Method of initialising an apparatus for blood treatment in the single-needle mode and apparatus for blood treatment in the single-needle mode

• US 9,238,098 B2
• Filed: 06/03/2011
• Issued: 01/19/2016
• Est. Priority Date: 06/04/2010
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Bocklet, Christoph, Schaefer, Ingo, Thys, Martin, Noack, Joachim, Mueller, Ralf
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US13/700,586
• Publication Number:
  US 20130079698A1
• Time in Patent Office: 1,691 Days
• Field of Search: 604 401- 616
• US Class Current: 1/1
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/306 Pressure control, e.g. using substantially rigid closed or gas buffered or elastic reservoirs
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 2205/07 having air pumping means
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16

Abstract

An apparatus and method for blood treatment for the single-needle mode, the apparatus having an extra-corporeal blood circuit with a blood infeed line running to the inlet and a blood return line leading away from the outlet, of a blood treating unit, includes in the blood return line a device, e.g., container, for amassing blood, which is in flow-permitting connection for gas transfer with a device, e.g., container, for storing gas. A pressure is calculated and set in the device for storing gas before the arterial and venous phases are started, with two constraints. First, the pressure should be sufficiently low to ensure both no infusion of air into the patient and also regulated flow of blood into the patient even at opposing pressures lower than ambient pressure. Second, the pressure should be sufficiently high to expel blood from the device for amassing blood into the device for storing gas.

Claims

1. A method of using a blood-treatment apparatus for single-needle mode, comprising:

during an arterial phase, making a connection between a device for amassing blood which encloses a sealed-off volume of space, and a device for storing gas which encloses a sealed-off volume of space, the device for amassing blood and the device for storing gas forming, together with a device for making a connection between the device for amassing blood and the device for storing gas, a sealed volume, which no gas can enter and from which no gas can exit, and feeding blood to the device for amassing blood, gas which is expelled from the sealed-off volume of space in the device for amassing blood being transferred to the device for storing gas, thus causing a pressure to be generated in the device for storing gas; and

during a venous phase, making a connection between the device for storing gas and the device for amassing blood, the device for amassing blood and the device for storing gas forming, together with the device for making a connection between the device for amassing blood and the device for storing gas, a sealed volume, which no gas can enter and from which no gas can exit, and gas which has been stored in the device for storing gas is transferred to the device for amassing blood, thus expelling the blood which is contained in the sealed-off volume of space in the device for amassing blood, an ongoing changeover being made between the arterial phase in which the device for amassing blood is filled with blood to an upper changeover point and the venous phase in which the device for amassing blood is emptied to a lower changeover point, thus causing blood to be fed to the extra-corporeal blood circuit in the arterial phase and blood to be extracted from the extra-corporeal blood circuit in the venous phase;

wherein, for initialisation of successive arterial and venous phases, a pressure p_{Air reservoir max.} which is to be set in the device for storing gas is calculated and, for the initialisation, the pressure p_{Air reservoir max.} previously calculated is set in the device for storing gas before the arterial and venous phases are started.

2. The method according to claim 1, wherein, to set the pressure p_{Air reservoir max.} which is to be set in the device for storing gas, gas is discharged from the device for storing gas or gas is fed to the device for storing gas.

3. The method according to claim 1, wherein, to calculate the pressure p_{Air reservoir max.} which is to be set in the device for storing gas, a volume of gas contained in the device for amassing blood is determined and the pressure p_{Air reservoir max.} which is to be set in the device for storing gas is determined based on the volume of gas contained in the device for amassing blood.

4. The method according to claim 3, wherein, to determine the volume of gas contained in the device for amassing blood, gas is transferred from the device for storing gas to the device for amassing blood to produce a preset difference in pressure between the device for storing gas and the device for amassing blood, an absolute pressure in the device for storing gas and an absolute pressure in the device for amassing blood being determined before and after production of the difference in pressure.

5. The method according to claim 4, wherein, to determine the absolute pressure, ambient pressure is measured, and respective relative pressures are measured in the device for storing gas and the device for amassing blood, values of the absolute pressure being calculated from values of the relative pressures and of ambient pressure.

6. The method according to claim 4, wherein, before gas is transferred from the device for storing gas to the device for amassing blood, a pressure which corresponds to ambient pressure is set in the sealed-off volume of space in the device for amassing blood and in the sealed-off volume of space in the device for storing gas.

7. The method according to claim 6, wherein, to set the ambient pressure, a connection is made between the device for storing gas and the device for amassing blood and air is admitted to/released from the device for storing gas and/or the device for amassing blood.

