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EP-4072613-B1 - SYRINGE-BASED MANUAL EXTRACORPOREAL BLOOD TREATMENT SYSTEMS AND METHODS EMPLOYING BATCH PROCESSING

EP4072613B1EP 4072613 B1EP4072613 B1EP 4072613B1EP-4072613-B1

Inventors

  • CHAWLA, Lakhmir Singh

Dates

Publication Date
20260513
Application Date
20201209

Claims (10)

  1. A manual blood treatment system (100) comprising: first (128) and second (136) reservoirs for holding a batch of blood from a patient (102); a first conduit (106) for conveying blood from a vascular access of the patient (102) during a first stage and for returning treated blood to the vascular access (104) during a third stage, the first conduit (106) having only a single lumen; a filter (132) for performing, during a second stage, an extracorporeal treatment on blood passing therethrough by removing waste molecules and/or fluid; and a first syringe (114) coupled to the first conduit (106) via a first valve (112) between the vascular access (104) and the first reservoir (128), wherein fluid ports of the first (128) and second (136) reservoirs are connected to each other by a flow path through the filter (132) such that the batch of blood can flow between the first (128) and second (128) reservoirs via the filter (132); a second syringe (142) is coupled to a drain line (138) from the filter (132) via a second valve (140), wherein the second syringe (142) is configured to apply a vacuum pressure to the filter (132) when the second valve is in a first orientation, and characterized in that the first reservoir (128) is constructed to be displaced vertically relative to the second reservoir (136) and the second reservoir (136) is configured to be displaced vertically relative to the first reservoir (128) during blood return to the first reservoir (128) such that a height difference between the first (128) and second (136) reservoirs causes blood to flow between the reservoirs due to gravity.
  2. The system of claim 1, wherein the first syringe (114) is configured to: apply a vacuum pressure to the vascular access (104) when the first valve (112) is in a first orientation to withdraw a volume of blood from the patient (102) via the first conduit (106), and apply a positive pressure when the first valve (112) is in a second orientation to push the withdrawn volume of blood along the first conduit (106) to the first reservoir (128).
  3. The system of any one of claims 1-2, wherein the second syringe is configured to apply a positive pressure to push effluent received from the filter (132) along the drain line (138) for disposal when the second valve (140) is in a second orientation.
  4. The system of any one of claims 1-3, wherein the filter (132) is constructed to provide a hemodialysis, hemofiltration, hemodiafiltration, or hemoperfusion treatment to the blood flowing along the flow path through the filter.
  5. The system of any of claims 1-4, further comprising: one or more additional valves disposed along the first conduit (106) between the vascular access (104) and the first valve (112) or between the first valve (112) and the first reservoir (128), wherein the first syringe (114) is further configured to: apply a vacuum pressure to a source of secondary fluid or drug connected to the one or more additional valves when the first valve (112) is in the first orientation to withdraw a volume of secondary fluid or drug, and apply a positive pressure when the first valve (112) is in the second orientation to push the withdrawn volume of secondary fluid or drug along the first conduit (106) to the first reservoir (128).
  6. The system of claim 5, wherein the secondary fluid or drug comprises at least one of replacement fluid, flushing fluid, intravenous fluid, anticoagulant, or anticoagulant reversal agent.
  7. The system of claim 2, wherein applying the positive pressure pushes blood from the first syringe (114) into the first blood reservoir (128).
  8. The system of any one of claims 1-7, wherein the filter (132) contains adsorption media that uses covalently bonded heparin or heparan sulfate.
  9. The system of any one of claims 1-7, wherein the filter (132) is an extracorporeal hemoadsorption filter device to remove cytokines from blood that contains porous sorbent beads.
  10. The system of any one of claims 1-9, wherein vascular access (104) comprises a needle, a catheter, or any other device for connecting to the patient.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS This application claims priority to US Provisional Patent Application Nos. 62/947,344, filed December 12, 2019, and 63/057,129, file July 27, 2020. BACKGROUND OF THE INVENTION FIELD The present disclosure relates generally to extracorporeal blood treatments, and more particularly, to manual extracorporeal blood treatment systems and methods employing batch processing. DE 19633 657 describes a blood treatment appliance that comprises a blood collection bag divided by at least one peel-off seam into at least two chambers. One chamber is connected to the blood tube and has an opening closed by a membrane and has an inlet and outlet. The blood inflow and outflow tubes lead to a shared blood tube or are separate. WO 92/20383 describes a fluid treatment system which is particularly suitable for treating blood. The system comprises a fluid delivery means for delivering the fluid to a membrane filtration means; the membrane filtration means being adapted for treating the fluid to remove a filtrate stream from the fluid; reservoir means connected to the filtration means for receiving a batch of treated fluid; treated fluid discharge means connected to the reservoir means for discharging treated fluid from the reservoir means; filtrate discharge means connected to the filtration means for discharging filtrate therefrom; and pressure sensor means for sensing the trans-membrane pressure in the membrane filtration means and controlling the rate of delivery of the fluid by the delivery means. EP 2720733 describes an apparatus for performing hemodialysis on a patient which comprises a first blood transfer means for selectively withdrawing blood from a patient and storing it in a first storage portion; second blood transfer means for removing filtered blood from a filtration device and storing it in a second storage portion; and a fluid measurement system for periodically measuring the respective volumes of blood in the first and second storage portions; adding the volume of blood in the first storage portion to the volume of blood in the second storage portion to calculate the total volume of blood within the first and second storage portions; and comparing the total measured volumes of blood within the first and second storage portions measured over a predetermined time interval to calculate the volume of fluid removed from the blood during that predetermined time interval. BRIEF SUMMARY OF THE INVENTION In one embodiment, the disclosure provides a manual blood treatment system comprising: first and second reservoirs for holding a batch of blood from a patient;a first conduit for conveying blood from a vascular access of the patient during a first stage and for returning treated blood to the vascular access during a third stage, the first conduit having only a single lumen;a filter for performing, during a second stage, an extracorporeal treatment on blood passing therethrough by removing waste molecules and/or fluid; anda first syringe coupled to the first conduit via a first valve between the vascular access and the first reservoir,wherein fluid ports of the first and second reservoirs are connected to each other by a flow path through the filter such that the batch of blood can flow between the first and second reservoirs via the filter, andthe first reservoir is constructed to be displaced vertically relative to the second reservoir and vice versa, such that a height difference between the first and second reservoirs causes blood to flow between the reservoirs due to gravity. In certain aspects, the first syringe is configured to: apply a vacuum pressure to the vascular access when the first valve is in a first orientation to withdraw a volume of blood from the patient via the first conduit, and apply a positive pressure when the first valve is in a second orientation to push the withdrawn volume of blood along the first conduit to the first reservoir. In certain aspects, the system further comprises a second syringe coupled to a drain line from the filter via a second valve, wherein the second syringe is configured to apply a vacuum pressure to the filter when the second valve is in a first orientation, and apply a positive pressure to push effluent received from the filter along the drain line for disposal when the second valve is in a second orientation. In certain aspect, the filter is constructed to provide a hemodialysis, hemofiltration, hemodiafiltration, hemoperfusion or a combination treatment to the blood flowing along the flow path through the filter. In certain aspects, the system further comprises one or more additional valves disposed along the first conduit between the vascular access and the first valve or between the first valve and the first reservoir, wherein the first syringe is further configured to apply a vacuum pressure to a source of secondary fluid or drug connected to the one or more additional valves when the first valve is in the first orientation