Patent Grant
10918776
The present invention relates to a medical apparatus for extracorporeal treatment of blood. The present invention also relates to a process of calculating set flow rates in a medical apparatus for delivery, collection or delivery and collection of fluids, such as for example in an apparatus for extracorporeal fluid processing.
In the field of biological fluid processing for medical use, several apparatuses are known which require manipulation of fluids of various nature. Known type of fluid processing system include extracorporeal blood treatment apparatus which are typically used to extract undesirable fluids and/or solutes from the patient's blood and/or add desirable fluids and/or substances to the blood. Extracorporeal blood treatment is used for treating patients unable to effectively remove excess water and undesirable particles from their blood, such as when a patient suffers temporary or permanent kidney failure. These patients may receive an extracorporeal blood treatment to add/or remove substances to their blood, to maintain an acid/base balance, and/or to remove excess body fluids, for example. Extracorporeal blood treatment is typically accomplished by removing the blood from the patient in e.g. a continuous flow, introducing the blood into a primary chamber, also referred to as blood chamber, of a filtration unit (such as a dialyzer or an hemofilter or an hemodiafilter) where the blood is allowed to flow along a semipermeable membrane. The semipermeable membrane selectively allows matter in the blood to cross the membrane from the primary chamber into a secondary chamber and also selectively allows matter in the secondary chamber to cross the membrane into the blood in the primary chamber, depending on the type of treatment. Cleared blood is then returned to the patient.
A number of different types of extracorporeal blood treatments may be performed. In an ultrafiltration (UF) treatment, undesirable fluids and particles is removed from the blood by convection across the membrane into the secondary chamber. In a hemofiltration (HF) treatment, the blood flows past the semipermeable membrane as in UF and desirable substances are added to the blood, typically by dispensing a fluid into the blood either via respective infusion lines before and/or after it passes through the filtration unit and before it is returned to the patient. In a hemodialysis (HD) treatment, a secondary fluid containing desirable substances is introduced into the secondary chamber of the filtration unit. Undesirable substances from the blood may cross the semipermeable membrane by diffusion into the secondary fluid and desirable substances from the secondary fluid may cross the membrane into the blood. In a hemodiafiltration (HDF) treatment, blood and secondary fluid exchange matter as in HD+UF, and, in addition, fluid is added to the blood, typically by dispensing it into the blood before its return to the patient as in HF.
To perform one or more of the above described treatments, extracorporeal blood treatment equipment may comprise a plurality of lines for delivering fluid directly to the patient or into the extracorporeal blood circuit.
When setting up the machine, an operator usually imposes the blood pump flow rate, the individual flow rates for each of the infusion lines, the flow rate for the dialysis line and for the effluent line (in reality this latter may alternatively be calculated based on the information of the set weight loss and treatment time or based on the set patient fluid removal rate). The set values for the flow rates on each line are used to control respective pumps: in other words, a plurality of pumps are used where each pump draws fluid from or supplies fluid to a respective fluid container according to the set flow rate value for the respective line. Setting up of the machine is therefore cumbersome as it entails the definition and entry on the part of the operator of a relatively high number of flow rates. Moreover, the independent setting of each one of the flow rates does not provide the operator with intuitive information in terms of medically relevant prescription parameters. Finally, the need for independently setting a plurality of parameters may be source of errors and does not allow to optimize fluid consumption.
In this situation, it is a general object of the present invention to offer a technical solution capable overcoming one or more of the above drawbacks.
More in detail, it is an object of the present invention to render available a medical apparatus for the extracorporeal treatment of blood and a process for calculating set flow rates in said apparatus capable of reducing as possible the actions required for setting up the apparatus.
Is a further object of aspects of the invention to define an apparatus and a process allowing the operator to set up a blood treatment apparatus using medically meaningful parameters which may result in an easier to use user interface.
It is an auxiliary object of the invention to offer a medical apparatus for the treatment of fluid and a process for calculating set flow rates in said apparatus which may facilitate flow rate setting before and during the treatment- and optimize the consumption of fluid with respect to the prescription target and the system constraints.
It is also an object of certain aspects of the present invention to render available a medical apparatus for the treatment of fluid and a process for calculating set flow rates in said apparatus capable of reducing as possible the frequency of container changes and consequent interruptions of treatment deliver.
Another auxiliary object is an apparatus capable of controlling operating parameters in a safe manner.
At least one of the above objects is substantially reached by an apparatus according to one or more of the appended apparatus claims. One or more of the above objects is also substantially reached by a process according to any one of the appended process claims.
Apparatus and processes according to aspects of the invention are here below described.
A first aspect concerns an apparatus for extracorporeal treatment of blood comprising a filtration unit having a primary chamber and a secondary chamber separated by a semi-permeable membrane; a blood withdrawal line connected to an inlet of the primary chamber, and a blood return line connected to an outlet of the primary chamber said blood lines being configured for connection to a patient cardiovascular system; a blood pump configured to control the flow of blood through the blood lines; an effluent fluid line connected to an outlet of the secondary chamber; at least two further fluid lines selected in the group comprising:
means, such as peristaltic pumps or flow regulating valves or centrifugal pumps, for regulating the flow of fluid through said fluid lines; and
a control unit connected to the means for regulating, the control unit being configured to:
In a second aspect according to the second aspect the control unit is further configured to control said means for regulating the flow of fluid based on said set values of the fluid flow rates. In other words the control unit uses the calculated set values of the fluid flow rates for e.g. controlling the rotational pump of the pumps or the position of the regulating valves used on the fluid lines.
In a third aspect according to any one of the preceding aspects a memory is provided storing a plurality of mathematical relations correlating fluid flow rates selected in said group, said control unit being connected to said memory.
In a fourth aspect according to the preceding aspect the control unit is further configured to calculate the set values at least of the second and third fluid flow rates by applying said prescribed dose value Dset and the set value of the first fluid flow rate entered by the operator to said mathematical relations.
In a fifth aspect according to any one of the preceding two aspects, wherein said mathematical relations stored in said memory comprise one or more of the following:
In a sixth aspect according to the preceding aspects all said mathematical relations specified in the fifth aspect are stored in said memory.
In a seventh aspect according to any one of the preceding aspects from the 3rd to the sixth, the control unit is further configured to allow the user to select at least two of said relations and to calculate the set values of at least the second and third of said fluid flow rates by applying the set value of the prescribed dose and the set value of the first fluid flow rate entered by the operator to the mathematical relations selected by the user.
In an eighth aspect according to any one of the preceding aspects from the fifth to the seventh, the convection-diffusion relation defines a first ratio R1 dividing the total fluid flow rate Qrep1+Qrep2+Qpbp through said infusion fluid lines by the fluid flow rate Qdial through said dialysis fluid line.
In a ninth aspect according to any one of the preceding aspects from the fifth to the eighth, the blood pre-dilution relation defines a second ratio R2 dividing the flow rate of blood or of plasma QBLOOD, QPLASMA by the sum of fluid flow rates Qrep1+Qpbp infused in the blood withdrawal line through said pre-dilution infusion fluid line and through said pre-blood pump infusion line.
In a tenth aspect according to any one of the preceding aspects from the fifth to the ninth, the pre-post relation defines a third ratio R3 dividing the sum of the fluid flow rates Qrep1+Qpbp through said pre-blood pump infusion line and pre-dilution infusion line by the fluid flow rate Qrep2 through said post-dilution infusion line.
In an eleventh aspect according to any one of the preceding aspects from the fifth to the tenth, the control unit is further configured to: store a preset value or preset range for each one of said first, second and third ratios R1, R2, R3.
In a twelfth aspect according to any one of the preceding aspects from the fifth to the eleventh, the control unit is further configured to allow entry by an operator of a set value or a set range for each one of said first, second and third ratios R1, R2, R3.
In a thirteenth aspect according to any one of the preceding aspects the blood pump is active in correspondence of a segment of the blood withdrawal line and the apparatus comprises the following fluid lines:
wherein the control unit is configured to calculate the set value for the fluid flow rate through each of the above-listed infusion lines which is not set by the operator based on said first fluid flow rate set by the operator and on said prescribed dose value Dset.
In a fourteenth aspect according to any one of the preceding aspects the blood pump is active in correspondence of a segment of the blood withdrawal line and the apparatus comprises the following fluid lines:
wherein the control unit is configured to calculate the set value for the fluid flow rate through each of the above-listed infusion lines which is not set by the operator based on said first fluid flow rate set by the operator and on said prescribed dose value Dset.
In a fifteenth aspect according to any one of the preceding aspects said prescribed dose value Dset comprises a prescribed value for a flow rate or a combination of flow rates.
