JP2005169108A - Medical device for recovering function of fibrillating heart by heart therapy remotely instructed by medical doctor through two-way communication - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To treat a condition requiring a fibrillation removing method by providing an implantable medical device. <P>SOLUTION: The medical device is used for controlling and monitoring arrhythmia. The medical device is used for recovering the function of a fibrillating heart in a subject by treatment instructed by a medical doctor through two-way communication between the device and the medical doctor, and has (a) a graft, (b) a wearable unit including a programmer and a positioning module, (c) a first interface for communication between the graft and the programmer, and (d) a second interface for the two-way communication through the positioning module between the medical doctor of an emergency team and the programmer, in which the data relating to the location of the subject and the condition of the heart of the subject is sent to the medical doctor for evaluation and the instruction for the therapy is sent from the medical doctor to the programmer. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

(Field of Invention)
The present invention relates generally to medical devices for restoring effective cardiac function, for monitoring cardiac arrest patients or subjects, and for emergency procedures. The medical device can be used to monitor and control arrhythmias, and the function of the fibrillation heart in the subject by treatment directed to the physician via bi-directional communication between the device and the physician. Can be used to recover. And the device comprises: (a) an implant; (b) a wearable unit comprising a programmer and a positioning module; (c) a first interface for communication between the implant and the programmer; and (d) A second interface for two-way communication between the physician in the emergency team and the programmer through the positioning module.

(Background of the Invention)
Heart disease is the leading cause of death in developed countries. Nearly two-thirds of patients die from coronary artery disease before arriving at the hospital. In the United States, sudden deaths are said to be about 1200 per day. Approximately 25% of victims of sudden death are usually healthy adults without any symptoms of heart disease prior to this sudden end event. Survival from cardiac arrest in hospitals is disastrous, according to published reports, ranging from 0-18%. Eisenberg et al. (1990) Ann. Emerg. Med. 19: 179-186.

  Cardiac arrest is not a simple dual event, but rather a complex electromechanical, neurohumoral, sudden and sudden event that can often be interrupted by applying an electric shock, or Can be inverted. Often, however, the events leading up to cardiac arrest and those immediately following require much more complex interventions to achieve successful resuscitation.

  Cardiac arrest occurs when there is an electrical or mechanical failure in the heart and the heart cannot pump blood and send oxygen to the brain. There are many contributing factors that can cause cardiac arrest, including hypertension, diabetes, obesity, aging and drug use. Cardiac arrest results in death if not treated immediately. Survival depends on timely defibrillation and application of appropriate medication. Mortality is higher than when treatment is delayed, but the prognosis is significantly improved when vigorous treatment is started immediately. To date, drug therapy has had little effect on mortality due to cardiac arrest. The initial goal of the last 30 years has been to teach cardiopulmonary resuscitation (CPR) technology to as many people as possible in an attempt to increase the proportion of survivors.

  Cardiac anatomies are described and illustrated in detail in many anatomy and cardiac surgery references, including standard textbooks such as: Surgery of the Chest (Sabiston and Spencer). Eds., Saunders Publ., Philadelphia). Basically, the heart has a special system of muscles that cause the heart tissue to contract regularly and continuously. The heart has two main pumping chambers, the left and right ventricles, in the heart. By contracting simultaneously, these chambers push blood into the aorta and pulmonary artery. Blood enters these ventricles from the left and right atria, respectively. The atrium is a small accessory chamber that contracts in a separate action, followed by major ventricular contractions separated by approximately 100 milliseconds (ms), known as AV delay. This contraction results from electrical excitation or depolarization waves that begin in the right atrium and spread to the left ventricle. The excitement then enters the atrial-ventricular node, which delays its path to the ventricle through the His bundle. Heart tissue contracts after its depolarization. The His bundle regulates the rate of depolarization from the atria to the ventricles. All muscle tissue surrounding a particular compartment contracts simultaneously, and the atria and ventricles contract in an appropriate time sequence. One complete contraction of both the atria and ventricles constitutes a beat.

  However, for patients with heart problems, depolarization held through the heart tissue can cause irregularity or chaos (fibrillation), which can cause the heart to beat unevenly or Stop, which can cause severe injury and death. Detection and monitoring of heart problems is based on aspects in the electrocardiogram (small signals known as P-waves prior to atrial contraction, while much larger signals (QRS complex) (mainly with R-waves) in ventricular contraction Accompany). P-waves and R-waves can be detected very reliably as timing signals by electrical leads in contact with the respective ventricles. Further, atrial and ventricular waves (“A wave and R wave”, respectively) can be detected using internal electrodes in contact with the myocardium. They differ in current, waveform and time of generation from ECG P and R waves. The A and V waves depend on the specific position of the electrode, its contact with the muscle, its size, shape, reference electrode and the like.

  As used herein, the term “implant” includes implantable defibrillators, implantable pacers, implantable syringes, and the like. The implant also includes an implantable stimulator that can be used to treat / prevent epileptic seizures.

