The present invention relates to an apparatus for the extracorporeal treatment of blood by veno-venous access.
More precisely, the invention relates to extracorporeal treatments which involve the removal of CO2 and, at the same time, a hemofiltration treatment or a “dialysis for acute” treatment.
The aforementioned treatments, like any extracorporeal treatment, necessarily require access to the patient through a vein of appropriate size such as, for example, the Femoral vein, the Jugular vein, the Carotid vein or others at the discretion of the physician.
For a generic treatment of CO2 removal, blood is drawn from the vein by means of a catheter, often two-way. The blood is pumped by a pump into tubes that lead it to a medical device, called oxygenator, which provides the gaseous exchange by extracting the CO2 and by administering O2 by partial pressure difference through a gas-permeable membrane. After passing through the oxygenator the blood is returned to the patient, often through the same (two-way) catheter from which it was taken.
The circuit, i.e. the set consisting of catheter, tubes, active components (such as the oxygenator or hemofilters) is complemented by accessories such as pressure sensors, air bubble sensors, blood leak sensors, drippers, debuggers, accesses for blood samples and for the administration of drugs, anticoagulants, etc., using components known to specialists in the field. Such known components will be omitted in the description of the present invention and in the drawings for greater clarity and brevity, but the same components are to be considered present where necessary. In other words, these components or devices are not described or represented in the drawings but it is obvious that these devices are present because they are necessary for the operation of the apparatus.
It is known that the efficiency of gaseous exchange is proportional to the surface of the gas-permeable membrane and to the flow of blood passing through it, generally expressed in ml/min (milliliters per minute). The higher the flow, the more effective the extraction of CO2.
It follows that, limited to the need to insert a catheter into the vein that is of the smallest size possible to obtain the desired effect, the goal of the aforementioned treatment, commonly called ECCO2R (Extra Corporeal CO2Remover), is to obtain the highest possible blood flow inside of the oxygenator.
In some devices, such as the one described in EP-1415673, the blood taken from the patient also passes through a component called “Hemofilter” which performs the functions of an artificial kidney.
Very often, in fact, simultaneously with the need to extract the excess of CO2 present in the blood, there is the need to perform on the patient also a “dialysis for acute” treatment commonly referred to as Hemofiltration, CVVH (Continuous Veno-Venous Hemofiltration) or CRRT (Continuous Renal Replacement Therapy).
The hemofilter usually consists of a set of capillary tubes of appropriate material (e.g. Polysulfone or other) in which blood flows.
These capillary tubes are porous with a well-defined pore size. Through the aforementioned porosity of the capillary fibers the plasmatic water passes through, which can in this way be removed together with the waste substances from the same or conveyed in it, such as Urea and others (dialysis); the plasma water can also be mixed with a special solution (replacement liquid) slid out of the capillary fibers to reintegrate some useful substances (electrolytes) that would otherwise be dispersed in the extracted waste liquid. Said substances, by diffusion and/or by convection, pass through the same porosity of the capillary fibers reaching the blood flow in transit.
Hemofiltration treatment requires a maximum blood flow of around 200-250 ml/min; some hemofilters, although able to withstand higher flows, are designed for these values. Significantly higher flow rates may result in abnormal imbalances in dialysis and fluid exchange rates and also hemolysis problems.
There are medical studies and publications that demonstrate how the combination of these two treatments (extracorporeal CO2 extraction and hemofiltration) provides a synergistic action to improve respiratory and renal failure, allowing the patient to increase the chances and speed of healing.
Some circuits place the oxygenator upstream of the hemofilter, others arrange it downstream. In any case, the flow of blood that passes through the two components is the same being the same arranged in series along the same blood line.
In the present description, specific reference will be made to the hemofilter as an active component acting in combination with the oxygenator in a veno-venous blood circuit.
