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WO2007072147A2 - Composition for diagnosing and treating circulatory system diseases - Google Patents

Composition for diagnosing and treating circulatory system diseases Download PDF

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Publication number
WO2007072147A2
WO2007072147A2 PCT/IB2006/003630 IB2006003630W WO2007072147A2 WO 2007072147 A2 WO2007072147 A2 WO 2007072147A2 IB 2006003630 W IB2006003630 W IB 2006003630W WO 2007072147 A2 WO2007072147 A2 WO 2007072147A2
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WO
WIPO (PCT)
Prior art keywords
circulatory system
composition
system diseases
diagnosing
solution
Prior art date
Application number
PCT/IB2006/003630
Other languages
French (fr)
Other versions
WO2007072147A3 (en
Inventor
Pieter Theo Ernst
Original Assignee
Ernst, Johanna, Catarina
Ernst, Pieter, Benjamin
Ernst, Hugo, Alexander
Ernst, Maxwell, Theodore
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2005907104A external-priority patent/AU2005907104A0/en
Application filed by Ernst, Johanna, Catarina, Ernst, Pieter, Benjamin, Ernst, Hugo, Alexander, Ernst, Maxwell, Theodore filed Critical Ernst, Johanna, Catarina
Publication of WO2007072147A2 publication Critical patent/WO2007072147A2/en
Publication of WO2007072147A3 publication Critical patent/WO2007072147A3/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A61K31/51—Thiamines, e.g. vitamin B1
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525—Isoalloxazines, e.g. riboflavins, vitamin B2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/727—Heparin; Heparan
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/0004—Homeopathy; Vitalisation; Resonance; Dynamisation, e.g. esoteric applications; Oxygenation of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Definitions

  • This invention relates to a composition for diagnosing and for treating circulatory system diseases and to a method of diagnosing and treating circulatory system diseases using the composition.
  • vascular disorders are one of the leading causes of ill health and premature death in many mammals and particularly humans. Common causes of vascular disorders include genetic factors, age, lifestyle and diet. Depending on the cause, the most common form of treatment for vascular diseases are diet, lipid and cholesterol lowering drugs, and surgery.
  • compositions for diagnosing and for treating circulatory system diseases in a mammal comprising a first solution which contains magnesium sulphate, heparin sodium, sodium bicarbonate in electro-potentiated water and a second solution which contains ascorbic acid, lignocaine, vitamin B12, thiamin, riboflavin, nicotinamide, pyridoxine, D-pantothenol in electro-potentiated water , the first and second solutions being mixable prior to administration by injection into a mammal suffering from a vascular occlusion disorder.
  • the first solution contains between 20 and 30 g/1000 ml, preferably 24.4 g/1000 ml of magnesium sulphate; between 0.200 and 0.300 g/1000 ml, preferably 0.226 g/1000 ml of heparin sodium; and between 15 to 25 g/1000 ml, preferably 20.800g/1000 ml of sodium bicarbonate.
  • the second solution contains between 20 and 30 g/1000 ml, preferably 24.4 g/1000 ml of ascorbic acid; between 15 and 25 g/1000 ml, preferably 21.4 g/1000 ml lignocaine; between 0.03 and 0.05 g/1000 ml, preferably 0.04 g/1000 ml vitamin B12; between 0.35 to 0.45 g/1000 ml, preferably 0.37 g/1000 ml thiamin; between 0.05 and 0.10 g/1000 ml, preferably 0.074 g/1000 ml ribovlavin; between 0.05 and 0.15 g/1000 ml, preferably 0.10 g/1000 ml nicotinamide; and between 0.150 to 0.250 g/1000 ml, preferably 0.184 g/1000 ml D-pantethol.
  • first and second solutions are made up in glass vials to 10 ml each and for the pH of the first solution, when made up to be between 8.0 and 8.40 and for the pH of the second solution, when made up to be between 2.9 and 3.6 and for the mixed, prior to administration solution to have a volume of 20 ml, a pH of between 6.8 and 7.4 and an ORP of between - 40mv and -90mv.
  • electro-potentiated water used in the solutions to have an oxygen reduction potential (ORP) of 730 mv and a pH between of 7.2 and 7.9 and for the electro-potentiated to be prepared by adding 750mg of sodium bicarbonate to 1000ml of water (USP) and placing the resulting solution in an induction system with the current set to a value where the Oxygen
  • ORP Reduction Potential
  • the invention also provides for the mixed, prior to administration solution to be administrable by direct injection, preferably into the femoral artery at groin level, into a mammal, preferably a human, alternatively for the mixed, prior to administration solution to be added to a saline solution, preferable a 200 ml saline solution, and for it to be administrable as an intravenous drip.
