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    • 专利摘要:
    Electromedical device (100) comprising a body (101) internally equipped with at least one battery (102) for supplying electric energy, and a data processing unit (107), receiving energy from said battery (102) and configured for electronically managing a supply of electricity to means of interaction with the human body; the said device (100) being characterized in that it comprises an optical communication stage (109), configured to at least receive a first optical signal and / or transmit a second optical signal for interrogation and response respectively. The present invention also relates to an associated system and method.
    公开号:CH713964A2
    申请号:CH00896/17
    申请日:2017-07-11
    公开日:2019-01-15
    发明作者:Pasquali Alessandro
    申请人:Slux Sagl；
    IPC主号:
    专利说明:

    Description
    FIELD OF THE FOUND
    [0001] The present invention relates to the field of medical devices and in detail concerns an electromedical device with an optical system.
    [0002] The present invention also relates to a method of interaction with an electromedical device by means of an optical signal.
    [0003] The present invention finally concerns an interaction system with an electromedical device with an optical system.
    STATE OF ART
    [0004] Peacemakers are electromedical devices typically installed or implanted within the human body, with one or more electrodes positioned near or within the myocardium, configured to perform a primary function of stabilizing and / or regulating the cardiac rhythm of the said myocardium by applying electrical signals to the muscle itself.
    [0005] Peacemakers are traditionally equipped with an internal energy source that typically consists of a battery. Over the years, the batteries have undergone technological upgrades such as to extend their life to several years of uninterrupted operation.
    [0006] The replacement of the battery of a peacemaker requires a surgical intervention and is a complex operation and in any case subject to risks. Often, however, the entire pacemaker is replaced rather than the battery. In fact the body of the pacemaker is totally sealed in such a way as to withstand for many years the hostile environment that the inside of the human body represents for the electronic circuits that are installed there, including the battery itself.
    [0007] The Applicant has observed that the effective duration of the useful life of the peacemaker's battery, and equivalent to its residual charge, depend on the actual use of electricity that the peacemaker needs to stabilize and / or regularize the rhythm of the myocardium. In fact, to stabilize and / or adaptively adjust the rhythm of the myocardium, pacemakers currently use data processing units which on the basis of the electrical signal transmitted by the myocardium during its operation determine the need for action or not by supplying electricity through the aforementioned electrodes.
    [0008] Pacemakers have recently become widespread with wireless reading systems. These pacemakers therefore integrate a radio module that can be interrogated by an external device. In particular, through said interrogation it is advantageously possible to acquire data relating to the status of the pacemaker itself. In particular, through this query it is advantageously possible to read the status of the pacemaker and in particular the residual duration of the charge of the battery; in this way it is possible to program the replacement intervention of the battery or the pacemaker itself.
    [0009] Security and privacy issues have recently emerged with pacemaker users who allow wireless communication. In fact, unauthorized third parties may be able to read records of patients with pacemakers stored in the pacemaker.
    [0010] The Applicant has observed that through the aforementioned wireless reading, the pacemaker can also be programmed - and if necessary deactivated completely. If unauthorized third parties fraudulently access the wireless connection, they could reprogram the pacemaker putting the patient's life at risk.
    [0011] The Applicant has also observed that the reading of a pacemaker through a wireless channel occurs using radio frequencies. Therefore, both the correct reading and the correct programming of the pacemaker should take place in an environment that is as isolated as possible from electromagnetically interfering sources, especially if the frequency is close to the frequency or frequencies used for reading and / or programming the device.
    [0012] To guarantee programming security, the current trend is to focus on the creation of firewall software programs, to be executed on the pacemaker data processing unit, which are designed to reduce the risk of programming first and subject to reading fraudulent.
    [0013] Such firewall programs have the disadvantage of requiring a part of the computational capacity of the data processing unit next to the device, determining an increase in the energy resources that the battery must use for different functions with respect to the primary function of the pacemaker itself.
    [0014] Although explicit reference has been made to a pacemaker, which due to its particular intended use plays an important role in ensuring the patient's health - if not life - in use, the Applicant noted that the considerations described above are valid for all electromedical devices that can be installed or implanted inside the human body, with particular emphasis on those devices which include means of interaction with the human body and configured to analyze and / or supply in the form of medication or energy parameters vital and respectively immunize and / or cure and / or support the said human body.
    [0015] A first object of the present invention is to describe an electromedical device implantable within the human body, which allows to solve the drawbacks described above.
    [0016] A further object of the present invention is to describe a method of interaction with an electromedical device implantable within the human body, which is capable of solving the aforementioned drawbacks.
    [0017] A further object of the present invention is to provide an interaction system with an electromedical device implantable within the human body, which is capable of solving the aforementioned drawbacks.
    SUMMARY OF THE INVENTION
    [0018] According to the present invention, an electro-medical device which can be implanted inside the human body is provided, which comprises a body provided inside with at least one battery for supplying electric power to control circuits, at least one control circuit. comprising a data processing unit, receiving energy from said battery and means for interacting with the human body, at least partially powered by said battery and configured to analyze and / or provide respectively vital parameters and respectively immunize and / or in the form of medication or energy or treat and / or sustain the said human body; the said electromedical device being characterized in that it comprises an optical communication stage, configured to at least receive a first optical signal and / or transmit a second optical signal for interrogation and response respectively.
    [0019] For the purposes of the present invention, to "sustain" the human body is intended to provide drugs or other bio-compatible substances suitable to provide an aid to the normal functioning of the human body and / or to stimulate - possibly also in response to an electrical signal feedback received from the human body - parts of the body itself.
    [0020] In particular, the said electro-medical device implantable within the human body is a pacemaker. Alternatively, preferably but not limited to, said electromedical device implantable inside the human body is a device for distributing insulin and / or a device for performing blood tests and / or a device for direct detection, preferably but not limited to continuous, of blood pressure and oxygen saturation values and / or a device for the distribution of pharmacological agents, including vaccines. Still alternatively, the said electro-medical device implantable within the human body is a brain stimulator or a gastric stimulator.
    [0021] According to a preferred but non-limiting aspect, the said means of interaction with the human body comprise one or more electrodes and / or sensors for measuring blood components and / or drug distribution devices.
    [0022] According to a further non-limiting aspect, the said electrode is an electrode configured in use to deliver an electrical energy to a myocardium, in order to regularize and / or stabilize the myocardial rhythm.
    [0023] According to the present invention, a pacemaker is more particularly realized which comprises at least one electrode configured in use to deliver an electrical energy to a myocardium, in order to regularize and / or stabilize its rhythm, and a body equipped to its internal of at least one battery for supplying electric power to said at least one electrode, and a data processing unit, receiving energy from said battery and configured to electronically manage said electric energy supply; the said pacemaker being characterized in that it comprises an optical communication stage, configured to at least receive a first optical signal and / or transmit a second optical signal for interrogation and response respectively.
    [0024] Advantageously, this allows, in the transmission and / or in the reception, to have a lower susceptibility to electromagnetic interference of signals or disturbances in the radio spectrum, and to make the moment when the pacemaker is intercepted and / or the moment less interceptable. in which it answers the question.
