Patent Application
20250041610
The present invention is generally directed to a system comprising a first intracardiac device for implantation within the heart of a patient and at least one second implantable device, for example an intracardiac device, and a method of operation of such system.
Active intracardiac devices, for example implantable intracardiac pacemakers (also known as implantable leadless pacemakers—ILP), are well known miniaturized medical devices which are entirely implanted into a heart chamber, either a ventricle or atrium of a patient. They are considered the future of cardiac pacing. Intracardiac pacemakers are used, for example, for patients who suffer from a bradycardia, with a heart that beats too slow to fulfill the physiological needs of the patient. Intracardiac devices may apply electrical stimulation in the form of pulses to the heart in order to generate a physiologically appropriate heart rate and/or in the form of fast pacing or shocks for cardioversion or defibrillation in order to restore a more normal heart rhythm. Active intracardiac devices may, e.g., deliver antitachycardia pacing (ATP), i.e., pacing the heart with a faster stimulation rate than the tachycardia rate to terminate a tachycardia. Alternative or additional functions of intracardiac devices comprise providing other electrical or electromagnetic signals to the heart or its surrounding tissue and sensing electrical or electromagnetic signals or other physiological parameters of the heart and/or its surrounding tissue. Due to the highly restricted device size, such device has a small battery capacity.
However, there are circumstances in which a patient suffers from various cardiac arrhythmias that require different cardiac therapies. In such cases, a system of implantable devices may be implanted comprising at least two medical devices or units.
Document U.S. Publication No. 2016/0067490 A1 discloses a dual-chamber, leadless pacing system comprising at least one atrial pacing device and at least one ventricular pacing device. In order to adjust the pacing rate in such system signals are transmitted from the atrial pacing device to the ventricular pacing device or from the ventricular pacing device to the atrial pacing device, wherein the respective pacing rate is adjusted based on the received signal. For that a separate communication unit of the atrial pacing device or the ventricular pacing device that includes suitable hardware (e.g., an antenna), firmware, software or any combination thereof consumes energy while communicating with the respective other pacing device.
As indicated above, the new technology brings a number of challenges with it. Due to the size restrictions of intracardiac devices requirements for energy consumption and use of electronic components have increased drastically. There are solutions available in which a basic VVIR functionality is implemented in a ventricular ILP, in which the rate response functionality is based on an accelerometer. This allows adjusting the ventricular pacing rate in case the patient is in atrial fibrillation. VVI(R) is one of the more commonly used pacing modes. VVI(R) is ventricular demand pacing. The ventricle is paced, sensed, and the pulse generator inhibits pacing output in response to a sensed ventricular event. This mode of pacing prevents ventricular bradycardia and is therefore primarily indicated for patients with atrial fibrillation and a slow ventricular response. However, since the pulse generator only paces and senses in the ventricle, there may be a loss of AV synchrony (i.e., the physiological condition of atrial electrical activity followed by ventricular electrical activity, with the interval between being that necessary for impulse conduction from atria to ventricles), which can potentially lead to pacemaker syndrome.
Intracardiac devices that are intended to be implanted in the heart's atrium require specialized design considerations. The available volume for device placement is smaller compared to the ventricle, and the atrial tissue is significantly thinner compared to the ventricle.
Accordingly, there is the need for implantable intracardiac devices to better cope with the requirements for energy consumption, tissue properties and available space.
The present disclosure is directed toward overcoming one or more of the above-mentioned problems, though not necessarily limited to embodiments that do.
A least the above problem is solved with a system comprising the features of claim 1 and a method of operation comprising the features of claim 7.