  • the invention provides further for a method of treating circulatory system diseases comprising administering a composition as described above to a mammal, preferably a human, in need thereof.
  • a mammal preferably a human
  • the method to be used to treat mammals, preferably humans, to bypass partially occluded blood vessels by stimulating ancillary blood vessel development, for the method to be used to treat blood vessel disorders associated with a decreased blood supply, and for the method to be used as a therapeutic adjunct to promote blood vessel development prior to bypass surgery and/or angioplasty.
  • the method to be used to treat a condition selected from the group of conditions consisting of: transient ischemic attack, arterial hypertension, diabetic retinopathy, erectile dysfunction, Raynaud's disease, coronary artery disease, memory and cognitive deficits associated with inadequate blood supply to brain, arterial leg ulcers, and venal leg ulcers.
  • the invention also provides for a method of diagnosing circulatory system diseases in a human patient comprising injecting, intra-arterially and preferably into the femoral artery at groin level, 20 ml of the above described solution into the patient and monitoring the patients post injection thermal sensitivity and/or perceptions of thermal sensitivity.
  • the first solution is prepared from the following constituents in the following concentrations: CONSTITUENT AMOUNT IN ⁇ /1000 ml SOLUTION Magnesium Sulphate 24.400
  • the above constituents are made up to 1000 ml by adding electro-potentiated water prepared as described below and the solution is stored in 10 ml aliquots in 10 ml clear glass vials until ready for use.
  • the solution should have a pH of between 8.0 and 8.4
  • the second solution is prepared from the following constituents in the following concentrations:
  • Vitamin B12 0.040
  • the above constituents are made up to 1000 ml by adding electro-potentiated water prepared as described below and the solution is stored in 10 ml aliquots in 20 ml amber glass vials until ready for use.
  • the solution should have a pH of between 2.9 and 3.6. 3. Preparation of electro-potentiated water.
  • Each litre or 1000 ml of electro-potentiated water is prepared by adding 750mg of sodium bicarbonate is added to 1000ml of water (USP) and the resulting solution placed in an induction system with the current is set to a value where the Oxygen Reduction Potential (ORP) reading after 2 minutes of current flow is 878 mv and the anodal stream is used.
  • the electro-potentiated water solution so produced should have an ORP of 730 mv and a pH of 7.2 - 7.9.
  • a ready to use of administrable solution is prepared by adding the contents of the clear 10ml vial holding 10 ml of the first solution is to the 20 ml amber vial holding 10 ml of the second solution.
  • the amber vial now holds 20 ml of the Ready to use or administrable solution.
  • the pH of the Ready to use or administrable solution should be between 6.8 and 7.4 and it should have an Oxygen Reduction Potential (ORP) of between -40mv and -90mv.
  • Intravenous treatment is typically administered over a period of 60-90 minutes and each injection of the solution comprises one treatment.
  • patients typically receive 20-40 treatments at a frequency of once or twice a week. It has been found that the above described treatments are effective in the treatment of diseases which are a consequence of disorders of the circulatory system.
  • disorders that have responded to the treatment include:
  • the undiluted administrable solution can also be injected intra-arterially in an affected limb and, when injected intra-arterially, it can be used to diagnose the severity of the vascular disorder in the injected limb.
  • a patient On intra-arterial injection, a patient will describe a feeling of warmth in all or part of the injected limb. If the entire limb feels 'warm' during the injection of the solution, then the circulatory disorder in the limb is either slight or non-existent.
  • a peripheral part of the limb is unaffected by the intra- arterial injection of the solution, then this indicates a significant circulatory disorder in that portion of the limb that is unaffected by injection.
  • the location of the arterial blockage is indicated by the location of the border between the affected and unaffected portion of the limb.
  • an injection of the solution into the femoral artery at the level of the groin will be associated with a feeling of warmth in the injected limb. If this feeling only extends to the knee, then this indicates that the major arterial obstruction is located at or immediately proximal to the level of the knee. On the other hand, if the feeling of warmth extends to the ankle, then the arterial obstruction is located at or immediately proximal to the ankle.
  • Serial arterial injections of the solution can also be used to monitor the response to treatment by noting changes in the location of the border between the affected (warm sensation) and unaffected region of the treated limb.