In a sixteenth aspect according to any one of the preceding aspects, said prescribed dose value Dset comprises a prescribed value for one selected in the group including:
In a seventeenth aspect according to the preceding aspect, the control unit is configured to correct the selected one of the above defined doses to take into account a predilution effect, when a fluid replacement or infusion line is present and delivers fluid upstream the treatment unit, by multiplying the dose value times a dilution factor Fdilution, which is < then 1, as per the following formula:
Dosecorr_xxx=Fdilution×Dose_xxx (with xxx=eff, conv, dial).
In an eighteenth aspect according to any one of the preceding aspects from the third to the seventeenth, said first fluid flow rate is the fluid removal rate Qpfr from the patient and wherein the control unit is configured to receive the set value of the patient fluid removal rate Qpfr and to calculate the fluid flow rate Qdial through the dialysis liquid fluid line and the fluid flow rate Qrep1, Qpbp, Qrep2 through the infusion fluid line or lines using at least two of said mathematical relations.
In a nineteenth aspect according to any one of the preceding aspects the control unit is further configured to allow entry by an operator of the set value for a blood flow QBLOOD through the blood withdrawal or blood return line.
In a twentieth aspect according to any one of the preceding aspects the control unit is configured to calculate the set value for the blood flow based on a sensed value of a patient parameter selected in the group comprising:
In a twenty-first aspect according to any one of the preceding two aspects the control unit is configured to control the blood pump using either the entered or the calculated set value for the blood flow QBLOOD.
In a twenty-second aspect according to any one of the preceding aspects the control unit is further configured to calculate the set value for the fluid flow rate Qpbp through said pre-blood pump infusion line as a function of:
In a twenty-third aspect according to any one of the preceding aspects from the third to the twenty-second, the apparatus further comprises a graphic user interface connected to said control unit, said control unit being configured to:
In a twenty-fourth aspect according to any one of the preceding aspects the means for regulating the flow of fluid through said fluid lines comprises a pre-dilution pump for regulating the flow through said pre-dilution fluid line and a post-dilution pump for regulating the flow through said post-dilution fluid line.
In a twenty-fifth aspect according to any one of the preceding aspects a dialysis fluid line is connected to the inlet of the secondary chamber, and the means for regulating the flow of fluid through said fluid lines comprises at least a dialysis fluid pump for regulating the flow through said dialysis fluid line.
In a twenty-sixth aspect according to any one of the preceding aspects said one or more infusion fluid lines comprise:
a pre-blood pump infusion line connected to the blood withdrawal line in a region of this latter which is positioned in use upstream the blood pump, the means for regulating the flow of fluid through said fluid lines comprises at least a pre-blood infusion pump for regulating the flow through said pre-blood pump infusion line.
In a twenty-seventh aspect according to any one of the preceding aspects the apparatus further comprises a memory storing a one or a plurality of optimization criteria, said control unit being connected to said memory and being further configured to calculate the set values at least one of the second and third fluid flow rates by applying the optimization criteria.
In a twenty-eighth aspect according to any one of the preceding aspects, the apparatus includes a waste container connected to an end of the effluent fluid line.
In a twenty-ninth aspect according to any one of the preceding aspects, the apparatus includes a first container of fresh fluid connected to an end of the pre-dilution infusion fluid line.
In a thirtieth aspect according to any one of the preceding aspects, the apparatus includes a second container of fresh fluid connected to an end of the post-infusion fluid line.
In a thirty-first aspect according to any one of the preceding aspects, the apparatus includes a third container of fresh fluid connected to an end of the dialysis liquid fluid line.
In a thirty-second aspect according to any one of the preceding aspects, the apparatus includes a fourth container of fresh fluid connected to an end of the pre-blood pump infusion fluid line.
In a thirty-third aspect according to any one of the preceding aspects from the twenty-seventh to the thirty-second, the optimization criteria comprises a first optimization criterion imposing that an emptying time of at least two among the containers of fresh fluid and, optionally, a filling time of the waste container are multiple of a same reference time.
In a thirty-fourth aspect according to any one of the preceding aspects from the twenty-seventh to the thirty-second, the optimization criteria comprises a first optimization criterion imposing that an emptying time of at least one among the containers of fresh fluid and/or a filling time of the waste container is substantially same as or multiple of the emptying time of one or more of the other containers of fresh fluid.
In a thirty-fifth aspect according to any one of the preceding aspects from the twenty-seventh to the thirty-fourth the optimization criteria comprises a second optimization criterion imposing that fluid consumption through said fluid lines is minimized.
In a thirty-sixth aspect according to any one of the preceding aspects from the twenty-seventh to the thirty-fifth the optimization criteria comprises a third optimization criterion imposing that a life time of said filtration unit is maximized.
In a thirty-seventh aspect according to any one of the preceding aspects from the twenty-seventh to the thirty-sixth the optimization criteria comprises a fourth optimization criterion imposes that urea clearance or dialysance of a given solute is maximized.
In a thirty-eighth aspect according to any one of the preceding aspects from the twenty-seventh to the thirty-seventh the control unit is configured to allow the user selecting one or more of said criteria and calculate said at least second and third flow rate using said selected criteria.
In a thirty-ninth aspect according to any one of the preceding aspects from the twenty-seventh to the thirty-seventh allow the user selecting one or more of said criteria and one or more of said mathematical relations and to calculate said at least second and third flow rate using said selected criteria and said selected mathematical relations.
In a fortieth aspect according to the preceding aspect the control unit is configured to determine if said selected criteria and said selected mathematical relations are compatible or conflicting and then:
in case the selected criteria and the selected mathematical relations are compatible, calculate the at least second and third flow rate based on the selected mathematical relations and optimization criteria,
in case one or more of the selected criteria is conflicting with one or more selected mathematical relations, execute one or more of the following sub-steps:
In a variant of the invention it should be noted that the control unit may be configured combine the use of the flow rate set-up procedure with the use of one or more optimization criteria. For example the control unit may be configured to:
A forty-first aspect relates to an apparatus for extracorporeal treatment of fluid comprising:
a filtration unit having a primary chamber and a secondary chamber separated by a semi-permeable membrane;
a blood withdrawal line connected to an inlet of the primary chamber, and a blood return line connected to an outlet of the primary chamber said blood lines being configured for connection to a patient cardiovascular system;
a blood pump configured to control the flow of blood through the blood lines;
an effluent fluid line connected, at one end thereof, to an outlet of the secondary chamber and, at its other end, optionally connected to a waste container;
at least two further fluid lines selected in the group of fluid lines comprising:
means for regulating the flow of fluid (17, 18, 21, 22, 27, P) through one or more said fluid lines (13, 15, 21, 25, 19); and
a control unit (10) connected to the means for regulating, the control unit being configured to:
calculate set values (Qiset) of two or more of the fluid flow rates selected in the group of fluid flow rates including:
by imposing that emptying times of at least two among the containers of fresh fluid (16, 20, 21, 26, S) and, optionally, the filling time of the waste container are multiple of a same reference time (Tr).
By defining the reference time Tr and a multiplication factor, it is possible to define in relation to each fresh fluid line e.g. the following:
Optionally the above relations may be applied, mutatis mutandis, to the filling time of the waste container.
In a forty-second aspect according to the forty-first aspect the control unit is configured to:
In a forty-third aspect according to the forty-first aspect the control unit is configured to:
In a forty-fourth aspect, according to any one of the preceding three aspects, the control unit is configured to use at least two reference times Tr1 and Tr2. This solution may be adopted when the apparatus includes at least four of the fluid lines selected in said group of fluid lines specified in aspect 41. The control unit is configured to calculate set values (Qiset) of two or more of:
by imposing that the emptying times of at least two among the containers of fresh fluid (16, 20, 21, 26, S) and, optionally, the filling time of the waste container are multiple of a first reference time (Tr1) and also imposing that that emptying times of at least two other among the containers of fresh fluid (16, 20, 21, 26, S) and, optionally, the filling time of the waste container are multiple of a second reference time (Tr2).
In other words, in accordance with this aspect it is possible to synchronize the emptying of two or more containers (e.g. container 16 and 20) of fresh fluid with reference to a first reference time such that for instance the emptying time of said two containers is multiple of the first reference time, while the emptying two or more other containers (e.g. containers 21 and 26, or 21, 26 and S) may be synchronized with reference to a second reference time such that for instance the emptying time of said two other containers is multiple of the second reference time. This may still allow a good degree of overall synchronization and time saving. Of course it is also possible to synchronize the filling of the waste container with reference to either one of the two reference times.
In principle, if the apparatus would include a relevant number of lines bringing and or withdrawing fluid from the blood circuit and leading to respective fresh fluid containers or waste containers, it may be possible to synchronize the emptying/filling of the containers in 3 or more groups where each group of containers is synchronized relative to a respective reference time.
