Pulmonary drug delivery device

Information

  • Patent Grant
  • 6435175
  • Patent Number
    6,435,175
  • Date Filed
    Tuesday, August 29, 2000
    24 years ago
  • Date Issued
    Tuesday, August 20, 2002
    22 years ago
Abstract
A nebulizer for delivering a drug to a patient includes an electronic control unit, a hand piece connected to the electronic control unit via a cable, and a cartridge detachably engaged with the hand piece. The electronic control unit includes a controller, a cartridge reader, a dosage storage element, and a display. The display preferably displays the drug name and the number of dosages remaining in the cartridge. The cartridge includes a head or nebulizer element for creating a fine mist or cloud of the drug in droplet form. The cartridge also includes a storage container containing a drug and a pump for pumping the drug to the nebulizer element. The cartridge also contains an information storage element for containing information regarding the drug and the drug delivery protocol for the patient. The information in the information storage element is transmitted to the electronic control unit when the cartridge is engaged with the hand piece.
Description




BACKGROUND OF THE INVENTION




The present invention relates generally to pulmonary drug delivery devices. More specifically, the invention relates to a nebulizer system for delivering a drug-containing aerosol to the lungs. The invention also relates to smart drug cartridges that contain information pertaining to the type of drug, the delivery protocol for the drug, and other patient specific information.




Drugs are increasingly being developed that are delivered to patients via inhalation. These drugs include various pharmaceutical compounds and mixtures directed to treat lung diseases such as asthma. Drugs that are directed to non-respiratory system diseases can also be delivered to the patient via inhalation. An example of this type of systemic drug is an inhaled form of insulin used to treat diabetes.




Most of these drugs require a precise unit dose delivery. If too little drug is given, the therapeutic effect of the drug can be reduced or lost entirely. If too much drug is delivered, the patient may suffer from toxic effects of the drug or may overdose.




Control of unit dose delivery is particularly hard for drugs delivered via inhalation. In the case of a nebulizer or inhaler-type devices, patients frequently forget if they took their medication. Even if a patient remembers that he or she took their medication, they might not know at what time their last inhalation was. This is problematic when a particular treatment or drug requires a specified time interval between successive doses.




Another difficulty that has arisen with respect to conventional inhalation devices relates to the preparation of the drugs. Sometimes one or more drugs are mixed with each other or a carrier prior to delivery. Albuterol, for example, typically requires that the drug (Albuterol) be mixed with a saline type solution. These mixtures can be prepared by the patient, or alternatively, by the patient's health care provider. Unfortunately, there may be mistakes made in preparing the final drug formulation.




Still another difficulty relates to mistakes made as to what drug is contained within a particular drug storage container. Consequently, the patient or health care provider might mistakenly administer the wrong drug. In yet another difficulty, the inhaled drug might have reached or exceeded the drug's expiration date. Unless the patient carefully reads the expiration label, there is a chance the patient is inhaling a drug that is expired. Another difficulty relates to patient compliance. Currently, drugs delivered via a nebulizer can take as long as ten to fifteen minutes to deliver the required dose. This long amount of time required to deliver each dose can reduce patient compliance.




Accordingly, there is a need for a device that can precisely control the unit dose delivery of an inhaled drug. The device can preferably monitor and assess various parameters such as when the last dose was delivered, the identification of the drug, the drug's expiration date, the concentration of the drug, the drug delivery protocol, etc. A device is needed that reduces the total time required to deliver an inhaled drug to a patient. Preferably, the device can be used at home. There also is a need for a drug cartridge that contains the drug as well as information relating to the drug and its intended delivery to the patient. Preferably, the information is stored in the drug cartridge and can be customized to a particular drug and/or patient.




