Diabetes treatment device

Abstract

The invention relates to a device for treating diabetes (1) in an individual, comprising:- at least one heat generator (5) configured to locally apply a quantity of heat in a target skin area of an individual;- at least one magnetic field generator (4) configured to locally generate a magnetic field in said target area;- a calculation unit (14) configured to calculate the application parameters of the heat generator (5) and the application parameters of the magnetic field generator (4) from a set of parameters representative of a glycemic state of an individual;- a control unit (3) configured to synchronously control the heat generator (5) and the magnetic field generator (4) so that the heat (Q) and the magnetic field (B) are applied simultaneously in said target skin area. Abstract figure: Figure 1

Description

Title of the invention: Diabetes treatment device Technical field

[0001] The present invention relates to the field of diabetes treatment. The invention relates to a diabetes treatment device which makes it possible to reduce or increase blood sugar levels by simultaneous and localized applications of heat and a magnetic field to certain skin areas of a human body. Prior art

[0002] Diabetes mellitus is caused by excessively high blood glucose levels. This is a sign of a patient's body's inability to metabolize glucose. Glucose metabolism depends on insulin, a hormone secreted by pancreatic 13-cells in the islets of Langerhans in the pancreas.

[0003] In some patients with diabetes mellitus, the pancreatic 13-cells are either destroyed or insufficient, and there is no longer any insulin secretion or secretion in adequate quantities (so-called "type 1" diabetes).

[0004] In so-called "type 1" diabetes, treatment generally involves injecting doses of insulin into a patient's body, sometimes several times a day, and monitoring the patient's diet.

[0005] A limited number of people with another type of diabetes mellitus called "type 2" (the patient's cells whose role is to capture and use glucose thanks to insulin become insensitive to insulin) also resort to insulin injections.

[0006] In order to determine blood sugar levels, the following procedure is generally followed. A patient's finger is pricked with a needle and pressed to cause a drop of blood to appear. A strip connected to a dedicated device for determining blood sugar is applied to the drop of blood. The device generally displays the patient's blood glucose level (glycemia) on an LCD screen. A decision is then made as to whether to administer an insulin injection. This is a cumbersome and time-consuming operation.

[0007] Devices implantable in a living body are also known for continuous monitoring of blood glucose in a patient's body. Generally, such implantable devices comprise a biosensor configured to measure parameters in the blood, and in particular a glucose level. Such a biosensor is an electrochemical sensor comprising electrodes in contact with the blood. The electrodes generate an electrical signal proportional to the concentration of glucose in the blood. The device also comprises a communication system configured to establish communication with an external device in order to transmit the measured data.

[0008] Insulin or glucagon needs depend on the person's physical and intellectual condition and activity and are regulated by hormones. Currently, conventional treatment, regardless of the type of diabetes, consists of injecting doses of insulin or glucagon into the patient's body. This is an invasive operation, and relatively restrictive for the patient.

[0009] Furthermore, treatments by injection of insulin or glucagon are not entirely satisfactory. Indeed, a distribution of insulin or glucagon continuously over time could lead to the establishment of insulin resistance in the patient, that is to say in which, despite the presence of insulin or glucagon, the patient's body is no longer able to establish its homeostasis.

[0010] An aim of the present invention is to propose a diabetes treatment device which is non-invasive and not very restrictive for the patient, and which can be used easily by the patient himself or by the practitioner.

[0011] Another aim of the present invention is to propose a device which makes it possible to regulate and in particular to reduce or increase blood sugar levels depending on the patient's determined glycemic state, thus leading to a reduction in the consumption of insulin or glucagon, and to lighten their treatment in their daily medical monitoring.

[0012] The object of the invention is also to provide a treatment device which can be used in combination with an insulin delivery device in order to adapt the dose of insulin to be injected according to the patient's need for insulin or glucagon.

[0013] The applicant has discovered that a combined localized application of a heat source and a magnetic field on certain skin areas close to the organs, such as the pancreas, of the patient makes it possible to regulate blood sugar, and in particular to reduce or increase blood sugar in the patient. Summary

[0014] The present disclosure improves the situation.

[0015] According to a first aspect, the present invention is a device for treating diabetes in an individual, comprising: - at least one heat generator configured to locally apply a quantity of heat to a target skin area of an individual; - at least one magnetic field generator configured to locally generate a magnetic field in said target area; - a computing unit configured to calculate the heat generator application parameters and the field generator application parameters magnetic from a set of parameters representative of an individual's glycemic state; - a control unit configured to synchronously control the heat generator and the magnetic field generator so that the heat (Q) and the magnetic field (B) are applied simultaneously in said target skin area.

