Patent Application
20230330315
The present invention relates to an apparatus for extracorporeal blood treatment and to a method for administering nutritional products in an apparatus for extracorporeal blood treatment.
Extracorporeal blood treatment involves removing blood from a patient, treating the blood externally to the patient, and returning the treated blood to the patient. Extracorporeal blood treatment is typically used to extract undesirable matter or molecules from the patient’s blood and add desirable matter or molecules to the blood. Extracorporeal blood treatment is used with patients unable to effectively remove matter from their blood, such as when a patient has suffered temporary or permanent kidney failure. These patients and other patients may undergo extracorporeal blood treatment to add or remove matter to their blood, to maintain an acid/base balance or to remove excess body fluids, or to perform extracorporeal gas exchange processes, for example.
In particular, the invention relates to chronic (long-term) hemodialysis (HD) therapy systems used to treat patients with chronic kidney failure. HD therapy is usually performed several times a week (e.g. 3 times a week) and each treatment has an average duration of some hours (e.g. 3.5 - 4.5 hours). During the therapy, the patient has two accesses (arterial/vein) where blood flows in/out from the body, wherein the average blood flow is usually between 250 and 400 ml/min.
The apparatuses for chronic (long-term) hemodialysis (HD) therapy comprise a device for online preparation of the dialysis liquid and/or replacement liquid. The device comprises one, two or more containers of concentrate located on respective injection lines which are predisposed to supply substances, such as electrolytes, buffer agents or others, towards a preparation line connected to a water source and located upstream a dialysis line. The concentrate containers may comprise concentrates in the liquid state or solid state, for example powder.
In patients receiving chronic hemodialysis, the National Kidney Foundation currently recommends a daily protein intake of 1.2 g/kg or more in patients undergoing hemodialysis. When malnutrition is present, a stepwise approach to treatment is used, beginning with dietary counseling and diet modifications, followed by oral nutritional supplements, and then by enteral nutrition supplements (usually consisting of a mixture of amino acids, glucose, and lipids) or parenteral nutritional supplements if needed.
In hemodialysis, it is known to administer IntraDialytic Parenteral Nutrition (IDPN) infusion e.g., through a venous access into the patient, typically, some minutes after dialysis has begun, and continued throughout the remainder of a dialysis session.
This is done by means of dedicated devices, such a bag, a dedicated line and a pump which are operated manually. This requires additional nurse workload.
In addition, the dialysis therapy parameters are corrected manually on the base of the operator experience, measurements or knowledge of the additional fluid/weight it is infused in this way. The manual correction of the dialysis therapy parameters does not allow to calculate in accurate manner the mass balance of the patient.
This is also a cumbersome and invasive solution and it is not usually well accepted by the patients/users.
An aim of the present invention is to provide for an apparatus for extracorporeal blood treatment that alleviates or minimizes or remedy the above-mentioned drawbacks.
It is an aim of the present description to provide an extracorporeal blood treatment apparatus and a method for administering nutritional products in an apparatus for extracorporeal blood treatment which are able to take into account the administered nutritional products to properly manage the mass balance of the patient during treatment.
It is an aim of the present invention to better control the administration of the nutritional products during therapy.
It is a further aim of the present description to control administration of the nutritional products through the same apparatus for extracorporeal blood treatment.
It is a further aim of the present description to reduce the workload of nurses.
It is a further aim of the present description to reduce complexity of devices dedicated to extracorporeal blood treatment with simultaneous administration of nutritional products.
It is a further aim to improve the comfort of patients undergoing treatment.
Document US5776345 is also known. This document discloses machine for acute treatment provided with a blood circuit to which a plurality of infusion lines may infuse fluids. A dialysis fluid container, a collection fluid container, a replacement fluid container and an anticoagulant container are connected to scales which weigh the contents. The replacement fluid adds material to the blood in order to adjust the pH of the blood, to add nutrients to the blood or to add fluid to the blood. Document US2012143116 discloses a renal failure therapy system including a blood pump, a dialysis fluid pump, a filtrate pump, one or more external infusion pumps, and a control unit configured to synchronize operation of the infusion pump to the blood pump and the filtrate pump. External pumps are fluidly connected to the blood return line. Each of the external pumps controllers pulls fluid from supplies which can include any suitable or desirable fluid, such as heparin, citrate, an electrolyte solution, an intravenous fluid, an antibiotic, a vasoactive drug, a total parenteral nutrition solution, an enteral nutrition solution fluid. The equation used to determine the calculated filtrate actual pump rate is based on filtrate pump rate=total input rate-total external output rate+prescribed net loss rate.