SUMMARY OF THE INVENTION




In a first aspect of the invention, a nebulizer for delivering a drug to a patient includes an electronic control unit, a hand piece connected to the electronic control unit, and a cartridge that is detachably engaged with the hand piece. The cartridge includes a storage container for containing the drug. A pump is located on the cartridge and pumps the drug to a nebulizer element. The cartridge also includes an information storage element. The information storage element contains information on the drug contained within the cartridge as well as drug delivery protocol. When the cartridge is engaged with the hand piece, the information in the information storage element is transmitted to the electronic control unit. Information is displayed on a display on the electronic control unit.




In another aspect of the invention, the electronic control unit of the device includes a controller, a cartridge reader, and a dosage storage element. The cartridge reader reads the information contained within the information storage element on the cartridge. The dosage storage element countdowns the remaining doses of the cartridge. The number of remaining doses is displayed on the display.




In another aspect of the invention, the device includes data transmission means for transmitting patient compliance: information to an output device.




It is an object of the invention to create a nebulizer device that can read pre-programmed information stored within a cartridge containing a drug. The information relates to the type of drug contained with the cartridge and the individual delivery protocol for the patient. The information can be pre-programmed by the drug manufacturer or health care provider. The device preferably displays the remaining number of doses in the cartridge on a display. The device operates in accordance with pre-preprogrammed set of instructions stored within the information stored within the cartridge. It is also an object of the invention to have a device that can transmit patient compliance information to external to an output device.




In still another aspect of the invention, a cartridge for containing a drug includes a drug storage container for storing the drug, a pump disposed in the cartridge for pumping drug from the storage container to a conduit, and a programmable information storage element disposed in the cartridge.











BRIEF DESCRIPTION OF THE DRAWINGS





FIG. 1

illustrates the pulmonary delivery device according to one embodiment of the invention, including the electronic control unit, the hand piece, and the cartridge.





FIG. 2

illustrates one embodiment of the cartridge.





FIG. 3

illustrates the pulmonary delivery device according to another embodiment of the invention.





FIG. 4

illustrates the pulmonary delivery device according to another embodiment of the invention.





FIG. 5

illustrates a schematic representation of the control unit.





FIG. 6

illustrates the pulmonary delivery device transmitting data to a patient compliance output device.





FIG. 7

is a schematic representation of the drug cartridge.





FIG. 8

is a schematic representation of another embodiment of the drug cartridge.











DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS





FIG. 1

illustrates the pulmonary drug delivery device


2


. The device


2


generally comprises an electronic control unit


4


, a hand piece


50


, and a cartridge


70


. The electronic control unit


4


includes a housing


5


and receives power via a power cord


6


. The power cord


6


is connected to a power source


8


. The power source may be a source of A/C current, as shown for example in

FIG. 1

, or alternatively, the power source


8


can also be a source of DC current. The device


2


can also include options for both A/C and DC current use. If A/C current is used a transformer (not shown) is used to convert A/C to DC current.




The electronic control unit


4


includes a display


10


preferably on a surface thereof. The display


10


can be a LCD screen or the like which is capable of displaying numbers and letters. Preferably the display


10


includes a portion for displaying the date


12


, the time


14


, a countdown number


16


indicating the number of doses remaining in the cartridge


70


, the drug name or identification


18


contained within the cartridge


70


, and an alarm indicator


20


. Other items can also be displayed such as the expiration date of the drug within the cartridge


70


, the dosage, the particle size, and the like (not shown).




The electronic control unit


4


preferably includes a speaker


22


housed within the electronic control unit


4


that is used to produce a sound alarm when one or more conditions are met. For example, the speaker


22


and the alarm indicator


20


might be triggered when the number of remaining doses falls below a pre-set number. As another example, the speaker


22


and alarm indicator might be triggered when the drug expiration date is near or has been surpassed. These features are preferably programmed into the electronic control unit


4


or cartridge


70


.




The device


2


also includes in the electronic control unit


4


an on/off switch


24


, a cancel switch


26


, a prime pump switch


28


, and a print/send switch


30


. These switches


24


,


26


,


28


, and


30


may take the form of a button or the like on the electronic control unit


4


. Programming buttons


31


are also preferably provided on the electronic control unit


4


. These programming buttons


31


can be used to change such things as the time and date displayed on the display


10


. Preferably, these programming buttons


31


are recessed so they are not accidentally hit during use of the device


2


.




