CH717520A2 - Portable device for the continuous analysis of a patient's bodily fluid. - Google Patents

Abstract

The invention relates to a device (1) for the continuous analysis of a patient's bodily fluid comprising a box comprising a bottom and a removable cover (4), the bottom (6) comprising a hole (18), through of which is arranged a needle carrying a sensor, and being intended to be applied against the skin of the patient, for a predefined period, in such a way that the needle punctures the skin of the patient and that the sensor is in contact with the body fluid of the patient to allow continuous analysis, a seal (38) being arranged between the lid (4) and the bottom to ensure the tightness of the case, the lid (4) housing electronic circuits (46) intended to transmit the results of the measurements to an external device, an electrical connector (48) being arranged to establish an electrical connection between the electronic circuits (46) and the sensor.

Description

Technical area

The present invention relates to a portable device for continuous analysis of a patient's body fluid. More specifically, the invention relates to a device of this type comprising a box comprising a bottom and a cover, assembled to each other in a removable manner, the bottom having a main external face at least partially covered with an adhesive material. and comprising a hole through which is arranged a needle carrying a sensor intended to analyze the patient's bodily fluid, the main external face being intended to be applied against the patient's skin via the adhesive material, for a predefined duration, such that the needle punctures the patient's skin and the sensor is in contact with the patient's body fluid to allow continuous analysis thereof.

State of the art

Many devices of this type are already known in the state of the art.

[0003] By way of example, the company Abbott currently markets a measuring device of the type mentioned above under the name FreeStyle Libre (https://www.freestylelibre.us/system-overview/freestyle-14-day .html). This device is marketed in the form of a pack comprising the measuring device itself, as well as an applicator, and makes it possible to carry out continuous measurement of a patient's blood sugar for fourteen days in a row. To this end, the device comprises a main face, covered with an adhesive material and having a hole through which is arranged a filament carrying a blood glucose sensor, this main face being intended to be arranged on the skin of the patient by means of the applicator. This device comprises a waterproof casing housing in particular electronic circuits making it possible to establish wireless communication with an external reading device. After fourteen days, the device should be removed from the skin and replaced with a new one, repeating the placement procedure on the patient's skin.

[0004] Thus, this system provides, like others, for the measuring device to be completely replaced at the end of its period of use, which implies that not only the part of the device which is in contact with the patient's skin be replaced, but also the entire electrical and electronic part, i.e. all the electronic circuits as well as the electrical power source of the device. If such an approach makes it possible to simplify the assembly of the device, in particular with the aim of making the case watertight, it involves the production of a large quantity of waste including in particular certain components whose potential lifespan exceeds the period of use of the device, i.e. here fourteen days.

[0005] Consequently, the need still exists to develop such a measuring device whose manufacturing and use processes optimize natural resources by creating less waste than the devices currently available on the market, while respecting the sanitary conditions required.

Disclosure of Invention

[0006] A main object of the present invention is to propose a construction of a device for the continuous analysis of a body fluid of a patient allowing ergonomic and simple installation of the device by the patient himself, on his skin. , while offering the possibility of using certain components of the device having a sufficient lifetime over several periods of analysis, and without however harming the sanitary conditions when wearing the device.

[0007] To this end, the present invention relates more particularly to a device for the continuous analysis of a body fluid of a patient, of the type mentioned above, characterized in that a seal is arranged between the lid and bottom to seal the case, the lid defining a housing for an electrical power source intended to allow the operation of electronic circuits arranged in the housing, including a memory and a circuit for wireless communication with a device external electronics and intended to allow the collection and transmission of the results of the continuous measurement carried out by the sensor to the external electronic device, at least one electrical connector being arranged to establish an electrical connection between the electronic circuits and the sensor.

[0008] Thanks to these characteristics, a set of components of the analysis device which have a lifespan greater than the period of use of the device is arranged in the cover and can therefore easily be reused over several periods. Indeed, it suffices to dissociate the cover from the bottom at the end of the analysis period, before or after removing the bottom from the patient's skin, to be able to subsequently associate the cover with a new bottom carrying a new needle, itself carrying even a new sensor. In addition, the fact that the assembly between the cover and the bottom is sealed makes it possible to protect the electrical and electronic components of the device inside the case.

[0009]Preferably, the device can advantageously include at least one printed circuit bearing at least part of the electronic circuits as well as electrical contactors intended to provide an electrical connection between an electrical power source and the electronic circuits. .

[0010] In this case, it is more particularly possible to provide that the printed circuit also carries the electrical connector or connectors arranged to establish an electrical connection between the electronic circuits and the sensor.