In a forty-fifth aspect according to any one of the aspects from the forty-first to the forty-fourth, the control unit is further configured to control said means for regulating based on said calculated set values, either automatically or after receipt of a confirmation signal.
In a forty-sixth aspect according to any one of the aspects from the forty-first to the forty-fifth the apparatus comprises at least the following fluid lines:
a pre-dilution infusion fluid line connected to the blood withdrawal line,
a post-dilution infusion fluid line connected to the blood return line,
a dialysis fluid line connected to the inlet of the secondary chamber.
In a forty-seventh aspect according to any one of the aspects from the forty-first to the forty-sixth the control unit is configured to calculate the set value for the fluid flow rate through each of the infusion fluid lines and dialysis fluid line by imposing that the emptying time of each given of said first, second and third containers is multiple of the same reference time Tr.
In a forty-eighth aspect according to any one of the aspects from the forty-first to the forty-sixth the control unit is configured to calculate the set value for the fluid flow rate through each of the infusion fluid lines and dialysis fluid line by imposing that the emptying time of each given of said first, second and third containers is same as or multiple of the emptying time of one or more other of said first, second and third containers.
In a forty-ninth aspect according to any one of the preceding aspects the blood pump is active in correspondence of a segment of the blood withdrawal line, the pre-dilution infusion fluid line is connected to the blood withdrawal line between the blood pump segment and the filtration unit, and a pre-blood pump infusion fluid line is connected to the blood withdrawal line in a region of this latter which is positioned between the blood pump segment and an end of the blood withdrawal line opposite the end connected to the filtration unit.
In a fiftieth aspect according to any one of the preceding aspects the control unit is configured to calculate the set value for the fluid flow rate through each of the infusion fluid lines and dialysis fluid line by imposing that the emptying time of each given of said first, second, third, and fourth containers is multiple of the same reference time Tr.
In a fifty-first aspect according to the preceding aspect the control unit is configured to calculate the set value for the fluid flow rate through each of the infusion fluid lines and dialysis fluid line by imposing that the emptying time of each given of said first, second, third, and fourth containers is same as or multiple of the emptying time of one or more other of said first, second, third, and fourth containers.
In a fifty-second aspect according to the preceding aspect the waste line is connected to the waste container and the control unit is configured to calculate the set value for the fluid flow rate through each of the fluid lines by imposing that the emptying time of each given of said containers of fresh fluid and the filling time of the waste container are multiple of the same reference time Tr and are optionally same as or multiple of the emptying time of one or more other containers of fresh fluid or filling time of the waste container.
In a fifty-third aspect according to any one of the preceding aspects the control unit is configured to store in a memory connected to the control unit the volume or weight of fluid which may be contained in each container of fresh fluid and optionally in said waste container.
In a fifty-fourth aspect according to the preceding aspect, said volume or weight of fluid is detected by a sensor associated to each respective container and connected to the control unit.
In a fifty-fifth aspect according to the fifty-third aspect, said volume or weight of fluid is entered by an operator for each respective container through a user interface connected to the control unit; or said volume or weight of fluid is determined by the control unit associating an identification code on each respective container to a respective volume.
In a fifty-sixth aspect according to the fifty-third aspect, said volume or weight of fluid is pre-stored in said memory.
In a fifty-seventh aspect according to any one of the preceding aspects the control unit is further configured to receive, for instance by allowing a corresponding selection by an operator, at least one set value for a treatment time T.
In a fifty-eighth aspect according to any one of the preceding aspects the control unit is further configured to receive, for instance by allowing a corresponding selection by an operator, at least one set value for a treatment dose Dset to be delivered to the patient during the treatment.
In a fifty-ninth aspect according to the preceding aspect the set value for the treatment dose comprises a prescribed value for one selected in the group including:
In a sixtieth aspect according to any one of the preceding aspects the control unit is further configured to receive, for instance by allowing a corresponding selection by an operator, at least one set value for one or more of:
a fluid flow rate Qrep1 through the pre-dilution infusion fluid line;
a fluid flow rate Qrep2 through the post-infusion fluid line;
a fluid flow rate Qpbp through the pre-blood pump infusion fluid line;
a fluid flow rate Qdial through the dialysis liquid fluid line;
a fluid flow rate Qeff through the effluent fluid line.
In a sixty-first aspect according to any one of the preceding aspects the apparatus comprises one or more scales weighing one or more of said containers.
In a sixty-second aspect according to any one of the preceding aspects the apparatus comprises a corresponding scale for each respective of said containers, said one or more scales being connected to the control unit and sending to the control unit corresponding weight signals.
In a sixty-third aspect according to any one of the preceding aspects the control unit is configured to:
In a sixty-fourth aspect according to any one of the preceding aspects the control unit is configured to:
In a sixty-fifth aspect according to any one of the preceding aspects the control unit is configured to:
In a sixty-sixth aspect according to any one of the preceding aspects the control unit is configured to:
A sixty-seventh aspect relates to an apparatus for extracorporeal treatment of fluid comprising:
a filtration unit having a primary chamber and a secondary chamber separated by a semi-permeable membrane;
a blood withdrawal line connected to an inlet of the primary chamber, and a blood return line connected to an outlet of the primary chamber said blood lines being configured for connection to a patient cardiovascular system;
a blood pump configured to control the flow of blood through the blood lines;
an effluent fluid line connected, at one end thereof, to an outlet of the secondary chamber and, at its other end, optionally connected to a waste container;
at least two further fluid lines selected in the group comprising:
means for regulating the flow of fluid through one or more said fluid lines; and
a control unit connected to the means for regulating, the control unit being configured to calculate set values Qiset of two or more of the fluid flow rates selected in the group including:
by executing the following steps:
In a sixty-eighth aspect according to any one of the preceding aspects the control unit is configured to:
In a sixty-ninth aspect according to any one of the preceding aspects the control unit is configured to:
In a seventieth aspect according to any one of the preceding aspects from the 41st to the 69th said control unit is configured to:
In a seventy-first aspect according to any one of the preceding aspects from the forty-first to the seventieth the control unit is configured to receive one set value set by an operator for one fluid flow rate selected in the group comprising:
In a seventy-second aspect according to any one of the preceding aspects from the forty-first to the seventy-first the control unit is configured to compute the reference time Tr by:
In a seventy-third aspect according to any one of the preceding aspects from the forty-first to the seventy-second wherein the apparatus comprises a separate scale detecting the weight of each respective container.
In a seventy-fourth aspect according to the preceding aspect, the control unit is configured to receive a weight Wi of one or more of said containers as measured by a corresponding scale associated to each container, wherein the weight of each respective container Wi used for the calculation of the set values of the fluid flow rates is determined either at the beginning of the treatment or at a prefixed checkpoint during treatment or responsive to a user input.
In a seventy-fifth aspect according to one of the preceding two aspects the control unit is configured to compare the detected weight of each container of fresh fluid to a respective threshold and to determine that a fresh fluid container is empty if the detected weight is below the respective threshold.
In a seventy-sixth aspect according to one of the preceding three aspects the control unit is configured to compare the detected weight of the waste fluid container a respective threshold and to determine that the waste container is full if the detected weight is above the threshold. The threshold may be fixed or the control unit may be configured to calculate as threshold a set value (Veff-change) of the waste container reference volume or weight, at which the control unit considers that the waste container is full, by imposing that the filling time of the waste container is substantially same as, proportional to, or multiple of the emptying time of one or more of the other containers of fresh fluid.
In a seventy-seventh aspect according to one of the preceding two aspects the control unit is configured to generate an empty container signal when the weight of one or more containers of fresh fluid is below the respective threshold and to generate a full container signal when the weight of said waste container is above the respective threshold.
In a seventy-eighth aspect according to any one of the preceding aspects the means for regulating the flow of fluid through said fluid lines comprises a pre-dilution pump for regulating the flow through said pre-dilution fluid line and a post-dilution pump for regulating the flow through said post-dilution fluid line,
In a seventy-ninth aspect according to any one of the preceding aspects the control unit is further configured to:
In an eightieth aspect according to any one of the preceding aspects said control unit is configured to allow entry of:
In an eighty-first aspect according to any one of the preceding aspects the control unit is further configured to calculate the set values (Qiset) of the fluid flow rates through said fluid lines by imposing that:
In an eighty-second aspect according to any one of the preceding aspects all containers of fresh fluid comprise a fluid having a same composition.
Alternatively, the fourth container of fresh fluid comprises a fluid having a composition different from that of the other containers of fresh fluid, for example said fourth container contains an anticoagulant (heparin or a regional anticoagulant such as a citrate solution): in this case the control unit is configured to calculate the set value of fluid flow rate through the pre-blood pump infusion line based on a predefined algorithm: e.g. the flow rate through the pre-blood pump infusion line may be set to be proportional to the set or calculated value of the blood pump flow rate. In a further alternative if the apparatus comprises the fourth container which includes a regional anticoagulant, for example a citrate based solution, then the second container leading to said post-dilution infusion fluid line includes an ionic balance solution, for example calcium ion based solution: in this case the control unit is configured to calculate the fluid flow rate through said pre-blood pump infusion fluid line and through said post-dilution infusion fluid line based on pre-defined algorithm(s).