In practice, the present invention is inserted in the specific technical field of the treatment of blood in which the blood is taken from a venous vessel of the patient, passes through an oxygenator and through a hemofilter, and is returned to the patient in a venous vessel. In other words, it is a veno-venous circuit in which only blood circulates.
Aim of the present invention is to optimize this dual extracorporeal treatment in a single blood treatment machine allowing, at the same blood flow rate withdrawn from (and subsequently returned) to the patient, to obtain a greater flow that passes through the oxygenator, contributing to the its better efficiency and duration, allowing to treat through the hemofilter a blood flow reduced and adequate to the specific hemofilter, generally designed to treat blood flows substantially lower than those suitable for the oxygenator.
It will therefore be possible to regulate the blood flow that will pass through the hemofilter to the values for which that particular hemofilter has been designed, including the significantly smaller pediatric hemofilters, and, at the same time, to send to the oxygenator a blood flow which is the sum of the flow coming from the patient and the flow passing through the hemofilter.
This particular characteristic is obtained with a circuit in a “ring” configuration where a main blood pump sucks the blood from the catheter inserted in a venous vessel of the patient and sends it to the oxygenator. A secondary blood pump (or other regulating means of the flow) draws a fraction of the main blood flow through a three-way connector disposed downstream of the oxygenator and, before it is returned to the patient, conveys it through the hemofilter.
The blood treated by the hemofilter and exiting the same is then conveyed, via another three-way connector, into the flow of blood that still has to transit into the oxygenator, upstream of it, and so on.
A “loop” is thus created, i.e. a secondary blood circulation ring independent of the main flow.
As an example, if the main blood pump sucks 500 ml/min from the patient's vessel and the secondary blood pump is set to a flow (optimal for a standard hemofilter) of 200 ml/min, after the three-way connector upwards disposed (also called first connector in the present description), in which the two flows add up, there will be 700 ml/min which will pass through the oxygenator, thus increasing its effectiveness thanks to this “virtual” flow increase.
In the circuits currently on the market, the flow of blood that passes through the oxygenator is equal to the flow of blood taken from the patient (in the above example of only 500 ml/min), while by using the present invention the flow is added to that passing through the hemofilter (therefore, 500+200, equal to 700 ml/min).
Subsequently, downstream of the oxygenator, the blood meets the downstream connector (also called second connector or second three-way connector in the present description), where a part of that flow (to be precise 200 ml/min referring to the previous example) is subtracted from the main flow and channeled into the “loop” to the hemofilter.
The remaining 500 ml/min will be returned to a patient venous vessel, purified by excess CO2 and dialysis waste.
As an alternative and/or in addition to the two above-mentioned blood pumps, blood flow regulators may be provided which are able to exert a similar action on the blood.
This circuit offers numerous advantages, among which the ones described below can be mentioned.
It allows, at the same flow rate taken by the patient to submit a greater flow to the oxygenator's action (with a consequent higher efficiency of CO2 extraction and lower risk of clots).
It allows, independently of the magnitude of the main blood flow, to accurately dose the blood flow to be passed through the hemofilter (without causing hemolytic damage and imbalance to the dialytic treatment).
It allows, in case of obstruction due to coagulation of the hemofilter (unfortunately frequent problem) to continue the treatment of CO2 extraction simply blocking the secondary blood pump, obviously giving up the dialysis treatment allowing to continue the more expensive ECCO2R treatment without damaging the relative equipment delegated to carry out this latter treatment.
If air bubbles are detected in the blood flow before returning to the patient, the bubbles can be automatically eliminated by stopping the main blood pump and circulating the blood with the bubbles through the hemofilter and the oxygenator where they will be eliminated. It allows, in case of temporary disconnection of the patient from the extracorporeal line (for example for the replacement of the catheter) to keep the blood circulating inside the oxygenator and the hemofilter thus avoiding the risk of clots, simply keeping the blood pump blocked main and running the secondary blood pump with recirculation function.
The ring conformation also avoids that the flow resistances of the two components are added together avoiding the frequent alarms of exceeding the pre-filter pressure which instead characterize the circuits which provide for the two components in cascade.
