Patent Description:
The present invention relates to devices for delivery of medication to the airways of a patient and more particularly to delivery mechanisms intended to deliver medication to a patient after the creation of positive end expiratory pressure.

Patients who suffer from respiratory ailments including chronic obstructive pulmonary disease, asthma, bronchitis, tuberculosis, or other disorder or condition that causes respiratory distress, often self-administer medication to treat symptoms for those ailments.

Presently, many patients attempt delivery of medications to the respiratory system through hand-heid metered dose inhalers (MDI) and dry powder inhalers (DPI). Small volume nebulizers (SVN) may also be used. An MDI is a device that helps deliver a specific amount of medication to the lungs, usually by supplying a short burst of aerosolized medicine that is inhaled by the patient. A typical MDI consists of a canister and an actuator (or mouthpiece). The canister itself consists of a metering dose valve with an actuating stem. The medication typically resides within the canister and is made up of the drug, a liquefied gas propellant and, in many cases, stabilizing excipient. Once assembled, the patient then uses the inhaler by pressing down on the top of the canister, with their thumb supporting the lower portion of the actuator.

Actuation of the device releases a single metered dose of liquid propellant that contains the medication. Breakup of the volatile propellant into droplets, followed by rapid evaporation of these droplets, results in an aerosol consisting of micrometer-sized medication particles that are then breathed into the lungs. Other MDI's are configured to be charged by twisting a cylinder
that charges the device. A button on a side of the cylinder is depressed by the user which results in a timed release of nebulized or aerosolized medication for inhalation by the patient.

DPI's involve micronized powder often packaged in single dose quantities in blisters or gel capsules containing the powdered medication to be drawn into the lungs by the user's own breath, These systems tend to be more expensive than the MDI, and patients with severely compromised lung function, such as occurs during an asthma attack, may find it difficult to generate enough airflow for satisfactory performance.

While used widely for the treatment of respiratory distress, treatment protocols using MDI's and DPI's ignore the physiological state of patients suffering from respiratory distress. That is, generally speaking, many patients presenting symptoms related to respiratory distress suffer from closed or inflamed alveoli. It is the inflammation of the airways within the lungs of the patient that causes discomfort and other symptoms related to their respiratory distress.

Unfortunately, common treatment techniques related to MDI and DPI use, deliver medication to inflamed and non-inflamed airways alike. The desired physiological response to the administered medications (i.e., the opening or reduced inflammation of the airways, etc.) is delayed as the medication is absorbed into the bloodstream and thereafter delivered to the closed or inflamed airways. Moreover, use of MDI' s or DPI's can be difficult to administer to very young or very old patients or others with decreased or low dexterity. For example, a patient suffering from an acute asthmatic attack may have a difficult time taking a deep enough breath to move an aerosol from an MDI down through the patients airway. A need exists, therefore, for improved systems and methods for lung recruitment and more efficient delivery of medication to the lung.

<CIT> describes a hand-held portable inhalator device.

Any "embodiment", "'aspect" or "example" which is disclosed in the description but is not covered by the claims should be considered as presented for illustrative purpose only. The invention, which is defined by the claims, will become more fully apparent in the light of the following description, taken in conjunction with the accompanying drawings. Understanding that these drawings merely depict exemplary embodiments of the present invention they are, therefore, not to be considered limiting of its scope. It will be readily appreciated that the components of the present not-claimed disclosure as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Nonetheless, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:.

The following detailed description of exemplary embodiments of the invention makes reference to the accompanying drawings, which form a part hereof and in which are shown, by way of illustration, exemplary embodiments in which the invention may be practiced. These exemplary embodiments are described in sufficient detail to enable those skilled in the art to practice the invention. Thus, the following more detailed description of the embodiments of the present invention is not intended to limit the scope of the invention, as claimed, but is presented for purposes of illustration only and not limitation to describe the features and characteristics of the present invention, to set forth the best mode of operation of the invention, and to sufficiently enable one skilled in the art to practice the invention. Accordingly, the scope of the present invention is to be defined solely by the appended claims.

The following detailed description and exemplary embodiments of the invention will be best understood by reference to the accompanying drawings, wherein the elements and features of the invention are designated by numerals throughout. A significant part of the problem encountered in airway-related medical conditions is the reduction in airway diameter accompanying an acute attack. Bronchospasm and its attendant bronchoconstriction prevent adequate gas exchange in the lung, resulting in elevated levels of carbon dioxide and decreased levels of oxygen in arterial blood. This blood gas imbalance results in an increase in the work of breathing, which is burdensome and stressful to a patient who is often in a state of alarm. The relationship between airway caliber to pressure (or work required) to drive air from one end of a tube to another is understood. The Hagen-Poiseuille equation, also known as the Hagen - Poiseuille law, Poiseuille law or Poiseuille equation, is a physical law that describes the pressure drop in a fluid flowing through a long cylindrical pipe. It can be successfully applied to blood flow in capillaries and veins, or to air flow in lung alveoli. It is believed that the Hagen -Poiseuille equation, when applied to compressible fluids such as air, expresses pressure required to maintain volumetric flow as a function of the radius of the airway raised to the <NUM>th power. As a result, even slight changes in the radius of an airway results in a significant change in pressure required to maintain the flow of air into the lung.

