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EP-4112093-B1 - SYSTEMS AND METHODS FOR MONITORING AND CONTROLLING FLUID BALANCE DURING A BIOLOGICAL FLUID PROCEDURE

EP4112093B1EP 4112093 B1EP4112093 B1EP 4112093B1EP-4112093-B1

Inventors

  • ALI, ZAHRA R.
  • NGUYEN, LAN T.

Dates

Publication Date
20260506
Application Date
20180926

Claims (11)

  1. An extracorporeal photopheresis system (5), comprising: a disposable fluid circuit (200) comprising an illumination container (68) configured to receive a target cell component; a separator (10) configured to work in association with the disposable fluid circuit (200), the separator (10) comprising a chamber configured to rotate about a rotational axis and convey whole blood from a blood source into an inlet region of the chamber for separation into a red blood cell component, a plasma component, and the target cell component; an irradiation device (20) configured to irradiate the target cell component in the illumination container (68); and a microprocessor-based controller in communication with the separator, wherein the controller is configured to draw anticoagulated whole blood into the disposable fluid circuit and the chamber at a whole blood flow rate, to separate the anticoagulated whole blood into the red blood cell component, the target cell component, and the plasma component, to direct the target cell component to the illumination container (68), to irradiate the illumination container (68) comprising the target cell component to create a treated target cell component, and to return to the blood source the treated target cell component, a portion of the red blood cell component remaining in the fluid circuit, and/or a portion of the plasma component remaining in the fluid circuit, wherein the microprocessor-based controller is further configured to: estimate an end-of-procedure fluid balance by calculating a total volume of anticoagulant solution having a citrate concentration to be used for the procedure, wherein the end-of-procedure fluid balance is estimated based on one or more manual or automatic inputs comprising an ACD ratio relating unanticoagulated extracorporeal whole blood to anticoagulant solution, an amount of whole blood to process, a citrate infusion threshold rate, a patient body weight associated with the blood source and a total blood volume of the blood source.
  2. The system (5) according to claim 1, wherein the controller is configured to estimate a maximum extracorporeal volume of red blood cells at any given time during the procedure based on the ACD ratio, a hematocrit of the blood source, a hematocrit of a priming fluid, and the total blood volume; wherein the controller is further configured to display to an operator the estimate of the maximum extracorporeal volume of red blood cells.
  3. The system (5) according to claim 1, wherein the controller is further configured to calculate the total volume of the blood source with information comprising a gender, a height, and weight of the blood source.
  4. The system (5) according to claim 1, wherein the controller is further configured to estimate a maximum extracorporeal volume of red blood cells during the procedure based on the ACD ratio, a hematocrit of the blood source, a hematocrit of a priming fluid, and the total blood volume.
  5. The system (5) according to claim 1 , wherein the controller is further configured to calculate the total volume of anticoagulant solution to be used for the procedure based on the whole blood flow rate calculated based on manual or automatic inputs comprising the ACD ratio, the citrate infusion threshold rate, and the patient body weight associated with the blood source.
  6. The system (5) according to claim 1, wherein the end-of-procedure fluid balance is further estimated based on a volume of fluid not returning to the blood source.
  7. A non therapeutic, non surgical method of performing an extracorporeal photopheresis procedure using a microprocessor-based controller in communication with a separator (10), a disposable fluid circuit (200) and an irradiation device (20), the separator (10) configured to work in association with the disposable fluid circuit (200), the disposable fluid circuit (200) comprising an illumination container (68) configured to receive a target cell component, the separator (10) comprising a chamber configured to rotate about a rotational axis and convey whole blood from a blood source into an inlet region of the chamber for separation into a red blood cell component, a plasma component and the target cell component and the irradiation device (20) configured to irradiate the target cell component in the illumination container (68), the microprocessor-based controller being configured to control the steps of: drawing anticoagulated whole blood into the disposable fluid circuit and the chamber at a whole blood flow rate, separating the anticoagulated whole blood into the red blood cell component, the target cell component, and the plasma component, directing the target cell component to the illumination container (68), irradiating the illumination container (68) comprising the target cell component to create a treated target cell component, returning to the blood source the treated target cell component, a portion of the red blood cell component remaining in the fluid circuit, and/or a portion of the plasma component remaining in the fluid circuit, estimating an end-of-procedure fluid balance by calculating a total volume of anticoagulant solution having a citrate concentration to be used for the procedure, wherein the end-of-procedure fluid balance is estimated based on one or more manual or automatic inputs comprising an ACD ratio relating unanticoagulated extracorporeal whole blood to anticoagulant solution, an amount of whole blood to process, a citrate infusion threshold rate, a patient body weight associated with the blood source and a total blood volume of the blood source.
  8. The method according to claim 7, the microprocessor-based controller being further configured to control the steps of estimating a maximum extracorporeal volume of red blood cells at any given time during the procedure based on the ACD ratio, a hematocrit of the blood source, a hematocrit of a priming fluid, and the total blood volume; and displaying to an operator the estimate of the maximum extracorporeal volume of red blood cells.
  9. The method according to claim 7, the microprocessor-based controller being further configured to control the step of calculating the total volume of the blood source with information comprising a gender, a height, and weight of the blood source.
  10. The method according to claim 7 , the microprocessor-based controller being further configured to control the step of estimating a maximum extracorporeal volume of red blood cells during the procedure based on the ACD ratio, a hematocrit of the blood source, a hematocrit of a priming fluid, and the total blood volume.
  11. The method according to claim 7 44 , the microprocessor-based controller being further configured to control the step of calculating the total volume of anticoagulant solution to be used for the procedure based on the whole blood flow rate calculated based on manual or automatic inputs comprising the ACD ratio, the citrate infusion threshold rate, and the patient body weight associated with the blood source.