Document EP2644215 discloses an intensive care apparatus for extracorporeal treatment of blood with a filtration unit, a blood circuit, a pre and/or post-dilution fluid line connected to the blood circuit, and a dialysis circuit. Pumps act on the fluid lines for regulating the flow of fluid. A control unit is configured to periodically calculate a new value for the patient fluid removal rate to be imposed on an ultrafiltration actuator in order to keep a predefined patient fluid removal rate across a reference time interval irrespective of machine down times. The apparatus presents an infusion line connected with the blood withdrawal line upstream the blood pump and with an infusion fluid container, which contain a drug, or a regional anticoagulant, or a nutrients solution or other. This infusion line is referred to as pre-blood pump infusion line.
An apparatus according to one or more of the appended claims, taken singly or in any combination, attains at least one of the above-indicated aims.
An apparatus and a method according to aspects of the invention and capable of achieving one or more of the above objects are here below described.
In a 1st independent aspect there is provided an apparatus for extracorporeal blood treatment for chronic (long term) therapy, comprising:
In a 2nd independent aspect there is provided a method for administering nutritional products in an apparatus for extracorporeal blood treatment, wherein the method comprises:
In a further aspect according to the previous aspects, the at least one sensing element (36) is a weighing device, in particular a weight scale, configured to provide a weight of the at least one nutritional bag (33), in particular wherein the control unit (100) is configured to receive a weight signal from the weighing device and to determine the first parameter (W) based on the weight variation over time of the nutritional bag, the first parameter being optionally the actual flow rate in the nutritional line.
The desired net ultrafiltration rate (nUFRtarget) may be a constant value during blood treatment or may change over time during blood treatment according to a function nUFRtarget(t).
The sensing element is in particular a scale collecting the weight of the nutritional bag over time.
In another aspect according to any one of the previous aspects, the patient prescription includes at least one of:
Notably, since the treatment is a chronic treatment, one of the prescription target to achieve is the total patient weight loss (WLtarget) at the end of the treatment, namely at the end of the total treatment time (T). In order to set up the machine the operator input data sufficient to calculate determine or acquire such values. On one side, the usual prescription includes total patient weight loss (WLtarget) and total treatment time (T); this may be provided by the e.g., physician or included in the patient prescription card. However, as an alternative, the total treatment time (T) may be provided with the ultrafiltration rate (UFR). These two values allow to calculate the total patient weight loss (WLtarget). Indeed, the three values are linked by the following relation:
In other terms, availability of two out of three terms allows to determine the third one (e.g., UFR and WLtarget allow to determine total treatment time).
Whenever, a further infusion (nutrition infusion) is added and is not sensed with the sensor (31, 32) configured to provide the second signal related to an ultrafiltration rate (UFR), the net ultrafiltration rate has to be increased of a quantity identical to the nutrition infusion rate to achieve the total patient weight loss (WLtarget) at the end of the treatment. Therefore, to achieve the total patient weight loss (WLtarget), the prescription may include the desired net ultrafiltration rate (nUFRtarget) and either a nutritional flow rate or a nutritional total weight to be infused during the treatment. With these two values and either the total treatment time (T) or the total patient weight loss (WLtarget), again the apparatus may control the dialysis treatment reaching the desired and prescribed total weight loss in the desired and prescribed total treatment time.
In a 3rd aspect according to aspect 1 or 2, a feeding rate (Qnutr) of the nutritional solution is delivered through the nutritional line; optionally an infusion pump is coupled to the nutritional line to deliver the feeding rate (Qnutr) of the nutritional solution through the nutritional line.
The infusion pump is particularly a peristaltic pump.
In a 4th aspect according to any one of aspects 1 to 3, the control unit is connected to the infusion pump and is programmed for controlling the infusion pump and optionally for changing a feeding rate (Qnutr) of the nutritional solution.
In a 5th aspect according to any one of aspects 1 to 4, the nutritional solution is delivered by commanding the infusion pump coupled to the nutritional line.
In a 5th bis aspect according to any one of aspects 1 to 5, the extracorporeal blood treatment apparatus includes a main body, the infusion pump is attached to the main body, in particular is placed on a front panel of the main body.
In a 5th ter aspect according to any one of aspects 1 to 5 bis, the nutritional line comprises a pump segment, a feeding tube segment connected to an inlet of the pump segment, and a delivery tube segment connected to an outlet of the pump segment.
In particular, the pump segment having a passage section for the nutritional solution larger than a passage section of the delivery tube segment and/or than a passage section of the feeding tube segment. In more detail, the passage section of the delivery tube segment is equal to the passage section of the feeding tube segment. Optionally, the nutritional line is a disposable line.
In a 5th quarter aspect according to the previous aspect, the feeding tube segment and/or the delivery tube segment include/s a respective removable connector, in particular a Luer connector.
In more detail, the removable connector of the delivery tube segment being connectable to a corresponding counter connector on the blood return line, for example on a deareation chamber.
