WO2021250232A1

WO2021250232A1 - Portable device for continuous analysis of a body fluid of a patient

Info

Publication number: WO2021250232A1
Application number: PCT/EP2021/065759
Authority: WO
Inventors: Philippe FRABOULET
Original assignee: Sensible Holding B.V.
Priority date: 2020-06-12
Filing date: 2021-06-11
Publication date: 2021-12-16
Also published as: CH717521A2

Abstract

The invention relates to a device (1) for the continuous analysis of a body fluid of a patient, the device comprising a housing (2) a hole (18) through which a needle (22) supporting a sensor (49) for analyzing the patient's body fluid is placed, and being characterized in that it comprises a needle holder (24) at least partially housed in the hole (18), that the needle (22) has a head (74) placed in a housing of the needle holder (24) and supporting at least one primary electrical contact (80) electrically connected to the sensor (49), and that the needle holder (24) includes at least one conductive track (60) configured so as to be connected to the primary electrical contact (80) and to define a secondary electrical contact located on a free face of the needle holder (24) located inside the housing (2), in order to enable the implementation of an electrical connection between the sensor (49) and at least one electronic circuit (46) housed in the housing (2). Drawing_references_to_be_translated

Description

PORTABLE DEVICE FOR CONTINUOUS ANALYSIS OF A PATIENT'S BODY FLUID

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 housing comprising a base having a main external face comprising a hole through which is arranged a needle carrying a sensor intended to analyze a body fluid of the patient, the main external face being intended to be applied against the skin of the patient for a predefined period of time, via an adhesive material, such that the needle punctures the skin of the patient and the sensor is in contact with the body fluid of the patient to allow continuous 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 Abbott company 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 a continuous measurement of a patient's blood sugar for fourteen days in a row. For this purpose, 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 patient's skin by means of the applicator. This device comprises a waterproof case 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, that the measuring device is 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 is replaced, but also all the electrical and electronic part, that is to say all the electronic circuits as well as the power source of the device. While such an approach makes it possible to simplify the assembly of the device, in particular with the aim of making the casing waterproof, 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, ie here fourteen days.

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

Disclosure of the invention

[0006] A main aim of the present invention is to provide a construction of a device for continuous analysis of a patient's body fluid allowing ergonomic and simple placement of the device by the patient himself, on his skin. , while being produced in the form of removable modules to offer the possibility of using certain components of the device having a sufficient lifespan over several analysis periods, and without however adversely affecting 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 from a patient, of the type mentioned above, characterized in that it comprises at least one needle holder. partially housed in the hole in the bottom of the housing, 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 needle holder integral with one another, the head bearing at the 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 an electrical contact secondary arranged on a free face of the needle support located inside the housing, to allow the implementation of an electrical connection between the sensor and at least one electronic circuit housed in the housing.

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 body 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 housing at the end of the analysis period, before or after. having removed the casing from the patient's skin, so as to subsequently be able to associate the casing and at least part of the components that it contains with a new sensor assembly carrying a new needle, itself carrying a new sensor.

Preferably, one can advantageously provide that the head of the needle carries 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 holder .

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

In this case, one can advantageously provide that the printed circuit is arranged in the housing such that the connector (s) electrics are positioned in abutment against the needle support to keep the latter resting against the bottom.

More particularly in this case, provision can be made for the housing 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 comprising one hole per electrical connector, through which the latter is arranged.

In addition, provision can 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 and, preferably, that the device comprises a sealing gasket housed in an annular groove formed in one of the elements among the cover and the bottom, and arranged to bear against an annular surface of the other element among the cover and the bottom so as to ensure the sealing of the housing. Thus, all the electrical or electronic components of the device are protected inside the housing.

Provision can advantageously be made for the cover and the bottom to be made integral with one another by screwing or by a bayonet-type connection.

The present invention also relates to a sensor assembly, comprising a needle support meeting the above characteristics and associated with a needle carrying a sensor, as well as its manufacturing process, comprising the steps of:

- Provide 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 to each other 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. 'needle when assembled to each other, the portions being arranged such that the needle holder 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, define a secondary electrical contact arranged on a free face of the needle support intended to be located at the inside the housing, to allow the implementation of an electrical connection between the sensor and at least one electronic circuit of the device housed in the housing, and

- assemble the portions with the needle interposed so 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 needle clamp.

