Abstract:
The medical device for distributing fluid comprises: 
       a syringe ( 12 ) for distributing a contrast product;    an actuator ( 28 ) which is suitable for acting on the syringe in order to ensure that the contrast product flows at a pressure greater than 30 bar;    an outlet ( 14 ) for injecting the contrast product towards the body of a patient, which outlet is connected to the syringe ( 12 ); it further comprises:    an inflation outlet ( 16 ) for a balloon;    a distributor ( 32 ) which is connected at the outlet of the syringe ( 12 ) and which is suitable for selectively connecting the same syringe ( 12 ) to the injection outlet ( 14 ) or to the inflation outlet ( 16 ); and    means ( 20; 22 ) for controlling the distributor ( 32 ) between a first state which connects the syringe to the injection outlet ( 14 ) and a second state which connects the syringe ( 12 ) to the inflation outlet ( 16 ).

Description:
TECHNICAL FIELD  
       [0001]     The present invention relates to a medical device for distributing at least one fluid, of the type comprising: 
        a syringe for distributing a contrast product;     an actuator which is suitable for acting on the syringe in order to ensure that the contrast product flows at a pressure greater than 30 bar;     an outlet for injecting the contrast product towards the body of a patient, which outlet is connected to the syringe.        
 
       BACKGROUND TO THE INVENTION  
       [0005]     Currently, it is known to carry out surgical interventions on the blood circulation system of a human being by the endoluminal route.  
         [0006]     These methods of treatment and intervention require angiography and angioplasty procedures.  
         [0007]     In order to follow the different phases of intervention, it is known for the practitioner to view the treated regions on a medical observation device which displays the treated region on a screen.  
         [0008]     In order to allow the blood circulation system to be seen in a satisfactory manner, and in particular the region which is to be treated, it is necessary to inject, during some phases of the intervention and at specific locations, a contrast product which appears in an identifiable manner on the screen.  
         [0009]     To this end, the practitioner uses several types of device, depending on the type of operation which has to be carried out or in accordance with the phases of this operation.  
         [0010]     In order to inject large volumes of contrast product, in the order of 200 ml, this volume being injected rapidly via a catheter having a small cross-section, the practitioner uses a so-called “high-pressure” injector. An injector of this type is capable of causing the volume of the contrast product to circulate at high speed via the catheter, this high speed being achieved by a high pressure, in the order of. 1200 psi (85 bar), in the catheter.  
         [0011]     Furthermore, the practitioner is obliged to use a coronary arteriography set which allows smaller quantities of the contrast product to be injected manually by means of a syringe and measurements of artery or vein pressure to be taken. This set generally also allows a cleaning solution to be injected, such as a solution of sodium chloride.  
         [0012]     Finally, in order to dilate some arteries or veins whose cross-section can be obstructed by abnormal deposits, the practitioner is obliged to arrange an inflatable balloon in the artery or vein which is to be treated and to connect this balloon to an inflation device which allows the balloon to be pressurised and the artery or vein to be dilated. These inflation devices are suitable for injecting a contrast product at a high pressure, in the order of 30 bar, in order to allow the dilation of the balloon, whilst ensuring that the balloon can be viewed in a satisfactory manner on a screen.  
         [0013]     Each of these devices which allows the contrast product to be injected at different pressures is associated with follow-up devices which allow the injection pressure of the contrast product to be measured as well as the duration and number of these injections.  
         [0014]     It will be appreciated that the interventions which require angiography and angioplasty procedures use a number of medical devices, which complicates the task of the practitioner and makes these interventions costly to carry out.  
       SUMMARY OF THE INVENTION  
       [0015]     The object of the invention is to provide a medical device for distributing fluid, which device allows the task of the practitioner to be facilitated during these angiography and angioplasty procedures and which reduces the cost of these interventions.  
         [0016]     To this end, the subject-matter of the invention is a medical device of the above-mentioned type, characterised in that it further comprises: 
        an inflation outlet for a balloon;     a distributor which is connected at the outlet of the syringe and which is suitable for selectively connecting the same syringe to the injection outlet or to the inflation outlet; and     means for controlling the distributor between a first state which connects the syringe to the injection outlet and a second state which connects the syringe to the inflation outlet.        