In a 5th quinquies aspect according to any one of the previous two aspects, the nutritional line further comprises at least one rigid portion comprising two pump connectors for receiving opposite ends of the pump segment, a delivery tube segment connector for receiving one end of the delivery tube segment and a feeding tube segment connector for receiving one end of the feeding tube segment.
In a 5th sexies aspect according to the previous aspect, the extracorporeal blood treatment apparatus includes a main body including a coupling device, the rigid body being configured to couple with the apparatus coupling device to position the nutritional line on the main body in specific arrangement with respect to the infusion pump, in particular the coupling device is placed on a front panel of the main body.
In a 6th aspect according to any one of aspects 3 or 4 or 5, the method comprises or the control unit is programmed for: commanding the infusion pump to feed the nutritional solution according to a feeding rate target (Qnutrtarget) during blood treatment; optionally the feeding rate target (Qnutrtarget) may be a constant value during blood treatment or may change over time during blood treatment according to a function (Qnutrtarget(t)).
In a 7th aspect according to any one of aspects 1 to 6, the first parameter (W) is the weight (W(t)) of the nutritional bag at an instant of time or an actual feeding rate in the nutritional line.
In a 7th bis aspect according to any one of aspects 1 to 7, the method comprises or the control unit is programmed for: controlling the infusion pump based on determining a feeding rate (Qnutr) based on the first parameter (W), comparing the feeding rate target (Qnutr target) during blood treatment and the feeding rate (Qnutr) and reducing a difference between the feeding rate target (Qnutrtarget) and the feeding rate (Qnutr).
In an 8th aspect according to any one of aspects 1 to 7, the second parameter (FR) is the ultrafiltration rate (UFR).
In a 9th aspect according to aspects 7 and 8, a net ultrafiltration rate (nUFR) is calculated by calculating a feeding rate (Qnutr) of the nutritional solution from the weight (W(t)) of the nutritional bag (33), in particular the weight variation over time, and by subtracting the feeding rate (Qnutr) from the ultrafiltration rate (UFR).
In a 9th bis aspect according to aspects 7 and 8, a net ultrafiltration rate (nUFR) is calculated by subtracting the feeding rate (Qnutr) from the ultrafiltration rate (UFR).
As above explained, usually in an apparatus for extracorporeal blood treatment for chronic therapy with the fresh dialysis fluid (for feeding the filtration unit and/or for infusion into the extracorporeal blood circuit) on-line prepared, the sensor (31, 32) for providing the second signal related to an ultrafiltration rate (UFR), allows the control unit to calculate the ultrafiltration rate (UFR). In chronic machine of the state of the art, all dialysis and replacement fluid flows are taken into account by the UFR since the sensor/s senses all fluids fed and removed from blood. In the current embodiments in accordance with the present aspects and claims, situation is different. Indeed, the sensor (31, 32) for providing the second signal related to an ultrafiltration rate (UFR) are not intended to and does not provide a second signal taking into account an infused nutritional solution amount.
In a 9th ter aspect according to any one of the previous aspects, the sensor (31, 32) for providing the second signal related to an ultrafiltration rate (UFR) takes into account a net amount/flow rate of the fresh dialysis fluid prepared by the preparation device (13), irrespective of the fresh dialysis fluid being fed to the filtration unit, removed from the filtration unit and infused into the blood circuit.
In a 9th quater aspect according to any one of the previous aspects, the sensor (31, 32) for providing the second signal related to an ultrafiltration rate (UFR) does not take into account amount/flow rate of the nutritional solution.
In a 9th quinquies aspect according to any one of the previous aspects, the sensor (31, 32) for providing the second signal related to an ultrafiltration rate (UFR) senses one or more of:
Therefore the sensor may work in any one of the HD, HF and HDF modes as above indicated.
In a 10th aspect according to any one of previous aspects 9, the method comprises or the control unit is programmed for: controlling the ultrafiltration device so that the net ultrafiltration rate (nUFR) matches the desired net ultrafiltration rate (nUFRtarget).
In a 11th aspect according to previous aspects 7 and 8, a patient weight loss (WL(t)) at an instant of time is calculated by integrating the ultrafiltration rate (UFR) at that instant of time and by subtracting the weight (W(t)) of the nutritional bag at that instant of time from the integrated ultrafiltration rate (UFR).
In a 12th aspect according to any one of the previous aspects, the method comprises or the control unit is programmed for:
controlling the ultrafiltration device so that the patient weight loss (WL) at the end of the blood treatment matches the total patient weight loss (WLtarget) to be achieved at the end of the blood treatment (programmed, wanted or expected).
In a 13th aspect according to any one of previous aspects 1 to 12, the method comprises or the control unit is programmed for:
In a 13th bis aspect according to any one of previous aspects, the method comprises or the control unit is programmed to receive, as prescription input, a total amount of the nutritional solution (Wnutrtarget) to be administered within the end of the total treatment time (T), to determine a nutritional feeding rate target (Qnutrtarget) to deliver the total amount of the nutritional solution (Wnutrtarget) at the latest at an end of the total treatment time (T) and to command the infusion pump to deliver the nutritional solution according to the nutritional feeding rate target (Qnutrtarget).