[0011] In general, provision can be made for the housing to be closed by a closure plate, on its side arranged facing the bottom, the closure plate comprising at least one hole through which is positioned the electrical connector arranged to establish an electrical connection between the electronic circuits and the sensor.

Preferably, the closure plate has as many holes as there are electrical connectors provided to establish an electrical connection between the electronic circuits and the sensor.

[0013] According to a first variant embodiment, when the printed circuit bears the electrical connector or connectors, provision may be made for the cover to have at least one abutment surface against which the printed circuit is held in abutment under the effect of a pressure that the closure plate applies to it.

[0014] In addition, in this case, it is possible to provide that the needle is carried by a needle support carrying one or more electrical tracks making it possible to ensure an electrical connection between each electrical connector and the sensor, and that at least one electrical connector is arranged to exert pressure on the needle support in such a way that it is held in abutment against the bottom.

[0015] In general, provision can advantageously also be made for the seal to be an O-ring seal housed in an annular groove formed in one of the elements from among the cover and the bottom, and arranged to bear against a annular surface of the other element among the cover and the bottom.

According to a preferred embodiment, provision can be made for the annular groove to be oriented in such a way that the O-ring seal undergoes an essentially radial compression.

In general, provision can be made for the cover and the bottom to be secured to each other by screwing or by a bayonet-type connection.

According to a preferred embodiment, the analysis device is arranged to analyze the patient's blood sugar, the sensor comprising three electrodes intended to be positioned in contact with the patient's body fluid.

Brief description of the drawings

Other characteristics and advantages of the present invention will appear more clearly on reading the detailed description of a preferred embodiment which follows, made with reference to the appended drawings given by way of non-limiting examples and in which : FIG. 1 represents a simplified perspective view of an analysis device according to a preferred embodiment of the invention; FIG. 2 represents a simplified perspective exploded view of the analysis device of FIG. 1, and FIGS. 3a and 3b represent simplified cross-sectional views of the analysis device of FIG. 1, along two respective sectional planes, substantially perpendicular to each other.

Embodiment(s) of the Invention

The figures are intended to illustrate the general principles of implementation of a device for continuous analysis of a body fluid of a patient according to a preferred embodiment of the present invention and are schematic.

[0021] FIG. 1 represents a simplified perspective view of a device 1 for the continuous analysis of a body fluid of a patient, here by way of non-limiting illustrative example of the interstitial fluid, which can in particular make it possible to measure the patient's glycemia continuously, for a predefined period, typically several days or even a few weeks.

The device 1 comprises a housing 2 made of two main parts, a cover 4 and a bottom 6 secured to each other in a removable manner, as will emerge from the following description.

The bottom 6 comprises a base plate 8 substantially in the shape of a disc and at least partially covered with an adhesive material 10. The base plate 8 has a main outer face (numeral reference 12 in Figure 2) substantially planar and intended to be positioned against the skin of a patient, through the adhesive material 10, to allow the realization of the continuous analysis of the bodily fluid of the patient.

The base plate 8 carries a wall 14 of generally annular shape and slightly curved in the direction of the axis of symmetry of the base plate 8.

The cover 4 has a shape substantially complementary to that of the wall 14 such that the case 2 generally has a smooth shape, without sharp edges.

[0026] Figure 2 shows a simplified perspective exploded view of the analysis device 1, illustrating its particular construction in more detail.

The adhesive material 10 is applied here against the base plate 8 in the form of a film having the general shape of a disc and comprising a central hole 16.

The base plate 8 is also provided with a central hole 18 aligned with that of the adhesive material 10. In addition, it is noted that optional channels 20 are made in the main outer face 12 to improve the holding of the adhesive material. 10 on the main external face 12.

The holes 16 and 18 are provided to define a through passage for a needle 22 intended to puncture the skin of the patient to be positioned in contact with the interstitial fluid of the patient and to perform the continuous analysis.

The needle 22 is carried by a needle holder 24 having two floors. A first external stage 26 is intended to be inserted into the central hole 18 of the base plate 8 to ensure correct and stable positioning of the needle 22 with reference to the housing 2. A second internal stage 28, of transverse dimensions greater than those of the first stage 26, is intended to cooperate with other components of the device 1, by mechanical and electrical interactions, as will emerge from the remainder of the description.

The base plate 8 is secured to the wall 14 by any suitable operation, for example by gluing or welding.

The wall 14 has a mechanical connecting member making it possible to make the bottom 6 integral with the cover 4. The mechanical connecting member has here, by way of non-limiting illustrative example, the shape of four threads 30 regularly spaced at inside the wall 14, each of which is followed by a stop 32.

[0033] In a complementary manner, the cover 4 comprises a cylindrical side 34 carrying four lugs 36 intended to cooperate with the threads 30 and the stops 32 to define a bayonet-type connection between the cover 4 and the bottom 6.