In particular, an inventive system comprises a first intracardiac device for implantation within the heart of a patient and at least one second implantable device, for example an intracardiac device. The system may therefore be a dual-chamber system, wherein the first intracardiac device and the at least one second intracardiac device each may form a single chamber device. Alternatively, the first intracardiac device and the at least one second intracardiac device, each may form a dual chamber device. For example, the first intracardiac device may provide a treatment with regard to a ventricle of the patient's heart and may be implanted within the ventricle wall of the heart and the second intracardiac device, for example, may provide a treatment with regard to an atrium of the patient's heart and may be implanted within the atrial wall of the heart. Alternatively, the at least one second device may be another implantable device, for example a device which is located fully within the body or partially within the body and outside the body of the patient carrying the first intracardiac device. The first intracardiac device comprises a first processing unit for controlling a first signal generator unit, a first measurement unit for determining at least one first bodily value and a second bodily value, and a first data memory comprising pre-defined first signal parameters for a first treatment signal. The first bodily value and the second bodily value may be the same physical or chemical measurand or different physical or chemical measurand. The second implantable device comprises a second processing unit for controlling a second signal generator unit and a second data memory comprising second pre-defined signal parameters for a second treatment signal. The second device may additionally comprise a second measurement unit for determining at least one third bodily value. The first processing unit, first signal generator unit, first measurement unit and first data memory are all electrically connected and contained within the housing of the first intracardiac device. The second processing unit, second signal generator unit, second measurement unit and second data memory are all electrically connected and contained within the housing of the second device. The first processing unit and/or the second processing unit may comprise hardware to support signal processing (e.g., scaling, filtering, rectification).
According to the present invention, the first signal generator unit is adapted to deliver a first electric and/or electromagnetic treatment signal to the patient's heart with at least one first signal parameter and an information carrying parameter, wherein the at least one first signal parameter of the first treatment signal is derived from the first data memory based on the at least one determined first bodily value, wherein the information carrying parameter is determined by the first processing unit based on the determined second bodily value. The first treatment signal is provided by the first signal generator and comprises a time-dependent changing electric and/or electromagnetic field applied to the cardiac tissue of the patient, for example a pacing signal, for treatment in order to improve the health condition of the patient. The electric and/or electromagnetic field may be applied, for example, by electrodes protruding from the first intracardiac device and fixed within the tissue of the respective chamber of the heart. The electrodes are electrically connected with the first signal generator unit. The first treatment signal is characterized by its first signal parameters, for example its start time position, its amplitude and/or frequency (rate) of the signal as well as signal morphology. The first signal parameters are derived from the first data memory, wherein the chosen first signal parameters are the pre-defined signal parameters stored in the first data memory. They are chosen by the first processing unit, for example, from a data matrix containing pre-defined signal parameters with a connection to possible measurable first bodily values. According to the at least one first bodily value determined by the first measurement unit, the suitable at least one first signal parameter is chosen from the data matrix. Accordingly, the first signal parameters are chosen from the data matrix containing pre-defined signal parameters based on recently measured first bodily value (i.e., vital sign of the patient's body such as heart rate). According to the present invention, the treatment signal further realizes an information carrying parameter which is determined by the first processing unit based on the determined second bodily value. The information carrying parameter is determined, for example calculated or derived from a respective data matrix of the first data memory containing pre-defined information carrying parameters, by the first processing unit based on the second bodily value determined by the first measurement unit. For example, the second bodily value may be an activity value determined by an accelerometer and/or impedance sensor of the first measurement unit thereby assessing the activity of the patient.