In a 14th aspect according to any one of aspects 1 to 13, the control unit is programmed for calculating and/or storing data related to the nutritional solution administered during the extracorporeal blood treatment.
In a 15th aspect according to previous aspect 14, said data related to the nutritional solution comprise at least one of: the weight of the at least one nutritional bag (W), a feeding rate (Qnutr) of the nutritional solution through the nutritional line, an amount of nutritional solution administered at an instant of time, a total amount of the nutritional solution to be administered, a composition of the nutritional solution.
In a 16th aspect according to any one of aspects 14 or 15, wherein the method comprises or the control unit is programmed for: displaying on a display screen the data related to the nutritional solution.
In a 17th aspect according to any one of aspects 1 to 16, the apparatus comprises a display screen connected to the control unit.
In an 18th aspect according to any one of aspects 1 to 17, at least one weighing device is a weight scale.
In a 19th aspect according to any one of aspects 1 to 18, the at least one nutritional bag is configured to be hanged on the at least one weighing device and/or the weighing device is configured to hang the nutritional bag.
In a 19th bis aspect according to any one of aspects 1 to 5, the extracorporeal blood treatment apparatus includes a main body, the at least one weighing device is attached to the main body, in particular is placed on lateral portion of the main body.
In a 20th aspect according to any one of aspects 1 to 19, collecting the weight comprises: measuring the weight at instants of time; optionally with an acquisition frequency between 0.01 Hertz and 100 Hertz.
In a 21st bis aspect according to any one of the previous aspects, the apparatus comprises an infusion line (11′) branching from the dialysis supply line (11) to infuse fresh dialysis fluid into the blood circuit, the sensor (31, 32) configured to provide a second signal related to an ultrafiltration rate (UFR) being operative at least upstream a branch of the infusion line (11′) to take into account for the fresh dialysis fluid fed either or both to the filtration unit (2) through the dialysis supply line (11) or/and the blood circuit through the infusion line (11′).
In a 21st bis aspect according to the previous aspect, the infusion line (11′) is a branch infusion line receiving fresh dialysis fluid prepared by the preparation device (13).
In a 21st aspect according to any one of aspects 1 to 20, the at least one sensor comprises at least one flowmeter placed on at least one of the dialysis supply line and the dialysis effluent line; wherein the second signal is a signal from said at least one flowmeter.
In a 21st bis aspect according to any one of aspects 1 to 21, the at least one sensor comprises at least one differential flowmeter placed on the dialysis supply line and the dialysis effluent line to sense a differential flow between the dialysis supply line and the dialysis effluent line; wherein the second parameter is a signal from said at least one differential flowmeter.
In a 21st ter aspect according to any one of the previous aspects, the apparatus comprises an infusion line (11′) branching from the dialysis supply line (11) to infuse fresh dialysis fluid into the blood circuit, the differential flowmeter configured to provide a second signal related to an ultrafiltration rate (UFR) being operative at least upstream a branch of the infusion line (11′) to take into account for the fresh dialysis fluid fed either or both to the filtration unit (2) through the dialysis supply line (11) or/and the blood circuit through the infusion line (11′).
In a 21st quater aspect according to any one of aspects 1 to 21, the at least one sensor comprises a flowmeter placed on the dialysis supply line and another flowmeter placed on the dialysis effluent line, in particular the control unit is configured to receive the signals from the two flowmeters to determine a differential flow between dialysis fluid supplied to the supply line and removed with the dialysis effluent line.
In a 21st quinques aspect according to any one of the previous aspects, the apparatus comprises an infusion line (11′) branching from the dialysis supply line (11) to infuse fresh dialysis fluid into the blood circuit, the flowmeter on the dialysis supply line being operative at least upstream a branch of the infusion line (11′) to take into account for the fresh dialysis fluid fed either or both to the filtration unit (2) through the dialysis supply line (11) or/and the blood circuit through the infusion line (11′).
In a 22nd aspect according to any one of aspects 1 to 20, the apparatus for extracorporeal blood treatment further comprises:
In a 23rd aspect according to any one of aspects 1 to 22, the ultrafiltration device comprises at least one dialysis pump coupled to the dialysis supply line and/or to the dialysis effluent line; optionally the at least one dialysis pump comprises a first dialysis pump coupled to the dialysis supply line and a second dialysis pump coupled to the dialysis effluent line.
In a 24th aspect according to previous aspect 23, the at least one dialysis pump is a volumetric pump.
In a 25th aspect according to previous aspect 24, the at least one dialysis pump is crossed by dialysis/effluent fluid.
