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    • 专利摘要:
    An implantable system (10) includes a first device (20), called a centralization device, adapted to be fixed in a position of attachment to a wall of the stomach of a patient, the centralization device (20). ) being received in the stomach when the centralizing device (20) is in the attachment position, and at least one second device (25). The implantable system (10) is characterized in that the centralizing device (20) comprises a controller (45), a power supply (55) and a transmitter / receiver (60) adapted to allow communication between the centralization device ( 20) and the second device (25) when the second device (25) is in an operating position, the second device (25) being located outside the patient's body when the second device (25) is in the position of operation.
    公开号:FR3059558A1
    申请号:FR1662059
    申请日:2016-12-07
    公开日:2018-06-08
    发明作者:Philippe Cinquin；Francois Boucher；Pascal DEFAYE；Pierre-Yves Gumery；Patrick TUVIGNON
    申请人:Centre Hospitalier Universitaire de Grenoble；Universite Grenoble Alpes；
    IPC主号:
    专利说明:

    Holder (s): UNIVERSITE GRENOBLE ALPES Public establishment, CENTER HOSPITALIER UNIVERSITAIRE GRENOBLE.
    Extension request (s)
    Agent (s): LAVOIX.
    (04) IMPLANTABLE SYSTEM.
    FR 3 059 558 - A1 (07) The invention relates to an implantable system (10) comprising a first device (20), called centralization device, suitable for being fixed in a position for fixing to a wall of the stomach of a patient, the centralizing device (20) being received in the stomach when the centralizing device (20) is in the fixing position, and at least one second device (25). The implantable system (10) is characterized in that the centralization device (20) comprises a controller (45), an electrical supply (55) and a transmitter / receiver (60) suitable for allowing communication between the centralization device ( 20) and the second device (25) when the second device (25) is in an operating position, the second device (25) being located outside the patient's body when the second device (25) is in the operating position operation.
    i
    Implantable system
    The present invention relates to an implantable system.
    A large number of implantable devices are used to monitor or stimulate certain organs of the human body. For example, cardiac pacing devices (or "pacemakers") are implanted in many patients. These devices generally include an energy source such as a battery, one or more sensors making it possible to monitor the behavior of the organ being monitored and / or a stimulation module designed to exert an action on the stimulated organ.
    However, it is necessary to regularly recharge or replace the batteries of such implanted devices. In particular, in many cases this replacement is carried out by a surgical operation. Such a procedure is relatively expensive and restrictive for the patient since it takes place in an operating room of a hospital establishment and that anesthesia is necessary, as well as an extended stay in the hospital establishment in order to monitor the consequences of the operation. In addition, as with any surgical procedure, there are risks that the patient may acquire an infection during the operation.
    In other cases, implanted devices of the aforementioned type are supplied from the outside by an energy storage module which is carried by the patient outside his body. For example, power supplies sometimes transmit energy by ultrasonic waves to the stimulation device, through the patient's skin and chest. However, the ultrasonic waves pass poorly through the bones, and great precision in the placement of the source of ultrasound is then necessary, in cases where the implanted device is located in the rib cage, in order to ensure a good supply. of the implanted device. In addition, such a feeding device external to the patient's body is unsightly.
    It also happens that implantable devices are equipped with wired connectors, allowing an electrical connection or a transfer of fluid between the implantable device and an external device. Through this, an electrical supply current or data measured by the sensors of the implanted device are exchanged with the external device. Again, these connectors opening through the patient's skin are unsightly, and necessarily present health risks as well as significant constraints for the patient in his everyday life.
    There is therefore a need for an implantable system which is less restrictive for the patient.
    To this end, an implantable system is proposed comprising:
    - A first device, called centralizing device, suitable for being fixed in a fixing position to a wall of the stomach of a patient, the centralizing device being received in the stomach when the centralizing device is in the position fixing, and
    - at least a second device, the implantable system being characterized in that the centralization device comprises a controller, an electrical supply and a transmitter / receiver suitable for allowing communication between the centralization device and the second device when the second device is in an operating position, the second device being located outside the patient's body when the second device is in the operating position.
    According to embodiments, the implantable system comprises one or more of the following characteristics, taken in isolation or according to all technically possible combinations:
    - the centralization device is configured to communicate with each second device by radio frequency communication;
    the centralization device comprises a sensor capable of measuring a value of a physiological parameter of the patient, the transmitter / receiver being configured to transmit the measured values to a second device, the second device considered being capable of detecting a physiological phenomenon of the patient from at least one of the measured values;
    - the implantable system comprises two second devices, and one of the second devices comprises at least one sensor capable of measuring a value of a physiological parameter of the patient, the transmitter / receiver being configured to receive from the second device comprising a sensor the measured values and for transmitting the measured values to the other second device, the other second device being capable of detecting a physiological phenomenon of the patient from at least one of the values received from the transmitter / receiver;
    the implantable system includes a memory capable of storing the values measured for a duration greater than or equal to one day;
    - the physiological phenomenon is a cardiac pathology;
    - the heart pathology is heart failure;
    - the sensor is an ultrasonic transmitter / receiver;
    - the sensor is an accelerometer capable of measuring values of an acceleration of the centralization device and the second device is configured to calculate a physiological parameter of the patient's heart from the measured acceleration values;
    - the sensor is able to measure a difference in electrical potential, acceleration, noise, orientation, pH or temperature;
    - the centralization device comprises a catheter capable of conveying a body fluid from the patient to the sensor, the sensor being capable of measuring a level of a biological marker in the body fluid;
    the sensor comprises at least one light source and at least one light radiation detector, the light source being configured to illuminate at least a portion of a patient's organ with light radiation, the detector being configured to measure a value of a reflection rate of the light radiation, the controller being configured to calculate an oxygenation rate of the blood circulating in the organ illuminated by the light source, from the reflection rate;
    - the system comprises a plurality of sensors, and the second device is capable of detecting the physiological phenomenon from values of at least two sensors;
    - the physiological phenomenon is chosen from the group consisting of: a heart rhythm disorder, atrial fibrillation, syncope, heart failure, sleep apnea, chronic obstructive pulmonary disease, emphysema, epilepsy, a disorder swallowing, eating disorder;
    - when the centralizing device is in the fixing position, the centralizing device is in the upper part of the stomach;
    the electrical supply comprises a removable electrical energy reserve and a connector suitable for accommodating the electrical energy reserve, the electrical energy reserve being suitable for supplying the controller electrically when the electrical energy reserve is electrically connected to the connector in a connection position and preferably being configured to be swallowed by the patient and to move spontaneously to the connection position from a disconnection position in which the reserve of electrical energy is received in the stomach of the patient and is disconnected from the connector;
    - the power supply includes an electrical energy generator capable of generating an electric current by reaction of at least one chemical species present in the patient's body, in particular glucose;
    - the power supply includes an electrical energy generator capable of generating an electrical current by converting mechanical energy into electrical energy.
