 fixed, the plunger rod 12 can be rotated. With the guide element 24 provided, the disk 21 can be rotated so that the corresponding openings 23, 25 in the disk 21 are aligned with the guide element 24, such as... Figure 10 As shown. Therefore, in other aspects, including such as Figure 9 The device 10 of the plunger rod 12 shown is used in conjunction with, as Figure 5 The device 10, including the plunger rod 12, operates in exactly the same manner, and its detailed description will not be repeated.

[0137] Device 10 may further include counter 36, such as Figure 8 As illustrated in the example, the counter 36 includes a window 36 in the distal side of the finger gripper 13, through which a portion of the distal side of the disc 21 is visible. This visible portion of the distal side of the disc 21 may be provided with numbers visible through the window 36. For example, with the disc 21 in a first position, the number '2' is visible through the window; rotating the disc 21 from the first position to a second position causes the number '1' to be displayed instead. Thus, in the first position, the counter 36 can indicate the remaining dose quantity in the medication chamber 15.

[0138] The device 10 may further include a clicker mechanism (not shown) to force the disk 21 into a first position or a second position. The clicker provides tactile feedback to allow the user to determine when the disk 21 is in the first or second position. The clicker can be configured in any suitable manner. For example, the distal side of the disk 21 and the proximal side of the guide element 24 may each include a series of protrusions and notches. Thus, when the disk 21 is in either the first or second position, the protrusions may be located in the notches.

[0139] The drug delivery device described above can be formed by providing a finger flange attachment 42 and a syringe 11 having an integral finger flange 41, and attaching the finger flange attachment 42 to the finger flange 41 of the syringe 11. The finger flange attachment 42 is shown in FIG. 17a. The finger flange attachment 42 includes a guide element 24 and an optional disk 21. The disk 21 can take the form of any of the above embodiments. In order to form the drug delivery device, it is further necessary to provide a plunger rod 12 configured to operate according to the above description. That is, the plunger rod 12 has a first region 30 and a second region 31 that cooperate with the guide element 24 and (optionally) the disk 21, such that when the device 10 is in a first configuration, the plunger rod 12 is allowed to move in a first range of motion to dispense a first dose of drug, but is blocked from moving in a subsequent range of motion, whereby the disk 21 or the plunger rod 12 can be rotated to place the device 10 in a second configuration in which the plunger rod 12 moves freely in a subsequent range of motion to dispense further drug.

[0140] The finger flange attachment 42 includes means for allowing the finger flange attachment 42 to be clamped to or otherwise attached to the finger flange 41 of the syringe 11. In FIG. 17a, the finger flange attachment 42 includes a body 43 in which a guide element 24 is formed. The body 43 further includes a C-shaped end 44 configured to fit onto the free end of the finger flange 41. The C-shaped end 44 can be configured to fit tightly against the free end of the finger flange 41 to securely position the finger flange attachment 42 to the syringe 11.

[0141] The assembly method of the drug delivery device is explained with reference to Figures 17a to 17c. The method includes: providing a finger flange attachment 42 as shown in Figure 17a; providing a syringe 11 and a plunger rod 12 (illustrated in the figure of Figure 17b); attaching the finger flange attachment 42 to the finger flange 41 of the syringe 11; and inserting the plunger rod 12 into the drug container 11 of the syringe 11.

[0142] It should be understood that this disclosure can be configured to deliver more than two doses of the drug. For example, Figure 5 The direct fit of the plunger shown will allow for the controlled delivery of three or more doses via additional regions including the plunger rod 12. Each region will include the same square cross-sectional profile, but offset by 45 degrees from the last region. The additional regions will be constructed by means of components corresponding in form and function to... Figure 5 The middle region of the third region 29 shown is separated. Therefore, when the middle region is located in the opening 23 of the disk 21, the disk 21 or the plunger rod 12 can be rotated 45 degrees to align with the contour of the subsequent adjacent region, allowing the subsequent adjacent region to pass through the disk 21.