Located in the electronic control unit


4


in the housing


5


is a communications port


32


. The communications port


32


can include a modem jack, a USB port, a serial port, or a parallel port commonly found in personal computers. The communications port might also include an infrared LED or a radio frequency transmitter. The aforementioned are examples of the data transmission means used to transmit data from the device


2


to an external location or device. A cable


22


is connected from the electronic control unit


4


to the hand piece


50


. The cable


22


includes one or more data transmission and power lines traveling between the hand piece


50


and the electronic control unit


4


.




The hand piece


50


preferably includes a housing


52


shaped to contain the cartridge


70


. At an end proximal to the cable


22


, the hand piece


50


includes one or more electrical connectors


54


that are connected to the data and power lines within the cable


22


. The electrical connectors


54


connect with corresponding electrical connectors (


88


,


90


) on the cartridge


70


. The electrical connectors


54


can include any number of commonly known components such as electrically conductive tabs, detents, projections, bumps, conductive springs, and the like. The housing


52


preferably includes one or more holes


56


therein to provide air to pass through during patient inhalation. The holes


56


might be eliminated entirely, however, if there is sufficient room for air to pass between the housing


52


and the cartridge


70


.




Preferably, the hand piece


50


includes an inhalation sensor


58


that detects the onset of inhalation. The inhalation sensor


58


is connected to a data line


60


that passes to an electrical connector


54


or the like. The inhalation sensor


58


reports the inhalation data to the controller


150


. Of course, the inhalation sensor


58


can instead be located within the cartridge


70


.




Still referring to

FIG. 1

, the cartridge


70


includes a body portion


72


. The body portion


72


is preferably shaped to closely fit within the hand piece


50


. In this regard, a hand-in-glove type of arrangement is made between the cartridge


70


and the hand piece


50


. The cartridge


70


can be removably engaged with the hand piece


50


. The cartridge


70


can include an optional mouthpiece portion


73


. The mouthpiece


73


might be permanently affixed to the cartridge


70


, or alternatively, the mouthpiece


73


might be detachable from the cartridge


70


. The cartridge


70


includes a drug storage container


74


that contains the drug


75


. The drug storage container


74


acts a reservoir since the drug


75


contained within the container


74


is preferably in liquid form. Preferably, the cartridge


70


is disposable after use.




The cartridge


70


also includes an information storage element


76


. The information storage element


76


stores data relating to the drug


75


within the cartridge


70


as well as information relating to the dosage and delivery of the drug


75


, i.e., drug delivery protocol. The information storage device


76


can include a programmable chip, such as that shown in

FIG. 1

, or alternatively, the information storage element


76


may include a radio frequency tag


130


, as shown in

FIG. 3

, or a bar code


140


, as shown in FIG.


4


. The information storage element


76


may also comprise a magnetic strip. The information storage element


76


is preferably programmable. Data such as the identification of the drug, the drug expiration date, the prescribed dosage of the drug, the minimum allowable time between doses, and drug delivery protocol, etc. can be programmed into the information storage element


76


. The data can be preprogrammed by the manufacturer, or alternatively, by a health professional such as a doctor or pharmacist. The data stored within the information storage element


76


can be tailored to a particular drug


75


as well as to the particular patient.




Still referring to

FIG. 1

, one or more data transmission lines


86


are used to communicate the data stored on the information storage element


76


to one or more electrical connectors


88


,


90


on the cartridge


70


. These electrical connectors


88


,


90


engage with corresponding electrical connectors


54


in the hand piece


50


. A pump


92


is located in or adjacent to the drug storage container


74


. The pump


92


is preferably a piezoelectric-driven pump


92


that is powered via power line


84


. The power line


84


terminates in an electrical connector


98


to provide communication with the a electrical connector


54


in the hand piece


50


that is coupled to a source of power.




