# US 9,750,864 B2 · Process and device for monitoring the supply of substitution fluid during an extracorporeal treatment of blood

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- Number: US 9,750,864 B2
- Document ID: US9750864B2
- Status: Granted
- Kind: B2
- Application number: 15/163,300
- Filed: 2016-05-24
- Published: 2016-09-15
- Granted: 2017-09-05
- Earliest claimed: 2004-05-11
- Assignees: Fresenius Medical Care Deutschland GmbH
- Applicants: Fresenius Medical Care Deutschland GmbH
- Inventors: Pascal Kopperschimdt
- Web page: https://patentgrep.com/patent/US9750864B2

## CPC

- A61M 1/342: {Adding solutions to the blood, e.g. substitution solutions (for preventing coagulation A61M1/3672)}
- A61B 5/02141: {Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits (A61B5/02233, A61B5/0235 take precedence)}
- A61B 5/7225: {Details of analogue processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation (input circuits for detecting, measuring, or recording bioelectric or biomagnetic signals A61B5/30; specific diagnostic methods using bioelectric or biomagnetic signals A61B5/316)}
- A61B 5/7257: {using Fourier transforms}
- A61M 1/1601: {Control or regulation}
- A61M 1/3431: {upstream of the filter}
- A61M 1/3434: {with pre-dilution and post-dilution}
- A61M 1/3437: {downstream of the filter, e.g. post-dilution with filtrate}
- A61M 1/3465: {using dialysate as substitution fluid}
- A61M 1/361: {before treatment}
- A61M 1/3612: {after treatment}
- A61M 1/3639: {Blood pressure control, pressure transducers specially adapted therefor}
- A61M 1/3653: {Interfaces between patient blood circulation and extra-corporal blood circuit}
- A61M 1/3655: {Arterio-venous shunts or fistulae}
- A61M 1/3658: {Indicating the amount of purified blood recirculating in the fistula or shunt}
- A61M 2205/3355: Controlling downstream pump pressure
- A61M 2205/702: automatically during use
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The invention relates to a process for monitoring the supply of substitution fluid upstream or downstream of a dialyzer or filter arranged in an extracorporeal blood stream. One embodiment provides, for the detection of predilution or postdilution, for measuring the pressure in the blood stream downstream of the dialyzer or filter, predilution or postdilution being recognized on the basis of the change in pressure following the shutting off and/or starting up of the substituate pump provided for conveying the substitution fluid. Another embodiment provides for recognizing predilution or postdilution on the basis of the comparison of the oscillating pressure signal attributable to the substituate pump to a characteristic reference signal. The characteristic reference signal to which the pressure signal of the substituate pump is compared is preferably the oscillating pressure signal of a blood pump arranged in the blood stream for conveying the blood upstream of the dialyzer or filter. In addition, the invention relates to an extracorporeal blood treatment device with a facility for detecting predilution or postdilution, which device operates according to the processes detailed above.

## Claims

### Claim 1

A device for the extracorporeal treatment of blood comprising:
a dialyser or filter divided by a membrane into a first chamber and a second chamber;
an extracorporeal blood stream including a hose segment between an arterial needle and an inlet of the first chamber, and a hose segment between an outlet of the first chamber and a venous needle;
a fluid system including the second chamber;
a substituate pump arranged in a substitution fluid line, said substitution fluid line leading to the hose segment between the outlet of the first chamber and the venous needle of the extracorporeal blood stream downstream of the dialyser or the filter; and
a device configured to determine the volume of fill (VPD) of the hose segment between the inlet of the first chamber and the connection site of the substitution fluid line to the hose segment between the outlet of the first chamber and the venous needle; wherein the device comprises:
a control unit for at least one of shutting off the substituate pump and starting up the substituate pump;
a pressure sensor for measuring the pressure in the extracorporeal blood stream downstream of the dialyser or the filter; and
an evaluation unit comprising:
means for determining an increase or decrease in the pressure after at least one of the shutting off the substitute pump which has been previously started up and the starting up the substitute pump which has been previously shut off;
means for determining the time difference between the beginning and the end of the pressure pulse increase or the pressure pulse decrease due to shutting off the substitute pump which has been previously started up or starting up the substitute pump which has been previously shut off; and
means for calculating the volume of fill (VPD) by multiplying the predetermined blood feed rate in the extracorporeal blood stream with the determined time difference between the beginning and the end of the pressure pulse increase or the pressure pulse decrease.

