Patent Description:
Current nasal medication or drug delivery devices may exhibit limitations and disadvantages related to controlling dose, such as containing only pre-inserted medication or requiring the use of a syringe for extracting a portion of the medication from the container or vial for providing a set metered dose, requiring the use of specific medication containers, or requiring exchange of the medication container. Although these devices may supply the user with a metered drug dose, these can pose a needle-stick risk and are generally medication-specific and dose-specific. Such delivery systems generally do not provide for adjustment or selection of the metered dose nor a solution for universal adaptation for different doses, medications, or medication containers. Such delivery systems also generally only provide a single nozzle/tip for all users instead of multiple optimally-designed nozzles for different users, doses, or medications, and some do not offer delivery of the desired nasal medication or drug in multiple user orientations.

<CIT> discloses a drug delivery device and corresponding method for delivering at least two medicaments.

<CIT> discloses a variable proportion dispenser.

<CIT> discloses a monodose nasal sprayer device.

<CIT> discloses a device for the delivery of predetermined doses of liquid medicament to a patient.

<CIT> discloses a medical device for dispensing a medical or pharmaceutical product. <CIT> discloses an apparatus for dispensing a controlled dose of a liquid fluid, such as a liquid pharmaceutical.

<CIT> discloses a dosing apparatus for dispensing of pharmaceutical composition.

The field of the disclosure generally relates to nasal medication or drug delivery devices, systems, and methods and, more particularly, to nasal medication or drug delivery devices, systems, and methods adapted to provide different metered volumes or doses.

Current nasal medication or drug delivery devices deliver medication or drugs to the nasal passages through the expulsion and atomization of liquids. Nasal spray bottles currently available are able to deliver multiple doses of one pre-set fixed volume. The MAD Atomizer by Teleflex, Inc. , for example, allows the user to set a metered dose by withdrawing or extracting the medication from a vial using a syringe. Similar devices like the NARCAN nasal spray offered by Teva Pharmaceutical Industries Ltd. only deliver one single dose per device. Moreover, most of these devices include a single nozzle for positioning in or in close proximity to the nasal passageway. Accordingly, improvements are sought in providing adjustability or selectability of metered doses of various medications.

In accordance with embodiments of the disclosure, improved nasal medication or drug delivery devices, systems, and methods advantageously provide for the user/patient to adjust, select, or otherwise set a metered dose or volume for delivery. In accordance with other embodiments of the disclosure, improved nasal medication or drug delivery devices and methods advantageously provide for broad adaptation to accommodation of different medication or drug containers, bottles, vessels, or vials (these and other medication containers are referred to herein as "vials"). In accordance with further embodiments of the disclosure, improved nasal medication or drug delivery devices and methods advantageously include the ability to use multiple interchangeable nozzle tips optimally designed for different users. In accordance with yet other embodiments of the disclosure, improved nasal medication or drug delivery devices and methods may allow use in multiple user or patient orientations. In accordance with yet other embodiments of the disclosure, improved nasal medication or drug delivery devices and methods may allow the administrator to avoid a high risk of needle-stick.

In some embodiments, the nasal delivery device includes a positive displacement mechanism for moving liquid from at least a first external reservoir to at least one of the first and second chambers. In some embodiments, the nasal delivery device includes a moveable mechanism coupled to at least one of the first chamber and the second chamber for adjustment of the metered dose volume. In some embodiments, the nasal delivery device includes a universal adapter for the attachment of different vials. In some embodiments, the nasal delivery device is configured to allow for particle separation of a liquid substance in specific target particle size.

In some embodiments, the nasal delivery device includes at least one anti-backflow membrane preventing backflow of liquids into the at least first chamber or from an external source into the at least first chamber or the second chamber. In some embodiments, at least the first chamber is fluidly connected to the second chamber allowing for free rotation and positioning of the at least first chamber with respect to the second chamber while maintaining a liquid seal therebetween.

In some embodiments, the nasal delivery device includes a puncture and seal mechanism for the attachment and extraction of liquid from one external reservoir to the at least first chamber within the device. In some embodiments, the nasal delivery device includes at least one disposable protective cap for preventing the contamination of medication or a drug contained within the device. In some embodiments, the nasal delivery device is configured to separately receive multiple different nozzle attachments. In some embodiments, the nasal delivery device is configured for at least one of single-use disposable and multiple uses.