The second device is able to determine the information carrying value provided with the first treatment signal and relates some information to the determined value of the information carrying parameter. For example, the second device compares pre-defined treatment signals and/or pre-defined first parameters of treatment signals contained in the first data memory with the most recently (i.e., just before) measured treatment signal or determined first parameters of such treatment signal of the first intracardiac device. According to the present invention, the second signal generator is adapted to deliver a second electric and/or electromagnetic treatment signal, for example to the patient's heart, wherein at least one second signal parameter of the second treatment signal is derived from second data memory based on the at least one determined third bodily value and is further based on the determined information carrying parameter of the first electric and/or electromagnetic treatment signal recently provided by the first intracardiac device. The second electric and/or electromagnetic treatment signal may comprise, for example, a time-dependent changing electric and/or electromagnetic field applied to the cardiac tissue of the patient, e.g., a pacing signal, for treatment in order to improve the health condition of the patient. The electric and/or electromagnetic field may be applied, for example, by electrodes protruding from the second device being an intracardiac device and fixed within the tissue of the respective chamber of the heart. The electrodes are electrically connected with the second signal generator unit. The second treatment signal is characterized by its second signal parameters, for example its start time position, its amplitude and/or frequency (rate) of the signal as well as signal morphology. The second signal parameters are derived from the second data memory, wherein the chosen second signal parameters are the pre-defined signal parameters stored in the second data memory. They are chosen by the second processing unit, for example, from a data matrix containing pre-defined signal parameters associated with possible measurable third bodily values. According to the at least one third bodily value determined by the second measurement unit, the suitable at least one second signal parameter is chosen from the data matrix. Accordingly, the second signal parameters are chosen from the data matrix containing pre-defined signal parameters for the second treatment signal based on the recently measured third bodily value (i.e., vital sign of the patient's body such as heart rate). The at least one second signal parameter is further adapted according to the determined information carrying parameter and prior to application of the second treatment signal to the patient. For example, the second processing unit uses the at least one signal parameter derived from the second data memory and increases, decreases or maintains at least one parameter of the at least one second signal parameters according to the most recently (i.e., from the just before provided first treatment signal) provided first treatment signal and recently determined information carrying parameter from this signal.
In one embodiment, the first and the second measurement unit are adapted to measure the patient's intracardiac electrocardiogram (IEGM) signal comprising, for example, the heart rate, PR-interval, QT-interval, ST-interval, P-wave and T-wave durations. With the IEGM signal, the first and the second measurement unit additionally may sense a pacing signal (e.g., its start time position and its duration as well as its frequency) from the respective other intracardiac device. Additionally, the first and the second measurement unit may be adapted to determine the impedance in order to derive cardiac tissue properties. The first and the second measurement unit may also sense multiple signals indicative of multiple contractions of the ventricle and determine the ventricular contraction rate from the multiple signals. Sensed signals may include, for example, far-field R-waves and/or heart sounds. Communication between at least two devices in this way may be possible by simply passively sensing the resulting electrical activity from the different devices in the heart. For example, dual chamber leadless pacer therapy, with one device sensing and pacing in the ventricle and a second sensing and pacing in the atrium, may rely on each device sensing the far-field activity from the electrically distant chamber to remain synchronized with each other. The first measurement unit further may comprise an accelerometer sensor and/or impedance sensor as indicated below.
In one embodiment the first treatment signal is an electric ventricular pacing signal, wherein the at least one first signal parameter of the first intracardiac device is the start time position of the ventricular pacing signal and/or its amplitude and/or the second treatment signal is an electric atrial pacing signal, wherein the signal parameter of the second device is an atrial pacing rate, an amplitude of the pacing signal, a duration of the pacing signal and/or the start time position of the atrial pacing signal.