### Claim 2 (depends on 1)

A device according to claim 1, wherein the device for determining the volume of fill (VPD) is configured to determine the volume of fill (VPD) of the hose segment between the inlet of the first chamber and the connection site of the substitution fluid line to a drip chamber arranged in the hose segment between the outlet of the first chamber and the venous needle.

### Claim 3

A device for the extracorporeal treatment of blood comprising:
a dialyser or filter divided by a membrane into a first chamber and a second chamber;
an extracorporeal blood stream including a hose segment between an arterial needle and an inlet of the first chamber, and a hose segment between an outlet of the first chamber and a venous needle;
a fluid system including the second chamber;
a substituate pump arranged in a substitution fluid line, said substitution fluid line leading to the hose segment between the outlet of the first chamber and the venous needle of the extracorporeal blood stream downstream of the dialyser or the filter; and
a device configured to determine the blood feed rate in the extracorporeal blood stream; wherein the device comprises:
a control unit for at least one of shutting off the substituate pump and starting up the substituate pump;
a pressure sensor for measuring the pressure in the extracorporeal blood stream downstream of the dialyser or the filter; and
an evaluation unit comprising:
means for determining an increase or decrease in the pressure after at least one of the shutting off the substitute pump which has been previously started up and the starting up the substitute pump which has been previously shut off;
means for determining the time difference between the beginning and the end of the pressure pulse increase or the pressure pulse decrease due to shutting off the substitute pump which has been previously started up or the starting up substitute pump which has been previously shut off; and
means for calculating the blood feed rate in the extracorporeal blood stream by dividing the predetermined volume of fill (VPD) of the hose segment between the inlet of the first chamber and the connection site of the substitution fluid line to the hose segment between the outlet of the first chamber and the venous needle and the determined time difference between the beginning and the end of the pressure pulse increase or the pressure pulse decrease.

### Claim 4 (depends on 3)

A device according to claim 3, wherein the predetermined volume of fill (VPD) is the volume of the hose segment between the inlet of the first chamber and the connection site of the substitution fluid line to a drip chamber arranged in the hose segment between the outlet of the first chamber and the venous needle.

### Claim 5

A device for the extracorporeal treatment of blood comprising:
a dialyser or filter divided by a membrane into a first chamber and a second chamber;
an extracorporeal blood stream including a hose segment between an arterial needle and an inlet of the first chamber, and a hose segment between an outlet of the first chamber and a venous needle;
a fluid system including the second chamber;
a substituate pump arranged in a substitution fluid line, said substitution fluid line leading to the hose segment between the arterial needle and the inlet of the first chamber of the extracorporeal blood stream upstream of the dialyser or the filter; and
a device configured to determine the volume of fill (VPD) of the hose segment between the inlet of the first chamber and the venous needle; wherein the device comprises:
a control unit for at least one of shutting off the substituate pump and starting up the substituate pump;
a pressure sensor for measuring the pressure in the extracorporeal blood stream downstream of the dialyser or the filter; and
an evaluation unit comprising:
means for determining an increase or decrease in the pressure after at least one of the shutting off the substitute pump which has been previously started up and the starting up the substitute pump which has been previously shut off;
means for determining the time difference between the shutting off the substitute pump and the beginning of the pressure drop in the extracorporeal blood stream downstream of the dialyser or the filter or the time difference between the starting up the substitute pump and the beginning of the pressure increase in the extracorporeal blood stream downstream of the dialyser or the filter; and
means for calculating the volume of fill (VPD) by multiplying the predetermined blood feed rate in the extracorporeal blood stream with the determined time difference between the shutting off the substitute pump and the beginning of the pressure drop in the extracorporeal blood stream downstream of the dialyser or the filter or the time difference between the starting up the substitute pump and the beginning of the pressure increase in the extracorporeal blood stream downstream of the dialyser or the filter.

