FR2889451A1 - Human`s e.g. patient, extracorporeal fluid circulating device for realizing e.g. hemodialysis operation, has leads placed between ends of two tubes, and closing unit closing simultaneously additional tubes or two portions of former tubes - Google Patents

Abstract

The device has two tubes (3, 4) each having ends (31, 41) connected to one of two channels of a catheter and ends (30, 40) connected to one of two channels of a dialysis machine. Leads (32, 33, 42, 43) are placed between the ends of the tubes, where the leads (32, 42) are connected to the leads (33, 43) by additional tubes (6, 7). Closing unit closes simultaneously the tubes (6, 7) or two portions (34, 44) of the tubes (3, 4) each situated between the leads.

Description

2889451 1

  IMPROVEMENT TO TRAFFIC DEVICES

EXTRA-BODY HUMAN LIQUID

  The present invention relates to a human body extracorporeal circulation device, such as dialysis, in particular hemodialysis.

  To perform dialysis of a human being, it is known to temporarily or permanently implant a two-way catheter type probe in a large blood vessel, connect one end of a pipe to one of the channels, a end of a second pipe to the other of the two channels and connect each of the other ends of the two pipes respectively to the inlet and outlet of the dialyser machine. In the dialyser machine is implanted, inter alia, a pump that draws the non-dialyzed blood reaching the entrance of the machine and which pumps the dialyzed blood at the machine outlet for a return to the patient.

  It is not uncommon that, during the same dialysis, the non-dialyzed blood can no longer be sucked by the dialyser machine: in fact, by the configuration of the implanted catheter and the nature of the human tissues By creating the wall of the blood vessels, there may be a drop in flow, or even an absence of flow at the entrance of the catheter through which the non-dialyzed blood is aspirated. Faced with this problem, a natural solution that would come to the mind of a technician would be to reverse the direction of rotation of the pump, while leaving at the same time, the catheter planted in the individual to be dialysed, the pipes connected both the catheter and the dialyser machine. However, in practice, the nurse in charge of dialysis can not perform this operation. Another solution that one might think of is to stop the machine momentarily and then try to move the implanted and fixed catheter to the skin: this would be too dangerous and, in addition, because of the nature of human tissue, is not certain at all that the result would be achieved.

  In practice, the current solution that the nurse applies consists in stopping the machine momentarily and disconnecting each end of the pipe connected to the catheter, reversing the two connections of the pipes to the catheter and then restarting the machine. The disadvantages of this current solution, as applied, are numerous. The stopping time of the dialysis operation may be consequent and hence a risk of coagulation of the entire dialysis circuit. The nurse's supervision must be increased at this time. Finally the disconnection is delicate and dangerous: major risk of infection, risk of air embolism, risk of contamination of the nurse by the blood of the patient.

  The object of the present invention is to remedy these drawbacks and thus to propose a solution which avoids disconnecting any hose from the dialysis device, and more generally from any extracorporeal circulation of human fluid, during this operation and which is furthermore fast, simple, without risk of infection or others as succinctly listed above.

  To this end, the invention relates to a human body extracorporeal circulation device of the type comprising two pipes, each pipe comprising an end intended to be connected to one of the two channels of a catheter which is itself intended to be implanted in a blood vessel of an individual, and another end intended to be connected to one of the two channels of a dialyser machine itself for dialysing the non-dialyzed blood from the individual, characterized in that between its two ends, each of the two pipes comprises two branches, the branch of one of the two pipes upstream being connected to the branch of the other of the two pipes further downstream by means of a complementary pipe, while the device comprises means for closing simultaneously the two complementary pipes connecting the branches between them or the two portions of pipe each located between the two branches of a same e pipe, in order to reverse the pipe portion upstream 2889451 3 of the most upstream diversions borrowed by the non-dialyzed blood and dialyzed blood without disconnection of the one and the other of the pipes.

  By extracorporeal, it is of course understood in the context of the invention, which takes place outside the human body.

  The present invention also relates to the features which will emerge during the following description, which should be considered in isolation or in all their possible technical combinations.