Another aspect of the invention features, in some embodiments, a nasal delivery device including at least one chamber fluidly connected to a second chamber with a rotatable mechanism disposed between the first and second chambers configured for adjusting a fluid displacement volume jointly defined by the first and second chambers.

In some embodiments, the nasal delivery device includes a spring plunger. In some embodiments, the nasal delivery device includes volumetric indicators along at least one of the first and second chambers. In some embodiments, a rotatable mechanism is configured for selection among pre-set locking positions for specific volume increments defined by the first and second chambers.

In some embodiments, the nasal delivery device includes a spring plunger mechanism including an anti-rotation locking mechanism.

Another aspect of the invention features, in some embodiments, a nasal dose delivery device including first and second telescoping dose container chamber portions configured to rotatably telescope to establish a selected dose volume and being further configured to slidingly telescope to deliver the selected dose volume.

In some embodiments, the nasal delivery device includes a threaded slider ring interposed between the first and second telescoping dose container chamber portions and configured such that relative rotation between the first and second telescoping dose container chamber portions adjusts a dose volume jointly defined by the first and second telescoping dose container chamber portions and wherein the threaded slider ring is further configured to be lockable in a first position during relative rotation between the first and second telescoping dose container chamber portions and unlockable to allow telescopic sliding between the first and second telescoping dose container chamber portions to deliver the selected dose volume.

In some embodiments, the nasal delivery device includes a vial piercer in fluid communication with the first and second telescoping dose container chamber portions to fill the selected dose volume with medicine from a vial. In some embodiments, the nasal delivery device is configured for attachment of multiple vials for titration of multiple substances prior to delivery.

Another aspect of the invention features, in some embodiments, an improved nasal medication or drug delivery device including: (<NUM>) at least one fluid or liquid chamber/reservoir fluidly connected or coupled to another chamber/reservoir, allowing for the free rotation and positioning of one chamber/reservoir with respect to the delivery device and to the other chamber/reservoir while maintaining a liquid seal between the chambers/reservoirs; (<NUM>) a puncture and seal mechanism for attachment and extraction of liquid from an external reservoir to a chamber/reservoir of the delivery device. In some embodiments, multiple nozzle pieces or nosepieces may be exchanged and attached to the delivery device. In some embodiments, the delivery device is a single use or multiple use design.

In some embodiments, the at least one chamber/reservoir is fluidly connected or coupled to another chamber/reservoir with a rotating mechanism for adjusting volume and/or fluid displacement in one or both chambers/reservoirs. In some embodiments, the at least one chamber/reservoir is fluidly connected or coupled to another chamber/reservoir containing a spring plunger. In some embodiments, the at least one chamber/reservoir is fluidly connected or coupled to another chamber/reservoir with volumetric indicators for the chamber/reservoir volume. In some embodiments, the at least one chamber/reservoir is fluidly connected or coupled to another chamber/reservoir having pre-set locking positions for specific volume increments. In some embodiments, the at least one chamber/reservoir is fluidly connected or coupled to another chamber/reservoir containing a spring plunger mechanism having an anti-rotation mechanism.

With reference to <FIG>, in accordance with an embodiment of the invention, a nasal medication or drug delivery device <NUM> includes an inner hollow chamber <NUM>, an outer hollow chamber <NUM> having threads <NUM>, a compression spring <NUM>, a vial or container adapter <NUM>, a first one-way valve or check valve <NUM>, such as a duckbill valve, a second one-way valve or check valve <NUM>, such as a duckbill valve, and a sealing member <NUM>, such as an O-ring seal. A nose cone or nosepiece <NUM> is formed integral with or attached to outer chamber <NUM>. A slidable fixing member <NUM>, such as a threaded nut, and flexible locking tabs <NUM> (see <FIG> and <FIG>), , e.g., cantilevered snap-fit tabs, serve to fix the position of chambers <NUM> and <NUM>. Various components discussed herein may be constructed of biocompatible materials, such as medical grade polyvinyl chloride (PVC), high density polyethylene (HDPE), polyethylene, polyetheretherketone (PEEK), or the like. The "chamber" as used herein, means complimentary portions of a container, such as two cylinders telescopingly engaged to form variable volume container. The term chamber can include any geometry of complementary container portions suitable to establish a variable container volume for use in delivery of metered dose volumes.