In a 25th bis aspect according to any one of the previous aspects, a first balance chamber operates on the dialysis supply line and a second balance chamber operates on the dialysis effluent line.
In a 26th aspect according to any one of aspects 1 to 25, the infusion pump and/or the blood pump is/are peristaltic pumps.
In a 27th aspect according to previous aspect 26, the infusion pump and/or the blood pump is/are coupled to tube section/s of the respective nutritional line or blood circuit.
In a 28th aspect according to any one of aspects 1 to 27, the blood circuit and the filtration unit are disposable and are coupled in removable manner to a main body of the apparatus and to the blood pump.
In a 29th aspect according to any one of aspects 1 to 28, the nutritional line is disposable and is coupled in removable manner to a main body of the apparatus and to the infusion pump.
In a 30th aspect according to any one of aspects 1 to 29, the dialysis circuit is not-disposable; optionally the dialysis circuit is configured to be sterilized after each or a predetermined number of blood treatments.
In a 31st aspect according to any one of aspects 1 to 30, the apparatus comprises a main body; wherein the infusion pump and the blood pump are supported by the main body; optionally a rotor of the infusion pump and a rotor of the blood pump are placed on a face of the main body.
In a 32nd aspect according to previous aspect 31, a pump section of the blood circuit is coupled in removable manner to a rotor of the blood pump; a pump section of the nutritional line is coupled in removable manner to a rotor of the infusion pump.
In a 33rd aspect according to aspects 31 or 32, the dialysis circuit is integrated in the main body; optionally the dialysis circuit is mounted fixed on the main body; optionally said at least one dialysis pump is mounted on the main body.
In a 34th aspect according to any one of the previous aspects 31 to 33, the control unit is contained in or supported by the main body.
In a 34th bis aspect according to any one of the previous aspects, the apparatus comprises a main body; wherein the main body includes a water inlet for feeding purified water to the preparation line.
In a 35th aspect according to any one of the previous aspects 1 to 34, the apparatus comprises the nutritional solution contained in said at least one nutritional bag, wherein the nutritional solution is a parenteral nutritional solution
In a 36th aspect according to any one of the previous aspects 1 to 35, the nutritional solution comprises a mixture of protein, carbohydrate and fat; optionally of amino-acids, glucose or dextrose and lipids.
In a 37th aspect according to the previous aspect 36, the nutritional solution consists of a solution of amino-acids at a concentration of 10% - 20%, a solution of glucose or dextrose at a concentration of 40% - 70%, a solution of lipids at a concentration of 15% - 30%.
In a 38th aspect according to any one of the previous aspects 1 to 37, a feeding rate (Qnutr) of the nutritional solution during blood treatment is between 50 ml/h and 500 ml/h, optionally between 100 ml/h and 200 ml/h, optionally of 150 ml/h.
In a 39th aspect according to previous aspects to any one of the previous aspects 1 to 38, a total amount of the nutritional solution administered at the end of the blood treatment is between 100 ml and 1000 ml, optionally between 300 ml and 500 ml.
In a 40th aspect according to any one of the previous aspects 1 to 39, the nutritional solution provides 150 - 200 kcal/h.
In a 41st aspect according to any one of the previous aspects 1 to 40, a plurality of nutritional bags are provided, each nutritional bag containing a component of the nutritional solution; optionally a first bag contains a solution of amino-acids, a second bag contains a solution of glucose or dextrose, a third bag contains a solution of lipids.
In a 42nd aspect according to the previous aspect 41, the plurality of nutritional bags are all connected to a common nutritional line or to the blood return line or directly to the patient vascular system.
In a 42nd aspect according to any one of the previous aspects 1 to 41, a total treatment time of the extracorporeal blood treatment is between 0.5 to 10 hours, optionally between 3 hours and 5 hours.
In a 43rd aspect according to any one of the previous aspects 1 to 42, the preparation device comprises a preparation line and at least one container, optionally a plurality of containers, of concentrate/s; wherein the container/s is/are located on respective injection line/s predisposed to supply substances to the preparation line; wherein the preparation line is connected to a liquid source, optionally a water source, optionally a reverse osmosis water plant.
In a 44th aspect according to the previous aspect 43, the regulating device comprises at least one injection pump placed on the injection line/s.
In a 45th aspect according to the previous aspects 43 or 44, the regulating device comprises at least one sensor placed on the injection line/s and/or on the preparation line.
In a 46th aspect according to the previous aspect 45, said at least one sensor is configured to detect a flow rate or a concentration or a conductivity of the substances and/or of the fresh dialysis fluid through the injection line/s and/or on the preparation line.
In a 47th aspect according to any one of the preceding aspects 1 to 46, at least one infusion line is connected to the blood circuit and to an infusion liquid source.
In a 48th aspect according to any one of the preceding aspect 47, the at least one infusion line is connected to the dialysis supply line and the infusion liquid is the fresh dialysis liquid.
