# US 10,307,526 B2 · Device and method for regulating a treatment device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,526 B2 - Document ID: US10307526B2 - Status: Granted - Kind: B2 - Application number: 14/167,303 - Filed: 2014-01-29 - Published: 2014-07-31 - Granted: 2019-06-04 - Earliest claimed: 2013-01-30 - Assignees: Fresenius Medical Care Deutschland GmbH - Applicants: Fresenius Medical Care Deutschland GmbH - Inventors: Alexander Heide; Dejan Nikolic; Arne Peters; Christoph Wiktor - Web page: https://patentgrep.com/patent/US10307526B2 ## CPC - A61M 1/16: with membranes - A61M 1/1605: {Physical characteristics of the dialysate fluid} - A61M 1/1613: {Profiling or modelling of patient or predicted treatment evolution or outcome} - A61M 1/1647: {with flow rate measurement of the dialysis fluid, upstream and downstream of the dialyser} - A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration - A61M 1/341: {by measuring the filtrate rate or volume} - A61M 1/3413: {Diafiltration} - A61M 1/3427: {back through the membrane, e.g. by inverted trans-membrane pressure [TMP]} - A61M 1/3607: {Regulation parameters} - A61M 1/3663: {Flow rate transducers; Flow integrators} - A61M 2205/3331: Pressure; Flow - A61M 2205/3334: Measuring or controlling the flow rate - A61M 2205/3365: Rotational speed - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A method and a device are disclosed for regulating an ultrafiltration in a dialysis treatment, in which the blood to be ultrafiltered in an extracorporeal blood circulation (109) flows through a blood chamber (110) of a dialyzer (113), which is subdivided by a semipermeable membrane (111) into a blood chamber (110) and a dialysis fluid chamber (108), and dialysis fluid in a dialysis fluid circulation (109) flows through the dialysis fluid chamber (108) of the dialyzer (113). The device has a blood pump (115) for controlling a blood flow in the extracorporeal blood circulation (112), a dialysis fluid pump (107) for controlling a dialysis fluid flow in the dialysis fluid circulation (109) upstream or downstream from the dialyzer (113), for controlling the dialysis fluid flow upstream of downstream from the dialyzer, a balancing device (104) for setting up a fluid balance in the dialysis fluid circulation between an inflow (106) and an outflow (105) of the dialysis fluid chamber (113) as a measure of the ultrafiltration, as well as a regulating unit (101) for regulating the blood pump (115), the throttle (117) and/or the dialysis fluid pump (107). The pumps or the throttles (117) are regulated so that a predetermined ultrafiltration is achieved. ## Claims ### Claim 1 A device (1, 2) for regulating an ultrafiltration in a dialysis treatment in which the blood to be ultrafiltered flows through a blood chamber (110) of a dialyzer (113) which is subdivided by a semipermeable membrane (111) into a blood chamber (110) and a dialysis fluid chamber (108) in an extracorporeal blood circulation (112), and dialysis fluid in a dialysis fluid circulation (109) flows through the dialysis fluid chamber (108) of the dialyzer (113), having a blood pump (115) for controlling a blood flow in the extracorporeal blood circulation (112), having a dialysis fluid pump (107) which is arranged in the dialysis fluid circulation (109) upstream from the dialyzer (113) for controlling a dialysis fluid flow in an inflow to the dialysis fluid chamber, having a variably adjustable throttle (117) arranged in the dialysis fluid circulation downstream from the dialyzer configured to control the dialysis fluid flow in the outflow out of the dialysis fluid chamber (108) by increasing and decreasing the resistance to dialysis fluid flowing out of the dialysis fluid chamber and through the throttle, said variably adjustable throttle having (1) a clocked valve or (2) a variably adjustable cross-sectional flow-through whose fluid resistance is adjustable solely through constricting or widening of the throttle, and without the inclusion of any fluid pumping mechanism in the dialysis fluid circulation downstream from the dialyzer, having a balancing device (104) configured to measure the fluid balance in the dialysis fluid circulation between the inflow (106) and the outflow (105) out of the dialysis fluid chamber (108) as a measure of the ultrafiltration, and for transmitting the measured fluid balance as an ultrafiltration parameter to a control and regulating unit (101), a control and regulating unit (101) configured to receive the ultrafiltration parameter from said balancing device and to regulate the throttle (117) so that a predetermined ultrafiltration value is achieved, said control and regulating unit connected to said throttle to provide control signals to the throttle, said throttle responsive to the control signals to control the dialysis fluid flow in said outflow, said control and regulating unit configured to control the throttle so that the ultrafiltration parameter measured and transmitted by the balancing device matches the predetermined ultrafiltration