Cytopheresis cartridges and use thereof
Inventors
Humes, H. David • Buffington, Deborah A. • Pino, Christopher J.
Assignees
Innovative Biotherapies Inc • Seastar Medical Inc
Publication Number
US-11866730-B2
Publication Date
2024-01-09
Expiration Date
2031-10-14
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Abstract
The present invention relates to a cytopheretic cartridge for use in treating and/or preventing inflammatory conditions within a subject and to related methods. More particularly, the invention relates to a cytopheretic cartridge that includes a housing and, disposed within the housing, a solid support capable of sequestering activated leukocytes and/or platelets.
Core Innovation
The invention relates to cytopheretic cartridges designed for treating and/or preventing inflammatory conditions by extracorporeally sequestering activated leukocytes and/or platelets, and inhibiting or deactivating their inflammatory activities. The cartridges comprise a rigid housing with defined inner volume, a fluid inlet and outlet port, and a solid support disposed within the housing to present a surface capable of sequestering such cells present in a body fluid. The solid support can be defined by fibers or planar members, and is fabricated from biocompatible materials that may also bear cell-adhesion molecules to enhance sequestration.
A key aspect of the invention is the control of the ratio of the solid support's surface area (SA) to the housing's inner volume (IV), to maximize therapeutic effect while avoiding excessive removal of essential cells. Appropriate values of SA/IV and design parameters such as surface area, inner volume, and packing density are selected according to the subject's needs—especially important for vulnerable populations such as infants or hemodynamically unstable patients. This control helps prevent life-threatening deficiencies such as leucopenia, neutropenia, and thrombocytopenia.
The invention further encompasses systems and methods for using cartridges in extracorporeal circuits for selective sequestration and possible deactivation of inflammatory cells. After sequestration, cells may be treated, for example using calcium chelators like citrate, to inhibit the release of pro-inflammatory substances or to deactivate the cells, with the option to return them to the subject. The methods and devices are applicable to a wide range of inflammatory conditions, including but not limited to SIRS, sepsis, autoimmune diseases, and various forms of acute organ failure.
Claims Coverage
There are two independent claims, each describing a method involving a cartridge for sequestering and treating activated leukocytes and/or platelets.
Method for processing activated leukocytes and/or platelets using a cartridge with specific SA/IV ratio
A method comprising: - Providing a cartridge with a rigid housing defining an inner volume (IV), a fluid inlet port and a fluid outlet port, the inner volume in fluid flow communication with both ports - The cartridge includes a solid support inside the housing, with a fluid contacting surface area (SA) capable of sequestering an activated leukocyte and/or an activated platelet from a body fluid entering via the inlet port - The cartridge has an SA/IV ratio ranging from greater than 150 cm−1 to 800 cm−1 - Introducing a body fluid into the housing under conditions permitting sequestration of activated leukocytes and/or platelets on the solid support surface - Treating the sequestered leukocyte and/or platelet to inhibit release of a pro-inflammatory substance or to deactivate the leukocyte and/or platelet
Method for treating inflammatory conditions using a cartridge with specific SA/IV ratio
A method comprising: - Providing a cartridge with a rigid housing that has an inner volume (IV), a fluid inlet port, and a fluid outlet port, inner volume in fluid flow communication with both ports - Inside the housing, a solid support is disposed, having a fluid contacting surface area (SA) capable of sequestering an activated leukocyte present in body fluid entering via the inlet port - The cartridge has an SA/IV ratio ranging from greater than 150 cm−1 to 800 cm−1 - Introducing a body fluid from a subject into the housing under conditions that permit sequestration of an activated leukocyte and/or activated platelet on the solid support - Treating the sequestered leukocyte and/or platelet to reduce the risk of developing or to alleviate inflammation associated with the inflammatory condition
The inventive features are centered on the use of a specially designed cartridge with defined SA/IV ratio for the selective sequestration and possible deactivation of activated leukocytes and platelets, applicable either to general processing of such cells or to the treatment of subjects with, or at risk for, inflammatory conditions.
Stated Advantages
The invention allows effective treatment and/or prevention of inflammatory conditions by selectively sequestering leukocytes and/or platelets and inhibiting their inflammatory activity.
Controlling the SA/IV ratio of the cartridge enables therapeutic efficacy while minimizing the risk of depleting critical cells, thus preventing life-threatening conditions such as leucopenia, neutropenia, and thrombocytopenia.
The device and methods can ameliorate complications related to sepsis, improve cardiovascular and renal parameters, and extend survival time in subjects with acute inflammation.
Use of calcium chelators like citrate in the system further inhibits leukocyte activation and release of pro-inflammatory substances, reducing systemic inflammation.
The cartridge design can be tailored for various populations, including pediatric and hemodynamically unstable patients, optimizing safety and efficacy.
Documented Applications
Treatment and/or prevention of inflammatory conditions, including systemic inflammatory response syndrome (SIRS), polyarteritis, Wegener's granulomatosis, autoimmune vasculitis, anti-neutrophil cytoplasmic antibody (ANCA) vasculitis, extracorporeal membrane oxygenation (ECMO), cardiopulmonary bypass syndrome, acute respiratory distress syndrome (ARDS), acute lung injury (ALI), chronic obstructive pulmonary disease (COPD), sepsis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, multiple sclerosis (MS), psoriasis, allograft rejection, asthma, acute renal failure, chronic renal failure (CRF), end stage renal disease (ESRD), cardiorenal syndrome (CRS), chronic heart failure (CHF), stroke, myocardial infarction (MI), hepatorenal syndrome, cirrhosis of the liver, diabetes mellitus (type 2 diabetes), and acute organ failure from ischemic reperfusion injury to myocardium, central nervous system, liver, kidney, or pancreas.
Support of organ and tissue procedures ex vivo, including organ harvesting for transplantation, tissue engineering applications, ex vivo generation of organs, and the manufacture and use of bio-microelectromechanical systems (MEMs).
Prevention and treatment of inflammation secondary to medical procedures, such as dialysis or cardiopulmonary bypass.
Amelioration of multi-organ dysfunction (MOD) following cardiopulmonary bypass and other severe systemic insults.
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