    Characteristics and advantages of the invention will appear on reading the description which follows, given solely by way of nonlimiting example and made with reference to the appended drawings, in which:
    - Figure 1 is a diagram of an example of an implantable system comprising an electrical supply,
    FIG. 2 is a schematic representation of the implantable device of FIG. 1, implanted in the body of a patient, and
    - Figure 3 is a schematic representation of the power of Figure 1.
    A first example of an implantable system 10 is shown in FIG. 1.
    The implantable system 10 comprises an anchor 15, a first device 20, called a centralization device, and at least a second device 25.
    It is understood by "implantable system" that at least one element from the list formed by the anchor 15 of the first device 20 and of the second device 25 is intended to be implanted in the human body.
    In particular, it is understood by "implantable" that at least one element among the anchor 15, the centralization device 20 and the second device 25 is intended to remain in the body of a patient P for a strictly greater duration to a week, preferably strictly greater than one month, preferably greater than or equal to one year.
    The implantable system 10 has been shown diagrammatically in FIG. 2 when the implantable system 10 is implanted in the body of patient P.
    The implantable system 10 is configured to detect at least one physiological phenomenon occurring in the patient P. It is understood by "physiological phenomenon" a phenomenon relating to a function of an organ of the body of the patient P. The physiological phenomenon is a pathology cardiac. For example, the physiological phenomenon is a heart rhythm disorder. For example, the physiological phenomenon is an atrial fibrillation of the heart of patient P.
    As a variant, the physiological phenomenon is a syncope. According to another variant, the physiological phenomenon is bradycardia.
    According to another variant, the physiological phenomenon is heart failure of the heart of patient P.
    According to the example of FIG. 2, the anchor 15 and the centralization device 20 are each implanted in the body of the patient P. The second device 25 has been shown in an operating position in FIG. 2.
    The anchor 15 is suitable for being fixed in a predetermined position in the stomach 30 of patient P.
    For example, the anchor 15 is configured to be fixed in the upper part of the stomach 30. In particular, the anchor 15 is configured to be fixed in the gastric fundus of the stomach 30. For example, the anchor 15 is intended to be fixed as close as possible to the angle of Hiss in the gastric fundus.
    As a variant, the anchor 15 is configured to be fixed in the lower part of the stomach 30.
    The anchor 15 is configured to support the centralizing device 20, preferably removably. In particular, the anchor 15 and the centralizing device 20 are configured to be fixed to each other, by a fixing device, and the anchor 15 is configured to keep the centralizing device 20 in a position of fixation when the anchor 15 is fixed in the stomach 30.
    The anchor 15 has a head 35 and a first connector 40.
    The head 35 is configured to anchor the anchor 15 in the predetermined position. In particular, the head 35 is configured to anchor the anchor 15 to the wall of the stomach 30.
    The head 35 is, for example, a gastrointestinal clip configured to enclose between two branches of the head 35 a portion of the wall of the stomach 30.
    As a variant, the head 35 is suitable for being sutured by a thread to the wall of the stomach 30.
    According to another variant, the head 35 is suitable for being buried inside the gastric mucosa after the latter has been dissected.
    The first connector 40 is configured to fix the centralization device 20 to the head 35.
    The centralization device 20 comprises at least one sensor 117, a first controller 45, a second connector 50, a power supply 55, a first transmitter / receiver 60 and a housing 65. For example, the centralization device 20 comprises two sensors 117 .
    Each sensor 117 is external to the first controller 45 but is capable of communicating with the first controller 45.
    Each sensor 117 is configured to measure values of a physiological parameter of the patient P. The physiological parameter is, for example, a parameter of an organ C.
    Organ C is separate from the stomach of patient P. For example, at least one sensor 117 is able to measure values of a parameter of the heart.
    For example, a sensor 117 is suitable for measuring a value of an acceleration of the centralizing device 20, such as an acceleration caused by a contraction of the heart C.
    As a variant or in addition, a sensor 117 is suitable for measuring a value of a difference in electrical potential between two electrodes of the sensor 117. The difference in electrical potential is, for example, measured between two points on the stomach wall, c ' that is, the two electrodes are in contact with the stomach wall. As a variant, the sensor 117 has only one electrode, and is capable of measuring the difference in electrical potential between the electrode and the anchor 15. As a variant, the anchor 15 has two electrodes and the sensor 117 is suitable for measure a potential difference between the two electrodes of the anchor 15.
