Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2001-06-15
2003-09-02
Brumback, Brenda (Department: 1654)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S003100, C514S008100, C530S849000, C424S001450
Reexamination Certificate
active
06613736
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the treatment of eye and nerve diseases in diabetic and non-diabetic patients. More specifically, the invention relates to a system and method for treating eye and nerve diseases in diabetic and non-diabetic patients with Chronic Intermittent Intravenous Insulin Therapy.
BACKGROUND OF THE INVENTION
Diabetic retinopathy is a major cause of blindness in the United States. While earlier detection and major advances in laser therapies have made significant impact on this chronic complication of diabetes, the number of diabetic patients suffering from diabetic retinopathy continues to increase. The Diabetes Control and Complication Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS) have both documented the benefit of tight blood glucose control on diabetic retinopathy and peripheral neuropathy. However, it is clear that tight blood glucose control was insufficient in 25% or more of the study participants to protect them from the onset or progression of diabetic retinopathy or neuropathy. It can be inferred that the number of patients who continued with tight control and nevertheless suffered from retinopathy and neuropathy would increase as time progressed. Indeed, during the first 1 to 1.5 years of studies designed to determine if tight blood glucose control would lessen diabetic complications, diabetic retinopathy actually increased dramatically in the tightly controlled patients. Other physicians have noted this increase in diabetic retinopathy in patients undergoing an acute and significant improvement in their blood glucose control. In the past, such worsening of diabetic retinopathy was attributed to decreased blood circulation in the retina and a consequent diminution in oxygen delivery to that tissue. However, such an explanation seemed less than credible in view of the short time course (1-1.5 years) and especially to the temporal relationship to the dramatic improvement in blood glucose control. This dichotomy suggested that the sudden worsening/appearance of diabetic retinopathy and other indications of neuropathy were linked to the fall in fasting, postprandial, and interprandial blood glucose levels.
What is needed is a system and method that increases retinal and neural glucose oxidation by enhancing pyruvate dehydrogenase activity and therefore treat retinopathy and central nervous system disorders in both diabetic and non-diabetic patients.
SUMMARY
Accordingly, the present invention is a system and method capable of increasing retinal and neural glucose oxidation by enhancing pyruvate dehydrogenase activity and therefore treats retinopathy and central nervous system disorders in both diabetic and non-diabetic patients. The current invention is the treating of eye and nerve diseases using insulin pulses to a patient utilizing Chronic Intermittent Intravenous Insulin Therapy to achieve an increase in retinal and neural glucose oxidation by enhancing pyruvate dehydrogenase activity, therefore treating retinopathy and central nervous system disorders in both diabetic and non-diabetic patients.
One preferred embodiment of the invention is a system for treating eye and nerve diseases in diabetic and non-diabetic patients through an intravenous administration of a pulse of insulin comprises a means for determining a respiratory quotient of a patient, a liquid or food containing glucose, an intravenous site, and a means of delivering a pulse of insulin at a regular interval of time.
In the preferred embodiment of the treatment system, any instrument capable of measuring the respiratory quotient determines a respiratory quotient of a patient. The respiratory quotient is defined as the ratio of carbon dioxide produced to oxygen consumed by the patient. In the preferred embodiment, a liquid or food containing glucose is consumed by the patient to prevent hypoglycemia. The preferred liquid or food containing glucose is GLUCOLA, however any similar liquid or food containing glucose that will prevent hypoglycemia in the patient may be used.
The preferred means of delivering insulin is an infusion device. It is preferable that the infusion device is capable of providing pulses of insulin on a prearranged interval, so long as there is sufficient glucose in the blood to keep the patient from becoming hypoglycemic. The preferred infusion device is also capable of delivering the pulses of insulin in as short duration of time as possible, without adversely affecting the vein at the site of infusion is used. However, less accurate devices may deliver the pulses and achieve the needed infusion profile of approximately six minutes.
In the preferred embodiment, the intravenous site is a temporary or permanent IV access site located in the body, forearm or hand of the patient. The amount of insulin is tailored to achieve increased retinal and neural glucose oxidation by enhanced pyruvate dehydrogenase activity. One method of monitoring retinal and neural glucose oxidation is PET scans. Alternatively, one may look for stabilization/reversal of diabetic retinopathy. In terms of neural function, there will be increased perception of sensation, especially in the feet, and a loss of the very painful “burning” or “pins and needles” sensation in the feet. There will also be improvement in autonomic neuropathy, especially gastroparesis and improvement in postural or orthostatic hypotension. Type 1 diabetic patients receive 20-35 milliunits of insulin per kilogram of body weight per pulse and type 2 diabetic patients receive 70-200 milliunits of insulin per kilogram of body weight per pulse. During periods of non-use, the IV site is preferably converted to a heparin or saline lock.
In one embodiment of the method of the invention, the patient is seated in a blood drawing chair and a 23 gauge needle/catheter is inserted into a body, hand or forearm vein to obtain vascular access. Although a 23 gauge needle catheter is preferred, any system of such access may accomplish the needed result, including indwelling catheters. After a short equilibration period, usually thirty minutes, the respiratory quotient (the ratio of carbon dioxide produced to oxygen consumed by the patient) of the patient is measured. The respiratory quotient measuring device may be any presently known model manufactured by any presently known supplier of such instruments. In the preferred embodiment, the patient is then asked to drink or eat liquid or food containing glucose usually on the order of 60 to 100 grams of glucose. In the preferred embodiment a pulse of insulin is administered intravenously on a regular interval of time, usually every six minutes, until the respiratory quotient (RQ) shows improvement, as indicated by a respiratory quotient of 0.90 or greater. In the preferred embodiment, improvement in RQ is generally achieved within one hour. In the preferred embodiment, the insulin/oral glucose phase is then followed by a rest period of usually one hour. In the preferred embodiment the entire procedure repeated until the desired effect is achieved.
The preferred method of insulin pulse delivery would be a prearranged interval, so long as there is sufficient glucose in the blood to keep the patient from becoming hypoglycemic. In order to determine the progress of the patient, it is preferable the RQ is measured every hour and blood glucose levels are checked every 30 minutes. The blood glucose level may be measured by any means which shows that the patient is not becoming hypoglycemic. In the preferred embodiment, the patient is free to move around after the initial insulin pulses have been administered. In the preferred embodiment, the intravenous site is converted to a heparin or saline lock. The patient returns to the blood drawing chair to receive their next series of insulin pulses. In the preferred embodiment, the subsequent insulin pulses must be covered by supplying glucose by mouth or other means. The total time of the preferred procedure is approximately 6-7 hours.
In the preferred embodiment, two successive days of three treatments are perfo
Brumback Brenda
Masamori Eric G.
Teller Roy
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