The drug


75


is pumped from the drug storage container


74


into a conduit


94


. The conduit


94


provides a passageway for the drug


75


from the drug storage container


74


to a nebulizer element


100


. The nebulizer element


100


creates a fine mist or cloud that includes small droplets of the drug


75


. By forming small droplets of the drug


75


by use of the nebulizer element


100


, the drug


75


is able to penetrate deep within the lungs with minimal loss of the drug


75


from adhesion to the cartridge


70


or to the back of the throat of the patient. The nebulizer element


100


can include any number of known devices used to generate a mist or cloud of drug


75


. For example, the nebulizer element


100


may include a piezoelectric vibratory element, an ultrasonic generator, a nozzle, a pneumatic-based element and the like.




U.S. Pat. No. 5,813,614 discloses an example of a preferred nebulizer element


100


. The '614 patent is incorporated by reference as if set forth fully herein. The nebulizer element


100


is an electrohydrodynamic nozzle


110


.





FIG. 2

illustrates one preferred embodiment of the nozzle


110


. The nozzle


110


aims inside the cartridge


70


that delivers the liquid drug


75


into the lumen of the cartridge


70


. Additional nozzles


110


(not shown) can also be located on the cartridge


70


. A discharge electrode


112


is also located within the lumen of the cartridge


70


. The nozzle


110


is preferably a high voltage nozzle


110


that imparts a negative charge to the drug


75


that is pumped out of the nozzle


110


. The nozzle


110


is preferably connected via a power line


114


to a source of high voltage direct current via an electrical connector


116


. The electrical connector


116


engages with a power electrical connector


54


in the hand piece


50


. The negative charge imparted to the drug


75


droplets counterbalances the effects of surface tension, thereby permitting the formation of extremely small drug


75


droplets. The discharge electrode


112


preferably has a positive charge that is formed by connecting the discharge electrode


112


to a DC high voltage source via a power line


115


and electrical connector


118


. The DC positive and negative voltages are produced by conventional circuitry that is controlled preferably by controller


150


. The discharge electrode


112


, with its positive charge, ionizes adjacent gas molecules and neutralizes the negative charge on. the aerosolized drug


75


. The discharge electrode


112


also tends to pull the aerosol droplets away from the nozzle


110


, thereby avoiding the buildup of condensed aerosol droplets on the nozzle


110


.





FIG. 3

illustrates a embodiment of the invention wherein the information storage element


76


is a radio frequency (RF) tag


130


. The RF tag


130


is affixed to the cartridge


70


. A RF tag receiver


132


is affixed to the hand piece


50


and is used to pickup the information stored on the RF tag


130


and send the data via data line


134


to an electrical connector


54


. This information is in turn reported to the electronic control unit


4


. Preferably, the RF tag


130


is programmable.





FIG. 4

illustrates another embodiment of the invention wherein the information storage element


76


is a bar code


140


. The bar code


140


is affixed to the cartridge


70


. A bar code reader


142


is affixed to the hand piece


50


and is used to pickup the information stored on the bar code


140


and send the data via data line


144


to an electrical connector


54


. This information is in turn reported to the electronic control unit


4


. The bar code


140


is preferably programmable in the sense that the manufacturer or health care provider can affix a pre-programmed bar code


140


onto the cartridge


70


.





FIG. 5

illustrates the controller


150


, the cartridge reader


152


, and the dosage storage element


154


. The controller


150


is preferably a microprocessor that controls the operation of the device


2


. The controller


150


receives signals from the on/off switch


24


, the cancel switch


26


, the prime pump switch


28


, the print/send switch


30


, and the program buttons


31


via respective signal lines. The inhalation sensor


58


also inputs a signal via signal line


59


to the controller


150


. When inhalation is detected, signals are output from the controller


150


via signal line


156


to control the display


10


and the pump


92


. The high voltages for the nozzle


110


and the discharge electrode


112


are powered via power lines


160


. The cartridge reader


152


receives and stores the data from information storage element


76


transmitted via data lines within the cable


34


. The cartridge reader


152


can comprise a microprocessor, memory, or the like. The cartridge reader


152


preferably reports the data contained within the information storage element


76


to the controller


150


. Information such as the name of the drug, the expiration date, the dosage, the time between dosages, and the delivery protocol, etc. are stored within the electronic control unit


4


.