    [0025] According to a further non-limiting aspect, the said optical communication stage comprises optically sensitive elements positioned at least in part on the outer surface of the said body.
    [0026] Advantageously, this allows the pacemaker to be made of sturdy material, for example metal.
    [0027] In particular, said optically sensitive elements comprise an optical transmitter element and an optical receiver element.
    [0028] According to a further non-limiting aspect, the said optical communication stage comprises at least one optical receiver element; said optical receiver element being positioned so as to have at least one sensitive surface at the outer surface of said body.
    [0029] According to a further non-limiting aspect, the said pacemaker comprises a radio transmitter stage electrically connected to the said data processing unit.
    [0030] Advantageously, this allows the pacemaker to receive the response signal transmission with few relative positioning constraints between the receiver and the pacemaker itself.
    [0031] In particular, the said radio transmitter is configured to transmit a radio response signal automatically following the reception of a specific first optical signal. In particular, said specific first optical signal is an interrogation signal.
    [0032] According to a further non-limiting aspect, the said optical communication stage is configured to transmit a second signal following the reception of the said first optical signal, and comprises at least one optical emitter element, the said optical emitter element having at least one surface thereof sensitive at the said outer surface of the said body.
    [0033] According to a further non-limiting aspect, the said pacemaker comprises a radio receiver stage electrically connected to the said data processing unit.
    [0034] Advantageously, this allows the command and interrogation signals to be sent with the traditional radio technology, leaving the retransmission of the response signal to the optical channel, with the guarantee of a low interception of the response signal.
    [0035] In particular, the said radio receiver is configured to receive a radio interrogation signal and to cause the automatic activation of the said optical communication stage.
    [0036] According to a further non-limiting aspect, the automatic activation of the said optical communication stage causes the transmission of the said second optical signal.
    [0037] According to a further non-limiting aspect, the said pacemaker comprises a memory, electrically connected to the said data processing unit, and electrically powered from or through the said battery.
    [0038] Advantageously, this allows a plurality of useful information to be memorized within the pacemaker, such as for example data of the patient wearing it and / or operating data; for stored data there is no need for medical records or external memories that may not always be accessible or otherwise be lost.
    [0039] According to a further non-limiting aspect, according to the previous aspect, said memory comprises historical electronic data of the operation of said pacemaker.
    [0040] According to a further non-limiting aspect, according to any one of the previous two aspects, the said memory comprises electronic data of residual charge of the said battery.
    [0041] According to a further non-limiting aspect, at least part of said historical electronic data of the operation of said electromedical device and / or said residual electronic charge data are transmitted with said response signal.
    [0042] Advantageously, this allows each query to know exactly how much charge remains in the battery.
    [0043] According to a further non-limiting aspect, the said data processing unit is configured to automatically update the residual electronic charge data stored on the said memory according to the actually remaining charge in said battery and / or according to a duration and / or frequency and / or energy delivered by said battery towards said at least one electrode.
    [0044] According to a further non-limiting aspect, the said data processing unit is electrically connected to the said optical communication stage and comprises at least one operative programming configuration in which it is programmed according to an optical programming signal received from the said stage of optical communication.
    [0045] According to a further non-limiting aspect, the said optical communication stage is a stage of optical directive communication.
    [0046] Advantageously, this allows to optimize the energy of the optical signal on a sector of volume of interest, and therefore allows to have - with the same optical transmission power - a greater gain in the direction of interest.
    [0047] In particular, said optical emitter element is installed on said body in such a way as to selectively emit an optical signal along a direction at least locally oblique with respect to the surface of said body. In other words, said optical emitter element has a main emission direction locally oblique with respect to a face of said body.
    [0048] According to a further non-limiting aspect, the said main emission direction is locally orthogonal with respect to the face of the said body.
    [0049] According to a further non-limiting aspect, the said face is a main face, characterized by an area greater than or equal to that of other faces of the body. In particular, for particular forms of the pacemaker, the said main faces are opposite symmetrical faces.
    [0050] The applicant has in fact found that most pacemakers have a flat body, in which the two main faces are installed substantially parallel to the pectoral portion of the body; therefore, having a main oblique emission direction, and in particular perpendicular to the face of said body, advantageously allows, when the device is then installed in the human body, to have a direction of the optical beam along the direction in which it meets less. skin possible, with the consequent reduction of the optical power necessary to effectively transmit the response signal.
    [0051] According to a further non-limiting aspect, the said body is a watertight body.
    [0052] According to a further non-limiting aspect, the said body has surfaces in use in contact with parts of the human body, said surfaces are biocompatible and / or hypoallergenic and / or stainless.
    [0053] According to a further non-limiting aspect, the said surfaces in use in contact with the said parts of the human body are external surfaces of the said body.
    [0054] According to a further non-limiting aspect, the said at least one electrode is electrically connected to a power supply stage by an electrically conductive cable, firmly connected to the body of the said pacemaker and is electrically isolated.
    [0055] According to a further non-limiting aspect, depending on the previous aspect, the said electrode is positioned at a first end of the said cable.
    [0056] This advantageously allows the myocardial rhythm to be regularized and stabilized by helping to position the pacemaker body in a convenient position; the applicant has in fact found that in the case of an optical communication, the pacemaker should be positioned free of obstacles to a direct optical path such as for example the bones of the rib. The solution of allowing an adjustable relative positioning between the electrodes and the body is therefore much more important where there is an optical communication, in reception or in retransmission, between the pacemaker and the interrogation system associated with it.
    [0057] According to a further non-limiting aspect, the said data processing unit electronically manages the said supply of electrical energy towards the said at least one electrode according to an electrical cardiac signal received from the said electrode or from further electrodes.
    [0058] According to a further non-limiting aspect, the said optical receiver element comprises at least one photodiode. In particular, said photodiode can be sensitive to one or more frequency radiations in one or more of the following ranges: infrared, ultraviolet, or visible. Advantageously, the use of a photodiode allows.
    [0059] According to a further non-limiting aspect, the said optical receiver element comprises at least one photo-voltaic cell.
    [0060] According to a further non-limiting aspect, in combination with the previous aspect, the said photovoltaic cell is electrically connected to the said battery.
    [0061] In particular, according to a further non-limiting aspect in combination with the previous one, the said connection is indirect. The said pacemaker, in fact, according to a further non-limiting aspect, comprises a charge regulator circuit.
    [0062] According to a further non-limiting aspect, the said charge regulator circuit is interposed between the said photovoltaic cell and the said battery.
    [0063] According to a further non-limiting aspect, the said device integrates a portion of optical fiber extending out from the said body, the said portion of optical fiber being optically connected to the said stage of optical communication.
    [0064] According to a further non-limiting aspect, in combination with the previous aspect, the said portion of optical fiber is flexible.
    [0065] Advantageously, the Applicant has observed that this solution allows a greater flexibility of installation of the device, allowing an easier optical interrogation without going through the illumination of thicker layers of skin. The solution is particularly advantageous if the device is installed in use in a position covered by thick muscle or bone bundles.