With reference to asthma, as an example ailment only, the early stage of an attack is a non-homogenous process. Some airways are narrower than others, while others are effectively occluded altogether. When an aerosol, for example, is administered to the passively breathing patient, the aerosol naturally travels preferentially down the airways of greatest diameter. Certain schools of thought in aerosol administration focus primarily on particle size, quantitative deposition, and even dose metering of stimulants such as catecholamine. It is believed that the lung, if recruited to an optimal functional residual capacity (or FRC), will respond more favorably to inhaled therapy. Broadly speaking, it is believed that the optimal amount of air in a lung is present during the end of a normal expiratory phase. The volume of air may be a different percent of total lung capacity depending on the type of lung condition being treated and the methodology applied.

FRC is made of two volumes, the residual volume (RV) which is the part of the lung that never empties and expiratory reserve volume (ERV) which represents the amount of air that can be exhaled after a normal breath has been completed. FRC is generally a measure of airway and alveoli dilation which are the primary mechanisms dictating the work of breathing on a breath-to-breath basis. Narrow airways can be thought of as narrow straws which require a significant amount of pressure in order to move air. Partially open alveoli can be thought of as small balloons that have not been inflated and are small in diameter. It is difficult to get air into a lung with a low FRC. In other instances, such as a severe asthma attack, air is trapped inside a lung with a high FRC. Bronchospasm, with critically narrowed airways allowing air to enter the lung but preventing its escape results in the trapping of air in the lungs.

Lungs with both high and low FRC can be treated with appropriately applied positive end-expiratory pressure (PEEP). Put simply, applying backpressure to an air-trapped lung will allow the lung to exhale more rapidly and completely. Back pressure applied to a poorly recruited lung will allow it to move air more efficiently while the same back pressure applied to an air-trapped lung will allow it to deflate to an optimal FRC. Unfortunately, asthma attacks may occur at locations with no nearby medical facility that could administer positive end-expiratory pressure therapy to relieve suboptimal FRC and its attendant complications. Attacks could also occur near medical facilities with sub-optimal treatment options.

The present invention as defined by the claims, describes a medicament for use in treating a respiratory ailment as defined by the claims, by use of an inhalator device primarily designed to permit a patient to self-administer respiratory medication after partial recruitment of a lung or permit a medical practitioner to assist a patient to do the same. As noted above, during a respiratory attack (e.g., acute asthma, etc.) a patient's airway and alveoli can be restricted minimizing the efficient delivery of medication and causing a patient distress. It is believed that lung recruitment (i.e., opening of closed alveoli and/or restricted airways) can be achieved through positive end-expiratory pressure (PEEP) means. PEEP is used in mechanical ventilation to denote the amount of pressure above atmospheric pressure present in the airway at the end of the expiratory cycle. That is, as a patient exhales against a means designed to cause a positive back pressure against the patient's breath, it is believed that partial recruitment of the lung occurs. Thus, PEEP is believed to improve gas exchange by preventing alveolar collapse, recruiting more lung units, increasing functional residual capacity, and redistributing fluid in the alveoli.

It is intended that the inhalator devices of the present invention be operable with different types of functional attachments or components so long as the end result is partial recruitment of a patient's lung prior to dispensation of medication into the inhalator device is achieved. Bearing that in mind, the inhalator devices of the present invention, in accordance with one aspect of the invention, may be described as a hand-held housing having a mouthpiece. The mouthpiece contains apertures for allowing a patient to inhale ambient air and exhale the withdrawn air against a predetermined level of positive pressure. Within the housing, a device for detecting an amount of pressure exerted by the patient during exhalation and the time over which that pressure is exerted is present. Once a threshold level of pressure within the device has been reached over a predetermined time period, a firing mechanism triggers dispensation of medication within the housing permitting the patient to inhale the medication after partial recruitment of the lung. In one aspect of the invention, an indicator device (i.e., audible, visual, and/or tactile device) signals to the patient when a medicated breath should be taken and held. Medication is delivered via the device at the beginning of the inhaled breath to optimize the amount of medication inhaled and the depth of the medication carried down the airway. Another indicator is present providing notice to the patient that he or she may release the breath after a certain period of time.

The present invention is intended to be operable with numerous inhalator configurations. Specific reference is made herein to a particular configuration of a mechanical inhalator device requiring no external source of power, other than the pressure generated by the patient by way of his or her exhalation. However, it is understood that any inhalator device is contemplated for use herein comprising a device for dispensing a medication once a predetermined level of pressure is detected within the device over a predetermined period of time. Although a mechanical device is more particularly set forth in this embodiment, examples of other devices of inhalators include, but are not limited to, electro-mechanical, electrical, chemo-electrical, and chemo-mechanical embodiments.

Referring now specifically to the figures, in one exemplary embodiment, with reference to <FIG>, a mechanical inhalator device is shown <NUM>. The inhalator device <NUM> has a mouthpiece <NUM> on a front end of housing <NUM>. The mouthpiece <NUM> may have a circular end, as shown in the exemplary embodiment, or any other shape (i.e., oval, rectangular, etc.) as suits a particular purpose. A medical cartridge housing (shown at <NUM> and <NUM>) contains a medical cartridge <NUM>. The medical cartridge <NUM> contains any type of medication desired to be delivered to the patient (e.g., Albuterol). A cap <NUM> encloses the medical cartridge <NUM> within the housing <NUM> and <NUM>. The medical cartridge <NUM> comprises a stem valve <NUM> that dispenses a predetermined quantity of medication once the stem valve <NUM> is pushed upward against the medical cartridge <NUM>. The stem valve <NUM> is in fluid communication with a chamber <NUM> within the mouthpiece <NUM>. The term "fluid" is used herein to denote a substance that has no fixed shape and yields easily to external pressure such as a gas (i.e., a compressible fluid) or a liquid (i.e., a non-compressible fluid). Importantly, the medical cartridge <NUM> is disposed within housing <NUM> and <NUM> such that in the event of mechanical failure of the device <NUM>, a patient may manually actuate stem valve <NUM> thereby releasing an administering dose of medication.

