CA2470870C - Equipment for controlling blood flow in an extracorporeal blood circuit - Google Patents
Equipment for controlling blood flow in an extracorporeal blood circuit Download PDFInfo
- Publication number
- CA2470870C CA2470870C CA002470870A CA2470870A CA2470870C CA 2470870 C CA2470870 C CA 2470870C CA 002470870 A CA002470870 A CA 002470870A CA 2470870 A CA2470870 A CA 2470870A CA 2470870 C CA2470870 C CA 2470870C
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- Prior art keywords
- cndot
- equipment according
- arterial pressure
- blood
- angular velocity
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Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B49/00—Control, e.g. of pump delivery, or pump pressure of, or safety measures for, machines, pumps, or pumping installations, not otherwise provided for, or of interest apart from, groups F04B1/00 - F04B47/00
- F04B49/06—Control using electricity
- F04B49/065—Control using electricity and making use of computers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
- A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
- A61M60/113—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/247—Positive displacement blood pumps
- A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
- A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
- A61M60/279—Peristaltic pumps, e.g. roller pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
- A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
- A61M60/37—Haemodialysis, haemofiltration or diafiltration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/515—Regulation using real-time patient data
- A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
- A61M60/546—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood flow, e.g. by adapting rotor speed
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/12—Machines, pumps, or pumping installations having flexible working members having peristaltic action
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/12—Machines, pumps, or pumping installations having flexible working members having peristaltic action
- F04B43/1253—Machines, pumps, or pumping installations having flexible working members having peristaltic action by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B2201/00—Pump parameters
- F04B2201/12—Parameters of driving or driven means
- F04B2201/1201—Rotational speed of the axis
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B2205/00—Fluid parameters
- F04B2205/01—Pressure before the pump inlet
Abstract
Equipment for controlling blood flow in an extracorporeal blood circuit, comprising at least a first sensor (11), designed to measure an arterial pressure (Part) upstream ofa peristaltic pump (9); at least a second sensor (12), designed to measure an angular velocity (.OMEGA.) of the peristaltic pump; a memory (14) designed to store at least one set value (Qset) of the desired blood flow through the access branch, and a calibration function (F) in at least the variables (vI), related to the angular velocity (.OMEGA.) of the pump, (v2), related to the arterial pressure (Part) in the portion of the said access branch upstream of the peristaltic pump, (v3), related to an actual flow of blood (Qactual) through the said access branch; and at least one control unit (13), capable of calculating an actual flow value (Qactual) by applying the function F to the values of angular velocity and arterial pressure (Part, .OMEGA.) measured by the sensors; comparing the actual flow (Qactual) with the desired flow (Qset); and varying the angular velocity of the said peristaltic pump if the Qactual - Qset lies outside a predetermined range.
Description
EQUIPMENT FOR CONTROLLING BLOOD FLOW IN AN
EXTRACORPOREAL BLOOD CIRCUIT
DESCRIPTION
The present invention relates to equipment for controlling blood flow in an extracorporeal blood circuit.
In particular, the equipment to which the invention relates is designed to operate on extracorporeal circuits of blood treatment machines, for example machines for haemodialysis, haemofiltration, haemodiafiltration or plasmapheresis.
The machines for the treatments described above are typically used for processes of treating the blood of patients whose renal function is pai-tially or totally compromised.
In particular, the blood treatment equipment indicated above typically coinprises an extracoiporeal circuit provided with at least one blood treatment unit, and with at least one access channel or branch designed to connect an area where blood is collected from the patient to a first chamber of the treatment unit; the extracorporeal circuit also comprises a second channel or retuin branch, extending downstream of the treatment unit from the said first chamber towards an area where the blood is returned to the patient.
In the access chamlel, there is also typically provided a peristaltic puinp designed to act on the access channel to progressively move the blood flow towards the treatment unit.
It should be noted that, regardless of the type of dialysis treatment to be carried out on the patient, it is extremely iinportant to know the precise quantity of blood collected from the patient and subsequently treated by the machine with which the extracorporeal blood circuit is associated.
In this respect, it should however be noted that the blood flow wliich can be obtained by using peristaltic pumps in the return portion of the extracorporeal circuit is actually dependent on various factors, the main ones of which are:
- the material, and consequently the elasticity, of the portion of line with which the peristaltic pump is associated;
- the geoinetry of the particular portion of the blood line with which the peristaltic pump is associated;
- the geometry of the pump rotor, and the angular velocity of the peristaltic pump;
- the pressure present, in particular, in the portions of tubing upstream and downstream of the peristaltic puinp;
- the temperature of the extracoiporeal circuit;
- the haematocrit value associated with the patient's blood;
- the geometry of the portion of tubing upstream of the puinp;
- the geometry, and in particular the passage section, of the access member used to collect blood from the patient.
Formerly, when it was necessary to calculate the flow supplied by a peristaltic pump, this flow was considered to be proportional, according to a suitable conversion factor, to the instantaneous angular velocity of the puinp.
In other words, the angular velocity of the puinp segment was multiplied by a consta.nt calibration factor in order to obtain a theoretical value of flow through the pump segment. According to circumstances, the resulting theoretical flow value was or was not shown on a suitable display of the machine.
However, because of the munerous factors mentioned briefly above, wllich affect the level of the flow actually supplied by the peristaltic pump, the calculation of the flow by means of a simple factor of proportionality with the angular velocity is clearly affected by errors which cannot be disregarded.
As will be easily understood, if, due to one or more of the described factors, the arterial pressure of the flow upstream of the pump reaches levels such that it impedes the movement of the blood flow provided by the peristaltic pump, the pLunp will produce an actual flow which is smaller than the estimated theoretical value.
Moreover, an increase in the angular velocity set for the pump is accompanied by an increase in the pressure drop created upstream of the pump, which will evidently amplify the effects briefly described above.
Additionally, it must be einphasized that the pressure conditions upstream of the pump not only depend on the velocity and characteristics of the pump, but are also closely related to the forin of access device (needle or otller) used for comiection to the patient's vascular system. In particular, in the case of needles, the procedLUes by which these needles are inserted into the patient's fistula, the conditions of the fistLila, and the physiological condition and haematocrit value of the patient are all significant factors.
The actual flow produced by the pLUnp can even vary dtuing a single treatment as a result of variations in the arterial pressure upstream of the ptunp, which, .35 evidently, significantly modify the mode of operation of the ptiunp.
As mentioned above, the structtue, in terms of materials and geoinetry, of the portion of tubing on which the pump acts can have a major effect on the flow which is actually generated by the peristaltic pump, where other conditions are held consta.nt.
In this connection, it should be noted that the dynainic behaviour of the tubing portion and pump is variable, witll respect to the time elapsing from the start of the treatment cycle, as a result of a deterioration, or more generally a variation, of the mechanical properties of the materials forming the line.
With the aim of overcoming the drawbacks described above, and of providing equipment for blood treatment in which it would be possible to know a flow value as close as possible to the flow actually passing through the pump portion of the extracorporeal circuit, U.S. Patent No. 5,733,257 describes a method of calibrating a peristaltic puinp, to be used with equipment provided with at least one internal flowrneter.
According to the invention described in the aforementioned patent, the method comprises the introduction of a fluid into the segment of tubing on which the pLunp acts, and the operation of the peristaltic pump at a constant rotation speed.
