Apparatus for controlling blood flow in an extracorporeal circuit

• US 7,794,419 B2
• Filed: 05/18/2005
• Issued: 09/14/2010
• Est. Priority Date: 05/18/2005
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Lodi, Carlo Alberto, Paolini, Francesco, Fontanazzi, Francesco
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US11/913,786
• Publication Number:
  US 20080275377A1
• Time in Patent Office: 1,945 Days
• Field of Search: 604/4.01, 604/5.01, 604/5.04, 604/6.09, 604/6.11, 604/6.06, 210/645, 210/646, 210/739, 210/741
• US Class Current: 604/6.06
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/279 Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/37 Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: A61M 60/585 User interfaces

Abstract

The apparatus for blood flow control in an extracorporeal circuit comprises: a user interface for setting a desired blood flow value (q_bREAL) and a datum relating to the vascular access, a memory for recording a plurality of mathematical relations having mathematical expressions relating to the vascular access organ to be used, and a control unit. The control unit identifies the vascular access, selects, from among the plurality of mathematical relations present in the memory, a relation which corresponds to the vascular access identified, and calculates, as a mathematical function of the set value for the desired flow (q_bREAL), a value at which to set the angular velocity of the pump associated to the extracorporeal circuit and/or a theoretical value of the arterial pressure upstream of the pump.

Claims

1. A blood treatment machine comprising:

an extracorporeal circuit having at least a blood treatment unit, at least an access branch extending between a blood removal zone of a patient and the treatment unit, at least a return branch extending between the treatment unit and a blood return zone to the patient, at least a vascular access organ interpositioned between said branches and a patient'"'"'s vascular system, and at least a pump associated to the extracorporeal circuit, and

an apparatus for controlling blood flow in the extracorporeal circuit, the apparatus comprising;

at least a user interface for enabling a setting of a desired value of blood flow (q_bREAL) through the access branch and in order to allow entry of at least a datum relating to the vascular access;

a memory storing a plurality of mathematical relations, each of said mathematical relations having a respective mathematical expression which is a function of the vascular access organ to be used and mathematically linking the blood flow through the access branch with an angular velocity of the pump;

a control unit, connected to the user interface and the pump, which control unit is programmed for performing a process as follows;

identifying the vascular access;

selecting, from among the plurality of mathematical relations present in the memory, the mathematical relation which corresponds to the identified vascular access;

calculating, using the mathematical relation loaded from said memory, at least one from following values;

a value at which the angular velocity of the pump can be set as a function of a set value for a desired flow (q_bREAL), and

a theoretical value of the arterial pressure in the arterial branch upstream of the pump, as a mathematical function of the set value for the desired flow (q_bREAL).

2. The machine of claim 1, wherein each of the plurality of mathematical relations comprises:

a respective first mathematical relation which enables a mathematical calculation of a theoretical arterial pressure value in the arterial branch upstream of the pump, as a mathematical function of the set value for the desired flow (q_bREAL), and

a respective second mathematical relation which enables a mathematical calculation of a value at which the angular velocity of the pump can be set as a function of the theoretical value of the arterial pressure in the arterial branch upstream of the pump.

3. The machine of claim 2, wherein the first mathematical relation enables a mathematical calculation of a theoretical value of arterial pressure in the arterial branch upstream of the pump as a mathematical function of the set value for the desired flow (q_bREAL) and the value of at least a parameter relating to the chemical/physical characteristics of the patient'"'"'s blood.

4. The machine of claim 3, wherein the parameter relating to the chemical/physical characteristics of the patient'"'"'s blood is a parameter relating to the viscosity of the patient'"'"'s blood.

5. The machine of claim 4, wherein the parameter relating to the patient'"'"'s blood viscosity comprises the hematocrit of the patient'"'"'s blood.

6. The machine of claim 5, wherein said apparatus comprises means for determining the hematocrit in the patient'"'"'s blood, which means operates on the extracorporeal circuit and is connected to the control unit.

7. The machine of claim 6, wherein the means for determining the hematocrit of the patient'"'"'s blood comprises means for measuring a hematic concentration of hemoglobin and a plasma concentration of sodium, the control unit estimating a value of hematocrit based on the hematic concentration of hemoglobin and the plasma concentration of sodium.

8. The machine of claim 6, wherein the control unit is programmed for verifying, at regular time intervals during the extracorporeal treatment, a value of the parameter relating to the chemical/physical characteristics of the patient'"'"'s blood, and mathematically recalculating corresponding theoretical values of the arterial pressure in the arterial branch upstream of the pump as a mathematical function of the set value for the desired flow (q_bREAL) and the value of the parameter at successive moments.

9. The machine of claim 1, wherein the user interface enables entry of an identifying datum of the vascular access to be used, the control unit associating to said vascular access identifying datum the respective mathematical relation from among the plurality of mathematical relations.

10. The machine of claim 1, wherein the user interface enables entry of a datum indicating that the identity of the vascular access is not known, the control unit being programmed to activate an automatic identification procedure of the vascular access, comprising following stages:

varying the angular velocity of the pump;

determining a plurality of real pressure values upstream of the pump, each being relative to an angular velocity of the pump;

identifying, using the real pressure values, a mathematical relation from the plurality of mathematical relations which corresponds to the used vascular access.

11. The machine of claim 1, wherein the control unit is programmed to calculate, using the mathematical relation loaded from the memory, a value at which to set the angular velocity of the pump as a function of the set value for the desired flow (q_bREAL), and to set the angular velocity of the pump at the calculated value.

12. The machine of claim 1, wherein the control unit is programmed to calculate, using the mathematical relation loaded from the memory, a theoretical value of the arterial pressure in the arterial branch upstream of the pump, as a mathematical function of the set value for the desired flow (q_bREAL), and to compare the calculated value with an acceptable interval.

13. The machine of claim 12, wherein following the comparison the control unit is programmed to signal whether the theoretical value of the arterial pressure is below a prefixed threshold and to calculate, using the mathematical relation, the angular velocity of the pump and the real flow corresponding to an arterial pressure equal to the prefixed threshold.

14. The machine of claim 12, wherein if after the comparison the control unit has revealed that the theoretical value of the arterial pressure is greater than a prefixed threshold, the control unit is programmed to calculate the limit angular velocity of the pump and the limit real flow corresponding to a pressure which is equal to the prefixed threshold.

15. The machine of claim 14, wherein the control unit is programmed to transmit to the user interface and to visualise on the user interface the value of the limit real flow, which it is possible to reach without falling below the prefixed threshold of arterial pressure.