  Recovery of normal heart beat can be achieved by a process called defibrillation. This defibrillation has been developed and used over the past 40 years. To remove cardiac defibrillation, a defibrillation pulse, which is a dense pulse of current, is applied to the heart. This defibrillation pulse depolarizes the heart's muscle fibers and thus allows the heart to return to normal beats. In addition, implantable defibrillators and arrhythmia controlled pacemakers have also been developed for the recovery of proper cardiac function in a confused pumping heart and have entered a wide range of clinical applications. In addition, thyroid hormones and analogs thereof have also been used for the treatment of heart failure, as described in US Pat. No. 5,158,978.

  A typical implantable defibrillator incorporates a pacemaker. This pacemaker delivers a pulse when the heart is not in contact with itself, which recovers the missing beat. This pulse is typically delivered via a pace lead attached to the ventricle. This ventricular depolarization can be detected by the same lead. An additional lead contacts the atrium and detects atrial depolarization or “P-wave” as desired. In the AV continuous pacer discussed below, the atrial lead is also used for atrial stimulation.

  Implantable defibrillators are useful in combination with pacemakers to treat a number of heart disorders, such as heart blocks, caused by impaired ability of the His bundle to excite normally from the atria to the ventricles. The implantable defibrillator itself is a battery powered, hermetically sealed, fully self-sustaining electrical device that is within 1 inch of the surface of the skin, in the pectoral muscles or axilla Transplanted into the body at such an appropriate site. The distal terminal of this lead is in direct contact with the inside of the heart for the right atrium and right ventricle and extends through the appropriate blood vessels for the defibrillator. The proximal terminal of the lead is removed from the vessel opening and electrically connected to the defibrillator. There are typically four or more electrodes involved in an implantable defibrillator-cardiac defibrillator pacer with a lead that reaches the heart via a venous route. These electrodes include: (1) One (monopolar) or two (bipolar) electrodes that sense and stimulate in contact with the right ventricle. If a single electrode is used, the electrical circuit is completed through a large area “unrelated” or “ground” electrode (usually a metal housing of the implant); (2) one (unipolar) Or two (bipolar) electrodes that sense and stimulate in contact with the right atrium as described in (1); and (3) one large electrode that defibrillates For the delivery of a pulse, but not necessarily in contact with the right atrium, but within the heart. The return electrode for the current is provided either by a larger surface electrode in the heart (probably in the right atrium) or a metal encasement in the implant. Previously, the preferred arrangement for defibrillation electrodes was outside the heart. For example, a shortened conical cup was sewn to the pericardial sac using its counterpart in the right heart. Alternatively, two “patches” were sewn into the ventricle using a cell removal pulse that passed through the heart between these electrodes. Inside the defibrillator, the stimulation pulse is formed by a pulse generator.

  In the past, pulse generators have taken several forms, but fall into two general categories: (1) the pulse generator consists of an RC timing circuit, and (2) A high-frequency clock (RC or crystal controlled oscillator) that is counted by a digital circuit. In the second type of circuit, the pulse generation period is typically a digital counter and logic circuit for generating an output pulse when a predetermined number of clock pulses are counted, as well as spontaneous or stimulated activity. Means are provided for responding to and resetting the counter. Early examples are found in US Pat. No. 3,557,796 (Keller et al.). With the miniaturization of stored program data processors, microprocessor cardioverter defibrillation systems have become more complex and still have more flexible counting arrangements.

  For example, the cardiac cycle number may be placed in a register, which is regularly incremented and tested according to software instructions. When this register is counted up to the programmed number, the software detects the stimulation pulse ("Multi-Mode Microprocessor-Based Programmable Cardiac", U.S. Patent Application No. 207,003, filed November 14, 1980 (Leckrone) et al) (which is incorporated herein by reference in its entirety) to branch.

  The level of electrical stimulation is very important. This is because the charge density in the myocardium around the bare electrode at the distal terminal of the lead determines whether the myocardium depolarizes and contracts. Electrical pulses for cell removal and on demand pacing are typically delivered to the heart through different methods. Defibrillation pulses from implanted devices have historically been delivered through large area electrical patches attached to the surface of the heart. Another electrode can be placed anywhere in the heart or body, or it can be placed under the heart or skin. The electrical patch and its counterpart are connected to a capacitor, which can be charged by a battery, generate a high voltage through the connector, and deliver an electrical cell removal pulse during contact with the tissue. Once this capacitor discharges the cell removal pulse, current enters the subject's heart directly, resulting in removal of heart fibrillation. This pulse then exits the tissue through the opposing electrode.

  Several factors are known to affect stimulation. This includes the stimulation pulse waveform, voltage, duration of stimulation or “pulse width”, electrode type including contact area, and contact tissue resistance and electrochemical factors, and the type of lead system used (ie, , Unipolar or bipolar). In a monopolar system, the return terminal is in the conductive containment of the implant. In a bipolar system, the terminal of the lead includes two spaced contact points, one of which is considered a reference or return electrode, and the other is a reference electrode for sensing or a return for stimulation. Called an electrode.