When the standard operating conditions have been reached, the pressure upstream of the portion of tubing on which the pump acts is measured, and the flow of fluid which actually passes through the pump portion is measured by ineans of the machine's internal flowmeter, in such a way that a pair of calibration values (actual flow and arterial pressure) are obtained as a fiulction of the angular velocity of the pump which has been selected.
The process described above is repeated while the arterial pressure upstream of the pump is varied by suitable means in such a way as to obtain different pairs of values of arterial pressure and actual flow for a single value of angular velocity. At this point, a calibration ctuve is calculated, and used to determine a relationship between pressure and actual flow with respect to the angular velocity in question. By repeating the calibration criterion described above for different values of angular velocity, it is possible to create a set of calibration curves; when the machine is put into operation, the calibration curves are used to calculate the actual flow of the peristaltic pump, once the angular velocity of the pump and the pressure in the portion of tubing upstream of the puinp have been determined by measurement. Also according to U.S. Patent No. 5,733,257, it is possible to use the information on the actual flow obtained by means of the aforesaid calibration curves to control the angular velocity of the pLUnp, in order to match the actual flow with that which is desired for the puiposes of the particular treatment to be carried out on the patient.
Given these aspects of the prior art, one object of the present invention is to provide novel equipment controlling blood flow in an extracorporeal blood circuit, which is easily applied and wllich, in particular, makes it possible to control and laiow the actual flow passing tlirough the peristaltic pump por-tion of the extracoi-poreal circuit, without any need to carry out preliminary calibration procedures on tbe machine, pi-oviclecl that the geon-ietrical cllaracteristics and the mechailieal propei-ties of the extracorporeal circuit are lanown.
In p~u-ticular, a funclan3ental object of the invention is to provide novel equipment wluch enables the actual flow through the peristaltic pump portion to be determined and the peristaltic pump to be controlled by a feeclbaclc system, in order to malce the actual flow which is generated esseiitially nlatch the value which is set by the user or required by the treatment in progress.
A fiu-ther and preferred object of the invention is to provide novel equipnient wl-dch can also measure the actual flow with a close approxiination, malcing allowance for the structural alteration undergoize in time by the material of the poi-tion of tubing on which the pez=istaltic pump acts.
According to the present invention, there is provided an equipment for controlling blood flow in an extracorporeal blood circuit, the said extracorporeal circuit having at least one blood treatment unit, at least one access branch extending between an area where blood is collected from a patient and the treatment unit, at least one peristaltic pump associated for operation with the said access branch of the extracorporeal circuit, and at least one return branch extending between the treatment unit and an area where the blood is returned to the patient, the said equipment comprising:
- at least a first sensor, designed to measure an arterial pressure (Part) in a portion of the said access branch upstream of the peristaltic pump, and to generate a corresponding first output signal proportional to the said arterial pressure (Part);
- at least a second sensor, designed to measure an angular velocity (c)) of the peristaltic pump and to generate a corresponding second output signal, proportional to the angular velocity of the said peristaltic pump;
- a memory designed to store at least one set value (Qset) of the desired blood flow through the said access branch, and a calibration function F in at least the following variables:
0 v1, related to the angular velocity of the pump ((,o), 4a = v2, related to the arterial pressure (Part) in the portion of the said access branch upstream of the peristaltic pump, = v3, related to an actual flow of blood (Qactual) through the said access branch;
- at least one control unit, connected for operation to the said sensors and to the said memory, for receiving the said first and second output signals and for storing the corresponding measured values of arterial pressure (Part) and angular velocity (w) in the said memory, the said control unit being capable of executing a control procedure comprising the following time succeeding operations:
= calculating an actual flow value (Qactual) by applying the said memory-resident calibration function F to the values of angular velocity and arterial pressure (Part, co) measured by means of the said sensors;
= comparing the said actual flow value (Qactual) with the said set flow value (Qset), characterized in that after the step of comparing said actual flow value (Qactual) with said set flow value (Qset), the control procedure comprises the following time succeeding steps:
= comparing the angular velocity with an acceptable maximum value which can be imparted to the pump, = varying the angular velocity of the said peristaltic pump if the difference between the actual flow and the desired flow (Qactual -Qset) lies outside a predetermined range.
F rther characteristics and advantages will be made clearer by the following description of some preferred, but not exclusive, embodiments of equipment for controlling blood flow in an extracoiporeal blood circuit according to tlle invention.
This description is provided below with the aid of the attached drawin-c's, provided solely for guidance and tlierefore without restrictive intent, in which:
- Figtue 1 is a schematic representation of equipnient for controlling blood flow in an extracorporeal blood circuit according to the present invention;
- Figz.u=e 2 is a flow diagram which illustrates schematically the steps of the procedure wliicIi can be executed, diuing the operation of the equipment, by a 4b control unit associated with equipinent for controlling blood flow in an extraeorporeal blood circuit accordino, to the present invention.
With reference to the attached Fig. 1, this represents the wliole of a piece of equipment for controlling blood flow in ail eatracoiporeal blood circuit, wliicli in ttu'n is indicated by the nLunber 2. The extracorporeal circuit 2 can be used, for exaniple, for cartyina out the extracorporeal circulation of blood, when the patient is to be subjectecl to treatments such as haemodialysis, haemofiltration, ultrafiltration, haeinodiafiltration, or any other coinbination of the treatments listed liere.
The ettracorporeal circuit 2 conventionally comprises at least one blood treatment uiiit 3, formed by a first chamber 4 and at least one second clianlber 5, separated from each other by a semi-permeable iiiembrane 6. At least one access branch 7 extends between an area wliere blood is collected fi=om a patient and the first chamber of the said treatment Lulit 4; at least one peristaltic pump 9 is associated for operation with a pump tube section 15 of the said access brancll of the extracorporeal circuit, and at least one return branch 8 extends downstream of the treatinent unit, between the aforesaid first chamber 4 and an area where the blood is rettuned to the 5 patient. Typically, means (not illustrated) of access to the patient's cardiovascular system are provided in the areas where the blood is collected from the patient and returned to him, these means consisting, for exainple, of needles of appropriate dimensions, catheters, or access devices of other kinds. It should be noted that the second chamber of the unit 3 can be coimected, for example, to a device 10 (not shown in detail) for sending a dialysis liquid towards the second chamber and for removing from the second chainber a dialysate in which the waste products and excess water from the blood have been accumulated.
The equipment for controlling the blood flow 1 has at least a first sensor 11, located in the access branclz, in a portion of the said branch upstream of the peristaltic pump 9, in such a way that an arterial pressure (Part) can be measured and a corresponding output signal 11 a proportional to the said arterial pressure can be generated. In practice, the first pressure sensor I 1 operates iminediately upstream of the peristaltic puinp and can measure the pressure in the portion of tubing interposed between the area where the blood is collected from the patient a.nd the said peristaltic puinp. It should be noted that a negative pressLUe, typically with respect to atmospheric pressure, is typically found in this portion.
The equipment 1 also comprises a second sensor 12, associated for operation with the peristaltic pLunp and designed to meastue an angular velocity co (omega) of the said pLunp and to generate a corresponding second output signal 12a, proportional to the rotation speed of the peristaltic pLunp. It should be noted that the sensors described above are connected for operation to a control i.uiit 13 to which the sensors send the first and the second signals respectively.