The mouthpiece <NUM> comprises a plurality of inhalation apertures <NUM> disposed about the outer periphery. The apertures <NUM> are in fluid communication with chamber <NUM>. The apertures <NUM> within the mouthpiece <NUM> permit a user of the device <NUM> to keep their mouth on the device <NUM> during the entire cycle of device use. That is, a patient may place his or her mouth over the mouthpiece <NUM> and draw in breath through the apertures <NUM>. The patient then exhales with his or her mouth still firmly placed on the mouthpiece <NUM>. A flapper check valve <NUM> within the mouth piece <NUM> closes off at least some of the apertures <NUM> creating back pressure against patient's exhalation. A one-way valve or PEEP valve <NUM> is disposed within the mouth piece <NUM> permitting a pre-determined quantity of air to escape the mouthpiece <NUM> once a threshold level of positive pressure pre-determined by the physician in the range of the <NUM> to <NUM> <NUM> is reached. The quantity of air that may escape and at what threshold pressure it may escape is a function of the size and configuration of the PEEP valve <NUM>. Each exhalation breath that reaches the threshold pressure for the required period of time is considered to be a "qualifying breath.

The housing <NUM> and mouthpiece <NUM> are constructed of rigid or semi-rigid plastic material or other suitable composite material suitable for use as a medical device to be placed in the mouth of a patient. For example, Delrin (manufactured by Dupont) or medical-grade acetyl may be used. Similarly, the PEEP valve is constructed from rigid or semi-rigid material, such as urethane, or other suitable material, including metal components, alloys or other composite materials. Plastic components may be injection molded, press molded, printed from a three-dimensional printer, or constructed using any other manufacturing process as is known in the art.

Once the required number of qualifying breaths has been achieved, a device <NUM> actuates the stem valve <NUM> which dispenses medication into the chamber <NUM>. In one embodiment, the chamber <NUM> extends from the front opening of the mouthpiece <NUM> to the rear of the mouthpiece <NUM> without a change in the inner volume of the chamber <NUM>. In another embodiment, the volume of the chamber <NUM> may be larger near the back end of the mouthpiece <NUM> and smaller near the front end of the mouthpiece <NUM>, or vice versa. In any event, the stem valve <NUM> is in fluid communication with the chamber <NUM>. In one embodiment of the invention, the device <NUM> which actuates the stem valve <NUM> comprises spring-loaded firing piston <NUM> positioned directly beneath the stem valve <NUM>. While the stem valve <NUM> and firing piston <NUM> are shown in a vertical orientation, it is understood that the stem valve <NUM> and firing piston <NUM> may also be horizontal or on an inclined plane as suits a particular orientation suited to the dispensing of the medication, so long as the firing piston <NUM> is configured to push the stem valve <NUM> into an actuated position or, in one aspect of the invention, the medical cartridge <NUM> is pushed downward while the stem valve <NUM> remains stationary. In any event, the stem valve <NUM> is actuated dispensing a volume of medication.

In one embodiment of the invention, the firing piston <NUM> is disposed within a spring member <NUM>. Spring member <NUM> is biased in an unloaded state that, when activated, will push the firing piston <NUM> upward against the stem valve <NUM> such that the stem valve <NUM> is also actuated. A lanyard or cord may be attached to an aperture 45a in the firing piston <NUM>. The lanyard is used to pull the firing piston <NUM> downward and place the firing piston <NUM> in a charged or loaded state. Trigger lever <NUM> has a lip 49a configured to mate with an opposing ledge 45b disposed on an upper level of the firing piston <NUM>. When placed in a loaded state, the lip 49a engages ledge 45b and holds the firing piston <NUM> in its charged or loaded state. When the trigger lever <NUM> is actuated, the lip 49a is moved away from the ledge 45b which allows the firing piston <NUM> to be forced by spring member <NUM> up against the stem valve <NUM> thereby actuating stem valve <NUM> and dispensing a volume of medication.

The trigger lever <NUM> is controlled by a cam <NUM> which in turn is rotated by a pressure sensing and timing device. This device comprises an exhale-actuated piston <NUM> in fluid communication with chamber <NUM> of the mouthpiece <NUM>. In one embodiment, the piston <NUM> is located within the housing <NUM> opposite the mouthpiece <NUM> and behind the firing piston <NUM>. When a patient blows through the mouthpiece <NUM> and creates a predetermined level of pressure for a predetermined period of time, the exhale-actuated piston <NUM> moves shuttle <NUM> via the connecting rod 42b in a manner that advances the timing gear <NUM> one position on the timing teeth <NUM>. On the following inhale breath, the piston <NUM> is returned to its initial position which in turn actuates the shuttle <NUM> and advances the timing gear <NUM> to the next ready position.

