FR2928838A1 - SENSOR CONNECTION / PROTECTION DEVICE, ESPECIALLY FOR BIOMEDICAL HEMODIALYSIS LINES - Google Patents

Abstract

Sensor connecting / protection device, in particular for biomedical hemodialysis lines, comprising a first membrane (6) made of a gas-permeable and liquid-impervious material interposed between a first (2) and a second (3) element connector comprising respectively a first lumen (2a) which can be connected to a blood liquid flow line and a second lumen (3a) which can be connected to a hemodialysis machine for detecting the pressure in the blood line. flow.The device comprises at least a second membrane (7), made of gas permeable and liquid impervious material, housed in the first and / or in the second connecting element and interposed between the first membrane and, respectively, the first and / or the second light.

Description

SENSOR CONNECTION / PROTECTION DEVICE, ESPECIALLY FOR BIOMEDICAL HEMODIALYSIS LINES

The present invention relates to a sensor connection / protection device, in particular for biomedical hemodialysis lines. The prior art described hereinafter refers in particular to biomedical hemodialysis lines but without precluding that known connector / sensor protection devices may be used in different fields of application having the same or similar technical disadvantages.

Biomedical hemodialysis lines generally include a hemodialysis machine, which acts as an artificial kidney by purifying the blood fluid from a patient, and a main line of blood fluid flow, which term designates the arterial or venous line. which transports the patient's blood fluid to the hemodialysis machine and brings it back to the patient, respectively. During the course of the hemodialysis, it is necessary to monitor various parameters, among which the pressure prevailing in the flow line, and there is provided for this one or more lines of pressure detection which communicate with the line of d flow and which are connected to the hemodialysis machine, which is equipped with a pressure sensor, hereinafter called a sensor. To prevent the blood liquid in the arterial or venous flow line from coming into contact with the sensor and thus damaging and contaminating it, a sensor connection / protection element is positioned between the pressure sensing line. and the hemodialysis machine. This device connection / sensor protection therefore has the function of protecting the sensor against the penetration of the blood liquid flowing in the flow line. The known sensor connection / protection devices comprise a first tubular connection element, open at its ends and having a first light capable of communicating with the flow line, and a second tubular connection element, also open at its ends. and having a second lumen adapted to communicate with the sensor of the hemodialysis machine, secured to each other by means of respective reciprocal coupling flanges. A gas permeable and liquid impermeable membrane is hermetically sealed between the mating flanges of the two tubular connecting members.