The control Lulit 13, consisting for example of a CPU, is associated with a memory 14, designed to store at least one set value (Qset) of the desired blood flow through the access branch, and a calibration function in the variables vl, v2, v3, which are described more fiilly below. In greater detail, vl is a variable related to the angular velocity of the pLunp, v2 is a variable related to the arterial pressure (Part) present in the portion of the said access brancli upstream of the said peristaltic piunp, and v3 is a variable related to an actual blood flow (Qactz.ial) through the said access branch.
The control i.mit 13 according to the invention ca11 execute a control procedLUe coinprising the following operations:
EXTRACORPOREAL BLOOD CIRCUIT
DESCRIPTION
The present invention relates to equipment for controlling blood flow in an extracorporeal blood circuit.
In particular, the equipment to which the invention relates is designed to operate on extracorporeal circuits of blood treatment machines, for example machines for haemodialysis, haemofiltration, haemodiafiltration or plasmapheresis.
The machines for the treatments described above are typically used for processes of treating the blood of patients whose renal function is pai-tially or totally compromised.
In particular, the blood treatment equipment indicated above typically coinprises an extracoiporeal circuit provided with at least one blood treatment unit, and with at least one access channel or branch designed to connect an area where blood is collected from the patient to a first chamber of the treatment unit; the extracorporeal circuit also comprises a second channel or retuin branch, extending downstream of the treatment unit from the said first chamber towards an area where the blood is returned to the patient.
In the access chamlel, there is also typically provided a peristaltic puinp designed to act on the access channel to progressively move the blood flow towards the treatment unit.
It should be noted that, regardless of the type of dialysis treatment to be carried out on the patient, it is extremely iinportant to know the precise quantity of blood collected from the patient and subsequently treated by the machine with which the extracorporeal blood circuit is associated.
In this respect, it should however be noted that the blood flow wliich can be obtained by using peristaltic pumps in the return portion of the extracorporeal circuit is actually dependent on various factors, the main ones of which are:
- the material, and consequently the elasticity, of the portion of line with which the peristaltic pump is associated;
- the geoinetry of the particular portion of the blood line with which the peristaltic pump is associated;
- the geometry of the pump rotor, and the angular velocity of the peristaltic pump;
- the pressure present, in particular, in the portions of tubing upstream and downstream of the peristaltic puinp;
- the temperature of the extracoiporeal circuit;
- the haematocrit value associated with the patient's blood;
- the geometry of the portion of tubing upstream of the puinp;
- the geometry, and in particular the passage section, of the access member used to collect blood from the patient.
Formerly, when it was necessary to calculate the flow supplied by a peristaltic pump, this flow was considered to be proportional, according to a suitable conversion factor, to the instantaneous angular velocity of the puinp.
In other words, the angular velocity of the puinp segment was multiplied by a consta.nt calibration factor in order to obtain a theoretical value of flow through the pump segment. According to circumstances, the resulting theoretical flow value was or was not shown on a suitable display of the machine.
However, because of the munerous factors mentioned briefly above, wllich affect the level of the flow actually supplied by the peristaltic pump, the calculation of the flow by means of a simple factor of proportionality with the angular velocity is clearly affected by errors which cannot be disregarded.
As will be easily understood, if, due to one or more of the described factors, the arterial pressure of the flow upstream of the pump reaches levels such that it impedes the movement of the blood flow provided by the peristaltic pump, the pLunp will produce an actual flow which is smaller than the estimated theoretical value.
Moreover, an increase in the angular velocity set for the pump is accompanied by an increase in the pressure drop created upstream of the pump, which will evidently amplify the effects briefly described above.
Additionally, it must be einphasized that the pressure conditions upstream of the pump not only depend on the velocity and characteristics of the pump, but are also closely related to the forin of access device (needle or otller) used for comiection to the patient's vascular system. In particular, in the case of needles, the procedLUes by which these needles are inserted into the patient's fistula, the conditions of the fistLila, and the physiological condition and haematocrit value of the patient are all significant factors.
The actual flow produced by the pLUnp can even vary dtuing a single treatment as a result of variations in the arterial pressure upstream of the ptunp, which, .35 evidently, significantly modify the mode of operation of the ptiunp.
As mentioned above, the structtue, in terms of materials and geoinetry, of the portion of tubing on which the pump acts can have a major effect on the flow which is actually generated by the peristaltic pump, where other conditions are held consta.nt.
In this connection, it should be noted that the dynainic behaviour of the tubing portion and pump is variable, witll respect to the time elapsing from the start of the treatment cycle, as a result of a deterioration, or more generally a variation, of the mechanical properties of the materials forming the line.
With the aim of overcoming the drawbacks described above, and of providing equipment for blood treatment in which it would be possible to know a flow value as close as possible to the flow actually passing through the pump portion of the extracorporeal circuit, U.S. Patent No. 5,733,257 describes a method of calibrating a peristaltic puinp, to be used with equipment provided with at least one internal flowrneter.
According to the invention described in the aforementioned patent, the method comprises the introduction of a fluid into the segment of tubing on which the pLunp acts, and the operation of the peristaltic pump at a constant rotation speed.
When the standard operating conditions have been reached, the pressure upstream of the portion of tubing on which the pump acts is measured, and the flow of fluid which actually passes through the pump portion is measured by ineans of the machine's internal flowmeter, in such a way that a pair of calibration values (actual flow and arterial pressure) are obtained as a fiulction of the angular velocity of the pump which has been selected.
The process described above is repeated while the arterial pressure upstream of the pump is varied by suitable means in such a way as to obtain different pairs of values of arterial pressure and actual flow for a single value of angular velocity. At this point, a calibration ctuve is calculated, and used to determine a relationship between pressure and actual flow with respect to the angular velocity in question. By repeating the calibration criterion described above for different values of angular velocity, it is possible to create a set of calibration curves; when the machine is put into operation, the calibration curves are used to calculate the actual flow of the peristaltic pump, once the angular velocity of the pump and the pressure in the portion of tubing upstream of the puinp have been determined by measurement. Also according to U.S. Patent No. 5,733,257, it is possible to use the information on the actual flow obtained by means of the aforesaid calibration curves to control the angular velocity of the pLUnp, in order to match the actual flow with that which is desired for the puiposes of the particular treatment to be carried out on the patient.
Given these aspects of the prior art, one object of the present invention is to provide novel equipment controlling blood flow in an extracorporeal blood circuit, which is easily applied and wllich, in particular, makes it possible to control and laiow the actual flow passing tlirough the peristaltic pump por-tion of the extracoi-poreal circuit, without any need to carry out preliminary calibration procedures on tbe machine, pi-oviclecl that the geon-ietrical cllaracteristics and the mechailieal propei-ties of the extracorporeal circuit are lanown.
In p~u-ticular, a funclan3ental object of the invention is to provide novel equipment wluch enables the actual flow through the peristaltic pump portion to be determined and the peristaltic pump to be controlled by a feeclbaclc system, in order to malce the actual flow which is generated esseiitially nlatch the value which is set by the user or required by the treatment in progress.
A fiu-ther and preferred object of the invention is to provide novel equipnient wl-dch can also measure the actual flow with a close approxiination, malcing allowance for the structural alteration undergoize in time by the material of the poi-tion of tubing on which the pez=istaltic pump acts.