  Advances in the development of defibrillators allow pulse parameters such as speed, pulse width and amplitude to be controlled by externally generated program signals, eg, a small reed switch actuating magnetic pulse in the defibrillator Using continuation, it became possible to change. Once the defibrillator is implanted and operates on a selected set of stimulation parameters (eg, pulse width and stored energy), a physician who does not know the current parameter information will respond to the implant at a later date It is very difficult to ascertain the exact level of these parameters without a programmer (bidirectional short range telecontroller) that can send the signal and interpret the response.

  The use of pacer catheters allowed demand pacing pulses to be applied to the heart on demand as needed to maintain an available heart rate. A pacer catheter is a long flexible probe, usually made of silastic or polyurethane, with an electrical lead running through the length of the catheter therein. At one end of the probe, the lead is connected to an electrode, which is an exposed metal surface. In a bipolar system, the lead is connected to a second exposed metal surface (referred to as the return electrode) once part of the probe is raised. Finally, at the other end of the probe, the lead is connected to a regulator that has a controller for detecting heart beats, and a pulse generator for detecting pacer pulses on demand is applied to the heart. Otherwise connected to the heart when it stops to contract.

  Pacer catheters are used by percutaneous perforations in veins that cut into veins or lead to the heart. The distal end of the probe with the pacer electrode is inserted into the vein and sewn into the heart and into the right atrium. When myocardial depolarization is detected through the pacer electrode, the detected signal is transmitted across the lead to the controller. If the lead fails to deliver from the heart to the signal, the controller detects the failure signal and causes the pulse generator to deliver a pacer pulse to the myocardium via the lead electrode when electrical demands occur. Trigger. Once released from the electrode, the pulse stimulates the right ventricle and causes heart depolarization. This pulse current circuit is completed via the return electrode.

  The approach for applying different low and high charge electrical pulses requires two procedures, one for inserting a pacer catheter and the other for attaching to a defibrillator electrical patch. These allow subjects to be subject to high risk conditions and long periods of recovery. However, this various high risks can be avoided by using a “lead” for defibrillation that can break through the vein and enter the heart to replace the patch.

  Furthermore, a single catheter can be inserted into the heart to apply both defibrillation and on demand pacer pulses. The catheter can be an implantable, self-contained system for detecting cardiac pulses and automatically transmitting defibrillation or demand pacer pulses to the heart in response to cardiac conditions.

  In general, catheters for applying defibrillation and on demand pacer pulses have a flexible probe that can be inserted into a vein and sewn through and into the right atrium of the heart. The return electrode and on demand pacer electrode are attached to the portion of the probe in the right atrium. A defibrillator electrode is attached to the portion of the probe in the right atrium. Connected to the other end of the probe is a regulator having a controller for sensing and analyzing cardiac electrical pulses. The regulator may further comprise a defibrillator capacitor and an on-demand pacer capacitor for transmitting the respective pulses to the heart. The capacitor for defibrillation is charged through a DC-AC converter powered by a battery located in the regulator. This regulator is inserted into the body (eg, as in the subcutaneous tissue of the chest wall) so that the system is independently contained within the body.

  As the heart generates its electrical signal, that signal is sensed and transmitted by the controller. The controller then uses this information to determine whether the heart is working properly. Otherwise, the controller automatically tells either the demand pacer or the defibrillator to send each pulse to the respective electrode. This pulse then moves the blood and moves to the surrounding heart tissue, thereby removing heart fibrillation or pacing on demand. Finally, this charge is returned to the implanted controller via the return electrode.

  Certain arrhythmias can also be corrected by low energy stimulation in the form of a strictly timed series of heart pulses. US Pat. No. 5,690,682 discusses a device for treating cardiac arrhythmias that includes an implantable drug delivery system for injecting pharmaceutical agents into the peritoneum. US Pat. No. 5,527,344 discusses pharmacology, arterial defibrillators, and methods for automatically delivering a defibrillation drug to a subject. Similarly, US Pat. No. 5,220,917 discusses an implantable pharmacological defibrillator with automatic recognition of ventricular fibrillation.

  However, the efficacy of these forms of treatment depends on many factors. Successful resuscitation depends on a number of medical devices. Defibrillation terminates rapid non-cooperative myocardial contraction. Many other important problems can still occur after successful defibrillation. There can be a very slow heart rate (bradycardia) and the heart rate can be vagus or no heart rate (cardiac arrest). There may be an electrical shock and there may be no effective mechanical contraction (electromechanical dissociation); these conditions are likely to save lives even after stopping or fibrillation has been successfully alleviated. threaten.

  Although implantable defibrillators have increased survival from sudden death, a significant number of patients with implantable cardioverter defibrillators still die prematurely. One contributing factor is that the implanted defibrillator does not perform its assigned function properly. The exact etiology is unknown, but can be either asystole or pulseless electrical activity (PEA). A rapid response is necessary to ensure the effectiveness of these therapies because the onset of fibrillation or cardiac arrest is rapid and damages the subject in a short period of time. Emergency medical team (EMT) or other medical assistance interventions are often required immediately to ensure survival. Unfortunately, subjects who have experienced cardiac arrest or fibrillation are unconscious and cannot obtain an EMT. Even if a caregiver contacts the EMT, the waiting time can be too long to ensure effective medical intervention.

