Pacemaker

Abstract: A pacemaker contains at least one sensor with associated electronic circuitry (6) for controlling the pacemaker function and an electrode system (RL) for emitting heart stimulation pulses. Means (2, 8; 10, 12, 14) are provided for enabling the sensor electronic circuitry in conjunction with the pacemaker implantation on the patient, which means comprise a device (2,8) for measuring the electrode impedance so as to enable the sensor electronic circuitry in response to the measured impedance value. The means for enabling the sensor electronic circuitry can alternatively comprise internal telemetry equipment (10,12) in the pacemaker and external telemetry equipment for communications between the telemetry equipments. The external telemetry equipment can contain programming equipment and the internal telemetry equipment be arranged to enable the sensor electronic ciruitry as soon as the programming equipment begins communicating with the internal telemetry equipment, or by sending a special command from the programming equipment. Alternatively the means for enabling the sensor electronic circuitry comprise a reed element (14), controllable by an externally applied magnetic field for enabling the sensor electronic circuitry (6).

Description: This invention relates to a pacemaker containing an electrode system for emitting heart stimulation pulses, at least one sensor with associated electronic circuitry for controlling the pacemaker function and means for enabling the sensor electronic circuitry in conjunction with pacemaker implantation. Pacemakers are working and continuously emitting stimulation pulses right from the time of their delivery from the factory. Pacemakers have hitherto been delivered with even the heart signal detector or some other sensor already enabled at the factory. Since a pacemaker may be stored for up to 1-2 years prior to implantation, the heart signal detector or the sensor consumes power needlessly, thereby reducing the life of the pacemaker. SU-A-1 158 203 attempts to reduce the power consumption during storage by using the tissue of the organism receiving the pacemaker to bridge a dielectric interlayer which prevents current flow during storage. Bridging the dielectric automatically allows current to flow in a pacemaker circuit and bridging automatically occurs when the pacemaker is being implanted. This dielectric is only a fraction of a millimeter in thickness and hence this method has the disadvantage that any irregularities, impurities or contaminants in the dielectric, or conducting foreign objects bridging the dielectric, can make a large difference to the leakage current occuring in the circuit and a correspondingly large difference in the storage life of the pacemaker. SU-A-641 966 attempts to reduce the power consumption during storage by only turning on the pacemaker power supply at the time of implantation. This is achieved by means of a special tool manipulated by the doctor. This method has the disadvantages of requiring a special tool and a certain degree of skill from the doctor to accurately deform the body wall of the pacemaker to actuate the pacemaker. If the doctor is not sufficiently skilful damage to the pacemaker can result or it may not be switched on. The object of the present invention is to eliminate these shortcomings in prior art pacemaker designs and achieve a pacemaker which is delivered with a sensor or heart signal detector which is only enabled in conjunction with the pacemaker's implantation and which does not require manipulation by the implanting doctor to switch it on. This object is achieved with a pacemaker of the above described type with the features cited in claim 1. Storage of the pacemaker with the heart signal detector or sensor disabled saves power with extended pacemaker life as a result. If it is assumed that a pacemaker with associated sensor equipment draws a basic current of 4µA during a storage period of 1 year and the invention reduces this power consumption by e.g. a mere 1µ A, pacemaker operational life would increase by 3 months. However, the invention is capable of achieving even greater power savings. According to one embodiment of the pacemaker according to the invention, the means for enabling the sensor electronic circuitry contain a device for measuring the electrode impedance so as to enable the sensor electronic circuitry when the impedance drops below a predesignated threshold value. In this way, automatic start-up of the sensor or heart signal detector is achieved when the pacemaker is implanted in the patient. Prior to implantation, the impedance of the electrode system is very high, so high that the impedance does not impose any load on the pacemaker. After the electrode system is connected to the heart, the impedance normally drops to about 500 ohms. So setting the threshold value for enabling sensor electronic circuitry, or the heart signal detector, at e.g. 2 kohms leaves a wide safety margin ensuring that sensor electronic circuitry, or the heart signal detector, is reliably activated at implantation. According to an additional advantageous embodiment of the pacemaker according to the invention, in which stimulation pulses are generated by the discharge of a reservoir capacitor through an electrode system, the electrode impedance is measured with the aid of means for measuring the time required to recharge the reservoir capacitor to a predesignated stimulation voltage between each stimulation pulse. As noted above, the electrode system's impedance is very high before implantation. In this instance, discharge of the reservoir capacitor between two stimulation pulses is determined only by leakage currents in the capacitor itself and possibly