According to the present invention, there is provided an equipment for controlling blood flow in an extracorporeal blood circuit, the said extracorporeal circuit having at least one blood treatment unit, at least one access branch extending between an area where blood is collected from a patient and the treatment unit, at least one peristaltic pump associated for operation with the said access branch of the extracorporeal circuit, and at least one return branch extending between the treatment unit and an area where the blood is returned to the patient, the said equipment comprising:
- at least a first sensor, designed to measure an arterial pressure (Part) in a portion of the said access branch upstream of the peristaltic pump, and to generate a corresponding first output signal proportional to the said arterial pressure (Part);
- at least a second sensor, designed to measure an angular velocity (c)) of the peristaltic pump and to generate a corresponding second output signal, proportional to the angular velocity of the said peristaltic pump;
- a memory designed to store at least one set value (Qset) of the desired blood flow through the said access branch, and a calibration function F in at least the following variables:
0 v1, related to the angular velocity of the pump ((,o), 4a = v2, related to the arterial pressure (Part) in the portion of the said access branch upstream of the peristaltic pump, = v3, related to an actual flow of blood (Qactual) through the said access branch;
- at least one control unit, connected for operation to the said sensors and to the said memory, for receiving the said first and second output signals and for storing the corresponding measured values of arterial pressure (Part) and angular velocity (w) in the said memory, the said control unit being capable of executing a control procedure comprising the following time succeeding operations:
= calculating an actual flow value (Qactual) by applying the said memory-resident calibration function F to the values of angular velocity and arterial pressure (Part, co) measured by means of the said sensors;
= comparing the said actual flow value (Qactual) with the said set flow value (Qset), characterized in that after the step of comparing said actual flow value (Qactual) with said set flow value (Qset), the control procedure comprises the following time succeeding steps:
= comparing the angular velocity with an acceptable maximum value which can be imparted to the pump, = varying the angular velocity of the said peristaltic pump if the difference between the actual flow and the desired flow (Qactual -Qset) lies outside a predetermined range.
F rther characteristics and advantages will be made clearer by the following description of some preferred, but not exclusive, embodiments of equipment for controlling blood flow in an extracoiporeal blood circuit according to tlle invention.
This description is provided below with the aid of the attached drawin-c's, provided solely for guidance and tlierefore without restrictive intent, in which:
- Figtue 1 is a schematic representation of equipnient for controlling blood flow in an extracorporeal blood circuit according to the present invention;
- Figz.u=e 2 is a flow diagram which illustrates schematically the steps of the procedure wliicIi can be executed, diuing the operation of the equipment, by a 4b control unit associated with equipinent for controlling blood flow in an extraeorporeal blood circuit accordino, to the present invention.
With reference to the attached Fig. 1, this represents the wliole of a piece of equipment for controlling blood flow in ail eatracoiporeal blood circuit, wliicli in ttu'n is indicated by the nLunber 2. The extracorporeal circuit 2 can be used, for exaniple, for cartyina out the extracorporeal circulation of blood, when the patient is to be subjectecl to treatments such as haemodialysis, haemofiltration, ultrafiltration, haeinodiafiltration, or any other coinbination of the treatments listed liere.
The ettracorporeal circuit 2 conventionally comprises at least one blood treatment uiiit 3, formed by a first chamber 4 and at least one second clianlber 5, separated from each other by a semi-permeable iiiembrane 6. At least one access branch 7 extends between an area wliere blood is collected fi=om a patient and the first chamber of the said treatment Lulit 4; at least one peristaltic pump 9 is associated for operation with a pump tube section 15 of the said access brancll of the extracorporeal circuit, and at least one return branch 8 extends downstream of the treatinent unit, between the aforesaid first chamber 4 and an area where the blood is rettuned to the 5 patient. Typically, means (not illustrated) of access to the patient's cardiovascular system are provided in the areas where the blood is collected from the patient and returned to him, these means consisting, for exainple, of needles of appropriate dimensions, catheters, or access devices of other kinds. It should be noted that the second chamber of the unit 3 can be coimected, for example, to a device 10 (not shown in detail) for sending a dialysis liquid towards the second chamber and for removing from the second chainber a dialysate in which the waste products and excess water from the blood have been accumulated.
The equipment for controlling the blood flow 1 has at least a first sensor 11, located in the access branclz, in a portion of the said branch upstream of the peristaltic pump 9, in such a way that an arterial pressure (Part) can be measured and a corresponding output signal 11 a proportional to the said arterial pressure can be generated. In practice, the first pressure sensor I 1 operates iminediately upstream of the peristaltic puinp and can measure the pressure in the portion of tubing interposed between the area where the blood is collected from the patient a.nd the said peristaltic puinp. It should be noted that a negative pressLUe, typically with respect to atmospheric pressure, is typically found in this portion.
The equipment 1 also comprises a second sensor 12, associated for operation with the peristaltic pLunp and designed to meastue an angular velocity co (omega) of the said pLunp and to generate a corresponding second output signal 12a, proportional to the rotation speed of the peristaltic pLunp. It should be noted that the sensors described above are connected for operation to a control i.uiit 13 to which the sensors send the first and the second signals respectively.
The control Lulit 13, consisting for example of a CPU, is associated with a memory 14, designed to store at least one set value (Qset) of the desired blood flow through the access branch, and a calibration function in the variables vl, v2, v3, which are described more fiilly below. In greater detail, vl is a variable related to the angular velocity of the pLunp, v2 is a variable related to the arterial pressure (Part) present in the portion of the said access brancli upstream of the said peristaltic piunp, and v3 is a variable related to an actual blood flow (Qactz.ial) through the said access branch.
The control i.mit 13 according to the invention ca11 execute a control procedLUe coinprising the following operations:
- calculation of an actLial flow value (Qactual) by application of the memory-resident calibration function F to the values of angular velocity (co) and arterial pressure (Part) measured by means of the first and second sensors, described briefly above;
- comparison of the actual flow value (Qactual), calculated by means of the calibration fiulction F, witli the user-specified or memory-resident set flow value (Qset); it should be noted that the value Qset can be fixed or variable in time according to a profile determined by the treatinent, depending on the requirements of the patient and the settings entered into the equipment;
- variation of the angular velocity of the peristaltic pump when the difference between the actual flow and the desired flow (Qactual - Qset) is outside a predeterinined acceptability range.
In practice, the control unit, by meastiuing the values of arterial pressure and angular velocity of the pump by means of the sensors, can use the calibration function to calculate the actual flow value and to correct the velocity of the plunp when the actual flow differs excessively from the desired flow value through the access branch of the extracorporeal circuit.
The control usiit, which is provided with a timer device, can execute the, operations described above at predetermined time intervals.
Figure 2 is a flow diagram showing a possible operating mode of the control unit 13, according to the present invention. In terms of operation, the control unit can operate both in a first operating mode, in which it waits for signals for activating and disabling the previously described control procedLUe entered by means of a manual cominand of the user, through a user interface device 15, and by means of manual entry of the set flow (Qset). In other words, in the first nianual operating mode, the control procedure is activated and disabled by a manual coininand of the operator in charge, wlio also manually enters the valh.ie of Qset.
Alternatively, the control unit can operate in a second operating mode, in which the previously described control procedure is activated at the start of the treatinent, in a fiilly autoniatic way. Where the implementation is concerned, the control unit can be dedicated to the equipment for controlling blood flow described herein, or can alternatively be integrated into the central control system of the machineiy with wliich the equipment in question is associated.