In accordance with one embodiment of the invention, a user dials in the number of qualifying breaths required to dispense medication by rotating the dial <NUM> to a desired number indicated on the exterior of the device <NUM>. The number of breaths that may be set to be taken is a function of the number of teeth <NUM> on the timing gear <NUM>. This action presets the trigger cam <NUM> to the arming position. The trigger cam <NUM> holds the firing piston <NUM> until rotated to the final position at which time the firing piston <NUM> is released. In one aspect of the invention, the trigger cam <NUM> is one component of a cam and gear cluster. Other components include a timing gear <NUM> having twelve or more teeth <NUM>. The twelve teeth comprise six release teeth and six ready teeth positioned in two rows. Additionally, the cam and gear cluster may comprise an advancement cam <NUM> biased by spring <NUM>. Spring <NUM> causes the cluster to rotate as the gear teeth <NUM> are released one notch at a time by movement of the shuttle <NUM>.

In one embodiment of the invention, the user arms the device <NUM> by pulling the firing piston <NUM> into the armed position using a lanyard (or other device) disposed through aperture 45a. The spring <NUM> is biased to the armed position and captured by the trigger lever <NUM> which is biased by the trigger cam <NUM> to hold the firing piston <NUM> in place. The user then places his or her mouth over the mouthpiece <NUM> and begins breathing through the device <NUM>. In one embodiment of the invention, the first exhale breath from the user causes the piston <NUM> to move in the cylinder. The piston <NUM>, which is in fluid communication with chamber <NUM> and connected to a shuttle <NUM> by connecting rod 42b, moves shuttle <NUM> to the right releasing the rotation of the gear and cam cluster by one release tooth <NUM>. The following inhaled breath moves the piston <NUM> connecting rod 42b and shuttle <NUM> to the left releasing the gear and cam cluster to rotate again by one tooth <NUM> into the next ready position. These actions are repeated on each inhale and exhale breath until the number of qualifying breaths has been reached and the final breath is taken. Coincident with the final breath, the trigger cam <NUM> releases the firing piston <NUM>. The medication is then injected into the chamber <NUM> and the user holds in the final breath for the prescribed period of time (e.g., <NUM> to <NUM> seconds).

As noted above, a spring <NUM> biases cam <NUM> to rotate and is operatively connected to timing gear <NUM>. Cam member <NUM> comprises a lip 48a mated with an edge 49b of the trigger lever <NUM>. Once the timing gear <NUM> is advanced a predetermined level of tooth positions, the cam member <NUM> is positioned such that a lip 48a of cam member <NUM> engages with the edge 49b of the trigger lever <NUM> pulling the trigger lever <NUM> back. In one aspect of the invention, a predetermined level of pressure required to move piston <NUM> (i.e., the amount of pressure the patient must maintain within the chamber <NUM>) ranges from <NUM> to <NUM> H2O. A predetermined level of time (i.e., the time that a patient is required to maintain a predetermined amount of pressure within the chamber <NUM> of the inhalator <NUM>) ranges from <NUM> to <NUM> seconds. Different ranges of pressure and time are contemplated herein as suits a particular application or prescription from a medical service provider.

In one aspect of the invention, a qualifying breath indicator is disposed within a portion of the housing <NUM> and operably connected to the firing piston <NUM>. In one embodiment, the breath indicator comprises a piston that is at least partially ejected to the outside of the housing <NUM> upon, or just prior to (e.g., <NUM> second before) actuation of the firing piston <NUM>. In this manner, the user is provided with a visual indicator that the firing piston <NUM> is being actuated and medicine is being dispensed for inhalation. In one aspect, the distal end of the breath indicator piston is colored green so the user observes a green piston exiting from the housing <NUM>. In another embodiment, the breath indicator comprises a metal member that is configured to resonate upon actuation of the firing piston <NUM>. The resonating sound acts as an audible indicator to the patient that medicine is being dispensed for inhalation. However, a breath indicator by any or numerous means may be used as suits a particular application.

In one embodiment of the present invention, an electro-mechanical inhalator device <NUM> is shown. Broadly speaking, the device <NUM> relies on principles similar to those described above, but accomplishes the end result through use of electro-mechanical means. Referring now to <FIG> generally, an inhalator device <NUM> is shown in accordance with one embodiment of the invention. The device <NUM> comprises an outer housing or main body <NUM> having a battery compartment <NUM>. A removable mouthpiece <NUM> is disposed on a front end of the housing <NUM>. A worm gear assembly <NUM> is disposed about a top, rear portion of the housing <NUM> next to an actuating lever <NUM>. The actuating lever <NUM> is operatively connected to medication cartridge <NUM>. At the rear of the device <NUM>, a circuit board <NUM> is operatively connected to the device <NUM> for the operational sequence and trigger actuating lever <NUM>. The circuit board base <NUM> is connected to the rear of housing <NUM>.