The controller


150


is associated with a dosage storage element


154


. The dosage storage element


154


contains information pertaining to the number of doses remaining for an individual cartridge


70


. The dosage storage element


154


is a non-volatile memory which can include a bubble memory, microprocessor based circuit, memory chip, or the like. Preferably, each cartridge


70


has an individual unique cartridge identifier that is stored within the information storage element


76


and reported to the cartridge reader


152


. The dosage storage element


154


preferably can associate a particular cartridge


70


with the number of remaining doses. This can be done even though the device


2


is turned off or the cartridge


70


is removed from the hand piece. When the inhalation sensor


58


detects the onset of inhalation, the controller starts the pump


92


to deliver the drug


75


to the nebulizer element


100


. Since the patient has taken a dosage of the drug


75


, the controller


150


reports this information to the dosage element


154


, which stores the new number of doses remaining.




The controller


150


, the cartridge reader


152


, and the dosage element


154


can be individual units, as shown for example in

FIG. 5

, or alternatively, be incorporated into a single control unit as shown in outline


170


. Control signals are transmitted to the pump


92


via pump control line


158


. Power to the controller


150


is delivered via power line


162


. A transmission line


164


transmits data to the communications device or communications port


32


. The actual communication device, whether it is a modem, network card, RF transmitter, or the like, can be part of the control unit


150


, or alternatively, separate from the control unit


150


and controlled via signals send via transmission line


164


.




During operation of the device


2


, the patient or health care provider turns on the device


2


via the on/off button


24


. At this point the controller


150


senses that there is no cartridge


70


in the hand piece


50


. The controller


150


sends a signal to the display


10


to display a message or indicator that the device


2


is ready for loading. The patient or other person then loads a cartridge


70


into the hand piece


50


. The cartridge


70


is pushed into the housing


52


such that electrical connections are made between the cartridge


70


and the electrical connectors


54


. Information stored within the information storage element


76


is then read by the cartridge reader


152


. The cartridge reader


152


reads the unique identifier of the cartridge


70


, the drug


75


name, the dosage information, the expiration date, the minimum time between doses, the drug delivery protocol, and any other information stored in the information storage element


76


. The dosage storage element


154


is loaded with information pertaining to the number or remaining doses. If the cartridge


70


has never been used before, then the dosage storage element


154


is initialized with the total number of doses in the cartridge


70


. If the cartridge


70


has already been used, the dosage storage element


154


recalls the number of doses remaining through the use of the unique cartridge identifier.




As an alternative to the unique cartridge identifier, the information storage element


76


located in the cartridge


70


can itself contain a countdown element to determine the number of doses remaining. In this case, the unique cartridge identifier may be eliminated entirely.




Once, loaded, the display preferably displays the number of doses remaining, the drug name, the date, and the time. The dosage storage element


154


also contains information indicating the last time the cartridge


70


was used. The dosage storage element


154


compares this time with the minimum time between doses for the particular drug. If the time interval is too small, the controller


150


will not let the pump


92


operate. Preferably, if the time interval is too small, the controller


150


also signals the display


10


to issue an alarm


20


. The speaker


22


may also notify the patient that not enough time has elapsed.




Once the container


70


is properly loaded and the minimum time between doses has elapsed, the drug can be delivered to the patient. The pump


92


can be primed by depressing the prime pump switch


28


. This might be needed, for example, on the first Use of a new cartridge


70


. On inhalation, the inhalation sensor


58


signals the controller


150


to pump the drug


75


via the pump


92


. The drug


75


delivered to the nebulizer element


100


where the liquid is converted to a cloud or mist of droplets for inhalation. Inhalation of the drug


75


may occur over a rather short time frame, preferably under a minute or so. This is significantly shorter than prior art nebulizers that can take around ten to fifteen minutes to deliver the drug to the patient. It should be understood, however, that a particular drug delivery protocol may require the drug


75


to be delivered over a longer period of time. This information is preferably stored in the information storage element


76


of the cartridge


70


.