 
         [0020]     According to specific embodiments, the device comprises one or more of the following features: 
        it comprises a storage reservoir for the contrast product, which reservoir is connected to the distributor and the distributor has a third state which connects the reservoir to the syringe;     it further comprises a storage reservoir for an auxiliary fluid and means for circulating the auxiliary fluid;     it comprises a switching valve which is interposed between the distributor and the injection outlet, which switching valve is connected to the means for circulating the auxiliary fluid, and the switching valve can be switched between a first state in which the means for circulating the auxiliary fluid are connected to the injection outlet and a second state in which the means for circulating the auxiliary fluid are connected to the distributor;     the switching valve comprises a moveable sliding valve which is held in a rest position, which defines the first state of the switching valve, under the action of a spring when there is no pressurised contrast product coming from the distributor, and the sliding valve is moveable, under the action of the pressurised contrast product coming from the distributor, towards a position of passage which defines the second state of the switching valve;     it comprises a pressure sensor which is connected to the injection outlet via the switching valve;     the pressure sensor is connected to the switching valve in such a manner that the pressure sensor is connected to the injection outlet when the switching valve is in the first state thereof;     it comprises a mixer which is interposed between the distributor and the inflation outlet and the mixer is further connected to the means for circulating the auxiliary fluid in order to ensure that the contrast product and the auxiliary fluid are mixed;     it comprises a selector which is connected at the outlet of the means for circulating the auxiliary fluid and at the inlet of the mixer and the switching valve, and the selector can be switched between a first state in which the means for circulating the auxiliary fluid are connected to the switching valve and a second state in which the means for circulating the auxiliary fluid are connected to the mixer; and     it comprises means for following up and adjusting the pressure of the contrast product at the syringe outlet.       
 
     
    
     BRIEF DESCRIPTION OF DRAWINGS  
       [0030]     The invention will be better understood from a reading of the following description, given purely by way of example and with reference to the drawings, in which.  
         [0031]      FIG. 1  is a schematic view of the medical device for distributing fluid according to the invention, illustrated in the rest position;  
         [0032]      FIG. 2  is an identical view to that of  FIG. 1 , the device being illustrated during an injection phase of the contrast product;  
         [0033]      FIG. 3  is an identical view to that of  FIG. 1 , the device being illustrated during an injection phase of a cleaning product;  
         [0034]      FIG. 4  is an identical view to that of  FIG. 1 , the device being illustrated during an inflation phase of a balloon; and  
         [0035]      FIG. 5  is an identical view to that of  FIG. 1 , the device being illustrated during a filling phase of the syringe. 
     
    
     DESCRIPTION OF PREFERRED EMBODIMENT  
       [0036]     The device  10  for distributing medical fluids illustrated in  FIG. 1  substantially comprises means  12  for pressurizing a contrast product and for distributing the product towards one or other of two separate outlets  14  and  16 .  
         [0037]     The injection outlet  14  is constituted by a connector which allows a distribution catheter for the contrast product to be connected at a specific point of the body. This catheter is advantageously equipped with a connector Y which allows a filamentary surgical tool to be introduced during angioplasty.  
         [0038]     The outlet  14  is more precisely capable of distributing the contrast product, or a rinsing solution, and of allowing the device to be connected to the body in order to carry out a measurement of internal pressure.  
         [0039]     The inflation outlet  16  of the balloon is constituted by a connector which allows a flexible connection tube to be connected to an inflatable angioplasty balloon.  
         [0040]     The outlet is suitable for allowing the distribution of pure contrast product or a mixture of contrast product and a neutral diluting solution, such as a solution of sodium chloride.  
         [0041]     The means for pressurising the contrast product  12  are connected to the outlets  14  and  16  by switching means  18  which will be described in detail below and which ensure a selective connection of one or other of the outlets to the means  12 .  
         [0042]     Furthermore, the device comprises an information processing unit  20  which allows the control of various elements which will be described below and the collection of information. This information processing unit  20  is connected to a remote control  22  and to a unit  24  for storing and presenting the information recorded.  
         [0043]     The means for pressurising the contrast product  12  comprise a syringe  12 A.  
         [0044]     The syringe  12 A is preferably disposable. It comprises, as known per se, a cylindrical body in which a moveable plunger is arranged. The syringe has a large capacity of between 100 and 500 ml.  
         [0045]     The syringe  12 A is received in a support (not shown) which allows the fluid and mechanical connection thereof to the other elements of the device.  
         [0046]     This support comprises in particular a pressure sensor  26  which allows the pressure of the contrast product to be determined at the outlet of the syringe. The sensor  26  is connected to the information processing unit  20 .  
         [0047]     The various sensors, such as the sensor  26 , are connected to the unit  20  via an information transmission bus  27 .  
         [0048]     In order to displace the plunger of the syringe  12 A, the device is equipped with an actuator  28  which is controlled by the information processing unit  20 . This actuator comprises a sensor  30  which allows the position of the syringe plunger to be determined and therefore the quantity of contrast product contained in the syringe at a given time. This sensor  30  is connected to the information processing unit  20 .  
         [0049]     The outlet of the syringe  12 A is connected to a first inlet of a distributor  32  having four paths and three states. A second inlet of the distributor  32  is connected to a reservoir  36  for the contrast product.  
         [0050]     The moveable part of the distributor  32  is connected mechanically to an actuator  34  which allows the distributor to be switched between these three positions. This actuator  34  is connected, for the control thereof, to the information unit  20 .  