    The first controller 45 is an information processing unit. The first controller 45 includes a first memory 75 and a first processor 80.
    The first memory 75 is suitable for storing the values measured by the sensor 117 during a storage period greater than or equal to one hour, preferably greater than or equal to one day, preferably greater than or equal to one week.
    The first processor 80 is able to manipulate and / or transform data represented as electronic or physical quantities in the first memory 75 into other similar data corresponding to physical data in the first memory 75, in registers or other types of display, transmission or storage devices.
    The first processor 80 is also configured to exchange information with the first transmitter / receiver 60.
    The second connector 50 is configured to cooperate with the first connector 40 to maintain the centralization device 20 in the fixing position.
    For example, the second connector 50 is configured to cooperate with the first connector 40 by snap-fastening.
    As a variant, the second connector 50 comprises a magnet configured to fix the second connector to the first connector. The magnet is, for example, an electromagnet.
    According to another variant, the first connector 40 is configured to be secured to the second connector 50 by screwing. As a variant, the first connector 40 comprises one or preferably two bayonets complementary to fixing orifices provided in the second connector 50.
    Preferably, the second connector 50 is provided so that the centralizing device 20 is separable from the anchor 15. In particular, the second connector 50 is configured so that the centralizing device 20 is separable from the anchor 15 when the anchor 15 is fixed in the stomach 30 of patient P.
    The power supply 55 has been shown in Figure 3.
    The power supply 55 is configured to supply the first controller 45 with a supply current C.
    The power supply 55 has a third connector 85 and a first reserve of electrical energy 90.
    The third connector 85 is configured to receive the supply current C from the first electrical energy reserve 90 and to supply the first controller 45 with the first supply current C.
    The third connector 85 is configured to receive the first reserve of electrical energy 90. In particular, the third connector 85 delimits a cavity 95 configured to at least partially accommodate the first reserve of electrical energy 90 in a connection position.
    According to the example of FIG. 3, the cavity 95 opens onto the outside of the box 65. In particular, the cavity 95 is configured to allow the insertion of the first reserve of electrical energy 90, from outside the box 65, in the cavity 95.
    The third connector 85 further comprises two first electrical contacts 100, configured to be electrically connected to the first electrical energy reserve 90 when the first electrical energy reserve 90 is in the connection position. In particular, the first two electrical contacts 100 open into the interior of the cavity 95.
    The first electrical energy reserve 90 is configured to store electrical energy. In particular, the first reserve of electrical energy 90 is configured to be charged with electrical energy outside the patient's body P and to discharge when the first reserve of electrical energy 90 is in the connection position. For example, the first reserve of electrical energy 90 comprises a battery. As a variant, the first reserve of electrical energy 90 comprises at least one capacitor or a supercapacitor.
    The first reserve of electrical energy is configured to supply the first controller 45 with the supply current C when the first reserve of electrical energy 90 is in the connection position.
    According to the example of FIG. 3, the first electrical energy reserve 90 comprises two second electrical contacts 105 complementary to the first electrical contacts 100.
    The first reserve of electrical energy 90 can be provided to be swallowed by the patient P.
    According to a variant, the first energy reserve 90 is suitable for being replaced by endoscopy.
    In particular, the first reserve of electrical energy 90 has a volume strictly less than 6 milliliters (ml).
    The first reserve of electrical energy 90 also has three dimensions, each measured in a respective direction, each direction being perpendicular to the other two directions, and each dimension is strictly less than 5 centimeters (cm).
    The first reserve of electrical energy 90 is movable between the connection position and a disconnection position. When the first reserve of electrical energy 90 is in the disconnected position, the first reserve of electrical energy 90 is received in the stomach 30 of the patient P but is not electrically connected to the third connector 85. For example, when the first reserve of electrical energy 90 is in the disconnected position, the first reserve of electrical energy is completely extracted from the cavity 95.
    The first reserve of electrical energy 90 is configured to spontaneously move from the disconnection position to the connection position. For example, the first reserve of electrical energy 90 includes attractors 110.
    Preferably, the first reserve of electrical energy 90 is configured to eject from the third connector 85 any other first reserve of used electrical energy 90. In other words, the first reserve of electrical energy 90 is configured to, if a first reserve of used electrical energy 90 is in the connection position, causing the disconnection of the first reserve of used electrical energy 90 and the displacement of the first reserve of used electrical energy from the connection position to the disconnection position.
    The attractors 110 are configured to exert on the first reserve of electrical energy 90, when the first reserve of electrical energy 90 is in the disconnected position, a force tending to move the first reserve of electrical energy 90 from the position of disconnection to the connection position.
    In addition, the attractors 110 are configured to maintain the first reserve of electrical energy 90 in the connection position.
    The attractors 110 comprise, for example, a first magnet capable of cooperating with a second magnet 112 of the third connector 85. As a variant, the first magnet is capable of cooperating with a ferromagnetic portion of the third connector 85. The first magnet and the second magnet 112 are, for example, electromagnets.
    The first transmitter / receiver 60 is configured to exchange information with the second device 25 when the second device 25 is in the operating position. The first transmitter / receiver 60 thus forms means of communication with the second device 25.
    The first transmitter / receiver 60 is, for example, a radio frequency communication module. It is understood by “radiofrequency communication module” that the first transmitter / receiver 60 is configured to communicate with the second device 25 via a signal comprising at least one electromagnetic radiofrequency wave. Radio frequency electromagnetic waves are electromagnetic waves with a frequency between 3 kilohertz and 3 gigahertz.