  • this invention provides a novel approach to treating blood vessel disease by stimulating the natural development of new blood vessels (angiogenesis) that bypass blood vessels that are partially blocked and it has been shown to be useful in the treatment of chronic degenerative diseases and as a therapeutic adjunct prior to by-pass surgery or angioplasty.
  • angiogenesis new blood vessels
  • the invention can, as described above, be used to determine the approximate location of an arterial obstruction affecting one or more limbs and can also be used to monitor responses to treatment.

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Alternative & Traditional Medicine (AREA)
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  • Urology & Nephrology (AREA)
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Abstract

This invention relates to a composition for diagnosing and for treating circulatory system diseases by administering a composition which comprises a first solution which contains magnesium sulphate, heparin sodium, sodium bicarbonate in electro-potentiated water and a second solution which contains ascorbic acid, lignocaine, vitamin B12, thiamin, riboflavin, nicotinamide, pyridoxine, D-pantothenol in electro-potentiated water. The first and second solutions are mixed prior to administration by injection into a mammal suffering from a vascular occlusion disorder. The invention also extends to a method of treating vascular disorders and to a method of diagnosing circulatory system diseases both using the composition.

Description

COMPOSITION FOR DIAGNOSING AND TREATING CIRCULATORY
SYSTEM DISEASES
FIELD OF THE INVENTION
This invention relates to a composition for diagnosing and for treating circulatory system diseases and to a method of diagnosing and treating circulatory system diseases using the composition.
BACKGROUND TO THE INVENTION
Vascular disorders are one of the leading causes of ill health and premature death in many mammals and particularly humans. Common causes of vascular disorders include genetic factors, age, lifestyle and diet. Depending on the cause, the most common form of treatment for vascular diseases are diet, lipid and cholesterol lowering drugs, and surgery.
Diet is a temporary measure at best and its success depends on the cause of the vascular disorder. Lipid and cholesterol lowering drugs can be effective, again depending on the cause of the vascular disorder and the degree to which it has progressed, but they are expensive and are normally taken for the remainder of the life of the sufferer. Surgery is effective but, because it is invasive and often involves bypassing major blood vessels that lead into the heart, it carries with it significant risks which are greater in the case of aged and physically unfit persons, which represent the population grouping most likely to require surgery to combat vascular disease. In addition, the above-described common forms of treatment of vascular diseases have a limited effectiveness and, in most cases, they are only able to slow the progression of the disease.
OBJECT OF THE INVENTION
It is an object of this invention to provide a composition for diagnosing and for treating circulatory system diseases which, at least party, offer an alternative to the above-described common forms of treatment of vascular diseases and to a method of diagnosing and treating circulatory system diseases using the composition.
SUMMARY OF THE INVENTION
In accordance with this invention there is provided a composition for diagnosing and for treating circulatory system diseases in a mammal said composition comprising a first solution which contains magnesium sulphate, heparin sodium, sodium bicarbonate in electro-potentiated water and a second solution which contains ascorbic acid, lignocaine, vitamin B12, thiamin, riboflavin, nicotinamide, pyridoxine, D-pantothenol in electro-potentiated water , the first and second solutions being mixable prior to administration by injection into a mammal suffering from a vascular occlusion disorder.
There is also provided for the first solution to contain between 20 and 30 g/1000 ml, preferably 24.4 g/1000 ml of magnesium sulphate; between 0.200 and 0.300 g/1000 ml, preferably 0.226 g/1000 ml of heparin sodium; and between 15 to 25 g/1000 ml, preferably 20.800g/1000 ml of sodium bicarbonate.
There is also provided for the second solution to contain between 20 and 30 g/1000 ml, preferably 24.4 g/1000 ml of ascorbic acid; between 15 and 25 g/1000 ml, preferably 21.4 g/1000 ml lignocaine; between 0.03 and 0.05 g/1000 ml, preferably 0.04 g/1000 ml vitamin B12; between 0.35 to 0.45 g/1000 ml, preferably 0.37 g/1000 ml thiamin; between 0.05 and 0.10 g/1000 ml, preferably 0.074 g/1000 ml ribovlavin; between 0.05 and 0.15 g/1000 ml, preferably 0.10 g/1000 ml nicotinamide; and between 0.150 to 0.250 g/1000 ml, preferably 0.184 g/1000 ml D-pantethol.
There is further provided for the first and second solutions to be made up in glass vials to 10 ml each and for the pH of the first solution, when made up to be between 8.0 and 8.40 and for the pH of the second solution, when made up to be between 2.9 and 3.6 and for the mixed, prior to administration solution to have a volume of 20 ml, a pH of between 6.8 and 7.4 and an ORP of between - 40mv and -90mv.