[0143] It should be understood that this disclosure is adaptable to drug delivery methods other than nasal administration. For example, the embodiments described herein can take the form of a needle-based injection device, by replacing the stopper 17 with a hypodermic needle. The hypodermic needle may include a Luer lock for attaching to the syringe outlet 16 in a conventional manner. By replacing the stopper 17 with a hypodermic needle, the embodiments described herein can be adapted for subcutaneous, intramuscular, or intravenous injection, depending on the drug to be delivered and the needle specification used.

[0144] List of reference numerals in the attached diagram:

[0145] 10 Drug Delivery Devices

[0146] 11. Pharmaceutical containers

[0147] 12-piston rod

[0148] 13-finger gripper

[0149] 14. The outer wall of the container

[0150] 15 pharmaceutical chambers

[0151] 16 Exports

[0152] 17 plugs

[0153] 18-piston

[0154] 19 drugs

[0155] 20 end surface

[0156] 21 discs

[0157] 22 discs

[0158] 23 Through the opening of the plate

[0159] 24 guiding elements

[0160] 25 through the opening of the guide element

[0161] 26 discs near the side

[0162] The far side of the second area of ​​the 27-piston rod

[0163] 28-end surface distal side

[0164] The third region of the 29-piston rod

[0165] 30-piston rod, first area

[0166] Second region of 31 plunger rod

[0167] 34 Part of the second section profile

[0168] The opening in plate 35 corresponds to the area of ​​section 34.

[0169] Counter / window on the distal side of the 36-finger gripper

[0170] 37 Key in the first region

[0171] 37' Second Region Key

[0172] 38 key slots

[0173] 40. A drug delivery device, comprising a finger flange attachment separate from the syringe.

[0174] 41 finger flange

[0175] 42-finger flange attachment

[0176] 43-finger flange body

[0177] 44-finger flange body C-shaped end

[0178] Disclosure was made in accordance with the following terms:

[0179] 1. A delivery system (10), comprising:

[0180] The syringe (11) includes a chamber (15) for containing a drug and an outlet (16) through which the drug (19) can be discharged from the chamber;

[0181] A plunger rod (12), movable relative to the syringe and configured to cause the drug to be expelled from the syringe when the drug is inside the syringe and the plunger rod is moved; and

[0182] The disc (21), when the device is in the first configuration, allows the plunger rod to move relative to the syringe in a first range of motion to dispense a first dose of the drug, and prevents the plunger rod from moving relative to the syringe in a subsequent range of motion to dispense further drugs;

[0183] The disc (21) or the plunger rod (12) is rotatable to place the device in a second configuration in which the plunger rod moves freely relative to the syringe within the subsequent range of motion to dispense further medication.

[0184] 2. The system according to Clause 1, wherein the disc (21) has an opening (23) through which the plunger rod (12) is displaced to dispense a drug, wherein the plunger rod (12) has a first region (30) formed to allow the first region (30) to pass through the opening (23) in the disc (21) to dispense the first dose of drug when the plunger rod (12) or the disc (21) is in a first rotational orientation about the longitudinal axis (XX) of the device (10), and wherein the plunger rod (12) has a second region (31) proximal to the first region (30), the second region (31) being formed to allow the plunger rod (12) or the disc (21) to be in the first rotational orientation. Prevent the second region (31) from passing through the opening (23); and optionally, wherein the second region (31) is formed to allow the second region (31) to pass through the opening (23) in the disc (21) to dispense a second dose of the agent when the plunger rod (12) or the disc (21) is in a second rotational orientation about the longitudinal axis (XX) of the device (10); and optionally, wherein the system is further configured to deliver more than two doses of the agent, wherein the plunger rod includes additional regions in addition to the first region and the second region, each additional region being formed to pass through the opening in the disc only when the plunger rod or the disc is in a predetermined rotational orientation about the longitudinal axis associated with the additional region.

