WO2022036432A1

WO2022036432A1 - Pacemaker with algorithmic function

Info

Publication number: WO2022036432A1
Application number: PCT/BR2021/050354
Authority: WO
Inventors: Paulo ROBERTO GOMES FERNANDES
Original assignee: Roberto Gomes Fernandes Paulo
Priority date: 2020-08-20
Filing date: 2021-08-20
Publication date: 2022-02-24
Also published as: BR102020017029A2

Abstract

The present invention relates to a pacemaker with algorithmic function that is designed to provide, among other information, correlations between time (date and time) and, for example, blood pressure values, action types (event) of the pacemaker stimulus, heart rate reading, and/or variation in blood pH, making it possible to correlate these data with patient activities or habits, with continuous operation.

Description

PACEMAKER WITH ALGORITHMIC FUNCTION

Summary of the Invention

[0001] The present invention provides a Pacemaker with an algorithmic function to be applied to it to provide, among other information, time correlation (Date and Time) with, for example, blood pressure values, type of actuation (event ) stimulation of the Pacemaker, Heart Rate (HR) recording, and/or blood pH variation, thus making it possible to correlate such data with the activities or habits of patients, in an uninterrupted operating regime.

[0002] All Pacemaker actions will be referenced and recorded on the abscissa axis in Time coordinate (Date and Time), giving the output (Output) in alphanumeric data and in flat graphic form (2D) always with the abscissa (time ) as a reference, in an exclusive chart or in a multiple chart of the interpolated column type, but with and for each individual record i. and. Date and Time X Heart Rate (HR) in operation; Date and Time X blood pressure (BP) ; Date and Time X Stimulation of increase and/or decrease in blood pressure (BP) through increase and/or decrease in heart rate; Date and Time X Arrhythmia interruption stimulus, etc., providing parameters obtained directly from the cardiac muscle, without the need for any other type of external auxiliary exam or indirect measurement, since there are already electrodes implanted directly in the cardiac muscle.

Prior Art

[0003] The state of the art does not evidence or suggest a Pacemaker with a continuous and complete monitoring function that provides, among other information, the relationship of Time - Date and Time X heart rate (HR) in operation; Date and Time X blood pressure (BP) ; Date and Time X Stimulation of increased blood pressure (BP) through increased heart rate; Date and Time X Arrhythmia interruption stimulus with recording (memories) and output data output in graphic form.

[0004] Still, the state of the art does not reveal or suggest real-time and uninterrupted monitoring of patients with Pacemaker, essential for adequate clinical, preventive and/or prophylactic follow-up aiming at monitoring the most appropriate treatment to be applied, especially in cases of treating recently operated patients and in periods of adaptation; it does not even reveal the remote monitoring in real time, to anticipate the occurrence of cardiac events through a history of pre-determined times.

[0005] Currently, the reports issued by the most modern devices disregard the times and dates of occurrence, revealing only the measurement in "BLOCK" of a certain package in volume of the percentage (%) of singular performance for a defined period, nothing more. The reports currently provided report a total result, without any definition as to types of occurrence and when they actually occurred.

[0006] For example, the report is limited to informing if the Pacemaker has acted 30, 40, 50 % since the date of its installation; or, simply, if it did not act.

[0007] The state of the art can be illustrated by the documents cited below. [ 0008 ] The North American document US2016317816 (Al ) of 03 . 11 . 2016, by BIOTRONIK SE & CO KG, relates to an implantable pacemaker having a housing and two electrodes disposed in said housing. The two electrodes are made of biocompatible materials that have different sensitivities to changes in pH. The two electrodes are connected to an activity monitoring unit which is adapted to determine an open circuit potential difference between the two electrodes and to generate an activity signal derived from said open circuit potential difference.

