Implant device for treating diseases using electrical fields

Abstract

The present invention relates to an implant device for treating diseases using electrical fields, comprising at least one electrode (500) for applying electrical fields to body tissue. The device is configured to be implanted in a person's body and comprises: an electrical field-generating module (100) with a voltage source (101) connected to a floating ground (102) and to the electrode (500) by means of at least one switch (103); a wireless charging module (200) configured to transform a variable magnetic field into an electric current; a wireless communication module (400) configured to receive electrical field generation instructions and to transmit information to an external device; and an energy management module connected to the wireless charging module (200), wherein the energy management module is configured to power the electrical field-generating module (100) and the wireless communication module (400).

Description

[0001] DESCRIPTION

[0002] Implant device for the treatment of pathologies using electric fields

[0003] Object of the invention

[0004] The present invention relates to an implant device for treating pathologies using electric fields. The implant device of the present invention can be used to treat various types of pathologies, such as tumors and, more particularly, glioblastoma, by applying electric fields.

[0005] Since it is an implantable device, it guarantees high efficacy in the direct application of treatment to tumor tissue, while eliminating the discomfort associated with current external devices, which patients must wear, with the associated inconvenience.

[0006] The implant device for treating pathologies using electric fields, object of the present invention, is of special application in the design, manufacture and marketing of medical devices.

[0007] Background of the invention and technical problem to be solved

[0008] Cancer is the second leading cause of death after cardiovascular disease. Glioblastoma is the most aggressive brain tumor, with an average survival rate of 16 to 18 months despite optimal treatment, including surgery, radiation therapy, and chemotherapy. This devastating scenario requires new lines of treatment.

[0009] Tumor Treating Fields (TTFields) are low-intensity, low-frequency alternating electric fields. Their mechanism of action is related to their antimitotic effects, which selectively disrupt cell division in tumor cells in various cancers such as glioblastoma, breast cancer, and lung mesothelioma.

[0010] TTFields have been shown to prolong survival and amplify the effect of chemotherapy in patients with glioblastoma multiforme (GBM), leading to their FDA approval for recurrent and newly diagnosed GBM.

[0011] Currently, there is one FDA-approved commercial device in the United States ("NovoTTF-100A System") that delivers TTFields. This device is for external use and cannot be implanted. In this device, TTFields are administered through a series of noninvasive transducers attached to the patient's skin, connected to a field generator and fitted with a portable battery at the waist (total weight 1.2 kg). The device consists of a helmet that patients wear after shaving their heads. Furthermore, it must be worn for at least 18 hours a day for the treatment to be effective. This device generates side effects on the skin and poses a significant social burden, which means its use and acceptance are limited.Skin complications have been described when using this device due to the irritating effect of the device and lack of adherence to treatment with the device due to the social burden of the oncology patient with a shaved head and a cumbersome helmet-type equipment placed on the head that the patient must wear practically all the time in what will be their last months of life.

[0012] Description of the invention

[0013] In order to overcome the aforementioned drawbacks, the present invention relates to an implant device for treating pathologies using electric fields. The implant device for treating pathologies using electric fields, object of the present invention, comprises at least one electrode for applying electric fields to at least one body tissue (e.g., brain tissue).

[0014] In a novel manner, the implant device for treating pathologies by means of electric fields, object of the present invention, is configured to be implanted in the body of a person and the device additionally comprises: or an electric field generation module connected to the at least one electrode, where the electric field generation module comprises at least one voltage source (for example, a battery) connected to a floating ground (a floating ground, such as, for example, a connection to the housing of the device), where the voltage source is connected to the at least one electrode by means of at least one switch configured to connect and disconnect the at least one electrode from the voltage source and where the electric field generation module comprises a microcontroller configured to control the opening and closing of the at least one switch;or a wireless charging module configured to transform a variable magnetic field (an energizing magnetic field originating from an external peripheral device) into an electric current; or a wireless communication module connected to the microcontroller, where the wireless communication module is configured to receive electric field generation instructions (and preferably also power-on, power-off, and low-power standby instructions) for treating at least one body tissue and to transmit information to an external device about operating parameters of the device and / or about body measurement parameters of the person implanted with the device, and;or a power management module connected to the wireless charging module, where the power management module is configured to power the electric field generation module and the wireless communication module. The device described above makes it possible to carry out a treatment by applying electric fields to body tissue, with a greater degree of effectiveness than other conventional devices, as it is a device configured to be implanted inside a person's body, thus applying the treatment closer to the tissue to be treated than in the case of conventional devices.

[0015] Additionally, through the device of the invention, described above, greater effectiveness of the treatments is ensured by guaranteeing total patient adherence to the treatment, since it is a device that does not cause discomfort to the user and that, once inserted into the user's body through surgery, remains permanently inserted inside the user's body.