    [0066] According to the present invention, a method of interaction with an electromedical device suitable for being installed within the human body is described, the said method comprising: - a step of generating a first signal by an electronic interrogation system of a electromedical device designed to be installed within the human body; - a step for transmitting the said first signal from the said electronic interrogation system to the said electromedical device suitable for being installed within the human body, and / or a transmission step by the said electromedical device suitable for being installed within the human body of a second signal; - an electronic processing step of said first signal by said electromedical device suitable for being installed within the human body, - in which at least one of said first signal and said second signal are optical signals.
    [0067] According to a further non-limiting aspect, the said method comprises a relative alignment step between at least a portion of the said electronic interrogation system and optically sensitive portions of the said electromedical device suitable for being installed within the human body.
    [0068] According to a further non-limiting aspect, the said first signal and / or the said second signal, when optical, are signals respectively transmitted and received with a directive transmission / reception. In other words, the said transmission step of the said first signal and / or the said transmission step of the said second signal are directive transmission steps.
    [0069] According to a further non-limiting aspect, the said transmission step by the said electromedical device suitable for being installed within the human body of the said second transmission signal follows the transmission step of the said first signal from the said electronic interrogation system .
    [0070] According to a further non-limiting aspect, according to one or more of the preceding aspects, the said first signal is an interrogation signal.
    [0071] According to a further non-limiting aspect, according to one or more of the preceding aspects, the said first signal is a command signal.
    [0072] According to a further non-limiting aspect, according to one or more of the preceding aspects, the said interrogation signal is configured to cause the automatic generation of the said second signal.
    [0073] According to a further non-limiting aspect, in accordance with one or more of the preceding aspects, the said command signal is a signal configured to cause, immediately or in a predefined future time, a variation of the operating mode of the said electromedical device suitable to be installed within the human body and / or activated or deactivated.
    [0074] According to a further non-limiting aspect, the said method comprises an alignment step between at least part of the said electronic interrogation system and the said electromedical device suitable for being installed within the human body.
    [0075] In greater detail, the said alignment step comprises an alignment step of an optical transmitter of the said electronic interrogation system with an optical receiver element of the said electro-medical device suitable to be installed within the human body or an alignment step of an optical receiver of said electronic interrogation system with an optical emitter element of said electromedical device suitable for being installed within the human body.
    [0076] In greater detail, according to a further non-limiting aspect, the said step of alignment comprises an alignment step of the said optical receiver element of the said electromedical device able to be installed within the human body along a preferential receiving direction, or a alignment step of at least part of said electronic interrogation system along a preferential emission direction of said optical emitter element.
    [0077] According to a further non-limiting aspect, in said step of alignment, at least part of said electronic interrogation system is placed in contact or substantially close to the body of the patient on which said electromedical device suitable to be installed within the human body is installed.
    [0078] According to a further non-limiting aspect, in combination with one or more of the preceding aspects, in said step the said electromedical device suitable for being installed within the human body is installed in a breastplate position so that the said optical emitter element is oriented substantially along the sagittal axis of the said patient.
    [0079] According to a further non-limiting aspect, in combination with one or more of the preceding aspects, in the method of interaction with an electromedical device suitable for being installed within the human body, there is a step for recharging the battery of the said electromedical device to be installed within the human body.
    [0080] In detail, according to a further non-limiting aspect, combined with the previous aspect, said recharging is a recharge with an optical signal.
    [0081] According to a further non-limiting aspect, in combination with one or more of the two previous aspects, said recharging step comprises an excitation step of a photovoltaic cell of said optical receiver element of said electromedical device suitable to be installed within the human body, said excitation pitch of said photovoltaic cell causing an at least partial recharging of said battery.
    [0082] According to a further non-limiting aspect, the said electromedical device is a pacemaker.
    [0083] According to a further non-limiting aspect, in combination with one or more of the preceding aspects, the said first signal causes an excitation of the said photodiode and of the said photovoltaic cell.
    [0084] According to the present invention, a system for interrogating a pacemaker according to any of the preceding aspects is provided, the said system comprising means for generating and transmitting a first signal to the said pacemaker and means for receiving a second signal from the said pacemaker, in which at least one of said first and said second signals are optical signals.
    [0085] According to a further non-limiting aspect, preferably the said interrogation signal and / or the said command signal, if in the optical domain, are signals in the visible range.
    [0086] For the sake of greater understanding of the present invention, the following definitions are applied: - "Transparency" means a characteristic such that the material under examination can pass radiation incident along a preferential direction, independently of the attenuation that this radiation undergoes in passing through the said material. - "Infrared" or "Infrared" means electromagnetic radiation which has a wavelength of approximately between 0.7 pm and 15 pm. - "visible" or "visible spectrum" means an electromagnetic radiation which has a wavelength indicatively comprised between 390 and 700 nm. - "Ultraviolet" or "ultraviolet" means an electromagnetic radiation which has a wavelength approximately between 400 nm and 10 nm.
    [0087] BRIEF DESCRIPTION OF THE DRAWINGS
    [0088] Some embodiments and some aspects of the invention will be described hereinafter with reference to the accompanying drawings, provided as a guide only and therefore not limiting, in which:
    The fig. from 1 to 4 respectively illustrate a first, second, third and fourth embodiment of a pacemaker subject of the invention; and fig. 5 illustrates a schematic diagram of a signal transmission between a pa cemaker query system and a pacemaker.
    DETAILED DESCRIPTION OF THE INVENTION
    [0089] The present invention first of all concerns a medical electro-medical device 100 used to be installed or implanted inside the human body, under the skin or in a deeper position. In the description that follows, specific reference will be made to a pacemaker, without this type of electromedical device being intended to limit the scope of protection of the present invention. In fact, what is described here specifically for a pacemaker can be generalized to electromedical devices implantable within the human body, which include means for interacting with the human body, at least partially powered by said battery and configured to analyze and / or supply in the form of a medicament or of energy respectively vital parameters and respectively immunize and / or cure and / or sustain the said human body.
    First embodiment [0090] In a first embodiment, shown in fig. 1, the pacemaker 100 comprises a body 101 from which at least one electrode 103a departs, and more preferably a first and a second electrode 103a, 103b which in use are positioned at or in substantial proximity to the myocardium and are configured to transmit to the latter signals appropriate for regularizing and / or stabilizing the cardiac rhythm. The body 101 is completely watertight, and is advantageously made of biocompatible metal material so as to minimize the risk of allergies or of interaction with the human body when installed there. The body 101 has a first and a second main surface, of greater extension, opposite to each other and preferably but not limited to one parallel to the other.
    [0091] The pacemaker 100 comprises an electric power source represented by at least one battery 102, preferably of the rechargeable type, which is electrically connected to a power circuit 106 - of a known type - designed to allow the supply of electricity to the electrodes 103a, 103b according to a control signal received from a microprocessor 107 included in the body of the pacemaker itself.
    [0092] In detail, the pacemaker 100 of the invention is provided with an optical communication stage 109, which in the first embodiment described herein comprises at least one optical receiver element 109a which is realized by a photodiode sensitive to optical radiation in the spectrum of the visible, infrared or ultraviolet or more of the previous spectra. The purpose of the photodiode is to be able to receive an optical interrogation signal s1 (t) or command s2 (t), transmitted by an electronic system 200 and re-transmitted to the microprocessor 107. For the purposes of the present invention the said signal of interrogation or command constitute a first signal transmitted by an interrogation system and received by the pacemaker 100.