In a 49th aspect according to any one of the preceding aspects 47 or 48, the at least one infusion line is connected to the blood return line.
Further characteristics of the present invention will better emerge from the detailed description that follows of some embodiments of the invention, illustrated by way of non-limiting examples in the accompanying figures.
The description will now follow, with reference to the appended Figures, provided by way of non-limiting example, in which:
An apparatus 1 for extracorporeal blood treatment for chronic (long term) therapy is represented in
A blood circuit is coupled to the primary chamber 3 of the filtration unit 2. The blood circuit comprises a blood withdrawal line 6 connected to an inlet 3a of the primary chamber 3, a blood return line 7 connected to an outlet 3b of the primary chamber 3. The withdrawal line 6 and blood return line 7 are configured for connection to a cardiovascular system of a patient “P”.
In use, the blood withdrawal line 6 and the blood return line 7 are connected to a needle or to a catheter or other access device which is then placed in fluid communication with the patient “P” vascular system, such that blood may be withdrawn through the blood withdrawal line 6, flown through the primary chamber 3 and then returned to the patient’s vascular system through the blood return line 7. An air separator, such as a deaeration chamber 8, may be present on the blood return line 7. Moreover, a monitor valve 9 may be present on the blood return line 7, downstream the deaeration chamber 8.
The blood flow through the blood circuit is controlled by a blood pump 10, for instance a peristaltic blood pump, acting either on the blood withdrawal line 6 or on the blood return line 7. The embodiment of
A dialysis circuit is connected to the secondary chamber 4 of the filtration unit 2 and comprises a dialysis supply line 11 connected to an inlet 4a of the secondary chamber 4 and a dialysis effluent line 12 connected to an outlet 4b of the secondary chamber 4 and to a drain, not shown.
The dialysis supply line 11 is connected to a preparation device 13 for preparing a fresh dialysis fluid. The preparation device 13 comprises a regulating device 14 for regulating the composition of the fresh dialysis fluid. The dialysis effluent line discharges a spent dialysis fluid into the drain.
In the example of
The regulating device 14 comprises injection pumps 22, 23, 24 placed on the injection lines 18, 19, 20 to move the fluid along the respective injection line 18, 19, 20 towards the preparation line 21 which collects the liquid, for example water, from a source 25. The preparation line 21 is located upstream the dialysis supply line 11 and has one end connected to the source 25, e.g. a deionized/purified water source or a reverse osmosis water plant, and an opposite end connected to the dialysis supply line 11. The source 25 may comprise the water source, as shown, or a source of ultra-pure liquid.
Concentration or conductivity sensors 26, 27, 28 are located on the preparation line 21 and are able to provide the control unit 100 with a signal related to conductivity or concentration of a predetermined substance (for example sodium) of the fluid crossing the preparation line 21 such that the control unit 100 is able to control the injection pumps 22, 23, 24 in order to regulate the conductivity Cd or concentration, for example of sodium [Na], of the liquid crossing the dialysis supply line 11. A fluid check organ 29 may be used to selectively enable or inhibit a passage of fluid across the dialysis line 21 and into the filtration unit 2 in case the liquid does not meet the required parameters.
An infusion line 11′ departs from the dialysis supply line 11 and is connected to the blood return line 7 to infuse part of the fresh dialysis fluid into the blood circuit.
An auxiliary infusion pump 45 may be coupled to the infusion line 11′ to deliver said part of the fresh dialysis fluid into the blood circuit.
Of course the infusion line 11′ may alternatively or in addition being connected to the blood withdrawal line 6 (in particular downstream the blood pump 10) for pre-infusing a substitution fluid.
An ultrafiltration device is configured to achieve a fluid removal from the patient through the semi-permeable membrane 5 of the filtration unit 2. The ultrafiltration device comprises a dialysis pump 30 located on the dialysis effluent line 12. In a variant embodiment, a first dialysis pump is coupled to the dialysis supply line 11 and a second dialysis pump coupled to the dialysis effluent line 12. A first flow-meter 31 is active on the dialysis supply line 11 and is placed between the fluid check organ 29 and the inlet 4a of the secondary chamber 4. A second flow-meter 32 is active on the dialysis effluent line 12 and is placed between the outlet 4a of the secondary chamber 4 and the dialysis pump 30.
The infusion line 11′ is connected to the dialysis supply line 11 between the first flow-meter 31 and the inlet 4a of the secondary chamber 4. The first flow-meter 31 and the second flow-meter 32 are connected to the control unit 100 and are configured to determine an ultrafiltration rate UFR.
