Use of platelet rich plasma composition in the treatment of cardiac conduction abnormalities

a technology of platelet rich plasma and cardiac conduction abnormality, which is applied in the field of treatment of cardiac conduction abnormalities, can solve the problems of reducing contractile efficiency, heart disease and stroke, and atrium contracting against a closed atrio-ventricular valv

Inactive Publication Date: 2010-05-06
BIOPARADOX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0011]Methods for treating cardiac conduction abnormalities (e.g., arrhythmias) are provided. Generally, the methods may include identifying a patient with a cardiac arrhythmia or an arrhythmia risk and delivering a platelet rich plasma (PRP) composition comprising PRP to treat the cardiac conduction abnormality. The cardiac conduction abnormality may be determined based on an abnormal heart beat, an electrocardiogram (ECG), electrophysiology study or by any other suitable mechanism. The functional effect of the conduction abnormality may also be assessed using electrocardiography, echocardiography, cardiac catheterization, cardiac magnetic resonance imaging, or cardiac nuclear medicine imaging. The cardiac abnormality or a heightened risk of a cardiac abnormality may be documented in, for example, a medical history, test results, patient file, procedure log, or other electronic or paper record. The PRP composition may be delivered to cardiac tissue in an amount sufficient to treat the conduction abnormality. For example, the amount may be about one to about three cubic centimeters, about three to about five cubic centimeters, about five to about seven cubic centimeters, or seven or more cubic centimeters. The PRP composition may comprise a platelet rich plasma, a buffering agent, and / or an anti-arrhythmic agent. In some examples, the PRP composition may be injected into the heart muscle or infused into one or more regions of the cardiac vasculature. The injection or infusion may be performed in a translumenal access procedure, a thorascopic procedure, an open chest procedure or any other access procedure.

Problems solved by technology

The disturbance may be caused by a blockage, delay, or misfiring of the electrical conduction system of the heart that controls the contraction and relaxation of the cardiac muscle.
Arrhythmias may vary in severity, from asymptomatic disease to sudden cardiac death, and may lead to heart disease and stroke.
For example, atrio-ventricular dyssynchrony, may cause the loss of the “atrial kick” which facilitates ventricular filling, or result in an atrium contracting against a closed atrio-ventricular valve.
Ventricular dyssynchrony, where the left and right ventricles contract at different times, may reduce contractile efficiency when one ventricle is contracting while the other ventricle is relaxed, and may result in interventricular septal displacement that reduces the net forward blood flow of the ventricle.
In still another example, atrial fibrillation results in a disorganized quivering of the atrial muscle and a loss of forward flow, which may predispose the patient to blood clot formation and a higher risk of stroke.
While some treatments may relieve some arrhythmias, the same treatments may aggravate or have no effect on other arrhythmias.
Drug treatments that may be used to treat arrhythmias may have undesirable side effects and / or may be required for months if not years in order to maintain a regular heart rate.
Indeed, some anti-arrhythmic agents even predispose a patient to an increased risk of certain arrhythmias.
Hemodynamically unstable patients suffering an acute arrhythmia may be treated with electrical shocks using an automatic external defibrillator (AED) or manual defibrillator, but electrical shocks are not always successful in ending an arrhythmia and may cause significant discomfort or even burn the skin.
However, these devices are subject to malfunction and may be difficult to implant in certain patients.
Ablation of abnormal conduction pathways, or the formation of scar tissue to control the propagation of electrical activity, such as the Maze procedure used for atrial fibrillation, also requires invasive procedures and may only be effective in treating a narrow range of arrhythmias and while also increasing the patient's arrhythmia risk during the procedure or surgery.
In some embodiments, the blood may be collected from a patient who is suffering a myocardial infarction that may, in turn, increase the patient's risk of arrhythmia.