### Claim 6

A device for the extracorporeal treatment of blood comprising:
a dialyser or filter divided by a membrane into a first chamber and a second chamber;
an extracorporeal blood stream including a hose segment between an arterial needle and an inlet of the first chamber, and a hose segment between an outlet of the first chamber and a venous needle;
a fluid system including the second chamber;
a substituate pump arranged in a substitution fluid line, said substitution fluid line leading to the hose segment between the arterial needle and the inlet of the first chamber of the extracorporeal blood stream upstream of the dialyser; and
a device configured to determine the blood feed rate in the extracorporeal blood stream; wherein the device comprises:
a control unit for at least one of shutting off the substituate pump and starting up the substituate pump;
a pressure sensor for measuring the pressure in the extracorporeal blood stream downstream of the dialyser or the filter; and
an evaluation unit comprising:
means for determining an increase or decrease in the pressure after at least one of the shutting off the substitute pump which has been previously started up and the starting up the substitute pump which has been previously shut off;
means for determining the time difference between the shutting off the substitute pump and the beginning of the pressure drop in the extracorporeal blood stream downstream of the dialyser or the filter or the time difference between the starting up the substitute pump and the beginning of the pressure increase in the extracorporeal blood stream downstream of the dialyser or the filter; and
means for calculating the blood feed rate by dividing the predetermined volume of fill (VPD) of the hose segment between the inlet of the first chamber and the venous needle by the determined time difference between the shutting off the substitute pump and the beginning of the pressure drop in the extracorporeal blood stream downstream of the dialyser or the filter or the time difference between the starting up the substitute pump and the beginning of the pressure increase in the extracorporeal blood stream downstream of the dialyser or the filter.

### Claim 7

A device for the extracorporeal treatment of blood comprising:
a dialyser or filter divided by a membrane into a first chamber and a second chamber;
an extracorporeal blood stream including a hose segment between an arterial needle and an inlet of the first chamber, and a hose segment between an outlet of the first chamber and a venous needle;
a fluid system including the second chamber;
a substituate pump arranged in a substitution fluid line, said substitution fluid line leading to the hose segment between the outlet of the first chamber and the venous needle of the extracorporeal blood stream downstream of the dialyser or the filter; and
a device configured to determine the volume of fill (VPD) of the hose segment between the inlet of the first chamber and the venous needle; wherein the device comprises:
a control unit for at least one of shutting off the substituate pump and starting up the substituate pump;
a pressure sensor for measuring the pressure in the extracorporeal blood stream downstream of the dialyser or the filter; and
an evaluation unit comprising:
means for determining an increase or decrease in the pressure after at least one of the shutting off the substitute pump which has been previously started up and the starting up the substitute pump which has been previously shut off;
means for determining the time difference between the stopping off the substitute pump and the beginning of the pressure increase in the extracorporeal blood stream downstream of the dialyser or the filter or the time difference between the starting the substitute pump and the beginning of the pressure drop in the extracorporeal blood stream downstream of the dialyser or the filter; and
means for calculating the volume of fill (VPD) by multiplying the predetermined blood feed rate in the extracorporeal blood stream with the determined time difference between the stopping off the substitute pump and the beginning of the pressure increase in the extracorporeal blood stream downstream of the dialyser or the filter or the time difference between the starting the substitute pump and the beginning of the pressure drop in the extracorporeal blood stream downstream of the dialyser or the filter.

### Claim 8

A device for the extracorporeal treatment of blood comprising:
a dialyser or filter divided by a membrane into a first chamber and a second chamber;
an extracorporeal blood stream including a hose segment between an arterial needle and an inlet of the first chamber, and a hose segment between an outlet of the first chamber and a venous needle;
a fluid system including the second chamber;
a substituate pump arranged in a substitution fluid line, said substitution fluid line leading to the hose segment between the outlet of the first chamber and the venous needle of the extracorporeal blood stream downstream of the dialyser or the filter; and
a device configured to determine the blood feed rate in the extracorporeal blood stream; wherein the device comprises:
a control unit for at least one of shutting off the substituate pump and starting up the substituate pump;
a pressure sensor for measuring the pressure in the extracorporeal blood stream downstream of the dialyser or the filter; and
an evaluation unit comprising:
means for determining an increase or decrease in the pressure after at least one of the shutting off the substitute pump which has been previously started up and the starting up the substitute pump which has been previously shut off;
means for determining the time difference between the stopping off the substitute pump and the beginning of the pressure increase in the extracorporeal blood stream downstream of the dialyser or the filter or the time difference between the starting the substitute pump and the beginning of the pressure drop in the extracorporeal blood stream downstream of the dialyser or the filter; and
means for calculating the blood feed rate by dividing the predetermined volume of fill (VPD) of the hose segment between the inlet of the first chamber and the venous needle by the determined time difference between the stopping off the substitute pump and the beginning of the pressure increase in the extracorporeal blood stream downstream of the dialyser or the filter or the time difference between the starting the substitute pump and the beginning of the pressure drop in the extracorporeal blood stream downstream of the dialyser or the filter.