[0016] The features set out in the following paragraphs may, optionally, be implemented, independently of one another or in combination with one another:

[0017] The application parameters include a heat generator application time (Te), a magnetic field generator application time (Tm), the magnetic field intensity (B), the heat quantity (Q).

[0018] The control unit is configured to control the heat generator and the magnetic field generator according to a cyclical application profile consisting of a heat and magnetic field application time followed by a pause time for the same glycemic state of the individual.

[0019] The cyclic application profile comprises five application cycles, each cycle consisting of a heat and magnetic field application time followed by a pause time.

[0020] According to one embodiment, the device comprises an application module comprising a hollow body having a longitudinal central axis, the hollow body comprising a proximal end and a distal end, the distal end being adapted to be positioned on the external surface of a target area of the skin of the individual, the hollow body comprising a housing adapted to receive a heat generator, a magnetic field generator and the control unit.

[0021] According to another embodiment, the device comprises at least two separate application modules each comprising a hollow body, the hollow body having a longitudinal central axis, each hollow body comprising a proximal end and a distal end, the distal end being adapted to be positioned on the external surface of a target area of the skin of an individual, each hollow body comprising a housing adapted to receive a heat generator and a magnetic field generator, the modules being connected to the control unit.

[0022] Preferably, the heat generator is an infrared lamp having a power of between 20 and 80 Watts, preferably between 20 and 55 Watts.

[0023] According to one embodiment, the lamp has a longitudinal central axis, the infrared lamp being arranged in the module so that its central axis coincides with the central axis of the module.

[0024] Preferably, the magnetic field generator comprises at least one turn wound in a spiral shape around a central axis, the turn being arranged so as to surround the lamp so that the central axis of the turn coincides with the central axis of the lamp.

[0025] According to one embodiment, the device further comprises an energy source configured to power the generators and a storage memory for storing the application parameters and the parameters representative of the glycemic state of the individual. Brief description of the drawings

[0026] Other characteristics, details and advantages will appear on reading the detailed description below, and on analyzing the attached drawings, in which: Fig.l

[0027] [Fig.l] is an illustration of a device for treating diabetes in a patient according to one embodiment. Fig. 2

[0028] [Fig.2] is a schematic sectional view of the diabetes treatment device according to one embodiment. Fig. 3

[0029] [Fig. 3] is a schematic view of the diabetes treatment device according to another embodiment. Fig. 4

[0030] [Fig.4] shows an exemplary embodiment of a diabetes treatment apparatus comprising a diabetes treatment device intended to be positioned near the external surface of an area of a patient's skin and a blood glucose measuring device. Description of the embodiments

[0031] The regulation of blood sugar involves a large number of organs and regulatory systems such as the endocrine and nervous systems which control the homeostasis of an individual. Blood sugar is one of the parameters representing the state of relaxation of an individual and is physiologically regulated around a reference value, generally between 0.80 and 1.10 g / l of blood for a healthy individual when fasting.

[0032] The present invention provides a diabetes treatment device which is adapted to locally apply heat and a magnetic field to a skin area of a human body for a determined application time in order to decrease or increase blood sugar levels. Such a device is particularly suitable for use in a patient suffering from diabetes in order to decrease or increase their blood sugar level so that it is close to its normal reference value. This treatment device is non-invasive, and easy to implement by the patient or practitioner. The use of this device thus makes it possible to induce a reduction in the quantity of insulin or glucagon to be injected into the patient during their medical monitoring, thus limiting the phenomenon of insulin resistance or resistance to glucagon.

[0033] A diabetes treatment device 1 according to one embodiment is described below with reference to Figures 1 to 3. The same reference numbers are used to describe identical elements of the system.

[0034] The diabetes treatment device 1 comprises an applicator 10 configured to apply an amount of heat and a magnetic field to the external surface of a target area of a patient's skin and a central computing unit 11 configured to transmit control signals to the applicator 10.

[0035] The applicator 10 comprises: - a heat generator 5 (LAMP) configured to locally apply heat to the target area of the patient; - a magnetic field generator 4 (COIL) configured to locally apply a magnetic field in the same area; - a control unit 3 (CONTROLLER) configured to synchronously control the heat generator 5 and the magnetic field generator 4 to simultaneously apply the heat source and the magnetic field in the target skin area for a predetermined application time.

[0036] The term "applied locally" or "local application" means any application of heat and magnetic field to a skin area closest to one of the organs, for example the pancreas, thyroid, pituitary gland and hypothalamus, so as to induce a thermal variation in the organ.