    [0093] The interrogation or control signals are configured to generate, when suitably received by the pacemaker, the following effects: in particular, to activate a part of the microprocessor to cause a response and / or an alteration of the functioning and / or behavior of the pacemaker , a variation of the power, frequency, voltage and / or current delivered through said at least one electrode, activation of the power stage 106 for supplying said at least one electrode or deactivating the power stage 106 for the power supply of said at least one electrode.
    [0094] Optionally, although not limited to, the photodiode is coupled to a solar cell 109b, whose purpose is to provide to convert the energy of the interrogation or optical control signal into electrical energy to help recharge the battery 102. Preferably, although not limitedly, the pacemaker 100 comprises a charge regulator stage 108 whose purpose is to regulate the voltage and / or current that are supplied to the battery 102, preventing for example and not limitedly the generation of overvoltages which could damage the battery itself or other components of the pacemaker 100; this charge regulator stage 108 is provided with an input powered directly by said solar cell 109b and is provided with an output supplying said battery 102.
    [0095] The pacemaker 100 of the invention, in said first embodiment also comprises a radiofrequency transmitter stage 110, which is electrically connected to the microprocessor 107. This radiofrequency transmitter stage 110 is configured so as to allow transmission of a response signal s3 (t) on a radiofrequency channel, preferably but not limited to the standard 13.56 MHz frequency of the RFIDs.
    [0096] During the traditional operation, the pacemaker 100 object of the invention provides where and when necessary electric energy to the electrodes 103a, 103b preferably according to an electrical signal of the myocardium received from the same electrodes or from other electrodes - not shown in the annexed figures for simplicity of treatment.
    [0097] In use, if the pacemaker 100 of the invention receives an interrogation signal s1 (t), this is processed by the optical receiver element 109a the information extracted from it is sent as an electrical signal to the microprocessor 107. In parallel, the interrogation signal s1 (t) is received by the solar cell 109b and converted from it into an electrical signal to supply the rest of the pacemaker circuits. If the interrogation signal s1 (t) is correctly received, the processor 107 queries the memory associated with it, extracts the requested information through the interrogation signal s1 (t) - for example and not limitedly, the remaining battery life - and causes activation of the radio frequency transmitter stage 110, for the retransmission of such information, on a radio channel.
    [0098] In use the pacemaker 100 object of the invention can also receive a command signal s2 (t) - for example and not limitedly, a command to stop supplying current to the electrodes 103a, 103b. This signal, in the present first embodiment, is also transmitted on an optical channel. If the pacemaker 100 receives a command signal s2 (t), this is processed by the optical receiver element 109a and sent as an electrical signal to the microprocessor 107. In parallel, the command signal s2 (t) is received by the solar cell 109b and converted from it to an electrical signal to power the rest of the pacemaker circuits. If the command signal s2 (t) is correctly received, the processor 107 determines an alteration of the operation of the pacemaker 100 itself according to the command received and, if so programmed, causes the activation of the radio-frequency transmitter stage 110, for the retransmission of an acknowledgment signal.
    [0099] Advantageously, the interrogation of the pacemaker 100 and the sending to the latter of control signals by means of an optical channel make it possible to reduce the risk of interference with electromagnetic sources which could cause a malfunction of the system or also cause reception of corrupt signals.
    Second embodiment [0100] In a second embodiment, shown in fig. 2, the pacemaker 100 comprises a body 101 from which at least one electrode 103a departs, and more preferably a first and a second electrode 103a, 103b which in use are positioned at or in substantial proximity to the myocardium and are configured to transmit to the latter signals appropriate for regularizing and / or stabilizing the cardiac rhythm. The body 101 is completely watertight, and is advantageously made of biocompatible metal material so as to minimize the risk of allergies or of interaction with the human body when installed there.
    [0101] The pacemaker 100 comprises an electric power source represented by at least one battery 102, preferably of the rechargeable type, which is electrically connected to a power circuit 106 - of a known type - designed to allow the supply of electricity to the electrodes 103a, 103b according to a control signal received from a microprocessor 107 included in the body of the pacemaker itself.
    [0102] In detail, the pacemaker 100 of the invention is provided with an optical communication stage 109, which in the second embodiment described herein comprises at least one optical transmitter element 109b which is realized by at least one photoemitter, preferably but not limited to a diode, transmitting an optical radiation in the visible, infrared or ultraviolet spectrum or to more than the previous spectra. The purpose of the photoemitter is to be able to transmit a response signal s3 (t) to an interrogation signal s1 (t) or to a command signal s2 (t) in radio frequency, which are then transmitted on a channel to radiofrequency, preferably but not limited to the standard 13.56 MHz frequency of the RFIDs; this response signal s3 (t) is transmitted according to a signal of the microprocessor 107. For the purposes of the present invention the said interrogation or command signal constitutes a first signal transmitted by an interrogation system and received by the pacemaker 100.
    [0103] The interrogation or control signals are configured to generate, when suitably received by the pacemaker, the following effects: in particular, to activate a part of the microprocessor to cause a response and / or an alteration of the functioning and / or behavior of the pacemaker , a variation of the power, frequency, voltage and / or current delivered through said at least one electrode, activation of the power stage 106 for supplying said at least one electrode or deactivating the power stage 106 for the power supply of said at least one electrode.
    [0104] The pacemaker 100 of the invention, in the second embodiment described herein integrates a radiofrequency receiver stage 111, which integrates in its interior and in any case within the body of the pacemaker itself an antenna, preferably but not limited in patch type and even more preferably but not limited to magnetic coupling. The radio frequency receiver stage 111 behaves like a passive RFID. Its antenna performs a double function not only to receive the information that the interrogation and / or command signals s1 (t), s2 (t) carry, but also to generate an electric power sufficient to supply the rest of the circuits of which the pacemaker 100 is composed, so as to allow the transmission of the response signal s3 (t), which in the second embodiment is of the optical type.
    [0105] Optionally, through the antenna of the radiofrequency receiver stage 111 it is also possible to supply the battery 102. Preferably, although not limitedly, the pacemaker 100 comprises a charge regulator stage 108 whose purpose is to regulate the voltage and / or or the current which is supplied to the battery 102, preventing for example and not limitedly the generation of overvoltages which could damage the battery itself or other components of the pacemaker 100; this charge regulator stage 108 is provided with an input supplied directly by the radio-frequency receiver stage 111 and is provided with an output supplying said battery 102.
    [0106] During the traditional operation, the pacemaker 100 object of the invention provides where and when necessary electric energy to the electrodes 103a, 103b preferably according to an electrical signal of the myocardium received from the same electrodes or from other electrodes - not shown in the annexed figures for simplicity of treatment.