Moving on to a inore detailed analysis of the operating steps executed by the control unit of the equipment in question (see Fig. 2 for reference), we can see that the control unit must initially receive an activation signal, in the form of a manual command or a suitable automatic activation signal (Start in Fig. 2) received following the execution of a particular treatment by the machineiy with which the control equipment is associated. It should be noted that the control unit can activate the control procedure not only after an activation signal has been received, but also if, for any reason, the value of Qset or of the arterial pressure Part varies or is varied (block 100 in Fig. 2).
When the control procedLUe has been activated, the control unit reads the set value of Qset and the actual value of Part; the control Luut then executes a step of verifying the stability of the arterial pressure Part (block 101), by commanding the measurement of the said arterial pressure at a predeterinined instant Tl and at a successive instant T2, and by making a comparison between the difference between the arterial pressures at the instants Tl and T2 and a predetermined range of acceptability; if the arterial pressure is not stable, or in other words if AP = Part (Tl) - Part (T2) falls outside a range of acceptability, the control unit waits for a predeterinined time interval (block 102) and then repeats the steps of ineasuring the arterial pressure at two successive time intervals to verify its stabilization. When the stability of the arterial pressure has been verified, the control unit 13 connnands the continuation of the procedure which comprises the calculation of the value of the actLial flow Qactual (block 103), the subsequent comparison of the actual flow Qactual with the set flow value Qset (block 104) and the subsequent variation of the angular velocity of the peristaltic pump, if Qactual - Qset does not lie within a range of acceptability (blocks 105).
As shown in Fig. 2, a step of comparing the value of Part with a threshold value considered critical for the treated patient is specified before the variation of the angular velocity of the peristaltic puinp. If the pressure is below this threshold.value, the algorithm is exited and the operator is alerted, by a warning message relating to the occuiTence of a limit pressLUe condition. Similarly, and particularly if the angular velocity of the puinp has to be increased, a step of coinparing the angular velocity of the peristaltic puinp before the variation with an acceptable maximum velocity of the said peristaltic pump is executed. If the peristaltic puinp has already reached a maxiinum value of angular velocity which it is Luidesirable to exceed, the control Luiit stops the procedure and sends a warning signal to the user interface, to inform the user that a limit velocity condition has been reached by the peristaltic pump, this condition evidently preventing the system from controlling the ptunp appropriately in order to provide an actual flow Qactual essentially equal to the desired value (Qset) which has been set.
It should be noted that the calibration fiulction F can also have at least one further variable v4 related to a time (Ti) elapsed from the start of the administered treatment. In practice, as soon as the treatment starts, the control unit stores a time data element relating to the instant of starting; the control unit can determine the time elapsed between the said instant of starting and each instant at which the said control procedure is executed, and can then calculate an actual flow value (Qactual) by applying the memory-resident calibration fiinction F to the value of the said elapsed time (Ti) and to the values of angular velocity and arterial pressLUe (Part, co ) measured by means of the said sensors.
In a first embodiment of the invention, the calibration function F is of the type v3 Y;-o,..,, a;=(v2)"-'=(vl)' ] + C, wllere a; and C are experimentally determined 1o lcnown parameters. More simply, the calibration fiinction F can be of the type v3 = a=vl+b=vl=v2+c=v2+d, where a, b, c, d are the experimentally determined laiown parameters, and where vl is the angular velocity of the puinp, v2 is the arterial pressure Part in the portion of the said access branch upstream of the said peristaltic pump, and v3 is an actual blood flow (Qactual) through the said access branch.
In particular, it was found that the following values of a, b, c, d (divided into two sets, each valid for a predetermined pressure range Part) can be used to obtain a suitable calibration function; in practice, the fiu-iction F coinprises two functions, F' and F", linked together with continuity, the first F' being valid in a first range of values of arterial pressure, and the second F" being valid in a second range of values of arterial pressure which follows the said first range.
Alternatively, w11en F is also a function of v4, the calibration function F is of the type v3 = [ Yi=o...n Yjt=o... , a;= bk= (v2)"-'a= (vl);= (v4)i. ] + C, where a;, bk and C are experimentally detennined lc-iown paraineters. In this second case, the function F can be, more specifically, of the type v3 = (a=vl+b=vl=v2+c=v2+d) =f(v4), where a, b, c, d are experimentally deterinined lalown parameters and f(v4) is a fiulction which is also lalown and experimentally determined in the variable v4.
It should also be emphasized that the memory 14 can be designed to store a plurality of calibration fi.ulctions Fl, F2, ... Fn, each at least in the variables vl, v2, v3 and if appropriate in the variable v4. Each of these calibration fi.ulctions can in practice be applicable to a corresponding type of extracorporeal circuit. More precisely, if multiple types of extracorporeal circuit are in production, with pump tube portions differing from each other, for example in respect of materials ancUor geometry or other characteristics, a corresponding appropriate calibration fi.uiction can be provided for and associated wit11 each of these types, and can be stored in the memoiy 14.
Each fi,inetion F can also be associated with a cozTesponding identification code of the corresponding extracorporeal circuit, so that the user can simply select the type of circuit installed and thus automatically select the coiTesponding fiinction F
to be used for the calculation of Qactual. Finally, it should be specified that the fiuiction F can also be a function of one or more of the following additional variables: v5, related to the geometric characteristics of an access meinber comlectable for operation to the said extracorporeal circuit; v6, related to the length of the portion of tube of the access branch upstream of the said peristaltic pump; v7, related to the pressure in the portion of access branch downstream of the peristaltic pump; v8, related to the temperatLUe of the extracorporeal circuit; and v9, related to the haematocrit value of the blood of the treated patient.
In practice, when a plurality of previously stored functions F is available, each relating to a corresponding type of extracorporeal circuit, and each capable of allowing for the rotation speed of the pump, the pressure Part, the time elapsed from the start of the use of the circuit, the type of access member in use and the length of the line upstream of the puinp, it is possible to provide a reliable determination of Qactual and a siinple and flexible instrument for controlling the peristaltic pLunp.
The invention also relates to a software program comprising instructions for making a control unit, whether of the dedicated type or associated with the machinery of which the extracorporeal circuit is a subordinate component, capable of executing the steps of the control procedure described above. From the practical point of view, this program can be stored on a magnetic and/or optical recording medium, in a read only memory, or in a volatile coinputer memory, or can be carried by an electric or electromagnetic carrier. Finally, the invention also comprises a machine for blood treatment, which is capable of carrying out one or more of the following treatments:
- haemodialysis, - haemofiltration, - haemodiafiltration, - pure ultrafiltration, - plasmapheresis, and which is also provided with equipment for controlling blood flow in an extracorporeal circuit as described and illustrated in the attached drawings.
- comparison of the actual flow value (Qactual), calculated by means of the calibration fiulction F, witli the user-specified or memory-resident set flow value (Qset); it should be noted that the value Qset can be fixed or variable in time according to a profile determined by the treatinent, depending on the requirements of the patient and the settings entered into the equipment;
- variation of the angular velocity of the peristaltic pump when the difference between the actual flow and the desired flow (Qactual - Qset) is outside a predeterinined acceptability range.