Brief description of the drawings

Other characteristics and advantages of the present invention will emerge 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 :

- Figure 1 shows a simplified perspective view of an analysis device according to a preferred embodiment of the invention;

FIG. 2 represents a simplified exploded perspective view of the analysis device of FIG. 1;

- Figures 3a and 3b show simplified cross-sectional views of the analysis device of Figure 1, along two respective section 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.

Mode (s) for carrying out the invention

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

Figure 1 shows a simplified perspective view of a device 1 for continuous analysis of a body fluid of a patient, here by way of example non-limiting illustration 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 made removably integral with one another, as will emerge from the remainder of the description.

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

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 that is substantially complementary to that of the wall 14 such that the housing 2 has a generally soft shape, without sharp edges.

[0023] FIG. 2 represents a simplified exploded perspective 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 having 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 formed in the main external face 12 to improve the strength 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 perforate the skin of the patient to be positioned in contact with the interstitial fluid of the patient and to carry out the continuous analysis thereof.

The needle 22 is carried by a needle support 24 having two stages. An external first 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, like this will emerge from the remainder of the description.

The base plate 8 is made integral with the wall 14 by any suitable operation, for example by gluing or by 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 apart. the interior of the wall 14, each of which is followed by a stop 32.

[0030] In a complementary manner, the cover 4 comprises a cylindrical flank 34 carrying four ears 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 can 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 screw thread.

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

Furthermore, the domed shape of the cover 4 and its cylindrical flank 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 circuit for wireless communication with an external electronic device (either a dedicated terminal, portable or not, or a tablet or a smartphone).

The printed circuit 40 further carries three electrical connectors 48 arranged to allow the establishment of an electrical connection between the electronic circuits 46 and a sensor (reference numeral 49, in FIG. 4) carried by the needle 22 and adapted to carry 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 which it carries in the housing of the cover 4.

For this purpose, the closure plate 50 is intended to be fitted inside the cylindrical side 34 of the cover 4, until it is positioned in abutment against a suitable internal shoulder 52. Optionally, provision can be made to glue or weld the closure plate 50 in the 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 housing of the cover 4.

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 more clearly certain construction details.

It emerges 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 made integral with the bottom 6, the sealing gasket 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 comprises several abutment surfaces 58 bearing against which the printed circuit 40 is positioned under the effect of the pressure of the closure plate 50. So optionally, there is preferably a plurality of compressible components 58 integral with the printed circuit 40 to define mechanical stops in relation to the closure plate 50.

We see that the power source 44 can advantageously be wedged against the bottom of the housing of the cover 4, to be properly held in place during movements of the housing 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, ensures 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.

Indeed, the electrical connectors 48 are arranged in abutment against the needle support 24 in particular for a mechanical purpose, to help maintain, on the one hand, 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 needle. sensor 49 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 49 and the electronic circuits 46. Thus, the abutting positioning of the electrical connectors 48 against the needle support 24 ensures the establishment of these electrical connections. Advantageously as an option, 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 possible variations in distance between the printed circuit. and needle support from one device to another.

We also see 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 support 24, to ensure its correct positioning and its retention in square.

Figures 4 and 5 illustrate in more detail the structure and construction of the sensor assembly, that is to say the needle holder 24 when associated with the needle 22, itself carrying the sensor 49, in respective views in exploded perspective and from above simplified. It is seen in Figure 4 that the needle support 24 can advantageously be produced in the form of two portions 70 assembled to one another with the interposition of the needle 22. For this purpose, the portions 70 have recesses 72 arranged to be located opposite one another and to 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-shaped, 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 is locked therein and the needle 22 is made integral with the needle support 24.

It also emerges 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 housing 2, in contact with the electrical connectors 48.