  This description given by way of nonlimiting example, will better understand how the invention can be made, with reference to the accompanying drawings in which: Figure 1 is a schematic and schematic view of a complete dialysis apparatus according to the invention; state of the art using a dialysis device according to the state of the art; Figure 2 is a schematic and synoptic view of a complete dialysis apparatus according to the state of the art using a dialysis device according to the state of the art and showing the inverted pipe connection; Figure 3 is a perspective view of an embodiment of the dialysis device according to the invention; Figures 4a to 4c respectively show the different operating steps of the dialysis device according to Figure 3; Figures 5a and 5b are sectional views schematically showing a device according to a possible alternative embodiment.

  The apparatus as shown in FIG. 1 which is generally referred to (1) is a complete apparatus for performing a dialysis operation.

  This apparatus (1) comprises in a manner known per se a dialyser machine (2) which itself comprises a suction pump (20). To this machine (2) are connected one of the two ends (30, 40) of pipes (3, 4) with a cylindrical section and made of transparent plastic material in order to be able to visualize the blood flowing through. The other of the two ends (31, 41) of pipes (3, 4) is connected respectively to both of the two paths of a catheter (5) intended to be implanted in a blood vessel of a individual to dialyser.

  As it exists and is currently implanted, and for safety reasons, the suction direction of the suction pump (20) can not be changed when the dialysis operation has begun. Thus, the aspiration of the non-dialyzed blood from the individual to be dialysed is always carried out by the pump (20) from the suction inlet (ASP) of the machine and the backflow of the dialysed blood is always carried out since the exit of discharge (REF) following the arrow (F). The non-dialyzed blood is always sucked from for example one of the catheter pathways and is still discharged from the other pathway of the catheter.

  In certain dialysis operations, by the design of certain catheters, the nature of the human tissue constituting the blood vessel, and the nature of the blood to be dialysed, it may be that the non-dialyzed blood is no longer properly aspirated from the catheter. that is to say with a sufficient flow rate, see can no longer be sucked at all, and this regardless of the proper operation of the dialyser machine.

  To solve this problem, the nurse in charge of dialysis disconnects the end (31,41) of each tube (3,4) connected to the catheter (5) and then reverses the connection so that the end (31) of the pipe (3) initially connected to the catheter path is found connected to the other path and that (41) of the pipe (40) to the other path of the catheter (5). Thus, the blood drawn to the machine is drawn from the end (41) of the hose (4) contrary to the initial suction direction in which the blood was sucked from the end (31).

  This operation has significant disadvantages such as: sometimes significant loss of time may lead to coagulation of the entire dialysis circuit, potential risk that the ends of the disconnected pipes are in contact with infectious germs, potential risk that the Ambient air enters the catheter thus causing a gas embolism, potential risk of contamination of the nurse by the blood of the patient.

  The dialysis device according to the invention bearing the general reference (1 ') overcomes these disadvantages by avoiding any disconnection of pipes.

  Referring to Figure 3, the dialysis device (1 ') of the type comprising two pipes (3,4), each pipe (3,4) having an end (31,41) intended to be connected to one of the two channels a catheter (5) itself intended to be implanted in a blood vessel of an individual, and another end (30, 40) intended to be connected to one of the two channels of a dialyser machine (2) itself intended to dialyze the non-dialyzed blood from the individual.

  According to the invention, between its two ends (30 and 31, 40 and 41), each (3,4) of the two pipes comprises two branches (32 and 33, 42 and 43), the diversion of each of the two pipes most upstream (32,42) being connected to the branch of the other of the two most downstream pipes (43, 33) by means of a complementary pipe (6, 7). In addition, the device (1 ') comprises means (8) for closing simultaneously the two complementary pipes (6, 7) connecting the branches (32-43, 42-33) or the two pipe portions ( 34,44) each located between the two leads (32-33,42-43) of the same pipe (3,4), in order to invert the upstream pipe portion (35,45) of the most upstream (32,42) borrowed by the non-dialyzed blood (35 or 45) and by the dialyzed blood (45 or 35) without disconnection of one (3) and the other (4) of the tubes.

  According to a variant of the invention, the closure means (8, 80, 81) consist of at least one clamp (80, 81) intended, in the closed position, to simultaneously clamp the two complementary hoses (6 , 7) or simultaneously clamping from the outside the two portions (34,44) located each between the two leads (32-33,42-43) of the same pipe (3,4).

  According to another variant of the invention (FIG. 5a, FIG. 5b), the closure means (8, 80, 81) are constituted by four valves, two of which are each mounted in a portion of pipe (34, 44) situated between the two leads (32-33, 42-43) and the two others of which are each mounted in one of the two complementary pipes (6, 7), the simultaneous closure of the two valves each mounted in the pipe portion (34, 44) located between the two branches causing the simultaneous opening of the two other valves (Figure 5a) and vice versa (Figure 5b).

