Selective cytopheresis devices and related methods thereof
Inventors
Humes, H. David • Buffington, Deborah
Assignees
University of Michigan Ann Arbor • Seastar Medical Inc
Publication Number
US-8425445-B2
Publication Date
2013-04-23
Expiration Date
2028-08-29
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Abstract
The present invention relates to systems and devices to treat and/or prevent inflammatory conditions within a subject and to related methods. More particularly, the invention relates to systems, devices, and related methods that sequester leukocytes and/or platelets and then inhibit their inflammatory action.
Core Innovation
The invention provides systems, devices, and methods to treat and/or prevent inflammatory conditions in a subject by extracorporeally sequestering leukocytes and/or platelets and inhibiting their inflammatory action. These devices sequester activated or primed leukocytes or platelets, then treat them with an agent, such as a calcium chelator, to deactivate the cells or inhibit the release of pro-inflammatory substances. The treated blood is subsequently returned to the subject.
A core aspect of the invention is the use of a selective cytopheresis inhibitory device (SCID), which defines a passageway configured to sequester one or more leukocytes or platelets from a biological sample. The system incorporates a region where these cells temporarily adhere to internal surfaces, such as the exterior of hollow fibers, and are exposed to an agent, preferably a calcium chelating agent like citrate, to inhibit their inflammatory activity before reinfusion to the subject.
The invention addresses the problem that various inflammatory diseases and medical procedures activate leukocytes and platelets, leading to unwanted inflammation, tissue damage, and potentially fatal organ dysfunction. Existing therapies for conditions such as SIRS, sepsis, and complications from cardiopulmonary bypass either are insufficient, cause adverse effects, or are expensive. There remains a need for an effective treatment that can reduce the inflammatory activity of these cells safely and efficiently.
Claims Coverage
The patent contains two independent claims, each covering inventive methods related to extracorporeal sequestration and treatment of activated leukocytes using a calcium chelator.
Method for extracorporeal sequestration and calcium chelator treatment of primed or activated leukocytes during cardio-pulmonary bypass
This feature includes: - Sequestering extracorporeally the primed or activated leukocytes from a subject undergoing a cardio-pulmonary bypass procedure. - Treating the sequestered cells with a calcium chelator to inhibit release of a pro-inflammatory substance from the cells or to deactivate the cells.
Method for treating inflammation in a subject during cardio-pulmonary bypass using extracorporeal sequestration and calcium chelator
This feature includes: - Sequestering extracorporeally primed or activated leukocytes from a subject undergoing a cardio-pulmonary bypass procedure. - Treating the sequestered leukocytes with a calcium chelator to inhibit release of a pro-inflammatory substance or to deactivate the leukocytes.
Both inventive features center on extracorporeal sequestration of primed or activated leukocytes and their treatment with a calcium chelator, specifically in the context of subjects undergoing cardio-pulmonary bypass.
Stated Advantages
The systems, devices, and methods provide unprecedented and surprising success in maximizing subject survival in models of inflammatory disease.
The invention can ameliorate or prevent the multi-organ effects of inflammatory diseases and conditions, such as sepsis and SIRS.
The treatment reduces the inflammatory activity of sequestered leukocytes and/or platelets without systemic administration of anti-inflammatory drugs.
Compared to conventional therapy, the invention demonstrates enhanced survival rates, improved cardiovascular performance, and reduced inflammatory markers.
The invention can be implemented using extracorporeal circuits and integrates with existing dialysis or bypass systems.
Citrate as a calcium chelator leads to inhibition of leukocyte and platelet pro-inflammatory activity in vitro and in vivo.
Documented Applications
Treatment and/or prevention of inflammatory conditions such as SIRS, sepsis, ischemia/reperfusion injury, acute respiratory distress syndrome (ARDS), and cardiopulmonary bypass syndrome.
Therapy for end stage renal disease (ESRD) and associated chronic inflammation.
Treatment of acute organ failure due to ischemic, toxic, or inflammatory injury, including kidney, liver, myocardium, central nervous system, and pancreas.
Use in organ and tissue support ex vivo, including organ harvesting, tissue engineering, and ex vivo organ generation.
Support for procedures or clinical scenarios resulting in leukocyte or platelet activation, including transplant rejection, trauma, burns, and immune-mediated disorders.
Treatment during cardiopulmonary bypass procedures to reduce inflammation and prevent organ dysfunction.
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