This membrane is able to pass air between the first and the second connecting element for the detection of the pressure inside the flow line and to prevent the passage of the blood fluid from the first to the second element connection, acting in practice as a separation barrier between the flow line and the sensor of the hemodialysis machine. These devices for connection / protection of known sensors are not free from disadvantages, among which the fact that they do not guarantee total protection of the sensor mounted on the hemodialysis machine. Indeed, when, due to manufacturing defects or because of problems occurring during use, the membrane does not provide a perfect seal, the blood liquid can accidentally reach the sensor mounted on the hemodialysis machine. Therefore, to prevent or at least substantially reduce the risk of this occurring, two series connected sensor / sensor devices are generally used. In this way, if the membrane contained in the first connecting device connected to the flow line were to be defective, it would be the membrane contained in the second connecting device, associated on the one hand with the first connecting device and on the other hand to the hemodialysis machine, to prevent the blood fluid from contaminating the sensor. The use of two known sensor connection / protection devices in each hemodialysis line is clearly accompanied by significant production and investment costs, as well as an increase in the minimum dimensions required to make the connection. between a flow line of the blood fluid and the corresponding hemodialysis machine. The main problem which the present invention aims to solve is that of eliminating the above-mentioned disadvantages of the prior art, by developing a sensor connection / protection device which, in the context of the use of a single known connection device, to prevent or at least significantly reduce the risk that the blood fluid comes into contact with the sensor mounted on the corresponding hemodialysis machine. In this context, an object of the present invention is to achieve the same technical effect as that obtained with two known connecting devices arranged in series, reducing compared to such a solution the number of components used and, consequently, production and machining costs. Another object of the present invention is to solve the problem and to achieve the aforementioned objects with a simple structure, relatively easy to put into practice, safe to use and operating effectively, significantly reducing the cost. This task and these objects, as well as others which will appear better hereinafter, are realized by the present sensor connection / protection device, intended in particular for biomedical hemodialysis lines, comprising. - A first substantially tubular connecting member open at its ends and comprising a first light adapted to communicate with a blood liquid flow line; a second substantially tubular connection element open at its ends and comprising a second lumen able to communicate with a hemodialysis machine to detect the pressure in the flow line; said first and second connecting members respectively comprising a first and second reciprocal coupling flange disposed in opposite portions to the respective sections comprising said first and second lumens integrally and coaxially associated with each other; a first membrane, made of a gas-permeable and liquid-impervious material, interposed between said first and said second connection element and whose peripheral edge is sealed between said first and second flanges to prevent the passage of the contained blood liquid; in the flow line of said first connecting member in said second connecting member; characterized in that it comprises at least a second membrane, made of a material permeable to gas and impervious to liquids, housed in said first and / or in said second connecting element and interposed between said first membrane and, respectively, said first and / or or said second light. Other features and advantages of the present invention will appear better on reading the detailed description of a preferred but not exclusive embodiment of a connection device / sensor protection, illustrated for purely indicative and not limiting on the accompanying drawings, in which: Figure 1 is a longitudinal sectional side view of a first embodiment of a sensor connection / protection device according to the invention; Figure 2 is a side view in longitudinal section of a second embodiment of a connection device / sensor protection according to the invention; Figure 3 is a side view in longitudinal section of a third embodiment of a connection device / sensor protection according to the invention; Figure 4 is a longitudinal sectional side view of a fourth embodiment of a sensor connection / protection device according to the invention; FIG. 5 is a longitudinal sectional side view of the second tubular connection element of a sensor connection / protection device according to the invention; Figure 6 is an enlargement of a detail of Figure 5.

Let us refer in particular to these figures, in which the reference numeral 1 designates as a whole a connection / sensor protection device, in particular for biomedical lines of hemodialysis. The connection device / sensor protection 1 comprises a first substantially molded, molded, open-ended first connecting element 2 comprising a first lumen 2a able to communicate with a blood liquid flow line, for example a line arterial or venous line of a biomedical line of hemodialysis, not shown in the figures.

The connecting device 1 further comprises a second substantially tubular connecting element 3, also shaped by molding, open at its ends and comprising a second lumen 3a capable of communicating with a hemodialysis machine, not shown in the figures, for the detection of the pressure in the flow line. More particularly, the hemodialysis machine comprises a pressure sensor, commonly called a sensor, capable of detecting the pressure of the blood liquid contained in the arterial or venous flow line. The first and second connecting members 2 and 3 respectively comprise a first and a second reciprocating flange 4 and 5 disposed in opposite portions to the respective sections comprising the first and second lumens 2a and 3a and associated with each other. to the other in a solidarity and coaxial way. More particularly, the second flange 5 has a substantially annular conformation and it also has an annular projection 5a, defined near the peripheral edge of said second flange, which extends outwards and can be housed in an annular groove 4a. defined in the first flange 4 and also having a substantially annular conformation. Preferably, the second flange 5 further has, in a position radially further inland from the annular projection 5a, one or more clamping members 5b, having a substantially triangular longitudinal section so as to define a profile substantially " toothed ", which can bear against an opposing surface 4b defined by the first flange 4 at the time of the mutual coupling of the flanges 4 and 5. The first and the second flange 4 and 5 are joined together, preferably by welding hot or ultrasonic, once the annular projection 5a engaged in the annular groove 4a. The connecting device 1 comprises a first membrane 6, made of gas-permeable and liquid-impervious material, interposed between the first and the second connecting element 2 and 3 and whose peripheral edge is sealed between the first and the second flange 4 and 5 to prevent the passage of the blood liquid contained in the flow line of the first connecting element 2 in the second connecting element 3. More particularly, the first membrane 6, generally made of gore tex (registered trademark), is positioned relative to the first or the second flange 4 and 5, before their mutual coupling, so that its peripheral edge is disposed facing the clamping elements 5b or the opposing surface 4b. Advantageously, the peripheral edge of the first membrane 6 is not involved in the welding and is simply mechanically clamped between the flanges 4 and 5 and, more particularly, between the clamping elements 5b and the corresponding counter surface 4b.