    According to one embodiment, the first transmitter / receiver 60 is capable of exchanging information with the second device 25 according to a Bluetooth Low Energy protocol. The Bluetooth Low Energy protocol is a protocol based on a standard of the “Bluetooth special interest group” and operating in the range between 2400 megahertz (MHz) and 2483.5 MHz.
    Alternatively, information transmission modes in the 402,405 megahertz (MHz) (Medical Implant Communication Service) or 2360 - 2390 MHz (Medical Body Area Networks) ranges can be used.
    The box 65 is configured to isolate the first controller 45 from the outside of the box 65. For example, the box 65 defines a chamber collecting at least the first controller 45 and the first transmitter / receiver 60.
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    The second device 25 is not implanted inside the body of the patient P when the device 25 is in the operating position. In particular, the second device 25 is located outside the body of the patient P when the second device 25 is in the operating position.
    For example, the second device 25 is installed in a doctor's office. As a variant, the second device 25 is installed in the home of the patient P. As a variant, the second device 25 is worn by the patient, for example the second device 25 is a mobile phone such as a smartphone, a tablet, a dedicated device or a module integrated into a mobile phone or tablet.
    The second device 25 is a display device capable of transmitting information to a user U.
    The second device 25 is also configured to detect the physiological phenomenon from the measured values.
    The second device 25 comprises a second transmitter / receiver 120, a second controller 135 and a man / machine interface 140.
    The second transmitter / receiver 120 is configured to exchange information with the first transmitter / receiver 60.
    The second controller 135 is configured to detect the physiological phenomenon from the values measured by the sensor 117.
    The second controller 135 includes a second memory 145 and a second processor 150.
    The man / machine interface includes, for example, a screen and a speaker.
    An organ C monitoring process is implemented by the implantable system 10.
    The monitoring method includes an implantation step, a measurement step, a transfer step, a detection step and a signaling step.
    During the implantation step, the anchor 15 and the centralizing device 20 are implanted in the body of patient P. The second device 25 is not implanted in the body of patient P.
    During the measurement step, each sensor 117 measures values of the parameter. For example, the sensor 117 periodically measures values of the corresponding parameter with a predetermined period.
    The measured values are stored in the first memory 75.
    The measured values are stored in the first memory 75 for a duration greater than or equal to one hour, for example greater than or equal to a day, for example greater than or equal to a week, for example greater than or equal to a month.
    During the transfer step, the measured values are transferred, by the centralization device 20, to the second device 25. For example, the transfer step is implemented when the patient P goes to his doctor's office assigned.
    As a variant, the transfer step is carried out periodically when the patient P is at home, for example once a day. According to a variant, when the patient carries the second device 25 with him, for example when the second device 25 is integrated into a mobile phone, the transfer step is implemented with a period less than or equal to one hour.
    For example, thanks to the measured potential difference values, the second device 25 displays an electrocardiogram of the patient P.
    After each transfer step, the first memory 75 is erased. In particular, the stored parameter values are deleted.
    During the detection step, the second controller 135 detects the physiological phenomenon from the measured values.
    According to a variant, the second controller 135 calculates operating data from the measured values and detects the physiological phenomenon from the operating data. The operating data are data derived from the measured values. For example, a heart rate is an example of operating data calculated from measurements of a potential difference between two electrodes or from acceleration values of the centralizing device 20. A time interval between two waves of polarization of an atrium of the heart is another example of operating data, and a variation of this time interval is another example of operating data. Another example of operational data is a correlation coefficient obtained by fitting a set of measured values with a set of reference values or a reference function.
    For example, the second controller 135 compares each measured value or each value of operating data with a predetermined threshold and detects the physiological phenomenon if one of the measured values is greater than or equal to the predetermined threshold.
    In another example, the physiological phenomenon is detected if several measured values or several values of operating data are greater than or equal to a predetermined threshold for a predetermined period of time. According to a variant, the second controller 135 detects the physiological phenomenon if one or more of the measured values or of the operating data values is greater than or equal to the predetermined threshold, or even if one or more of the measured values or of the data values d exploitation is not included in a data range framed by two predetermined thresholds.
    According to another example, the physiological phenomenon is detected if several measured values or several values of operating data belong to a predetermined region of the space IR n , where IR is the set of real numbers and n represents the number of values. According to a variant, the second controller 135 detects the physiological phenomenon if one or more of the measured values or of the operating data values belong to a predetermined region of the space IR n .
    The predetermined thresholds or the predetermined region of the HL space are, for example, determined by a machine learning method. Machine learning methods are also known as machine learning. For example, the implantable system records the values measured while the patient undergoes more conventional examinations (external electrocardiogram or morphological examinations, for example ultrasound examinations, possibly performed during functional tests, for example stress tests). These more classic examinations are chosen to allow a diagnosis to be made, and a machine learning method makes it possible to determine combinations of the values measured by the implantable system which correspond to the physiological or pathological phenomenon studied. In everyday life, when the measured values check these characteristics again, the second controller 135 will detect the physiological or pathological phenomenon.
    According to a variant, the second controller 135 detects the physiological phenomenon from values measured by at least two separate sensors 117.
    According to one embodiment, the second controller 135 detects atrial fibrillation from the acceleration values and / or the measured electric voltage values. The second controller 135 detects, for example, atrial fibrillation from an analysis of the electrical voltage values to detect the presence or absence, in the electrocardiogram, of a signal representative of a polarization P wave of the atrium of the heart. Alternatively, analyzing the variation in the time interval between two R waves can detect atrial fibrillation.
    The signaling step is then implemented.
