# US 2022/0031920 A1 · Apparatus for extracorporeal blood treatment

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- Number: US 2022/0031920 A1
- Document ID: US20220031920A1
- Status: Published application
- Kind: A1
- Application number: 17/502,145
- Filed: 2021-10-15
- Published: 2022-02-03
- Earliest claimed: 2016-12-22
- Assignees: Gambro Lundia AB
- Applicants: Gambro Lundia AB
- Inventors: Anders Nilsson
- Web page: https://patentgrep.com/patent/US20220031920A1

## CPC

- A61M 1/1605: {Physical characteristics of the dialysate fluid}
- A61M 1/1609: {after use, i.e. downstream of dialyser}
- A61M 1/1607: {before use, i.e. upstream of dialyser}
- A61M 1/3406: {Physical characteristics of the filtrate, e.g. urea}
- A61M 1/3437: {downstream of the filter, e.g. post-dilution with filtrate}
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- 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

An extracorporeal blood treatment apparatus is provided comprising a filtration unit connected to a blood circuit and to a dialysate circuit, a preparation device for preparing and regulating the composition of the dialysis fluid; a control unit is configured for receiving a desired sodium mass transport at the end of the treatment session and for setting the sodium concentration value for the dialysis fluid in the dialysis supply line at a set point to achieve the desired sodium mass transport at the end of the treatment session.

## Claims

### Claim 1

An apparatus for extracorporeal blood treatment comprising:
a filtration unit including a primary chamber and a secondary chamber separated by a semi-permeable membrane;
a blood withdrawal line connected to an inlet of the primary chamber;
a blood return line connected to an outlet of the primary chamber, said blood withdrawal line and blood return line being configured for connection to a patient cardiovascular system;
a dialysis supply line;
a dialysis effluent line connected to an outlet of the secondary chamber;
a preparation device for preparing a dialysis fluid connected to said supply line and including a regulator for regulating the composition of the dialysis fluid; and
a control unit connected to the regulator and programmed to receive a desired mass transport of a substance at the end of a treatment session and a value representative of a first parameter, wherein the desired mass transport is a set amount of the substance that is transported over the semi-permeable membrane of the filtration unit during the treatment session, the first parameter being chosen from the group consisting of a plasma conductivity, a plasma conductivity-related parameter, a concentration of the substance in the blood, a concentration-related parameter of the substance in the blood, a conductivity of the dialysis fluid, a conductivity-related parameter of the dialysis fluid, a concentration of the substance in the dialysis fluid, and a concentration-related parameter of the substance in the dialysis fluid,
wherein said control unit is programmed for setting a second parameter value for the dialysis fluid in the dialysis supply line at a set point, said second parameter of the dialysis fluid being chosen from a group consisting of the conductivity of the dialysis fluid, the conductivity-related parameter of the dialysis fluid, the concentration of the substance in the dialysis fluid, and the concentration-related parameter of the substance in the dialysis fluid, and
wherein the setting of the second parameter value in the dialysis fluid includes a sub-step of calculating the second parameter value as a function of the desired mass transport, and wherein the second parameter value in the dialysis fluid is set such that the set amount of the substance is transported over the semi-permeable membrane at the end of the treatment session.

### Claim 2 (depends on 1)

The apparatus according to claim 1, wherein the control unit is configured to calculate the second parameter value as a function of a parameter that measures an efficiency of the filtration unit for the substance.

### Claim 3 (depends on 1)

The apparatus according to claim 1, wherein the control unit is configured to calculate the second parameter value as a function of a respective adjusting factor taking account of the Donnan effect.

### Claim 4 (depends on 1)

The apparatus according to claim 1, wherein the control unit is configured to calculate the second parameter value as a function of a patient distribution volume of the substance.

### Claim 5 (depends on 1)

The apparatus according to claim 1, wherein the control unit is configured to calculate the second parameter value as a function of a total treatment time.

### Claim 6 (depends on 1)

The apparatus according to claim 1, wherein the control unit is configured to calculate the second parameter value as a function of an ultrafiltration rate and/or an expected total ultrafiltered volume.

### Claim 7 (depends on 1)

The apparatus according to claim 1, wherein the control unit is configured to calculate the second parameter value as a function of a main contribution term based on the first parameter and as a function of an adjustment contribution term based on the desired mass transport.

### Claim 8 (depends on 7)

The apparatus according to claim 7, wherein the main contribution term has the dimensions of a concentration.

### Claim 9 (depends on 7)

The apparatus according to claim 7, wherein the main contribution term is a concentration of the substance at a dialysis treatment where the substance concentration of the dialysis fluid does not change upstream of the filtration unit versus downstream of the filtration unit.

### Claim 10 (depends on 1)

The apparatus according to claim 1, wherein the main contribution term is a dialysis fluid concentration of sodium at an isonatric dialysis.

### Claim 11 (depends on 1)

The apparatus according to claim 1, wherein the control unit is configured to calculate the adjustment contribution term as a function of one or more of the following:
a parameter that measures an efficiency of the filtration unit for the substance,
a distribution volume of the substance,
an ultrafiltration rate and/or an expected total ultrafiltered volume,
a total treatment time, or
a respective adjusting factor taking account of the Donnan effect.