8. An apparatus for blood treatment for single-needle mode, comprising:

a device for amassing blood which encloses a sealed-off volume of space;

a device for storing gas which encloses a sealed-off volume of space;

a device for making a connection between the device for amassing blood and the device for storing gas, wherein the device for amassing blood and the device for storing gas form, together with the device for making a connection between the device for amassing blood and the device for storing gas, a sealed volume, which no gas can enter and from which no gas can exit;

a device for feeding blood to the device for amassing blood in an extra-corporeal blood circuit, the extra-corporeal blood circuit having a blood infeed line which runs to an inlet of a blood-treating unit and a blood return line which leads away from an outlet of the blood-treating unit;

a device for compressing gas; and

a control and calculating unit which co-operates with the device for amassing blood, with the device for storing gas, with the device for making a connection between the device for amassing blood and the device for storing gas and with the device for compressing gas such that, in an arterial phase when the device for amassing blood is being filled, gas which is expelled from the device for amassing blood is transferred to the device for storing gas and, in a venous phase for emptying the device for amassing blood, gas which has been stored in the device for storing gas is transferred to the device for amassing blood by the device for compressing gas, blood thus being able to be transferred to the extra-corporeal blood circuit in the arterial phase and to be extracted from the extra-corporeal blood circuit in the venous phase,

wherein the control and calculating unit is configured such that, for initialisation of successive arterial and venous phases, a pressure p_{Air reservoir max.} which is to be set in the device for storing gas is calculated and, for the initialisation, the pressure p_{Air reservoir max.} previously calculated is set in the device for storing gas before the arterial and venous phases are started and, on the pressure being set, the arterial and venous phases are started.

9. The apparatus according to claim 8, wherein the control and calculating unit is configured such that, to set the pressure p_{Air reservoir max.} which is to be set in the device for storing gas, the device for compressing gas is operated, thus causing gas to be discharged from the device for storing gas or gas to be fed to the device for storing gas.

10. The apparatus according to claim 8, wherein the control and calculating unit is configured such that, to calculate the pressure p_{Air reservoir max.} which is to be set in the device for storing gas, a volume of gas contained in the device for amassing blood is determined and the pressure p_{Air reservoir max.} which is to be set in the device for storing gas is determined based on the volume of gas contained in the device for amassing blood.

11. The apparatus according to claim 10, wherein a device for determining absolute pressure is provided in the device for amassing blood and the device for storing gas, the control and calculating unit being configured such that, to determine the volume of gas contained in the device for amassing blood, gas is transferred from the device for storing gas to the device for amassing blood to produce a preset difference in pressure between the device for amassing blood and the device for storing gas, and the absolute pressure in the device for storing gas and the absolute pressure in the device for amassing blood are determined before and after production of the difference in pressure.

12. The apparatus according to claim 11, wherein the device for determining absolute pressure includes a device for measuring ambient pressure, a device for measuring relative pressure in the device for storing gas, and a device for measuring relative pressure in the device for amassing blood, the control and calculating unit being configured such that respective values of absolute pressure are calculated from measured values of relative pressure and ambient pressure.

13. The apparatus according to claim 8, wherein the device for making a connection between the device for amassing blood and the device for storing gas has a first connecting path and a second connecting path, the first connecting path having a bypass line, having a bypass valve, which connects the device for amassing blood to the device for storing gas, and the second connecting path having a line for feeding gas, the device for compressing gas being arranged in the line for feeding gas.

14. The apparatus according to claim 11, wherein the control and calculating unit is configured such that, before gas is transferred from the device for storing gas to the device for amassing blood, a pressure which corresponds to ambient pressure is set to produce a difference in pressure in the sealed-off volume of space in the device for amassing blood and in the sealed-off volume of space in the device for storing gas.

15. The apparatus according to claim 14, wherein a device for air admission/release is provided, the control and calculating unit being configured such that, to set the ambient pressure, a connection is made between the device for storing gas and the device for amassing blood, and air is admitted to/released from the device for storing gas and/or the device for amassing blood.

16. The apparatus according to claim 13, wherein the line for feeding gas has a first section which connects the device for amassing blood to the discharge end of the device for compressing gas, and a second section which connects the inlet end of the device for compressing gas to the device for storing gas, the device for air admission/release being provided in the first section of the line.

17. The apparatus according to claim 8, wherein the device for amassing blood takes the form of a container of a preset volume which is arranged in the blood return line of the extra-corporeal blood circuit.

18. The apparatus according to claim 8, wherein the device for storing gas takes the form of a container of a preset volume.

19. The apparatus according to claim 8, wherein the device for feeding blood in the extra-corporeal blood circuit takes the form of a blood pump which is arranged in the blood infeed line.

20. The apparatus according to claim 8, wherein the control and calculating unit has a device for changing over between the arterial phase and the venous phase which are configured such that the device for feeding blood in the extra-corporeal blood circuit is operated in the arterial phase, the device for amassing blood being connected to the device for storing gas, thus causing gas expelled from the device for amassing blood to be transferred to the device for storing gas when the device for amassing blood is being filled, and the device for compressing gas is operated in the venous phase, the device for storing gas being connected to the device for amassing blood, thus causing gas which has been stored in the device for storing gas to be transferred to the device for amassing blood by the device for compressing gas to empty the device for amassing blood.