         [0051]     A first outlet of the distributor  32  is connected to a first inlet of an adjustable mixer  38  which allows the contrast product to be distributed towards the inflation outlet  16 .  
         [0052]     A second outlet of the distributor  32  is connected to an inlet of a switching valve  40  which allows the distribution of contrast product towards the injection outlet  14 .  
         [0053]     The distributor  32  is suitable, in a first state, for ensuring that the outlet of the syringe  12 A is connected to the second distributor outlet which is connected to the switching valve  40 . The outlet of the reservoir  36  for contrast product and the first inlet of the mixer  38  are therefore isolated.  
         [0054]     In the second state thereof, the distributor  32  ensures that the outlet of the syringe  12 A is connected to the first inlet of the mixer  38 , the outlet of the reservoir  36  for contrast product and the inlet of the switching valve  40  being isolated.  
         [0055]     In the third state thereof, the distributor ensures that the reservoir  36  for contrast product is connected to the outlet of the syringe  12 A, the inlets of the mixer and the switching valve being isolated.  
         [0056]     Furthermore, the device according to the invention advantageously comprises means  41  for distributing a cleaning or diluting liquid. In the embodiment envisaged, this product is constituted by a solution of sodium chloride.  
         [0057]     These means  41  comprise a reservoir  42  for cleaning or diluting solution. A pump  44  is provided at the outlet of this reservoir  42  in order to ensure that the fluid is circulated in the device. The pump  44  is connected, for the control thereof, to the information processing unit  20 .  
         [0058]     The outlet of the pump  44  is connected to an inlet of a selector  46  which is constituted by a distributor having three paths and two states. The moveable part of the selector is connected mechanically to an actuator  48  for the displacement thereof. This actuator  48  is controlled by the information processing unit  20 .  
         [0059]     A first outlet of the selector  46  is connected to the second inlet of the mixer  38 .  
         [0060]     The second outlet of the selector  46  is connected to a second inlet of the switching valve  40 .  
         [0061]     The selector  46  is suitable for ensuring, in a first state, that the outlet of the pump  44  and the second inlet of the switching valve are connected, the second inlet of the mixer  38  not being supplied, and, in a second state, that the pump  44  and the mixer  38  are connected, the second inlet of the switching valve  40  being isolated.  
         [0062]     The mixer  38  can be adjusted in order to define the content of contrast product and diluting fluid in the mixture. In order to be adjusted, the mixer is connected to the information processing unit  20 .  
         [0063]     The switching valve  40  comprises an inlet for the contrast product, which inlet is connected to the second outlet of the distributor  32 , and an inlet for the cleaning fluid, which inlet is connected to the second outlet of the selector  46 .  
         [0064]     Furthermore, the switching valve  40  comprises an injection outlet which is directly connected to the injection outlet  14  via a tube.  
         [0065]     Finally, the switching valve  40  comprises a pressure measuring outlet which is connected to a pressure sensor S 4 . This sensor is connected to the information processing unit  20 .  
         [0066]     In order to ensure a selective connection of the inlets and outlets, the switching valve  40  is equipped with a moveable sliding valve  60  which is constituted by two pistons  62 A,  62 B which are connected to each other and which are mounted so as to be able to slide in a cylindrical chamber.  
         [0067]     The sliding valve  60  is held in a rest position under the action of a spring  64 . In this rest position, as illustrated in  FIG. 1 , the injection outlet  14  is connected to the sensor  54  via the space delimited between the two pistons  62 A,  62 B. In this position, the piston  62 B blocks the introduction inlet for the contrast product.  
         [0068]     Under the action of the pressure of the contrast product, the sliding valve is capable of sliding displacement, as illustrated in  FIG. 2 , in such a manner that the inlet for the contrast product is connected to the injection outlet for the contrast product, the sensor  54  and the inlet for the cleaning fluid being isolated from the injection outlet.  
         [0069]     The unit  24  for storing and presenting the information comprises a display unit which allows the user to have at his disposal the pressure measured by the pressure sensor  54 . It further comprises an indicator for the pressure measurement which is measured by the sensor  26  and which corresponds to the pressure present in the balloon or during injection via the path  14 .  
         [0070]     This unit is also suitable for storing the application time of these various pressures, as well as the quantity of contrast product introduced, this quantity being derived from the information provided by the position sensor  30 .  
         [0071]     The remote control  22  further comprises means  2 A for adjusting the mixer  38  in order to determine the proportion of contrast product and diluting liquid.  
         [0072]     Finally, the remote control  22  comprises means  22 B for selecting the operational mode of the injecting device from an operational mode “coronary arteriography” and an operational mode inflation.  
         [0073]     By way of a variant, the means  22 A and  22 B are arranged in the information processing unit  20 .  