The ultrafiltration rate UFR is a difference between the spent dialysis fluid exiting the outlet 4b of the secondary chamber 4 and the prepared fresh dialysis fluid routed to the inlet 4a of the secondary chamber 4 and infused into the blood circuit through the infusion line 11′ (
As shown in
The first flow-meter 31 and the second flow-meter 32 provide the control unit 100 with an instant value of the respective flows and thus enable the control unit 100 to calculate an instant ultrafiltration rate UFR. Alternatively, a differential sensor may be provided, active on the dialysis supply line 11 and on the dialysis effluent line 12 and therefore able directly to provide a signal relating to the ultrafiltration rate UFR. Instead of flowmeters, balance chambers may operatively be coupled to the dialysis circuit is provided. The balance chambers principle operates so that the amount of fluid entering into the first chamber on the dialysis supply line 11 is equal to the amount of fluid exiting from the dialysis effluent line 12. To achieve the ultrafiltration, an ultrafiltration line (not represented) is added to the effluent line upstream the balancing chamber. An ultrafiltration pump removes the desired amount of ultrafiltered liquid before that the spent dialysis liquid reaches the second balance chamber thereby achieving an ultrafiltered volume. In this alternative embodiment, the second parameter is related to the amount of liquid volume that is removed through the ultrafiltration line and in particular is the ultrafiltration rate through the ultrafiltration line. Of course absolute volume variation through ultrafiltration line may be measured too.
The apparatus 1 further comprises one nutritional bag 33 containing a nutritional solution and a nutritional line 34 having a first end in fluid communication with the nutritional bag 33 and a second end connected to the blood return line 7 for infusing the nutritional solution into the patient vascular system through said blood return line 7. In an alternative embodiment, the nutritional solution may be infused directly into the patient vascular system. An infusion pump 35 is coupled to the nutritional line 34 to deliver the nutritional solution through the nutritional line 34. A sensing element in the form of a weighing device 36 is configured to weigh the nutritional bag 33 while the nutritional solution is infused and to provide a first signal allowing calculation of a first parameter W related to a weight of the nutritional bag 33 and, therefore, to the weight or volume of nutritional solution contained in the nutritional bag 33. In general, the weighing device 36 provides the time variation of the bag weight which is directly linked to the actual flow rate of the nutritional solution through the nutritional line. Indeed, the control unit knows the nutritional line cross section and may therefore easily and very accurately calculate the actual flow rate of the nutritional solution through the nutritional line starting from measurements of weight/weight variation over time of the corresponding bag. Optionally the first parameter is the weight of the nutritional bag 33 measured over time. As an alternative, a flow meter on the nutritional line may be used as a sensing element.
Finally, though less precise, the pump speed may be used to determine flow rate through the nutritional line, the speed being monitored through a suitable sensor, such as a Hall sensor or a sensor sensitive to pump electric parameters such as resistance or power consumption.
As shown in
The control unit 100 is housed in the main body 37. The infusion pump 35 and the blood pump 10 are peristaltic pumps supported by the main body 37. Each peristaltic pump comprises an actuator or motor, not shown, connected to a rotor. The rotor of the infusion pump 35 and the rotor of the blood pump 10 are placed on a front face of the main body 37.
The blood circuit and the filtration unit 2 are disposable (i.e. they are disposed after each blood treatment) and are coupled in removable manner to the main body 37. The pump section of the withdrawal line 6 is coupled in removable manner to the rotor of the blood pump 10. The nutritional line 34 is disposable and is coupled in removable manner to the main body 37. A pump section of the nutritional line 34 is coupled in removable manner to the infusion pump 35.
The extracorporeal blood treatment apparatus main body 37 includes a coupling device; the rigid body 44 is configured to couple with the apparatus coupling device to position the nutritional line on the main body in specific arrangement with respect to the infusion pump so that the pump segment may be precisely received around the infusion pump rotor. In particular the coupling device is placed on the front panel of the main body 37.
The dialysis circuit is not-disposable and is configured to be sterilized after each blood treatment. Tubes, pumps, sensors of the dialysate circuit are not configured to be replaced after each treatment but only for maintenance purposes or in case of faults. Therefore, the dialysis circuit is integrated in the main body 36 and mounted fixed in or on the main body 37. The dialysis pump 30 is a volumetric pump crossed by the effluent fluid and is mounted in the main body 37.
The control unit 100 is contained in or supported by the main body 37. The control unit 100 is connected to the blood pump 10, the weighing device 36, the infusion pump 35, the injection pumps 22, 23, 24 of the regulating device 14, the concentration or conductivity sensors 26, 27, 28, the first flow-meter 31, the second flow-meter 32, the fluid check organ 29 and to the dialysis pump 30 of the ultrafiltration device. The control unit 100 controls the weighing device to measure the weight at instants of time, e.g. with an acquisition frequency 1 Hertz. The control unit 100 is also connected to a display screen 38 (
The control unit 100 may comprise a digital processor (CPU) with memory (or memories), an analogical type circuit, or a combination of one or more digital processing units with one or more analogical processing circuits. In the present description and in the claims it is indicated that the control unit 100 is “configured” or “programmed” to execute steps: this may be achieved in practice by any means which allow configuring or programming the control unit 100. For instance, in case of a control unit 100 comprising one or more CPUs, one or more programs are stored in an appropriate memory: the program or programs containing instructions which, when executed by the control unit 100, cause the control unit 100 to execute the steps described and/or claimed in connection with the control unit 100. Alternatively, if the control unit 100 is of an analogical type, then the circuitry of the control unit 100 is designed to include circuitry configured, in use, to process electric signals such as to execute the control unit 100 steps herein disclosed.