[0016] Additionally, the device of the invention prevents the discomfort and burns caused to the skin by other conventional devices.

[0017] The device of the invention also eliminates the social stigma that was created by the application of conventional devices consisting of a helmet that the user had to wear for practically the entire day.

[0018] According to a first embodiment of the invention, the device comprises a single electrode and the electric field generation module comprises a single switch configured to connect and disconnect the electrode from the voltage source.

[0019] According to a second embodiment of the invention, the device comprises a single electrode and the electric field generation module comprises: either a first switch configured to connect and disconnect the electrode from the voltage source, and; or a second switch configured to connect and disconnect the electrode from the floating ground.

[0020] In this second embodiment, the device is configured such that: either when the first switch is in the closed state connecting the electrode to the voltage source, the second switch is in the open state, keeping the electrode isolated from the floating ground (and at a potential different from the floating ground), and; or when the first switch is in the open state keeping the electrode isolated from the voltage source, the second switch is in the closed state, keeping the electrode connected to the floating ground.

[0021] According to a third embodiment of the invention, the device comprises two electrodes and the electric field generation module comprises: either a first switch configured to connect and disconnect a first electrode from the voltage source; or a second switch configured to connect and disconnect the first electrode from the floating ground; or a third switch configured to connect and disconnect a second electrode from the voltage source, and; or a fourth switch configured to connect and disconnect the second electrode from the floating ground.

[0022] In this third embodiment, the device is configured such that: either when the first switch is in a closed state connecting the first electrode to the voltage source, the second switch is in an open state keeping the first electrode isolated from the floating ground, the third switch is in an open state keeping the second electrode isolated from the voltage source and the fourth switch is in a closed state connecting the second electrode to the floating ground, and; or when the first switch is in an open state keeping the first electrode isolated from the voltage source, the second switch is in a closed state connecting the first electrode to the floating ground, the third switch is in a closed state connecting the second electrode to the voltage source and the fourth switch is in an open state keeping the second electrode isolated from the floating ground.

[0023] Through the various embodiments described, it is achieved that there is always a difference in electrical potential between the electrodes and, therefore, an electric field applied to the body tissue inside the body of the user of the device.

[0024] According to one possible configuration of the device, the wireless charging module comprises: either an antenna that in turn comprises a coil configured to transform the variable magnetic field into an alternating current, and; or a rectifier connected to the antenna, where the rectifier is configured to convert the alternating current into direct current.

[0025] The wireless communication module may be configured to transmit to an external device information about the remaining power level (battery level) of the device and / or the temperature at which the device is located.

[0026] The device may comprise a temperature sensor and may be configured to measure the temperature of body tissue. In this case, the wireless communication module may be configured to transmit information about the temperature of the body tissue to an external device. As already introduced, the device of the invention may be configured to be implanted inside the skull of a person. In this case, the device may comprise a brain electrical activity sensor configured to measure the electrical activity of brain body tissue. Likewise, in this case, the wireless communication module may be configured to transmit information about the brain electrical activity of the person implanted with the device to an external device.

[0027] Preferably, the at least one electrode is made of a biocompatible material. Preferably, all electrodes are made of a biocompatible material.

[0028] Furthermore, preferably, the at least one switch is a transistor.

[0029] Brief description of the figures

[0030] A series of figures, non-limiting examples, are briefly described here, which help to better understand the invention:

[0031] Figure 1 shows a schematic view of the different modules that can be incorporated into the implant device for treating pathologies using electric fields.

[0032] Figure 2 shows a schematic view of the electric field generation module, according to a first embodiment of the implant device for treating pathologies using electric fields.

[0033] Figure 3 shows a schematic view of the electric field generation module, according to a second embodiment of the implant device for treating pathologies using electric fields. Figure 4 shows a schematic view of the electric field generation module, according to a third embodiment of the implant device for treating pathologies using electric fields.

[0034] Figure 5 shows a schematic view of a possible embodiment of the wireless charging module.

[0035] Detailed description

[0036] The following is a description of some possible embodiments of the implant device for treating pathologies using electric fields.

[0037] As shown in Figure 1, according to preferred embodiments of the invention, the device comprises an electric field generation module (100), a wireless charging module (200), a power management module (300) and a wireless communication module (400).

[0038] The device also comprises at least one electrode (500) configured to apply an electric field to a body tissue. This at least one electrode (500) is made of a biocompatible material, and is the element of the device responsible for applying the electric field or electric fields to the surrounding body tissue or tissues.

[0039] The electric field generation module (100) comprises a voltage source (101) (typically a battery) connected to a floating ground (102) or local ground (for example, the device housing).

[0040] The voltage source (101) is connected to the at least one electrode (500) via at least one switch (103) (e.g., a transistor). According to a first embodiment of the device, shown in Figure 2, the device comprises a single electrode (500) and the electric field generation module (100) comprises a single switch (103) configured to connect and disconnect the voltage source (101) to said electrode (500).