in other components. Recharging of the reservoir capacitor to the predesignated stimulation voltage is therefore very fast. After implantation, however, the impedance of the electrode system is much lower, so a far bigger charge is discharged through the electrode system in every stimulation pulse. The time required to recharge the reservoir capacitor between two stimulation pulses is therefore much longer. Recharge time is normally less than 1 ms before implantation and in the 3 - 10 ms range after implantation. According to another advantageous embodiment of the pacemaker according to the invention, the reservoir capacitor is recharged in steps. Thus, charging takes place for a given period of time, and the reservoir capacitor's voltage is thereafter compared with the aid of a comparator to the predesignated stimulation voltage. If the capacitor voltage is less than the stimulation voltage, the capacitor is connected to the battery for additional charging for a second period of time. The capacitor voltage is then again compared to the predesignated stimulation voltage. This procedure is repeated until the capacitor voltage reaches or exceeds the predesignated stimulation voltage, whereupon charging terminates. The periods of time in which the reservoir capacitor is connected to the battery during the recharging process are primarily of equal length, e.g. 1 ms. According to another advantageous embodiment of the pacemaker according to the invention, measurement of electrode impedance can be performed by a simple measurement of the reservoir capacitor's voltage before and after emission of a stimulation pulse. Prior to pacemaker implantation, when the impedance of the electrode system is high, the difference in voltage before and after a stimulation pulse is relatively small, whereas this voltage difference is much bigger after the electrode system has been installed in the heart. The large drop in voltage measured during the stimulation pulse after implantation is used for enabling the sensor electronic circuitry or the heart signal detector. According to an alternative realization of the inventive idea, the means for enabling the sensor or heart signal detector comprise internal telemetry equipment in the pacemaker and external telemetry equipment for communications between the telemetry equipments. In this manner, the sensor or the heart signal detector can be enabled "from the outside", e.g. when external telemetry equipment contains programming equipment, and the internal telemetry equipment is devised in such a way that the sensor, or the heart signal detector, is enabled as soon as the programming equipment begins communicating with the internal telemetry equipment. The programming equipment and the internal telemetry equipment are then constructed such that the sensor or heart signal detector is only enabled when communication is established exactly between the actual pacemaker and its associated programming equipment. Another example of the programming equipment is not useful for enabling the sensor or heart signal detector in question. Alternately, the sensor or the heart signal detector can be enabled with a special programming command. According to yet an alternative embodiment of the pacemaker according to the invention, the means for enabling the sensor electronic circuitry or heart signal detector contains a reed element switch, controllable by an externally applied magnetic field, for enabling the sensor electronic circuitry or the heart signal detector, e.g. by application of a magnet in the vicinity of the pacemaker. According to one refinement of the invention, the pacemaker is a dual chamber design with two heart signal detectors, means being devised to enable each detector at the time the pacemaker is implanted. Thus, the inventive idea can be used to advantage even in dual chamber pacemakers. Examples of selected embodiments of the pacemaker, according to the invention, with a heart signal detector will now be described in greater detail, referring to the accompanying drawing which uses a block diagram to illustrate a pacemaker utilizing various versions of the inventive idea. In order to produce stimulation pulses with an appropriate amplitude to the heart, a reservoir capacitor C1 is charged to a predesignated stimulation voltage by connecting the capacitor C1 to the battery E via a resistor R1 with the switch S1. When the voltage of capacitor C1 exceeds the predesignated stimulation voltage, the switch S1 opens and terminates recharging. The switch S1 is controlled by a recharge logic unit 2. When a stimulation pulse is delivered to the heart, represented in the FIGURE with impedance RL, the switch S2 closes for a brief time so the reservoir capacitor C1 is discharged through heart impedance RL. The switch S2 is controlled by a control logic unit 4. Capacitor C1 is discharged in proportion to the magnitude of the heart electrode system's impedance RL. Prior to pacemaker implantation, the impedance RL of the electrode system is very high, so the pacemaker does not sense any load, and discharge of the reservoir capacitor C1 is determined by leakage currents in the capacitor itself and other components. When the pacemaker is implanted and the electrode system is applied in the heart, the magnitude of the impedance RL drops drastically. This drop in impedance is used for enabling the heart signal detector 6. The impedance RL can be measured in different ways. Since the magnitude of the charge emitted through the impedance RL is governed by the magnitude of the impedance, the impedance can be determined by measuring the time required to recharge the reservoir capacitor C1 between each stimulation pulse, i.e. the time the switch