value. ### Claim 2 (depends on 1) The device (1, 2) according to claim 1, wherein a predetermined value can be set for the blood flow. ### Claim 3 (depends on 1) The device (1, 2) according to claim 1, wherein a predetermined value can be set for the dialysis fluid flow and the regulating unit is adjusted to regulate the blood flow. ### Claim 4 (depends on 1) The device (1, 2) according to claim 1, wherein a profile for the ultrafiltration rate can be preselected by the regulating unit (101) in which intervals with a positive ultrafiltration rate alternate with intervals having a negative ultrafiltration rate. ### Claim 5 (depends on 1) The device (1, 2, 51) according to claim 1, wherein the control and regulating unit (101) is adapted to preselect an ultrafiltration rate, a hemofiltration rate and/or an ultrafiltration volume or hemofiltration volume that is to be withdrawn during the course of treatment. ### Claim 6 (depends on 1) The device (1, 2, 51) according to claim 1, wherein the blood pump is arranged in an inlet line to the blood chamber. ### Claim 7 (depends on 1) The device (1, 2, 51) according to claim 1, wherein the throttle (117) is designed as a clocked valve. ### Claim 8 (depends on 1) The device according to claim 1, wherein the regulating unit is further configured to regulate the blood pump (115). ### Claim 9 (depends on 1) The device according to claim 1, wherein the regulating unit is further configured to regulate the dialysis fluid pump (107). ### Claim 10 A device (1, 2) for regulating an ultrafiltration in a dialysis treatment in the blood to be ultrafiltered in an extracorporeal blood circulation (112) in which blood flows through a blood chamber (110) of a dialyzer (113) which is subdivided by a semipermeable membrane (111) into the blood chamber (110) and a dialysis fluid chamber (108), and dialysis fluid flows in a dialysis fluid circulation (109) through the dialysis fluid chamber (108) of the dialyzer (113), having a blood pump (115) for controlling a blood flow in the extracorporeal blood circulation (112), having a dialysis fluid pump arranged downstream from the dialyzer (113) in the dialysis fluid circulation (109) for control of a dialysis fluid flow in an outflow out of the dialysis fluid chamber, having a variably adjustable throttle arranged upstream from the dialyzer in the dialysis fluid circulation, said throttle configured to control the dialysis fluid flow in an inflow to the dialysis fluid chamber by increasing and decreasing the resistance to dialysis fluid flowing into the dialysis fluid chamber, said variably adjustable throttle having (1) a clocked valve or (2) a variably adjustable cross-sectional flow-through whose fluid resistance is adjustable solely through constricting or widening of the throttle, and without the inclusion of any fluid pumping mechanism in the dialysis fluid circulation upstream from the dialyzer, having a balancing device (104) configured to measure a liquid balance in the dialysis fluid circulation between the inflow (106) and the outflow (105) of the dialysis fluid chamber (113) as a measure of the ultrafiltration, and for transmitting the measured ultrafiltration to a control and regulating unit (101), a control and regulating unit (101) configured to receive the measured ultrafiltration and to regulate the throttle so that a predetermined ultrafiltration is achieved, said control and regulating unit connected to said throttle to provide control signals to the throttle, said throttle responsive to the control signals to control the dialysis fluid flow in said inflow, said control and regulating unit configured to control the throttle so that the measured and transmitted ultrafiltration of the balancing device matches the predetermined ultrafiltration value. ### Claim 11 (depends on 10) The device according to claim 10, wherein the regulating unit is further configured to regulate the blood pump (115). ### Claim 12 (depends on 10) The device according to claim 10, wherein the regulating unit is further configured to regulate the dialysis fluid pump (107). ### Claim 13 A device (1, 2) for regulating an ultrafiltration in a dialysis treatment in which the blood to be ultrafiltered flows through a blood chamber (110) of a dialyzer (113) which is subdivided by a semipermeable membrane (111) into a blood chamber (110) and a dialysis fluid chamber (108) in an extracorporeal blood circulation (112), and dialysis fluid in a dialysis fluid circulation (109) flows through the dialysis fluid chamber (108) of the dialyzer (113), Having a blood pump (115) for controlling a blood flow in the extracorporeal blood circulation (112), Having a dialysis fluid pump (107) which is arranged in the dialysis fluid circulation (109) upstream from the dialyzer (113) for controlling a dialysis fluid flow in an inflow to the dialysis fluid chamber, Having a variably adjustable throttle (117) arranged in the dialysis fluid circulation downstream from the dialyzer configured to control the dialysis fluid flow in the outflow out of the