CH717521A2 - Portable device for the continuous analysis of a patient's bodily fluid. - Google Patents

Abstract

The invention relates to a device for the continuous analysis of a patient's bodily fluid comprising a housing a hole through which is arranged a needle (22) carrying a sensor (49) intended to analyze a patient's bodily fluid, characterized in that it comprises a needle support at least partially housed in the hole, that the needle (22) has a head (74) arranged in a housing of the needle support and carrying at least one primary electrical contact (80) arranged in electrical connection with the sensor (49), and that the needle support comprises at least one conductive track arranged so as to be connected to the primary electrical contact (80) and to define a secondary electrical contact arranged on a free face of the needle support located inside the housing, to allow the implementation of an electrical connection between the sensor (49) and at least one electronic circuit housed in the housing. The invention also relates to a sensor assembly and a method of manufacturing a sensor assembly.

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 case comprising a bottom having a main external face comprising a hole through which is arranged a needle carrying a sensor intended to analyze a bodily fluid of the patient, the main external face being intended to be applied against the patient's skin for a predefined period of time, by means of an adhesive material, in such a way that the needle punctures the patient's skin and that the sensor is in contact with the patient's bodily fluid to allow for ongoing analysis.

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 being made in the form of removable modules to offer the possibility of using certain components of the device having a sufficient lifetime over several periods of analysis, and without harming the sanitary conditions when wearing the device.

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 that it includes a needle holder at least partially housed in the hole in the bottom of the case, that the needle has a head of which at least one transverse dimension is greater than its average transverse dimension, the head being arranged in a housing of the needle holder, so as to make the needle and the needle holder integral one from the other, the head carrying at least one primary electrical contact arranged in electrical connection with the sensor, and that the needle support comprises at least one conductive track arranged so as to be connected to the primary electrical contact, inside the housing, and to define a secondary electrical contact arranged on a free face of the needle support located at the inside the box, to allow the implementation of an electrical connection between the sensor and at least one electronic circuit housed in the box.

[0008] Thanks to these characteristics, a large set of components of the analysis device, which have a lifespan greater than the period of use of the device and which can be protected from environmental constraints, can be reused over several periods while that the components which are directly exposed to the environment, in particular by being in direct contact with the skin or with a bodily fluid of the patient, can be easily replaced. Indeed, it suffices to dissociate the sensor assembly, that is to say the needle support carrying the needle itself carrying the sensor, from the bottom of the box at the end of the analysis period, before or after having removed the case from the patient's skin, in order to be able subsequently to associate the case and at least some of the components that it contains with a new sensor assembly carrying a new needle, itself carrying a new sensor.

[0009]Preferably, provision may advantageously be made for the head of the needle to carry at least two, preferably at least three, primary electrical contacts, each of which is associated with a conductive track and with a secondary electrical contact of the needle support. .

[0010] In general, provision can be made for the device to comprise at least one printed circuit bearing the electronic circuit as well as an electrical connector by secondary electrical contact that the needle support comprises, arranged to establish an electrical connection between the circuit electronics and the corresponding secondary electrical contact.

[0011] In this case, provision can advantageously be made for the printed circuit to be arranged in the casing in such a way that the electrical connector or connectors are positioned in abutment against the needle support in order to keep the latter resting against the bottom.

[0012] More particularly in this case, provision can be made for the case to include a cover associated with the bottom and defining a housing in which the printed circuit is housed, the housing being closed, on its side arranged opposite the bottom by a plate of closure having one hole per electrical connector, through which the latter is arranged.

[0013] In addition, it is possible to provide that the cover has at least one abutment surface against which the printed circuit is held in abutment under the effect of a pressure that the closing plate applies to it and, preferably, that the device comprises a seal housed in an annular groove formed in one of the elements from among the cover and the bottom, and arranged to bear against an annular surface of the other element from among the cover and the bottom so as to ensure the tightness of the box. Thus, all the electrical or electronic components of the device are protected inside the case.

[0014] Advantageously, provision may be made for the cover and the bottom to be secured to one another by screwing or by a bayonet-type connection.