  Although there have been many advances in the development of new drugs and devices for the treatment of subjects with cardiac arrest, these drugs and devices in the prior art have little or no positive for survival. Ineffective, still less than 10%. One reason for this low survival is that successful treatment depends on determining the exact cause of abnormal cardiac contraction or lack of contraction and responding immediately to the episode.

(Summary of the Invention)
When a person with a defibrillator and / or tachycardia controller experiences symptoms when the intervention is required in the form of a stimulus, shock with or without injection of a biochemical promoter into the heart At any time, the subject is in an unstable state and at high risk of death. In such a situation, a person may require prompt medical attention and further intervention, either via telemedicine or to the field for testing, evaluating and treating the subject. Can be delivered by any of the EMT arrivals. This care provider is informed and must provide as much information about the patient's condition as practical to make life-saving decisions. In addition, information about the patient's location must be available.

  Accordingly, it is an object of the present invention to provide an implantable medical device to treat a condition that requires a defibrillation method, wherein the medical device has its life-threatening fibrillation. To detect through. These sensors monitor heart electrical activity and other physical or chemical parameters (eg, arterial oxygen, carbon dioxide pressure, exercise, intracardiac pressure, among many other possible parameters). The medical device further controls the arrhythmia and restores the subject's fibrillating heart function and transfers data regarding the patient's heart condition, allowing the physician to immediately manage this condition, and It makes it possible to provide treatment via timely telemedicine. The device also transmits data regarding the patient's location to the emergency team so that the patient can be quickly positioned and get immediate relief on site.

  A medical device for monitoring and controlling arrhythmias and for restoring the function of the subject's fibrillating heart by treatment directed by the physician via bi-directional communication between the device and the physician Consists of: (a) an implant; (b) a wearable unit (including a programmer) and a positioning module; (c) a multi-faceted first interface of communication between the implant and the programmer; And (d) a second interface for bi-directional communication via the positioning module between the emergency team physician and programmer. Here, data regarding the location of the subject and the condition of the subject's heart is sent to the physician for evaluation, and instructions for treatment are sent from the physician to the programmer.

Additional objects and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims.
Item 1 A medical device, wherein the medical device is a medical device for monitoring and controlling arrhythmias and is instructed by a physician via two-way communication between the device and the physician A medical device for restoring fibrillation heart function in a subject by treatment comprising:
(A) graft;
(B) a wearable unit including a programmer and a positioning module;
(C) a first interface for communication between the implant and the programmer; and (d) a second interface for bi-directional communication between the physician of the emergency team and the programmer via the positioning module. Where data about the subject's location and the subject's heart condition is sent to the physician for evaluation, and instructions for treatment are sent from the physician to the programmer. 2 interfaces,
A medical device comprising:
Item 2 The medical device according to Item 1, wherein data about the subject's location is for locating the subject and providing rapid medical treatment for the subject A medical device that is a navigation aid for the emergency team.
Item 3 The medical device according to Item 1, wherein the graft is: (a) a sensor module for monitoring the state of the heart;
(B) a defibrillation module for restoring the electromechanical function of the heart by stimulation and / or shock;
(C) an optional infusion module to deliver biomedical agents to the heart as needed concomitantly with the stimulus or shock of step (b);
(D) a data processing module for determining the type of intervention; and (e) an energy source for the sensor module, the defibrillation module, the infusion module and the data processing module;
A medical device comprising:
Item 4 The medical device according to Item 1, wherein the first interface is configured to receive instructions from the sensor and to send instructions to the defibrillator for activation. A medical device that is a first interface for bi-directional communication between a programmer and the implant.
Item 5. The medical device of item 1, wherein the second interface communicates with the emergency team via the positioning module and a GPS satellite.
Item 6. The medical device of item 1, wherein the second interface communicates with the emergency team via a mobile telephone positioning system.
Item 7. The medical device according to Item 1, wherein the positioning module includes a GPS receiver.
Item 8. The medical device according to Item 2, wherein the data processing module (a) applies a stimulus or shock to the heart to restore heart function, (b) assisting A medical device that determines the type of intervention selected from activating the second interface for waiting, or (c) waiting at a monitoring module.
Item 9 The medical device according to Item 2, wherein the sensor module monitors electrical parameters, physical parameters, and / or chemical parameters.
Item 10. The medical device according to Item 8, wherein the sensor module monitors arterial oxygen, carbon dioxide pressure, heart motion and / or intracardiac pressure.
Item 11 The medical device according to Item 1, wherein the subject is a human.
Item 12 The medical device according to Item 2, wherein the biomedical factor comprises thyroid hormone or adrenal hormone, wherein the factor enhances responsiveness of the fibrillating heart A medical device.
Item 13 The medical device according to Item 12, wherein the thyroid hormone is selected from the group comprising thyroxine, triiodothyronine, and a thyroxine analog.
Item 14 The medical device according to Item 12, wherein the adrenal hormone is epinephrine.
Item 15. A method for emergency treatment of a patient with sudden cardiac arrest to restore the effective cardiac function of a subject, the step of operating the medical device according to Item 1, and a doctor's instructions And applying the therapy under control.