In one embodiment the information carrying parameter is a time period by which a pre-defined first electric and/or electromagnetic treatment signal section is shortened or prolonged, e.g., an AV delay value is shortened or prolonged, and/or a rate of a pre-defined first electric and/or electromagnetic treatment signal. Also, the VA-interval may be modulated. This shortening or prolonging time period may be between −50 ms and 50 ms, preferably between −15 ms and 15 ms, and more preferably between −8 ms and 8 ms. The negative values are regarded as shortening time period and the positive values are regarded as prolonging time period. In a further embodiment, the shortening or prolonging time period are between −8 ms and −3 ms or between 3 ms and 8 ms. In all intervals mentioned before the respective boundary values are included. The AV delay is the time period between the start time position of the atrial pacing signal and the start time position of the ventricular pacing signal. In this embodiment, the first intracardiac device, e.g., a ventricular ILP, may sense the start time position of the atrial pacing signal produced by the second device using the first measurement unit. In addition, the second device, e.g., an atrial ILP, may sense the start time and position of the ventricular pacing signal produced by the first intracardiac device using the second measurement unit. The first and the second devices are individually programmed and contain the expected AV delays and/or pacing rate for a particular heart rate stored in the first data memory and the second data memory. In case both devices ‘know’ the present heart rate of the patient they may have an ‘expectation’ of when the ventricular pace should happen, i.e., they know the ‘usual’ AV delay and/or pacing rate. A shortening or prolongation of the ‘usual’ AV delay by the ventricular ILP and/or change in the pacing rate may be used to communicate information to the atrial device. E.g., if the ventricular device is pacing at a shorter AV delay than expected, i.e., the pacing signal of the ventricular ILP begins by a certain time period earlier or later, the atrial ILP detects the shortening or prolongation of the AV delay by comparing the measured AV delay with the pre-defined AV delay stored in its data memory. If a shortening of the AV delay is determined, the second processing unit derives the information that the atrial pacing rate shall be increased. In contrast, if the atrial pacing rate is higher than indicated by the accelerometer and/or impedance of the ventricular ILP, the ventricular ILP would delay delivering the ventricular pace, which would be an indicator for the atrial ILP to lower the pacing rate. Additionally or alternatively, in one embodiment, if a change in the ventricular pacing rate is detected, the atrial pacing is adapted accordingly so that pacing remains in synchrony with each other. Hence, in case the patient develops sequences of atrial tachycardias the two leadless pacemakers would work in an asynchrony, the accelerometer and/or impedance based sensor indicated pacing rate would be available in the ventricular ILP allowing for standard VVIR pacing.
The inventive system uses the treatment signal of the first intracardiac device for communication of information to the second device which adapts its treatment signal according to the received information. For example, it may increase or decrease the atrial pacing rate based on the changing AV delay and or changing pacing rate in the ventricle. An active communication (for example, NF communication or blue tooth communication) using a separate communication channel is not necessary for communication between the first intracardiac device and the second device. Accordingly, as the separate communication channel is not used with this communication, there is no energy consumption with regard to such communication. The energy used in connection with the first treatment signal is not significantly changed. Additionally, no special modulating unit is necessary as only a small shift of the start time position of the first treatment signal contains the information. The information carrying parameter does not alter the treatment activity of the first treatment signal as its small value, compared to typical near-field electrical signals, does not influence the effectiveness of treatment but is reliably measurable by the second measurement unit.
In one embodiment, the information carrying parameter takes into account the variability in the timing of far-field signals, e.g., far-field atrial detections in the first intracardiac device (e.g., the ventricular device). For example, it is likely that the atrial and ventricular devices detect the atrial event at slightly different times due to the signal processing and detection mechanism for far-field sensing in the ventricular device. This means that the AV delay as measured by the second device (e.g., atrial intracardiac device) and the first intracardiac device (e.g., ventricular device) may be slightly different. This difference may be considered when setting tolerances for increasing or decreasing the AV delay by the second device to communicate a pacing rate.
In one embodiment the first bodily value comprises the intrinsic atrial activity and/or the intrinsic ventricular activity and/or the third bodily value comprises the intrinsic ventricular activity. For example, the first measurement unit and the second measurement unit detect the ECG or IEGM of the patient's heart, for example high resolution and high gain IEGM.
In one embodiment the first bodily value comprises the intrinsic near-field ventricular electrical activity and/or the intrinsic far-field atrial electrical activity and/or the atrial pacing delivered by the second device. The third bodily value may comprise the intrinsic near-field atrial electrical activity and/or the intrinsic far-field ventricular electrical activity and/or the ventricular pacing delivered by the first intracardiac device.
Alternatively or additionally, the first bodily value comprises the intrinsic or paced atrial activity and/or the intrinsic or paced ventricular activity and/or the third bodily value comprises the intrinsic ventricular and/or atrial activity and/or the intrinsic or paced atrial activity.
In one embodiment the second bodily value is a signal determined by an accelerometer sensor, wherein the accelerometer sensor is integrated within the first measurement unit. The accelerator sensor is, for example, adapted for measuring activity to determine the desired pacing rate, posture and/or heart sound data. Alternatively or additionally, the second bodily value is an impedance signal measured at a bodily tissue or within a bodily fluid, for example within the blood of the heart's ventricle. For example, the impedance caused by the pH value (i.e., the acidity or basicity) of the patient's blood may be a characteristic parameter with regard to the activity of the patient. The impedance sensor may be integrated within the first measurement unit.
