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-9498566-B2
Publication Date
2016-11-22
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 for treating and/or preventing inflammatory conditions by extracorporeally sequestering leukocytes and/or platelets from a subject and inhibiting or deactivating their inflammatory actions. These systems utilize a device in which blood or body fluid from a patient is processed so that leukocytes and/or platelets are captured within a defined region, and an agent—most notably a calcium chelating agent like citrate—is present to inhibit the release of pro-inflammatory substances or deactivate the sequestered cells.
The problem addressed by the invention is the contribution of activated or primed leukocytes and platelets to severe, and sometimes fatal, inflammation in conditions such as systemic inflammatory response syndrome (SIRS), sepsis, ischemia/reperfusion injury, and organ failure. Existing therapies are often inadequate, expensive, or associated with adverse effects, and there is a clinical need for a method that can directly target the inflammatory actions of these cells to reduce tissue damage and mortality.
The systems and devices described in the invention accomplish cell sequestration in a device containing surfaces, such as hollow fibers, capable of binding leukocytes and/or platelets under conditions of controlled, low shear stress. The immobilized cells are then exposed to an agent—preferably citrate—either infused or immobilized on the device, which inhibits their pro-inflammatory activity by lowering ionized calcium levels. The systems can be incorporated as single devices or as part of multi-device circuits (such as hemodialysis or cardiopulmonary bypass systems) for selective cytopheresis, applicable to various biological fluids and a broad range of inflammatory conditions.
Claims Coverage
The independent claim of this patent specifies one main inventive feature with several components and dependent variations.
System for treating activated platelets with sequestration and calcium chelation
A system for treating activated platelets from a subject in need thereof, comprising: - A device with a housing defining a passageway for body fluid from the subject, and a fiber or plurality of fibers within the housing. - Each fiber has an exterior surface that binds the platelets. - A calcium chelating agent, specifically citrate, is present in an amount sufficient to inhibit the release of a pro-inflammatory substance from the activated platelets or to deactivate the platelets. The claim specifies that the system is configured for targeting activated platelets via binding to fiber surfaces and simultaneous exposure to citrate as the agent for inhibition or deactivation of inflammatory platelet activity.
The claim coverage centers on a system for extracorporeal treatment of activated platelets using a specialized device and citrate for selective inhibition of inflammatory activity, with specific structural and functional requirements for platelet sequestration and chemical intervention.
Stated Advantages
Provides unprecedented and surprising success in maximizing subject and patient survival across a range of inflammatory diseases and conditions.
Effectively inhibits inflammatory activity of leukocytes and/or platelets without requiring expensive anti-septic agents or causing adverse immunological and cardiovascular reactions.
Sequestration and deactivation of inflammatory cells can reduce multi-organ effects and improve clinical outcomes such as diminished inflammation, improved cardiovascular parameters, and increased survival times.
Can be incorporated into existing extracorporeal circuits (e.g., hemodialysis, cardiopulmonary bypass) using standard components and controlled flow configurations.
Permits selective modulation of activated or primed leukocytes and platelets, thereby offering a targeted approach to treating or preventing inflammatory conditions.
Documented Applications
Treatment and/or prevention of systemic inflammatory response syndrome (SIRS), sepsis, acute respiratory distress syndrome (ARDS), cardiopulmonary bypass syndrome, rheumatoid arthritis, lupus, inflammatory bowel disease, multiple sclerosis, psoriasis, allograft rejection, asthma, chronic renal failure, cardiorenal syndrome, hepatorenal syndrome, and acute organ failure from ischemic reperfusion injury or toxic injury.
Use during medical procedures that induce inflammation, such as dialysis or cardiopulmonary bypass surgery, to decrease secondary inflammatory injury.
Amelioration of multi-organ dysfunction and mortality in acute sepsis and acute renal failure.
Potential use for supporting the development and use of tissues and organs ex vivo, including organ harvesting for transplantation and tissue engineering applications.
Evaluation and prevention of acute lung injury (ALI) and acute kidney injury (AKI) induced by cardiopulmonary bypass.
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