    [0107] In use, if the pacemaker 100 of the invention receives an interrogation signal s1 (t), this is processed by the radio-frequency receiver stage 111, and the information extracted from it is sent as an electrical signal to the microprocessor 107. In parallel, the interrogation signal s1 (t) part of the power of the interrogation signal s1 (t) is converted by the antenna, by coupling as preferably said but not limitedly magnetic, into an electric signal to supply the rest of the circuits of the pacemaker. If the interrogation signal s1 (t) is correctly received, the processor 107 queries the memory associated with it, extracts the requested information through the interrogation signal s1 (t) - for example and not limitedly, the remaining battery life - and causes the activation of the optical communication stage 109, for the retransmission of such information, on an optical channel.
    [0108] In use the pacemaker 100 object of the invention can also receive a command signal s2 (t) - for example and not limitedly, a command to stop supplying current to the electrodes 103a, 103b. This signal, in the present first embodiment, is also transmitted on an optical channel. If the pacemaker 100 receives a command signal s2 (t), this is processed by the radiofrequency receiver stage 111 and sent as an electrical signal to the microprocessor 107. In parallel, part of the power of the command signal s2 (t) is converted by the antenna, for coupling as said preferably but not limitedly magnetic, in an electrical signal to power the rest of the pacemaker circuits. If the command signal s2 (t) is correctly received, the processor 107 determines an alteration of the operation of the pacemaker 100 itself according to the received command and, if so programmed, causes the activation of the optical communication stage 109, for the retransmission of an acknowledgment signal.
    [0109] Advantageously, the Applicant has observed that the sending of response signals by optical communication allows to reduce the risk of interference with electromagnetic sources which could cause a malfunction of the system or also cause the reception of corrupt signals by the system of interrogation, and likewise allows the risk of fraudulent interception of the information contained therein to be reduced.
    Third embodiment [0110] In a third embodiment, shown in fig. 3, the pacemaker 100 comprises a body 101 from which at least one electrode 103a departs, and more preferably a first and a second electrode 103a, 103b which in use are positioned at or in substantial proximity to the myocardium and are configured to transmit to the latter signals appropriate for regularizing and / or stabilizing the cardiac rhythm. The body 101 is completely watertight, and is advantageously made of biocompatible metal material so as to minimize the risk of allergies or of interaction with the human body when installed there.
    [0111] The pacemaker 100 comprises an electric power source represented by at least one battery 102, preferably of the rechargeable type, which is electrically connected to a power circuit 106 - of a known type - designed to allow the supply of electricity to the electrodes 103a, 103b according to a control signal received from a microprocessor 107 included in the body of the pacemaker itself.
    [0112] In detail, the pacemaker 100 of the invention is provided with an optical communication stage 109, which in the second embodiment described herein comprises at least one optical transmitter element 109b which is made by at least one photoemitter, preferably but not limited to a diode, transmitting an optical radiation in the visible, infrared or ultraviolet spectrum or to more than the preceding spectra, and at least an optical receiver element 109a which is realized by a photodiode sensitive to optical radiation in the visible infrared spectrum or ultraviolet or more than the previous spectra. The purpose of the photodiode is to be able to receive an optical interrogation signal s1 (t) or command s2 (t), transmitted by an electronic system 200 and re-transmitted to the microprocessor 107. For the purposes of the present invention the said signal of interrogation or command constitute a first signal transmitted by an interrogation system and received by the pacemaker 100.
    [0113] The purpose of the photoemitter is to be able to transmit a response signal s3 (t) to an interrogation signal s1 (t) or to a command signal s2 (t) optical. Advantageously, therefore, the third embodiment relates to a pacemaker 100 which integrates totally optical communication functions, without the possibility of interaction with radiofrequency devices.
    [0114] The interrogation or control signals are configured to generate, when suitably received by the pacemaker, the following effects: in particular, to activate a part of the microprocessor to cause a response and / or an alteration of the functioning and / or behavior of the pacemaker , a variation of the power, frequency, voltage and / or current delivered through said at least one electrode, activation of the power stage 106 for supplying said at least one electrode or deactivating the power stage 106 for the power supply of said at least one electrode.
    [0115] Optionally, although not limited to, the photodiode is coupled to a solar cell 109b, whose purpose is to provide to convert the energy of the interrogation or optical control signal into electrical energy to help recharge the battery 102. Preferably, although not limitedly, the pacemaker 100 comprises a charge regulator stage 108 whose purpose is to regulate the voltage and / or current that are supplied to the battery 102, preventing for example and not limitedly the generation of overvoltages which could damage the battery itself or other components of the pacemaker 100; this charge regulator stage 108 is provided with an input powered directly by said solar cell 109b and is provided with an output supplying said battery 102.
    [0116] During the traditional operation, the pacemaker 100 object of the invention provides where and when necessary electric energy to the electrodes 103a, 103b preferably according to an electrical signal of the myocardium received from the same electrodes or from other electrodes - not shown in the annexed figures for simplicity of treatment.
    [0117] In use, if the pacemaker 100 of the invention receives an interrogation signal s1 (t), this is processed by the radiofrequency receiver stage 111, and the information extracted from it is sent as an electrical signal to the microprocessor 107. In parallel, the interrogation signal s1 (t) part of the power of the interrogation signal s1 (t) is converted by the antenna, by coupling as preferably said but not limitedly magnetic, into an electric signal to supply the rest of the circuits of the pacemaker. If the interrogation signal s1 (t) is correctly received, the processor 107 queries the memory associated with it, extracts the requested information through the interrogation signal s1 (t) - for example and not limitedly, the remaining battery life - and causes the activation of the optical communication stage 109, for the retransmission of such information, on an optical channel.
    [0118] In use the pacemaker 100 object of the invention can also receive a command signal s2 (t) - for example and not limitedly, a command to stop supplying current to the electrodes 103a, 103b. This signal, in the present third embodiment, is also transmitted on an optical channel. If the pacemaker 100 receives a command signal s2 (t), this is processed by the optical communication stage 109 and sent as an electrical signal to the microprocessor 107. In parallel, part of the power of the command signal s2 (t) is converted by the cell 109b, in an electrical signal to power the rest of the pacemaker circuits. If the command signal s2 (t) is correctly received, the processor 107 determines an alteration of the operation of the pacemaker 100 itself according to the received command and, if so programmed, causes the activation of the optical communication stage 109, for the retransmission of an "acknowledgment" signal.
    [0119] Advantageously, the Applicant has observed that the sending of reply signals by optical communication allows to reduce the risk of interference with electromagnetic sources which could cause a malfunction of the system or also cause the reception of corrupted signals by the interrogation, and likewise allows the risk of fraudulent interception of the information contained therein to be reduced.
    Fourth embodiment [0120] In a fourth embodiment, shown in fig. 4, the pacemaker 100 comprises a body 101 from which at least one electrode 103a departs, and more preferably a first and a second electrode 103a, 103b which in use are positioned at or in substantial proximity to the myocardium and are configured to transmit to the latter signals appropriate for regularizing and / or stabilizing the cardiac rhythm. The body 101 is completely watertight, and is advantageously made of biocompatible metal material so as to minimize the risk of allergies or of interaction with the human body when installed there.
    [0121] The pacemaker 100 comprises an electric power source represented by at least one battery 102, preferably of the rechargeable type, which is electrically connected to a power circuit 106 - of a known type - designed to allow the supply of electricity to the electrodes 103a, 103b according to a control signal received from a microprocessor 107 included in the body of the pacemaker itself.