The mouthpiece <NUM> comprises a primary chamber <NUM> with an inhale valve <NUM> disposed on a top portion of primary chamber <NUM>. The inhale valve <NUM> comprises a plurality of apertures <NUM> leading from a top portion of the inhale valve <NUM> to a moveable plate <NUM>. Plate <NUM> is disposed atop an adjustable post <NUM> with a spring member <NUM> biasing the plate <NUM> against the bottom of apertures <NUM>. In this manner, the inhale valve <NUM> is biased in a normally closed position and is opened when negative pressure is induced within the primary chamber <NUM> of mouthpiece <NUM>. In other words, the plate <NUM> of inhale valve <NUM> is moved downward when a user of the inhalator inhales sufficiently to overcome the tension of spring <NUM>. The mouthpiece <NUM> also comprises a cylinder <NUM> configured to be inserted within the mouth of a patient. The bottom of the mouthpiece <NUM> comprises a valve shown generally at <NUM>. In one aspect of the invention, though not in every aspect, the valve <NUM> is a PEEP valve having a plurality of inner apertures <NUM> on an inside of the mouthpiece <NUM> and atop the valve <NUM> and a plurality of outer apertures <NUM> on the outside of the mouthpiece <NUM> and on a bottom of the valve <NUM>. A plate <NUM> is disposed atop an adjustable rod <NUM> and spring <NUM> assembly much like the inhale valve on the top of the mouthpiece <NUM>. In contrast to the inhale valve <NUM>, the plate <NUM><NUM> of the PEEP valve opens when the primary chamber <NUM> of the mouthpiece <NUM> experiences positive pressure. That is, when the user blows on the mouthpiece <NUM>, plate <NUM> is directed downward against spring member <NUM> opening a passage between upper apertures <NUM> and lower apertures <NUM>. The tension of spring member <NUM> may be selected in order to predetermine the quantity of pressure required to move the plate <NUM> downward sufficient to allow the passage of air. Both rods in the upper and lower valves may be threaded into a portion of the valve and therefore have an adjustable length. In this manner, the tension of the springs <NUM><NUM> and <NUM> may be adjusted. In one aspect of the invention, the valve <NUM> opens when subject to a positive pressure pre-determined by medical personnel in the range of <NUM> to <NUM> H2O and the valve <NUM> opens when subject to a negative pressure of not greater than <NUM> H2O.

The mouthpiece <NUM> is detachably mounted to body <NUM> through a plurality of grooves <NUM> disposed within the housing and mating lips <NUM> disposed within the mouthpiece <NUM>. The grooves <NUM> are placed horizontally across a front face of the body <NUM>. Mating lips <NUM> are likely placed horizontally across a back face of the mouthpiece <NUM>. The mouthpiece <NUM> is mounted and/or removed from the body <NUM> by sliding the mating lips <NUM> horizontally through grooves <NUM> until the inlet <NUM> of the body <NUM> is substantially aligned with back outlet <NUM> of the mouthpiece <NUM>. The groove and lip combination, however, may be arranged vertically or in an inclined plane as suits a particular design. An arrangement of circular grooves and mating lips is also contemplated for use. In this manner, the mouthpiece <NUM> is attached and/or detached from the body <NUM> of the device <NUM> by twisting the groove/lip mating pair into locking engagement. Other attachment means may also be used as suits a particular application and design.

A cavity is formed in the top of the body <NUM> configured to receive medicine cartridge <NUM> therein. In one aspect of the invention, medicine cartridge <NUM> comprises a cylindrical container with pressurized fluids therein. As with other medicine cartridges known in the art, the distal end of the cartridge comprises a stem valve <NUM> which, when compressed, dispenses a predetermined volume of medicine from the valve <NUM>. The stem valve <NUM> is in fluid communication with inlet <NUM> and, once connected to the mouthpiece <NUM>, is also in fluid communication with primary chamber <NUM> of mouthpiece <NUM>.

Inlet <NUM> of the body <NUM> is in fluid communication with pressure sensor <NUM>. When a patient blows on the mouthpiece <NUM>, the upper valve <NUM> closes and the lower PEEP valve <NUM> opens. Depending on the tension of spring <NUM> and the volume of air exhaled by the patient, an amount of positive pressure within the primary chamber <NUM> is created. Pressure sensor <NUM> is configured to detect the pressure within primary chamber <NUM> and the amount of time pressure is continuously maintained. The pressure sensor <NUM> is configured to relay a signal to circuit board <NUM> when a qualifying breath has been achieved. Pressure sensor <NUM> is configured with tolerances to relay signals when a pressure that is within a predetermined (or threshold) for the predetermined (or threshold) period of time. In one embodiment the threshold pressure ranges from between <NUM> and <NUM> H2O and the threshold period of time ranges from between <NUM> and <NUM> seconds.

As noted above, a qualifying breath is achieved when a patient blows through the mouthpiece <NUM> and creates a predetermined (or threshold) level of pressure for a predetermined (or threshold) period of time. In one aspect of the invention, the pressure sensor <NUM> is configured to be biased in an open or "detecting" configuration. The pressure sensor <NUM> closes upon detecting approximately <NUM> of H2O and re-opens upon detecting that pressure is less than <NUM> of H2O. Other pressure sensor configurations are contemplated herein. In one aspect of the invention, a qualifying breath is achieved only after the patient maintains the predetermined threshold of pressure within the mouthpiece <NUM> for the predetermined period of time and the pressure sensor <NUM> detects a decrease in the pressure within the mouthpiece <NUM>. The decrease in pressure indicates that the patient is no longer blowing into the mouthpiece <NUM> and is preparing to take another breath. In this manner, if the required number of qualifying breaths has been achieved, medication can be dispensed just prior to an inhalation event. Advantageously, the timing of the dispensing of the medication at the end of an exhalation cycle and just prior to an inhalation event permits the maximum inhalation of medicine into the patients lungs as medicine is drawn into the lungs at the beginning of an inhalation event (i.e., at the point of highest intake of air into the lungs). In one aspect of the invention, a qualifying breath is not achieved until after the patient maintains the predetermined threshold of pressure (e.g., between <NUM> and <NUM> of H2O) within the mouthpiece for the predetermined period of time (e.g., between <NUM> and <NUM> seconds) and the pressure sensor <NUM> detects a decrease in the pressure within the mouthpiece <NUM> to below <NUM> H2O. However, in one aspect of the invention, the pressure within the chamber on the exhalation cycle can range from between <NUM> and <NUM> H2O. Other pressures, including those on the end portion of an exhalation cycle, re contemplated herein as suits a particular application.