The present invention also relates to a sensor assembly, comprising a needle support corresponding to the above characteristics and associated with a needle carrying a sensor, as well as its method of manufacture, comprising the steps consisting in: provide yourself with a needle carrying a sensor and having a head of which at least one transverse dimension is greater than the average transverse dimension of the needle, the head carrying at least one primary electrical contact arranged in electrical connection with the sensor, manufacture at least two needle support portions intended to be assembled together to define a needle support, the portions being shaped in such a way that they define between them a housing for the head of the needle when they are assembled together, the portions being arranged in such a way that the needle support comprises at least one conductive track arranged so as to, on the one hand, be positioned against the primary electrical contact of the needle, inside the housing, and, on the other hand, defining a secondary electrical contact arranged on a free face of the needle support intended to be located inside the housing, to allow the setting work of an electrical connection between the sensor and at least one electronic circuit of the device housed in the case, and assembling the portions with interposition of the needle in such a way that its head is embedded inside the housing, to make the needle integral with the needle support while establishing electrical contact between the sensor and the secondary electrical contact of the needle holder.

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; Figure 2 shows a simplified perspective exploded view of the analysis device of Figure 1; 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; Figure 4 shows a simplified exploded perspective view of a sensor assembly according to a preferred embodiment, and Figure 5 shows a simplified top view of the sensor assembly of Figure 4.

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.

[0018] 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 substantially disc-shaped base plate 8 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, by means of the adhesive material 10, to allow the performance of the continuous analysis of a 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.

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 carry out 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 for making 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.

[0030] 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 (numeral reference 49, in Figure 4) carried by the needle 22 and suitable for carrying out an analysis of the interstitial fluid of the patient 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.

[0038] 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 made 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 49 carried by the needle 22.

[0043] 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 49 carried by 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 49 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 stage 28 of the needle holder 24, to ensure its correct positioning and its maintenance in square.

[0045] Figures 4 and 5 illustrate in greater detail the structure and construction of the sensor assembly, i.e. the needle holder 24 when associated with the needle 22, itself carrying the sensor 49, in respective exploded perspective and simplified top views.

It is seen in Figure 4 that the needle holder 24 can advantageously be made in the form of two portions 70 assembled to each other with the interposition of the needle 22. For this purpose, the portions 70 have recesses 72 arranged to be located opposite each other and define a housing for the head 74 of the needle 22.

In addition, each portion 70 also has a conduit 76, intended to communicate the housing with the outside of the needle support 24 and thus define a passage for the needle 22. Indeed, the needle 22 has here a general T-shape, its head 74 having a width greater than the average width of the needle 22. Thus, when the head 74 is housed between the two portions 70, it finds itself enclosed there and the needle 22 is secured to the needle support 24.

It is also apparent from Figure 4 that the head 74 of the needle 22 here carries three primary electrical contacts 80, each of which is connected to an electrode of the sensor 49.

When the sensor assembly is assembled, the primary electrical contacts 80 are located in the housing of the needle support 24, the conductive tracks 60 of the latter being arranged to be positioned in abutment against these primary electrical contacts 80, ensuring the electrical connection between the sensor 49 and the secondary electrical contacts defined by the conductive tracks 60 on the free face of the needle support 24 intended to be located in the case 2, in contact with the electrical connectors 48.

The sensor assembly can be manufactured by any known suitable manufacturing method without departing from the scope of the present invention. Thus in particular, the needle support 24 may be manufactured by conventional molding, the conductive tracks 60 then being overmolded during the molding operation. Alternatively, it is possible to manufacture the needle support 24 by implementing 3D printing techniques, preferably with simultaneous production of the conductive tracks 60.

[0051] Furthermore, it is possible to provide any construction and any manufacturing material suitable for the needle 22, in particular as regards the way in which the sensor 49 is made integral with it, without however 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 interstitial fluid of the patient.

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 sensor assembly, as well as the bottom if necessary, after each predefined period, of the order of a few weeks, while by continuing to use the same cover as well as all the components it contains, in particular all the 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 sensor assembly 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 even by means of a current external electronic device. tablet or smartphone.

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.

[0056] 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 body fluid of a patient according to the characteristics of the present invention as defined in the claims.

Claims (11)