dialysis fluid chamber (108) by increasing or decreasing the resistance to dialysis fluid flowing out of the dialysis fluid chamber and through the throttle, said variably adjustable throttle having (1) a clocked valve or (2) a variably adjustable cross-sectional flow-through whose fluid resistance is adjustable solely through constricting or widening of the throttle, Having a balancing device (104) configured to measure the fluid balance in the dialysis fluid circulation between the inflow (106) and the outflow (105) out of the dialysis fluid chamber (108) as a measure of the ultrafiltration, and for transmitting the measured fluid balance as an ultrafiltration parameter to a control and regulating unit (101), Wherein the balancing device has a differential flow-measuring unit (104) for measuring the differential flow between a flow in the inflow to the dialysis fluid chamber (108) and the outflow out of the dialysis fluid chamber, a branch from the inflow or the outflow to the branch of the dialysis fluid from the inflow or the outflow into another flow path (212) as well as a device for adjusting the flow rate (211) in the inflow, in the outflow and/or in the additional flow path, this measuring unit beign controllable so that the measured differential flow fulfills a predetermined condition, and having a device (211) for determining the flow rate in the additional flow path as a measure of the fluid balance, A control and regulating unit (101) configured to receive the ultrafiltration parameter from said balancing device and to regulate the throttle (117) so that a predetermined ultrafiltration value is achieved, Said control and regulating unit connected to said throttle to provide control signals to the throttle, said throttle responsive to the control signals to control the dialysis fluid flow in said outflow, Said control and regulating unit configured to control the throttle so that the ultrafiltration parameter measured and transmitted by the balancing device matches the predetermined ultrafiltration value. ### Claim 14 (depends on 13) The device (2) according to claim 13, wherein the predetermined condition of the differential flow is based on an integration of the differential flow over a predetermined integration interval. ### Claim 15 A method for regulating an ultrafiltration in a dialysis treatment in which blood to be ultrafiltered in an extracorporeal blood circulation (112) flows through a blood chamber (110) of a dialyzer (113) which is subdivided by a semipermeable membrane (111) into a blood chamber (110) and a dialysis fluid chamber (108), and dialysis fluid in a dialysis fluid circulation (109) flows through the dialysis fluid chamber (108) of the dialyzer (113), and in which upstream from the dialyzer (113) there is a dialysis fluid pump (107) controlling a dialysis fluid flow in an inflow to the dialysis fluid chamber (108), downstream from the dialyzer there is a variably adjustable throttle (117) controlling the dialysis fluid flow in an outflow out of the dialysis fluid chamber (108), and without any additional dialysis fluid pump in the outflow of the dialysis fluid chamber, said variably adjustable throttle having (1) a clocked valve or (2) a variably adjustable cross-sectional flow-through whose fluid resistance is adjustable solely through constricting or widening of the throttle, a balancing device (104) measuring a fluid balance in the dialysis fluid circulation between the inflow and the outflow out of the dialysis fluid chamber (108) as a measure of the ultrafiltration and transmitting the measured fluid balance to a control and regulating unit (101), and a blood pump (107) controlling blood flow rate in the extracorporeal blood circulation (109) and wherein the method comprises regulating the throttle (117) by (1) regulating the clocking of the clocked valve or (2) constricting or widening the cross-sectional flow-through the throttle, and without any fluid pumping, said regulating by the control and regulating unit so that the ultrafiltration measured and transmitted by the balancing device achieves a predetermined ultrafiltration. ### Claim 16 (depends on 15) The method for regulating an ultrafiltration according to claim 15, wherein a profile for the ultrafiltration rate is preselected, in which intervals with a positive ultrafiltration rate alternate with intervals having a negative ultrafiltration rate. ### Claim 17 (depends on 15) The method for regulating an ultrafiltration according to claim 15, further comprising regulating the dialysis fluid pump (107). ### Claim 18 (depends on 15) The method for regulating an ultrafiltration according to claim 15, further comprising regulating the blood pump (115). ### Claim 19 The method for regulating an ultrafiltration in a dialysis treatment in which blood to be ultrafiltered in an extracorporeal blood circulation (112) flows through a blood chamber (110) of a dialyzer (113) which is subdivided by a semipermeable membrane (111) into a blood chamber (110) and a dialysis fluid chamber (108), and