There is also provided for the electro-potentiated water used in the solutions to have an oxygen reduction potential (ORP) of 730 mv and a pH between of 7.2 and 7.9 and for the electro-potentiated to be prepared by adding 750mg of sodium bicarbonate to 1000ml of water (USP) and placing the resulting solution in an induction system with the current set to a value where the Oxygen
Reduction Potential (ORP) reading after 2 minutes of current flow is 878 mv and the anodal stream used.
The invention also provides for the mixed, prior to administration solution to be administrable by direct injection, preferably into the femoral artery at groin level, into a mammal, preferably a human, alternatively for the mixed, prior to administration solution to be added to a saline solution, preferable a 200 ml saline solution, and for it to be administrable as an intravenous drip.
The invention provides further for a method of treating circulatory system diseases comprising administering a composition as described above to a mammal, preferably a human, in need thereof. There is also provided for the method to be used to treat mammals, preferably humans, to bypass partially occluded blood vessels by stimulating ancillary blood vessel development, for the method to be used to treat blood vessel disorders associated with a decreased blood supply, and for the method to be used as a therapeutic adjunct to promote blood vessel development prior to bypass surgery and/or angioplasty.
There is further provided for the method to be used to treat a condition selected from the group of conditions consisting of: transient ischemic attack, arterial hypertension, diabetic retinopathy, erectile dysfunction, Raynaud's disease, coronary artery disease, memory and cognitive deficits associated with inadequate blood supply to brain, arterial leg ulcers, and venal leg ulcers.
The invention also provides for a method of diagnosing circulatory system diseases in a human patient comprising injecting, intra-arterially and preferably into the femoral artery at groin level, 20 ml of the above described solution into the patient and monitoring the patients post injection thermal sensitivity and/or perceptions of thermal sensitivity.
EXAMPLES
The above and additional features of the invention will be apparent from the following non-limiting description of a preferred embodiment of a composition for diagnosing and for treating circulatory system according to the invention.
1. Preparation of the first solution.
The first solution is prepared from the following constituents in the following concentrations: CONSTITUENT AMOUNT IN α/1000 ml SOLUTION Magnesium Sulphate 24.400
Heparin Sodium 0.226
Sodium Bicarbonate 20.800
The above constituents are made up to 1000 ml by adding electro-potentiated water prepared as described below and the solution is stored in 10 ml aliquots in 10 ml clear glass vials until ready for use. The solution should have a pH of between 8.0 and 8.4
2. Preparation of the second solution.
The second solution is prepared from the following constituents in the following concentrations:
CONSTITUENT AMOUNT IN q/1000 ml SOLUTION
Ascorbic Acid 24.400
Lignocaine 21.400
Vitamin B12 0.040
Thiamin 0.370
Riboflavin 0.074
Nicotinamide 0.100
Pyridoxine 0.184
D-Pantothenol 0.184
As with the first solution, the above constituents are made up to 1000 ml by adding electro-potentiated water prepared as described below and the solution is stored in 10 ml aliquots in 20 ml amber glass vials until ready for use. The solution should have a pH of between 2.9 and 3.6. 3. Preparation of electro-potentiated water.
Each litre or 1000 ml of electro-potentiated water is prepared by adding 750mg of sodium bicarbonate is added to 1000ml of water (USP) and the resulting solution placed in an induction system with the current is set to a value where the Oxygen Reduction Potential (ORP) reading after 2 minutes of current flow is 878 mv and the anodal stream is used. The electro-potentiated water solution so produced should have an ORP of 730 mv and a pH of 7.2 - 7.9.
4. Preparation of "Ready to use" composition.
When it is necessary to administer the composition according to the invention a ready to use of administrable solution is prepared by adding the contents of the clear 10ml vial holding 10 ml of the first solution is to the 20 ml amber vial holding 10 ml of the second solution. The amber vial now holds 20 ml of the Ready to use or administrable solution. The pH of the Ready to use or administrable solution should be between 6.8 and 7.4 and it should have an Oxygen Reduction Potential (ORP) of between -40mv and -90mv.
5. Administration.
A. To treat circulatory disorders.
Conventionally the administrable solution is added to a 200 ml saline solution for intravenous administration. Intravenous treatment is typically administered over a period of 60-90 minutes and each injection of the solution comprises one treatment. For maximum effectiveness patients typically receive 20-40 treatments at a frequency of once or twice a week. It has been found that the above described treatments are effective in the treatment of diseases which are a consequence of disorders of the circulatory system.