In some embodiments, nose cone <NUM> may include a disposable nose cone cover or cap useful for preventing the contamination of the medication or drugs contained within delivery device <NUM> and/or may include a foam nose cone bumper (not shown) that fits over an end of nose cone <NUM> to be inserted into the nasal passageway that may be anthropomorphically adapted for specific recipient populations of certain ages or weights with unique nasal passage shapes or sizes. A foam nose cone bumper may be made of a soft material for purposes of sealing and may be sized to preventing deep insertion into the nasal passageway for safety. Nose cone <NUM> itself may be configure with an integral nose cone bumper for the same purposes. Moreover, in some embodiments, nose cone <NUM> and/or outer chamber <NUM> may be varied for use with multiple interchangeable nozzle tips optimally designed for different users or patients of different ages and weights or with unique nasal passage shapes. In yet other embodiments, nose cone <NUM> may be detachable and re-attachable from the rest of outer chamber <NUM> and may have different shapes and/or sizes or different outer chambers <NUM> may have nose cones <NUM> having different shapes and sizes for different users or patients.

The various components of delivery device <NUM>, e.g., locking tabs <NUM>, fixing member <NUM>, outer chamber <NUM>, etc., may be formed from any suitable material using any suitable process and assembled into a functional device or system. Delivery device <NUM> then may be employed by a user or patient to advantageously delivery medication or drugs inside the user or patient's the nasal cavity.

Valves <NUM> and <NUM>, which may be one-way check valves, such as duckbill valves, as shown in more detail in <FIG>, are fluidly coupled together and to adapter <NUM> to work to provide dual-positive-displacement valve operation. In some embodiments, valves <NUM> and <NUM> work together to allow airflow for priming only in one direction (e.g., from a fluid volume reservoir or chamber and then out nose cone <NUM>) and fluid flow also only in one direction (e.g., from a medical or drug vial or reservoir toward the fluid volume reservoir or chamber and then out nose cone <NUM>) through the combination of the valves with no or little, if any, backflow of air or fluid. A fluid volume chamber <NUM> and a plunger <NUM> (see <FIG>), for example, a spring driven plunger or spring plunger, disposed within delivery device <NUM>, along with one-way check valves <NUM> and <NUM>, form a positive displacement pump for moving liquid from at least one supply reservoir (the vial) to another reservoir (chamber <NUM>), as described below. In certain other embodiments, any or all of valves <NUM> and <NUM>, as well as a valve <NUM> (described below), may be valve and membrane combinations that provide a similar anti-backflow function as do duckbill valves.

Vial connector adapter <NUM> ("connector adapter") may be a universal connector adapter for a variety of commonly used containers, reservoirs or vials. Connector adapter <NUM> incorporates a cylindrical container or vial connector <NUM> that includes, for example, an annular press-fit or snap-fit connector 117a and a sealing member 117b, such as an O-ring, as shown in <FIG>, which forms a dynamic radial seal to the inner chamber <NUM> to prevent or at least reduce the likelihood of fluid leakage once a typical medication or drug container or vial is connected (see <FIG>). Connector <NUM> allows for rotation at its annular portion <NUM> (see <FIG>) in the rotational directions schematically indicated by the hashed perspective circular arrow <NUM> in <FIG>. This rotation is about an imaginary longitudinal axis (not shown) in the center of and perpendicular to the plane of sealing member 117b while the sealing function is maintained. This allows the attached vial and inner chamber <NUM> to be rotated relative to each other such that the vial may be maintained in a generally vertically aligned and upside-down position, as in <FIG>, no matter whether the user or patient is standing, sitting, or lying prone, for example.

In certain embodiments, the press-fit or snap-fit connector <NUM> may include components or structures, such as a ratcheting mechanism, that allow the rotational position or angle of the annular portion of connector <NUM> relative to inner chamber <NUM> to be locked or secured in discrete rotational positions, for example, by using rotational orientation markers on connector <NUM> and/or on the lower components of inner chamber <NUM> that mate with connector <NUM>. Such a mechanism may be used to align the vial generally vertically as shown in <FIG> to prevent rotation of the attached vial when the user or patient is using delivery device <NUM> to pump the medication or drugs into the nasal passageways. The ratcheting mechanism may be released and relocked for setting another rotational position to adjust the vial to be generally aligned vertically and upside down when needed, for example, if the user or patient changes their position. This mechanism serves to prevent air from being forced into the fluid volume chamber <NUM> (described below) of the delivery device <NUM> from the vial when filling the chamber <NUM> or to prevent air from being pumped into the nasal passageway.