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

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 leaving within the scope of the invention. Thus, for example, provision could be made for the needle to be made of silicon with a deposition of electrodes and conductive tracks produced in a conventional manner. Those skilled in the art will be able to 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 contacting the sensor with the patient's interstitial fluid.

It emerges from the above that the continuous analysis device according to the present invention offers a particularly advantageous construction. Indeed, the housing 2 of the analysis device has a relatively compact construction thus ensuring great wearing comfort. In addition, its seal allows the patient to exercise certain physical activities such as swimming, for example, without the risk of compromising the proper functioning of the analysis device. In addition to these advantageous characteristics, the construction of the housing allows the patient, by very simple manipulations, to replace only the sensor assembly, as well as the bottom possibly, after each predefined period, of the order of a few weeks, any 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 can optionally be made for the base to also be reusable and for only the adhesive material and the sensor assembly to be replaced at the end of each period, without however 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 terminal, fixed or portable, or even by means of a current external electronic device. tablet or smartphone type.

It will be noted that the constituent elements of the housing 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 attempts 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 glucose, the exact shapes of the constituent elements of the box as illustrated and described, or the number of connectors necessary to ensure the electrical connection between the electronic circuits and the sensor.

In general, a person skilled in the art will not encounter any particular difficulty in adapting the present teaching according to his 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

1. Device (1) portable for continuous analysis of a patient's body fluid comprising a housing (2) comprising a bottom (6) having a main external face (12) comprising a hole (18) through which is arranged a needle (22) carrying a sensor (49) intended to analyze a body fluid of the patient, said main external face (12) being intended to be applied against the skin of the patient for a predefined duration, by means of a adhesive material (10), such that said needle (22) perforates the skin of the patient and that said sensor (49) is in contact with the body fluid of the patient to allow continuous analysis thereof, characterized in that it comprises a needle holder (24) at least partially housed in the hole (18) of said base (6), in that said needle (22) has a head (74) of which at least one transverse dimension is greater than its transverse dimension medium, said head (74) being arranged in a housing of said sup needle port (24), so as to make said needle (22) and said needle holder (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 holder (24) comprises at least one conductive track (60) arranged so as to be connected to said primary electrical contact (80), inside of said housing, and in defining a secondary electrical contact arranged on a free face of said needle support (24) located inside said housing (2), to allow the implementation of an electrical connection between said sensor (49). ) and at least one electronic circuit (46) housed in said housing (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 holder (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 housing (2) such that said or said electrical connectors (48) are positioned in abutment against said support. needle (24) to keep the latter resting against said bottom (4).

5. Device (1) according to claim 4, characterized in that said housing (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 opposite said bottom (6), by a closure plate (50) comprising a hole (54) by an 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 closure 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 from 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 housing (2).

8. Device (1) according to one of claims 5 to 7, characterized in that said cover (4) and said bottom (6) are made integral with one another 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 continuous analysis of a patient's body fluid, of the type comprising a housing (2) comprising a bottom (6) having a main external face (12) comprising a hole (18) through which is intended to be arranged a needle (22) carrying a sensor (49) intended to analyze a body fluid of the patient, the main external face (12) being intended to be applied against the skin of the patient for a predefined period of time, via an adhesive material (10), such that the needle (22) punctures the skin of the patient and the sensor (49) either in contact with the patient's body 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 holder (24) carrying a needle (22) itself carrying 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 mean transverse dimension, said head (74) being arranged in a housing of said needle holder (24), so as to make said needle (22) and said needle holder (24) integral with one of the 'other, said head (74) carrying at least one primary electrical contact (80) arranged in connection electrical 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 in defining a secondary electrical contact arranged on a free face of said needle support (24) intended to be located inside the housing (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 housing (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),

- manufacturing 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 one to the other, said portions (70) being arranged such that said needle support (24) comprises 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, defining a secondary electrical contact arranged on a free face of said needle support (24) intended to be located inside of the housing (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 housing (2), and

- Assemble said portions (70) with the interposition of said needle (22) such that its head (74) is embedded inside said housing, to make said needle (22) integral with said needle support (24) while by making electrical contact between said sensor (49) and the secondary electrical contact of said needle holder (24).