S1 must be closed to recharge the capacitor C1 to the predesignated stimulation voltage. After a stimulation pulse has been delivered and the switch S2 has opened, the switch S1 closes, and recharging of the reservoir capacitor C1 begins. A comparator 8 compares the voltage or the subvoltage of the capacitor C1 to a reference voltage Uref, corresponding to the predesignated stimulation voltage. When the voltage in the capacitor C1 reaches the value Uref, the comparator 8 sends a signal to the charging logic unit 2 which opens the switch S1. The capacitor C1 is then ready to emit a new stimulation pulse. As noted above, the impedance RL is very high before pacemaker implantation, so the capacitor C1 only loses a very small part of its charge between the stimulation pulses, and the recharge time is short in this instance, i.e. less than 1 ms. After pacemaker implantation, the impedance RL is much lower, and the time required to recharge the capacitor C1 is much longer. Thus, this difference in recharging time constitutes a measure of the impedance RL in the heart electrode system, and the signal detector 6 is enabled when recharging time becomes sufficiently long. The limit value for enabling the heart signal detector 6 is normally in the 3 - 10 ms range. The actual recharging time after the pacemaker has been implanted is usually longer, so the heart signal detector 6 can be safely enabled as soon as the pacemaker and electrode system have been implanted. Recharging of the reservoir capacitor C1 can e.g. occur in steps, so the switch S1 is closed for a fixed period of time, e.g. 1 ms. It opens thereafter, the capacitor voltage is compared to the reference voltage Uref and the switch S1 then recloses once again for 1 ms if the capacitor voltage is less than Uref. A new comparison to Uref is made 1 ms later, and the process continues until the capacitor voltage reaches or exceeds the reference voltage Uref, recharging then terminating. The number of recharge periods required to achieve the reference voltage is a measure here of the charge fed to the reservoir capacitor C1 and, thus, also a measure of the impedance RL. In this procedure, the charging logic unit 2 contains a clock for supplying the requisite time base. When the electrode system has been connected, the magnitude of the load impedance RL is about 500 ohms. So setting the limit value for enabling the heart signal detector 6 at e.g. 2 kohms leaves a wide margin of safety. In one practical embodiment, the different components can have the following numerical values: Battery voltage, E = 2.8 V Resistor, R1 = 2.5 kohms Capacitor, C1 = 10 µF Reference voltage, Uref = 2.4 V The capacitor C1 discharges through the impedance RL for 1 ms. When RL = 2 kohms, the voltage across the capacitor C1 drops in stimulation with about 117 mV. The switch S1 must thereafter remain closed for about 6.4 ms for the capacitor C1 to recharge to Uref = 2.4 V. If the pacemaker is assumed to be implanted and the electrode impedance RL is less than 2 kohms, the heart signal detector 6 is enabled if the voltage difference across capacitor C1 exceeds 117 mV or if the capacitor recharging time exceeds 6.4 ms. One alternative way of measuring electrode impedance RL in order to establish when the heart signal detector 6 should be enabled is to measure the difference in capacitor voltage before and after stimulation, i.e. before and after closure of the switch S2. Since the voltage difference increases with declining impedance RL, measurement of this voltage makes it possible to determine when the heart signal detector 6 should be enabled. In another embodiment of the pacemaker according to the invention, the heart signal detector 6 can be enabled by telemetric means, either immediately before or after implantation. To this end, this embodiment of the pacemaker according to the invention contains a communications logic unit 10 with a telemetry coil 12 for communications with external telemetry equipment with whose help the heart signal detector 6 can also be enabled. The heart signal detector 6 can be automatically enabled so it turns on as soon as programming equipment for telemetry begins communicating with the pacemaker, or the heart signal detector, can be enabled with a special programming command. In the first case the programming equipment thus has a protocol adapted to the associated pacemaker, such that the sensor is enabled as soon as a communication channel is established between the programming equipment and the pacemaker going together. To turn on a programming equipment which is not intended for the pacemaker in question does not however, result in enabling of the sensor or heart signal detector. In another version of the pacemaker according to the invention, the communications logic unit 10 is equipped with a reed element 14, controllable by an externally applied magnetic field, for enabling the heart signal detector 6 immediately before or after implantation. Above the invention has been described as applied to a single chamber pacemaker. However, the invention can be applied with advantage to a dual chamber pacemaker with two heart detectors. The invention idea can even be utilized with other pacemaker functions, such as sensor electronic circuitry for controlling pacemaker function with sensors, e.g. piezoelectric movement or activity sensors, accelerometers and oxygen sensors, which should not be enabled until the pacemaker is implanted. Pacemakers are thus often equipped with runaway protection preventing the pacing rate from becoming too fast. This runaway protection can also be disabled to advantage until the time of pacemaker implantation in order to save power and thereby extend battery and pacemaker life.