In certain other embodiments, the press- or snap-fit connector <NUM>, which receives and mates to the lower components of inner chamber <NUM> during assembly by pushing these lower components into connector <NUM> (see <FIG>), is not used. Instead, a cantilevered press-fit or snap-fit connector may be used (not shown). In these embodiments, components of this cantilevered press-fit or snap-fit connector are part of and assembled with a different vial connector that connects to a different inner chamber by pushing the cantilevered connector into a lower receiving and mating portion of this inner chamber.

Connector adapter <NUM> may include vial receiving protrusions having flexible tapered clips <NUM>, as shown in <FIG>, <FIG>. Clips <NUM> are flexible enough to allow for their expansion over a top rim of the vial to help securely fix and hold the vial in place in connector adapter <NUM>, such as in <FIG>. Tapered outer clips <NUM> are useful for reproducibly latching and controlling the depth of the vial in connector adapter <NUM>.

<FIG> shows a vial puncture mechanism of connector adapter <NUM> that may be used when a vial is attached in adapter <NUM>. The puncture mechanism includes, for example, a hollow puncturing needle <NUM> that punctures the vial's seal. The Needle <NUM> is preferable designed with height shorter than the vial adapter to reduce needle stick and safety concerns.

Needle <NUM> includes an air supplying channel <NUM> and a medication or drug supplying channel <NUM>. Air supplying channel <NUM> provides external air through the one-way check valve <NUM>, such as a duckbill valve, into the seated and punctured vial to prevent, or at least reduce the likelihood of, fluid backflowing from the vial into air supplying channel <NUM>. Medication or drug supplying channel <NUM> provides the medication or drug when drawn (and thus reducing/adjusting the volume of fluid in the vial) into the volume chamber <NUM> of delivery device <NUM> via negative pressure, such as when delivery device <NUM> is being primed for use. Air supplying channel <NUM> may be used to equilibrate the pressure in the vial as medication or drug fluid is being drawn into delivery device <NUM>.

<FIG> show how outer chamber <NUM>, fixing member <NUM>, and inner chamber <NUM> of delivery device <NUM> are connected, coupled, or joined with tight tolerance. For example, threads <NUM> of outer chamber <NUM> may join to corresponding mating threads <NUM> of fixing member <NUM>, which is positioned over and makes sliding contact with inner chamber <NUM>, as shown in <FIG>, <FIG>. Threads <NUM> allow outer chamber <NUM> to be rotated clockwise or counterclockwise (from a view looking down on nose cone <NUM>, as would be understood by one of ordinary skill in the art) with respect to threads <NUM> of fixing member <NUM> to which they are mated. Outer chamber <NUM> may be adjusted vertically in this manner with respect to inner chamber <NUM>, such that rotation of outer chamber <NUM> may be used to change the volume of chamber <NUM> to set a specific volume of medication or drug fluid <NUM> to be atomized during use, which will be described further below. Fixing member <NUM> also includes cut out sections, portions, or grooves <NUM> on its interior circular opening that fits over rails, slides, or guides <NUM> of interior chamber <NUM>, which allow sliding vertical motion of fixing member <NUM> up and down along guides <NUM> with respect to inner chamber <NUM> and serves to prevent or limit rotational motion of fixing member <NUM> with respect to inner chamber <NUM> as volume is set or during administration of medication or drugs. Over a range of volume settings, spring <NUM> is biased to keep the top of fixing member <NUM> positioned against locking tabs <NUM> before the user or patient presses the flange or tab <NUM> (shown in <FIG> and <FIG>) for administration. Spring <NUM> is compressed from its most relaxed or resting position when smaller volumes than the maximum volume are being set (see <FIG>), as will be described below. During administration, the fixing member moves down inner chamber <NUM> away from locking tabs <NUM>. The maximum vertical position of outer chamber <NUM> with respect to inner chamber <NUM> is determined by unscrewing outer chamber <NUM> from fixing member <NUM> until fixing member <NUM> is captured between a bottom part of the threads or bottom end <NUM> (See <FIG>) of outer chamber <NUM> and tabs <NUM> without the user or patient pressing flange or tab <NUM> and spring <NUM> is in its most resting and relaxed state. The minimum vertical position of outer chamber <NUM> with respect to inner chamber <NUM> is determined by screwing outer chamber <NUM> onto fixing member <NUM> until the underside of flange or tab <NUM> of outer chamber <NUM> makes contact with tabs <NUM> and top rim surface <NUM> of inner chamber <NUM> shown in <FIG>.