  In accordance with the present invention, an implantable medical device has been provided to treat a condition requiring defibrillation.

(Detailed description of the invention)
The present invention provides a medical device that monitors and controls arrhythmias, restores the function of a subject's fibrillating or stopped heart, and regardless of the location of the subject. A device to get EMT intervention if necessary. A medical device for monitoring and controlling arrhythmias, and a treatment directed by a physician via two-way communication between the device and the physician to restore the function of the subject's fibrillating heart A medical device comprising: (a) an implant; (b) a wearable unit (including a programmer) and a positioning module; (c) a first interface for communication between the implant and the programmer And (d) a second interface for two-way communication between the emergency team physician and programmer via a positioning module, wherein data regarding the subject's location and the subject's heart condition are: Sent to the doctor for evaluation and instructions for treatment are sent from the doctor to the programmer.

  “Cardiac arrest” refers to a condition in which the subject's heart stops beating and cannot provide blood circulation. Causes of cardiac arrest include, but are not limited to, heart disease, generalized disease, anesthesia, and surgical procedures. Cardiac arrest can also be “sudden death”, which is not clearly related to any potential disease or existing condition.

  “Heart condition”, “cardiac condition” or “heart disease” includes thrombosis, arrhythmias, and bradycardia, cardiac arrest, electromechanical dissociation (EMD) and PEA.

  An implantable sensor for blood oxygen levels is disclosed in US Pat. No. 6,122,536 (the '536 patent). The contents of the '536 patent and the references cited in the' 536 patent are hereby incorporated by reference.

  In one embodiment of the invention, the medical device sends information about the subject's location to the emergency team to locate the subject and apply a rapid medical procedure to the subject, where the The data is used for navigation purposes.

  In another embodiment of the present invention, the medical device implant comprises: (a) a sensor module for monitoring the condition of the heart; (b) the electromechanical function of the heart by stimulation and / or shock. (C) an optional infusion module for delivering a biomedical agent to the heart as needed simultaneously with the stimulation and / or shock of step (b); (d) intervention A data processing module for determining the type; and (e) an energy source for the sensor module, defibrillation module, infusion module and data processing module.

  In another embodiment of the present invention, the first interface of the medical device is defibrillated for bi-directional communication between the programmer and the implant for receiving signals from the sensor and for activation. To send instructions to the vessel.

  In another embodiment, the second interface of the medical device communicates with the emergency team via a positioning module and a GPS satellite.

  In another embodiment of the invention, the second interface of the medical device communicates with the emergency team via a mobile phone positioning system.

  In another embodiment of the invention, the positioning module of the medical device comprises a GPS receiver.

  In another embodiment of the present invention, the data processing module of the medical device makes a preliminary decision about the selection of one of the interventions selected from the group consisting of: To restore cardiac function Applying a stimulus or shock to the heart; (b) activating a second interface for assistance by sending data to the emergency team regarding the patient's location and the patient's heart condition; or (c) Wait for monitoring mode.

  In another embodiment of the invention, the sensor module of the medical device monitors electrical, physical and / or chemical parameters.

  In another embodiment of the present invention, the sensor module of the medical device monitors arterial oxygen, carbon dioxide pressure, heart motion and / or intracardiac pressure.

  In another embodiment of the invention, the subject is a human.

  In another embodiment of the invention, the biomedical agent used in the medical device comprises thyroid mormon or adrenal hormone, where the agent enhances the responsiveness of the fibrillating heart.

  In yet another embodiment of the invention, the thyroid hormone is selected from the group comprising thyroxine, triiodothyrone and thyroxine analogs.

  In a further embodiment of the invention, the adrenal hormone is epinephrine or adrenaline.

  As used herein, “VIP” and its derivatives refer to any natural VIP peptide or any synthetic peptide (which is substantially similar to a natural VIP peptide and exhibits natural VIP activity). Maintained, but manipulated to alter or enhance its activity). “Substantially similar” means a peptide in which an amino acid that is not essential to the VIP activity of the peptide has been altered in an attempt to alter or enhance its activity, although the peptide is still a native VIP. Maintains a high level of amino acid sequence similarity to the peptide.

  As used herein, thyroid hormone is thyroxine (3- (4- (4-hydroxy-3,5-diiodophenoxy) -3,5-diiodophenyl) -L-alanine. Or T4; hereinafter thyroxine) and 3,5,3 ′ triiodothyronine (hereinafter triiodothyronine or T3) L form. T3 is qualitatively similar to thyroxine in its biological effect, but is more potent on a molar basis. Some T3 is synthesized in the thyroid, but most naturally occurring T3 is synthesized by metabolism of thyroxine in peripheral tissues by the enzyme 5 'deiodinase. A series of thyroxine analogs and synthetic methods are described in US Pat. No. 3,109,024.

  The present invention also provides a method for emergency treatment of a patient who suddenly stopped cardiac in order to restore the effective cardiac function of a subject, which method operates a medical device according to claim 1 And applying treatment under the direction and control of a physician.