Description

Cross-Reference to Related Applications This application claims the benefit of U.S. Provisional Patent App. No. 62/567,081 filed October 2, 2017. Field of the Disclosure The present disclosure relates generally to systems and methods for monitoring and controlling fluid balance in medical procedures and, in particular to systems and methods for monitoring and controlling fluid volumes in a blood processing procedure. Background Whole blood is made up of various cellular and non-cellular components such as red cells, white cells and platelets suspended in its liquid component, plasma. Whole blood may be separated into its constituent components (cellular, liquid or other), and the separated component(s) may be administered to a patient in need of that particular component or components. The administration of blood and/or blood components is common in the treatment of patients suffering from disease. Rather than infuse whole blood, individual components may be administered to the patient(s) as their needs require. For example, administration (infusion) of platelets may often be prescribed for cancer patients whose ability to make platelets has been compromised by chemotherapy. Infusion of white blood cells (i.e., mononuclear cells) after the cells have undergone some additional processing or treatment may also be prescribed for therapeutic reasons, including treatment of diseases that specifically involve the white blood cells. Thus, it may be desirable to separate and collect the desired blood component from whole blood and then treat the patient with the specific blood component. The remaining components may be returned to the patient or retained for other uses. There are several diseases or disorders which are believed to primarily involve mononuclear cells, such as cutaneous T-cell lymphoma, organ allograft rejection after transplantation and autoimmune diseases such as rheumatoid arthritis and systemic sclerosis, among others. Cutaneous T-cell lymphoma (CTCL) is a term that is used to describe a wide variety of disorders. Generally, CTCL is a type of cancer of the immune system where T-cells (a type of mononuclear cell) mutate or grow in an uncontrolled way, migrate to the skin and form itchy, scaly plaques or patches. More advanced stages of the disease also affect the lymph nodes. Therapeutic treatment options for CTCL have previously been limited. While chemotherapy has been utilized, this particular form of treatment also has many associated undesirable side effects, such as lowered resistance to infection, bleeding, bruising, nausea, infertility and hair loss, just to name a few. Organ allograft rejection may be characterized as the rejection of tissues that are foreign to a host, including transplanted cardiac tissue as well as lung, liver and renal transplants. Immunosuppression drug therapy following transplantation is common. However, there are potential drawbacks including reoccurring infection due to the compromised competence of the immune system caused by this type of therapy. Similarly, graft versus host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. The differences between the donor's cells and recipient's tissues often cause T-cells from the donor to recognize the recipient's body tissues as foreign, thereby causing the newly transplanted cells to attack the recipient. GVHD may complicate stem cell or bone marrow transplantation, thereby potentially limiting these life-saving therapies. Therefore, after a transplant, the recipient may be administered a drug that suppresses the immune system, which helps reduce the chances or severity of GVHD. Autoimmune diseases, including rheumatoid arthritis (RA) and progressive systemic sclerosis (PSS), can be characterized by an overactive immune system which mistakes the body's own tissues as being a foreign substance. As a result, the body makes autoantibodies that attack normal cells and tissues. At the same time, regulatory T-cells, which normally function to regulate the immune system and suppress excessive reactions or autoimmunity, fail in this capacity. This may lead to among other things, joint destruction in RA and inflammation of the connective tissue in PSS. EP 3 132 817 A1 discloses methods and systems for the processing and washing of a photopheresis treated mononuclear cell product. US 9 393 359 82 discloses a method of collecting whole blood in a suitable anticoagulant, holding the anticoagulated whole blood for a selected period of time, separating concentrated red blood cells from the previously held whole blood and storing the same. Summary Insofar as the term embodiment or aspect or alternative is used in the following, or features are presented as being optional, this should be interpreted in such a way that the only protection sought is that of the invention claimed and defined in the appended claims. Acc