In the embodiment with the nozzle


110


, the controller


150


also controls the charge of the nozzle


110


and the charge on the discharge electrode


112


. Minute charged droplets are formed containing a negative charge. These droplets are then attracted to and neutralized by the discharge electrode


112


. The neutralized droplets then pass out of the cartridge


70


and into the patient's lungs.




An optional security feature can also be employed with the device


2


. For example, each electronic control unit


2


may be initialized with a unique patient code. When the cartridges


70


are programmed by the manufacturer or health care provider, the information storage element


76


is also programmed with this patient identification code. During loading of the cartridge


70


, the device


2


compares the code from the cartridge


70


with the code from the electronic control unit


4


. If the patient identification codes from the cartridge


70


and the electronic control unit


2


do not match, then the device


2


will. not operate.




The present device can deliver any number of drugs


75


to a patient. For example, in addition to drugs


75


for the treatment of lung diseases such as asthma, the device


2


can also deliver chemotherapeutics and chemopreventatives to prevent lung cancer. Other examples include anti-infective agents used to treat infection of the lungs. The device can also be used to deliver morphine or insulin to a patient. The device is also useful for the delivery of DNA, proteins, and peptides.




The device


2


, in another aspect of the invention, as seen in

FIG. 6

, transmits patient compliance information to a patient compliance output device


180


. The patient compliance output device


180


can include, for example, a local printer, an offsite database accessible via a local area network (LAN) or a global communications network such as the Internet, a home base station, or a personal computer and the like.




The communications port


32


, depending on its configuration, can transmit data to any number of patient compliance output devices


180


. For example, a serial, parallel, or USB port may be connected via a cable to a local printer (not shown). A network card or a modem can be used to transmit data through a LAN or through the Internet. A RF transmitter or infrared LED can be used to transmit data to a nearby base station.




The information that is transmitted can include such things as the time, date, time between dosages, dosage delivered, etc. for each inhalation. This information can be delivered after each use of the device


2


, or alternatively, at a pre-set time. For example, the device


2


can transmit data upon the switching of the print/send switch


30


. Alternatively, the device


2


might transmit automatically at a pre-programmed time. For instance, the device


2


might be programmed to send data once a week or once a month. This information is used by the patient and/or health care provider to monitor patient compliance.





FIG. 7

illustrates a general schematic representation of a cartridge


70


including a drug storage container


74


having a drug


75


therein. A pump


92


is provided in the cartridge


70


to pump drug


75


into a conduit


94


. The conduit


94


terminates to a head


102


which generates the mist or cloud of drug


75


. The head


102


, which can include the nebulizer element


100


can be found in the cartridge


70


or elsewhere such as in a hand piece


50


or the like (not shown). The cartridge


70


also includes an information storage element


76


that stores data relating to the drug


75


, information relating to delivery of the drug


75


, or information relating to the patient. The information storage element


76


is advantageously programmable. The information storage element


76


can include a programmable chip, RF transmitter, magnetic strip, bar code,or the like. The information or data stored in the information storage element


76


is read by reader which is preferably contained within a hand piece


50


or similar device.




The cartridge


70


is termed a “smart cartridge” in the sense that information pertaining to the drug


75


, the delivery of the drug


75


, and/or patient information is stored within the cartridge


70


. A device with a reading mechanism can then access this information and control drug delivery


75


consistent with the data and/or instructions stored in the cartridge


70


.