dialysis fluid in a dialysis fluid circulation (109) flows through the dialysis fluid chamber (108) of the dialyzer and in which a dialysis fluid pump is provided downstream from the dialyzer (113) to control the dialysis fluid flow in an outflow out of the dialysis fluid chamber, a variably adjustable throttle (117) is provided upstream from the dialyzer controlling the dialysis fluid flow in an inflow to the dialysis fluid chamber, and without any additional dialysis fluid pump in the inflow into the dialysis fluid chamber, said variably adjustable throttle having (1) a clocked valve or (2) a variably adjustable cross-sectional flow-through whose fluid resistance is adjustable solely through constricting or widening of the throttle, a balancing device (104) is provided for measuring a liquid balance in the dialysis fluid circulation (109) between the inflow and the outflow out of the dialysis fluid chamber (108) as a measure of the ultrafiltration, and transmitting the measured fluid balance to a control and regulating unit (101), and a blood pump (115) controlling a blood flow in the extracorporeal blood circulation and such that the method comprises regulating the throttle by (1) regulating the clocking of the clocked valve or (2) constricting or widening the cross-sectional flow-through the throttle, and without any fluid pumping, said regulating by the control and regulating unit so that the ultrafiltration measured and transmitted by the balancing device achieves a predetermined ultrafiltration. ### Claim 20 (depends on 19) The method for regulating an ultrafiltration according to claim 19, further comprising regulating the dialysis fluid pump (107). ### Claim 21 (depends on 19) The method for regulating an ultrafiltration according to claim 19, further comprising regulating the blood pump (107). ### Claim 22 A method for regulating an ultrafiltration in a dialysis treatment in which blood to be ultrafiltered in an extracorporeal blood circulation (112) flows through a blood chamber (110) of a dialyzer (113) which is subdivided by a semipermeable membrane (111) into a blood chamber (110) and a dialysis fluid chamber (108), and dialysis fluid in a dialysis fluid circulation (109) flows through the dialysis fluid chamber (108) of the dialyzer (113), and a blood pump (107) controlling blood flow rate in the extracorporeal blood circulation (109), and in which upstream from the dialyzer (113) there is a dialysis fluid pump (107) controlling a dialysis fluid flow in an inflow to the dialysis fluid chamber (108), downstream from the dialyzer there is a variably adjustable throttle (117) controlling the dialysis fluid flow in an outflow out of the dialysis fluid chamber (108), said variably adjustable throttle having (1) a clocked valve or (2) a variably adjustable cross-sectional flow-through whose fluid resistance is adjustable solely through constricting or widening the throttle, a balancing device (104) measuring a fluid balance in the dialysis fluid circulation between the inflow and the outflow out of the dialysis fluid chamber (108) as a measure of the ultrafiltration and transmitting the measured fluid balance to a control and regulating unit (101), Wherein the balancing device has a differential flow measuring unit (104) for measuring the differential flow between a flow in the inflow to the dialysis fluid chamber (108) and the outflow out of the dialysis fluid chamber, a branch from the inflow or the outflow to the branch of the dialysis fluid from the inflow or the outflow into another flow path (212) as well as a device for adjusting the flow rate (211) in the inflow, in the outflow and/or in the additional flow path, this measuring unit being controllable so that the measured differential flow fulfills a predetermined condition, and having a device (211) for determining the flow rate in the additional flow path as a measure of the fluid balance and wherein the balancing between an inflow and an outflow from the dialysis fluid chamber, the method comprising, Measuring a differential flow between an inflow to the dialysis fluid chamber (108) and an outflow out of the dialysis fluid chamber, Using the measured differential flow as a control variable for the device for setting a flow rate in another flow path (212) which branches off from the inflow or the outflow and determining the flow rate in the additional flow path as a measure of the fluid balance, and wherein the method further comprises regulating the throttle (117) by (1) regulating the clocking of the clocked valve or (2) constricting or widening the cross-sectional flow-through the throttle, said regulating by the control and regulating unit so that the ultrafiltration measured and transmitted by the balancing device achieves a predetermined ultrafiltration. ### Claim 23 (depends on 22) The method for regulating an ultrafiltration according to claim 22, wherein a predetermined condition is fulfilled for the differential flow, based on integration of the differential flow over a predetermined integration interval.