    [0122] In detail, the pacemaker 100 of the invention is provided with an optical communication stage 109, which in the second embodiment described herein comprises at least one optical transmitter element 109b which is realized by at least one photoemitter, preferably but not limited to a diode, transmitting an optical radiation in the visible, infrared or ultraviolet spectrum or to more than the preceding spectra, and at least an optical receiver element 109a which is realized by a photodiode sensitive to optical radiation in the visible infrared spectrum or ultraviolet or more than the previous spectra. The purpose of the photodiode is to be able to receive an optical interrogation signal s1 (t) or command s2 (t), transmitted by an electronic system 200 and retransmitted to the microprocessor 107. The purpose of the photoemitter is to be in capable of transmitting a response signal s3 (t) to an interrogation signal s1 (t) or to a command signal s2 (t) optical. Advantageously, therefore, the third embodiment relates to a pacemaker 100 which integrates totally optical communication functions, without the possibility of interaction with radiofrequency devices. For the purposes of the present invention, the said interrogation or command signal constitutes a first signal transmitted by an interrogation system and received by the pacemaker 100.
    [0123] Furthermore, the pacemaker 100 of the invention, in the fourth embodiment described herein integrates a radiofrequency receiver stage 111, which integrates in its interior and in any case within the body of the pacemaker itself an antenna, preferably but not limited to patch type and even more preferably but not limited to magnetic coupling. The radio frequency receiver stage 111 behaves like a passive RFID. Its antenna performs a double function not only to receive the information that the interrogation and / or command signals s1 (t), s2 (t) carry, but also to generate an electric power sufficient to supply the rest of the circuits of which the pacemaker 100 is composed, so as to allow the transmission of the response signal s3 (t), which in the second embodiment is of the optical type. The pacemaker 100 of the invention, in said fourth embodiment also comprises a radiofrequency transmitter stage 110, which is electrically connected to the microprocessor 107. This radiofrequency transmitter stage 110 is configured so as to allow the transmission of a signal s3 (t) of response on a radiofrequency channel, preferably but not limited to the standard 13.56MHz frequency of the RFIDs.
    [0124] Advantageously, therefore, the fourth embodiment of the pacemaker 100 object of the invention combines the advantages of the previous three embodiments, and allows the maximum operating flexibility: it can in fact be controlled and / or interrogated with signals which, at discretion of the user, they can be both optical and radiofrequency and - parts - can respond with signals that are both optical and radiofrequency.
    [0125] The interrogation or control signals are configured to generate, when appropriately received by the pacemaker, the following effects: in particular, to activate a part of the microprocessor to cause a response and / or an alteration of the functioning and / or behavior of the pacemaker , a variation of the power, frequency, voltage and / or current delivered through said at least one electrode, activation of the power stage 106 for supplying said at least one electrode or deactivating the power stage 106 for the power failure of said at least one electrode [0126] Optionally although not limited to the photodiode is coupled to a solar cell 109b, the purpose of which is to provide to convert the energy of the interrogation or optical control signal into electrical energy to help recharge the battery 102. Preferably, although not limited to, the pacemaker 100 comprises a regulator stage charging 108 whose purpose is to regulate the voltage and / or current which are supplied to the battery 102, preventing for example and not limitedly the generation of overvoltages which could damage the battery itself or other components of the pacemaker 100; this charge regulator stage 108 is provided with an input powered directly by said solar cell 109b and is provided with an output supplying said battery 102.
    [0127] During the traditional operation, the pacemaker 100 object of the invention provides where and when necessary electric energy to the electrodes 103a, 103b preferably according to an electrical signal of the myocardium received from the same electrodes or from other electrodes - not shown in the annexed figures for simplicity of treatment.
    [0128] In use, if the pacemaker 100 of the invention receives an interrogation signal s1 (t), this is processed by the radio-frequency receiver stage 111, and the information extracted from it is sent as an electrical signal to the microprocessor 107. In parallel, the interrogation signal s1 (t) part of the power of the interrogation signal s1 (t) is converted by the antenna, by coupling as preferably said but not limitedly magnetic, into an electric signal to supply the rest of the circuits of the pacemaker. If the interrogation signal s1 (t) is correctly received, the processor 107 queries the memory associated with it, extracts the requested information through the interrogation signal s1 (t) - for example and not limitedly, the remaining battery life - and causes the activation of the optical communication stage 109, for the retransmission of such information, on an optical channel.
    [0129] In use the pacemaker 100 object of the invention can also receive a command signal s2 (t) - for example and not limitedly, a command to stop supplying current to the electrodes 103a, 103b. This signal, in the present first embodiment, is also transmitted on an optical channel. If the pacemaker 100 receives a command signal s2 (t), this is processed by the radiofrequency receiver stage 111 and sent as an electrical signal to the microprocessor 107. In parallel, part of the power of the command signal s2 (t) is converted by the antenna, for coupling as said preferably but not limitedly magnetic, in an electrical signal to power the rest of the pacemaker circuits. If the command signal s2 (t) is correctly received, the processor 107 determines an alteration of the operation of the pacemaker 100 itself according to the received command and, if so programmed, causes the activation of the optical communication stage 109, for the retransmission of an acknowledgment signal.
    [0130] Advantageously, the Applicant has observed that the sending of response signals by optical communication allows to reduce the risk of interference with electromagnetic sources which could cause malfunctioning of the system or also cause the reception of corrupt signals by the system of interrogation, and likewise allows the risk of fraudulent interception of the information contained therein to be reduced.
    [0131] The response signal s3 (t), regardless of whether it is transmitted on a radiofrequency channel or on an optical channel - in accordance with the previously described embodiments - is a signal automatically transmitted following reception at least of an interrogation signal s1 (t). In detail, the automatic transmission of the response signal s3 (t) depends on a correct reception of the said at least one interrogation signal s1 (t). The response signal s3 (t) can also be a response signal transmitted automatically upon receipt of a command signal s2 (t). In this case, preferably but not limited to this response signal s3 (t) may be an acknowledgment signal.
    [0132] For the purposes of the present invention, "correct reception" means the reception of a signal of sufficient power to cause the excitation of the transmission stage of the pacemaker 100, said signal being also provided with the correct formatting.
    [0133] Where interrogation signals s1 (t), command signals s2 (t) or response signals s3 (t) of optical type are involved, in use the pacemaker 100 object of the invention - in any of the previously described embodiments - it must be suitably coupled to the interrogation system 200, which is advantageously shown in fig. 5. In particular, this system comprises at least one portion 201, which preferably but not limitedly comprises an optical module and a radiofrequency module, both with the ability to receive and transmit radio and optical signals, mobile with respect to a central body 203 which integrates optical and radio frequency transmission and reception stages.
    [0134] Both the first and the second, and the third, that the fourth embodiment of the pacemaker 100 object of the invention advantageously comprise optical communication stages 109 whose sensitive elements present a directive radiation or reception, and in particular possess one own preferential radiation sector 115 which, preferably but not limited to, defines a radiation cone.