In an eighty-third aspect according to any one of the preceding aspects the apparatus comprises one or two syringe lines leading to respective syringe containers (S) including an anticoagulant solution or a ionic balance solution, the control unit being configured to calculate the fluid flow rate through said syringe line or lines based on pre-defined algorithm(s).
In an eighty-fourth aspect according to any one of the preceding aspects the control unit is configured to check if the calculated set value for the fluid flow rate through the post-dilution infusion line is higher than a prefixed fraction of the blood flow rate.
In an eighty-fifth aspect according to the preceding aspect wherein if the calculated set value for the fluid flow rate through the post-dilution infusion line is higher than a prefixed fraction of the blood flow rate, the control unit is configured to activate a correction procedure comprising:
In an eighty-sixth aspect according to any one of the preceding aspects the control unit is configured to:
An eighty-seventh aspect concerns a process of setting up a medical apparatus for the delivery and/or collection of fluids, the apparatus comprising:
the process comprising the following steps:
In an eighty-eighth aspect according to the preceding aspect, the apparatus comprises:
a filtration unit having a primary chamber and a secondary chamber separated by a semi-permeable membrane;
a blood withdrawal line connected to an inlet of the primary chamber, and a blood return line connected to an outlet of the primary chamber said blood lines being designed to be connected to a patient cardiovascular system;
a blood pump configured to control the flow of blood through the blood lines;
an effluent fluid line connected, at one end thereof, to an outlet of the secondary chamber and, at its other end, optionally connected to a waste container;
at least two fluid lines selected in the group comprising:
the pump or a valve regulator being configured to regulate the flow of fluid through said fluid lines and a control unit being connected to the pump or valve regulator,
wherein the process is executed by the control unit and comprises the following steps:
calculating set values of two or more of the fluid flow rates selected in the group including:
by imposing that an emptying time of at least one among the containers of fresh fluid and/or a filling time of the waste container is substantially same as, or multiple of, the emptying time of one or more of the other containers of fresh fluid,
storing said calculated set values in identified retrievable memory locations for subsequent use to control said means for regulating the flow of fluid.
In an eighty-ninth aspect according to the preceding aspect, the apparatus comprises:
a filtration unit having a primary chamber and a secondary chamber separated by a semi-permeable membrane;
a blood withdrawal line connected to an inlet of the primary chamber, and a blood return line connected to an outlet of the primary chamber said blood lines being designed to be connected to a patient cardiovascular system;
a blood pump configured to control the flow of blood through the blood lines;
an effluent fluid line connected, at one end thereof, to an outlet of the secondary chamber and, at its other end, optionally connected to a waste container;
at least two fluid lines selected in the group comprising:
the pump or a valve regulator being configured to regulate the flow of fluid through said fluid lines and a control unit being connected to the pump or valve regulator,
wherein the process is executed by the control unit and comprises the following steps:
calculating set values of two or more of the fluid flow rates selected in the group including:
by that emptying times of at least two among the containers of fresh fluid and, optionally, the filling time of the waste container are multiple of a same reference time Tr, and optionally storing said calculated set values in identified retrievable memory locations for subsequent use to control said means for regulating the flow of fluid.
By defining the reference time Tr and a multiplication factor, it is possible to define in relation to each fresh fluid line e.g. the following:
Optionally the above relations may be made with the filling time of the waste container.
In a ninetieth aspect according to the one of the preceding two aspects, the apparatus comprises at least the following three fluid lines:
a pre-dilution infusion fluid line connected to the blood withdrawal line,
a post-dilution infusion fluid line connected to the blood return line,
a dialysis fluid line connected to the inlet of the secondary chamber;
and wherein the process comprises the following further steps:
allowing selection by an operator of at least one set value for a parameter selected in the group comprising:
determining the weight or volume Wi, Vi of the respective container at the beginning of the treatment or at a prefixed checkpoint or responsive to an operator's input,
calculating the set value for the fluid flow rate through each of the above-listed fluid lines by imposing that emptying times of at least two among the containers of fresh fluid and, optionally, the filling time of the waste container are multiple of a same reference time Tr.
In a ninety-first aspect according to the preceding aspect, the emptying time of each given of said first, second, third and fourth containers and/or the filling time of the waste container is substantially the same as, or multiple of, the emptying time of one or more other of said first, second, third and fourth containers, said set value for the fluid flow rate through each of the above-listed three fluid lines being calculated dividing said weight or volume Wi, Vi of the respective container by the value of reference time Tr.
In a ninety-second aspect according to the one of the preceding aspects from 87th to 91st, the calculation of reference time Tr may be made as disclosed in connection with the above apparatus aspects.
In a ninety-third aspect according to the one of the preceding aspects from 87th to 92nd the process comprises to:
In a ninety-fourth aspect according to the preceding aspect the process comprises to:
In a ninety-fifth aspect according to the ninety-third aspect the process comprises to:
A ninety-sixth aspect concerns a process of setting up a medical apparatus for the delivery or collection of fluid, the apparatus comprising:
a filtration unit having a primary chamber and a secondary chamber separated by a semi-permeable membrane;
a blood withdrawal line connected to an inlet of the primary chamber, and a blood return line connected to an outlet of the primary chamber said blood lines being designed to be connected to a patient cardiovascular system;
a blood pump configured to control the flow of blood through the blood lines;
an effluent fluid line connected to an outlet of the secondary chamber;
at least two fluid lines selected in the group comprising:
a pre-dilution infusion fluid line connected to the blood withdrawal line,
a pre-blood pump infusion line connected to the blood withdrawal line in a region of this latter which is positioned in use upstream the blood pump
a post-dilution infusion fluid line connected to the blood return line,
a dialysis fluid line connected to the inlet of the secondary chamber;
means for regulating the flow of fluid through said fluid lines;
a control unit connected to the means for regulating,
the method comprising the following steps executable by the control unit:
allow entry by an operator of the set value for at least a first fluid flow rate selected in the group including:
allow entry of a set value for a prescribed dose Dset to be delivered,
calculate set values of at least a second and a third of the fluid flow rates of said group of flow rates, based on the said first fluid flow rate set by the operator and on said prescribed dose value Dset by applying said prescribed dose value Dset and the set value of the first fluid flow rate entered by the operator to mathematical relations stored in a memory connected to the control unit.
In a ninety-seventh aspect according to the ninety-sixth said means for regulating the flow of fluid are controlled based on said set values of the fluid flow rates.
In a ninety-eighth aspect according to any one of the preceding two aspects, said mathematical relations stored in said memory comprise one or more of the following:
In a ninety-ninth aspect according to any one of the preceding three aspects the process comprises selecting at least two of said relations and calculating the set values of at least the second and third of said fluid flow rates by applying the set value of the prescribed dose and the set value of the first fluid flow rate entered by the operator to the selected mathematical relations.
In a one-hundredth aspect according to any one of the preceding four aspects, the convection-diffusion relation defines a first ratio R1 dividing the total fluid flow rate Qrep1+Qrep2+Qpbp through said infusion fluid lines by the fluid flow rate Qdial through said dialysis fluid line, the blood pre-dilution relation defines a second ratio R2 dividing the flow rate of blood or of plasma QBLOOD, QPLASMA by the sum of fluid flow rates Qrep1+Qpbp infused in the blood withdrawal line through said pre-dilution infusion fluid line and through said pre-blood pump infusion line, and the pre-post relation defines a third ratio R3 dividing the sum of the fluid flow rates Qrep1+Qpbp through said pre-blood pump infusion line and pre-dilution infusion line by the fluid flow rate Qrep2 through said post-dilution infusion line.
In a one-hundred-first aspect according to any one of the preceding five aspects the process may include selection of optimization relations as disclosed in connection with the above apparatus aspects.
In a one-hundred-second aspect according to any one of the preceding apparatus aspects, the apparatus comprises one or more scales weighing one or more of said containers, optionally wherein a corresponding scale is provided for each respective of said containers, said scales being connected to the control unit and sending to the control unit corresponding weight signals, wherein the control unit is configured to receiving the initial weight W, of one or more of said containers from one or more of said scales.
In a one-hundred-third aspect a data carrier is provided comprising instructions which when executed by the control unit of an apparatus according to any one of the preceding apparatus aspects render said control unit configured to execute the respective steps described in the preceding aspects.
