1. A hematopoictic growth factor delivery composition, the composition comprising:
a hematopoictic growth factor capable of stimulating hematopoictic cell activity when administered to a mammalian host;
a first biocompatible polymer and a liquid vehicle in which the first biocompatible polymer is at least partially soluble at some temperature, the first biocompatible polymer interacting with the liquid vehicle to impart reverse thermal viscosity behavior to the composition over at least some temperature range, so that the composition is in a lower-viscosity form when the temperature of the composition is at a first temperature within the range and the composition is in a higher-viscosity form when the temperature is at second temperature within the range that is higher than the first temperature; and
a second biocompatible polymer being a protective colloid that inhibits the dissolution into aqueous liquids of the first biocompatible polymer at least when the composition is in the higher-viscosity form;
wherein the liquid vehicle comprises from 60 weight percent to 96 weight percent of the composition, the first biocompatible polymer comprises from 5 weight percent to 33 weight percent of the composition, and the second biocompatible polymer comprises from 0.1 weight percent to 5 weight percent of the composition: and
wherein the hematopietic growth factor comprises G-CSF, the first biocompatible polymer comprises a polyoxyalkylene block copolymer comprising at least one block of a polyoxyethylene and at least one block of a polyoxypropylene, and the second biocompatible polymer comprises a cellulosic polymer.
2. The hematopoictic growth factor delivery composition of claim 1, wherein the first temperature is lower than 20\xb0 C. and the second temperature is higher than 25\xb0 C.
3. The hematopoictic growth factor delivery composition of claim 2, wherein the first temperature is in a range of from 1\xb0 C. to 20\xb0 C. and the second temperature is higher than 25\xb0 C.
4. The hematopoictic growth factor delivery composition of claim 3 wherein the second temperature is 37\xb0 C.
5. The hematopoietic growth factor delivery composition of claim 4, wherein the higher-viscosity form has a viscosity that is at least 3 times as large as the viscosity of the lower-viscosity form.
6. The hematopoietic growth factor delivery composition of claim 1, wherein the lower-viscosity form is a flowable medium and the higher-viscosity form is a gel.
7. The hematopoietic growth factor delivery composition of claim 6, wherein the second biocompatible polymer has an affinity for water such that the second biocompatible polymer inhibits deterioration of the gel by invasion of the composition by aqueous biologic fluids when the composition is administered to a biologic host.
8. A method of packaging and storing the hematopoietic growth factor delivery composition of claim 6, comprising placing the composition in a container when the composition is in the form of the flowable medium and, after the placing, raising the temperature of the composition in the container to convert the composition to the gel for storage, wherein the gel form in the container can be converted back to the form of a flowable medium for administration to the host by lowering the temperature of the composition in the container.
9. The hematopoietic growth factor delivery composition of claim 1, wherein the polyoxyethylene comprises at least 70 weight percent of the first biocompatible polymer.
10. The hematopoietic growth factor delivery composition of claim 1, wherein the polyoxypropylene has the formula (C3H6O)b, where b is an integer.
11. The hematopoictic growth factor delivery composition of claim 1, wherein the polyoxypropylene has the formula.
where b is an integer.
12. The hematopoietic growth factor delivery composition of claim 1, wherein the second biocompatible polymer has a weight average molecular weight of at least 5,000 Daltons.
13. The hematopoictic growth factor delivery composition of claim 1, wherein the cellulosic polymer comprises methylcellulose.
14. The hematopoietic growth factor delivery composition of claim 1, wherein the cellulosic polymer comprises hydroxymethylcellulose.
15. The hematopoietic growth factor delivery composition of claim 1, wherein the cellulosic polymer comprises hydroxyethylcellulose.
16. The hematopoictic growth factor delivery composition of claim 1, wherein the cellulosic polymer comprises hydroxypropyl cellulose.
17. The hematopoietic growth factor delivery composition of claim 1, wherein the cellulosic polymer comprises hydroxypropyl methylcellulose.