    [0135] In detail, the optical coupling with the pacemaker 100 of the invention takes place in the following ways. Typically, and preferably, the pacemaker 100 of the invention is installed inside the body at the trunk, preferably in the pectoral or subclavicular area, facing such that its faces 101 a, 101 b are oriented substantially orthogonally with respect to to the sagittal axis.
    [0136] In fact, for all the previously described embodiments of the pacemaker, the body preferably has a flattened shape, vaguely shaped like a parallelepiped with preferably but not limitedly rounded edges. The body of the pacemaker 100 therefore defines a first and a second main face 101 a, 101 b, preferably although not limited to substantially identical area. The two main faces 101a, 101b are opposite and lie on two planes preferably but not limitedly parallel.
    [0137] In particular, the installation of the pacemaker takes place in such a way that the sensitive elements of the optical communication stage 109 are exposed near the front portion of the trunk, and preferably but not limitedly not hindered by the presence of a rib. The Applicant has in fact found that the skin allows a conduction of optical radiation sufficient to allow the transmission of signals, especially if the pacemaker 100 of the invention is installed inside the human body or almost under the skin.
    [0138] The aforementioned coupling is advantageously achieved substantially by placing the movable portion 201 of the interrogation system 200 against the user's body in the vicinity of the pacemaker 100 itself, so that the optical transceiver stage of this movable portion 201 is substantially aligned along the an ideal axis 116 that connects the latter with the sensitive elements of the pacemaker 100. Since each optical sensing element has a strongly directive reception or transmission, ideally such that the preferential radiation or reception axis coincides with the ideal axis 116 , but also a sector 115 for radiation or reception of optical signals, the coupling with respect to the ideal axis 116 must not be perfect but may be slightly changed both in terms of translation and of reciprocal angle without thereby causing system malfunctions. In other words, what is the main radiation direction of the optical transmitter on the moving portion 201 of the interrogation system, in association with the main receiving direction of the sensitive portion of the optical receiver element 109a or, equivalently, established which is the direction of main reception of the optical receiver on the mobile portion of the interrogation system, in association with the main transmission direction of the optical transmitter element 109b, a relative positioning step is provided between the said movable portion 201 of the said interrogation system and the sensitive portion of the optical transmitter element 109b or of the optical receiver element 109a. In particular, the relative positioning step is a relative alignment step, such that the movable portion 201, and in particular its transmitter and / or optical receiver, are aligned at least roughly with the aforementioned main radiation or reception direction.
    [0139] The activation of the radiofrequency stages - especially on the interrogation system 200 - can advantageously be performed manually or automatically or still contextually on the basis of the type of pacemaker 100 according to the first, second, third or fourth form of realization previously described.
    [0140] The Applicant has found that among the optical radiations previously described, the one that provides the best transmission characteristics through the skin is the optical radiation in the visible spectrum, since it has fewer adverse effects particularly with respect to infrared radiation.
    [0141] In particular, the applicant has observed that if the interrogation system 200 transmits an interrogation signal s1 (t) or command s2 (t) in the ultraviolet spectrum, the said system and therefore the interrogation process therein associated - must include a transmission of a query with a signal of lower power than 100 microwatts per square centimeter at a wavelength corresponding to 254 nanometers. With a light radiation, preferably though not limitedly, the light has an irradiation greater than 10 pW / cm2 / nm.
    [0142] A first programming of the aforesaid data processing unit is performed when the said pacemaker is positioned outside the human body. This programming, preferably but not limited to, is the first programming that is chronologically performed on the pacemaker itself, for example and not limitedly in the factory, on the basis of standardized parameters that could be known to the manufacturer. Further programming of the microprocessor 107 is possible by sending command signals s2 (t).
    [0143] Where the previously described embodiments integrate a solar cell 109b, if the power regulator stage, having evaluated the electric power generated by the solar cell 109b, considers it sufficient to cause an at least partial recharge of the battery 102, in use there will be a step of at least partial recharging of the battery, which is therefore a recharging with an optical signal, and which in detail can take place by excitation of the solar cell 109b or through an optical signal carrying information - as in the case of the first optical interrogation signal or of control - or through a simple indirect illumination of the solar cell 109b by means of an optical radiation source.
    [0144] All the embodiments of the pacemaker 100 described above can optionally be provided with a portion of optical fiber, of a flexible type, connected with said body 101 and having a first end freely accessible and a second end, positioned within said body 101 and in particular connected with the optical communication stage 109. Depending on the fact that this optical communication stage 109 is in use provided with a single optical receiver element, a single optical transmitter element or both of the previous elements, through the optical fiber can communicate with the optical communication stage 109 in transmission and / or in reception, without the need for relative alignment with the body 101 in its portion where at least part of the sensitive elements of the optical communication stage 109 is exposed; on the contrary, the relative alignment takes place on the free end of the optical fiber.
    [0145] The Applicant has in fact observed that certain electromedical devices, for various reasons could be installed more in depth than the position in which a pacemaker is installed, as well as the pacemaker itself - for particular needs, it could be installed in depth or behind a bone. In this case, in use, the optical fiber should be installed in the human body in such a way that the free end of the fiber faces towards a portion of surface skin, or even extends outside the skin itself. The relative alignment previously discussed, in addition to or alternatively to the sensitive portions of the communication stage 109 on the body 101, takes place with the free end of the optical fiber.
    [0146] The Applicant notes that the method previously illustrated in its various aspects explicitly excludes each installation step of said device in the human body and each step of interaction of said device with the human body itself.
    [0147] The advantages of the pacemaker and more generally of the electromedical device object of the invention, in its first, second, third and fourth form of realization of the invention are clear in light of the preceding description. This device allows, in the transmission and / or in the reception, to have a lower susceptibility to electromagnetic interference of signals or disturbances in the radio spectrum, and to make the time when it is interrogated and / or the moment in which it responds less interceptable. query.
    [0148] If in particular the device object of the invention is a pacemaker, since at least one of the steps of transmission of the interrogation or command signal towards the pacemaker and the step of transmission of the response signal from the latter to the system of interrogation takes place along an optical transmission channel, there is also a reduction in the interference which could otherwise be created in the unwanted electromagnetic coupling between the cables towards the electrodes 131a, 131b and the radio transmitter, so installed on the pacemaker itself. how much on the query system. Therefore, although the embodiment in which the optical communication stage 109 includes both the optical receiver element and the optical transmitter element optimizes the advantage of reducing the risk of interference in the general interrogation step, also the remaining embodiments concur with the decrease it.
    [0149] It is also understood that the method object of the present invention, which in the previous portions of description has been declined in a particular way to a pacemaker, can be applied in particular way to an electro-medical device suitable to be installed inside the body human. More in detail, the said method allows to achieve the same advantages when associated with an electromedical device provided with at least one electrode and adapted to be installed inside the human body.
    [0150] Parts of the process or method described in the present invention can be - when possible - realized by means of a data processing unit, technically replaceable with one or more electronic processors designed to execute a portion of a predefined software program or firmware loaded on a non-transient memory support. This software program can be written in any known programming language. The electronic processors, if in a number equal to two or more, can be connected to each other by means of a data connection such that their calculation powers are shared in any way; the same electronic processors can therefore be installed in positions that are also geographically different.