The particular conformation of the clamping elements 5b makes it possible to guarantee the maintenance of the peripheral edge of the first membrane 6, at the same time defining a kind of labyrinth capable of preventing any infiltration of blood liquid. According to the invention, the connecting device 1 comprises at least one second membrane 7, made of a material permeable to gas and impermeable to liquids, housed in the first and / or in the second connecting element 2 and 3 and interposed between the first membrane 6 and, respectively, the first and / or second lumen 2a and 3a. Advantageously, the second membrane 7 is also made of gore tex.

More particularly, once the second membrane 7 has been introduced and positioned in the first and / or the second connecting element 2 and 3 between the first membrane 6 and, respectively, the first and / or the second light 2a and 3a, said second membrane is secured to the first and / or the second connecting element 2 and 3. The securing of the second membrane 7 is preferably by hot welding or ultrasound and so that the connection with the first and / or second connecting element 2 and 3 is hermetically sealed. The second membrane 7 is properly spaced from the first membrane 6 so as to define a hermetically sealed inspection chamber 8 which allows an operator to visually monitor the possible percolation of blood liquid through the first membrane 6. Advantageously, the first and / or the second connecting element 2 and 3 comprise a housing 9 for the second membrane 7 which defines a substantially annular support surface 9a for the peripheral edge of the second membrane 7. Preferably, the second membrane 7 is housed in the second connecting element 3 and the housing 9 is defined by a receptacle for the insertion of connecting means of the second connecting element 3 to the hemodialysis machine, means whose conical lateral surface diverges outwards and whose the bottom defines the bearing surface 9a. The connecting means of the second connecting element 3 to the hemodialysis machine may consist of a connecting line C connected to the hemodialysis machine or, alternatively, of a coupling R which is inserted by one of the hemodialysis machine. its end regions in the receptacle defining the housing 9 and which has at the opposite end a female luer cone which can engage a corresponding male luer cone connected to the hemodialysis machine. Because, in use, the first membrane 6 has a tendency to "bend", that is to say, to curve towards the second light 3a under the effect of the pressure prevailing in the line flow, the second connecting element 3 comprises, facing the second flange 5, a plurality of ribs 10 which extend radially from a central zone coaxial with the first and the second lumen 2a and 3a. The ribs 10 are therefore able to support the first membrane 6 in its displacements, so as to prevent it from experiencing dangerous breaks during the use of the connecting device 1. FIGS. 1 to 3 show three embodiments of FIG. a connecting device 1 according to the invention, which are differentiated from each other by the conformation of the portion of the first connecting element 2 which comprises the first light 2a and which can be connected to the flow line.

More particularly, in FIGS. 1, 2 and 3, the part of the first connecting element 2 comprising the first lumen 2a respectively comprises a receptacle 11 for inserting the end of a bypass line D coming from the flow line. , a cone which can be introduced into the end of the bypass line D and a male luer connector 12 which is housed in a corresponding female luer connector, not shown in the figure, positioned opposite the end of the branch line D. The The operation of the present invention is as follows. When using the connecting device 1 in a hemodialysis line, the flow line is constituted by the arterial or venous line in which the blood liquid flows.

In this field of application, the connecting device 1, connected in a sealed manner on the one hand to the arterial or venous line and on the other hand to the hemodialysis machine, respectively by the branch line D and the line of link C, let the air through the first and second membrane 6 and 7 to allow the sensor mounted on said hemodialysis machine to detect the pressure within the arterial or venous line. Since it is possible that, due to wear or inaccurate tolerances, the connection between the second connecting element 3 and the connecting line C is not perfectly sealed, a part of the blood liquid circulating in the the arterial or venous line may flow into the branch line D and enter the first connecting element 2 through the first lumen 2a. There, the blood liquid meets the first membrane 6 which, under normal operating conditions, prevents it from passing into the second connecting element 3 and thus into the second lumen 3a.

When the first membrane 6 is not sealed between the first and second flanges 4 and 5, the blood liquid enters the second connecting element 3 and is blocked by the second membrane 7.