[ 0009 ] Chinese patent CN110339479A (A) of 18 . 10 . 2019, by YANCHENG INST TECH, refers to a wireless charging and remote monitoring device for an Implantable Cardiac Pacemaker, which includes a wireless charging device and a remote monitoring device. The wireless charging device includes a transmitting unit and a receiving unit. The receiving unit is disposed on a user's body. The transmitting unit charges the receiving unit through magnetic coupling resonance between the transmitting coil and the receiving coil; the remote monitoring device includes electrodes, amplification and filtering circuitry, a microprocessor, a wireless module and a user terminal. The electrodes convert the user's cardiac activity into The electrical signal is sent to the amplified and filtered circuit, then the amplified and filtered electrical signal is sent to the microprocessor, and the data in the microprocessor is sent to the terminal. from the user via the wireless module. The invention wirelessly charges the rechargeable battery in implanted cardiac pacemaker through magnetic coupling resonance mode, prolongs the wearing period of cardiac pacemaker and can remotely monitor heart condition during charging to check if arrhythmia occurs.

[00010] External monitoring systems and devices are not mentioned in the present invention, as they do not present correlation with the present invention.

Description of the Invention

[00011] The present invention provides a Pacemaker comprising an algorithmic function to be applied thereto for the processing of data collected through electrodes already implanted in the cardiac muscle. Said data, when processed through the algorithmic time correlation function (Date and Time) of the present invention, will provide, among other information, Date and Time X Heart Rate (HR) in operation; Date and Time X blood pressure (BP); Date and Time X Stimulation of increase and/or decrease in blood pressure (BP) through increase and/or decrease in heart rate; Date and Time X Arrhythmia interruption stimulus, Date and Time X pH variation, and so on. , with alphanumeric output data (text) and in graphic form, thus providing reliable parameters obtained directly from the heart muscle, without the need for any other type of external auxiliary exam or with data collected through indirect readings or by capture in noisy body mass media or in the form of erroneous/failed electrode contacts glued to the skin of the human body.

[ 00012 ] More specifically, the present invention has the scope to provide, to a Pacemaker, a function of relation of Time (Date and Time) X Heart Rate (HR) ; Time (Date and Time) X Blood Pressure (BP) ; Time (Date and Time) X Stimulation of increase and/or decrease in blood pressure (BP) through increase and/or decrease in heart rate; Time (Date and Time) X Stimulus to interrupt arrhythmias in the Pacemaker's performance, providing exact data on the date and time of cardiac events and the Pacemaker's response/performance/behavior versus the patient's habits and customs, in remote and uninterrupted monitoring .

[00013] Said function, once implemented, provides more accurate and complete information, located in the time (date and time) of the cardiac event(s); and determinants for the orientation of clinical treatment of patients. Additionally, the fact that such information is provided in real time, through direct communication, as currently occurs with several models of Pacemaker, makes the clinical analysis of the patient and the behavioral analysis of the implanted device a constant in the monitoring. [00014] The real-time monitoring of patients with Pacemaker is essential for adequate prophylactic-preventive treatment as well as for the adequate follow-up of the development of the applied treatment, mainly in newly operated patients, but of vital importance in the history of long-term patients. period of use of the Pacemaker.

[00015] The proposed function also provides an alert subroutine, also informing in real time, in a pre-programmed system, any significant or extraordinary alteration of certain parameters, such as an activity of the Pacemaker outside the expected range of Blood Pressure (BP) or severe arrhythmias. Along with the function of the present invention, a gradation in severity scale of the intercurrences, detected by the Pacemaker and classified after the data processing, is provided. An alert, or even an alarm, could be immediately issued depending on the extent of the severity of the event, thus turning the Pacemaker into an active element of cardiac monitoring, in real time.

[ 00016 ] The fact that such data are provided with date and time, as well as being provided in real time, can be decisive for the patient.

[ 00017 ] In patients who depend exclusively or almost exclusively on the Pacemaker, such monitoring with complete information is even more critical.

[ 00018 ] Also, the possibility of monitoring in real time with evidenced dates and times, will describe a history, record trends and promote remote monitoring of possible predictions of cardiac events associated with the patient's routine where clinical supervision can predict or anticipate the occurrence of high-risk cardiac events or heart muscle failure.