    During the signaling step, the second controller 135 controls the emission, via the man / machine interface 140, of an alert signal intended for the patient P and / or his doctor.
    The alert signal informs patient P and / or his doctor that the physiological phenomenon has occurred. For example, the alert signal contains a date of occurrence of the physiological phenomenon, a frequency of appearance of the physiological phenomenon, a duration of the physiological phenomenon, or even a heart rate of the patient P during the physiological phenomenon.
    The alert signal is, for example, transmitted simultaneously to a rescue organization. For example, the alert signal is sent to a rescue organization via a wireless telephone network. Alternatively, the alert signal is sent over the Internet.
    Because the centralizing device 20 is in the stomach, the replacement of the first reserve of electrical energy 90 is easy and can, for example, be carried out endoscopically from the esophagus, in a simple and rapid manner. In addition, the replacement of the first reserve of electrical energy 90 poses little risk of infection since no incision is made.
    The use of attractors 110 makes it even simpler to place the first reserve of electrical energy 90, even without endoscopy, since it then suffices for patient P to swallow the first reserve of electrical energy 90.
    In addition, the implantable system 10 does not assume that the patient P is permanently carrying electrical energy storage means outside his body, nor that unsightly electrical conductors open out of the body of the patient P. The implantable system 10 is therefore not very restrictive for the patient.
    The upper part of the stomach 30 is close to the heart C, and the contractions of the heart C therefore cause a displacement of the centralization device 20. Thanks to the positioning of an acceleration sensor 117 in the stomach, atrial fibrillation is then effectively detected, not only by an electrical measurement of the activity of the heart but also by the measurement of the acceleration of the centralization device 20.
    The implantable system therefore improves patient safety P.
    In addition, the positioning of the centralization device 20 in the stomach again makes it possible to reduce the stresses for the patient P.
    In addition, the processing of the data acquired by the sensors 117 is carried out by the second device 25, which is located outside the patient's body. The power consumption of the centralization device 20 is then limited, which decreases the frequency at which the power supply of the centralization device 20 must be changed. The constraints for the patient P are therefore here again limited.
    According to a variant of the first example, the measurement step is implemented during non-continuous time periods. For example, values are measured during first time ranges separated by second time ranges during which no value is measured. According to one embodiment, the first time slots have a duration of 30 seconds, and the second time slots have a duration of 30 minutes.
    Thus, the first device 20 is put to sleep for a large proportion of the time. The energy consumption of the implantable system 10 is therefore reduced. This embodiment is particularly suitable for the detection of physiological phenomena whose evolution is slow, such as heart failure.
    The first example of an implantable system 10 was given for the case of the detection of atrial fibrillation of the patient P. Alternatively, the implantable system 10 can also make it possible to detect other cardiovascular pathologies, for example heart failure. . However, it should be noted that the positioning of the centralization device in the stomach 30 of the patient P makes it possible to measure parameters of a wide variety of organs C. The implantable system 10 is therefore capable of being adapted to detection of a large number of distinct physiological phenomena.
    For example, the physiological phenomenon is a respiratory disorder. Chronic obstructive pulmonary disease is an example of a respiratory disorder.
    Alternatively, the physiological phenomenon is emphysema.
    According to another variant, the physiological phenomenon is epilepsy.
    According to another variant, the physiological phenomenon is an eating disorder.
    According to another variant, the physiological phenomenon is sleep apnea. For example, the sensor 117 is capable of detecting a contraction of the diaphragm and the second controller 135 is configured to detect sleep apnea if a period of time without contraction of the diaphragm has a duration greater than or equal to a predetermined threshold.
    According to another variant, the physiological phenomenon is a swallowing disorder, or an eating disorder such as insufficient hydration.
    In addition, many types of sensors 117 are likely to be used.
    For example, the sensor 117 is a light emitter / receiver comprising at least one light source and at least one light radiation detector. For example, the sensor 117 comprises two light sources. According to one embodiment, the sensor 117 then comprises two light radiation detectors.
    The light source or sources are configured to illuminate at least a portion of an organ of the patient P with light radiation. For example, each light source is configured to illuminate a portion of the heart muscle. The portion is, for example, a portion of a heart cavity.
    The illuminated organ is, alternatively, a blood vessel such as the aorta of patient P.
    Alternatively, the blood vessel is the vena cava.
    According to another variant, the illuminated organ is the gastric wall.
    According to another variant, the illuminated organ is the diaphragm.
    Each light radiation has a wavelength. For example, at least one wavelength is chosen for its level of absorption or reflection by certain molecules. For example, at least one light radiation has a visible wavelength. A wavelength of 660 nanometers is an example of a visible wavelength.
    Alternatively, the light radiation from at least one light source is infrared light radiation. For example, infrared radiation has a wavelength of 950 nanometers.
    According to one embodiment, a wavelength is equal to 660 nanometers and another wavelength is equal to 950 nanometers. These wavelengths are absorbed and / or reflected differently by the unsaturated hemoglobin (denoted Hb) and the saturated hemoglobin (denoted HbO 2 ), and therefore allow a good evaluation of the relationship between these two molecules.
    The detector is configured to measure a value of a reflection rate of each light radiation on the illuminated organ. For example, the detector includes a photodiode.
    Alternatively, the detector is configured to measure an absorption rate of each light radiation.
    The second controller 135 is configured to receive from the detector the measured reflection rate values, and to calculate an oxygenation rate of the blood circulating in the illuminated organ from the received values. For example, the second controller 135 is configured to calculate an oxygenation rate of capillary blood circulating in the gastric wall. Alternatively, the second controller 135 is configured to calculate an oxygenation rate of capillary blood circulating in the heart muscle, or blood present in the heart chambers, or blood present in the aorta or in the vena cava.