### Claim 12 (depends on 1)

The apparatus according to claim 1, wherein the first parameter is a blood related parameter chosen from the group consisting of the plasma conductivity and the concentration of the substance in the blood, and wherein the second parameter of the dialysis fluid is chosen from the group consisting of the conductivity of the dialysis fluid and the concentration of the substance in the dialysis fluid.

### Claim 13 (depends on 12)

The apparatus according to claim 12, wherein the first parameter is the plasma conductivity, and the second parameter of the dialysis fluid is the concentration of the substance in the dialysis fluid, the substance being sodium.

### Claim 14 (depends on 7)

The apparatus according to claim 7, wherein the sub-step of calculating the second parameter value as a function of the main contribution term and the adjustment contribution term includes a sub-step of calculating an algebraic sum of at least the main contribution term and the adjustment contribution term, wherein the adjustment contribution term has the dimensions of a concentration.

### Claim 15 (depends on 1)

The apparatus according to claim 1, wherein the sub-step of calculating the second parameter value includes calculating the second parameter value to achieve a desired diffusive mass transport over a treatment time.

### Claim 16 (depends on 1)

The apparatus according to claim 1, wherein the sub-step of calculating the second parameter value includes calculating the second parameter value to achieve a desired total mass transport over a treatment time.

### Claim 17 (depends on 1)

The apparatus according to claim 1, wherein the adjustment contribution term is a sodium concentration set point adjustment relative to an isonatric dialysis to provide a treatment configured to achieve either (i) a desired total or diffusive mass transport over a total treatment time or (ii) a desired total mass transport over the total treatment time.

### Claim 18 (depends on 1)

The apparatus according to claim 1, wherein the control unit drives the regulator for regulating the conductivity or the concentration of the substance in the dialysis fluid, wherein the substance is an ionic substance, and wherein the control unit sets the second parameter value for the dialysis fluid in the dialysis supply line at the calculated set point.

### Claim 19 (depends on 1)

The apparatus according to claim 1, wherein the control unit is programmed to calculate the second parameter value according to one of the following two relationships:
to achieve a desired total mass transport, defined as:
c
d
,
M
=
c
d
,
isoNa
+
M
-
(
V
2
-
f
cd
·
V
1
)
·
c
d
,
isoNa
V
2
-
(
1
+
f
cd
)
·
V
1
,
or
to achieve a desired diffusive mass transport, defined as:
c
d
,
M
d
=
c
d
,
isoNa
+
M
d
-
(
V
2
-
f
cd
·
V
1
-
V
u
α
)
·
c
d
,
isoNa
V
2
-
(
1
+
f
cd
)
·
V
1
,
wherein fcd, V1, V2, and Vu are defined as:
f
cd
=
(
1
-
α
)
·
Q
u
α
·
K
u
-
Q
u
V
1
=
V
0
α
·
(
1
-
(
1
-
V
u
V
0
)
α
·
K
u
Q
u
)
V
2
=
f
cd
·
K
u
·
T
·
V
u
V
u
=
Q
u
·
T
and
wherein:
cd,Md is a dialysis fluid sodium concentration to achieve a desired diffusive sodium mass transfer at the treatment time T;
cd,M is a dialysis fluid sodium concentration to achieve a desired total sodium mass transfer at the treatment time T;
cd,isoNa is a dialysis fluid concentration of sodium at an isonatric dialysis;
Md is a desired diffusive mass transport of sodium;
M is a desired total mass transport of sodium;
V0 is a patient distribution volume of sodium;
Qu is an ultrafiltration rate;
T is a set total treatment time;
Vu is an expected total ultrafiltered volume;
Ku is a filtration unit clearance for sodium; and
α is a Donnan factor.

### Claim 20

An apparatus for extracorporeal blood treatment comprising:
a filtration unit including a primary chamber and a secondary chamber separated by a semi-permeable membrane;
a blood withdrawal line connected to an inlet of the primary chamber;
a blood return line connected to an outlet of the primary chamber, said blood withdrawal line and blood return line being configured for connection to a patient cardiovascular system;
a dialysis supply line;
a dialysis effluent line connected to an outlet of the secondary chamber;
a preparation device for preparing a dialysis fluid connected to said supply line and including a regulator for regulating the composition of the dialysis fluid; and
a control unit connected to the regulator and programmed to receive a desired sodium mass transport at the end of a treatment session and a total treatment time, wherein the desired sodium mass transport is a set mass of sodium that is transported over the semi-permeable membrane of the filtration unit during the treatment session,
wherein said control unit is programmed for setting a parameter value for the dialysis fluid in the dialysis supply line at a set point, said parameter of the dialysis fluid being either a conductivity of the dialysis fluid, or a concentration of a substance in the dialysis fluid, and
wherein the setting of the parameter value in the dialysis fluid includes a sub-step of calculating the parameter value as a function of the desired sodium mass transport and as a function of the total treatment time, and wherein the second parameter value in the dialysis fluid is set such that the set mass of sodium is transported over the semi-permeable membrane at the end of the treatment session.

### Claim 21 (depends on 20)

The apparatus according to claim 20, wherein the control unit is configured to calculate the parameter value as a function of an ultrafiltration rate and/or an expected total ultrafiltered volume.

### Claim 22 (depends on 20)

The apparatus according to claim 20, wherein the control unit is programmed to receive the desired sodium mass transport in grams or millimols amount, the desired sodium mass transport being not a sodium concentration.