Aspects of the invention are shown in the attached drawings, which are provided by way of non-limiting example, wherein:
A blood withdrawal line 6 is connected to an inlet of the primary chamber 3, and a blood return line 7 is connected to an outlet of the primary chamber 3. In use, the blood withdrawal line 6 and the blood return line 7 are connected to a needle or to a catheter or an implanted port or other access device (not shown) which is then placed in fluid communication with the patient vascular system, such that blood may be withdrawn through the blood withdrawal line, flowed through the primary chamber and then returned to the patient's vascular system through the blood return line. An air separator, such as a bubble trap 8, may be present on the blood return line; moreover, a safety clamp 9 controlled by a control unit 10 may be present on the blood return line downstream the bubble trap 8. A bubble sensor 8a, for instance associated to the bubble trap 8 or coupled to a portion of the line 7 between bubble trap 8 and clamp 9 may be present: if present, the bubble sensor is connected to the control unit 10 and sends to the control unit signals for the control unit to cause closure of the clamp 9 in case one or more bubbles are detected. As shown in
Going back to
The dialysis fluid pump 21, the infusion fluid pump 18 (or pumps 18, 27) and the effluent fluid pump 17 are part of means for regulating the flow of fluid through the respective lines and, as mentioned, are operatively connected to the control unit 10 which controls the pumps as it will be in detail disclosed herein below. The control unit 10 is also connected to a memory 10a and to user interface 12, for instance a graphic user interface, which receives operator's inputs and displays the apparatus outputs. For instance, the graphic user interface 12 may include a touch screen, a display screen and/or hard keys for entering user's inputs or a combination thereof.
The embodiment of
The apparatus of
The apparatus of
A further embodiment is shown in
Of course the above described blood treatment apparatus are of exemplifying character only and further variants may be envisaged without departing from the scope of the invention.
For instance the above apparatuses may also include a syringe pump S connected via a respective line to one of the blood lines 6 and 7. In
The means for regulating have been described as one or more pumps (in particular of the peristaltic type); however it is not to be excluded that other flow regulating means such as valves or combinations of pumps and valves may be used.
In the present specification, dose refers to a flow rate or to a combination of flow rates.
For example, one of the following magnitudes may be used as dose:
In the course of the following description reference will be made to the above dose definitions which are relating to doses not normalized to patient body weight (BW) or patient surface area (PA). Of course the same principles and formulas below described could be normalized to body weight or patient surface area by dividing the dose value by either body weight BW or surface area PA.
Normalized Dose=Dose/BW
or
NDose=Dose/PA×1.73 (when normalised to a 1.73 m2 surface area patient)
Furthermore, the above defined doses could be corrected to take into account the predilution effect, when a fluid replacement line is present upstream the treatment unit, such as lines 15 and 22 in the enclosed drawings. Each of the above defined doses could be corrected multiplying the dose value times a dilution factor Fdilution:
Dosecorr_xxx=Fdilution×Dose_xxx (with xxx=eff, conv, dial, etc)
The dilution factor Fdilution may be defined according to one of the following:
Where Qpre is the total predilution infusion rate (where two infusion lines are present upstream the treatment unit, as lines 15 and 22, Qpre combines PBP infusion 15 and pre-replacement infusion 22)
QBLOOD: blood flow rate
QPLASMA: plasma flow rate
Qpw: plasma water flow rate
Hct: haematocrit
Fp: plasma water fraction, which is a function of total protein concentration (typical value Fp=0.95)
In practice, the effluent dose corrected for the predilution effect would be: Dosecorr_eff=Fdilution×Dose_eff.
The control unit 10 is connected to the various sensors, to the means for regulating the flow rate through the various lines (in the above examples this means comprises the pumps active on the lines and the switch valves) and to the user interface. The control unit 10 may comprise a digital processor (CPU) and necessary memory (or memories) such as memory 10a, an analogical type circuit, or a combination thereof. In the course of the present description it is indicated that the control unit is “configured” or “programmed” to execute certain steps: this may be achieved in practice by any means which allow configuring or programming the control unit. For instance, in case of a control unit comprising one or more CPUs, a program may be stored in an appropriate memory containing instructions which, when executed by the control unit, cause the control unit to execute the steps herein described. Alternatively, if the control unit is of an analogical type, then the circuitry of the control unit may be designed to include circuitry configured in use to execute the steps herein disclosed.
In the example of
The memory 10a associated with or connected to the control unit 10 stores a plurality of mathematical relations correlating the fluid flow rates Qrep1, Qrep2 and Qdial. The mathematical relations stored in said memory may be the following:
The control unit 10 allows the user, e.g. through user interface 12, to select e.g. two of said relations (step 201 in
Qrep1+Qrep2+Qdial+Qpfr=Qeff (FBE)
In case a syringe pump (not shown in
Note that preset values for each one of said first, second and third ratios R1, R2, R3 may be pre-stored in the memory or that the control unit may allow entry by an operator of a set value for each one of said first, second and third ratios R1, R2, R3, e.g. via the user interface 12. In this last case, the control unit may be configured to:
In one alternative, the memory 10a of the apparatus of
For instance, optimization criteria stored in memory 10a may comprise a first optimization criterion imposing that an emptying time of at least one among the containers of fresh fluid 16, 20, 21, 26 and/or a filling time of the waste container is substantially same as, or multiple of, or proportional to the emptying time of one or more of the other containers of fresh fluid (See below section “synchronization of containers emptying or filling”). A second optimization criterion stored in the memory 10a may impose that fluid consumption through the fluid lines is minimized. A third optimization criterion stored in memory 10a may impose that a life time of filtration unit 2 is maximized. A fourth optimization criterion stored in the memory 10a may impose that urea clearance or dialysance of a given solute is maximized.
In practice, if optimization criteria are stored in memory 10a, the control unit 10 may be configured to allow the user to select (step 202), e.g. via the user interface 12, the criteria he wants to have satisfied and may be further configured to calculate the set values for Qrep1, Qrep2, Qdial, Qeff based on the selected optimization criteria and on the above mentioned fluid balance equation (FBE).
Alternatively, the control unit may be configured to allow the user to select one or more of said criteria, e.g. maximization of fluid consumption, and one of the mathematical relations (e.g. the value for ratio R1). Then the control unit would calculate the set values for Qrep1, Qrep2, Qdial, Qeff using said selected criterion and mathematical relation account being taken of above mentioned fluid balance equation (FBE).
If the memory 10a stores a plurality of mathematical relations and a plurality of optimization criteria, and if the user contemporaneously selects a number of optimization criteria together with a number of relations, then the control unit 10 may also be configured to determine if said selected criteria and said selected mathematical relations are compatible or conflicting (see conflict check step 205 in
In accordance with a variant, as already explained in the summary section the control unit may use the flow-rate setup procedure to initially calculate the flow rates set values through the various lines and during a first interval in the treatment control the means for regulating using said calculated set values. Then, after a certain time interval or upon detection of a user input, the control unit may recalculate the set values for the flow rates through the various lines exclusively based on one or more optimization criteria and, apply the newly calculated set values during a second time period subsequent to the first time period. For instance the flow-rate setup procedure may allow setting of the flow rates such that a certain delivered dose is attained. On the other hand, if at a certain point the user wants to privilege bag-emptying synchronization he may select to impose the first optimization criteria so that the control unit may recalculate the set values of the flow-rates allowing to synchronize as possible the emptying of the fluid bags.
In the example of
Note that in this case the memory 10a associated with or connected to the control unit 10 stores a plurality of mathematical relations correlating the fluid flow rates Qrep1, Qrep2, Qpbp and Qdial. The mathematical relations stored in said memory may be the following:
In the example of
In the example of
Again referring to the circuits of
In accordance with a first solution, see the flowchart of
Once the reference time Tr is calculated (step 303), the control unit is configured to determine the fluid flow rate in each one of the fresh fluid lines by dividing a weight Wi of the respective container by the value of reference time Tr (step 304). For the sake of simplicity, the description given above in connection with steps 303 and 304 was restricted to the simultaneous emptying of all the bags/containers being used (see also
To give more flexibility to the system, it is possible to attribute a weighting factor per pump/bag in such a manner that the emptying time of a given bag could be a multiple of the emptying time of one or more bags.
Tr=(ΣWi·ci)/Dose
Once the Qiset values are calculated, following one or the other of the above sequence of steps, they are stored in a memory (step 305) and then applied to control the pump speeds as described herein below in greater detail with reference to certain embodiments (step 307). In accordance with an optional aspect the control unit may issue a signal to the user interface 12 requesting a confirmation (306) from the user before actually applying the calculated values of Qiset to control the pumps.
