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Method for treating patients with ischemic cardiac disease after myocardial infarction

IPC classes for russian patent Method for treating patients with ischemic cardiac disease after myocardial infarction (RU 2308982):
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FIELD: medicine, cardiology.

SUBSTANCE: it is necessary to carry out medullary aspiration out of iliac crest to isolate autologous mononuclear medullary cells due to gradient centrifuging. They should be delivered into area of post-infarction myocardial necrosis due to introducing into coronary artery. Moreover, cellular suspension should be infiltrated into area of myocardial necrosis without preliminary cultivation at the quantity of about 70-110 mln. cells. For this purpose one should introduce a microcatheter into coronary artery so that arterial diameter and that of a microcatheter should coincide and it is necessary to supply the cells through it under the pressure of 2 atm. The innovation suggested enables to increase the quantity of mononuclear cells deposited in myocardium and decrease balloon's damaging impact upon the wall of coronary artery during introducing cellular suspension.

EFFECT: higher efficiency of therapy.

1 ex

 

The invention relates to the field of medicine, particularly cardiology, and relates to a method of treating coronary heart disease (CHD), myocardial infarction. Heart failure is the end point of the disease patients with this pathology [1, 2, 3]. Heart transplantation remains the only radical method of treatment of end-stage heart failure. However, the shortage of donor complications associated with immunosuppressive therapy, are major limitations of this method of treatment [3, 4]. This makes the search for new alternative approaches, which include cell transplantation [5].

There is a method of treatment of patients with ischemic heart disease, myocardial infarction [6], when the infarct - related coronary artery is injected with a suspension of autologous mononuclear bone marrow cells that were pre-cultured for days with autologous blood plasma, on the 7th day during repeated coronary angiography, the introduction of cell suspension takes place during occlusion of the lumen of the coronary artery by the balloon.

This method is the closest to the claimed technical essence and the achieved result and selected as a prototype.

The disadvantage of this method is the necessity of using additional container during the introduction of the tile is offered by the mist, that may increase the risk of complications of interventional procedures, and the need for culturing autologous mononuclear bone marrow cells with autologous blood plasma during the day.

The purpose of the invention is improving the effectiveness of treatment by increasing the amount deposited in the myocardium of mononuclear cells and reduce the risk of complications of interventional procedures by reducing the damaging effects of balloon on the wall of the coronary artery during injection of the cell suspension.

This goal is achieved technical solution that represents a method for the treatment of patients with coronary artery disease, myocardial infarction, involving the introduction of a suspension of autologous mononuclear bone marrow cells without cultivation in the coronary artery supplying the area of myocardial infarction. The cell suspension is injected in the amount of 70-110 million cells. There is no need to use the container for occlusion of a coronary artery during injection of cell suspensions, the jamming of the coronary artery to produce a microcatheter, which deliver mononuclear cells in the bone marrow. Aspiration of bone marrow conduct of the iliac crest after the puncture her predavanja barb. Autologous mononuclear bone marrow cells secrete the method of gradient centrifuge the Finance.

New in the proposed method is the introduction of cell suspension in the number of 70-110 million cells without prior cultivation that does not require additional costs, under a pressure of 2 ATM after jamming artery multipurpose nylon for infusion microcatheter with a diameter of 1.0 to 1.5 mm, length 150 see a Pressure of 2 ATM allows you to infilterate myocardium without damaging the wall of the coronary artery.

Distinctive features showed in the inventive combination of new properties that are not explicitly derived from the prior art in this field and obvious to the specialist. Identical set of features in proanaliziruesh patent and scientific and medical literature is not detected. The proposed solution can be used in health care.

Based on the foregoing should be considered as the invention with the relevant conditions of patentability: Novelty", "Inventive step", "Industrial applicability".