The objects and the advantages of the present invention will be more evident from the following description, which refers to the attached drawings which constitute an exemplary embodiment and in which:
With reference to the drawings of the attached figures, a blood treatment apparatus according to the present invention is of the type comprising a blood circuit (BC) defined by a main pump (2) and by one or more ducts through which the blood withdrawn from a patient passes to be treated at a given flow value (V1). The blood circuit is provided with an oxygenator device (4), which performs a treatment on the blood at a first flow value, and of a hemofilter (7), which performs a treatment on the blood at a second flow value, lower than the said first flow value.
The oxygenator (4) is arranged and acting on a first portion (21) of the blood circuit and the hemofilter (7) is arranged and acting on a second portion (22) of the blood circuit arranged in parallel with the first portion (21) so as to form a ring or “loop”.
The second portion (22) is connected to the first portion (21) downstream and upstream of the oxygenator (4), the blood entering the second device (7) being taken downstream of the oxygenator (4) and the blood in exit from the second device (7) being conveyed in the first portion (21) upstream of the oxygenator.
Flow regulation means (6; 60, 61), as described below, are provided for determining in the first portion (21) a flow (V3) of a value equal to the sum of the flow value (V2) of the second section (22) and the flow value (V1) of the blood taken from the patient and returned to the patient.
The blood circuit (BC) provided with the related devices (4) and (7) as well as the flow regulators (6, 60, 61) and the connecting pipes and connecting fittings, is entirely comprised by the apparatus object of the invention, schematically represented from a rectangle (M) in discontinuous line in the drawings. In practice, the apparatus in question is a single machine (M) with inside it oxygenator (4), hemofilter (7), pumps, ducts, etc.
According to the example of
The supplementary blood pump (6) can be placed upstream of the hemofilter (7).
Again with reference to the example of
The input branches (31, 32) of the first connector (3) are connected, respectively, one (31) to the circuit portion downstream of the main blood pump (2) and the other (32) to the downstream end or of exit of the second portion (22). The output branch (33) is connected to the portion of circuit (21) on which the oxygenator (4) is arranged.
The input branch (51) of the second connector (5) is connected to the portion of circuit (21) on which the oxygenator (4) is arranged. The output branches (52, 53) are connected, respectively, one (52) to the outlet of the treated blood (portion 24) directed towards the patient's venous vessel, the other (53) to the upstream end or withdrawal end of the second portion (22).
According to the example of
In this embodiment, the apparatus comprises a first three-way connector (3) arranged upstream of the main pump (2) and a second three-way connector (5) arranged downstream of said oxygenator (4). The inlet and outlet branches of the three-way connectors are marked with the same references as the connectors in the example shown in
The downstream end or output end of said second portion (22) is connected to the first connector (3), in particular to the input branch (32), the upstream end or withdrawal end of said second portion (22) being connected to the second connector (5), at the output branch (53).
In practice, the flow value (V2) in the second portion (22) is equal to said second flow value (i.e. the flow suitable for the correct functioning of the hemofilter), while the flow value (V3) in the first portion (21) is equal to the sum of the flow withdrawn (and returned) to the patient (also called first value V1) and of the flow (V2) circulating in the second portion (22).
According to the current practice and according to what is shown in the drawings of
By way of example and in a manner obtainable with the example previously described and illustrated in
Referring again to the illustrated examples, in particular in
The blood is pumped downstream into the extracorporeal circuit by the main blood pump (2) in a section of tube (23) which defines the initial portion of the blood circuit of the apparatus.
The main blood flow from the initial portion of pipe (23) reaches the three-way connector (3) which connects the same portion of pipe (23) with the outlet end of the portion of pipe (22) on which it is arranged and acting the hemofilter (7) and the said first portion (21) of the circuit.