    The physiological phenomenon that the implantable system 10 is capable of detecting is then a drop in the oxygen saturation of the hemoglobin of patient P. The drop is, for example, caused by cardiac or respiratory pathology.
    According to another variant, at least one sensor 117 is a sensor for a biological marker of a body fluid F of the patient P. The body fluid F is, for example, the contents of the stomach or the extra-cellular fluid in the level of the stomach wall where the first device 20 is implanted.
    According to another variant, the centralization device 20 comprises a first catheter configured to deliver a bodily fluid F from the patient P from the organ C to the sensor 117. For example, the organ C is the peritoneum, and the fluid F is the peritoneal fluid.
    The biological marker is, for example, glucose.
    As a variant, the biological marker is an ion present in the body fluid F. For example, the sensor 117 is suitable for measuring the pH of the body fluid F. In particular, the sensor 117 is suitable for measuring the pH of the gastric contents or of the peritoneal fluid of patient P.
    The sensor 117 is then able to measure a level of the biological marker in the body fluid F. For example, the sensor 117 is able to measure a level of glucose in the peritoneal fluid, and the first computer 45 is able to estimate a value of patient's blood sugar P.
    According to another variant, at least one sensor 117 is configured to estimate an orientation of the centralization device 20 relative to the vertical. The first controller 45 is then configured to detect a position of the patient P. In particular, the first controller 45 is configured to detect a lying position, a sitting position or an intermediate position between the lying and sitting positions of the patient P.
    For example, the sensor 117 comprises at least one item from the list formed by: a gyroscope, a magnetometer and an accelerometer.
    According to another variant, at least one sensor 117 is able to measure a body temperature of the patient P.
    According to another variant, at least one sensor 117 is a microphone. The sensor 117 is configured to measure a noise emitted by the organ C. The second controller 135 is able to detect the physiological phenomenon from the analysis of the measured noises. For example, the second controller 135 is able to detect a heart rhythm disorder, an abnormality of a heart valve, a pulmonary pathology or even a digestion disorder from the measured noises.
    According to another variant, at least one sensor 117 is an ultrasonic transmitter / receiver. For example, the sensor 117 is capable of emitting at least one beam of ultrasound and of measuring a parameter of a beam reflected on all or part of the heart of the patient P. The parameter of the beam is, for example, a reflection rate , or even a phase shift.
    The second controller 135 is, for example, suitable for calculating a dimension or an amplitude of contraction of the patient's heart P from the measurements provided by the sensor 117. In particular, the second controller 135 is configured to calculate an ejection fraction of the heart from the dimensions or amplitudes of contraction measured.
    Alternatively, the beam emitted is reflected on a blood vessel such as the aorta and the operating data includes a variation in the diameter of the blood vessel. Alternatively, the vessel is the vena cava.
    According to one embodiment, the sensor 117 is configured to evaluate a blood flow or a blood pressure in a blood vessel by Doppler effect.
    A pressure sensor is another example of sensor 117.
    According to another variant, the first device 20 comprises several sensors 117, and the second controller 135 is configured to detect the physiological phenomenon from values measured by at least two sensors 117. According to another variant, the second controller 135 is suitable for detect at least two distinct physiological phenomena from the values measured by the sensor (s) 117.
    A second example of an implantable system 10 will now be described. The elements identical to the first example of an implantable system 10 in FIG. 1 are not described again. Only the differences are highlighted.
    The implantable system 10 comprises two second devices 25.
    One of the second devices 25 is a display device as described above. The other second device 25 will be designated subsequently by the expression “measuring device”. In order to distinguish them from one another, the two second devices 25 will be designated in the remainder of the second example by the expressions "display device" and "measurement device" respectively.
    The measuring device 25 is implanted, in its operating position, in the body of patient P. In particular, the measuring device 25 is implanted outside the stomach 30 of patient P.
    According to a variant, the measuring device 25 is not implanted in the body of the patient P but is carried by the patient P. For example, the measuring device 25 is fixed around a member of the patient P by a strap. It should be noted that other operating positions and other methods of attachment are possible.
    The measuring device 25 does not include a man-machine interface 140.
    The measuring device 25 comprises at least one sensor 117.
    The second transmitter / receiver 120 of the measuring device 25 is configured to transmit the measured values to the first transmitter / receiver 60.
    The first memory 75 is also configured to store the values measured by the sensor or sensors of the measurement device 25.
    The first transmitter / receiver 60 is configured to transmit to the display device 25 the values measured by the sensor or sensors 117 of the measurement device 25.
    The second controller 135 is then configured to detect at least one physiological phenomenon from at least one of the values measured by the sensor or sensors 117 of the measurement device 25.
    The implantable system 10 is then capable of being used for the detection of physiological phenomena for which the positioning of the sensor 117 in the stomach is not favorable.
    According to a variant of the second example, the centralizing device 20 does not include a sensor 117. Only the measuring device 25 includes at least one sensor 117. The centralizing device 20 then plays a role of storage and transmission to the display 25 of the measured values.
    According to another variant, the implantable system 10 comprises at least two measuring devices 25.
    A third example of an implantable system 10 will now be described. The elements identical to the first example of an implantable system 10 are not described again. Only the differences are highlighted.
    The power supply 55 does not have a third connector 85 or an electrical energy reserve 90.
    The power supply 55 includes an electric power generator. It is understood by "electric power generator" that the electric power generator is not configured to be charged with electric energy by an electric current.
    The electrical energy generator is capable of generating at least one electrical current by reaction of at least one chemical species present in the body of the patient P. More specifically, the electrical energy generator is capable of generating the supply current vs.