In one embodiment the second device only allows change of the second electric and/or electromagnetic treatment signal previously applied to the patient's heart if the second measurement unit has received a or any confirmation of the most recently determined information carrying parameter. The confirmation may be provided by at least one second transmission of the information carrying parameter in a consecutive manner (i.e., an additional second time or even more than a second time, e.g., three times or four times in a consecutive manner) thereby forming a set of at least two consecutive first treatment signals, both containing the same information carrying parameter value. The number of consecutive first treatment signals comprising the same information carrying parameter values which is necessary for second treatment signal change is pre-defined for each system. This is advantageous because it enhances the safety and reliability of the system.
Further, it is of advantage that the communication of the devices is visible to the clinician or outside world. Existing surface ECG systems can be used to assess heart rhythm (such as AV delay or rate) and therefore interpret the signaling from either or both devices. This may improve troubleshooting or may be used to interpret how to program the first intracardiac device and the at least one second device, for example, how to program rate response based on observation of AV delay.
The above problem is also solved by a method of operation of a system comprising a first intracardiac device after implantation within the heart of a patient and at least one second implantable device, for example an intracardiac device,
The above method has the advantages as explained with regard to the system above. The embodiments mentioned and explained above with regard to the systems also apply to the method indicated above.
Additional features, aspects, objects, advantages, and possible applications of the present disclosure will become apparent from a study of the exemplary embodiments and examples described below, in combination with the Figures and the appended claims.
The present invention will now be described in further detail with reference to the accompanying schematic drawing, wherein
The pacing instructions and first signal parameters may be updated by the programmer using the communication unit 128.
The first processing unit 120 may communicate with first signal generator unit 124 and first measurement unit 126. First signal generator unit 124 and first measurement unit 126 are electrically coupled to electrodes 111, 112. First measurement unit 126 is configured to monitor signals from electrodes 111, 112 in order to monitor electrical activity of heart 20. Further, the first measurement unit 126 may include an accelerometer and/or a pressure sensor and/or an impedance sensor. First signal generator unit 124 is configured to deliver electrical stimulation to ventricle 21 via electrodes 111,112.
First processing unit 120 may control first signal generator unit 124 to generate and deliver electrical stimulation to ventricle 21 via electrodes 111,112. Electrical stimulation may include pacing pulses. First processing unit 120 may control first signal generator unit 124 to deliver electrical stimulation therapy according to one or more ventricular therapy programs including pacing instructions and values, which may be stored in first data memory 122.
First measurement unit 126 may include circuits that acquire electrical signals from the sensor(s). Electrical signals acquired by first measurement unit 126 may include intrinsic cardiac electrical activity, such as intrinsic ventricular and/or intrinsic ventricular cardiac electrical activity. First measurement unit 126 may filter, amplify, and digitize the acquired electrical signals to generate raw digital data. First processing unit 120 may receive the digitized data generated by First measurement unit 126. In some examples, first processing unit 120 may perform various digital signal processing operations on the raw data, such as digital filtering.
Processing unit 120 may sense cardiac events based on the data received from first measurement unit 126. For example, first processing unit 120 may determine ventricular events based on the data received from first measurement unit 126. In some examples, first processing unit 120 may determine ventricular activation based on the data received from first measurement unit 126. For example, first processing unit 120 may detect far-field R-waves (FFRWs) indicative of ventricular activation based on the data received from first measurement unit 126.