FIG. 8

illustrates another embodiment of the cartridge


70


. In this embodiment, the cartridge


70


includes a drug storage container


74


containing the drug


75


and an information storage device


76


. The information storage device


76


is preferably programmable. A port


104


is located in the drug storage container


74


and includes a hollow passageway that is in fluidic communication with the drug storage container


74


. The port


104


can be a male-type port


104


as shown in

FIG. 8

, or alternatively, the port


104


can be a female-type port


104


. During operation, the cartridge


70


is inserted into a device


105


wherein the port


104


engages with a corresponding port


106


in the device


105


. The port


106


is connected to a conduit


107


. The conduit


107


then leads to a pump


108


that delivers the drug


75


to a head


102


or nebulizer element


100


(not shown in FIG.


8


).




In another aspect of the invention, information such as the number of doses remaining, the date and time of the last dose, and drug delivery protocol information can be re-written and stored within the information storage element


76


in the cartridge


70


. This feature is useful when a patient might have multiple electronic control units


4


. For example, a patient might have a device


2


for home use and a separate device


2


at work or at school. The patient might use the home device


2


in the morning and the non-home device


2


in the afternoon. The patient would use the same cartridge


70


for each device


2


. By writing information to the information storage element


76


on the cartridge


70


, the cartridge


70


can effectively be used on different devices


2


. For example, if a patient tried to use the cartridge


70


on his or her device


2


at work soon after using the same cartridge


70


at the home device


2


, the device


2


at work can recognize that not enough time has elapsed between doses. The work device


2


will not deliver the drug


75


until enough time has passed. Similarly, if a patient used the tenth remaining dose at his or her home device


2


and then another dose later in the day on the same cartridge


70


with the work device


2


, the number of remaining doses (eight) would be stored within the cartridge


70


. When the cartridge


70


is later used with the home device


2


, the home device


2


reads that eight doses are remaining the cartridge


70


. In this embodiment the information storage element


76


has read-write capabilities. The information storage element


76


can comprise a read write memory, and preferably, non-volatile memory which can include a memory chip, bubble memory, or the like. The information storage element


76


can also include a bi-directional RF tab, or read-writeable magnetic strip.




While embodiments of the present invention have been shown and described, various modifications may be made without departing from the scope of the present invention. For example, the nebulizer element


100


may be positioned external to the cartridge


70


such as in the hand piece


50


. In addition, the pump


92


might be placed external to the cartridge


70


. The invention, therefore, should not be limited, except to the following claims, and their equivalents.