  GPS is currently available in various forms. “Basic GPS includes satellites, navigation payload (which generates GPS signals, ground stations, data links, and related commands) and control equipment (which is operated and maintained by the Department of Defense) Standard Positioning Service (SPS) is defined as a private commercial service provided by basic GPS; and as a GPS-based system that provides higher real-time accuracy than SPS, ”(Quoted from: Positioning System Policy, The White House, Office of Sinece and Technology Policy, National Secur. ty Council, March 29,1996). The Department of Transportation serves as the leading agency within the US government for all federal civilian GPS issues (ibid). In collaboration with the Department of Commerce, the Department of Defense, and the Department of State, the Department of Transportation will lead the commercial application of GPS technology and the promotion of acceptance of GPS and US government augmentation as standards in national and international transportation systems. In collaboration with other sectors and agencies, unify the GPS private augmentation system provided by the US government to minimize duplication of costs and efforts (ibid).

  The Absolute Positioning mode is defined with respect to a well-defined coordinate system and is usually a geocentric system (ie, a system whose origin coincides with the center of mass of the Earth). In cheap systems, this method produces significant spatial uncertainty on the order of 10 meters or more. For better accuracy, differential GPS has been developed. This incorporates a “differential correction factor” into the position calculation of a mobile receiving station that determines the positioning error at a specific location and then operates in the same range by means of real-time transmission of corrections, Tracking allows the position to be defined more accurately. This difference correction cancels the fluctuation error in the GPS signal by using another GPS receiver installed at a certain position at a known position. As used herein, “GPS” encompasses all embodiments.

  Each EMT base can function as a reference point. The receiver at that station calculates its position from continuously received GPS satellite data and compares this position with its known position. This difference is a local instantaneous error of the received GPS signal. This difference value then corrects for errors in the position transmitted by other GPS receivers (eg, on EMT mobile units and worn by fibrillation victims) during the same time of observing the same satellite. It is used to correct the position collected by the GPS receiver) in real time.

  As shown in FIG. 1, the communication between the implantable defibrillator and the wearable unit is either unidirectional (only from the implantable defibrillator to the wearable unit) or bidirectional. It can be. However, all modern implantable defibrillators include an electronic device for two-way communication at the defibrillator site, which receives instructions from a “programmer” and Its operating parameters, its identifying information (manufacturer, model, serial number, etc.) and its past or current data flow (observed symptoms, digitized electrograms stored from past symptoms, and current electricity For sending out information about the record diagram and other inputs to its implantable defibrillator from its various sensors. Thus, each implantable defibrillator is available in at least two ways to send information to a nearby receiving device: transmission through its own communication system and magnetic field through the subject tissue Its ability to generate a moderately strong magnetic field when giving a defibrillation shock. Thus, an implantable defibrillator will cause an implantable defibrillator to experience abnormal beats (defined by pre-selected conditions by the physician or specified by factory-set default conditions). At the moment of recognition, it can be modified to send information via a one-way (outbound) system.

  Outbound transmission does not constitute any security issue. If an external, wearable system is capable of receiving transmissions, this system will function accordingly, otherwise the implantable defibrillator will simply not receive the signal. "Send out to the endless extent". Such telemetry systems of implantable defibrillators can operate in a short range (approximately a few meters) and use little energy for transmission, so they are suitable for high frequency transmission It does not violate any regulation or significantly affect the life expectancy of the implantable defibrillator energy source. The transmission of the shock itself does not constitute any further energy demand beyond what is needed for therapeutic purposes. This wearable unit should have sufficient signal processing equipment to distinguish between a defibrillation shock and any other interference from its environment. This requires additional pattern recognition intelligence in the wearable unit.

  To ensure that the wearable unit is never confused by receiving signals from other sources other than the implantable defibrillator assigned to the monitor, preferably two criteria Incorporated: The wearable unit is designed to be close enough to receive signals from the implantable defibrillator whenever it is worn It has a receiving antenna for the signal from the defibrillator. Such an exclusive antenna pair usually relies on the axial alignment of an implantable transmit coil antenna as shown in FIG. 4 and an external coil antenna on the body surface.

  In cases where communication is outbound or only in one direction (from the implantable defibrillator to the wearable unit), one purpose of the system is to alert the EMT about the crisis and damage the team Helping to find people. This can be achieved via GPS in combination with a radio beacon embedded in a wearable unit.

  As shown in FIG. 3, the antenna from the implantable defibrillator transmits an indication of a critical event to the wearable unit's antenna. This security can be enhanced by a wearable unit that has the ability to detect an identification code from an implantable defibrillator.

  This wearable unit receives the GPS information and sends its location, along with its identity, to the EMT station (ETS). If this is a simple GPS system, this location may be inaccurate.

  An ETS always receives its GPS information and its own absolute position is known, so the ETS can correct errors in the GPS data it receives. As the ETS becomes sufficiently close to the subject, it may also receive a transmission from the wearable unit of the subject and thus provide a correction to the data received from the wearable unit of the subject. Once the mobile unit (MU) is dispatched, the corrected location of the subject is transmitted from the ETS to the MU. This antenna represents a radio beacon on a wearable unit that is sent to the MU to assist the EMT in finding the subject. There are many ways to achieve a radio beacon that meets FCC regulations and other limitations.

