Chemical apparatus and process disinfecting – deodorizing – preser – Blood treating device for transfusible blood
Reexamination Certificate
1998-06-10
2003-09-30
Sykes, Angela D. (Department: 3762)
Chemical apparatus and process disinfecting, deodorizing, preser
Blood treating device for transfusible blood
C604S004010, C604S005010, C604S005040, C128S898000, C210S651000
Reexamination Certificate
active
06627151
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a new method for the effective therapeutic treatment of diseases associated with a deterioration of the macrocirculation, microcirculation and organ perfusion to achieve an improvement of the local environment and the metabolic situation and to aim at the improvement of organ function or the stabilization of organ function with imminent functional deterioration.
The present invention relates especially to a new method for the effective treatment of cardiological and systemic diseases.
In the past ophthalmological diseases like age-related maculopathy (AMD) retinal vein occlusion, diabetic retinopathy, arterial occlusion, uveal effusion syndrome, NAION, Stargardt's-disease, uveitis, and maculopathy of different origin could not be treated with a generally accepted therapy. For example for the treatment of AM lasering treatments, radiation and operation were used. However these methods had no effect on the further development of the disease in many of the patients suffering therefrom. This principle has now been extended to cardiological diseases. Therapy refractory angina pectoris of coronary heart disease is the major disease. CHD is a severe progressive disease which occurs in the elderly. It is considered to be the most frequent cause of death in patients beyond an age of 65 years. There are more than 10 Million Americans suffering from this disease. An increasing number of patients after standard therapies such as coronary angioplasty, bypass operation and drug therapy are exhausted, demand new approaches. Extracorporeal haemorheotherapy (rheopheresis, rheo-apheresis) is a so far not considered or applied new treatment.
There is an increasing number of patients who underwent coronary angioplasty and/or coronary bypass surgery and are now again suffering from anginal pain due to the progression of the atherosclerotic disease. Even the new technique of transmyocardial laser revascularisation does not help them for more than 1-2 years. They then again depend on the conventional pharmacological therapy of coronary heart disease such as nitrates, beta-blockers and calcium antagonists, which become more and more ineffective during this stage of the disease. New types of antianginal medications are not expected to be developed during the next decade. As these patients finally have no therapeutic alternative in the very last stage of the disease, there is a great need for a new and effective therapeutic treatment of the above mentioned cardiological and systemic diseases.
In the early 90S the inventors of the present invention observed that the elimination of fibrinogen and plasma proteins of higher molecular weight led to an increase of the visual acuity of patients suffering from macular disease and uveal effusion syndrome (Brunner, Borberg et al. Acta Medica Austriaca 1991, 18, supplement 1, page 63 to 65). In this document 1 patient with uveal effusion syndrome and 16 patients with maculopathy were treated. The haematocrit was reduced by erythrocyte apheresis. Fibrinogen and plasma proteins were eliminated by plasma exchange using a solution of 5% human albumin. The visual acuity of 9 of the patients with maculopathy was significantly increased after one therapy.
In a further publication from 1991 (Brunner, Borberg et al., Dev. Ophthalmol., Karger (Public.) Basel, 1992, vol. 23, p. 275 to 284) it was studied whether clinical improvements could be obtained by plasma exchange therapy with patients suffering from intermediate uveitis using a solution of 5% human albumin. It was found out that both the haemorheological and immunomodulatory effects of this treatment could be beneficial in this disease. Human albumin as well as preserved serum were used as exchange fluids.
However, a general concept for the effective therapeutic treatment of cardiological diseases was not described in these documents.
Therefore it was the object of the invention to provide a method for the effective treatment of diseases associated with a deterioration of the macrocirculation, microcirculation and organ perfusion to achieve an improvement of the local environment and the metabolic situation and to aim at the improvement of organ function or the stabilization of organ function with imminent functional deterioration, especially for the effective treatment of cardiological and systemic diseases.
SUMMARY OF THE INVENTION
This object is solved by a method, which comprises the treatment of blood of patients by extracorporeal plasmapheresis techniques.
In a preferred embodiment the diseases are selected from the group comprising arterial occlusion, venous thrombosis, apoplexia, cerebral infarction, transitory iechasmic attack, multiple cerebral infarction syndrome, dementia, Alzheimer's disease, diabetes mellitus, burns, Septicaemia (Sepsis), Raynaud's syndrome, ulceration of the skin due to rheological alterations, ophthalmologic diseases especially maculopathy, retinal vein occlusion and uveal effusion syndrome, cardiologic and systemic diseases.
According to a preferred embodiment of the invention the cardiological and systemic diseases which can be treated are selected from the group comprising therapy refractory angina pectoris of patients with coronary heart disease, diseases of coronary microcirculation (“small vessel disease”, “syndrome X”), disturbances of cerebral microcirculation (e.g. Morbus Binswanger), diabetic retinopathy, diabetic nephropathy, diabetic neuropathy, diabetic cardiomyopathy, pulmonary hypertension, artery occlusion, retinal vein occlusion.
In a further preferred embodiment the plasmapheresis technique is selected from the following techniques: blood cell plasma separation, plasma differential separation, plasma differential precipitation, plasma differential adsorption, plasma differential filtration.
The treatment comprises the steps of withdrawing the blood from the patient, treatment of the blood by the plasmapheresis techniques mentioned above and re-infusing the treated blood.
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Brunner, R.; Erythrocyte apheresis in combination with elimination of fibrinogen and plasma proteins of higher molecular weight in macular disease and in uveal effusion syndrome; Acta Med. Austriaca, 1991, spec. Issue 1, 63-65.*
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Brunner, Borberg et al. “Plasma Exchange and Immunoglobulins in the Treatment of Intermediate Uveitis”,Dev. Ophthalmol., Karger (Public.) Basel, vol. 23, p. 275-284, 1992.
Brunner, Borberg et al
Borberg Helmut
Brunner Richard
Tauchert Michael
Bianco Patricia
Needle & Rosenberg P.C.
Sykes Angela D.
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