[0037] The central unit 11 (CENTRAL UNIT) comprises a communication interface 12 (INT2), a storage memory 13 (MEM) and a calculation unit 14 (CALC). The central unit 11 is configured to generate a control signal intended to be transmitted to the control unit 3 of the applicator 10 to activate in a synchronized manner the heat generator and the magnetic field generator in order to apply a quantity of heat and a magnetic field with a given profile during a predefined application time.

[0038] The control unit 3 of the Applicator also comprises a communication interface 9 (INT1) which allows communication with the central unit 11 to receive the control signal.

[0039] The applicator 10 further comprises a power source 6 providing electrical energy to the heat generator 5 and the magnetic field generator 4 when the user uses the diabetes treatment device. The power source 6 can also provide energy to the control unit 3. The power source is formed for example by four 3.7 Volt lithium cells. The applicator also includes a charging connector 7 for charging the energy source 6 and a visual and / or audible indicator of the state of charge of the lithium battery (not shown in [Fig.2]).

[0040] The communication interface 12 is configured to communicate with the control unit 3 of the applicator and with a blood glucose measuring device 30 of the patient. The communicator interface 12 is also configured to communicate with an external database to retrieve, for example, medical data relating to the patient.

[0041] The storage memory 13 is adapted to store data transmitted by the blood glucose measuring device 30, the data retrieved from the database as well as the data entered for example by the patient and / or the practitioner before using the applicator via an input device. It also makes it possible to store all the operations carried out by the applicator. The data form a set of parameters representative of the patient's glycemic state.

[0042] According to one embodiment, this set of parameters comprises blood glucose values of the patient measured by any measuring device known to those skilled in the art. This set of parameters may comprise at least one other parameter chosen from the following parameters: the temperature of the target skin area, the overall body temperature of the patient, the heart rate, the weight, the age, the time of the last insulin injection, the nature of the organ located near the target skin area.

[0043] The calculation unit 14 is configured to calculate, from the parameters representative of the patient's glycemic state, application parameters of the heat generator and the magnetic field generator and generates a control signal intended to be transmitted to the applicator to activate the heat generator 5 and the magnetic field generator 4.

[0044] The application parameters include a quantity of heat Q to be applied by the heat generator, the intensity of the magnetic field applied by the magnetic field generator B and the application time At.

[0045] According to one embodiment, the central unit 11 and the applicator 10 are two distinct physical entities which are put into communication via the two communication interfaces 9, 12. The central unit can be for example a smart mobile phone or a smart watch, a tablet or a computer.

[0046] The communication interfaces 9, 12 are for example of the short-range radio interface type of Bluetooth, Wifi or a communication interface of the 2G, 3G, 4G or 5G type.

[0047] According to another embodiment not illustrated, the central unit 11 and the applicator 10 are integrated into a single physical entity. In this case, the treatment device comprises a single central unit which comprises the calculation unit 14, the storage memory 13, the control unit 3 and a single communication interface to allow the diabetes treatment device to communicate with a device for measuring the patient's blood sugar and with an external database to retrieve, for example, medical data relating to the patient.

[0048] An embodiment of the applicator 10 is described below with reference to [Fig. 2]. The applicator 10 comprises a module 2 which extends along a longitudinal axis 23. The module is in the form of a hollow body comprising a proximal end 21 and a distal end 22. The module 2 comprises an internal housing 24. The two generators 4, 5, the control unit 3 and the energy source 6 are arranged in the housing 24. The two generators 4, 5 are arranged at the distal end. The distal end 22 of the module 2 comprises an opening adapted for the emission of heat and the magnetic field towards the target skin area.

[0049] In the context of the present invention, the term "proximal" means the position closest to the application area of interest, i.e. the target skin area, while the term "distal" should herein be understood as meaning the furthest from the target skin area. In other words, the distal end of the applicator is the end positioned opposite the target area.

[0050] According to one embodiment, the heat generator 5 is configured to generate heat through the opening of the distal end. This heat generator comprises an infrared source, preferably an infrared lamp having a power of between 20 and 80 Watts, preferably between 20 and 55 Watts.

[0051] In the example of [Fig.2], the lamp has a longitudinal central axis coincident with the longitudinal axis 23 of the hollow body of the module 2. Preferably, the lamp 5 comprises a copper shield adapted to limit the diffusion of the electric field produced by the lamp beyond a determined zone.

[0052] According to the example of [Fig.2], the magnetic field generator 4 is configured to generate a magnetic field at the distal end. The generator 4 comprises a coil wound in a spiral shape around the longitudinal central axis 23. The coil comprises at least one loop. According to one exemplary embodiment, the coil comprises a single loop. According to another exemplary embodiment, the coil comprises several loops.