    For example, the electrical energy generator comprises two electrodes, the electrodes being immersed in the gastric juices of the patient P when the centralizing device 20 is in the fixing position. As a variant, the electrodes of the electrical energy generator are provided for bathing in the intestine of the patient P when the centralizing device 20 is in the fixing position.
    Each electrode contains at least one enzyme. As a variant, each electrode comprises at least one microorganism. For example, each electrode of the electrical energy generator comprises an electrical conductor covered with the enzyme or the microorganism, the assembly thus formed being surrounded by a membrane. The membrane is, for example, configured to be crossed by certain chemical species naturally present in the stomach or intestine of patient P.
    When the electrodes of the electrical energy generator are immersed in the gastric juices or in the intestinal fluid, one of the electrodes acts as an anode in a redox reaction involving a first chemical species. At the same time, the other electrode acts as a cathode in a redox reaction involving a second chemical species.
    By the oxidation and the simultaneous reduction of the first chemical species and the second chemical species, an electrical voltage appears between the two electrical conductors. The supply current C is then generated.
    The first chemical species is, for example, glucose. The second chemical species is, for example, oxygen.
    The third example of an implantable system 10 does not require electrically charging an electrical energy reserve 90 nor making the electrical energy reserve 90 penetrate into the body of patient P.
    The constraints for patient P are again reduced.
    According to a fourth example, the electrical energy generator is capable of generating at least one electrical current by converting mechanical energy into electrical energy. In particular, the electric energy generator is capable of generating at least one electric current from the movements of the stomach 30.
    According to a fifth example, the first controller 45 detects the physiological phenomenon from the measured values. Only a message comprising the results of the detection is transmitted to the second device 25.
    In the above description, the functions of the implantable system 10 have been separated into several examples to facilitate their understanding by the reader. However, it should be noted that the previous examples are likely to be combined to generate new embodiments.
    The implantable system 10 is particularly suitable for the detection of heart failure. In this case, at least one of the sensors 117 is chosen from the group formed by: a sensor measuring a difference in electrical potential, an accelerometer, an ultrasound transmitter / receiver, a light transmitter / receiver and a microphone. For example, two sensors 117 integrated into the centralization device 20 are chosen from the assembly formed by: a sensor measuring a difference in electrical potential, an accelerometer, an ultrasound transmitter / receiver, a light transmitter / receiver and a microphone .
    The second controller 135 is then configured to detect heart failure from values measured by the sensors 117 and / or from operating data calculated from the values measured by the sensors 117.
    For example, the second controller 135 is configured to detect heart failure from electrical potential values.
    For example, the second controller 135 is configured to detect heart failure from acceleration values.
    According to one embodiment, the second controller 135 is configured to detect heart failure from a combination of electrical potential, acceleration and patient orientation values.
    For example, the second controller 135 is configured to detect heart failure from values of blood oxygenation rate or a heart ejection fraction.
    For example, the second controller 135 is configured to detect heart failure from a combination of values measured by all of the sensors 117 and values from all of the operating data.
    If one of the sensors 117 is an ultrasound transmitter / receiver, the second controller 135 calculates a fraction of ejection of the heart from variations in the dimensions of the heart and detects heart failure if the fraction of ejection is less than or equal to a corresponding threshold.
    Alternatively, heart failure is detected from an analysis of heart or lung sounds.
    In addition, the above description has been given in the case where the anchor 15 and the centralization device 20 form two separate devices. It should be noted that the centralizing device 20 and the anchor 15 are capable of forming a single device, the anchor 15 and the centralizing device 20 then not being separable from one another. For example, the anchor 15 came integrally with the housing 65 of the centralization device 20.
    权利要求:
    Claims (17)
    [1" id="c-fr-0001]
    1. - Implantable system (10) comprising:
    - A first device (20), called centralization device, suitable for being fixed in a position for fixing to a wall of the stomach (30) of a patient (P), the centralization device (20) being received in the stomach (30) when the centralizing device (20) is in the fixing position, and
    - at least a second device (25), the implantable system (10) being characterized in that the centralization device (20) comprises a controller (45), a power supply (55) and a transmitter / receiver (60) of its own to allow communication between the centralizing device (20) and the second device (25) when the second device (25) is in an operating position, the second device (25) being located outside the patient's body (P ) when the second device (25) is in the operating position.
    [2" id="c-fr-0002]
    2. - implantable system (10) according to claim 1, wherein the centralization device (20) is configured to communicate with each second device (25) by radio frequency communication.
    [3" id="c-fr-0003]
    3. - implantable system (10) according to claim 1 or 2, wherein the centralization device (20) comprises a sensor (117) capable of measuring a value of a physiological parameter of the patient (P), the transmitter / receiver (60) being configured to transmit the measured values to a second device (25), the second device (25) considered being capable of detecting a physiological phenomenon of the patient (P) from at least one of the measured values.
    [4" id="c-fr-0004]
    4. - implantable system (10) according to any one of claims 1 to 3, comprising two second devices, wherein one of the second devices (25) comprises at least one sensor (117) capable of measuring a value of a physiological parameter of the patient (P), the transmitter / receiver (60) being configured to receive the measured values from the second device (25) comprising a sensor (117) and to transmit the measured values to the other second device, l the other second device (25) being able to detect a physiological phenomenon of the patient (P) from at least one of the values received from the transmitter / receiver (60).
    [5" id="c-fr-0005]
    5. - implantable system (10) according to claim 3 or 4, wherein the controller (45) comprises a memory (75) capable of storing the measured values for a duration greater than or equal to one day.