Of course, those skilled in the art may implement other types of removable mechanical connection suitable for the present invention without departing from the scope of the invention as defined by the appended claims, such as for example a connection by no screw.

A seal 38, here having the form of an O-ring seal, is arranged between the cover 4 and the bottom 6 to seal the case 2.

Furthermore, the curved shape of the cover 4 and its cylindrical side 34 define a housing intended to house a printed circuit 40 carrying electrical contactors 42 arranged to cooperate with the terminals of an electrical power source 44, a battery or a battery, as well as various electronic circuits 46 including in particular a memory and at least one wireless communication circuit with an external electronic device (either a dedicated terminal, portable or not, or a tablet or a smartphone).

The printed circuit 40 also carries three electrical connectors 48 arranged to allow the establishment of an electrical connection between the electronic circuits 46 and a sensor (not visible) carried by the needle 22 and adapted to perform an analysis of the patient's body fluid according to predefined criteria.

A closure plate 50 is provided to enclose the printed circuit 40 and the components it carries in the housing of the cover 4.

For this purpose, the closure plate 50 is intended to be embedded inside the cylindrical side 34 of the cover 4, until it is positioned in abutment against an internal shoulder 52 adapted. Provision may optionally be made for gluing or welding closure plate 50 in cover 4 as required.

The closure plate 50 has three holes 54, each of which is intended to cooperate with one of the electrical connectors 48 to ensure the connection between the electronic circuits 46 and the sensor carried by the needle 22 located outside the cover housing 4.

[0041] Figures 3a and 3b show simplified cross-sectional views of the analysis device 1, along two respective sectional planes, substantially perpendicular to each other, and which make it possible to illustrate certain construction details more clearly.

It is apparent from these sectional views that the seal 38 is arranged here, by way of non-limiting illustration, in an annular groove 56 formed in the cylindrical side 34 of the cover 4. When the cover 4 is secured to the bottom 6, the seal 38 is placed in abutment against an internal cylindrical surface of the wall 14 of the bottom 6, being compressed essentially in a radial direction.

Furthermore, it appears from Figure 3a that the housing of the cover 4 has several abutment surfaces 58 bearing against which the printed circuit 40 is positioned under the effect of the pressure of the closure plate 50. optional, a plurality of compressible components 58 integral with the printed circuit 40 are preferably provided to define mechanical stops in relation to the closure plate 50.

It is noted that the power source 44 can advantageously be wedged against the bottom of the housing of the cover 4, to be well held in place during movements of the case 2, or even shocks that it could undergo.

The precise axial positioning of the printed circuit 40 thus obtained with reference to the cover 4, makes it possible to ensure precise positioning of the free ends of the electrical connectors 48 intended to allow the implementation of the electrical connection between the electronic circuits 46 and the sensor carried by the needle 22.

[0046] Indeed, the electrical connectors 48 are arranged in abutment against the needle support 24 in particular for a mechanical purpose, to contribute to the maintenance, on the one hand, of the printed circuit 40 against the abutment surfaces 58 of the cover 4 and, on the other hand, of the needle support 24 against the bottom 6. In addition, conductive tracks 60 are formed on the free surface of the second internal stage 28 of the needle support 24, being connected to electrodes of the sensor carried by the needle 22. These conductive tracks 60 are positioned so as to be located opposite the electrical connectors 48 to ensure the implementation of an electrical connection between each of the electrodes of the sensor and the electronic circuits 46. Thus, the positioning in abutment of the electrical connectors 48 against the needle support 24 ensures the establishment of these electrical connections. Advantageously optionally, provision can be made for the electrical connectors to include springs (not visible) arranged in such a way that the height of each electrical connector can vary within a predefined range in order to be able to take into account any variations in distance between the printed circuit and needle support from one device to another.

It is also seen in the views of Figures 3a and 3b that the bottom 6 comprises a recess 62 defining a housing for at least a portion of the second floor 28 of the needle holder 24, to ensure its correct positioning and its maintenance in square.

It emerges from the foregoing that the continuous analysis device according to the present invention offers a particularly advantageous construction. In fact, the case 2 of the analysis device has a relatively compact construction, thus ensuring great wearing comfort. In addition, its sealing allows the patient to perform certain physical activities such as swimming, for example, without risk of compromising the proper functioning of the analysis device. In addition to these advantageous characteristics, the construction of the box allows the patient, by very simple manipulations, to replace only the bottom and the needle after each predefined period, of the order of a few weeks, while continuing to use the same cover as well as all the components it contains, in particular the entire electronic part of the device. Provision may optionally be made for the bottom to also be reusable and for only the adhesive material and the needle to be replaced at the end of each period, without thereby departing from the scope of the present invention.

