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Home Communications Lockout-device-for-controlled-release-of-drug-from-patient-activateddispenser

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 Lockout device for controlled release of drug from patient-activateddispenser

Details
Inventors: Rubsamen, Reid M.; Lloyd, Lester J.; Johansson, Eric T.;
Assignee: Aradigm Corporation (Hayward, CA)
Primary Examiner: Lewis; Aaron J.
Assistant Examiner:
Attorney, Agent or Firm: Bozicevic; Karl Fish & Richardson

A method of controlling access to a drug in an aerosol drug delivery device by an electronic lock and key means is disclosed. Access is limited to the intended user by providing the intended user with a uniquely coded, machine readable key means that matches the unique code of the lock means. Contacting matching lock and key means signals a controlling means to allow use of the device. Specifically, the method is applied to a method of pain control provided by the intrapulmonary delivery of a pharmaceutically active pain relief formulation. The formulation is automatically released from a hand-held, self-contained, portable device comprised of a means for automatically releasing a measured amount of drug into the inspiratory flow path of a patient in response to information obtained from a means for measuring and separately determining inspiratory flow rate and inspiratory volume of a patient. Reproducible dosing is obtained by providing for automatic release in response to a separately measured inspiratory rate and inspiratory volume. To obtain repeatability in dosing the narcotic formulation is repeatedly released at the same measured (1) inspiratory flow rate and (2) inspiratory volume. To maximize the efficiency of the delivery the narcotic formulation is released at (1) a measured inspiratory flow rate in the range of from about 0.10 to about 2.0 liters/second and (2) a measured inspiratory volume in the range of about 0.15 to about 0.8 liters. Abuse of narcotic formulations is avoided by providing a tamper-resistant device which includes a variety of security features including an electronic lock and key means and a pre-programmed microprocessor designed to avoid overdosing.

DETAILED DESCRIPTION The present invention relates to a package containing medicine, the package being constructed so that it is difficult to open the package without contacting a sensor on the package to a mating receptacle (such as a serialized semiconductor) possessed by the patient for whom the medicine is intended.
The mating receptacle bears a machine readable code indicating the identity of the patient that is matched to the package containing the medicine.
Contacting the package sensor to the serialized semiconductor provides a keying feature to allow the patient access to the medicine.
A particular and preferred means for permitting the package to be activated by the patient, a Touch Serial Number (TSN, manufactured by Dallas Semiconductor) as termed herein, includes a semiconductor encoded with a device family code, a unique 48 bit serial number (providing 2.
8.
times.
10.
sup.
14 possible combinations), and a cyclic redundancy check (hereinafter CRC) byte, all housed in a metallic container.
The front surface of the container serves as one electrical contact, while the back and side surfaces of the container serve as the other electrical contact providing a 2-wire serial interface that allows the mating receptacle to be reset; a command word to be written into the TSN; and data to be read from the TSN.
A TSN is preferably attached to a means (such as a bracelet or badge) that allows the patient to wear the TSN.
The package containing the medicine will include a microcomputer programmed with the family code, serial number and CRC byte of the matching TSN and will include a TSN-compatible serial port for contact with the TSN.
Programming of the microcomputer is accomplished by setting the microcomputer to "learn" mode with a command sent by computer via the package's serial port.
The TSN is then contacted to the package's serial port, allowing the microcomputer within the package to read the TSN's data and store the data in the microcomputer's internal non-volatile memory.
In a preferred method of using the device, the user will have approximately three seconds after turning on the package to contact his or her TSN to the serial port



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