[0185] 3. The system (10) according to Clause 1, wherein the disc (21) is configured to rotate about the longitudinal axis of the device (10) between a first position and a second position, wherein in the first position the disc (21) allows the plunger rod to move in a first range of motion and blocks the plunger rod from moving in a subsequent range of motion, and in the second position the plunger rod is free to move relative to the syringe in the subsequent range of motion to dispense further medication; and optionally, wherein the system further includes a guide element (24) having an opening (25) through which the plunger rod (12) is movable to dispense medication, the opening being configured to prevent the plunger rod from rotating about the longitudinal axis of the device; and optionally, wherein the disc (21) includes an opening (23) that overlaps with the opening (25) of the guide element (24). And wherein, when the disc is in the first position, the plunger rod (12) is allowed to move through the opening of the disc and the opening of the guide element in the first range of motion, but is blocked from moving in the subsequent range of motion; and wherein, when the disc is in the second position, the plunger rod is allowed to move through the opening of the disc and the opening of the guide element in the subsequent range of motion to discharge further agent; and optionally, wherein the plunger rod (12) includes a first region (30) at the distal end of the plunger rod and a second region (31) at the proximal end of the plunger rod, and wherein the first region and the second region have the same cross-sectional profile and include n-order rotational symmetry, where n is an integer; and wherein the cross-sectional profiles of the first region and the second region are offset by an angle α about the longitudinal axis of the plunger rod; and optionally, wherein Optionally, the plunger rod (12) includes a first region (30) at the distal end of the plunger rod and a second region (31) at the proximal end of the plunger rod, wherein the first region includes a first cross-sectional profile and the second region includes a second cross-sectional profile different from the first cross-sectional profile; and optionally, the shape of the opening (25) in the guide element (24) is determined to be a superposition of offset cross-sectional profiles of the first and second regions of the plunger rod (12); and optionally, the shape of the opening (23) in the disc (21) is determined to match the cross-sectional profiles of the first and second regions of the plunger rod. Optionally, the shape of the opening (25) in the guide element (24) is determined to be the superposition of the first cross-sectional profile and the second cross-sectional profile of the plunger rod (12); and optionally, the shape of the opening (23) in the disk (21) is determined to be the superposition of the first cross-sectional profile and the second cross-sectional profile of the plunger rod (12); and optionally, the plunger rod (12) includes a third region (29) disposed between the first region and the second region (30, 31), and the shape of the cross-sectional profile included in the third region is determined such that the disk can rotate freely when the third region is located within the opening of the disk (21).

[0186] 4. The system (10) according to Clause 1, wherein the plunger rod (12) is configured to rotate about the longitudinal axis of the device (10) between a first position and a second position, wherein in the first position the disc (21) allows the plunger rod to move in a first range of motion and blocks the plunger rod from moving in the subsequent range of motion, and in the second position the plunger rod is free to move relative to the syringe in the subsequent range of motion to dispense further medication.

[0187] 5. The system (10) according to any of the preceding clauses, wherein the plunger rod (12) includes an elongated element capable of linearly sliding over its range of motion; and optionally, wherein the plunger rod (12) includes a plunger configured to compress a drug reservoir (32); and optionally, wherein the plunger rod (12) includes a piston rod capable of linearly sliding into the syringe (11).

[0188] 6. The system (10) according to Clause 2, wherein the syringe includes a barrel and an outlet (16) at the distal end of the barrel.

[0189] 7. The system (10) according to Clause 16, wherein the syringe includes a piston (18) that is in sealed contact with the barrel wall and is slidable within the barrel by movement of the plunger rod (12) to discharge the drug (19) from the outlet (16).

[0190] 8. The system (10) according to any of the preceding clauses, wherein the plunger rod (12) is configured such that substantially half of the agent (19) in the chamber (15) is discharged when the plunger rod moves in the first range of motion, and substantially half of the agent in the chamber is discharged when the plunger rod moves in the second range of motion.

[0191] 9. The system (10) according to any of the preceding clauses further includes a stopper (17) located at the outlet (16) of the device to facilitate insertion of the stopper and the outlet into the orifice of the patient into which the medication is to be delivered.