18. The hematopoictic growth factor delivery composition of claim 1, wherein the cellulosic polymer comprises carboxymethylcellulose.
19. The hematopoietic growth factor delivery composition of claim 1, wherein the cellulosic polymer comprises ethyl hydroxyethyl cellulose.
20. The hematopoietic growth factor delivery vehicle of claim 1, wherein the second biocompatible polymer has a weight average molecular weight of at least 10,000 Daltons.
21. The hematopoictic growth factor delivery vehicle of claim 1, wherein the liquid vehicle is an aqueous liquid.
22. The hematopoictic growth factor delivery vehicle of claim 1, comprising an antigen.
23. The hematopoietic growth factor delivery composition of claim 1, wherein the composition is contained within an injection device that is actuatable to administer the composition to the host by injection.
24. The hematopoietic growth factor delivery composition of claim 1, wherein the host is a human.
25. A hematopoietic growth factor delivery composition, the composition comprising:
a hematopoietic growth factor capable of stimulating hematopoietic cell activity when administered to a host;
a first biocompatible polymer and a liquid vehicle in which the first biocompatible polymer is at least partially soluble at some temperature, the first biocompatible polymer interacting with the liquid vehicle to impart reverse thermal viscosity behavior to the composition over at least some temperature range, so that the composition is in a lower-viscosity form when the temperature of the composition is at a first temperature within the range and the composition is in a higher-viscosity form when the temperature is at second temperature within the range that is higher than the first temperature; and
a second biocompatible polymer being a protective colloid that inhibits the dissolution into aqueous liquids of the first biocompatible polymer at least when the composition is in the higher-viscosity form;
wherein the liquid vehicle comprises from 60 weight percent to 96 weight percent of the composition, the hematopoietic growth factor comprises from 0.00000001 weight percent to 0.000005 weight percent of the composition, the first biocomipatible polymer comprises from 5 weight percent to 33 weight percent of the composition and the second biocompatible polymer comprises from 0.1 weight percent to 5 weight percent of the composition; and
wherein the hematopoietic growth factor comprises G-CSF, the first biocompatible polymer comprises a polyoxyalkylene block compolymer comprising at least one block of a polyoxyethylene and at least one block of a polylxpropylene, and the second biocompatible polymer comprises a cellulosic polymer.
26. The hematopoietic growth factor delivery composition of claim 25, the first temperature is in a range of from 1\xb0 C. to 20\xb0 C. and the second temperature is in a range of from 25\xb0 C. to 37\xb0 C.
27. The hematopoietic growth factor delivery composition of claim 26, wherein the second biocompatibie polymer has an affinity for water such that the second biocompatible polymer inhibits deterioration of the gel by invasion of the composition by aqueous biologic fluids when the composition is administered to a biologic host.
28. The hematopoietic growth factor delivery composition of claim 25, wherein the cellulosic polymer comprises methylcellulose.
29. The hematopoietic growth factor delivery composition of claim 25, wherein the cellulosic polymer comprises hydroxymethylcellulose.
30. The hematopoietic growth factor delivery composition of claim 25, wherein the cellulosic polymer comprises hydroxyethylcellulose.
31. The hematopoietic growth factor delivery composition of claim 25, wherein the cellulosic polymer comprises hydroxypropyl cellulose.
32. The hematopoietic growth factor delivery composition of claim 25, wherein the cellulosic polymer comprises hydroxypropyl methylcellulose.
33. The hematopoietic growth factor delivery composition of claim 25, wherein the cellulosic polymer comprises carboxymethylcellulose.
34. The hematopoietic growth factor delivery composition of claim 25, wherein the cellulosic polymer comprises ethyl hydroxyethyl cellulose.
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 diagnostic device comprising
at least one pair of electrodes for attachment to a patient and an electrical circuit connected to the electrodes for delivering therapeutic energy to the patient;
a sensor for monitoring autonomic nervous system activity of the patient and providing a series of outputs indicative of the activity; and
a recorder for storing the outputs.
