What is claimed:
1. A method of increasing systemic bioavailability of a hormone administered by inhalation comprising:
administering to the respiratory system of a patient or animal in need of said hormone aerodynamically light particles that have a mass mean diameter greater than 5 m, an aerodynamic diameter less than 4.7 m and that include said hormone,
wherein the particles are delivered and deposited to the patient’s or animal’s lungs and the hormone is released in the patient’s or animal’s blood stream for at least 4 hours.
2. The method of claim 1 wherein the hormone is insulin.
3. The method of claim 1 wherein the hormone is testosterone.
4. The method of claim 1 wherein the particles further include a biodegradable material.
5. The method of claim 1 wherein the mass mean diameter is greater than 10 m.
6. The method of claim 1 wherein the mass mean diameter is greater than 20 m.
7. The method of claim 1 wherein the hormone is released in the patient’s or animal’s blood stream for at least 10 hours.
8. The method of claim 1 wherein the hormone is released in the patient’s or animal’s blood stream for at least 24 hours.
9. The method of claim 1 wherein the hormone is released in the patient’s or animal’s blood stream for at least 48 hours.
10. A method of delivering a hormone to the pulmonary system to a patient or animal, comprising:
administering, via inhalation, particles that include a hormone and a biodegradable material, have an aerodynamic diameter less than about 4.7 m and a mass mean diameter greater than about 5 m,
wherein the hormone is delivered and deposited in the patient’s or animal’s lungs and is released in the patient’s or animal’s blood stream for at least 4 hours.
11. A method of increasing the bioavailabilty of a hormone, comprising:
administering to a patient or animal, via inhalation, particles that include a hormone and a biodegradable material, have an aerodynamic diameter less than about 4.7 m and a mass mean diameter greater than about 5 m,
wherein the hormone is delivered and deposited in the patient’s or animal’s lungs and is released in the patient’s or animal’s blood stream for at least 4 hours.
12. A method for making aerodynamically light particles for administration of a hormone to the respiratory tract by inhalation, the method comprising forming particles that include the hormone and a biodegradable material and that have an aerodynamic diameter that is less than 4.7 m and a mass mean diameter that is greater than 5 m.
13. The method of claim 12 wherein the hormone is insulin.
14. The method of claim 12 wherein the hormone is testosterone.
15. The method of claim 12 wherein the mass mean diameter is greater than 10 m.
16. The method of claim 12 wherein the mass mean diameter is greater than 20 m.
17. The method of claim 12 wherein the aerodynamically light particles are made by spray-drying.
18. The method of claim 12 wherein the aerodynamically light particles are made by solvent evaporation.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A cardiac monitor for detecting a cardiac event, the monitor comprising:
(a) a sensor for sensing an analog signal from a human heart;
(b) a device coupled to the sensor, the device having an analog-to-digital circuit system contained therein for digitizing the analog signal to produce a digitized waveform; and
(c) a processor electrically coupled to the analog-to-digital circuit system, said processor configured to:
(i) compute a plurality of values of a heart signal parameter from the digitized waveform;
(ii) compute a plurality of heart rate values associated with the plurality of values of the heart signal parameter;
(iii) store data pertaining to the plurality of values of the heart signal parameter and the plurality of heart rate values;
(iv) select a plurality of heart rate boundaries defining a plurality of heart rate bins, thereby grouping the data pertaining to the plurality of values of the heart signal parameter according to heart rate, wherein the heart rate boundaries are based on a target number of entries in the plurality of heart rate bins;
(v) set a plurality of detection thresholds corresponding to the plurality of heart rate bins;
(vi) determine a first major positive threshold and a first major negative threshold for said heart values in each of said bins;
(vii) determine a number of data entries of said heart values which exist between said first positive and said first negative major thresholds for each bin defining sub-threshold entries;
(viii) sum the number of heart value entries within said first major positive and first major negative thresholds for all of said bins defining a total number of sub-threshold entries;
(ix) set the first major positive and first major negative thresholds to a predetermined set of values if said total number of sub-threshold entries is less than predetermined number of entries needed for ischemia detection, or calculate a minor negative threshold and a minor positive threshold for a selected bin as a function of the sub-threshold entries; and
(x) apply a test to detect a cardiac event, wherein the test is based on at least one of the detection thresholds.
2. The cardiac monitor as recited in claim 1 where processor is further configured to:
(i) compute a median of said heart rate values in a selected bin; data entry deviations as a function of the sub-threshold entries for each bin; and
(ii) calculate a second major positive and negative threshold for a selected bin as a function of the median of said heart rate values and a positive and negative dispersion of heart rate values in said selected bin.
3. The cardiac monitor as recited in claim 2 where the processor is further configured to:
(i) calculate an average positive and negative interval as a function of the second major positive and negative thresholds and said median for a selected bin where the sub-threshold entries are greater than a function of the total number of sub-threshold entries over all bins; and
(ii) calculate a further minor negative and positive threshold within each bin as a function of the positive and negative measure of dispersion and average positive and negative intervals.