  If the system is augmented by instructions from an expert to an implantable defibrillator to control its operation (eg, injection, energy level, etc.), additional safety interconnections must be established. This is described in more detail in the next section.

  The implant may also communicate processed data of its own computation derived from its initial input. For example, it may be determined that there is no fibrillation but a stimulus for termination of the arrhythmia is required. This may convey an identification code for the arrhythmia encountered and recognized, and a code for processing in use.

  WU represents a wearable unit, which either (1a) a very specific electric field sensor for detecting messages from the implant, or (2b) defibrillates or defibrillates the heart It consists of a sensor that detects the transient magnetic field of the current pulses emitted to the patient's body. The WU comprises a mobile phone that is programmed to dial 911 when it detects one of the two above inputs. Reliability for identifying the caller's location is the responsibility of the mobile service provider, which alerts the EMT center of incident and approximates the patient's coordinates I will provide a. The WU also includes a radio beacon to assist the mobile EMT team to locate this patient.

  As a further modification, the WU may either (1′a) a very specific electric field sensor to detect a message from the graft, or (2′b) to defibrillate or defibrillate the heart Communicate with the implant by having a sensor that detects the transient magnetic field of the current pulses emitted into the patient's body. The WU is programmed to dial 911 when it detects one of the two above inputs, and provides the patient's permanent identification, graft and other appropriate information to the EMTs'Center phone number or e- A mobile phone that communicates with a mail address (moved there by Mobile Service Provider with coordinates). The identification of the caller's location is performed by the Mobile Service Provider, which then alerts the EMT center of the incident and provides the patient's approximate coordinates with further information . In addition, the WU includes a programmer that couples to the patient's mobile phone to establish two-way communication between the implant and the physician or EMT via the cellular telephone link. In addition, the WU includes a radio beacon to assist the Mobile EMT to reach the patient.

  The implant can also be programmed non-invasively. The need for implant electrical parameters (eg, stimulus speed, stimulus intensity, amplifier gain, or “sensitivity” to detect biological signals) varies from patient to patient, As it changes even over time, the need for non-invasive regulation of the implant has been recognized and met by various methods, including communication by coded magnetic pulses that can close the reed switch. Currently, the ability to change the graft is greatly increased. The “program” sent to the inside of the graft is selected based on the data collected by the graft itself and the performance of the heart itself. This information (including electrograms sent continuously by the implant) can be telemetered outside by the implant to provide information to the physician if necessary to fine-tune the manipulation of the implant through programming. . This is used in defibrillators and implantable pumps.

  The following examples provide illustrations but do not limit the invention.

(Example 1)
As shown in FIG. 2, the graft detector detects chaotic symptoms from its sensor (10) that can be life-threatening. The detector (20), via input from its sensor (10), has many other possible parameters, among other things the electrical activity of the heart and other physical or chemical parameters (eg arterial oxygen, Monitor carbon dioxide pressure, exercise, and intracardiac pressure. At block 25, a determination is made whether this event is fibrillation. If fibrillation is detected, the implant may be programmed to initiate communication block 30 for detection of this event to the emergency team or need treatment by allowing charging of the capacitor in block 40 Either you continue to evaluate the next information until you recognize gender.

  If communication begins at this time, a link needs to be established between the implantable defibrillator 10 and the wearable transponder / transmitter / repeater or programmer 200 on the subject 5 body. The wearable device 200 then automatically attempts to establish a link with the emergency team, as described in further detail below. The implant block 40 may also begin to charge its delivery system for treatment (charging the condenser or filling the metering vessel block 55 with a chemical agent). If a disordered state is detected at block 20, but is classified as not fibrillation at block 25, a decision is made at block 60 whether to administer antiarrhythmic pacing. If it is appropriate to do so, a preselected stimulation protocol is executed by block 65. If no stimulation is required, the implant continues to monitor (block 40) and analyzes the input but remains silent. Any chaotic state stops spontaneously-operation is postponed until the crisis is over or the next message from block 20 appears. When communication begins, it should end according to a specific protocol (see below). The implant records in its memory (65) and returns monitoring. If fibrillation continues to be detected by block 25, the implant will need treatment according to its operating rules and will decide to prepare for delivery. If the action is indicated by block 70, this may be performed at block 75. If it is not possible to determine whether the graft will intervene, request an instruction from the emergency team via block 80. This waits for T seconds and then enters a “default operation” (D.1.) That can combine infusion and shock. If a shock is indicated as a treatment according to the operating rules, the capacitor status is queried until ready (42), and then a shock is enabled at block 45. If the shock is successful (48), the implantable defibrillator records and returns to monitoring. If it fails, the next action is possible. If communication has begun, this ends then (D.3). If instructions from the WU are present, the implantable defibrillator receives instructions for treatment and executes them or performs a default action after T seconds of action (D.3.1). If the default action is successful, return to monitoring. If the default treatment fails as in (D-4), the activation rule repeats the shock treatment at the next highest intensity (40-45) or delivers fluid to the heart and delivers the shock treatment at the next higher level. Repeat (40-45) to determine the next step, including (E). If the disorder condition does not resolve at this point, the implantable defibrillator activates the wearable device and communicates the SOS signal to the emergency team. While continuing the protocol so that the implantable defibrillator is programmed (F), the wearable device becomes a radio beacon to assist the emergency team in positioning the subject.