Examples of disorders that have responded to the treatment include:
Intermittent Claudication,
Transient Ischemic Attack,
Arterial Hypertension,
Diabetic Retinopathy, Erectile dysfunction,
Raynaud's Disease,
Coronary Artery Disease,
Memory and cognitive deficits associated with inadequate blood supply to brain, Arterial Leg Ulcers, and
Venal Leg Ulcers.
B. To diagnose the severity of vascular disorder of an affected limb.
As an alternative to intravenous administration the undiluted administrable solution can also be injected intra-arterially in an affected limb and, when injected intra-arterially, it can be used to diagnose the severity of the vascular disorder in the injected limb.
On intra-arterial injection, a patient will describe a feeling of warmth in all or part of the injected limb. If the entire limb feels 'warm' during the injection of the solution, then the circulatory disorder in the limb is either slight or non-existent.
By contrast, if a peripheral part of the limb is unaffected by the intra- arterial injection of the solution, then this indicates a significant circulatory disorder in that portion of the limb that is unaffected by injection. The location of the arterial blockage is indicated by the location of the border between the affected and unaffected portion of the limb. For example, an injection of the solution into the femoral artery at the level of the groin will be associated with a feeling of warmth in the injected limb. If this feeling only extends to the knee, then this indicates that the major arterial obstruction is located at or immediately proximal to the level of the knee. On the other hand, if the feeling of warmth extends to the ankle, then the arterial obstruction is located at or immediately proximal to the ankle.
Serial arterial injections of the solution can also be used to monitor the response to treatment by noting changes in the location of the border between the affected (warm sensation) and unaffected region of the treated limb.
It is envisaged that this invention provides a novel approach to treating blood vessel disease by stimulating the natural development of new blood vessels (angiogenesis) that bypass blood vessels that are partially blocked and it has been shown to be useful in the treatment of chronic degenerative diseases and as a therapeutic adjunct prior to by-pass surgery or angioplasty.
In addition, the invention can, as described above, be used to determine the approximate location of an arterial obstruction affecting one or more limbs and can also be used to monitor responses to treatment.

Claims

1. A composition for diagnosing and for treating circulatory system diseases in a mammal, characterised in that the composition comprises a first solution which contains magnesium sulphate, heparin sodium, sodium bicarbonate in electro-potentiated water and a second solution which contains ascorbic acid, lignocaine, vitamin B12, thiamin, riboflavin, nicotinamide, pyridoxine, D-pantothenol in electro-potentiated water , the first and second solutions being mixable prior to administration by injection into a mammal suffering from a vascular occlusion disorder.
2. A composition for diagnosing and for treating circulatory system diseases as claimed in claim 1 characterised in that the first solution contains between 20 and 30 g/1000 ml of magnesium sulphate, between 0.200 and 0.300 g/1000 ml of heparin sodium, and between 15 to 25 g/1000 ml of sodium bicarbonate.
3. A composition for diagnosing and for treating circulatory system diseases as claimed in claim 2 characterised in that the first solution contains 24.4 g/1000 ml of magnesium sulphate, 0.226 g/1000 ml of heparin sodium, and 20.800g/1000 ml of sodium bicarbonate.
4. A composition for diagnosing and for treating circulatory system diseases as claimed in any one of the preceding claims characterised in that the second solution contains between 20 and 30 g/1000 ml ascorbic acid, between 15 and 25 g/1000 ml lignocaine, between 0.03 and 0.05 g/1000 ml vitamin B12, between 0.35 to 0.45 g/1000 ml thiamin, between 0.05 and 0.10 g/1000 ml ribovlavin, between 0.05 and 0.15 g/1000 ml nicotinamide and between 0.150 to 0.250 g/1000 ml D-pantethol.
5. A composition for diagnosing and for treating circulatory system diseases as claimed in claim 4 characterised in that the second solution contains 24.4 g/1000 ml of ascorbic acid, 21.4 g/1000 ml lignocaine, 0.04 g/1000 ml vitamin B12, 0.37 g/1000 ml thiamin, 0.074 g/1000 ml ribovlavin, 0.10 g/1000 ml nicotinamide and 0.184 g/1000 ml D-pantethol.
6. A composition for diagnosing and for treating circulatory system diseases as claimed in any one of the preceding claims characterised in that the first and second solutions are made up in glass vials to 10 ml each.