The continuous analysis device according to the present invention is advantageously arranged to allow reading of the results of the measurements carried out in a known manner, by means of a dedicated, fixed or portable terminal, or else thanks to a current external electronic device. tablet or smartphone.

[0050] It will be noted that the constituent elements of the case can be manufactured on a large scale and at low cost, such as for example by a relatively simple conventional molding process, or even by 3D printing.

The foregoing description sets out to describe a particular embodiment by way of non-limiting illustration and, the invention is not limited to the implementation of certain particular characteristics which have just been described, such as, for example, the application of the device to the measurement of blood sugar, the exact shapes of the constituent elements of the box as illustrated and described, or even the number of connectors necessary to ensure the electrical connection between the electronic circuits and the sensor. Similarly, it is possible to provide any construction and any manufacturing material suitable for the needle, in particular as regards the way in which the sensor is secured thereto, without thereby departing from the scope of the invention. Thus, provision could for example be made for the needle to be made of silicon with a deposit of electrodes and conductive tracks made in a conventional manner. Those skilled in the art may provide for the implementation of any known alternative without departing from the scope of the present invention, such as for example the implementation of a hollow needle containing the sensor and having a window towards its free end to allow a bringing the sensor into contact with the patient's body fluid.

[0052] In general, those skilled in the art will not encounter any particular difficulty in adapting the present teaching according to their own needs and producing a device for the continuous analysis of a patient's bodily fluid according to the characteristics of the present invention as defined in the claims.

Claims (10)

1. Portable device (1) for the continuous analysis of a patient's bodily fluid comprising a case (2) comprising a bottom (6) and a cover (4), removably assembled together , said bottom (6) having a main outer face (12) at least partially covered with an adhesive material (10) and comprising a hole (18) through which is arranged a needle (22) carrying a sensor intended to analyze the fluid patient's body, said main outer face (12) being intended to be applied against the patient's skin by means of said adhesive material (10), for a predefined duration, in such a way that said needle (22) pierces the skin of the patient and said sensor is in contact with the patient's bodily fluid to allow continuous analysis thereof, characterized in that a seal (38) is arranged between said cover (4) and said bottom (6) to seal said box (2), said cover (4) defining a housing for a source of power supply (44) intended to allow the operation of electronic circuits (46) arranged in said housing, including a memory and a circuit for wireless communication with an external electronic device and intended to allow the collection and transmission of the results of the continuous measurement performed by said sensor to the external electronic device, at least one electrical connector (48) being arranged to establish an electrical connection between said electronic circuits (46) and said sensor. 2. Device (1) according to claim 1, characterized in that it comprises at least one printed circuit (40) carrying at least a part of said electronic circuits (46) as well as electrical contactors (42) intended to ensure a connection electrical between an electrical power source (44) and said electronic circuitry (46). 3. Device (1) according to claim 2, characterized in that said printed circuit (40) also carries said at least one electrical connector (48) arranged to establish an electrical connection between said electronic circuits (46) and said sensor. 4. Device (1) according to one of claims 1 to 3, characterized in that said housing is closed by a closure plate (50), on its side arranged facing said bottom (6), said closure plate ( 50) comprising at least one hole (54) through which is positioned said at least one electrical connector (48) arranged to establish an electrical connection between said electronic circuits (46) and said sensor. 5. Device (1) according to claims 3 and 4, characterized in that said cover (4) has at least one abutment surface (58) against which said printed circuit (40) is held in abutment under the effect of a pressure that said closing plate (50) applies to it. 6. Device (1) according to claim 5, characterized in that said needle (22) is carried by a needle support (24) carrying at least one electrical track (60) making it possible to ensure an electrical connection between said at least one electrical connector (48) and said sensor, and in that said at least one electrical connector (48) is arranged to exert pressure on said needle support (24) in such a way that the latter is held in abutment against said bottom (4). 7. Device (1) according to one of the preceding claims, characterized in that said seal (38) is an O-ring seal housed in an annular groove (56) formed in one of the elements among said cover (4) and said bottom (6), and arranged to bear against an annular surface of the other element among said cover (4) and said bottom (6). 8. Device (1) according to claim 8, characterized in that said annular groove (56) is oriented such that said O-ring seal undergoes an essentially radial compression. 9. Device (1) according to one of the preceding claims, characterized in that said cover (4) and said bottom (6) are secured to one another by screwing or by a bayonet-type connection. 10. Device (1) according to one of the preceding claims, characterized in that it is arranged to analyze the patient's blood sugar, said sensor comprising three electrodes intended to be positioned in contact with the patient's body fluid.