<FIG> illustrates the structure of plunger <NUM> of outer chamber <NUM>. Plunger <NUM> (driven by spring <NUM>, thus forming a spring plunger) includes one-way check valve <NUM>, a hollow rod <NUM>, and the atomizing tip <NUM>, which are located or disposed within a hollow portion or channel <NUM> of outer chamber <NUM> in assembling delivery device <NUM>. Valve <NUM> and atomizing tip <NUM> are press-fitted into hollow portion or channel <NUM> with hollow rod <NUM> disposed in between. These components are in mechanical and fluid cooperative communication with each other in order to function as part of pump and fluid atomizing mechanisms to spray the medication or drug into the nasal passageway from fluid chamber <NUM>.

<FIG> with <FIG> illustrate how plunger <NUM> and pumping action operate. Valves <NUM> and <NUM> work together to fill and prime delivery device <NUM> as follows. To evacuate air from fluid chamber <NUM> without or reducing the likelihood of drawing fluid into chamber <NUM> from the fluid container or vial, the user or patient presses on flange or tab <NUM>. This action pushes plunger <NUM> down into chamber <NUM> with valve <NUM> open and valve <NUM> closed, which applies positive pressure to the air in chamber <NUM> and forces the air out through plunger <NUM> to be expelled from tip <NUM>. Fluid is prevented from entering chamber <NUM> from the vial or at least very minimized because valve <NUM> is closed in this instance. Then user or patient then stops pressing flange or tab <NUM> and spring <NUM> forces outer chamber <NUM> and plunger <NUM> up and away from chamber <NUM>. While this upward motion occurs, valve <NUM> is closed and valve <NUM> is open. This results in a negative pressure being applied to the fluid in the vial to fill chamber <NUM>. These actions may have to be repeated to fully prime delivery device <NUM> to the set amount or metered volume of fluid in chamber <NUM> for subsequent administration by the user or patient. To deliver the atomized fluid to the user or patient, they may simply press flange or tab <NUM> of primed delivery device <NUM> or metered pump the metered volume of fluid from chamber <NUM> up through plunger <NUM> and out atomizing tip <NUM> with valve <NUM> open and valve <NUM> closed, as above.

Referring to <FIG>, <FIG>, outer chamber <NUM> is designed to fit and move along with fixing member <NUM> over inner chamber <NUM> when flange or tab <NUM> is pressed, which causes plunger <NUM> to apply pressure to the fluid in chamber <NUM> to dispense atomized fluid from tip <NUM>. Outer chamber <NUM> is in contact with spring <NUM> attached to inner chamber <NUM>. That contact is made with one end of spring <NUM> held in place by a keeper groove, cylindrical, or circular channel <NUM> located within the interior of nose cone <NUM> of outer chamber <NUM>. The other or opposite end of spring <NUM> bears against a cylindrical collar <NUM> disposed or positioned between an inner portion <NUM> of outer chamber <NUM> and an inner portion <NUM> of inner chamber <NUM>, as shown in <FIG>, in assembled delivery device <NUM>. Sealing member <NUM> serves to prevent or reduce the likelihood of leakage of fluid from chamber <NUM> and is positioned and held in place to do so between cylindrical collar <NUM> and inner chamber <NUM>, as shown in <FIG>, <FIG>. The left side of <FIG> shows delivery device <NUM> with spring <NUM> in a rest or its most relaxed state, that is, uncompressed or in its least compressed state, and fluid <NUM> in chamber <NUM>. <FIG> shows delivery device <NUM> when a user or patient has pressed flange or tab <NUM> of nose cone <NUM> with their fingers, for example, as shown in <FIG> with a finger at location <NUM> and thumb at location <NUM>, to activate the pumping mechanism to administer a dose of fluid <NUM>, as described above.