In practice, the control unit, by meastiuing the values of arterial pressure and angular velocity of the pump by means of the sensors, can use the calibration function to calculate the actual flow value and to correct the velocity of the plunp when the actual flow differs excessively from the desired flow value through the access branch of the extracorporeal circuit.
The control usiit, which is provided with a timer device, can execute the, operations described above at predetermined time intervals.
Figure 2 is a flow diagram showing a possible operating mode of the control unit 13, according to the present invention. In terms of operation, the control unit can operate both in a first operating mode, in which it waits for signals for activating and disabling the previously described control procedLUe entered by means of a manual cominand of the user, through a user interface device 15, and by means of manual entry of the set flow (Qset). In other words, in the first nianual operating mode, the control procedure is activated and disabled by a manual coininand of the operator in charge, wlio also manually enters the valh.ie of Qset.
Alternatively, the control unit can operate in a second operating mode, in which the previously described control procedure is activated at the start of the treatinent, in a fiilly autoniatic way. Where the implementation is concerned, the control unit can be dedicated to the equipment for controlling blood flow described herein, or can alternatively be integrated into the central control system of the machineiy with wliich the equipment in question is associated.
Moving on to a inore detailed analysis of the operating steps executed by the control unit of the equipment in question (see Fig. 2 for reference), we can see that the control unit must initially receive an activation signal, in the form of a manual command or a suitable automatic activation signal (Start in Fig. 2) received following the execution of a particular treatment by the machineiy with which the control equipment is associated. It should be noted that the control unit can activate the control procedure not only after an activation signal has been received, but also if, for any reason, the value of Qset or of the arterial pressure Part varies or is varied (block 100 in Fig. 2).
When the control procedLUe has been activated, the control unit reads the set value of Qset and the actual value of Part; the control Luut then executes a step of verifying the stability of the arterial pressure Part (block 101), by commanding the measurement of the said arterial pressure at a predeterinined instant Tl and at a successive instant T2, and by making a comparison between the difference between the arterial pressures at the instants Tl and T2 and a predetermined range of acceptability; if the arterial pressure is not stable, or in other words if AP = Part (Tl) - Part (T2) falls outside a range of acceptability, the control unit waits for a predeterinined time interval (block 102) and then repeats the steps of ineasuring the arterial pressure at two successive time intervals to verify its stabilization. When the stability of the arterial pressure has been verified, the control unit 13 connnands the continuation of the procedure which comprises the calculation of the value of the actLial flow Qactual (block 103), the subsequent comparison of the actual flow Qactual with the set flow value Qset (block 104) and the subsequent variation of the angular velocity of the peristaltic pump, if Qactual - Qset does not lie within a range of acceptability (blocks 105).
As shown in Fig. 2, a step of comparing the value of Part with a threshold value considered critical for the treated patient is specified before the variation of the angular velocity of the peristaltic puinp. If the pressure is below this threshold.value, the algorithm is exited and the operator is alerted, by a warning message relating to the occuiTence of a limit pressLUe condition. Similarly, and particularly if the angular velocity of the puinp has to be increased, a step of coinparing the angular velocity of the peristaltic puinp before the variation with an acceptable maximum velocity of the said peristaltic pump is executed. If the peristaltic puinp has already reached a maxiinum value of angular velocity which it is Luidesirable to exceed, the control Luiit stops the procedure and sends a warning signal to the user interface, to inform the user that a limit velocity condition has been reached by the peristaltic pump, this condition evidently preventing the system from controlling the ptunp appropriately in order to provide an actual flow Qactual essentially equal to the desired value (Qset) which has been set.
It should be noted that the calibration fiulction F can also have at least one further variable v4 related to a time (Ti) elapsed from the start of the administered treatment. In practice, as soon as the treatment starts, the control unit stores a time data element relating to the instant of starting; the control unit can determine the time elapsed between the said instant of starting and each instant at which the said control procedure is executed, and can then calculate an actual flow value (Qactual) by applying the memory-resident calibration fiinction F to the value of the said elapsed time (Ti) and to the values of angular velocity and arterial pressLUe (Part, co ) measured by means of the said sensors.
In a first embodiment of the invention, the calibration function F is of the type v3 Y;-o,..,, a;=(v2)"-'=(vl)' ] + C, wllere a; and C are experimentally determined 1o lcnown parameters. More simply, the calibration fiinction F can be of the type v3 = a=vl+b=vl=v2+c=v2+d, where a, b, c, d are the experimentally determined laiown parameters, and where vl is the angular velocity of the puinp, v2 is the arterial pressure Part in the portion of the said access branch upstream of the said peristaltic pump, and v3 is an actual blood flow (Qactual) through the said access branch.
In particular, it was found that the following values of a, b, c, d (divided into two sets, each valid for a predetermined pressure range Part) can be used to obtain a suitable calibration function; in practice, the fiu-iction F coinprises two functions, F' and F", linked together with continuity, the first F' being valid in a first range of values of arterial pressure, and the second F" being valid in a second range of values of arterial pressure which follows the said first range.
Alternatively, w11en F is also a function of v4, the calibration function F is of the type v3 = [ Yi=o...n Yjt=o... , a;= bk= (v2)"-'a= (vl);= (v4)i. ] + C, where a;, bk and C are experimentally detennined lc-iown paraineters. In this second case, the function F can be, more specifically, of the type v3 = (a=vl+b=vl=v2+c=v2+d) =f(v4), where a, b, c, d are experimentally deterinined lalown parameters and f(v4) is a fiulction which is also lalown and experimentally determined in the variable v4.
It should also be emphasized that the memory 14 can be designed to store a plurality of calibration fi.ulctions Fl, F2, ... Fn, each at least in the variables vl, v2, v3 and if appropriate in the variable v4. Each of these calibration fi.ulctions can in practice be applicable to a corresponding type of extracorporeal circuit. More precisely, if multiple types of extracorporeal circuit are in production, with pump tube portions differing from each other, for example in respect of materials ancUor geometry or other characteristics, a corresponding appropriate calibration fi.uiction can be provided for and associated wit11 each of these types, and can be stored in the memoiy 14.
Each fi,inetion F can also be associated with a cozTesponding identification code of the corresponding extracorporeal circuit, so that the user can simply select the type of circuit installed and thus automatically select the coiTesponding fiinction F
to be used for the calculation of Qactual. Finally, it should be specified that the fiuiction F can also be a function of one or more of the following additional variables: v5, related to the geometric characteristics of an access meinber comlectable for operation to the said extracorporeal circuit; v6, related to the length of the portion of tube of the access branch upstream of the said peristaltic pump; v7, related to the pressure in the portion of access branch downstream of the peristaltic pump; v8, related to the temperatLUe of the extracorporeal circuit; and v9, related to the haematocrit value of the blood of the treated patient.
In practice, when a plurality of previously stored functions F is available, each relating to a corresponding type of extracorporeal circuit, and each capable of allowing for the rotation speed of the pump, the pressure Part, the time elapsed from the start of the use of the circuit, the type of access member in use and the length of the line upstream of the puinp, it is possible to provide a reliable determination of Qactual and a siinple and flexible instrument for controlling the peristaltic pLunp.