[0192] 10. The system (10) according to Clause 9, wherein the stopper (17) is configured to atomize the liquid agent (19) when it is discharged through the outlet (16) and through the agent passage in the stopper.

[0193] 11. The system (10) according to any of the preceding clauses, wherein the agent (19) is received in the chamber (15) of the syringe (11).

[0194] 12. The system (10) according to any of the preceding clauses, wherein the syringe is provided with a drug, and optionally, wherein the drug is a vaccine suitable for nasal administration, and optionally, wherein the vaccine is an RSV vaccine.

[0195] 13. An apparatus comprising a finger flange attachment (42) for use with a syringe and a plunger rod (12), the finger flange attachment comprising a disc (21) which, when attached to the finger flange of the syringe, can be configured to allow the plunger rod to move relative to the syringe in a first range of motion to dispense a first dose of medication, and to prevent the plunger rod from moving relative to the syringe in a subsequent range of motion to dispense further medication.

[0196] 14. The device according to Clause 13, wherein the disc (21) is rotatable to a second configuration in which the plunger rod is allowed to move relative to the syringe over the subsequent range of motion to dispense further medication.

[0197] 15. A method of operating a delivery system (10), the delivery system (10) comprising:

[0198] The syringe (11) includes a chamber (15) for containing a drug and an outlet (16) through which the drug (19) can be discharged from the chamber;

[0199] A plunger rod (12), movable relative to the syringe and configured to cause the drug to be expelled from the syringe when the drug is inside the syringe and the plunger rod is moved; and

[0200] The disc (21), when the device is in the first configuration, allows the plunger rod to move relative to the syringe in a first range of motion to dispense a first dose of the drug, and prevents the plunger rod from moving relative to the syringe in a subsequent range of motion to dispense further drugs;

[0201] The disc (21) or the plunger rod (12) is rotatable to place the device in a second configuration in which the plunger rod moves freely relative to the syringe within the subsequent range of motion to dispense a further dose of the drug.

[0202] The method includes:

[0203] Insert the outlet (16) into the patient's first nostril;

[0204] The plunger rod (12) is moved relative to the syringe (11) within a first range of motion to expel the first dose of the drug;

[0205] The device is placed in the second configuration;

[0206] Insert the outlet into the patient's second nostril; and

[0207] The plunger rod is moved relative to the syringe within the subsequent range of motion to expel the further dose of medication.

Claims

1. A delivery system (10), comprising: The syringe (11) includes a chamber (15) for containing a drug and an outlet (16) through which the drug (19) can be discharged from the chamber; A plunger rod (12) is movable relative to the syringe and is configured to cause the drug to be discharged from the syringe when the drug is in the syringe and the plunger rod is moved; as well as The disc (21), when the delivery system is in the first configuration, allows the plunger rod to move relative to the syringe in a first range of motion to dispense a first dose of medication, and prevents the plunger rod from moving relative to the syringe in a subsequent range of motion to dispense further medication; The disc (21) or the plunger rod (12) is rotatable to place the delivery system in a second configuration in which the plunger rod moves freely relative to the syringe over the subsequent range of motion to dispense further medication.

2. The system according to claim 1, wherein, The plunger rod (12) includes a first region (30) and a second region (31), and optionally, the first region and the second region are integrally formed.

3. The system (10) according to claim 2, wherein, The first region (30) of the plunger rod (12) is located at the distal end of the plunger rod, and the second region (31) of the plunger rod (12) is located at the proximal end of the plunger rod, wherein the first region and the second region have the same cross-sectional profile and include n-order rotational symmetry, where n is an integer; wherein the cross-sectional profiles of the first region and the second region are offset by an angle α about the longitudinal axis of the plunger rod; and, optionally, wherein the angle α is not equal to .