The method is as follows: under local anesthesia with 0.5%solution of novocaine dotted line in the iliac crest in the area of predavanja spine, aspirinum 100-120 ml of bone marrow in two 60-ml syringe with 4 ml of heparin and 6 ml of physiological solution of 0.9% NaCl, with the method of gradient centrifugation allocate mononuclear cells in the bone marrow. otomat suspension of mononuclear bone marrow cells with a concentration of from 2 to 5 to 10 6cells in 1 ml of Performing coronary angiography, then set the microcatheter into the coronary artery so that the artery diameters and microcatheter coincided and was jamming the coronary artery, then carry out the introduction of a suspension of mononuclear bone marrow cells under a pressure of 2 ATM, which leads to infiltration of the myocardium introduced cells.

Example. Patient R., aged 44, was admitted to the Department of cardiovascular surgery, Institute of cardiology, Tomsk scientific 6 months after myocardial infarction. The patient perform a standard examination. According to the stress perfusion scintigraphy of the myocardium with thallium 199 reveal stable 38% passing 15% defects in myocardial perfusion. In addition, establish a reduced ejection fraction of the left ventricle to 42%. When performing coronary angiography revealed stenosis of the anterior interventricular artery and perform stenting of stenoses. On the 14th day after admission to hospital under local anesthesia with 0.5%solution of novocaine dotted line in the iliac crest in the area of predavanja spine, aspirinum 100 ml of bone marrow, the method of gradient centrifugation produce autologous mononuclear bone marrow cells, perform coronary angiography, kateteriziruyut the mouth of the anterior interventricular artery, spend Microcat the Ter 1 mm to match the diameter of the catheter and artery, jam anterior interventricular artery and under a pressure of 2 ATM impose a suspension of mononuclear bone marrow cells in the amount of 80 million in 20 ml of physiological solution of 0.9% NaCl with the addition of a contrast agent omnipaque-350 (Nycomed, Ireland). Media fixed delay of contrast in the myocardium of about 60 seconds. The video archive in digital format Dicom. All these interventions the patient tolerates well, there have been no complications. After treatment, the patient is followed over 6 months and state the positive results of the treatment, which is manifested by a decrease in end-diastolic volume of the left ventricle, increased ejection fraction of the left ventricle, decreasing the amount of stable perfusion defect by 15%. During the observation period do not exhibit clinical signs of chronic heart failure.

The proposed method was applied in 8 patients and showed that by reducing the risk of complications during their time increasing the efficiency of treatment of patients with ischemic heart disease, myocardial infarction, by reducing the severity of processes postinfarction remodeling of the left ventricle, improving contractile function and myocardial perfusion.

References

1. McMurray JJ, Stewart S. Epidemiology, aetiology and prognosis of heart falure. Heart 2000; 83(5): 596-602.

2. Cowie MR, Wood DA, Coats AJ, et al. Incidence and aetiology of heart failure; a population-based study. Eur Heart J 1999; 20(6): 421-428.

3. Levy D, Kenchaiah S, Larson MG, et al. Long-term trends in the incidence of and survival with heart failure. N Engi J Med 2002; 347(18): 1397-1402.

4. Kherani AR, Garrido MJ, Cheema FH, et al. Nontransplant surgical options for congestive heart failure. Congest Heart Fail 2003; 9(1): 17-24.

5. Dimarakis I, Nagy A. Habib, Myrtle Y.A. Gordon. Adult bone marrow-derived stem cells and the injured heart: just the beginning? Eur J Cardiothorac Surg 2005; 28: 665-676.

6. B.E. Strauer, Brehm m, Zeus T., et al. Repair of infarcted myocardium by autologous intracoronary mononuclear bone marrow cell transplantation in humans. Circulation 2002; 106: 1913-1918.

Method of treatment of ischemic heart disease, myocardial infarction, consisting of bone marrow aspiration from the iliac crest and the allocation of autologous mononuclear bone marrow cells by the method of gradient centrifugation and their delivery in the area of post-infarction necrosis of the myocardium by injection into the coronary artery, wherein the cell suspension without prior cultivation in the number of 70-110 million cells infiltrate into the zone of necrosis of the myocardium, while installing the microcatheter into the coronary artery so that the artery diameters and microcatheter coincided, and served through him at the cells under a pressure of 2 ATM.

 

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