Method for treating diabetes mellitus in a patient
First Claim
1. A method of treating diabetes mellitus in a diabetic patient in need thereof, by reproducibly dosing insulin for systemic effect to the patient'"'"'s circulatory system via the patient'"'"'s lungs in order to obtain an acceptable blood glucose level in the diabetic patient thereby reducing or eliminating the need for injection of insulin in the diabetic patient, said method comprising:
- (a) supplying a predetermined amount of powdered insulin to a hand held device, said predetermined amount being in excess of that amount required, in the bloodstream of said patient, to produce or maintain an acceptable serum glucose level in said patient;
(b) exhaling;
(c) contacting said insulin with a compressed gas to form a cloud in said hand held device, said cloud comprising a repeatable amount of insulin, said repeatable amount being in excess of that amount required, in the bloodstream of said patient, to produce or maintain an acceptable serum glucose level in said patient, said cloud comprising insulin particles in the range between 0.5 and 6 microns; and
(d) inhaling said cloud at an inspiratory flow rate in the range of 0.1 to 2.0 liters per second and wherein the inhaling of said cloud occurs with a high volume that comprises 65% to 100% of the patient'"'"'s total lung volume;
(e) producing an acceptable blood glucose level in the diabetic patient, wherein the acceptable blood glucose level is produced by systemically absorbing a controlled dose of insulin that comprises a percentage of the supplied amount of powdered insulin.
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Accused Products
Abstract
The need for the delivery of insulin by injection can be reduced or eliminated by delivering aerosolized insulin. Repeatability of dosing is obtainable by using either regular insulin or monomeric insulin. When delivering insulin (not monomeric) by inhalation, the total inhaled volume should be about the same at each delivery to obtain repeatable results. The patient can be coached (by teaching) to inhale a given amount of air and can also be coached (by teaching) to inhale at a given flow rate. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. A dry powder or a liquid insulin formulation is delivered to the patient from a mechanical or electronic hand-held, self-contained device.
233 Citations
24 Claims
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1. A method of treating diabetes mellitus in a diabetic patient in need thereof, by reproducibly dosing insulin for systemic effect to the patient'"'"'s circulatory system via the patient'"'"'s lungs in order to obtain an acceptable blood glucose level in the diabetic patient thereby reducing or eliminating the need for injection of insulin in the diabetic patient, said method comprising:
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(a) supplying a predetermined amount of powdered insulin to a hand held device, said predetermined amount being in excess of that amount required, in the bloodstream of said patient, to produce or maintain an acceptable serum glucose level in said patient; (b) exhaling; (c) contacting said insulin with a compressed gas to form a cloud in said hand held device, said cloud comprising a repeatable amount of insulin, said repeatable amount being in excess of that amount required, in the bloodstream of said patient, to produce or maintain an acceptable serum glucose level in said patient, said cloud comprising insulin particles in the range between 0.5 and 6 microns; and (d) inhaling said cloud at an inspiratory flow rate in the range of 0.1 to 2.0 liters per second and wherein the inhaling of said cloud occurs with a high volume that comprises 65% to 100% of the patient'"'"'s total lung volume; (e) producing an acceptable blood glucose level in the diabetic patient, wherein the acceptable blood glucose level is produced by systemically absorbing a controlled dose of insulin that comprises a percentage of the supplied amount of powdered insulin. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method of treating diabetes mellitus in a patient in need thereof, by administering insulin replacement therapy for systemic effect delivered by inhalation in order to eliminate or reduce the need for injections of insulin, said method comprising:
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supplying a predetermined amount of powdered insulin to a mechanical hand held device, said predetermined amount being in excess of that amount required, in the bloodstream of said patient, to produce or maintain an acceptable serum glucose level in said patient; contacting said insulin with a compressed gas to form a cloud in a given area of said hand held device, said cloud comprising a repeatable amount of insulin, said repeatable amount being in excess of that amount required, in the bloodstream of said patient, to produce or maintain an acceptable serum glucose level in said patient, said cloud comprising insulin particles in the range between 0.5 and 6 microns; exhaling a determined volume of air; inhaling said cloud at an inspiratory flow rate in the range of 0.1 to 2.0 liters per second and wherein the inhaling of said cloud occurs with a high volume that comprises 65% to 100% of the patient'"'"'s total lung volume; producing an acceptable blood glucose level in the patient, wherein the acceptable glucose level is produced by systemically absorbing a controlled dose of insulin that comprises a percentage of the supplied amount of powdered insulin; repeating the above steps when the patient'"'"'s blood glucose levels rise or are expected to rise above a predetermined range and wherein for each repetition of the inhalation, the patient inhales substantially the same total volume. - View Dependent Claims (10, 11, 12)
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13. A method of administering a controlled and repeatable dose of insulin to a diabetic patient that is sufficient to control the patient'"'"'s blood glucose level, the method comprising the steps of:
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supplying a predetermined amount of dry insulin powder to a hand held mechanical inhalation device; contacting the powder with a volume of air in a given area of the hand held device to form a standing cloud comprised of human insulin particles and air in the given area of the hand held device; exhaling a volume of air; inhaling the insulin and air cloud, followed by continual inhalation with additional air until a determined point of inspiration is reached, wherein the point is a point V(h) corresponding to a high volume and wherein it is determined by coaching (by teaching) the patient to inhale to high volume, which corresponds to 65% to 100% of total lung volume; wherein when the above steps are repeated in order to administer subsequent doses of insulin the patient, as a result of the coaching, inhales each subsequent dose with about the same high volume by inhaling to about the same determined point V(h). - View Dependent Claims (14, 15, 16, 17, 18, 24)
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- 19. The method of 18, wherein the total inhaled volume during the inhalation step is a determined volume that is determined by coaching the patient to perform a specific breathing maneuver.
Specification