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Cartridge and method for increasing myocardial function

Inactive Publication Date: 2015-05-14
SEASTAR MEDICAL INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention provides methods for improving heart function in subjects with chronic heart failure or acute decompensated heart failure. These methods involve sequestering activated leukocytes and / or activated platelets present in the subject's body fluid and treating them to inhibit release of pro-inflammatory substances or deactivate them. The treatment can be done to increase myocardial function or to reduce inflammation associated with the heart failure. The methods involve using a cartridge with a rigid housing and a solid support for sequestering the leukocytes and platelets. The sequestered cells can then be treated to reduce inflammation and alleviate the symptoms of heart failure.

Problems solved by technology

Several of these conditions, such as, for example, chronic heart failure (CHF) and acute decompensated heart failure (ADHF), through abnormal or excessive chronic activation of the immune system, may result in life threatening myocardial dysfunction.
While inflammation and a systemic immune response can be beneficial in certain circumstances, they can also be fatal.
Inflammatory injury in organs can result in microvascular damage induced by leukocyte activation and aggregation, as well as platelet activation and aggregation.
Activated leukocytes additionally cause damage by extravasating across the endothelium into the tissue, where they release toxic agents normally intended to destroy invading microbes or clear out necrotic debris.
Further, the interaction of activate leukocytes and the endothelium can lead to increased vascular permeability with fluid leakage from the intravascular space to the tissue interstitium with resulting hypovolemia, hypotension, and cardiovascular instability.
Activated platelets additionally cause damage by enhancing the activation and endothelial transmigration of leukocytes.
When these processes are not controlled, they can lead to tissue injury and death.
The myocardial calcium sensitizing agent (levosimendan) and the vasodilatory recombinant B-type natriuretic peptide (niseritide) have also failed to meet clinical efficacy end points with an increase in risks of arrhythmias or hypotension ((see, e.g., Cohn et al.
However, such an approach results in, and is limited by further declines in renal functions.

Method used

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  • Cartridge and method for increasing myocardial function
  • Cartridge and method for increasing myocardial function
  • Cartridge and method for increasing myocardial function

Examples

Experimental program
Comparison scheme
Effect test

example 1

Treatment of Inflammation Associated with Acute Sepsis in an Animal Model

[0180]Activated leukocytes, especially neutrophils, are major contributors to the pathogenesis and progression of sepsis as well as other clinical inflammatory disorders. This example describes in vivo experiments that evaluate the effect of different SCD cartridges on leukocyte sequestration and deactivation. The results demonstrate that the choice of a particular SCD cartridge can have a profound effect on the pathogenesis and progression of sepsis in a large animal model. In particular, the results demonstrate that a SCD cartridge having a larger sequestration area is more effective than a SCD cartridge having a smaller sequestration area in alleviating complications associated with sepsis and in prolonging survival.

(I) Methods and Materials

A—Animal Model

[0181]The efficacy of the SCD cartridge in treating inflammation was evaluated in a well-established porcine model of acute septic shock. (See, e.g., Humes ...

example 2

In Vitro Studies of Leukocyte Sequestration and Deactivation

[0209]This example describes in vitro experiments to evaluate the effect of the SCD device on leukocyte sequestration and activation.

(I) Methods and Materials

[0210]A—In Vitro Assessment of Leukocyte Interaction with the Membrane of a SCD Cartridge

[0211]A custom microscopic flow chamber system was set up to enable microscopic analysis of leukocyte interaction with the SCD membrane. The flow chamber consisted of a polycarbonate housing with an inlet and outlet for perfusion. A polysulfone membrane was affixed to the polycarbonate block with a gasket which directed shear flow. The thickness of the gasket (100 μm) along with the length (2 cm) and the width of the channel (1 5 mm) determined the volume of the flow chamber. Microscopic imaging was accomplished through an optical window made up of a cover glass affixed to the bottom of the polycarbonate block. Either isolated blood or purified leukocytes were used for this study.

[...

example 3

Use of SCD Device During Cardiopulmonary Bypass Surgery

[0218]Systemic Inflammatory Response Syndrome (SIRS) can occur in association with cardiopulmonary bypass (CPB) surgery, resulting in multiple organ dysfunction (MOD). Activated neutrophils have been implicated as major inciting factors in this process. This example describes in vitro and in vivo experiments that evaluate the effect of SCD cartridges for use during CPB surgery. The results demonstrate that the usage of SCD cartridges may disrupt the systemic leukocyte response during CPB surgery, leading to improved outcomes for CPB-mediated MOD.

(I) Background

[0219]Leukocytes, especially neutrophils, are major contributors to the pathogenesis and progression of many clinical inflammatory disorders, including systemic inflammatory response syndrome (SIRS), sepsis, ischemia / reperfusion injury, acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI). Cardiac surgical advances have been dependent upon the techniques...

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PUM

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Abstract

The present invention relates to a cytopheretic cartridge for use in treating and / or preventing inflammatory conditions that affect myocardial function and to related methods. The cartridge can be used in treating a subject with myocardial dysfunction, such as a subject with chronic heart failure and / or acute decompensated heart failure.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of International Patent Application No. PCT / US2012 / 059615, filed Oct. 10, 2012, which claims priority to and the benefit of U.S. Provisional Patent Application No. 61 / 584,337, filed Jan. 9, 2012, the contents of each of which are incorporated by reference herein.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH[0002]This invention was made with government support under grant number W81XWH-10-2-0137, awarded by the US Army Medical Research and Material Command. The government has certain rights in the invention.FIELD OF THE INVENTION[0003]The present invention relates to cartridges, systems, and methods for treating and / or preventing inflammatory myocardial conditions in a subject. More particularly, the present invention relates to cartridges and systems for sequestering and reducing the inflammatory activity of cells associated with myocardial inflammation, such as leukocytes and platelets, and to relate...

Claims

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Application Information

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IPC IPC(8): A61M1/16A61M1/36A61M1/34
CPCA61M1/1625A61M1/3472A61M2202/0427A61M2202/0439A61M1/3666A61M1/3679A61K31/00A61K31/194A61M1/3486A61M1/3489A61M1/3689A61M1/3672A61P7/02A61P9/04A61M1/3623B01D61/20A61M1/16A61M1/34A61M1/3687A61M2205/126A61M2210/125
Inventor HUMES, H. DAVIDBUFFINGTON, DEBORAH A.
Owner SEASTAR MEDICAL INC
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