The pressure sensor <NUM> and circuit board <NUM> are operably connected to power source <NUM>. In one aspect of the invention, the power source <NUM> is a portable power source such as a battery, rechargeable battery or the like. In yet another aspect, the entire device may be tethered to a non-portable energy source. The power source <NUM> and circuit board <NUM> are coupled to a motor <NUM>. Once the predetermined number of qualifying breaths has been detected by the circuit board <NUM>, the motor <NUM> actuates the worm <NUM> which in turn rotates the worm gear assembly <NUM>. The worm gear assembly <NUM> comprises a worm gear and an eccentric bearing <NUM> disposed about a central axis <NUM>. The worm gear assembly <NUM> is disposed beneath the back of actuating lever <NUM>. When the worm assembly <NUM> is activated, worm <NUM> rotates axis <NUM> until the bearings <NUM> turn from a first position to a second position. The first bearing position is configured such that the rear <NUM> of the actuating lever <NUM> is in a downward position. The second bearing position is configured such that the rear <NUM> of the actuating lever <NUM> is in an upward position. In one aspect of the invention, the actuating lever <NUM> comprises a pivot pin slot <NUM> where the lever is mounted to the top of the housing <NUM>. A pivot member is disposed through an aperture in the housing <NUM> and through the pivot pin slot <NUM>. Actuating lever <NUM> also comprises an adjusting screw <NUM> configured to rest on top of medicine cartridge <NUM>. When the rear <NUM> of actuating lever <NUM> is driven upward by the worm gear assembly <NUM>, the lever <NUM> pivots about the pivot, driving the front of the lever <NUM> downward. The downward thrust of the front end of lever <NUM><NUM> drives the medicine cartridge <NUM> downward and actuates stem valve <NUM> releasing a dose of medicine.

A return spring cartridge <NUM> is disposed beneath the lever <NUM> near the pivot slot <NUM>. The return spring cartridge <NUM> is configured to bias the rear of the lever <NUM> in a downward position. In this manner, after the worm gear assembly <NUM><NUM> drives the rear <NUM> of the actuating lever <NUM> upward, the return spring cartridge <NUM> will push the rear end <NUM> back down to compensate for a slow return of the medication cartridge <NUM> return action. The actuating lever <NUM> is designed such that the rear <NUM> of the actuating lever <NUM> comes into contact with switch <NUM> after stem valve <NUM> is actuated. When actuated, switch <NUM> closes a circuit sending a current to the motor <NUM> (thereby operating the worm assembly <NUM>) until the lever <NUM> returns to a position where switch <NUM> is disengaged (i.e., lever is in a downward position). This terminates the circuit and its attendant current to the motor <NUM> ending operation of the worm gear assembly <NUM>, In this manner, the worm gear assembly <NUM> and lever <NUM> are returned to a "pre-firing" state readying the device <NUM><NUM> for its next use.

Circuit board <NUM> is covered by a board cover <NUM> and is mounted to a base <NUM>. The circuit board <NUM> is a printed circuit board, or PCB, used to mechanically support and electrically connect electronic components using conductive pathways, tracks or signal traces etched from copper sheets laminated onto a non-conductive substrate, but may comprise any circuit board known in the art capable of carrying out the logic described herein. In one aspect of the invention, the circuit board comprises a PLC circuit or programmable logic controller circuit. A PLC may include a sequential relay control, motion control, process control, distributed control systems, and/or networking as is known in the art. In other aspects of the invention, PLRs (programmable logic relays) may be used. PLR products such as PICO Controller, NANO PLC, and others known in the art are contemplated for use herein. In one aspect of the invention, the circuit board <NUM> has a memory storage component capable of storing information related to the number of times the device has been fired as the result of the user having achieved the required number of qualifying breaths. In one aspect of the invention, the circuit board <NUM> includes a data port which may be operably connected to a computer terminal. In this manner, the circuit board logic may be programmed to adjust the number of qualifying breaths required to actuate the actuation lever <NUM>. A computer readable software program capable of operating on any computer operating system known in the art is configured to communicate with the circuit board <NUM> via a physical connection with the computer system. However, the data may also be relayed to the computer operating system via a wireless signal.

A plurality of LED's are mounted to the circuit board <NUM> and aligned along an edge of the housing <NUM> of the device <NUM> to be visible through the mounting base <NUM>, In one aspect of the invention, the lights all turn on when a user picks up the inhalator <NUM> or creates a minimum amount of pressure within: the primary chamber <NUM> via an initializing breath. For each qualifying breath thereafter, one of the plurality of lights is extinguished. When the last light is extinguished a green light appears indicating to the user that medication is going to be administered and that the patient should inhale the medication and hold the breath until the green light turns off, In one aspect of the invention, the appearance of the green light is coincident to the actuation of lever <NUM>. In an additional aspect of the invention, the patient hears an audible tone also indicating that medication is going to be administered and that the patient should inhale the medicine. The timing and sequence of the lighting and/or sound, however, are adjustable as suits a particular application. For example, a single yellow light can appear for each qualifying breath leading to a final green light. In other words, for each exhalation event that reaches the predetermined pressure for the predetermined quantity of time, a yellow light appears. Once the required number of yellow lights is established, a green light appears and medication is administered. The sequence and timing are adjustable via a connection to a computer terminal or PLC controls or individual control switches mounted directly to the circuit board <NUM>.