In accordance with a third alternative solution, which is shown in the flowchart of
Qiset=(Wi/ci)/Tr, where Tr≤(ΣWi·ci)/Dose
On its turn, ci for each respective container may be calculated as a function of an intermediary factor bi obtained (see step 404) by dividing either the dose or the sum of said proposed values Qi of the flow rates by the respective proposed value Qi. In the example of
ci=Round [bi/min(bi . . . bn)], where “min(bi . . . be)” is a function selecting the minimum among the bi factors, and
“Round” is a function determining the natural number nearest to the result of quotient bi/min(bi . . . bn).
Once the Qiset values are calculated, they may be stored in a memory (step 406) and then applied to control the pump speeds as described herein below in greater detail with reference to certain embodiments (step 408). In accordance with an optional aspect the control unit may issue a signal to the user interface 12 requesting a confirmation (407) from the user before actually applying the calculated values of Qiset to control the pumps.
As a further variant applicable to the above described three alternative solutions, the calculation of the reference time Tr may be done as follows: the control unit may be configured to allow entry of the treatment time T, and calculate the reference time Tr either as the treatment time T or as a sub-multiple of the treatment time T. As disclosed hereinbefore once Tr has been calculated, each flow rate may be set as Qiset=Wi/Tr or as Qiset=Wi/(Tr·ci) where ci is an integer from e.g. 1 to 5. In another variant for the calculation of Tr, the control unit 10 may be configured to receive one set value set by an operator for one fluid flow rate through one of the lines present in the blood treatment apparatus. For instance, the operator may set the fluid flow rate Qrepi through the pre-dilution infusion fluid line 15, or the fluid flow rate Qrep2 through the post-infusion fluid line 25, or the fluid flow rate Qpbp through the pre-blood pump infusion fluid line 21, a fluid flow rate Qdial through the dialysis liquid fluid line 27. The setting may be done through the user interface or via any other input. Once the input of a flow rate to a certain fluid line is set, the control unit is configured to identify the container associated to the fluid line for which the fluid flow rate has been set and to detect the respective initial weight. Then, the control unit may calculate the reference time Tr dividing the initial weight Wi of the identified container by the set value of the fluid flow rate set by the operator. Once Tr has been calculated, each flow rate may be set as Wi/Tr or as Qiset=Wi/(Tr·ci) where ci is an integer from e.g. 1 to 5.
In accordance with a fourth alternative solution, the control unit may be configured to execute a synchronization algorithm able to combine the use of proposed values for the set flow rates (for instance initially set by the user or calculated using one or more of the mathematical relations, as above described) with at least a certain degree of synchronization in the emptying of the containers; in other words, a purpose of the algorithm is to minimize the number of user interventions while keeping the flow rates in the ‘neighborhood’ of some initial settings (which may be manual or computed settings). In practice this algorithm is designed to change according to a certain set percentage the initially set or calculated flow rates in order to reduce as possible the number of container/bag changes across a certain time period, e.g. 24 hours, without substantially changing the initially set or calculated flow rates.
The starting point of the algorithm (see
Also the blood flow rate setting for the blood pump may be entered or calculated by the control unit, see step 500.
At step 503, an allowed adjustment parameter ‘A’ is defined as maximum relative change allowed on bag/container change periods in order to optimize bag synchronization and reduce number of user interventions (step 503A). The algorithm also considers ‘ratios of interest’ R0k which are parameters defined in the algorithm as ratios between change periods (time between one container change and the next change of the same container) of pairs of containers (step 503B). Ratios of interest are defined for each pair of lines and respective containers. K is an integer which may vary from 1 to M, and M may be pre-stored in the control unit memory or the control unit may be configured to receive it from a user input. The algorithm takes into account that more interventions (container changes) are saved when identifying a ‘1 to 1’ container synchronization ratio between two lines (because in that case the containers of the two lines are changed at the same time), than when having a ‘1 to 4’ ratio.
Next table 1 provides the list of the optimum ratios of interest when considering all synchronization ratios up to ‘order 5’ in relation with a pair of containers indicated as bag1 and bag2. The first 8 R0k values are used in some examples reported at the end of the detailed description.
In the above table referring for instance to the third more interesting ratio (corresponding to k=3), it is possible to see that k=3 matches with Bag1-Bag2=1 to 3, meaning that Bag2 is changed 3 times while Bag1 is changed once. This corresponds to a change bag period of Bag1 which is 3.0 times longer than the change bag period for Bag2: thus, one user intervention out of 4 is saved compared to a situation where no synchronization at all would be present. Indeed, with k=3 there would be 2 single bag changes of Bag2+1 simultaneous bag changes of Bags 1 and 2 with a total of 3 interventions, whilst in case of no synchronization there would be 3 single bag changes of Bag2+1 single bag change of Bag2, meaning a total of 4 interventions. As K increases the degree of synchronization goes down and, consequently, the number of bag or container changes saved also goes down.
Referring now to the general case of a treatment apparatus with N lines leading to respective N bags or containers, the control unit may be configured to execute the following steps, after the value of A has been selected or predefined (at step 503, see
Step 504: calculate Ti container change period Ti=Vi/Qi and rank each circuit according to the calculated container change period, where i=1 to N (Ti increasing with i),
Step 505: compute all period ratios Rij=Ti/Tj, with i>j
Step 506: compare each period ratio Rij to the preset list of ratios of interest R0k, k=1 to M,
Step 507: compute the number of degrees of freedom NF; this number if given by the sum of the number of lines less the number of constraints (see further below),
Step 508: for each ratio Rij where a k value exists verify that (1−A)·R0k<Rij<(1+A)·R0k, compute the number of daily saved container changes,
Step 509: Select the NF ratios Rij providing the largest number of saved container changes; the selection of the ‘best’ Rij has to ensure the definition of NF independent relations between NF+1 variables (with the ‘NF+1’th relation: Qeff=ΣQiset),
Concerning the mentioned degrees of freedom NF (step 507 above), the following should be noted. In an apparatus having N lines (e.g. a number of infusion lines, a dialysate line, a line leading to a syringe and an effluent line), then the effluent line flow rate may verify condition Qeff=/Qiset; moreover the syringe line may have a fixed flow rate; the N−2 other lines are infusion or dialysate lines leading to respective containers having fixed volume. In the case where both effluent and syringe bag/container volumes are fixed, the associated bag change periods are also fixed and the N−2 bag change periods for the other lines remain to be defined. As these N−2 periods/flow rates are already linked by the relation Qeff=/Qiset, only NF=N−3 relations may be considered for defining all the flow rates. In the scenario where both effluent and syringe bag/container volumes are let free, then the number of degrees of freedom is NF=N−1, since effluent bag volume (Veff) and syringe volume (Vsyr) are two additional variables in the system.
In accordance with an aspect, the selection of the NF ratios Rij (step 509 above) providing for the highest number of saved bag changes considers also the ‘degrees of freedom’ issue. The selection of the ‘best’ Rij has to ensure the definition of NF independent relations between NF+1 variables (with the ‘NF+1’th relation being Qeff=/Qi).
Note that irrespective of which one of the above described sequences of steps is used for the determination of Qiset, once these set values Qiset have been calculated (e.g. using one or more mathematical relations and/or one or more optimization criteria), then the control unit 10 may be configured to display the calculated set values. As mentioned, the control unit may also be configured to ask, or wait, for a confirmation which may be entered by the user, e.g. through action onto the user interface 12. The control unit 10 is designed to control the means for regulating the flow rate based on the calculated set values either automatically (i.e. with no need of any action on the part of an operator), or after the appropriate confirmation is entered and a confirmation signal received at the control unit.
The control unit 10 may also be configured store, e.g. in the memory 10a connected to the same control unit, the maximum volume of fluid which may be contained in each container of fresh fluid. The control unit may also be configured to store in a memory connected to the same control unit the maximum volume of fluid which may be contained in said waste container. The volume each container may host may be detected by a sensor associated to each respective container and connected to the control unit, or may be entered by an operator for each respective container through a user interface connected to the control unit, or determined by the control unit associating an identification code (indicia such as a bar code, an RFID or other identification means may be associated to the container) on each respective container to a respective volume, or said volume may be pre-stored in said memory. By knowing the volume of fluid that may be hosted in each container, the control unit may be configured to generate an alarm signal and/or to stop the treatment when the minimum quantity of fluid in one fresh fluid container (i.e. in one among the infusion fluid containers 16, 23, 26 and the dialysis fluid container 20) is reached, corresponding to a “empty container” threshold. In this situation, the user knows that he is supposed to substitute all fresh fluid containers (if the user selected the simultaneous emptying criteria and the emptying is simultaneous on all bags/containers as shown in
In the embodiments of
In the above description the it has been indicated that the blood pump may be controlled by the control unit 10 using a set value of the blood flow rate QBLOOD entered by the user (step 200 in
In any case, the control unit 10 may control the blood pump using either the entered or the calculated set value for the blood flow QBLOOD.