The action of pressing tab <NUM> compresses spring <NUM>, which causes outer chamber <NUM> to slide over inner chamber <NUM> and plunger <NUM> to force fluid <NUM> to move through nose cone <NUM> for atomization. This action empties or reduces the volume of fluid <NUM> in chamber <NUM>, as shown by comparing <FIG> with <FIG>. The arrows in <FIG> show the relative direction of motion of spring <NUM>, outer chamber <NUM>, and plunger <NUM> with respect to inner chamber <NUM> before and during the compression action.

When priming device <NUM> or pumping medication or drugs, the extent of travel of outer chamber <NUM> down along inner chamber <NUM> is checked or stopped, as shown in <FIG>, by the upper circular portion or rim <NUM> of inner chamber <NUM> making contact with the underside of the flange or tab <NUM>. Certain embodiments of the invention may include an anti- rotation mechanism or structures and/or components (not shown) that prevent rotation of the outer chamber <NUM> relative to fixing member <NUM>, which may cause administration or other problems during activation of plunger <NUM> by the user or patient to prime or pump medication or drugs to the nasal passageway. In certain other embodiments, an anti-rotation mechanism or structures and/or components (not shown) may be included to prevent rotation of the spring plunger for the same reason.

<FIG> also show atomizing nose cone <NUM> for insertion into the nasal cavity of the user or patient. The structure of nose cone <NUM>, including its length, shape, and diameter, are important to its function to fit in the user or patient's nasal cavity and to atomize the flow of the fluid <NUM> into the user or patient's nasal passage. Nose cone <NUM> may include inner channels (not shown) in tip <NUM> for forced flow of medication or drug fluid in a spiral pattern to increase the fluid particle or drop velocity for promoting atomization. These inner channels and other associated internal structures have a specific structure(s) for this purpose, including length(s), diameter(s), and geometric shape(s) to generate the needed or target fluid particle or drop velocity, separation, size, spiraling or swirling motion, cone angle and/or pattern of the atomized spray of the fluid exiting delivery device <NUM> during administration.

Referring to <FIG>, <FIG>, and <FIG>, outer chamber <NUM>, with its nose cone <NUM>, may be mechanically and rotatably moved vertically up or down relative to fixing member <NUM> and inner chamber <NUM> via internal threads <NUM> of fixing member <NUM> that correspond to and mate with threads <NUM> of fixing member <NUM>. Rotating outer chamber <NUM> rotates or screws threads <NUM> on threads <NUM> of non-rotating fixing member <NUM>. This rotation may be used to set the amount or volume of the medication or drug that will be drawn into the medication or drug volume reservoir from the vial, which, along with plunger <NUM>, forms chamber <NUM>. The user or patient may set a volume in chamber <NUM> by rotating outer chamber <NUM> to line up a bottom <NUM> of outer chamber <NUM> (see <FIG> and <FIG>) with measured, calibrated, or metered numerical chamber dosage or volume indicators, such as a dosage or volumetric scale or grid <NUM> formed as part of, inscribed on, or otherwise attached to inner chamber <NUM>. It should be noted that in certain embodiments, a pre-set locking mechanism may be provided for positions of outer chamber <NUM> relative to indicator <NUM> when setting specific volumes or volume increments to prevent rotation of the outer chamber <NUM>, for example, during administration. The left side of <FIG> shows the volume of chamber <NUM> set to the maximum value by rotating outer chamber <NUM> to unscrew threads <NUM> from threads <NUM> of fixing member <NUM> until fixing member <NUM> is sandwiched between the bottom threaded end <NUM> of outer chamber <NUM> and tabs <NUM>. Spring <NUM> also will be in its corresponding resting or most relaxed state The right side of <FIG> shows the volume of chamber <NUM> when set to a smaller value after rotating outer chamber <NUM> in the opposite direction to screw threads <NUM> onto/along threads <NUM> of fixing member <NUM> and lining up the bottom <NUM> of outer chamber <NUM> with the chosen volume set point on indicator <NUM>. An exemplary smaller increment for the volume or dosage scale of indicator <NUM> may be <NUM> with a maximum volume or dosage of <NUM> also indicated. For volume or dosage that is set less than the maximum, fixing member <NUM> need not touch tabs <NUM> and may be positioned along threads <NUM> of outer chamber <NUM>, as shown on the right side of <FIG>. Spring <NUM> also correspondingly will be in between its resting or most relaxed state and its most compressed state. When flange or tab <NUM> is pressed for the pumping action, spring <NUM> will reach its most compressed state when flange or tab <NUM> contacts rim <NUM>.