4. The system (10) according to claim 2, wherein, The first region (30) of the plunger rod (12) is located at the distal end of the plunger rod, and the second region (31) of the plunger rod (12) is located at the proximal end of the plunger rod, wherein the first region includes a first cross-sectional profile, and the second region includes a second cross-sectional profile different from the first cross-sectional profile.

5. The system (10) according to any one of claims 2 to 4, wherein, The disc (21) includes an opening (23) through which the plunger rod (12) is displaced to dispense the medication.

6. The system (10) according to claim 5, wherein, The shape of the opening (23) in the disc (21) is determined to match the cross-sectional profile of the first and second regions of the plunger rod, or the shape of the opening (23) in the disc (21) is determined to be the superposition of the first and second cross-sectional profiles of the plunger rod (12).

7. The system according to claim 5 or claim 6, wherein, The first region (30) of the plunger rod (12) is formed to allow the first region (30) to pass through the opening (23) in the disc (21) to dispense the first dose of the agent when the plunger rod (12) or the disc (21) is in a first rotational orientation about the longitudinal axis (XX) of the delivery system (10), and wherein a second region (31) of the plunger rod (12) is proximal to the first region (30), and the second region (31) is formed to prevent the second region (31) from passing through the opening (23) when the plunger rod (12) or the disc (21) is in the first rotational orientation.

8. The system according to claim 7, wherein, The second region (31) is configured to allow the second region (31) to pass through the opening (23) in the disc (21) to dispense a second dose of the agent when the plunger rod (12) or the disc (21) is in a second rotational orientation about the longitudinal axis (XX) of the delivery system (10).

9. The system according to any one of claims 5 to 8, wherein, The delivery system is configured to deliver more than two doses of medication, wherein the plunger rod includes additional regions in addition to the first and second regions, each additional region being formed to pass through an opening in the disk only when the plunger rod or the disk is in a predetermined rotational orientation about a longitudinal axis associated with the additional region.

10. The system (10) according to any one of the preceding claims, wherein, The disc is configured to rotate relative to the syringe to position the delivery system in the second configuration.

11. The system (10) according to any one of the preceding claims, wherein, The disc (21) is configured to rotate about the longitudinal axis of the delivery system (10) between a first position and a second position, in which the disc (21) allows the plunger rod to move in a first range of motion and blocks the plunger rod from moving in the subsequent range of motion, and in the second position, the plunger rod is free to move relative to the syringe in the subsequent range of motion to dispense further medication.

12. The system (10) according to any one of the preceding claims includes a guide element (24) having an opening (25) through which the plunger rod (12) is movable to dispense a drug, the opening being configured to prevent the plunger rod from rotating about the longitudinal axis of the delivery system.

13. The system (10) according to claim 12 when dependent on claim 5, wherein, The opening (23) of the disc (21) overlaps with the opening (25) of the guide element (24), and wherein, when the disc is in the first position, the plunger rod (12) is allowed to move through the opening of the disc and the opening of the guide element within the first range of motion, and is blocked from moving within the subsequent range of motion; and When the disc is in the second position, the plunger rod is allowed to move through the opening of the disc and the opening of the guide element within the subsequent range of motion to discharge further medication.

14. The system (10) according to claim 12 or claim 13 when dependent on claim 2, wherein, The shape of the opening (25) in the guide element (24) is determined to be the superposition of the offset cross-sectional profiles of the first and second regions of the plunger rod (12), or wherein the shape of the opening (25) in the guide element (24) is determined to be the superposition of the first cross-sectional profile and the second cross-sectional profile of the plunger rod (12).

15. The system (10) according to any one of claims 1 to 10, wherein, The plunger rod (12) is configured to rotate about the longitudinal axis of the delivery system (10) between a first position and a second position. In the first position, the disc (21) allows the plunger rod to move in a first range of motion and blocks the plunger rod from moving in the subsequent range of motion. In the second position, the plunger rod is free to move relative to the syringe in the subsequent range of motion to dispense further medication.