It should be noted that the control unit may be designed to include some safety features: for instance the filtration fraction is an important factor to be considered. Since the flow rates may automatically be set by the control unit 10, it is may be convenient to ensure that all pumps infusing in post-dilution do not cause an excessive filtration fraction (e.g. post-dilution flow rate>20% of blood flow rate). In this respect the control unit 10 may be configured to check if the calculated set value for the fluid flow rate through the post-dilution infusion line is higher than a prefixed fraction of the blood flow rate and in the affirmative activate a correction procedure. The correction procedure may comprise issuing a warning to the user interface, or it may comprise issuing a command to stop the treatment, or it may comprise correcting the delivery of fluid through one or more of the other lines, or (in case for instance the blood treatment apparatus includes a switch on the post-dilution line) issuing a command to switch 100 and/or 101 to temporary connecting a post-dilution fluid line to the blood withdrawal line. For instance referring to
All containers of fresh fluid may comprise a fluid (e.g. a replacement solution) having a same composition. The fact that the flow rates are not set individually implies that if the same type of composition is used during the treatment for containers there is no unexpected outcome regarding the electrolytic balance and/or acid-base equilibrium of the patient.
It may be envisaged that a container of fresh fluid comprises a fluid having a composition different from that of the other containers of fresh fluid: for instance the fourth container may contain an anticoagulant, such as a citrate solution; in this case the control unit 10 is configured to calculate the set value of fluid flow rate through the pre-blood pump infusion line to be proportional to the set or calculated value of the blood pump flow rate for achieving an adequate anticoagulation level. The other pump flow rates are adjusted so as to become follow the relations selected or the optimization criteria selected: for instance, if the optimization criteria of synchronous emptying time has been selected, the lines leading to the remaining bags/containers may be controlled such as these other containers empty at the same time as the citrate bag/container. Alternatively, the control unit could use the citrate bag/container in a way that it is not synchronized with the emptying of the other fluid bags/containers and is thus managed separately (e.g. flow rate is proportional to blood flow rate). In a further alternative, fourth bag/container emptying is synchronized with the other bags/containers and the blood pump flow rate setting is adjusted so as to be proportional to the citrate pump flow rate. Of course one could also envisage that all infusion bags/containers used be citrate-containing bags/containers: in this case synchronization may be made with no problems.
Reference is made to an apparatus as shown in
It is assumed that the following prescription is entered by the user via user interface 12:
The following criteria are stored in memory 10a:
The operator selects:
The control unit 10 then computes the flow rates as follows:
In order to maximize filter life time, replacement is set in PRE-dilution, rather than POST-dilution.
Reference is made to an apparatus as shown in
Prescription:
The following criteria are stored in memory 10a:
The operator selects:
The control unit 10 then computes the flow rates as follows:
Qeff=Qdial+Qrep1+Qrep2+Qpfr to be minimized Eq. 1:
Dset-urea=QBLOOD/(QBLOOD+Qrep1)×Qeff=65×38=2470 ml/h Eq. 2:
Qrep2>200 ml/min Eq. 3:
R2>0.10 Eq. 4:
In order to meet the Urea dose target while minimizing fluid consumption (Qeff), it is necessary to maximize the ratio QBLOOD/(QBLOOD+Qrep1)
According to the set constraints, this requires to set Qrep1=0.10×QBLOOD=1320 ml/h (from eq.4).
Equation 2 allows to define Qeff=2470×(1+0.10/1)=2717 ml/h.
Qdial and Qrep2 have then to be defined from:
Qdial+Qrep2=2717−100−1320=1297 ml/h Eq.1bis:
Qrep2>200 ml/h Eq.3:
As no selected constraints allow fixing Qdial and Qrep2 values among the multiple solutions of equations 1bis and 3, the control unit may be configured to:
Referring to
Each pump flow rate is then calculated as:
Qrep1=5000/2.6=1923 ml/h
Qdial=4500/2.6=1730 ml/h
Qrep2=3500/2.6=1346 ml/h
The above flow rates are then set as set values, and the respective pumps 18, 21 and 27 controlled accordingly by the control unit 10, as shown in
Again referring to
Tr=(5000·c1+5000·c2+5000·c3)ml/3000 ml/h=4.17 h
where c1, c2 and c3 are weighing factors in this case respectively set equal to 1, 1 and 2.
Each pump flow rate is then calculated as:
Qrep1=5000/(4.17·c1)=1200 ml/h
Qdial=5000/(4.17·c2)=1200 ml/h
Qrep2=5000/(4.17·c3)=600 ml/h
The above flow rates are then imposed as set values and the respective pumps 18, 21 and 27 controlled accordingly by the control unit 10, as shown in
Referring to the circuit of
Q1=1900 ml/h−proposed flow rate for QDIAL through line 19
Q2=650 ml/h−proposed flow rate for QREP1 through line 15
Q3=450 ml/h−proposed flow rate for QREP2 through line 25
Each container 20, 16 and 26 is a 5 L bag, and the set dose is the sum of the above Qi values, namely 3000 ml/h.
In the case where no synchronization is implemented, then the situation would be as per
According to this example where the machine attempts to achieve a certain degree of synchronization without substantially changing the proposed flow rates, c1, c2 and c3 are calculated as follows:
First the control unit calculates intermediary parameters Bi using the formula:
bi=Dose/Q, (where is the flow rate of the ith pump)
The following results are obtained:
b1=3000/1900=1.58
b2=3000/650=4.62
b3=3000/450=6.67
The value of ci are obtained by normalizing the values of bi with respect to their minimum and rounding the result to the closest natural number, using the formula:
ci=Round(bi/min(b1 . . . bn))
With the following results:
c1=Round(1.58/1.58)=1
c2=Round(4.62/1.58)=3
c3=Round(6.67/1.58)=4
From c1, c2 and c3 the flow rate Qi of a given pump is calculated as follows:
Tr=(ΣWi/ci)/Dose
Qi=(Wi/ci)/Tr, where Wi is the initial weight of the Bag
Tr=(5000/1+5000/3+5000/4)/3000=2.6389 h
Q1set=(5000/1)/2.6389=1895 ml/h
Q2set=(5000/3)/2.6389=632 ml/h
Q3set=(5000/4)/2.6389=474 ml/h
As shown in
The following is a general example according to the fourth synchronization solution described above which follows the general flowchart of
QBLOOD and the proposed Qi values are set by the user or calculated by the control unit at step 500. At this step, the patient fluid removal rate QPFR is fixed or entered by the user at 100 ml/h. Then the dose value is set or calculated (step 501) and the volume of the of each bag detected or entered by the user (step 502).
The following parameters are selected or preprogrammed (step 503):
It is assumed that the apparatus comprises a circuit similar to that of
At step 504 the Ti values are calculated and ranked by the control unit.
Table 2 below recaps the initial flow rates Qi (2nd column), the bag volumes (3rd column), the change bag periods Ti (4th column) using the initial Qi values and the corresponding number of daily bag changes (5th column).
Table 3 below ranks the change bag periods Ti from the shortest to the longest.
At step 505, the Rij=Ti/Tj (i>j) are calculated by the control unit. Table 4 provides the computation of period ratios Rij=Ti/Tj (i>j)
Then at step 506, the control unit compares the Rij ratios to the ratios of interests R0k of table 1 creating the ratios Rij/R0k. Table 5 shows the ratios Rij/R0k; At step 508 the control unit table 5 also checks the ratios Rij/R0k which stay within the ‘A’ criterion, namely those which verify the condition:
(1−A)·R0k<Rij<(1+A)·R0k.
Note that table 5 also includes an identification of ratios which result within ‘A’ criterion (see cells with underlined values, namely those which verify the condition: (1−A)·R0k<Rij<(1+A)·R0k).
1.03
1.00
0.91
0.94
0.90
1.07
1.03
At step 507 (this step may be executed at any time before step 509 below described), the control unit computes the degrees of freedom NF. Table 6 indicates the number of degrees of freedom (NF).
Then the control unit provides a computation of the number of bag change saved for all Rij within the above criterion for the A parameter and identifies the most effective combinations complying also with the available NF=2 degrees of freedom.
Table 7 shows this computation of the number of bag change saved and identifies (see arrow) of the NF=2 most effective combinations.
Then the control unit calculates and optionally stores the flow rates
Table 8 provides a summary of selected Rij ratios and flow rate relations obtained using below Equations:
Flow rate relations derived from selected Rij and related R0k values:
Then follows the computation of flow rates using Rij ratios selected in table 8. The adjusted flow rates are recapped in Table 9 below which clarifies how with a relatively small adjustment to the initially proposed flow rates a certain degree of synchronization in the container emptying has been achieved thus saving significant time in container changes.