[0041] According to this first embodiment of the device, the electrode (500) is floating, that is, it is not connected to ground or mass.

[0042] According to a second embodiment of the device, shown in Figure 3, the device comprises a single electrode (500) and the electric field generation module (100) comprises two switches (103), where a first switch (103a) is configured to connect and disconnect the voltage source (101) to the electrode (500) and a second switch (103b) is configured to connect and disconnect the electrode (500) from the floating ground (102).

[0043] In this second embodiment of the device, the switches (103) are configured to work in a complementary manner, that is, when the first switch (103a) is closed (connecting the electrode (500) to the voltage source (101)), the second switch (103b) is open (thereby keeping the electrode (500) isolated (and at a different potential) from the floating ground (102)). On the contrary, when the first switch (103a) is open (thereby keeping the electrode (500) electrically isolated (disconnected) from the voltage source (101)), the second switch (103b) is closed (connecting the electrode (500) to the floating ground (102)).

[0044] According to a third embodiment of the device, shown in Figure 4, the device comprises two electrodes (500) and the electric field generation module (100) comprises four switches (103), where a first switch (103a) is configured to connect and disconnect the voltage source (101) to a first electrode (500a), a second switch (103b) is configured to connect and disconnect the first electrode (500a) to the floating ground (102), a third switch (103c) is configured to connect and disconnect the voltage source (101) to a second electrode (500b) and a fourth switch (103d) is configured to connect and disconnect the second electrode (500b) to the floating ground (102).In this third embodiment of the device, the switches (103) are configured to work in a complementary manner in pairs, such that, when the first switch (103a) is closed (connecting the first electrode (500a) to the voltage source (101)), the second switch (103b) is open (thereby keeping the first electrode (500a) isolated (at a different potential) from the floating ground (102)), the third switch (103c) is also open (thereby keeping the second electrode (500b) isolated (electrically disconnected) from the voltage source (101)) and the fourth switch (103d) is closed (connecting the second electrode (500b) to the floating ground (102)).

[0045] On the contrary, when the first switch (103a) is open (thereby keeping the first electrode (500a) electrically isolated from the voltage source (101)), the second switch (103b) is closed (connecting the first electrode (500a) to the floating ground (102)), the third switch (103c) is closed (connecting the second electrode (500b) to the voltage source (101)) and the fourth switch (103d) is open (thereby keeping the second electrode (500b) isolated (and at a different potential) from the floating ground (102)).

[0046] The electric field generation module (100) comprises a microcontroller (104) configured to control the opening and closing of the switches (103) in any of the embodiments of the device.

[0047] A possible configuration of the wireless charging module (200) is shown in Figure 5. According to this configuration, the wireless charging module (200) comprises an antenna (201) formed by a coil for picking up a variable magnetic field, where said variable magnetic field is generated by a generator (a peripheral device for generating a variable magnetic field) external to the device of the invention, where said generator is configured to generate a variable magnetic field, for the wireless transmission of energy to the device of the invention.

[0048] Thus, by means of the antenna (201 ), the wireless charging module (200) receives energy wirelessly from an external generator. In the antenna (201 ) the variable magnetic field is converted into an alternating electric current. The wireless charging module (200) comprises a rectifier (202) to rectify the alternating electric current generated in the antenna (201 ) and transform it into a direct current that feeds the energy management module (300).

[0049] The power management module (300) is configured to supply electrical power to the voltage source (101) and the microcontroller (104) of the electric field generation module (100) and the wireless communication module (400).

[0050] The energy management module (300) may comprise a rechargeable battery and / or the electronic elements necessary to recharge it, as well as to ensure the proper functioning of the battery by measuring the current and voltage of the battery and controlling said variables (current and voltage).

[0051] The wireless communication module (400) is configured to receive data about the electric field treatment that it is to provide. To do this, the wireless communication module (400) is connected to the microcontroller (104) of the device.

[0052] Likewise, the wireless communication module (400) may be configured to transmit to an external device data about the charge status of the battery and / or the voltage source (101), the internal temperature of the device, the brain electrical activity (for which the device may comprise a sensor of the user's brain electrical activity) and / or the temperature of the tissues surrounding the device of the invention (for which the device may comprise a temperature sensor configured to measure the temperature of the surrounding body tissue), when it is implanted inside the body of a user (for example, inside the head of a user).

[0053] The wireless communication module (400) may comprise a transmitting antenna configured to communicate with an external device using a secure communication protocol, not only in terms of its physical integrity, but also in terms of the integrity of the data exchanged, the guarantee of secure exchange and the reliability of the service and in a band reserved for industrial, scientific and medical (ISM) uses (between 400 MHz and 2.4 GHz).