[0053] The coil comprises, for example, a circular section. In the example of [Fig.2], the coil 4 is arranged so as to surround the lamp so that the central axis of the coil coincides with the central axis of the lamp. In other words, the axis longitudinal central axis 23 of the module, the central axis of the lamp and the central axis of the coil are merged. The heat generated by the lamp and the magnetic field lines generated by the coil propagate towards the target skin area in a common coverage region.

[0054] The profile of the magnetic field is adjusted in intensity and shape by modulation of the current passing through the coil. This modulation is controlled by the control unit 3 according to the control signal transmitted by the calculation unit 11.

[0055] For example, the intensity of the generated magnetic field may be 1 Gauss at the application distance of the applicator, with a frequency between 10 Hz and 20 Hz. The waveform may be triangular or square.

[0056] According to another embodiment, the applicator may comprise a plurality of separate modules, each of the modules comprising a heat generator and a magnetic field generator. Each of the modules comprises a hollow body having a longitudinal axis 27, 28. The application modules are connected to a common control unit 3 which is configured to control the modules according to the clinical needs of the patient. The application modules are also each powered by a power source.

[0057] Such a device makes it possible to position the application modules according to the clinical needs of the patient near different target areas.

[0058] The control unit 3 is configured to activate the plurality of application modules. The activation configuration of the different application modules can be adapted according to the customer's needs. According to an exemplary embodiment, the control unit 3 is configured to simultaneously activate the plurality of modules. According to another exemplary embodiment, the control unit 3 is configured to sequentially activate the plurality of application modules.

[0059] In the exemplary embodiment illustrated in [Fig. 3], the diabetes treatment device comprises two application modules 17, 18 which each comprise a heat generator and a magnetic field generator. This device makes it possible, for example, to apply heat and a magnetic field simultaneously or successively to two distinct skin areas of an individual. In other words, the control unit 3 can transmit a control signal to activate the two application modules 17 and 18 simultaneously or successively. According to an exemplary embodiment, one of the application modules can be positioned near the skin area closest to the pancreas and the second application module near the skin area closest to the thyroid or the pituitary gland.

[0060] The diabetes treatment device of the present invention is easy to use and does not require the presence of a healthcare professional, however the collection of blood glucose data allows the patient or treating physician to view history. The patient can therefore use it as part of their medical monitoring of their blood sugar at home. The patient then does not need to go to the doctor.

[0061] With reference to [Fig.4], a blood glucose control method 100 is described below using a control system 100 comprising a blood glucose measuring device 30 and a diabetes treatment device 1 as described above.

[0062] The blood glucose measuring device 30 may be a device implantable in the patient's body. It may also be a device external to the patient's body. In the case where the blood glucose measuring device is implantable, the patient's blood glucose level may be monitored continuously or at regular intervals.

[0063] The blood glucose measuring device 30 comprises a sensor 31, a calculation unit 34 (CALC2) and a communication interface 32 (INT3) configured to communicate with the central unit 11 of the diabetes treatment device 1.

[0064] In the case where the measuring device is an implant in the human body, the sensor 31 of the blood glucose measuring device 30 is configured to continuously detect signals which are produced by the patient's body, depending on the need for insulin. These signals are then transmitted to the calculation unit 34 which is configured to determine from these signals a parameter representative of the patient's blood glucose. The parameter representative of the blood glucose is then transmitted by the blood glucose measuring device via the communication interface 32 to the central unit 11.

[0065] In the case where the measuring device is a device external to the human body, the patient's blood glucose level is generally measured by the patient several times a day, in order to check that he is not in a state of hypoglycemia. The frequency of this check depends on the physiological state of the patient. The calculation unit 34 of the measuring device is configured to determine the blood glucose level from a drop of blood taken from the patient. The determined blood glucose value is then transmitted by the blood glucose measuring device via the communication interface 32 to the central unit 11. According to another exemplary embodiment, the blood glucose value is entered manually by the patient or the practitioner on an input interface of the central unit 11 of the diabetes treatment device 11.

[0066] The calculation unit 14 calculates from this parameter and the other parameters which are previously stored in the storage memory 13 the application parameters of the heat generator 5 and the magnetic field generator 4. The calculation unit 14 generates a control signal which is transmitted to the applicator 10.

[0067] The applicator 10 of the diabetes treatment device is positioned proximate a target area of a patient's skin. The applicator is located outside the patient's body.

[0068] The heat generator, for example the lamp 5 and the magnetic field generator 4 are activated simultaneously to respectively provide a quantity of heat Q, a magnetic field B, for a determined time At according to the control signal transmitted by the calculation unit 14. The combined action of the application of heat and the magnetic field acts on the blood sugar value, and in particular leads to a reduction in blood sugar.