Ventricular device 100 may include a housing, fixation tines, and electrodes 111, 112. The housing may have a pill-shaped cylindrical form factor in some examples. Fixation tines are configured to connect (e.g., anchor) ventricular device 100 to heart 20. Fixation tines may be fabricated from a shape memory material, such as Nitinol. In some examples, fixation tines may connect ventricular device 100 to heart 20 within one of the chambers of heart 20. For example, as illustrated and described herein with respect to
Ventricular device 100 may include one or more electrodes 111, 112 for sensing electrical activity of heart 20 and/or delivering electrical stimulation to heart 20. Ventricular device 100 includes two electrodes 111,112, although more than two electrodes may be included on an ventricular device in other examples. Electrodes 111, 112 may be spaced apart a sufficient distance to be able to detect various electrical signals generated by the heart 20, such as P-waves generated by atria and FFRWs generated by ventricles. The housing houses electronic components of ventricular device 100. Electronic components may include any discrete and/or integrated electronic circuit components that implement analog and/or digital circuits capable of producing the functions attributed to ventricular device 100 described above.
The first communication unit 128 may enable leadless device 100 to communicate with other electronic devices, such as a programmer or other external patient monitor. In some examples, housing 108 may house an antenna for wireless communication. Housing may also include the first power source 132.
The structure of atrial device 200 may be similar to the structure of ventricular device 100 as described above. For example, atrial device 100 may have a housing, fixation tines, and electrodes that are similar to housing, fixation tines, and electrodes of ventricular device 100. Additionally, the atrial device 200 may have a second processing unit similar to the first processing unit 120, a second data memory similar to the first data memory 122, a second signal generating unit similar to the first signal generating unit 124, and a second measurement unit similar to the first measurement unit 126, but an accelerometer and/or an impedance sensor and/or any other sensor used to determine the patient's activity level for rate response is not needed in the atrial device. Further, the atrial device 200 may comprise a second communication module similar to the first communication unit 128 for communication with a programmer or an external patient monitor.
In addition, based on typical programming of shorter AV delays at higher pacing rates, the proposed solution is intrinsically safe. In order to transmit the information to further increase of the desired atrial pacing rate to the atrial device 200 the ventricular device 100 would need to further shorten the paced AV delay. It is conceivable that the information carrying parameter (i.e., the value by which the AV delay is shortened or prolonged) used to communicate a change of the atrial pacing rate has to fall within predetermined values (e.g., a change of the expected AV delay by a time period between 3 ms to 8 ms (prolongation) and between −8 ms to −3 ms (shortening) are considered a signal. Changes in AV delay which do not fall within these expected ranges would be considered noise). In one embodiment the signal transmission using the information carrying parameter has to be repeated in a specific sequence to validate the input for the atrial device 200, for example, three times consecutively.
In another embodiment, communication between multiple leadless (intracardiac) pacing devices in this way may be possible by simply passively sensing the resulting electrical activity from the respective other device(s) in the heart. Dual chamber leadless pacer therapy, with the ventricular device 100 sensing and pacing in the ventricle and the atrial device 200 sensing and pacing in the atrium, relies on each device sensing the far-field activity from the electrically distant chamber to remain synchronized with each other. Far-field atrial activity is sensed by the ventricular device for VDD therapy, and preliminary preclinical data indicate that far-field electrical signals from ventricular activity are also present in the atrium. An example ventricular far-field signal recorded in the atrium is shown in
The technical advantage of this present invention is the ability to provide atrial rate responsive pacing in a leadless pacemaker system consisting of two independent devices 100, 200. The atrial device 200 can be designed simpler (less electronic components), smaller, and having a longer device lifetime, without compromising patient therapy. Further, duplication of device functionality like rate response based on an accelerometer and/or impedance sensor is avoided, for example, in the atrial device 200. Instead, the ventricular device 100 calculates the ventricular pacing rate and communicates this information to the atrial device 200.
It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.
| Number | Date | Country | Kind |
|---|---|---|---|
| 22150271.9 | Jan 2022 | EP | regional |
This application is the United States National Phase under 35 U.S.C. § 371 of PCT International Patent Application No. PCT/EP2022/084522, filed on Dec. 6, 2022, which claims the benefit of European Patent Application No. 22150271.9, filed on Jan. 5, 2022, and U.S. Provisional Patent Application No. 63/289,784, filed on Dec. 15, 2021, the disclosures of which are hereby incorporated by reference herein in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/084522 | 12/6/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63289784 | Dec 2021 | US |