         [0074]     The remote control  22  further comprises means  22 C for controlling the distribution of the contrast product or of a mixture of contrast products and the diluting fluid, as well as means  22 D for controlling the distribution of the cleaning fluid.  
         [0075]     Finally, the remote control  22  comprises means  22 E for adjusting the operating speed of the actuator, which corresponds to the adjustment of the flow rate and the pressure which are imposed at the outlet of the syringe  12 A.  
         [0076]     The information processing unit  20  allows collection of information provided by the various sensors of the device, as well as control of the actuators which allow the state of the distributor  32  and the selector  46  to be changed and the actuator  28  and the pump  44  to be started.  
         [0077]     It further allows the mixer  38  to be controlled in order to modify the proportion of the contrast product and the diluting liquid in the mixture obtained.  
         [0078]     In particular, the information processing unit  20  is suitable for ensuring that the distributor and the selector are controlled in order to obtain the various operational phases, as illustrated in FIGS.  2  to  5 .  
         [0079]     When the user selects an operational mode “coronary arteriography” from the remote control  22 , the information processing unit controls the distributor  32  and the selector  46  so that they are both in the first state thereof, as illustrated in  FIG. 2 .  
         [0080]     In this operational mode, it is possible for the user to bring about an injection of contrast product from the injection outlet  14  by acting on the control means  22 C.  
         [0081]     During such a command, the pump  44  is maintained in the stopped state. Conversely, the actuator  28  is activated at a fixed speed in accordance with the desired flow rate at the outlet.  
         [0082]     The contrast product contained in the syringe  12 A is transferred towards the switching valve  40 . The piston  62 B of the sliding valve is pushed in, as illustrated in  FIG. 2 , in such a manner that the contrast product circulates as far as the injection outlet  14 .  
         [0083]     When the practitioner wishes to carry out a pressure measurement of the patient, he controls the stopping of the injection from the remote control. The stopping of the actuator  28  is then controlled in such a manner that, with the pressure of the contrast product being reduced, the sliding valve of the switching valve  40  returns to the position of  FIG. 1 . The sensor  54  is then connected to the injection outlet  14  and is suitable for providing pressure information which is representative of the pressure of the patient in the region of the connection point of the injection outlet  14 .  
         [0084]     When the practitioner wishes to carry out a cleaning operation, by injecting the cleaning liquid contained in the reservoir  42 , he acts on the control means  22 D of the remote control. The distributor and the selector are then retained in or brought into the first state thereof, the pump  44  is activated and the actuator  28  is stopped or held in a stopped state, as illustrated in  FIG. 3 .  
         [0085]     Under the action of the pressure of the cleaning fluid, the cleaning fluid circulates via the switching valve  40 , more precisely in the space defined between the pistons  62 A,  62 B. The cleaning fluid then circulates as far as the injection outlet  14 .  
         [0086]     In order to bring about the inflation of a balloon, the user switches the device to “inflation” mode from the remote control  22 .  
         [0087]     The information processing unit  20  ensures that the distributor  32  and the selector  46  are automatically switched into the second state thereof, as illustrated in  FIG. 4 .  
         [0088]     The pump  44  and the actuator  28  are activated.  
         [0089]     Since the switching valve  40  is no longer being supplied either with contrast product or with cleaning liquid, it is in the rest position thereof.  
         [0090]     As illustrated in  FIG. 4 , the mixer  3 . 8  is then supplied with contrast product and diluting liquid. In accordance with the proportion of the mixture adjusted from the remote control, a mixture of contrast product and diluting liquid is distributed under pressure towards the inflation outlet  16 .  
         [0091]     The pressure in the balloon is controlled from the unit  24  for storing and presenting the information recorded.  
         [0092]     Finally, and in an automatic manner, the device ensures that the syringe  12 A is filled from the contrast product contained in the reservoir  36  when the information processing unit  20  determines, based on the information obtained by the sensor  30 , that the syringe  12 A is insufficiently full.  
         [0093]     To this end, the distributor  32  is automatically brought into the third state thereof, as illustrated in  FIG. 5 , whilst the selector  46  is left in the first or second state thereof. In this state, the pump  44  is switched off and the actuator  28  is controlled in order to ensure that the plunger is displaced away from the syringe outlet so as to draw in the contrast product contained in the reservoir  36  via the device  32 . After the syringe has been filled, the distributor  32  is returned to the initial state thereof.  
         [0094]     It will be appreciated that, with a device of this type, the same source of contrast product is used simultaneously to ensure the inflation of a balloon via the inflation outlet  16  and the injection of contrast product directly into the patient via the outlet  14 .  
         [0095]     Furthermore, the various injections and inflations are controlled from the same remote control and the measurements recorded from the patient are displayed in the same unit for storing and presenting the information recorded, which facilitates the carrying out of operations by the practitioner.