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-11118162-B2
Publication Date
2021-09-14
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 present invention introduces a cytopheretic cartridge designed to treat and/or prevent inflammatory conditions in a subject by extracorporeally sequestering activated leukocytes and/or platelets and inhibiting or deactivating their inflammatory activity. The cartridge comprises a rigid housing with fluid inlet and outlet ports and a solid support disposed within the housing. The solid support presents a large fluid contacting surface area optimized for capturing these activated cells from body fluids, such as blood, as they flow through the cartridge.
A key discovery in the invention is that controlling the ratio of the solid support's active surface area (SA) to the inner volume (IV) of the cartridge housing is critical to effective treatment. This SA/IV ratio must be sufficient to capture enough activated cells to treat inflammation, while avoiding excessive sequestration that could lead to harmful deficiencies such as leucopenia, neutropenia, or thrombocytopenia. The invention specifies advantageous SA/IV ratios and solid support packing densities for different patient types, including those with limited available blood volume, such as infants or critically ill patients.
The invention also details the selection and configuration of the solid support, which may comprise fibers (hollow or solid), planar support members, or membranes (porous, semi-porous, or non-porous), made from biocompatible materials and optionally functionalized with cell-adhesion molecules to enhance sequestration. Methods are provided for using the cartridge to process bodily fluids under conditions (notably, low shear forces and use of calcium chelators like citrate) that favor sequestration and deactivation/inhibition of pro-inflammatory substances released by the captured cells.
The problem addressed is the lack of adequate treatments for various inflammatory conditions where activated leukocytes and platelets play a critical pathogenic role, including systemic inflammatory response syndrome (SIRS), sepsis, organ failure, and complications from surgical interventions such as cardiopulmonary bypass. Standard therapies often manage symptoms but do not selectively target or deactivate the inflammatory cells driving these conditions. This invention aims to overcome these limitations by specifically sequestering and modulating the activity of inflammatory cells in a controlled extracorporeal device.
Claims Coverage
The independent claim defines one inventive feature covering a cytopheretic cartridge for sequestering activated leukocytes and/or platelets with specific structural and functional characteristics.
Cartridge with a controlled SA/IV ratio and solid support packing density for sequestering activated leukocytes and/or platelets
A cartridge comprising: - A rigid housing that defines an inner volume (IV), a fluid inlet port, and a fluid outlet port, wherein the inner volume is in fluid flow communication with the fluid inlet and outlet ports. - A solid support disposed within the housing, defining a fluid contacting surface with a surface area (SA) capable of sequestering an activated leukocyte and/or an activated platelet if present in a body fluid entering via the fluid inlet port. - The cartridge is characterized by an SA/IV ratio ranging from greater than 150 cm−1 to 800 cm−1. - The solid support is disposed within the housing at a packing density in the range from 20% to 65%.
The claim is directed to a cartridge specifically optimized to sequester activated leukocytes and/or platelets using a defined surface area to inner volume ratio and packing density of the solid support, enhancing its efficacy for treating inflammatory conditions.
Stated Advantages
The cartridge enables effective treatment or prevention of inflammatory conditions by selective sequestration and deactivation of activated leukocytes and platelets.
Control of the SA/IV ratio and packing density allows the device to efficiently treat inflammation without causing harmful cell deficiencies such as leucopenia, neutropenia, or thrombocytopenia.
Adjustable cartridge parameters support use in a wide variety of patient populations, including infants, children, and hemodynamically unstable patients with limited blood volume.
The device is compatible with various extracorporeal circuits and can be integrated with other treatments, such as hemofiltration or cardiopulmonary bypass.
Use of the device has been shown in examples to improve cardiovascular stability, renal function, and survival time in animal models of sepsis.
Documented Applications
Treatment and/or prevention of inflammatory conditions including, but not limited to, systemic inflammatory response syndrome (SIRS), sepsis, polyarteritis, Wegener's granulomatosis, autoimmune vasculitis, extracorporeal membrane oxygenation (ECMO), cardiopulmonary bypass syndrome, acute respiratory distress syndrome (ARDS), acute lung injury (ALI), chronic obstructive pulmonary disease (COPD), rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, multiple sclerosis, 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), and acute organ failure from ischemic reperfusion injury.
Use in medical procedures associated with acute inflammation, such as trauma, surgery, organ transplantation, and cardiopulmonary bypass.
Integration into extracorporeal blood circuits including hemofiltration, hemodialysis, hemodiafiltration, and CPB (cardiopulmonary bypass) systems.
Support for ex vivo tissue and organ development procedures, including organ harvesting for transplantation, tissue engineering, and use in bio-microelectromechanical systems (MEMs).
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