Other sequences or visual and/or audible indicators of the administration of medication are contemplated for use herein. For example, in one embodiment of the invention the pressure sensor <NUM> is configured to transmit a signal to the circuit board <NUM> when a first threshold of pressure is detected and when a subsequent lower threshold of pressure is detected. In this manner, an inference may be made generally when the user has ceased blowing on the inhalator <NUM>. The first threshold pressure (i.e., for transmitting the signal) may be from <NUM> to <NUM> H2O and the second lower threshold pressure (i.e., indicating a breath has terminated) may be from <NUM> to <NUM> H2O, though other pressure ranges may be used. In one aspect of the invention, the motor <NUM> will not actuate the worm gear assembly <NUM> and subsequently administer medication to the patient until after the predetermined number of qualifying breaths has been achieved and after the user has ceased blowing on the inhalator <NUM>.

In yet another aspect of the invention, a tactile sensor is placed on the cylinder <NUM> of mouthpiece <NUM>. The tactile sensor is operably connected to the circuit board <NUM> and is designed to send a signal to the circuit board <NUM> when placed into contact with the skin of a patient. In one embodiment, the circuit board <NUM> is configured to place the inhalator <NUM> into "sleep mode" to preserve battery power until the tactile sensor is actuated. In another embodiment, the circuit board <NUM> is configured to provide an audible, visual and/or tactile signal to the user as a reminder that the user should keep his or her mouth on the cylinder <NUM> during the entire exhalation and inhalation process. In other words, once the tactile sensor is actuated, a signal is provided to the user if contact with the tactile sensor is terminated prior to the actuation of the firing piston. In yet another embodiment, if contact with the tactile sensor is terminated prior to actuation of the firing piston, the circuit board <NUM> is configured to prevent actuation of the piston despite having detected the predetermined number of qualifying breaths. In this manner, medication will only be discharged if the number of qualifying breaths has been achieved, the user has ceased blowing on the device <NUM>, and contact between the skin of the user and the mouthpiece <NUM> is maintained.

With reference now to <FIG> and <FIG>, in accordance with one aspect of the invention, an inhalator device <NUM> is shown. Similar to the inhalator device <NUM>, this device comprises a mouthpiece <NUM> having a primary chamber <NUM> with an inhale valve <NUM> disposed on a top portion of primary chamber <NUM>. The inhale valve <NUM> comprises a plurality of apertures <NUM> leading from a top portion of the inhale valve <NUM> to a moveable plate <NUM>. Plate <NUM> is disposed atop an adjustable post <NUM> with a spring member <NUM> biasing the plate <NUM> against the bottom of apertures <NUM>. The inhale valve <NUM> is biased in a normally closed position and is opened when negative pressure is induced within the primary chamber <NUM> of mouthpiece <NUM>. In other words, the plate <NUM> of inhale valve <NUM> is moved downward when a user of the inhalator <NUM> inhales sufficiently to overcome the tension of spring <NUM> opening an airway permitting the ingress of air into the mouthpiece <NUM>. The mouthpiece <NUM> comprises an oval <NUM> configured to be inserted into the mouth of a patient. The bottom of the mouthpiece <NUM> comprises a valve shown generally at <NUM>. In one aspect of the invention, the valve <NUM> comprises a PEEP valve having a plurality of apertures <NUM> on the outside of the mouthpiece <NUM> and on a bottom of the valve <NUM>. A plate <NUM> is disposed atop an adjustable rod <NUM> and spring <NUM> assembly much like the inhale valve <NUM> on the top of the mouthpiece <NUM>. In contrast to the inhale valve <NUM>, the plate <NUM> of the PEEP valve <NUM> opens when the primary chamber <NUM> of the mouthpiece <NUM> experiences positive pressure. That is, when the user blows on the mouthpiece <NUM>, plate <NUM> is directed downward against spring member <NUM> opening a passage between apertures <NUM> and the ambient air. The tension of spring member <NUM> may be selected in order to predetermine the quantity of pressure required to move the plate <NUM> downward sufficient to allow the passage of air. Both rods in the upper and lower valves may be threaded into a portion of the valve and therefore have an adjustable length. In this manner, the tension of the springs <NUM> and <NUM> may be adjusted.

A cavity is formed in the back of the housing <NUM> configured to receive a medicine cartridge <NUM> therein. In one aspect, medicine cartridge <NUM> comprises a cylindrical container with pressurized fluids therein. The distal end of the cartridge <NUM> comprises a valve <NUM>. The valve 271is operatively coupled to a button <NUM> on the side of the cartridge <NUM>. When the device <NUM> is charged, a predetermined volume of medicine is disposed from the valve <NUM> when the button <NUM> is depressed. The valve <NUM> is in fluid communication with inlet <NUM> and, once connected to the mouthpiece <NUM>, is also in fluid communication with primary chamber <NUM> of mouthpiece <NUM>.