Claims: A pacemaker containing an electrode system (RL) for emitting heart stimulation pulses, at least one sensor with associated electronic circuitry for controlling the pacemaker function and means (2, 8; 10, 12, 14) provided for enabling the sensor electronic circuitry (6) in conjunction with pacemaker implantation, characterized in that said means for enabling the sensor electronic circuitry (6) contain a device (2, 8) for measuring the electrode impedance (RL) so as to enable the sensor electronic circuitry (6) in response to the measured impedance (RL) value. A pacemaker according to claim 1, characterized in that said means for enabling the sensor electronic circuitry (6) are disposed to enable the sensor electronic circuitry when the measured electronic impedance (RL) is below a predeterminal threshold valule. A pacemaker of claims 1 or 2, characterized in that the electrode system's impedance (RL) is greater than 933 333 ohms before implantation. A pacemaker of claims 1, 2 or 3 in which the stimulation pulses are generated by the discharge of a reservoir capacitor (C1) through an electrode system, characterized in that said device for measuring the electrode impedance (RL) contains means (2, 8, S1) for measuring the time required to recharge the reservoir capacitor (C1) to a predesignated stimulation voltage between each stimulation pulse. A pacemaker of claim 4, characterized in that, the time measurement means contain a switch (S1) and a comparator (8), the switch being so devised so it connects the reservoir capacitor (C1) to a battery (E) to recharge for a given period of time, the comparator thereafter comparing the capacitor's voltage to the predesignated stimulation voltage, and if the capacitor's (C1) voltage is less than the predesignated stimulation voltage, the switch (S1) reconnects the capacitor (C1) to the battery (E) for a second period of time, the comparator (8) thereafter comparing capacitor (C1) voltage, and if the voltage is still less than the predesignated stimulation voltage, the switch (S1) again reconnects the capacitor (C1) to the battery (E) for a third period of time etc. until the capacitor's (C1) voltage reaches or exceeds the predesignated stimulation voltage, whereupon recharging terminates. A pacemaker of claim 5, characaterized in that the periods of time in which the reservoir capacitor (C1) is connected to the battery (E) are of equal length. A pacemaker of any of claims 1 - 3, characterized in that the device for measuring the electrode impedance (RL) contains measurement means devised to measure the voltage of the reservoir capacitor (C1) before and after emission of a stimulation pulse. A pacemaker comprising an electrod system (RL) for emitting heart stimulation pulses, at least one sensor with associated electronic circuitry for controlling the pacemaker function, and means for enabling the sensor electronic circuitry (6) in conjunction with pacemaker implatation, said means for enabling the sensor electronic circuitry comprising internal telemetry equipment (10, 12) in the pacemaker and external telemetry equipment for communications between the telemetry equipments, characterized in that the external telemetry equipment contains programming equipment, and in that the internal telemetry equipment (10, 12) is devised to enable the sensor electronic circuitry (6) as soon as the programming equipment begins communicating with the internal telemetry equipment or by sending a special command from the programming equipment. A pacemaker of claim 8, characterized in that the programming equipment is adapted to the particular, associated example of pacemaker. A pacemaker comprising an electrod system (RL) for emitting heart stimulation pulses, at least one sensor with associated electronic circuitry for controlling the pacemaker function and means for enabling the sensor electronic circuitry in conjunction with pacemaker implantation, characterized in that said means for enabling the sensor electronic circuitry (6) contain a reed element (14), controllable by an externally applied magnetic field, for enabling the sensor electronic circuitry (6). A pacemaker of any of claims 1 - 10, characterized in that the sensor and sensor electronic circuitry form a heart signal detector (6), and in that the electrode system (RL) for supplying heart stimulation pulses is connected to the heart signal detector (6) for sensing heart signals and conducting them to the heart signal detector. A pacemaker according to claim 11, characterized in that it comprises two heart signal detectors (6) and means (2, 8; 10, 12, 14) are provided for each heart signal detector (6) for enabling the heart signal detector (6) in conjunction with pacemaker implantation.

Inventors: ANDERSSON PETER, BUDGIFVARS GOERAN, LINDBERG JAN, VOCK JOSEF, ANDERSSON, PETER, BUDGIFVARS, GOERAN, LINDBERG, JAN, VOCK, JOSEF, Budgifvars, Göran
Applicants: PACESETTER AB
Application year: 1993
Main classification: A61N1
IPC codes: A61N1