# US 11,433,167 B2 · Connection test for blood treatment machines > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,433,167 B2 - Document ID: US11433167B2 - Status: Granted - Kind: B2 - Application number: 16/307,093 - Filed: 2017-06-27 - Published: 2020-10-01 - Granted: 2022-09-06 - Earliest claimed: 2016-06-30 - Assignees: Gambro Lundia AB - Applicants: Gambro Lundia AB - Inventors: Jan Sternby; Björn Ericson - Web page: https://patentgrep.com/patent/US11433167B2 ## CPC - A61M 1/1601: {Control or regulation} - A61M 1/1647: {with flow rate measurement of the dialysis fluid, upstream and downstream of the dialyser} - A61M 1/3656: {Monitoring patency or flow at connection sites; Detecting disconnections} - A61M 1/3658: {Indicating the amount of purified blood recirculating in the fistula or shunt} - A61M 1/1607: {before use, i.e. upstream of dialyser} - A61M 1/1609: {after use, i.e. downstream of dialyser} - A61M 2205/18: with alarm - A61M 2205/276: preventing unwanted use - A61M 2205/3334: Measuring or controlling the flow rate - A61M 2205/3368: Temperature - A61M 2205/70: with testing or calibration facilities - 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 control device for a blood treatment machine performs a connection test (50) by causing the blood treatment machine to switch (51, 53) between a first and a second operating state by reversing a blood pump so as to change a flow direction of blood through both a dialyzer and access devices connected to a patient. Based on an output signal of at least one sensor in the blood treatment machine (52, 54), the control device computes (55) an efficiency change parameter that represents a change in in-vivo clearance of the blood treatment machine during the switch of the blood treatment machine between the first and second operating states. The control device evaluates (56) the efficiency change parameter to jointly detect connection errors at the dialyzer, resulting in co-current flow of treatment fluid and blood through the dialyzer, and at the access devices, resulting in access recirculation of blood. ## Claims ### Claim 1 A control device for a blood treatment machine, wherein the blood treatment machine comprises: an extracorporeal blood flow circuit with first and second access devices for connection to upstream and downstream portions, respectively, of a vascular access of a patient and having a blood pump operable to generate a flow of blood in the extracorporeal blood flow circuit from one of the first and second access devices through a blood compartment of a dialyzer and to another of the first and second access devices; and a treatment fluid flow circuit configured to generate a flow of treatment fluid through a treatment fluid compartment of the dialyzer, said treatment fluid compartment being separated from the blood compartment by a semi-permeable membrane, wherein said control device is configured to, during a connection test: cause the blood treatment machine to switch between a first operating state in which the blood pump is operated in a default direction to pump the blood from the first access device through the blood compartment of the dialyzer to the second access device, and a second operating state in which the blood pump is operated in a reverse direction to pump the blood from the second access device through the blood compartment of the dialyzer to the first access device, acquire an output signal of at least one sensor in the blood treatment machine, compute, based on the output signal, an efficiency change parameter that represents a change in in-vivo clearance of the blood treatment machine during the switch of the blood treatment machine between the first and second operating states, and evaluate the efficiency change parameter to determine if the first or second operating state involves a dual fault condition comprising both a co-current dialyzer configuration, in which the flow of blood through the blood compartment and the flow of treatment fluid through the treatment fluid compartment are in a common direction along the semi-permeable membrane, and a reversed access device configuration, in which the first and second access devices are connected to the downstream and upstream portions, respectively, of the vascular access. ### Claim 2 (depends on 1) The control device of claim 1, which is further configured to generate a warning signal indicating that the blood treatment machine has failed the connection test, if the first operating state is determined to involve the dual fault condition. ### Claim 3 (depends on 1) The control device of claim 1, which is operatively associated with an interface device configured to output instructions for an operator of the blood treatment machine, wherein the control device is configured to, if the first operating state is determined to involve the dual fault condition, operate the interface device to instruct the operator to change a connection of the treatment fluid flow circuit or the extracorporeal blood flow circuit to the dialyzer, and change a connection of the first and second access devices to the vascular access. ### Claim 4 (depends on 1) The control device of claim 1, which is further configured to generate a confirmation signal indicating that the blood treatment machine has passed the connection test, if the second operating state is determined to involve the dual fault condition. ### Claim 5 (depends on 1) The control device of claim 1, which is further configured to selectively enable the blood treatment machine to perform a blood treatment session, if the second operating state is determined to involve the dual fault condition. ### Claim 6 (depends on 1) The control device of claim 1, which is further configured to compare the efficiency change parameter to a first range indicating the dual fault condition in the first operating state, a second range indicating the dual fault condition in the second operating state, a third range indicating the co-current dialyzer configuration and not the reversed access device configuration in the first operating state, and a fourth range indicating the reversed access device configuration and not the co-current dialyzer configuration in the first operating state. ### Claim 7 (depends on 6) The control device of claim 6, which is further configured to obtain status values defining one or more of an estimated cardiac output of the patient, an estimated blood flow rate in the vascular access of the patient, a mass transfer area coefficient of the dialyzer, a flow rate of blood through the blood compartment of the dialyzer during the first and second operating states, and a flow rate of treatment fluid through the treatment fluid compartment of the dialyzer during the first and