Claims

CLAIMS 1. Implant device for the treatment of pathologies by means of electric fields comprising at least one electrode (500) for the application of electric fields to at least one body tissue, where the device is characterized in that it is configured to be implanted in the body of a person and where the device additionally comprises: or an electric field generation module (100) connected to the at least one electrode (500), where the electric field generation module (100) comprises at least one voltage source (101) connected to a floating ground (102), where the voltage source (101) is connected to the at least one electrode (500) by means of at least one switch (103) configured to connect and disconnect the at least one electrode (500) from the voltage source (101) and where the electric field generation module (100) comprises a microcontroller (104) configured to control the opening and closing of the at least one switch (103);or a wireless charging module (200) configured to transform a variable magnetic field into an electric current; or a wireless communication module (400) connected to the microcontroller (104), where the wireless communication module (400) is configured to receive instructions for generating electric fields for treating the at least one body tissue and to transmit information to an external device about operating parameters of the device and / or about body measurement parameters of the person implanted with the device, and; or a power management module (300) connected to the wireless charging module (200), where the power management module is configured to power the electric field generation module (100) and the wireless communication module (400).

2. Implant device for the treatment of pathologies using electric fields according to claim 1, characterized in that the device comprises a single electrode (500) and the electric field generation module (100) comprises a single switch (103) configured to connect and disconnect the electrode (500) from the voltage source (101).

3. Implant device for treating pathologies by means of electric fields according to claim 1, characterized in that the device comprises a single electrode (500) and the electric field generation module (100) comprises: o a first switch (103a) configured to connect and disconnect the electrode (500) from the voltage source (101), and; o a second switch (103b) configured to connect and disconnect the electrode (500) from the floating ground (102); where the device is configured so that: o when the first switch (103a) is in the closed state connecting the electrode (500) to the voltage source (101), the second switch (103b) is in the open state, keeping the electrode (500) isolated from the floating ground (102), and;or when the first switch (103a) is in the open state keeping the electrode (500) electrically isolated from the voltage source (101), the second switch (103b) is in the closed state, keeping the electrode (500) connected to the floating ground (102).; 4. Implant device for the treatment of pathologies by means of electric fields according to claim 1, characterized in that the device comprises two electrodes (500) and the electric field generation module (100) comprises: o a first switch (103a) configured to connect and disconnect a first electrode (500a) from the voltage source (101); or a second switch (103b) configured to connect and disconnect the first electrode (500a) from the floating ground (102); or a third switch (103c) configured to connect and disconnect a second electrode (500b) from the voltage source (101), and; or a fourth switch (103d) configured to connect and disconnect the second electrode (500b) from the floating ground (102); where the device is configured so that: or when the first switch (103a) is in a closed state connecting the first electrode (500a) to the voltage source (101), the second switch (103b) is in an open state keeping the first electrode (500a) isolated from the floating ground (102), the third switch (103c) is in an open state keeping the second electrode (500b) electrically isolated from the voltage source (101) and the fourth switch (103d) is in a closed state connecting the second electrode (500b) to the floating ground (102), and;or when the first switch (103a) is in the open state keeping the first electrode (500a) electrically isolated from the voltage source (101), the second switch (103b) is in the closed state connecting the first electrode (500a) to the floating ground (102), the third switch (103c) is in the closed state connecting the second electrode (500b) to the voltage source (101) and the fourth switch (103d) is in the open state keeping the second electrode (500b) isolated from the floating ground (102).; 5. Implant device for the treatment of pathologies using electric fields according to any of the preceding claims, characterized in that the wireless charging module (200) comprises: o an antenna (201) which in turn comprises a coil configured to transform the variable magnetic field into an alternating current, and; or a rectifier (202) connected to the antenna (201), where the rectifier (202) is configured to convert alternating current into direct current.

6. Implant device for the treatment of pathologies using electric fields according to any of the preceding claims, characterized in that the wireless communication module (400) is configured to transmit to an external device information about the level of remaining energy of the device and / or the temperature at which the device is located.

7. Implant device for the treatment of pathologies by means of electric fields according to any of the preceding claims, characterized in that it comprises a temperature sensor configured to measure the temperature of the body tissue, and where the wireless communication module (400) is configured to transmit information about the temperature of the body tissue to an external device.

8. Implant device for the treatment of pathologies by means of electric fields according to any of the preceding claims, characterized in that it is configured to be implanted inside the skull of a person, and where the device comprises a brain electrical activity sensor configured to measure the electrical activity of the brain body tissue, and where the wireless communication module (400) is configured to transmit to an external device information about the brain electrical activity of the person who has implanted the device.

9. Implant device for the treatment of pathologies using electric fields according to any of the preceding claims, characterized in that the at least one electrode (500) is made of a biocompatible material.

10. Implant device for the treatment of pathologies by means of electric fields according to any of the preceding claims, characterized in that the at least one switch (103) is a transistor.

Images