The invention also relates to a software program comprising instructions for making a control unit, whether of the dedicated type or associated with the machinery of which the extracorporeal circuit is a subordinate component, capable of executing the steps of the control procedure described above. From the practical point of view, this program can be stored on a magnetic and/or optical recording medium, in a read only memory, or in a volatile coinputer memory, or can be carried by an electric or electromagnetic carrier. Finally, the invention also comprises a machine for blood treatment, which is capable of carrying out one or more of the following treatments:
- haemodialysis, - haemofiltration, - haemodiafiltration, - pure ultrafiltration, - plasmapheresis, and which is also provided with equipment for controlling blood flow in an extracorporeal circuit as described and illustrated in the attached drawings.
Claims (25)
1. Equipment for controlling blood flow in an extracorporeal blood circuit, the said extracorporeal circuit having at least one blood treatment unit, at least one access branch extending between an area where blood is collected from a patient and the treatment unit, at least one peristaltic pump associated for operation with the said access branch of the extracorporeal circuit, and at least one return branch extending between the treatment unit and an area where the blood is returned to the patient, the said equipment comprising:
- at least a first sensor, designed to measure an arterial pressure (Part) in a portion of the said access branch upstream of the peristaltic pump, and to generate a corresponding first output signal proportional to the said arterial pressure (Part);
- at least a second sensor, designed to measure an angular velocity (.omega.) of the peristaltic pump and to generate a corresponding second output signal, proportional to the angular velocity of the said peristaltic pump;
- a memory designed to store at least one set value (Qset) of the desired blood flow through the said access branch, and a calibration function F in at least the following variables:
.cndot. v1, related to the angular velocity of the pump (.omega.), .cndot. v2, related to the arterial pressure (Part) in the portion of the said access branch upstream of the peristaltic pump, .cndot. v3, related to an actual flow of blood (Qactual) through the said access branch;
- at least one control unit, connected for operation to the said sensors and to the said memory, for receiving the said first and second output signals and for storing the corresponding measured values of arterial pressure (Part) and angular velocity (.omega.) in the said memory, the said control unit being capable of executing a control procedure comprising the following time succeeding operations:
.cndot. calculating an actual flow value (Qactual) by applying the said memory-resident calibration function F to the values of angular velocity and arterial pressure (Part, .omega.) measured by means of the said sensors;
.cndot. comparing the said actual flow value (Qactual) with the said set flow value (Qset), characterized in that after the step of comparing said actual flow value (Qactual) with said set flow value (Qset), the control procedure comprises the following time succeeding steps:
.cndot. comparing the angular velocity with an acceptable maximum value which can be imparted to the pump, .cndot. varying the angular velocity of the said peristaltic pump if the difference between the actual flow and the desired flow (Qactual -Qset) lies outside a predetermined range.
- at least a first sensor, designed to measure an arterial pressure (Part) in a portion of the said access branch upstream of the peristaltic pump, and to generate a corresponding first output signal proportional to the said arterial pressure (Part);
- at least a second sensor, designed to measure an angular velocity (.omega.) of the peristaltic pump and to generate a corresponding second output signal, proportional to the angular velocity of the said peristaltic pump;
- a memory designed to store at least one set value (Qset) of the desired blood flow through the said access branch, and a calibration function F in at least the following variables:
.cndot. v1, related to the angular velocity of the pump (.omega.), .cndot. v2, related to the arterial pressure (Part) in the portion of the said access branch upstream of the peristaltic pump, .cndot. v3, related to an actual flow of blood (Qactual) through the said access branch;
- at least one control unit, connected for operation to the said sensors and to the said memory, for receiving the said first and second output signals and for storing the corresponding measured values of arterial pressure (Part) and angular velocity (.omega.) in the said memory, the said control unit being capable of executing a control procedure comprising the following time succeeding operations:
.cndot. calculating an actual flow value (Qactual) by applying the said memory-resident calibration function F to the values of angular velocity and arterial pressure (Part, .omega.) measured by means of the said sensors;
.cndot. comparing the said actual flow value (Qactual) with the said set flow value (Qset), characterized in that after the step of comparing said actual flow value (Qactual) with said set flow value (Qset), the control procedure comprises the following time succeeding steps:
.cndot. comparing the angular velocity with an acceptable maximum value which can be imparted to the pump, .cndot. varying the angular velocity of the said peristaltic pump if the difference between the actual flow and the desired flow (Qactual -Qset) lies outside a predetermined range.
2. Equipment according to claim 1, characterized in that it also comprises a timer device connected for operation to the control unit, the said control unit being capable of executing the said control procedure at predetermined time intervals.
3. Equipment according to claim 1, characterized in that it also comprises a user interface device capable of sending to the control unit at least one signal for activating the said control procedure and at least one signal for disabling it.
4. Equipment according to claim 3, characterized in that the said user interface device is capable of receiving a manual setting of the set flow (Qset) and of transmitting this setting to the said control unit.
5. Equipment according to claim 4, characterized in that the said control unit is capable of operating, selectively, either in a first operating mode, in which it waits for the said activating and disabling signals and the said manual setting of the set flow for activating the said control procedure, or in a second operating mode, in which it automatically executes the said control procedure during the said treatment.
6. Equipment according to claim 1, characterized in that the said control procedure also comprises a step of verifying the stability of the said arterial pressure (Part).
7. Equipment according to claim 6, characterized in that the step of verifying the stability of the said arterial pressure (Part) comprises the following sub-steps: measuring a first arterial pressure (Part1) at a predetermined instant (T1), measuring a second arterial pressure (Part2) at an instant (T2) following the said predetermined instant (T1), comparing a difference between the first and second arterial pressures with a predetermined range of acceptability, waiting for a predetermined time interval and repeating the said steps of measuring and the said step of comparing if the difference between the first and second arterial pressures does not lie within the said predetermined range of acceptability, and continuing the said control procedure if the difference between the first and second arterial pressures lies within the said predetermined range of acceptability.
8. Equipment according to claim 6, characterized in that the said step of verifying the stability of the arterial pressure is executed before the said step of calculating the actual flow.
9. Equipment according to claim 1, characterized in that there is provided, after the said step of comparing the said actual flow value (Qactual) with the said set flow value (Qset), and before the said step of varying the angular velocity of the said peristaltic pump, a step of comparing the Part with a threshold value considered critical for the patient being treated, and in that, if the pressure is below this threshold value, an exit is made from the algorithm and the operator is alerted by means of a warning message relating to the occurrence of a limit pressure condition.
10. Equipment according to claim 1, characterized in that the calibration function F also has at least the following further variable:
.cndot. V4, related to a time (Ti) elapsed from a start condition of the said control procedure, the said control unit being capable of determining a time which has elapsed between the said start condition and each instant in which the said control procedure is executed, and of calculating an actual flow value (Qactual) by applying the said memory-resident calibration function F to the value of the said time (Ti) elapsed and to the values of angular velocity and arterial pressure (Part, .omega.) measured by means of the said sensors.
.cndot. V4, related to a time (Ti) elapsed from a start condition of the said control procedure, the said control unit being capable of determining a time which has elapsed between the said start condition and each instant in which the said control procedure is executed, and of calculating an actual flow value (Qactual) by applying the said memory-resident calibration function F to the value of the said time (Ti) elapsed and to the values of angular velocity and arterial pressure (Part, .omega.) measured by means of the said sensors.
11. Equipment according to claim 1, characterized in that the calibration function F is of the type v3 =[.SIGMA.i=0...n a i.cndot. (v2)n-i.cndot. (v1)i]
+ C, where ai and C are experimentally determined known parameters.