In this way, an operator, also thanks to the transparency of the materials used to manufacture the connection elements 2 and 3, in particular the second connection element 3, can detect the presence of blood liquid in the volume between the two membranes 6 and 7, that is to say in the inspection chamber 8, which allows it to interrupt the hemodialysis process in time and restore correct connections between the parts. In practice, it is noted that the described invention achieves the intended objects and it is emphasized in particular that it allows to significantly reduce, compared to known connection devices, the possibility that the blood fluid circulating in the line of d The flow may accidentally reach the hemodialysis machine.

In addition, with equal technical effect, the manufacturing costs of a connection device according to the invention are significantly lower than those resulting from the series arrangement of two known connection devices.

Although the device according to the invention has been designed for the protection of the sensors mounted on the hemodialysis machines in the biomedical hemodialysis lines, it can be used more generally as a filter connection device in each connection between a d-line. flow of blood fluid and a hemodialysis machine when it is necessary to prevent the blood fluid from coming into contact with the hemodialysis machine itself. The invention thus conceived is susceptible of numerous modifications and variations which all fall within the scope of the appended claims. In addition, all parts can be replaced by other technically equivalent elements. In practice, the materials used, as well as the shapes and contingent dimensions, may be any depending on the requirements without departing from the scope of the claims below.

Claims (8)

Sensor connecting / protection device, in particular for biomedical hemodialysis lines, comprising. a first substantially tubular connecting member (2) open at its ends and comprising a first lumen (2a) adapted to communicate with a blood liquid flow line; a second substantially tubular connecting member (3) open at its ends and comprising a second lumen (3a) adapted to communicate with a hemodialysis machine for the detection of the pressure in the flow line; said first and second connecting members respectively comprising a first (4) and a second (5) reciprocal coupling flange, disposed in opposite portions to the respective sections comprising said first and second lumens associated with each other, solidarity and coaxial way; a first membrane (6), made of a gas-permeable and liquid-impervious material, interposed between said first and second connecting members and whose peripheral edge is sealed between said first and said second flanges to prevent passage of the liquid blood contained in the flow line of said first connecting member in said second connecting member; characterized in that it comprises at least one second membrane (7), made of gas-permeable and liquid-impervious material, housed in said first and / or in said second connecting element and interposed between said first membrane and, respectively, said first and / or said second light. 2. Device according to claim 1, characterized in that said second membrane (7) is integrally integrally sealed with said first (2) and / or said second connecting element. 3. Device according to claims 1 and 2, characterized in that said second membrane is associated by welding to said first (2) and / or said second (3) connecting element. 4. Device according to any one of the preceding claims, characterized in that said second membrane (7) is spaced from said first membrane (6) so as to define an inspection chamber (8) hermetically sealed. 5. Device according to any one of the preceding claims, characterized in that said first and / or said second connecting element comprises a housing (9) for said second membrane (7), said housing defining a bearing surface (9a ) substantially annular for the peripheral edge of said second membrane. 6. Device according to any one of the preceding claims, characterized in that said second membrane (7) is housed in said second connecting element (3). 7. A method for producing a sensor connection / protection device, in particular for biomedical hemodialysis lines, comprising the steps of: molding a first substantially tubular connecting element (2) open at its ends and comprising a first lumen (2a) adapted to communicate with a blood flow line; - Molding a second substantially tubular connecting member (3) open at its ends and having a second lumen (3a) adapted to communicate with a hemodialysis machine for detecting the pressure in the flow line; said first and second connecting members respectively comprising a first (4) and a second (5) reciprocal coupling flange disposed in opposite portions with respect to respective portions comprising said first and said second lumens; -positioning a first membrane (6), made of gas-permeable and liquid-impervious material, with respect to said first or said second flange; - Securing said first flange with said second flange by sealingly sealing the peripheral edge of said first membrane, the latter being interposed between said first and said second tubular connection element to prevent the passage of the blood liquid contained within the flow line of said first connecting member in said second connecting member; characterized in that it comprises the steps of: - inserting a second membrane (7), made of gas-permeable and liquid-impervious material, inside said first and / or said second connecting element by positioning it between said first membrane and, respectively, said first and / or said second light; - Securing said second membrane with said first and / or said second connecting element. 8. Method according to claim 7, characterized in that said securing of said second membrane is by welding.