    [6" id="c-fr-0006]
    6. - Implantable system (10) according to any one of claims 3 to 5, in which the physiological phenomenon is a cardiac pathology.
    [7" id="c-fr-0007]
    7. - implantable system (10) according to claim 6, wherein the cardiac pathology is heart failure.
    [8" id="c-fr-0008]
    8. - Implantable system (10) according to any one of claims 3 to 7, wherein the sensor (117) is an ultrasonic transmitter / receiver.
    [9" id="c-fr-0009]
    9. - implantable system (10) according to any one of claims 3 to 7, in which the sensor (117) is an accelerometer capable of measuring values of an acceleration of the centralization device (20) and the second device ( 25) is configured to calculate a physiological parameter of the patient's heart (P) from the measured acceleration values.
    [10" id="c-fr-0010]
    10. - implantable system (10) according to any one of claims 3 to 7, in which the sensor (117) is capable of measuring a difference in electrical potential, an acceleration, a noise, an orientation, a pH or a temperature. .
    [11" id="c-fr-0011]
    11. - implantable system (10) according to any one of claims 3 to 7, in which the centralization device (20) comprises a catheter capable of conducting a bodily fluid (F) from the patient (P) to the sensor (117) , the sensor (117) being able to measure a level of a biological marker in the body fluid (F).
    [12" id="c-fr-0012]
    12. - implantable system (10) according to any one of claims 3 to 7, in which the sensor (117) comprises at least one light source and at least one light radiation detector, the light source being configured to illuminate at least a portion of a patient's organ (P) with light radiation, the detector being configured to measure a value of a reflection rate of light radiation, the controller (45) being configured to calculate a blood oxygenation rate circulating in the organ illuminated by the light source, from the reflection rate.
    [13" id="c-fr-0013]
    13. - implantable system (10) according to any one of claims 3 to 12, comprising a plurality of sensors (117), in which the second device (25) is capable of detecting the physiological phenomenon from values of at least minus two sensors (117).
    [14" id="c-fr-0014]
    14. - Implantable system (10) according to any one of claims 3 to 13, in which the physiological phenomenon is chosen from the group consisting of: a heart rhythm disorder, atrial fibrillation, syncope, heart failure, sleep apnea, chronic obstructive pulmonary disease, emphysema, epilepsy, swallowing disorder, eating disorder.
    [15" id="c-fr-0015]
    15. - implantable system (10) according to any one of claims 1 to 14, wherein the electrical supply (55) comprises a reserve (90) of removable electrical energy and a connector (85) suitable for accommodating the reserve of electrical energy (90), the electrical energy reserve (90) being suitable for electrically supplying the controller (45) when the electrical energy reserve (90) is electrically connected to the connector (85) in a connection position and preferably being configured to be swallowed by the patient (P) and to move spontaneously to the connection position from a disconnection position in which the reserve of electrical energy (90) is received in the stomach (30 ) of the patient (P) and is disconnected from the connector (85).
    [16" id="c-fr-0016]
    16. - implantable system (10) according to any one of claims 1 to 15, in which the electrical supply (55) comprises an electrical energy generator capable of generating an electrical current by reaction of at least one chemical species present in the patient's body (P), including glucose.
    [17" id="c-fr-0017]
    17. - implantable system (10) according to any one of claims 1 to 16, in which the electrical supply (55) comprises an electrical energy generator capable of generating an electrical current by converting mechanical energy into electrical energy .
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    同族专利:
    公开号 | 公开日
    KR20190104326A|2019-09-09|
    CA3046107A1|2018-06-14|
    EP3551282B1|2021-11-03|
    WO2018104472A1|2018-06-14|
    JP2020513276A|2020-05-14|
    US20200060621A1|2020-02-27|
    FR3059558B1|2021-05-14|
    CN110234391A|2019-09-13|
    EP3551282A1|2019-10-16|
    引用文献:
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    US20060111753A1|2001-05-01|2006-05-25|Imran Mir A|Gastric stimulation anchor and method|
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    WO2006010025A2|2004-07-07|2006-01-26|Medtronic Transneuronix, Inc.|Treatment of the autonomic nervous system|FR3093428A1|2019-03-08|2020-09-11|Universite Grenoble Alpes|Composition and associated delivery device for hydrogen therapy|
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    法律状态:
    2017-12-20| PLFP| Fee payment|Year of fee payment: 2 |
    2018-06-08| PLSC| Publication of the preliminary search report|Effective date: 20180608 |
    2019-12-12| PLFP| Fee payment|Year of fee payment: 4 |
    2020-12-23| PLFP| Fee payment|Year of fee payment: 5 |
    2021-10-26| PLFP| Fee payment|Year of fee payment: 6 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1662059|2016-12-07|
    FR1662059A|FR3059558B1|2016-12-07|2016-12-07|IMPLANTABLE SYSTEM|FR1662059A| FR3059558B1|2016-12-07|2016-12-07|IMPLANTABLE SYSTEM|
    US16/466,062| US20200060621A1|2016-12-07|2017-12-07|Implantable system|
    CN201780078225.0A| CN110234391A|2016-12-07|2017-12-07|Implantable system|
    KR1020197018375A| KR20190104326A|2016-12-07|2017-12-07|Portable system|
    PCT/EP2017/081877| WO2018104472A1|2016-12-07|2017-12-07|Implantable system|
    EP17808521.3A| EP3551282B1|2016-12-07|2017-12-07|Implantable system|
    JP2019531155A| JP2020513276A|2016-12-07|2017-12-07|Implantable system|
    CA3046107A| CA3046107A1|2016-12-07|2017-12-07|Implantable system|
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