+ C, where ai and C are experimentally determined known parameters.
12. Equipment according to claim 10, characterized in that the calibration function F is of the type v3 =[.SIGMA.i-0...n .SIGMA.k=0...m a i.cndot. b k.cndot. (v2)n-i-k.cndot. (v1)i.cndot. (v4)k] + C, where a i, b k and C are experimentally determined known parameters.
13. Equipment according to claim 11, characterized in that the calibration function F is of the type v3 = a.cndot.v1+b.cndot.v1 .cndot.v2+c.cndot.v2+d, where a, b, c, d are experimentally determined known parameters.
14. Equipment according to claim 12, characterized in that the said calibration function F is of the type v3 =(a.cndot.v1+b.cndot.v1.cndot.v2+c.cndot.v2+d).cndot.f(v4), where a, b, c, d are experimentally determined known parameters and f(v4) is a function which is also known and experimentally determined in the variable v4.
15. Equipment according to any one of claims 1 to 14, characterized in that the said memory is designed to store a plurality of calibration functions F1, F2, ... Fn, each at least in the variables v1, v2, v3, and each applicable to a corresponding one of a plurality of types of extracorporeal circuits.
16. Equipment according to claim 15, characterized in that each of the said calibration functions F is also a function of the said variable v4.
17. Equipment according to claim 16, characterized in that each of the said calibration functions F is also a function of at least one or more of the following further variables:
- v5, related to the geometrical characteristics of an access member connectable for operation to the said extracorporeal circuit;
- v6, related to the length of the portion of tube of the access branch upstream of the said peristaltic pump.
- v5, related to the geometrical characteristics of an access member connectable for operation to the said extracorporeal circuit;
- v6, related to the length of the portion of tube of the access branch upstream of the said peristaltic pump.
18. Equipment according to claim 17, characterized in that the said function F
comprises two functions F' and F", linked together with continuity, the first F' being valid in a first range of values of arterial pressure, and the second F"
being valid in a second range of values of arterial pressure which follows the said first range.
comprises two functions F' and F", linked together with continuity, the first F' being valid in a first range of values of arterial pressure, and the second F"
being valid in a second range of values of arterial pressure which follows the said first range.
19. Equipment according to claim 3, characterized in that the control unit is capable of activating the control procedure not only after an activation signal has been received, but also if the value of Qset or of the arterial pressure Part varies or is varied.
20. A readable memory having recorded thereon instructions for execution by a computer to carry out said control procedure of the equipment as claimed in any one of the claims 1 to 20.
21. The readable memory according to claim 20, characterized in that said readable memory comprises a magnetic or optical recording medium.
22. The readable memory according to claim 20, characterized in that said readable memory is a computer memory.
23. Program according to claim 20, characterized in that said readable memory is a read only memory.
24. Machine for treating blood in an extracorporeal circuit, characterized in that it comprises equipment for controlling the blood flow according to any one of claims 1 to 19.
25. Machine for treating blood in an extracorporeal circuit according to claim 24, characterized in that it is capable of carrying out one or more of the following treatments:
- haemodialysis, - haemofiltration, - haemodiafiltration, - pure ultrafiltration, - plasmapheresis.
- haemodialysis, - haemofiltration, - haemodiafiltration, - pure ultrafiltration, - plasmapheresis.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT2001TO001222A ITTO20011222A1 (en) | 2001-12-27 | 2001-12-27 | BLOOD FLOW CONTROL EQUIPMENT IN A BLOOD CIRCUIT-EXTRA-BODY. |
| ITTO2001A001222 | 2001-12-27 | ||
| PCT/IB2002/005595 WO2003055542A1 (en) | 2001-12-27 | 2002-12-20 | Equipment for controlling blood flow in an extracorporeal blood circuit |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2470870A1 CA2470870A1 (en) | 2003-07-10 |
| CA2470870C true CA2470870C (en) | 2009-04-28 |
Family
ID=11459355
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002470870A Expired - Lifetime CA2470870C (en) | 2001-12-27 | 2002-12-20 | Equipment for controlling blood flow in an extracorporeal blood circuit |
Country Status (10)
| Country | Link |
|---|---|
| US (3) | US7824354B2 (en) |
| EP (1) | EP1458431B1 (en) |
| JP (2) | JP4486818B2 (en) |
| KR (1) | KR100939514B1 (en) |
| AT (1) | ATE421347T1 (en) |
| CA (1) | CA2470870C (en) |
| DE (1) | DE60231000D1 (en) |
| ES (1) | ES2321490T3 (en) |
| IT (1) | ITTO20011222A1 (en) |
| WO (1) | WO2003055542A1 (en) |
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-
2001
- 2001-12-27 IT IT2001TO001222A patent/ITTO20011222A1/en unknown
-
2002
- 2002-12-20 AT AT02788424T patent/ATE421347T1/en not_active IP Right Cessation
- 2002-12-20 DE DE60231000T patent/DE60231000D1/en not_active Expired - Lifetime
- 2002-12-20 CA CA002470870A patent/CA2470870C/en not_active Expired - Lifetime
- 2002-12-20 ES ES02788424T patent/ES2321490T3/en not_active Expired - Lifetime
- 2002-12-20 JP JP2003556117A patent/JP4486818B2/en not_active Expired - Lifetime
- 2002-12-20 US US10/500,331 patent/US7824354B2/en active Active
- 2002-12-20 WO PCT/IB2002/005595 patent/WO2003055542A1/en active Application Filing
- 2002-12-20 EP EP02788424A patent/EP1458431B1/en not_active Expired - Lifetime
- 2002-12-20 KR KR1020047010035A patent/KR100939514B1/en active IP Right Grant
-
2008
- 2008-01-22 US US12/017,402 patent/US7648477B2/en not_active Expired - Lifetime
-
2009
- 2009-05-26 US US12/471,818 patent/US7993297B2/en not_active Expired - Lifetime
- 2009-12-21 JP JP2009288987A patent/JP5048749B2/en not_active Expired - Lifetime
Also Published As
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|---|---|
| KR100939514B1 (en) | 2010-02-03 |
| EP1458431B1 (en) | 2009-01-21 |
| DE60231000D1 (en) | 2009-03-12 |
| ATE421347T1 (en) | 2009-02-15 |
| JP2010099484A (en) | 2010-05-06 |
| US20080119777A1 (en) | 2008-05-22 |
| AU2002353400A1 (en) | 2003-07-15 |
| JP4486818B2 (en) | 2010-06-23 |
| US20050043665A1 (en) | 2005-02-24 |
| US7993297B2 (en) | 2011-08-09 |
| JP2005512736A (en) | 2005-05-12 |
| ITTO20011222A1 (en) | 2003-06-27 |
| ES2321490T3 (en) | 2009-06-08 |
| KR20040071250A (en) | 2004-08-11 |
| US7648477B2 (en) | 2010-01-19 |
| WO2003055542A1 (en) | 2003-07-10 |
| US7824354B2 (en) | 2010-11-02 |
| CA2470870A1 (en) | 2003-07-10 |
| JP5048749B2 (en) | 2012-10-17 |
| ITTO20011222A0 (en) | 2001-12-27 |
| US20100324465A1 (en) | 2010-12-23 |
| EP1458431A1 (en) | 2004-09-22 |
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| EEER | Examination request | ||
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Effective date: 20221220 |