16. The system (10) according to any one of the preceding claims, wherein, The plunger rod (12) includes a third region (29) disposed between the first region and the second region (30, 31), wherein the shape of the cross-sectional profile of the third region is determined such that the disk can rotate freely when the third region is located within the opening of the disk (21).

17. The system (10) according to any one of the preceding claims, wherein, The plunger rod (12) includes an elongated element capable of linearly sliding over its range of motion; and optionally, the plunger rod (12) includes a plunger configured to compress a drug reservoir (32); and optionally, the plunger rod (12) includes a piston rod capable of linearly sliding into the syringe (11).

18. The system (10) according to any one of the preceding claims, wherein, The syringe includes a barrel, and the outlet (16) is located at the distal end of the barrel. Optionally, the syringe includes a piston (18) that is in sealing contact with the barrel wall and is slidable within the barrel by movement of the plunger rod (12) to discharge a drug (19) from the outlet (16).

19. The system (10) according to any one of the preceding claims, wherein, The plunger rod (12) is configured such that when the plunger rod moves in the first range of motion, substantially half of the agent (19) in the chamber (15) is discharged, and when the plunger rod moves in the second range of motion, substantially half of the agent in the chamber is discharged.

20. The system (10) according to any one of the preceding claims further comprises a stopper (17) at the outlet (16) of the delivery system to facilitate insertion of the stopper and the outlet into the orifice of the patient into which the medication is to be delivered, and preferably, wherein, The stopper (17) is configured to atomize the liquid agent (19) as it exits through the outlet (16) and through the agent passage in the stopper.

21. The system (10) according to any one of the preceding claims, wherein, The drug (19) is contained in the chamber (15) of the syringe (11).

22. The system (10) according to any one of the preceding claims, wherein, The syringe is provided with a drug, and optionally, the drug is a vaccine suitable for nasal administration, and optionally, the vaccine is an RSV vaccine.

23. An apparatus comprising: Finger flange attachment (42), and A plunger rod (12) for use with a syringe. The finger flange attachment includes a disc (21) which, when attached to the finger flange of the syringe, can be configured to allow the plunger rod to move relative to the syringe in a first range of motion to dispense a first dose of medication, and to prevent the plunger rod from moving relative to the syringe in a subsequent range of motion to dispense further medication.

24. The device according to claim 23, wherein, The disc (21) can be rotated to a second configuration in which the plunger rod is allowed to move relative to the syringe over the subsequent range of motion to dispense further medication.

25. A method of operating a delivery system (10), the delivery system (10) comprising: The syringe (11) includes a chamber (15) for containing a drug and an outlet (16) through which the drug (19) can be discharged from the chamber; A plunger rod (12) is movable relative to the syringe and is configured to cause the drug to be discharged from the syringe when the drug is in the syringe and the plunger rod is moved; as well as The disc (21), when the delivery system is in the first configuration, allows the plunger rod to move relative to the syringe in a first range of motion to dispense a first dose of medication, and prevents the plunger rod from moving relative to the syringe in a subsequent range of motion to dispense further medication; The disc (21) or the plunger rod (12) is rotatable to place the delivery system in a second configuration in which the plunger rod moves freely relative to the syringe over the subsequent range of motion to deliver a further dose of the drug. The method includes: Insert the outlet (16) into the patient's first nostril; The plunger rod (12) is moved relative to the syringe (11) within a first range of motion to expel the first dose of the drug; The delivery system is placed in this second configuration; Insert the outlet into the patient's second nostril; and The plunger rod is moved relative to the syringe within the subsequent range of motion to expel the further dose of medication.

26. A method of operating a delivery system, the method comprising: Insert the outlet (16) of the syringe (11) into the patient's first nostril; The plunger rod (12) is moved relative to the syringe within a first range of motion to expel a first dose of the drug; Rotate the disc (21) relative to the plunger rod to place the delivery system in the second configuration; Insert the outlet into the patient's second nostril; as well as This causes the plunger rod to move relative to the syringe within a subsequent range of motion to expel a further dose of the drug.

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