Reference is made to an apparatus as shown in
Prescription:
The following criteria are stored in memory 10a:
The operator selects:
The control unit 10 then computes the flow rates as follows:
Qeff=Qdial+Qrep1+Qrep2+Qpfr to be minimized Eq.1:
Dset-urea=QBLOOD/(QBLOOD+Qrep1)×Qeff=65×38=2470 ml/h Eq.2:
Qrep2>200 ml/min Eq.3:
R2>0.10 Eq.4:
In order to meet the Urea dose target while minimizing fluid consumption (Qeff), it is necessary to maximize the ratio QBLOOD/(QBLOOD+Qrep1)
According to the set constraints, this requires to set Qrep1=0.10×QBLOOD=1320 ml/h (from eq. 4).
Equation 2 allows to define Qeff=2470×(1+0.10/1)=2717 ml/h.
Qdial and Qrep2 have then to be defined from:
Qdial+Qrep2=2717−100−1320=1297 ml/h Eq.1bis:
Qrep2>200 ml/h Eq.3:
From the above first phase of computation, the following has been defined:
Qeff=2717 ml/h,
Qrep1=1320 ml/h,
In other words some flow rates are not completely defined. As above discussed in connection with the fourth solution of synchronization, a synchronization algorithm may be performed by the control unit from an arbitrary set of values; for example the above calculated flow rates where Qdial=550 ml/h (=>Qrep2=747 ml/h). The issue in this case is the choice of the ‘allowed adjustment’ parameter A, since a specific flow rate range is defined for Qdial [0;1297], allowing for a large range of bag change period. For this application case, the value of ‘A’ is selected at 0.3 (while 0.1 was used in example 6).
Qrep1, as well as Veff, are fixed; then number of degrees of freedom is NF=4−3=1 and consequently one single synchronization relation may be introduced. The initial input data to the synchronization algorithm are indicated in Table 10 while in Table 11 a ranking of change bag periods Ti is given.
Then the control unit computes period ratios Rij=Ti/Tj (i>j). Table 12 recaps the computed values for Rij=Ti/Tj.
Then the control unit compares the Rij ratios to the ratios of interests R0k of table 1 creating the ratios Rij/R0k and also checks the ratios Rij/R0k which stay within the ‘A’ criterion, namely those which verify the condition:
(1−A)·R0k<Rij<(1+A)·R0k. Below table 13 an identification of ratios which result within ‘A’ criterion (see cells with underlined values, namely those which verify the condition: (1−A)·R0k<Rij<(1+A)·R0k).
0.70
1.36
0.88
0.68
1.21
0.91
1.24
1.18
0.91
0.73
0.99
1.02
0.71
0.54
The number of degrees of freedom NF is then identified. Table 14 indicates the number of degrees of freedom (NF).
Then the control unit identifies the best relation with NF=1 and respecting the limitations on the A value as well as the fixed parameters. Tables 15 and 16 indicate that the ‘best’ relation to introduce is Qrep2=Qeff/3, allowing to save more than 4 user interventions a day (˜/17%). Note that relation 2/1 (Qrep1−Qeff) is discarded since both Qeff and Qrep1 are fixed.
Relation 4/2 (Qdial−Qrep1) leads to Qdial=Qpre which is not compatible with Qeff=ΣQi
The above selected Rij ratios and flow rate relations (table 16) are used by the control unit for computation of flow rates Qiset (in this case Q3 and Q1 respectively corresponding to Qrep2=391.3 ml/h and Qdial=905.7 ml/h) as per below table 17.
To secure the result, the algorithm might be repeated using a different set of initial flow rates; in this case it is verified that the same result is obtained with Qdial=100 ml/h (=>Qrep2=1197) as initial flow rate (same result except permutation of Qrep2 and Qdial values).
Note that in the above example, in the case adjustment of Qrep1 is allowed, then NF=2 and 6.5 additional user interventions may be saved by setting Qrep1=Qeff/2 (computation steps not reported).
One positive aspect of the present invention is a simplification in setting of treatment prescription.
Moreover, the setting is more intuitive for the medical personnel.
In accordance with certain aspects, frequency of bag/container changes is reduced, with a positive impact on the treatment since lesser interruptions help in providing more continuous and accurate treatment.
Here below the components and corresponding reference numerals used in the detailed description are listed.
| Number | Date | Country | Kind |
|---|---|---|---|
| 11007041 | Aug 2011 | EP | regional |
The present application is a continuation of U.S. application Ser. No. 14/342,025, filed on Jun. 3, 2014, which is a U.S. National Stage Application of International Application No. PCT/IB2012/001620, filed Aug. 23, 2012, which claims priority to European Patent Application No. 11007041.4, filed Aug. 30, 2011, the entire contents of each of which are incorporated herein by reference and relied upon.
| Number | Name | Date | Kind |
|---|---|---|---|
| 4731731 | Cochran | Mar 1988 | A |
| 5366630 | Chevallet | Nov 1994 | A |
| 5389078 | Zalesky et al. | Feb 1995 | A |
| 5567320 | Goux et al. | Oct 1996 | A |
| 6558343 | Neftel | May 2003 | B1 |
| 6730233 | Pedrazzi et al. | May 2004 | B2 |
| 6860866 | Graf et al. | Mar 2005 | B1 |
| 6939471 | Gross et al. | Sep 2005 | B2 |
| 7351218 | Bene | Apr 2008 | B2 |
| 7563240 | Gross et al. | Jul 2009 | B2 |
| 8216478 | Noack et al. | Jul 2012 | B2 |
| 8512271 | Moissl et al. | Aug 2013 | B2 |
| 8617393 | Remkes et al. | Dec 2013 | B2 |
| 8668825 | Pouchoulin et al. | Mar 2014 | B2 |
| 8900172 | Pohlmeier | Dec 2014 | B2 |
| 20020121471 | Pedrazzi et al. | Sep 2002 | A1 |
| 20040182787 | Chevallet | Sep 2004 | A1 |
| 20050070637 | Ferrarini et al. | Mar 2005 | A1 |
| 20060054215 | Remkes | Mar 2006 | A1 |
| 20060124548 | Soichirou | Jun 2006 | A1 |
| 20060157413 | Bene et al. | Jul 2006 | A1 |
| 20070062861 | Lannoy | Mar 2007 | A1 |
| 20070066928 | Lannoy | Mar 2007 | A1 |
| 20080149551 | Brugger | Jun 2008 | A1 |
| 20080154170 | Lannoy | Jun 2008 | A1 |
| 20090221948 | Szamosfalvi et al. | Sep 2009 | A1 |
| 20100168925 | Hilgers et al. | Jul 2010 | A1 |
| 20110017667 | Delmage | Jan 2011 | A1 |
| 20110037968 | Li | Feb 2011 | A1 |
| 20150034536 | Rada | Feb 2015 | A1 |
| Number | Date | Country |
|---|---|---|
| 3442744 | Jun 1986 | DE |
| 19928407 | Oct 2000 | DE |
| 10213179 | Aug 2003 | DE |
| 10218846 | Sep 2003 | DE |
| 10212247 | Dec 2003 | DE |
| 10302691 | Apr 2004 | DE |
| 60113624 | Jun 2006 | DE |
| 102006032926 | Jan 2008 | DE |
| 102006045437 | Apr 2008 | DE |
| 60315118 | Sep 2008 | DE |
| 102007052571 | May 2009 | DE |
| 0658352 | Jun 1995 | EP |
| 1348457 | Oct 2003 | EP |
| 1430920 | Jun 2004 | EP |
| 2163271 | Mar 2010 | EP |
| 2324871 | May 2011 | EP |
| 2433662 | Mar 2012 | EP |
| 9716220 | May 1997 | WO |
| 98023311 | Jun 1998 | WO |
| 98050091 | Nov 1998 | WO |
| 0176661 | Oct 2001 | WO |
| 0195956 | Dec 2001 | WO |
| 02062454 | Aug 2002 | WO |
| 03028860 | Apr 2003 | WO |
| 2005107833 | Nov 2005 | WO |
| 2006011009 | Feb 2006 | WO |
| 2007073739 | Jul 2007 | WO |
| 2007140993 | Dec 2007 | WO |
| 2008080055 | Jul 2008 | WO |
| 2008135193 | Nov 2008 | WO |
| 2009144522 | Dec 2009 | WO |
| 2009147478 | Dec 2009 | WO |
| 2010028860 | Mar 2010 | WO |
| 2010029401 | Mar 2010 | WO |
| 2010043593 | Apr 2010 | WO |
| Entry |
|---|
| PRISMA System—Operator's Manual For use with Software versions R03.10; GAMBRO DASCO S.p.A.; Catalog No. 6983811, Rev. A; P/N 9032167800, Rev. A (Sep. 2006)—276 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 20180318488 A1 | Nov 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14342025 | US | |
| Child | 16036423 | US |