The control unit 100 is configured to or programmed for receiving signals from the sensors and from other inputs and for commanding pumps and valves according to said signals, in order to perform the blood treatment and to administer nutritional products to the patient during blood treatment. The control unit 100 is also configured to or programmed for displaying data on the display screen 38.
The nutritional solution contained in the nutritional bag 33 comprises a mixture of amino-acids, glucose or dextrose and lipids. For instance, the solution consists of 300 ml of amino-acids at a concentration of 15%, 150 ml of dextrose at a concentration of 50% and 150 ml of lipids at a concentration of 20%. The amount of nutritional solution contained in the nutritional bag 33 may be the total amount administered to the patient at the end of the blood treatment and may correspond to 800 kcal per treatment or 200 kcal/h.
In an alternative embodiment, shown in
According also to the method of the invention, the control unit 100 is programmed for receiving a patient prescription for the blood treatment, i.e. target values for the blood treatment and target values for the administration of the nutritional products to the patient. These target values may be entered manually, e.g. through the display touch screen 38 or a keyboard placed on the main body 37 of the apparatus 1. The prescription may alternatively be read from a patient card or from another kind of storage media device or received by the machine by means of a data transmission channel (wired or wireless).
The control unit 100 is programmed for receiving:
The control unit 100 is programmed for calculating:
The control unit 100 is programmed for controlling:
In particular, the control unit 100 is programmed for controlling the ultrafiltration device (dialysis pump 30) such that the flow rate of the spent dialysis fluid Qeff is equal to Qefftarget wherein
According to other embodiments, the target value entered directly into the control unit 100 may be, instead of the target weight loss rate WLRtarget, the desired net ultrafiltration rate nUFRtarget (corresponding to the target weight loss rate WLRtarget).
According to other embodiments, instead of the desired nutritional feeding rate target Qnutrtarget, the control unit 100 is programmed for receiving as input a total amount of the nutritional solution Wnutr target administered to the patient P at the end of the treatment time T. The control unit 100 is programmed for calculating the desired nutritional feeding rate target Qnutrtarget as Wnutrtarget/T or to calculate a desired nutritional feeding rate target Qnutrtarget(t) which changes over time during treatment and such that the integration of Qnutrtarget(t) over time T is equal to Wnutrtarget.
According to other embodiments, the control unit is programmed for integrating the ultrafiltration flow rate UFR (second parameter) received from the first flow-meter 31 and the second flow-meter 32, and by subtracting the weight W(t) of the nutritional bag (first parameter) from the integrated ultrafiltration rate UFR to calculate the patient weight loss (WL(t)) at time t. Then to compare the calculated patient weight loss (WL(t)) at time t with the target total weight loss at the end of the blood treatment WLtarget and to stop the treatment when the patient weight loss is equal to WLtarget.
According to some embodiments, the nutritional feeding rate Qnutr, the ultrafiltration flow rate UFR(t), the net ultrafiltration rate nUFR(t) and other related values are constant over time during blood treatment.
According to some embodiments, the feeding rate Qnutr of the nutritional solution, the ultrafiltration flow rate UFR(t), the net ultrafiltration rate nUFR(t) and other related values may be controlled to change over time during blood treatment. For instance, the net ultrafiltration rate nUFR(t) (or the weight loss rate WLR) may be greater at the start of the blood treatment, when the patient P may release more of liquid, than at the end. For instance, the nutritional feeding rate target Qnutr may be greater at the end of the blood treatment, where it is more likely that the nutritional solution is not eliminated through the blood treatment, than at the start.
The control unit 100 may be programmed for changing the feeding rate Qnutr of the nutritional solution by controlling the infusion pump 35 and/or for changing the ultrafiltration flow rate UFR(t) by controlling the dialysis pump 30.
The control unit 100 may also be programmed for storing data related to the nutritional solution administered during the extracorporeal blood treatment and to display on the display screen said data together with other values related to the blood treatment. For instance, said data may comprise at least one of: the weight of the at least one nutritional bag, a feeding rate Qnutr, an amount of nutritional solution administered at an instant of time, the total amount of the nutritional solution to be administered, a composition of the nutritional solution.
While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20168991.6 | Apr 2020 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/059331 | 4/9/2021 | WO |