In the section of circuit (21) the blood flow (V3) is equal to the sum of the main flow (V1) produced by the pump (2) and the one (V2) coming from the hemofilter (7) produced by the additional pump (6).
The flow (V3) of the tube (21), sum of the two flows (V1) and (V2), enters the oxygenator (4). Downstream, from the oxygenator (4) through the second part of the portion (21) it reaches the three-way connector (5). At the connector (5) the blood flow (V2) for the hemofilter (7) is subtracted by the secondary pump (6) from the flow (V3).
In the terminal portion of the circuit (24) the original main blood flow (V1) remains, which is returned to the patient through access (12).
In the example of
Again according to the example of
This solution, apart from the advantage of not requiring a second blood pump, requires a “flow meter/regulator” (61) along the line (22) to check the correct distribution of the flows.
In the example of
In the example of
In accordance with the present invention it is also possible to realize a process for the extracorporeal blood treatment which involves the passage of blood into a blood circuit defined by a main pump (2) and by one or more ducts through which the blood to be treated passes, the blood being withdrawn from a patient to a given flow value (V1); said circuit being provided with an oxygenating device (4), which performs a treatment on the blood at a first flow value, and of a hemofilter (7), which performs a treatment on the blood at a second flow value, lower than said first flow value.
Advantageously, the blood is passed through the oxygenator (4), which is arranged and acting on a first portion (21) of the blood circuit, and the hemofilter (7) which is arranged and acting on a second portion (22) of the blood circuit arranged in parallel with the first portion (21). The second portion (22) is connected to the first portion (21) downstream and upstream of the oxygenator (4), the blood entering the second device (7) being taken downstream of the oxygenator (4) and the blood in exit from the second device (7) being conveyed in the first portion (21) upstream of the oxygenator; there being provided means for regulating the flow (6; 60, 61) for determining in said first portion (21) a flow (V3) of a value equal to the sum of the flow value (V2) of the second portion (22) and of the value of the flow (V1) with which the blood is taken from the patient and returned to the same.
In other words, the process allows, at the same flow rate taken by the patient, to subject to the action of the oxygenator a greater flow (with consequent greater efficiency in extracting CO2). It also allows, independently of the magnitude of the main blood flow, to accurately dose the blood flow to pass through the hemofilter (without causing hemolytic damage and imbalance to the dialysis). It allows, in case of obstruction due to coagulation of the hemofilter, to continue the CO2 extraction treatment by simply blocking the secondary blood pump. If air bubbles are detected in the blood flow before returning to the patient, the bubbles can be automatically eliminated by stopping the main blood pump and circulating the blood with the bubbles through the hemofilter and the oxygenator where they will be eliminated. Another advantage of the process is that of allowing, in the case of temporary disconnection of the patient from the extracorporeal line (for example for the replacement of the catheter) to keep the blood circulating inside the oxygenator and of the hemofilter thus avoiding the risk of clots, simply keeping the main blood pump blocked and running the secondary blood pump with recirculation function.
In accordance with a further aspect of the process that can be implemented with the present invention, it is also possible to perform a treatment on the ultrafiltrate exiting the hemofilter (7). In practice, as previously described with reference to
The apparatus of the invention consists of a single machine (M) which allows the treatment of blood for the removal of CO2 with maximum flows which normally do not exceed 500 ml/min with regard to the first flow value (V1) and 250 ml/min for the second flow value (V2). The access is carried out by veno-venous way in correspondence with peripheral vessels (for example femoral vein, subclavian vein or jugular vein) and preferably with a double-lumen catheter smaller than 15 Fr, for example of 13 Fr. In practice, the connections indicated by (1) and (12) in the drawings are both supported by the double lumen catheter. Naturally, the invention is not limited to what has been described and illustrated, but it can be widely varied with regard to the arrangement and the nature of the components used according to the inventive teaching described above and claimed below.
Number | Date | Country | Kind |
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102017000038389 | Apr 2017 | IT | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IB2018/052431 | 4/7/2018 | WO | 00 |