  According to this same variant, the opening and closing of the four valves is advantageously controlled by a single actuating means (9).

  According to this variant, the four valves are advantageously mounted on a single axis forming a plug whose rotation triggers the simultaneous opening of the two pipe portions (34,44) at the same angle θ and the simultaneous closure of the two complementary pipes (6, 7) at an angle of the same value O. In the variant shown in Figures 5a and 5b, the value of the angle 0 is of the order of 90.

  According to an advantageous characteristic and as illustrated, the complementary pipes (6, 7) as well as the pipe portions (34, 44) situated between the two branches (32-33, 42-43) are of the same diameter as that of the portions of the pipes situated downstream (36,46) and upstream (35,45) of the branches, the connection between respectively a downstream (36,46) or upstream (35,45) portion of a pipe (3, 4), the complementary pipe (6,7) and the pipe portion (34,44) located between two branches (32-33,42-43) being made by a connection (10) in Y or T, one branch of which (100) derivation form.

  Advantageously, all the pipes (3,4,6,7) and connection (10) are made of a transparent plastic material. According to the illustrated embodiment, the four connectors (10) are identical.

  According to the preferred and illustrated embodiment, the diameter of each branch (100, 101, 102) of the fitting (10) is greater than that of each pipe portion located furthest downstream (36, 46) and the most upstream (35, 45 ), that of each portion of pipe (34,44) located between two branches (32-33,42-43) and that of each complementary pipe (6,7) so that these portions (34,44) ) of complementary pipes and hoses (6,7) fit within the legs (100,101,102) of the T-piece or Y-piece (10). According to the preferred embodiment, the device comprises a closed housing (90) around the branches (32,33, 42,43) and in which are housed the portions of pipes (34,44) located between two branches (32-33,42-43) of the same pipe (3,4), the complementary pipes (6, 7) and the shut-off means (8).

  The operation of the device according to the invention which has just been described is broken down below: Prior to dialysis, the nurse in charge of the operation ensures that the complementary tubes (6, 7) or the portions (34,44) of 2889451 8 pipes (3,4) between two leads (32-33,42-43) of the same pipe (3,4) are closed by means of closing means provided for this purpose. As shown in the figure, the device (1 ') provides a clamp (80) whose branches simultaneously pinch the complementary pipes (6,7). It ensures, in a conventional manner, also the connection between each end (31, 41) of pipe (3.4) and one of the two paths of the catheter (5) and the other end (30.40 ) to the dialysis machine: the dialysis operation can then begin. Non-dialyzed blood is then sucked by the suction pump (20) and thus flows from the pathway through the pipe portion (35) furthest upstream of the pipe (3) and then through that (34) located between the two branches (32,33) and arrives at the dialyser (2) through the portion of the pipe (3) furthest downstream (36) and dialysed blood is discharged at the outlet of the dialyser (2) into the portion of the pipe (4) furthest downstream (46), passes through the portion (44) of pipe located between the two leads (42,43) and that (45) located upstream to the other catheter way (5).

  In the case where non-dialyzed blood can no longer be sucked by the suction pump (20) and therefore no longer flows through the hose (3), the nurse simultaneously pinches the outside of the portions ( 34, 44) of the two pipes (3, 4) situated between the two branches (32-33, 4243) by means of two clamps (80, 81) and comes to remove the clamp (80) simultaneously pinching the outside of the two complementary pipes (6,7).

  The portions of each pipe (3,4) the most upstream (35,45) by which the non-dialyzed and the dialyzed blood are respectively borrowed are then reversed: indeed, the non-dialyzed blood is then sucked from the catheter (5), by the suction pump (20) operating in the same direction of rotation, and flows through the pipe portion (45) of the pipe (4) and then through the complementary pipe (6) and finally by the portion of the pipe further downstream (36). The dialyzed blood is then discharged from the outlet (41) of the machine (2), flows through the portion of the pipe (4) furthest downstream (46), 2889451 9 passes through the complementary pipe (7) and finally by the portion of the pipe (3) the most upstream (35) to the other path of the catheter (5).