Claims
  • 1. A pulmonary drug delivery device comprising:an electronic control unit, said electronic control unit including: a controller; a cartridge reader; a display; a hand piece connected to said electronic control unit via a cable; a cartridge having a lumen therethrough, the cartridge being detachably engaged with said hand piece, said cartridge including a drug storage container including a drug stored therein, an electrically chargeable nozzle and a discharge electrode disposed within the lumen of the cartridge, a pump for pumping the drug out of the electrically chargeable nozzle, and an information storage element disposed on the cartridge; wherein the controller controls the pump and the charge of the nozzle and the charge on the discharge electrode in accordance with instructions stored in the information storage element.
  • 2. A pulmonary drug delivery device according to claim 1, said electronic control unit further comprising a dosage storage element.
  • 3. A pulmonary drug delivery device according to claim 2, said dosage storage element storing the number or remaining doses for said cartridge.
  • 4. A pulmonary drug delivery device according to claim 3, said electronic control unit further comprising data transmission means.
  • 5. A pulmonary drug delivery device according to claim 1, said electronic control unit further comprising an alarm.
  • 6. A pulmonary drug delivery device according to claim 1, said hand piece further comprising an inhalation sensor.
  • 7. A pulmonary drug delivery device according to claim 2, the dosage storage element comprises a memory.
  • 8. A pulmonary drug delivery device according to claim 1, wherein the information storage element is programmable.
  • 9. A pulmonary drug delivery device according to claim 8, the information storage element comprises a programmable memory.
  • 10. A pulmonary drug delivery device according to claim 8, the information storage element comprises an RF tag.
  • 11. A pulmonary drug delivery device according to claim 8, the information storage element comprises a bar code.
  • 12. A pulmonary drug delivery device according to claim 8, wherein the information storage element also stores drug identification information.
  • 13. A pulmonary drug delivery device according to claim 8, wherein the information storage element also stores drug delivery protocol.
  • 14. A pulmonary drug delivery device according to claim 8, wherein the information storage element also stores the minimum time between dosages.
  • 15. A pulmonary drug delivery device according to claim 1, wherein said cartridge contains a plurality of doses.
  • 16. A pulmonary drug delivery device according to claim 1, wherein said display displays the number of remaining dosages.
  • 17. A pulmonary drug delivery device for delivering a drug to a patient comprising:an electronic control unit, said electronic control unit including: a controller; a cartridge reader; a dosage storage element; a display; a hand piece connected to said electronic control unit via a cable; and a cartridge having a lumen therethrough, the cartridge being detachably engaged with said hand piece, said cartridge including a drug storage container including a drug stored therein, an electrically chargeable nozzle and a discharge electrode disposed within the lumen of the cartridge, a pump for pumping the drug out of the electrically chargeable nozzle, and an information storage element disposed on the cartridge; wherein the controller controls the pump and the charge of the nozzle and the charge on the discharge electrode in accordance with instructions stored in the information storage element.
  • 18. A pulmonary drug delivery device for delivering a drug to a patient comprising:an electronic control unit, said electronic control unit including: a controller; a cartridge reader; a dosage storage element; data transmission means for transmitting patient compliance information to an output device; a display; a hand piece connected to said electronic control unit via a cable; and a cartridge having a lumen therethrough, the cartridge being detachably engaged with said hand piece, said cartridge including a drug storage container including a drug therein, an electrically chargeable nozzle and a discharge electrode disposed within the lumen of the cartridge, a pump for pumping the drug out of the electrically chargeable nozzle, and an information storage element disposed on the cartridge; wherein the controller controls the pump and the charge of the nozzle and the charge on the discharge electrode in accordance with instructions stored in the information storage element.
  • 19. A pulmonary drug delivery device according to claim 18, said dosage storage element storing the number of remaining doses for said container.
  • 20. A pulmonary drug delivery device according to claim 18, the dosage storage element comprises a memory.
  • 21. A pulmonary drug delivery device according to claim 18, wherein the information storage element is programmable.
  • 22. A pulmonary drug delivery device according to claim 21, the information storage element comprises a programmable memory.
  • 23. A pulmonary drug delivery device according to claim 21, the information storage element comprises an RF tag.
  • 24. A pulmonary drug delivery device according to claim 21, the information storage element comprises a bar code.
  • 25. A cartridge for containing a drug comprising:a lumen region inside the cartridge; a drug storage container for storing the drug; a pump disposed in the cartridge for pumping drug from the storage container to a conduit; an electrically chargeable nozzle coupled to the conduit, the electrically chargeable nozzle disposed so as to aim inside the lumen; a discharge electrode disposed within the lumen of the cartridge; a programmable information storage element disposed on the cartridge, the programmable information storage element containing information regarding operation of the pump and information regarding electrical charges that are to be applied to the electrically chargeable nozzle and the discharge electrode using an external controller.
  • 26. A cartridge according to claim 25, the information storage element comprises a programmable memory.
  • 27. A cartridge according to claim 25, the information storage element comprises an RF tag.
  • 28. A cartridge according to claim 25, the information storage element comprises a bar code.
  • 29. A method of delivering a drug to a patient comprising the steps of:providing an electronic control unit having a hand piece connected thereto; providing a cartridge containing a drug therein, the cartridge further including a lumen therethrough, a drug storage container adapted to contain a drug therein, an electrically chargeable nozzle and a discharge electrode disposed within the lumen, a pump for pumping the drug out of the electrically chargeable nozzle, and an information storage element; engaging the cartridge with the hand piece; retrieving data stored in the information storage element and transmitting the data to the electronic control unit, the data including instructions for pumping the drug and charging the electrically chargeable nozzle and the discharge electrode; and delivering the drug to the patient in accordance with the data transmitted to the electronic control unit.
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