Method used

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  • Use of platelet rich plasma composition in the treatment of cardiac conduction abnormalities
  • Use of platelet rich plasma composition in the treatment of cardiac conduction abnormalities
  • Use of platelet rich plasma composition in the treatment of cardiac conduction abnormalities

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0103]PRP was prepared using a centrifuge unit made by Harvest (Plymouth, Mass). (Similar units are available as The Biomet GPS system, the Depuy Symphony machine and the Medtronic Magellan machine.) Approximately 55 cc of blood was drawn from the patient using a standard sterile syringe, combined with 5 cc of a citrate dextrose solution for anticoagulation, and then spun down to isolate the platelets according to the manufacturer's protocol. These platelets were then resuspended in approximately 3 cc of plasma. The resulting platelet rich plasma solution (PRP) was quite acidic and was neutralized with using approximately 0.05 cc of an 8.4% sodium bicarbonate buffer per cc of PRP under sterile conditions to approximately physiologic pH of 7.4. The PRP was not activated through addition of exogenous activators. This PRP composition is referred to herein as autologous platelet extract (APEX).

example 2

Cardiac Muscle

[0104]Adult female mice (n=19) underwent left anterior descending (LAD) artery ligation (45 minutes) followed by 5 minutes reperfusion to mimic myocardial infarction. An APEX composition was prepared as described in Example 1 The extract was not activated through the addition of exogenous agent(s).

[0105]Unactivated PRP (n=10) or saline (n=9) was injected into murine myocardium. Three weeks later MRI was used to evaluate ejection fraction.

[0106]The data is shown in FIG. 1. PRP improves cardiac function by 28% (as measured by Left Ventricular Ejection Fraction) relative to control at 3 weeks after a heart attack. The data is statistically significant at p=0.04. This data supports the use of PRP in an ischemia-reperfusion heart model.

example 3

Treatment of a Reperfusion Arrhythmia in an Animal Model

[0107]Arrhythmias frequently occur when ischemic cardiac tissue is reperfused with blood. This can occur in a variety of situations; however the most common is following an acute myocardial infarction. Typically, when blood flow is successfully reestablished after a coronary artery has been blocked, reperfusion arrhythmias can occur. These arrhythmias are usually in the form of ventricular ectopy including, but not limited to, non-sustained ventricular tachycardia, sustained ventricular tachycardia and ventricular fibrillation. These arrhythmias can result in hemodynamic compromise and, in some cases, death.

[0108]The successful test of PRP in an animal model simulating a reperfusion arrhythmia following an acute myocardial infarction was conducted as follows: In a 40 Kg swine, the left anterior descending artery was identified using coronary angiography and then occluded with an angioplasty balloon (thus mimicking a myocardial ...

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PUM

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Abstract

Methods and kits for treating a cardiac arrhythmia using a platelet rich plasma (PRP) composition are provided. Any type of arrhythmia may be treated using the PRP composition. The PRP composition may comprise PRP developed using blood collected from a patient suffering the cardiac arrhythmia. The PRP composition may be buffered to a physiological pH and may include one or more anti-arrhythmic agents, anti-coagulants, or other drugs. The PRP composition may be delivered using a nebulizer, minimally invasively, or surgically. In some embodiments, the PRP composition may be coated on one or more medical devices. The PRP composition may be delivered to an identified portion of the electrical conduction system of the heart affected and/or causing the arrhythmia to occur.

Description

BACKGROUND OF THE INVENTION[0001]1. Field of the Invention[0002]This invention relates generally to treatment of cardiac conditions and more specifically to treatment of a cardiac conduction abnormality (e.g., arrhythmia) using a composition comprising platelet rich plasma.[0003]2. Description of the Related Art[0004]Arrhythmias are a common disorder where the regular electric pacemaker activity of the heart may be disturbed. The disturbance may be caused by a blockage, delay, or misfiring of the electrical conduction system of the heart that controls the contraction and relaxation of the cardiac muscle. Arrhythmias may vary in severity, from asymptomatic disease to sudden cardiac death, and may lead to heart disease and stroke. According to the American Heart Association, about 2.2 million Americans suffer from atrial fibrillation, one type of arrhythmia.[0005]To maintain regular, rhythmic beating, the heart comprises an electrical conduction system that controls the contraction of...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K35/16A61M25/00A61N1/362A61P9/00
CPCA61K35/16A61N1/36114A61N1/362A61M2202/0415A61M2202/0007A61M16/14A61M15/009A61K45/06A61B5/4848A61B5/0402A61M2202/0427A61K35/19A61K9/0073C12N5/0644A61M15/00A61K9/0075A61K9/0078A61N1/3629A61P9/00A61B5/318
Inventor MISHRA, ALLAN KUMARBRINTON, TODD JEFFREY
Owner BIOPARADOX
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