As described above, during priming or administration, flange or tab <NUM> is pressed to pump air with or without the fluid through plunger <NUM> to be expelled from delivery device <NUM>. The volume of fluid in chamber <NUM> along with activation of the plunger from the user or patient's finger press on flange or tab <NUM> may determine the actual dose or volume of the medication or drug delivered during one or more strokes or pumps of plunger <NUM>. During the pumping action, fixing member <NUM> slides down along guides <NUM>, spring <NUM> compresses further, and plunger <NUM> moves down against the volume of fluid whose volume had been set and then drawn into chamber <NUM>. When the user or patient releases flange or tab <NUM>, fixing member <NUM> moves back up guides <NUM> until it makes contact with tabs <NUM> and the spring decompresses to its resting or most relaxed vertical state or position.

The changeable volume or dose setting <NUM> produces a corresponding changeable increase or decrease in pressure while outer chamber <NUM> of delivery device <NUM> is rotated. Rotation to move outer chamber <NUM> down along inner chamber <NUM> will push air or fluid out of delivery device <NUM> with positive pressure. Rotating it up will draw the medication or drug from an attached vial into chamber <NUM>. The dose or volume <NUM> depends on the relative position of outer chamber <NUM> to fixing member <NUM> and to the volume set by outer chamber <NUM> on the measured, calibrated, or metered numerical chamber dosage or volume indicators <NUM>. The volume indicators <NUM> can be configured as a guide indicator for the user to determine the correct dose per medication or patient.

In some embodiments, a syringe plunger is configured with a conical shape for creating a fluid liquid seal with the need to use sealing O-rings. In some embodiments, the components are configured to be assembled by press-fit or snap-fit attachment for quick and easy assembly.

In some embodiments, a <NUM> degree rotating connector adapter allows for universal orientation drug delivery (vertical or horizontal patients). In some embodiments, the device includes ergonomic outer grip features and designs to aid and instruct the user for proper and secure holding of the device.

In some embodiments, the nasal drug delivery device allows for attachment of multiple vials for automatic titration of multiple substances while administering, e.g., where one vial may be a drug and the other vial may be a diluting agent where the device allows for the mixing of the drugs prior to delivery.

In some embodiments, the device includes interchangeable atomization tips for delivering different particle sizes specific for different drugs. Interchangeable tips allow for delivery of different compound forms as in foam or gel substance.

In some embodiments, a rotating connector adapter with set locking positions with indicators based on target patient orientation.

In some embodiments, an atraumatic nose cone design is configured to prevent trauma to patient. In some embodiments, interchangeable nose cones are provided for different size patients (i.e. pediatric versus adult patients.

It should be understood that delivery device <NUM> described herein may be single use or multi-use, depending on the embodiment. It also should be understood that all of the components of delivery device <NUM> through which the medication or drug fluid flows or moves are mechanically and fluidly cooperatively connected, coupled, or in communication, whether direct or indirect.

The specific embodiments described above are merely exemplary, and it should be understood that these embodiments may be susceptible to various modifications and alternative forms.

Claim 1:
A nasal delivery device (<NUM>) for delivering a medication or drug to a nasal passageway
in a metered amount, comprising:
an atomizing nose cone (<NUM>) for insertion into the nasal cavity of the user or patient;
a connection adapter (<NUM>) having a receiving portion comprising a puncturing member (<NUM>) for puncturing a first external reservoir seal;
one or more sealing members (117b) presented on the connection adapter (<NUM>);
a first chamber (<NUM>) presenting a metered amount indicator (<NUM>) and being fluidly coupled to the connection adapter (<NUM>); and
a second chamber (<NUM>) having a fluid atomizing tip (<NUM>), the second chamber (<NUM>) fluidly coupled to the first chamber (<NUM>), and the second chamber (<NUM>) being movable relative to the first chamber (<NUM>) to a set position along the metered amount indicator (<NUM>) to thereby establish a selected metered dose volume jointly defined by the first chamber (<NUM>) and the second chamber (<NUM>); and
a positive displacement mechanism for moving liquid from the at least first external reservoir to at least one of the first and second chambers (<NUM>, <NUM>).