[ 00019 ] Thus, the present invention has the scope to incorporate to a Pacemaker, be it of any type or brand, a function to precisely identify on which date and time of day or night the Pacemaker acted and at what intensity; if in strenuous or basal activity of the patient, and inform in real time, any intercurrences, accompanied by date and time, and with graphic record. [00020] This function is very valuable to identify harmful or beneficial habits to the Pacemaker's useful life; your battery and the well-being of the user/patient, as they will be able to combine a better therapy with their lifestyle.

[00021] Among the obvious advantages and differentials of the present invention in relation to the prior art, the applicant lists the following:

1) a short, temporary measurement such as an existing 'Holter' type exam will not be performed;

2) the patient does not need to be connected to any other device to perform the measurements;

3) it will not be necessary any type of indirect reading that circulates the musculature or tissues, indicating more contacts and low accuracy of the readings.

4) the reading will be taken directly from the cardiac muscle (heart);

5) greater accuracy of readings due to the elimination of interference;

6) once the Pacemaker is implanted, it will no longer be necessary to use accessories to obtain this new function and parameters; and

7) the implementation of the function of the present invention is compatible with any brand of any Pacemaker manufacturer.

[00022] Note that in the existing state-of-the-art models there is not, in the monitoring offered, for example, the detail of hours/minutes in which the signal generator was stimulated or inhibited. [00023] In no Pacemaker currently marketed there is exact mention of the day and time when the Pacemaker is due to stimulation, inhibition or defibrillation.

[00024] Thus, the present invention provides a pacemaker with an algorithmic function, characterized in that it comprises an algorithmic function that correlates data to a temporal function (date and time), to provide information about the behavior of the Pacemaker and the patient. in which said device is arranged, said algorithmic function is stored in a Pacemaker processing module that processes the information obtained by the electrodes and provided by a timing device, said timing device (clock) being arranged in the Mark -Step for time synchronization.

[00025] The algorithmic function of the Pacemaker of the present invention collects data from and/or supplied by the electrodes and, by processing the data from the timing device, provides time correlation information (Date and Time) with pressure values blood pressure, type of action (event) of the pacemaker stimulus, heart rate (HR) recording, and/or blood pH variation, among others; the collected data are referenced and recorded on the abscissa axis in Time coordinate (Date and Time), giving the output (Output) in alphanumeric data and in flat graphic form (2D) with the abscissa (time) as reference, in an exclusive and /or multiple of interpolated column type .

[00026] The above explanation, although broad, does not exclude other modalities that may eventually arise from the present invention, both for a constructive model differentiator as well as new features, contemplated as a result of the practical development of the present invention, therefore, the present invention is not limited to the topics described above.

Claims

1. PACEMAKER WITH ALGORITHMIC FUNCTION, characterized by comprising an algorithmic function that correlates data to a temporal function (date and time), to provide information about the behavior of the Pacemaker and the patient in which the device is located willing.

2. PACEMAKER, according to claim 1, characterized in that it comprises a timing device (clock) for time synchronization.

3. PACEMAKER, according to claim 1, characterized in that the algorithmic function is stored in a Pacemaker processing module that processes the information obtained by the electrodes and provided by the timing device.

4. PACEMAKER, according to claim 3, characterized in that the algorithmic function collects data from and/or supplied by the electrodes and, by processing the data from the timing device, provides time correlation information (Date and Time ) with blood pressure values, type of action (event) of the Pacemaker stimulus, Heart Rate (HR) record, and/or blood pH variation, among others.

5. PACEMAKER, according to claim 3, characterized in that the collected data are referenced and recorded on the abscissa axis in Time coordinate (Date and Time), giving the output (Output) in alphanumeric data and in flat graphic form ( 2D) with the abscissa (time) as a reference, in an exclusive and/or multiple interpolated column graph.