  The invention that has just been described is particularly simple to use and is also very simple to implement since it does not need sophisticated and / or expensive equipment. In addition, the total sterility of the dialysis device is ensured.

  Of course, it goes without saying that other embodiments may be provided without departing from the scope of the invention.

  Thus, for example, it can be provided any means for closing pipes that can be operated manually or by any automated mechanical means (possibly assisted hydraulically) such as for example that illustrated in Figures 5a and 5b which are schematic views similar to the Figures 4a and 4c, in which the identical elements bear the same references.

  In addition, although this does not appear in FIGS. 4a to 4c, the branches and complementary pipes are preferably made of transparent plastics material such as that used for the known embodiment of the pipes (3, 4) according to FIGS. 2.

  Finally, although the system has been described in connection with dialysis performed on a patient, it also applies to hemodialysis, plasmapheresis and more generally to any treatment requiring extracorporeal circulation via a double pathway catheter.

Claims (8)

  1-human body extracorporeal circulation device, (1 ') of the type comprising two pipes (3,4), each pipe (3,4) having an end (31,41) intended to be connected to one of the two pathways of a catheter (5) itself intended to be implanted in a blood vessel of an individual, and another end (30, 40) intended to be connected to one of the two channels of a dialyser machine itself. same intended for dialysing the non-dialyzed blood from the individual, characterized in that between its two ends (30 and 31, 40 and 41), each of the two pipes (3,4) comprises two leads (32 and 33, 42 and 43), the bypass of each of the two most upstream pipes (32,42) being connected to the bypass of the other of the two most downstream pipes (43,33) by means of a complementary pipe ( 6,7), while the device (1 ') comprises means (8,80,81) for closing simultaneously the two complementary pipes (6,7) connecting the by-passes s between them (32-43; 42-33) or the two pipe portions (34,44) each located between the two leads (32-33,42-43) of the same pipe (3,4), so to reverse the upstream pipe portion (35,45) of the most upstream shunts (32,42) taken by the non-dialyzed blood (35 or 45) and the dialyzed blood (45 or 35) without disconnecting the one and the other of the pipes (3,4).   2-Device according to claim 1, characterized in that the closure means (8,80,81) are constituted by at least one clamp (80,81) intended, in the closed position, to simultaneously pinch from the outside the two complementary pipes (6, 7) or simultaneously clamping from the outside the two portions (34, 44) each located between the two branches (32-33, 42-43) of the same pipe (3, 4).   3-Device according to claim 1, characterized in that the closure means (8,80,81) are constituted by four valves, two of which are each mounted in a pipe portion (34,44) located between the two 2889451 11 the two others are each mounted in one of the two complementary pipes (6, 7), the simultaneous closing of the two valves each mounted in the portion of pipe situated between the two branches causing the simultaneous opening of the two other valves and vice versa.   4-Device according to claim 3, characterized in that the opening and closing of the four valves is controlled by a single actuating means (9).   5-Device according to claim 4, characterized in that the four valves are mounted on a single axis forming a plug whose rotation triggers the simultaneous opening of the two pipe portions (34,44) at the same angle 0 and simultaneous closure two complementary pipes (6, 7) at an angle of the same value O.  6-Device according to any one of the preceding claims characterized in that the complementary pipes (6,7) and the pipe portions (34,44) located between the two branches are of the same diameter as the portions of the pipes located downstream (36,46) and upstream (35,45) of the branches (32-33,42-43), the connection between respectively a downstream (36,46) or upstream (35,45) portion of a pipe (3, 4), the complementary pipe (6, 7) and the portion of pipe located between two branches (32-33, 42-43) being made by a connection (10) made of Y or T, one branch ( 100) derivation form.   7-Device according to claim 6, characterized in that all the pipes and fitting are made of a transparent plastic material.   8-Device according to claim 6 or 7, characterized in that the four connections (10) are identical.   Device according to any one of claims 6 to 8, characterized in that the diameter of each branch of the connector is greater than that of each pipe portion located furthest downstream and upstream, to that of each portion of pipe located between two branches and to that of each complementary pipe so that these portions of complementary pipes and pipes fit into the branches of the tee or Y-joint. 10-Device according to the any one of the preceding claims, characterized in that it comprises a closed housing (90) around the leads (32,33,42,43) and in which are housed the portions of pipes (34,44) located between two leads d a same pipe (3, 4), the complementary pipes (6, 7) and the shut-off means (8).