(Example 2)
The implanted defibrillator first detected defibrillation symptoms from its sensor that could be life-threatening. The sensor monitored cardiac electrical activity and other physical or chemical parameters (eg, arterial oxygen, carbon dioxide pressure, exercise, intracardiac pressure), among many other possible parameters. The implanted defibrillator was either programmed to initiate communication of the detection of this event to the EMT or simply continued to evaluate information until the need for treatment was recognized. If communication was initiated at this time, a link was established between the implant and a wearable transponder / transmitter / repeater or programmer on the subject's body. The wearable unit then attempted to automatically establish a link with the EMT. The implanted defibrillator began to charge its delivery system for treatment (charging the condenser and / or filling the metering container with the drug).

  The implanted defibrillator can then initiate myocardial reactivation and communicate the signal to the programmer and then to the EMT via GPS (only if the first attempt fails). The decision to shock at maximum intensity (or maximum energy) and / or inject bolus medications from an implantable reservoir into the heart is made by qualified doctors or highly trained emergency medical personnel. It can be done before, during or after the first event. A link between the decision maker and the implanted device, or subject (if conscious) with such symptoms, was immediately and reliably established. A quick link between the decision maker and the device or wearer of the device was also established at this time to achieve optimal results. The GPS of the present invention was used to quickly establish a link.

(Example 3)
Communication of both patient location data and patient heart condition data was accomplished by replacing the GPS of Example 1 with a mobile phone location system. A mobile telephone location system is disclosed in Sheffer et al., US Pat. No. 5,844,522. The '522 patent uses a reverse voice channel signal (always on) as the tracking beacon of the electric field direction detector unit to quickly and accurately track the x, y and z coordinate positions To do. The use of the device shown in the above example provides a quick response to the patient's cardiac arrest in two ways. When a cardiac arrest occurs, the medical device of the present invention communicates data about both the patient's heart condition and the patient's location to the emergency team or physician either directly or via a mobile phone system. . A quick response to a heart problem can be provided in two ways: (1) The data communicated about the patient's heart condition allows the physician to quickly take on the situation and provide treatment by telemedicine in a timely manner; and Using the communicated data about the location, the emergency team can quickly locate the patient's location to provide on-the-spot assistance. Due to the rapid response, the proportion of survivors of patients who experience cardiac arrest using these devices is expected to increase significantly, especially for those who live away from medical centers or doctors. It has recently been reported to New York Timem that placing external defibrillators on sports arenas and American Airlines planes has resulted in an improvement in survival from about 50% sudden death. This illustrates the importance of prompt attention by those skilled in the art using defibrillators.

  All references cited herein are hereby incorporated by reference, both above and below. Although the present invention has been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced. Accordingly, the description and examples should not be construed as limiting the scope of the invention, which is indicated by the appended claims.

FIG. 1 schematically shows the basic structure of a medical device. FIG. 2 schematically illustrates one embodiment of a medical device. (10) sensor; (20) detector; (30) communication switch; (31) the implant sends an activation signal to the wearable unit; (35) the wearable unit starts transmitting via GPS; and (36) GPS activation; (40) Capacitor; (42) Determine efficacy; (43) Anti-tachycardia device; (45) Shock permit; (48) Successful results; (49) The graft continues to monitor and analyze its input but remains silent; (50) Metering pump; (55) Determine whether intervention is required; (60) Application (65) No further actuation is required and is recorded in the graft; (66) Initiating stimulation therapy; (70) Determining whether automatic infusion is required; (75) Infusion; 80) Experts should contact To determine whether or not. FIG. 3 schematically illustrates one embodiment of a medical device arrangement. (10) an implantable defibrillator for detecting and transmitting signals and applying stimuli and / or shocks; (200) receiving a GPS transmission and controlling the implantable defibrillator; and A wearable unit for assessing heart condition by analyzing data received from an implantable defibrillator; (300) an emergency team station; (400) a mobile unit. FIG. 4 schematically shows the arrangement of the medical device in detail. (2) transmit antenna in implantable defibrillator; (3) receive antenna on implantable defibrillator; (4) axis of lineup; A) an antenna for GPS reception and two-way RF communication, including radio beacons; (6) a wearable receiver-transmitter unit; and (7) a harness or belt to hold the wearable unit.

Claims (1)

A medical device, wherein the medical device is a medical device for monitoring and controlling arrhythmias, and by treatment directed by the physician via two-way communication between the device and the physician A medical device for restoring fibrillation heart function in a subject, comprising:
(A) graft;
(B) a wearable unit including a programmer and a positioning module;
(C) a first interface for communication between the implant and the programmer; and (d) a second interface for bi-directional communication between the physician of the emergency team and the programmer via the positioning module. Where data about the subject's location and the subject's heart condition is sent to the physician for evaluation, and instructions for treatment are sent from the physician to the programmer. 2 interfaces,
A medical device comprising:

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