    [0151] The data processing unit can be a general purpose processor specifically configured through said software or firmware program to perform one or more parts of the method identified in the present invention, or be a dedicated ASIC or processor, specifically programmed for performing at least part of the operations of the method or process of the present invention.
    [0152] Finally, it is clear that the object of the present invention can be applied to additions, modifications or obvious variants for a person skilled in the art, without thereby departing from the scope of protection provided by the annexed claims.
    权利要求:
    Claims (22)
    [1]
    claims
    1. Electromedical device implantable inside the human body (100), which comprises a body (101) provided inside with at least one battery (102) for supplying electrical energy to control circuits, at least one control circuit comprising a data processing unit (107), receiving energy from said battery and interaction means (103a, 103b) with the human body, at least partially fed through said battery (102) and configured to analyze and / or supply in the form of medicament or energy vital parameters and respectively immunize and / or cure and / or support the said human body; the said electromedical device (100) being characterized in that it comprises an optical communication stage (109), configured to at least receive a first optical signal and / or transmit a second optical signal for interrogation and response respectively.
    [2]
    2. Device (100) according to claim 1, characterized in that it is a pacemaker and in that it comprises at least one electrode (103a, 103b) configured in use to deliver an electrical energy to a myocardium, in order to regularize and / or stabilizing its rhythm, in which said data processing unit (107) receives energy from said battery (102) and is configured to electronically manage said electric energy supply.
    [3]
    3. Device (100) according to any one of claims 1 or 2, characterized in that said optical communication stage (109) comprises optically sensitive elements positioned at least partly on their side in correspondence with the outer surface of said body.
    [4]
    4. Device (100) according to claim 3, characterized in that said optically sensitive elements comprise an optical transmitter element and an optical receiver element (109a, 109c).
    [5]
    5. Device (100) according to any one of the preceding claims, characterized in that it comprises a radio transmitter stage (110) and / or a radio receiver stage (111) electrically connected to said data processing unit (107).
    [6]
    6. Device (100) according to claim 5, characterized in that said radio transmitter (110) is configured to transmit a radio signal (s3 (t)) of response in automatic mode following the reception of a specific first signal ( s1 (t)) optical.
    [7]
    7. Device (100) according to any one of the preceding claims, characterized in that the said optical communication stage (109) is configured to transmit a second signal (s3 (t)) following the reception of the said first signal (s1 ( t)) optical, and comprises at least one optical emitter element (109c), said optical emitter element (109c) having at least one sensitive surface thereof at said outer surface of said body (101).
    [8]
    8. Device (100) according to claim 5, characterized in that the said radio receiver stage (111) is configured to receive a radio interrogation signal (s1 (t)) and to cause the automatic activation of the said communication stage optic (109), in which the automatic activation of the said optical communication stage (109) causes the transmission of the said second optical signal.
    [9]
    9. Device (100) according to any one of the preceding claims 1-8, characterized in that it comprises a memory, electrically connected to said data processing unit (107), and electrically powered from or through said battery, said memory comprises data historical electronic data concerning the operation of said device (100) and / or electronic data of remaining charge of said battery, and in which at least part of said historical electronic data of the operation of said pacemaker and / or said residual electronic charge data are transmitted with said response signal (s3 (t)).
    [10]
    10. Device (100) according to any one of the preceding claims, characterized in that the said data processing unit (107) is electrically connected to the said optical communication stage (109) and comprises at least one operative programming configuration in which it is programmed in accordance with an optical programming signal received from said optical communication stage (109).
    [11]
    11. Device (100) according to any one of the preceding claims, characterized in that the said optical communication stage (109) is a directive optical communication stage.
    [12]
    12. Device (100) according to claim 3, characterized in that said optical emitter element (109b) is installed on said body (101) in such a way as to selectively emit an optical signal along a direction at least locally oblique with respect to the surface of the said body (101).
    [13]
    13. Device (100) according to any one of the preceding claims, characterized in that the said optical receiver element comprises at least one photovoltaic cell electrically connected to the said battery (102).
    [14]
    14. Device (100) according to any one of the preceding claims, characterized in that it comprises a portion of optical fiber extending out from said body, said portion of optical fiber being optically connected to said optical communication stage.
    [15]
    15. Method of interaction with an electromedical device suitable for being installed within the human body (100), the said method comprising: - a step of generating a first signal (s1 (t), s2 (t)) by a electronic interrogation system (200) of an electro-medical device capable of being installed within the human body (100); - a step of transmission of the said first signal (s1 (t), s2 (t)) from the said electronic interrogation system (200) towards the said electromedical device suitable to be installed within the human body (100), and / or a transmission step by said electromedical device adapted to be installed within the human body (100) of a second signal (s3 (t)); - an electronic processing step of said first signal (s1 (t), s2 (t)) by said electromedical device suitable for being installed within the human body (100), - in which at least one of said first signal is said second signal are optical signals.
    [16]
    16. Method according to claim 15, comprising a relative alignment step between at least a portion of said electronic interrogation system (200) and optically sensitive portions of said electromedical device adapted to be installed within the human body (100).
    [17]
    17. Method according to claim 15 or claim 16, wherein said first signal (s1 (t)) and / or said second signal (s3 (t)), when optical, are signals respectively transmitted and received with a transmission / directive reception.
    [18]
    18. Method according to any one of the preceding claims 15-17, wherein the said first signal (s1 (t)) is an interrogation signal and / or a command signal.
    [19]
    19. Method according to claim 17, wherein said alignment step comprises an alignment step of an optical receiver element (109a) of said electromedical device able to be installed within the human body (100) along a preferential direction (116) reception, or a step of aligning at least part of said electronic interrogation system (200) along a preferential emission direction of said optical emitter element (109c).
    [20]
    20. The method according to any one of the preceding claims 13-19, comprising a step for recharging a battery (102) of said electromedical device suitable for being installed within the human body (100), said recharging being a recharging with an optical signal and comprising an excitation step of a photovoltaic cell (109b) of said optical receiver element of said electromedical device able to be installed within the human body (100), said excitation step of said photovoltaic cell causing an at least partial recharging of said battery (102 ).
    [21]
    21. interrogation system (200) of an electromedical device according to any one of the preceding claims 1-14, said system comprising means for generating and transmitting a first signal towards said pacemaker (100) and means for receiving a second signal from said pacemaker, in which at least one of said first and said second signals are optical signals.
    [22]
    22. System according to claim 21, wherein said interrogation signal and / or said command signal, if in the optical domain, are signals in the visible range.
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    公开号 | 公开日
    CH713964B1|2021-10-29|
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    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
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    优先权:
    申请号 | 申请日 | 专利标题
    CH00896/17A|CH713964B1|2017-07-11|2017-07-11|Electromedical device that can be implanted inside the human body and method of communication with it.|CH00896/17A| CH713964B1|2017-07-11|2017-07-11|Electromedical device that can be implanted inside the human body and method of communication with it.|
    PCT/IB2018/055078| WO2019012423A1|2017-07-11|2018-07-10|Electro medical device implantable within the human body and method of communication with the same|
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