second operating states, and determine at least one of the first, second, third, or fourth ranges as a function of the status values. ### Claim 8 (depends on 1) The control device of claim 1, which is further configured to evaluate the efficiency change parameter to determine if the first and second operating states involve a respective single fault condition comprising either the co-current dialyzer configuration or the reversed access device configuration. ### Claim 9 (depends on 8) The control device of claim 8, which is further configured to generate a warning signal for an operator of the blood treatment machine, if the first and second operating states are determined to involve the single fault condition. ### Claim 10 (depends on 8) The control device of claim 8, which is configured to, if the first and second operating states are determined to involve the single fault condition, instruct the operator to check connections of the treatment fluid flow circuit and the extracorporeal blood flow circuit to the dialyzer and a connection of the first and second access devices to the vascular access. ### Claim 11 (depends on 8) The control device of claim 8, which is further configured to compare the efficiency change parameter to a first range indicating the dual fault condition in the first operating state, a second range indicating the dual fault condition in the second operating state, and a third range indicating the single fault condition in each of the first and second operating states. ### Claim 12 (depends on 11) The control device of claim 11, wherein a fourth range is defined between the first and third ranges, and a fifth range is defined between the second and third ranges, and wherein the control device is further configured to, if the efficiency change parameter falls within the fourth or fifth ranges, instruct the operator to indicate a mass transfer area coefficient of the dialyzer. ### Claim 13 (depends on 1) The control device of claim 1, which is further configured to obtain dedicated connection test settings for the blood pump and the treatment fluid flow circuit and apply the dedicated connection test settings for controlling the blood pump and the treatment fluid flow circuit during the first and second operation states. ### Claim 14 (depends on 13) The control device of claim 13, which is configured to apply the dedicated connection test settings to cause the blood pump, by a control signal, to generate a fixed and predefined flow rate of blood through the dialyzer during the first and second operating states, and to cause the treatment fluid flow circuit, by a further control signal, to generate a fixed and predefined flow rate of treatment fluid through the dialyzer during the first and second operating states. ### Claim 15 (depends on 14) The control device of claim 14, wherein the predefined flow rate of blood is in the approximate range of 200 to 300 ml/min. ### Claim 16 (depends on 14) The control device of claim 14, wherein the predefined flow rate of treatment fluid is in the approximate range of 200 to 400 ml/min. ### Claim 17 (depends on 14) The control device of claim 14, which is further configured to cause the treatment fluid flow circuit, by the further control signal, to generate a fixed fluid property of the treatment fluid, as measured by the at least one sensor, during the first and second operating states. ### Claim 18 (depends on 1) The control device of claim 1, which is configured to compute the efficiency change parameter to represent a ratio of the in-vivo clearance of the blood treatment machine in the first and second operating states. ### Claim 19 (depends on 1) The control device of claim 1, wherein the output signal represents a physical and/or chemical property of the treatment fluid measured by the at least one sensor downstream or upstream of the dialyzer in the treatment fluid flow circuit. ### Claim 20 (depends on 1) The control device of claim 1, wherein the output signal represents at least one of a temperature or a concentration of a substance that is present in the blood and is capable of exchanging across the semi-permeable membrane. ### Claim 21 (depends on 1) The control device of claim 1, wherein said at least one sensor includes a sensor from the group consisting of: a concentration sensor, a temperature sensor, a conductivity sensor, an optical absorbance sensor, a polarimetry sensor, and a density sensor. ### Claim 22 (depends on 1) A blood treatment machine comprising the control device according to claim 1. ### Claim 23 A method of performing a connection test of a blood treatment machine comprising an extracorporeal blood flow circuit with first and second access devices for connection to upstream and downstream portions of a vascular access of a patient and having a blood pump operable to generate a flow of blood in the extracorporeal blood flow circuit from one of the first and second access devices through a blood compartment of a dialyzer and to another of the first and second access devices, and a treatment fluid flow circuit configured to generate a flow of treatment fluid through a treatment fluid compartment of the dialyzer, said treatment fluid compartment being separated from the blood compartment by a semi-permeable membrane, said method comprising: switching the blood treatment machine between a first operating state in which the blood pump is operated in a default direction to pump the blood from the first access device through the blood compartment of the dialyzer to the second access device, and a second operating state in which the blood pump is operated in a reverse direction to pump the blood from the second access device through the blood compartment of the dialyzer to the first access device; computing, based on an output signal of at least one sensor in the blood treatment machine, an efficiency change parameter that represents a change in in-vivo clearance of the blood treatment machine when switched between the first and second operating states; and evaluating the efficiency change parameter to determine if the first or second operating state involves a dual fault condition comprising both a co-current dialyzer configuration, in which the flow of blood through the blood compartment and the flow of treatment fluid through the treatment fluid compartment are in a common direction along the semi-permeable membrane, and a reversed access device configuration, in which the first and second access devices are connected to the downstream and upstream portions, respectively, of the vascular access. ### Claim 24 (depends on 23) A computer-readable medium comprising computer instructions which, when executed by a processor, cause the processor to perform the method of claim 23.