Inlet <NUM> of the housing <NUM> is also in fluid communication with pressure sensor <NUM>. When a patient blows on the mouthpiece <NUM>, the upper valve <NUM> closes and the lower PEEP valve <NUM> opens, Depending on the tension of spring <NUM> and the volume of air exhaled by the patient, an amount of positive pressure within the primary chamber <NUM> is created. Pressure sensor <NUM> is configured to detect the pressure within primary chamber <NUM> and the amount of time pressure is continuously maintained. The pressure sensor <NUM> is configured to relay a signal to circuit board <NUM> when a qualifying breath has been achieved. Pressure sensor <NUM> is configured with tolerances to relay signals when a pressure that falls within a predetermined range for the pre-determined period of time similar to those ranges discussed herein. The circuit board <NUM> is operatively coupled to motor <NUM>. Motor <NUM> is positioned such that when the cartridge <NUM> is properly disposed within the rear of housing <NUM>, a piston <NUM> disposed about the bottom of the motor <NUM> is positioned directly above the button <NUM>. When activated, motor <NUM> drives piston <NUM> downward to dispense the medication.

A bypass trigger <NUM> is disposed on the back of the housing <NUM>. The bypass trigger <NUM> is operatively coupled to piston <NUM> which activates the button <NUM>. In this manner, in the event the device <NUM> does not fire as anticipated, or the patient is not capable of creating the prescribed pressure within the device <NUM> for the predetermined number of breaths or the predetermined amount of time, the patient may manually fire the device <NUM> by depressing the trigger <NUM> and administer medication. In one aspect of the invention, the housing <NUM> comprises a battery <NUM> operatively coupled to an on/off switch <NUM> and the circuit board <NUM>. The housing <NUM> comprises a removable plate <NUM> accessing compartment <NUM> that contains the battery <NUM>. A plurality of lights <NUM> are disposed on the side <NUM> of housing <NUM>. As noted above, in one aspect of the invention, lights may be activated in any number of sequences to indicate that a qualifying breath has been achieved, that medication is being administered and an inhalation breath should be taken and held, and/or how long an inhalation breath should be held,.

The devices and embodiments shown herein make reference to valves for inhalation and valves for exhalation. However, in one aspect of the invention only one valve is present restricting the exhalation flow out of the mouth of the patient through the chamber. In yet another embodiment, a two-way valve may be used that provides means for the ingress of ambient air into the chamber for patient inhalation and also provides means for restricting the exhalation flow out of the mouth of the patient. In another embodiment, the chamber does not have any valves. Rather, a volume of exhalation flow from the patient is restricted by placing a plurality of holes about the exterior of the mouthpiece or other location in the housing of the device in fluid communication with the mouthpiece. Like the embodiments described above, the amount of pressure required to activate the valve is adjustable as suits a particular application by valve design and/or sizing and number of holes placed in the mouthpiece.

A method of administering medication to a patient comprises providing a hand-held, portable inhalator device to the patient, the device comprising a mouthpiece comprising a chamber and a medication source in fluid communication with the chamber. Any references in the description to methods of treatment refer to the compounds, pharmaceutical compositions and medicaments of the present invention for use in a method for treatment of the human or animal body by therapy. The mouthpiece further comprises an aperture configured to permit egress of fluid out of the chamber. The device also comprises a trigger configured to dispense medication from the medication source into the chamber. The method further comprises placing the mouth of the patient about the mouthpiece and exhaling into the mouthpiece and out of the aperture for a predetermined period of time at a threshold level of positive pressure to achieve a qualifying breath and dispensing a quantity of medication into the chamber after the qualifying breath. In one aspect of the invention, the method further comprises dispensing the quantity of medication into the chamber after a plurality of qualifying breaths as suits a particular prescription or patient need, In another aspect, each qualifying breath comprises exhaling through the mouthpiece for between approximately <NUM> and <NUM> seconds at a pressure within the mouthpiece ranging from between approximately <NUM> to <NUM> H2O and the patient is provided with a visual or audible indicator when a qualifying breath has been achieved. In another aspect of the invention, contact between the mouth of the patient and the mouthpiece of the device is substantially constant between qualifying breaths.

In another aspect, a method of administering medication to a patient comprises placing an inhalator device into the mouth of a patient. The device comprises a mouthpiece comprising a chamber, a fluid outlet, and a fluid inlet. It also comprises a medication source in fluid communication with the chamber and a first valve disposed about the fluid inlet. The first valve is biased in a closed position and configured to open to permit the ingress of ambient air into the chamber when subject to a threshold level of negative pressure. A second valve is disposed about the fluid outlet and is biased in a closed position and configured to open when subject to a first threshold positive expiratory end pressure to permit egress of fluid from the chamber. A trigger is disposed on the device and configured to dispense medication into the chamber. The method further comprises exhaling through the mouthpiece for a threshold period of time at a second threshold level of positive pressure and dispensing a quantity of medication into the chamber after the second threshold level of positive pressure is maintained within the chamber for a threshold period of time.

Claim 1:
A medicament for use in a method of treating a respiratory ailment
selected from obstructive pulmonary disease, asthma, bronchitis and tuberculosis, wherein the medicament is to be administered to a patient via a hand-held, portable inhalator device, the device comprising: a mouthpiece comprising a chamber;
a medication source in fluid communication with the chamber;
an aperture configured to permit egress of fluid out of the chamber;
a trigger configured to dispense medication front the medication source into the chamber and wherein the method comprises placing the mouth of the patient about the mouthpiece and exhaling into the mouthpiece and out of the aperture for a predetermined period of time at a threshold level of positive pressure to achieve a qualifying breath; and
dispensing a quantity of medication into the chamber after the qualifying breath.