1. Portable device (1) for the continuous analysis of a patient's bodily fluid comprising a housing (2) comprising a bottom (6) having a main outer face (12) comprising a hole (18) through which is arranged a needle (22) carrying a sensor (49) intended to analyze a bodily fluid of the patient, said main external face (12) being intended to be applied against the skin of the patient for a predefined duration, via a adhesive material (10), such that said needle (22) punctures the patient's skin and said sensor (49) is in contact with the patient's bodily fluid to allow continuous analysis thereof, characterized in that it comprises a needle support (24) at least partially housed in the hole (18) of said bottom (6), in that said needle (22) has a head (74) of which at least one transverse dimension is greater than its average transverse dimension, said head (74) being arranged in a housing of said needle holder (24), so as to making said needle (22) and said needle support (24) integral with each other, said head (74) carrying at least one primary electrical contact (80) arranged in electrical connection with said sensor (49), and in that said needle support (24) comprises at least one conductive track (60) arranged to be connected to said primary electrical contact (80), inside said housing, and to define a secondary electrical contact arranged on a free face of said needle support (24) located inside said box (2), to allow the implementation of an electrical connection between said sensor (49) and at least one electronic circuit (46) housed in said box (2). 2. Device (1) according to claim 1, characterized in that said head (74) carries at least two, preferably at least three, primary electrical contacts (80) each of which is associated with a conductive track (60) and with a secondary electrical contact of said needle holder (24). 3. Device (1) according to claim 1 or 2, characterized in that it comprises at least one printed circuit (40) carrying said at least one electronic circuit (46) and an electrical connector (48) by electrical contact secondary of the needle support (24), arranged to establish an electrical connection between said at least one electronic circuit (46) and said corresponding secondary electrical contact. 4. Device (1) according to claim 3, characterized in that said printed circuit (40) is arranged in said box (2) such that said electrical connector or connectors (48) are positioned in abutment against said support of needle (24) to hold the latter bearing against said bottom (4). 5. Device (1) according to claim 4, characterized in that said box (2) comprises a cover (4) associated with said bottom (6) and defining a housing in which is housed said printed circuit (40), said housing being closed, on its side arranged facing said bottom (6), by a closure plate (50) having a hole (54) per electrical connector (48), through which the latter is arranged. 6. Device (1) according to claim 5, 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 pressure that said closing plate (50) applies to it. 7. Device (1) according to claim 5 or 6, characterized in that it comprises a seal (38) 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) so as to seal said case (2). 8. Device (1) according to one of claims 5 to 7, characterized in that said cover (4) and said bottom (6) are secured to each other by screwing or by a bayonet-type connection . 9. Device (1) according to one of the preceding claims, characterized in that it is arranged to analyze the patient's blood sugar, said sensor (49) comprising three electrodes intended to be positioned in contact with the patient's body fluid. 10. Sensor assembly for a portable device (1) for the continuous analysis of a patient's bodily fluid, of the type comprising a case (2) comprising a bottom (6) having a main outer face (12) comprising a hole (18) through which is intended to be arranged a needle (22) carrying a sensor (49) intended to analyze a bodily fluid of the patient, the main external face (12) being intended to be applied against the skin of the patient for predefined time, via an adhesive material (10), such that the needle (22) punctures the patient's skin and the sensor (49) is in contact with the patient's bodily fluid to allow continuous analysis, the sensor assembly comprising a needle support (24) shaped to be able to be at least partially housed in the hole (18) of the housing (2), said needle support (24) carrying a needle (22) itself carrying even a sensor (49), the sensor assembly being characterized in that said needle (22) has a head (74) of which at least one transverse dimension is greater than its average transverse dimension, said head (74) being arranged in a housing of said needle holder (24), so as to making said needle (22) and said needle support (24) integral with each other, said head (74) carrying at least one primary electrical contact (80) arranged in electrical connection with said sensor (49), and in that said needle support (24) comprises at least one conductive track (60) arranged to be connected to said primary electrical contact (80), inside said housing, and to define a secondary electrical contact arranged on a free face of said needle support (24) intended to be located inside the case (2), to allow the implementation of an electrical connection between said sensor (49) and at least one electronic circuit (46 ) of the device (1) housed in the box (2). 11. A method of manufacturing a sensor assembly according to claim 11, comprising the steps of: – provide a needle (22) carrying a sensor (49) and having a head (74) of which at least one transverse dimension is greater than the average transverse dimension of said needle (22), said head (74) bearing at at least one primary electrical contact (80) arranged in electrical connection with said sensor (49), – manufacture at least two portions (70) of needle support (24) intended to be assembled together to define a needle support (24), said portions (70) being shaped in such a way that they define between them a housing for the head of said needle (22) when they are assembled together, said portions (70) being arranged in such a way that said needle support (24) comprises at least at least one conductive track (60) arranged so as, on the one hand, to be positioned against said primary electrical contact (80) of said needle (22), inside said housing, and, on the other hand, to define a secondary electrical contact arranged on a free face of said needle support (24) intended to be located inside the case (2), to allow the implementation of an electrical connection between said sensor (49) and at least an electronic circuit (46) of the device (1) housed in the box (2), and – assembling said portions (70) with the interposition of said needle (22) in such a way that its head (74) is embedded inside said housing, to make said needle (22) integral with said needle holder (24) while making electrical contact between said sensor (49) and the secondary electrical contact of said needle holder (24).