2. The diagnostic device of claim 1 wherein the sensor is a heart rate sensor.
3. The diagnostic device of claim 1 wherein the sensor is a blood pressure monitor.
4. The diagnostic device of claim 1 wherein the sensor is a skin resistivity sensor.
5. The diagnostic device of claim 1 wherein the sensor is an iris pupil diameter measuring device.
6. The diagnostic device of claim 1 wherein the circuit has the capability of producing at least one carrier frequency and at least one beat frequency differing from the carrier frequency for delivering therapeutic electrical interferential energy to the patient.
7. The diagnostic device of claim 6 wherein the recorder comprises a data processor having a calculating device for manipulating the sensor outputs and providing a data processor output representative of the reaction of the patient to the electrical interferential energy.
8. The diagnostic device of claim 6 wherein the recorder comprises a data processor having a calculating device for manipulating the sensor outputs and providing a data processor output representative of sympathetic nervous system activity and parasympathetic nervous system activity.
9. The diagnostic device of claim 6 wherein the recorder comprises a data processor having a calculating device for manipulating the sensor outputs and providing a data processor output representing a ratio of sympathetic nervous system activity and parasympathetic nervous system activity.
10. The diagnostic device of claim 1 wherein the circuit is capable of producing electrical energy.
11. The diagnostic device of claim 1 wherein the circuit is capable of producing electromagnetic energy.
12. An interferential diagnostic device comprising
a pair of electrodes for attachment to a patient and a circuit connected to the electrodes for producing a carrier frequency and a beat frequency differing from the carrier frequency for delivering electrical interferential energy to the patient;
a sensor for monitoring autonomic nervous system activity of the patient and providing a series of outputs indicative of the activity; and
a system for monitoring the sensor outputs for determining which beat frequency produces an desired reaction of the autonomic nervous system.
13. The electrical interferential diagnostic device of claim 12 wherein the circuit includes a subcircuit for adjusting the carrier frequency and the system determines which combination of carrier and beat frequencies that produce a desired reaction of the autonomic nervous system.
14. The electrical interferential diagnostic device of claim 11 wherein the sensor is a heart rate sensor.
15. The electrical interferential diagnostic device of claim 11 wherein the recorder comprises a data processor having a calculating device for manipulating the sensor outputs and providing a data processor output representative of the reaction of the patient to the electrical interferential energy.
16. The electrical interferential diagnostic device of claim 11 wherein the recorder comprises a data processor having a calculating device for manipulating the sensor outputs and providing a data processor output representative of sympathetic nervous system activity and parasympathetic nervous system activity.
17. The electrical interferential diagnostic device of claim 11 wherein the recorder comprises a data processor having a calculating device for manipulating the sensor outputs and providing a data processor output representing a ratio of sympathetic nervous system activity and parasympathetic nervous system activity.
18. A method of determining a preferred treatment regimen for a patient, comprising
applying a series of different treatments to a patient and sensing autonomic nervous system activity of the patient in response to the treatments; and
selecting a preferred one of the treatments for the patient based on the response to the series of treatments.
19. The method of claim 18 further comprising applying a series of the preferred treatments to the patient.
20. The method of claim 18 wherein the electrical treatments comprise electrical interferential treatments.
21. The method of claim 18 wherein the series of treatments produces a variety of responses of the sympathetic and parasympathetic nervous systems and the preferred one of the treatments is a treatment that promotes activity of the parasympathetic nervous system relative to activity of the sympathetic nervous system.
22. The method of claim 18 wherein the step of sensing comprises sensing heart rate variability.
23. The method of claim 18 wherein the applying step comprises placing at least a pair of electrodes on the patient, delivering energy through the electrodes and recording the reaction of the autonomic nervous system and then varying the position of the pair of electrodes, delivering energy through the electrodes and recording the reaction of the autonomic nervous system.