7. A composition for diagnosing and for treating circulatory system diseases as claimed in any one of the preceding claims characterised in that the pH of the first solution, when made up is between 8.0 and 8.40 and the pH of the second solution, when made up to be between 2.9 and 3.6.
8. A composition for diagnosing and for treating circulatory system diseases as claimed in any one of the preceding claims characterised in that the mixed administration solution has a volume of 20 ml, a pH of between 6.8 and 7.4 and an Oxygen Reduction Potential (ORP) of between -40mv and -90mv.
9. A composition for diagnosing and for treating circulatory system diseases as claimed in any one of the preceding claims characterised in that the electro-potentiated water used in the solutions has an oxygen reduction potential (ORP) of 730 mv and a pH between of 7.2 and 7.9.
10. A composition for diagnosing and for treating circulatory system diseases as claimed in claim 9 characterised in that the electro-potentiated water is prepared by adding 750mg of sodium bicarbonate to 1000ml of water (USP) and placing the resulting solution in an induction system with the current set to a value where the Oxygen Reduction Potential (ORP) reading after 2 minutes of current flow is 878 mv and the anodal stream used.
11. A composition for diagnosing and for treating circulatory system diseases as claimed in any one of the preceding claims characterised in that the mixed, prior to administration solution is administrable by direct injection into a mammal.
12. A composition for diagnosing and for treating circulatory system diseases as claimed in any one of claims 1 to 10 characterised in that the mixed, prior to administration solution to be added to a saline solution and for it to be administrable as an intravenous drip.
13. A composition for diagnosing and for treating circulatory system diseases as claimed in 12 characterised in that the saline solution is a 200 ml saline solution.
14. A composition for diagnosing and for treating circulatory system diseases as claimed in any one of the preceding claims characterised in that the mammal is a human.
15. A method of treating circulatory system diseases comprising administering a composition as claimed in any one of the preceding claims to a mammal in need thereof.
16. A method of treating circulatory system diseases as claimed in claim 15 characterised in that the composition is injected into the femoral artery at groin level.
17. A method of treating circulatory system diseases as claimed in claim 15 characterised in that the composition is added to a saline solution and administered as an intravenous drip.
18. A method of treating circulatory system diseases as claimed in any one of claims 15 to 17 characterised in that the mammal is a human,
19. A method of treating circulatory system diseases as claimed in any one of claims 15 to 18 to bypass partially occluded blood vessels by stimulating ancillary blood vessel development.
20. A method of treating circulatory system diseases as claimed in claim 19 characterised in that the method is used as a therapeutic adjunct to promote blood vessel development prior to bypass surgery and/or angioplasty.
21. A method of treating a circulatory system disease as claimed in claim 15 characterised in that the circulatory system disease is selected from the group of conditions consisting of: transient ischemic attack, arterial hypertension, diabetic retinopathy, erectile dysfunction, Raynaud's disease, coronary artery disease, memory and cognitive deficits associated with inadequate blood supply to brain, arterial leg ulcers, and venal leg ulcers.
22. A method of diagnosing circulatory system diseases in a human patient comprising injecting, intra-arterially, 20 ml of the composition as claimed in any one of the preceding claims into the patient and monitoring the patients post injection thermal sensitivity and/or perceptions of thermal sensitivity.
23. A method of diagnosing circulatory system diseases in a human patient as claimed in claim 22 characterised in that the composition is injected into the femoral artery at groin level.
PCT/IB2006/003630 2005-12-19 2006-12-15 Composition for diagnosing and treating circulatory system diseases WO2007072147A2 (en)

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US9089602B2 (en) 2008-07-25 2015-07-28 Reven Pharmaceuticals, Inc. Compositions and methods for the prevention and treatment of cardiovascular diseases
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US6284293B1 (en) * 2000-04-12 2001-09-04 Jeffery J. Crandall Method for generating oxygenated water
AU2096002A (en) * 2000-12-08 2002-06-18 Pieter Theo Ernst Therapeutic treatment
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US11110053B2 (en) 2008-07-25 2021-09-07 Reven Pharmaceuticals Inc. Compositions and methods for the prevention and treatment of cardiovascular diseases
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AU2012204311B2 (en) * 2011-01-06 2017-05-04 C. Lowell Parsons Method for manufacturing composition comprising local anesthetic, heparinoid, and buffer
WO2012094515A1 (en) 2011-01-06 2012-07-12 Parsons C Lowell Method for manufacturing composition comprising local anesthetic, heparinoid, and buffer
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