[0069] At the end of the application time, the control unit 3 stops the two generators 4, 5. The blood glucose level is measured again by the blood glucose measuring device 30 and the new blood glucose value is transmitted to the central unit 11. This new value is recorded in the storage memory 13 of the central unit. The calculation unit 14 is configured to compare the new blood glucose value with an initially set reference value, for example a value between 0.80 and 1.10 g / l of blood. According to another example, the calculation unit 14 is configured to determine whether the decrease in blood glucose is significant, for example of the order of 0.5 to 2 g / l of blood. If the new blood glucose value has not reached the reference value or the decrease is not sufficient, a second cycle of heat and magnetic field application is recalculated by the calculation unit 14 from the new blood glucose value.

[0070] The blood glucose measurement and the cycle of heat and magnetic field application are repeated until a blood glucose value close to the reference value or an acceptable decrease in blood glucose is obtained.

[0071] In another operating mode of the system, the generators 4 and 5 of the applicator are activated according to a pre-programmed treatment profile stored in the central unit. The treatment profile comprises, for example, five cycles of application of heat and magnetic field, lasting 1 minute followed by a 40-second pause. The power of the light sent by the heat generator 5, the intensity of the magnetic field of the magnetic field generator 4 and its profile are also predetermined. The applicator stops, for example, when the five application cycles have been executed.

[0072] According to another embodiment, the activation of the applicator, i.e. the simultaneous activation of the heat generator and the magnetic field generator, can be carried out manually by the user, namely the practitioner or the patient. The central unit displays the application parameters, i.e., for example, the intensity of the magnetic field B, the quantity of heat Q and the duration of application of the magnetic field Tm and the heat Te. The patient or the practitioner enters these parameters into the applicator to manually activate the applicator. Industrial application

[0073] Thanks to the simultaneous application of heat and the magnetic field, the system of the present disclosure makes it possible to regulate blood sugar and in particular to reduce or increase blood sugar which leads to a reduction in the need for insulin. Thus, in his daily medical monitoring, the patient can reduce the quantity of insulin to be injected into the body or the injection frequency. The present system can be used easily by the practitioner or the patient, to regulate blood sugar without the operation being invasive and restrictive for the patient.

Claims

Claims

1. Device for treating diabetes (1) in an individual, comprising: - a heat generator (5) configured to locally apply a quantity of heat in a target skin area of an individual; - a magnetic field generator (4) configured to locally generate a magnetic field in said target area; - a calculation unit (14) configured to calculate the application parameters of the heat generator (5) and the application parameters of the magnetic field generator (4) from a set of parameters representative of a glycemic state of an individual; - a control unit (3) configured to synchronously control the heat generator (5) and the magnetic field generator (4) so that the heat (Q) and the magnetic field (B) are applied simultaneously in said target skin area;- an application module (2) comprising a hollow body having a longitudinal central axis (23), the hollow body comprising a proximal end (21) and a distal end (22), the distal end being adapted to be positioned on the external surface of a target area of the skin of the individual, the hollow body comprising a housing adapted to receive a heat generator (5), a magnetic field generator (4) and the control unit (3).;

2. Device according to claim 1, wherein the application parameters comprise a time of application of the heat generator (Te), a time of application of the magnetic field generator (Tm), the intensity of the magnetic field (B), the quantity of heat (Q).

3. Device according to claim 1 or 2, wherein the control unit (3) is configured to control the heat generator (5) and the magnetic field generator (4) according to a cyclical application profile consisting of a heat and magnetic field application time followed by a pause time for the same glycemic state of the individual.

4. A device according to claim 3, wherein the cyclic application profile comprises five application cycles, each cycle consisting of a time of application of heat and magnetic field followed by a pause time.

5. Device according to one of claims 1 to 4, in which the heat generator (5) is an infrared lamp having a power of between 20 and 80 Watts, preferably between 20 and 55 Watts.

6. Device according to claim 5, in which the lamp has a longitudinal central axis, the infrared lamp being arranged in the module so that its central axis coincides with the central axis of the module (23).

7. Device according to claim 6, in which the magnetic field generator (4) comprises at least one turn wound in a spiral shape around a central axis, the turn being arranged so as to surround the lamp so that the central axis of the turn coincides with the central axis of the lamp.

8. Device according to one of claims 1 to 7, further comprising an energy source (6) configured to power the generators (4, 5) and a storage memory (13) for storing the application parameters and the parameters representative of the glycemic state of the individual.

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