Surgery – Liquid medicament atomizer or sprayer
Reexamination Certificate
2002-06-20
2003-09-09
Lewis, Aaron J. (Department: 3761)
Surgery
Liquid medicament atomizer or sprayer
C128S200160, C128S202250, C128S204210
Reexamination Certificate
active
06615825
ABSTRACT:
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 pulmonary drug delivery device includes a hand piece that is electrically connected to a control unit. A cartridge is engagable with the hand piece and includes a drug reservoir, a pump connected to the drug reservoir, an electrically chargeable nozzle connected to the pump, a discharge electrode, and an information storage element. The control unit controls the pump and the electrical charge of the nozzle and discharge electrode in accordance with instructions stored within the information storage element.
In a second aspect of the invention, a method of delivering a drug to a patient includes the steps of providing a pulmonary drug delivery device having a hand piece electrically connected to a control unit. A cartridge is provided containing the drug in a drug reservoir. The cartridge includes a pump connected to the reservoir, an electrically chargeable nozzle coupled to the pump, and a discharge electrode, and an information storage element. The cartridge is engaged with the hand piece and data is retrieved from the information storage element using the control unit. The data includes instructions for pumping the drug and charging the electrically chargeable nozzle and the discharge electrode. The drug is delivered to the patient in accordance with the data stored in the information storage element.
It is an object of the invention to create a pulmonary drug delivery 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.
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Lewis Aaron J.
Sensormedics Corporation
Sidley Austin Brown & Wood LLP
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