Source: https://patents.google.com/patent/US20040138715
Timestamp: 2018-03-24 02:54:25
Document Index: 261514233

Matched Legal Cases: ['art 8', 'art 8', 'art 8', 'art 8', 'art 8', 'art.\n13', 'art.\n24', 'art.\n44']

US20040138715A1 - Synchronized atrial anti-tachy pacing system and method - Google Patents
Synchronized atrial anti-tachy pacing system and method Download PDF
US20040138715A1
US20040138715A1 US10435071 US43507103A US2004138715A1 US 20040138715 A1 US20040138715 A1 US 20040138715A1 US 10435071 US10435071 US 10435071 US 43507103 A US43507103 A US 43507103A US 2004138715 A1 US2004138715 A1 US 2004138715A1
US10435071
US7162300B2 (en )
Christianus Van Groeningen
Joanneke Groen
Malcolm Begemann
A system and method for an implantable cardiac pacing device provide for delivery of anti-tachycardia pacing of the atrium upon detection of atrial tachycardia combined with automatic re-synchronization of ventricular pacing directly following the last atrial pulse of the anti-tachycardia scheme. At the onset of delivery of the ATP train or like scheme of ATP, an appropriate ventricular pacing interval is calculated to enable asynchronous pacing of the ventricle during the ATP and synchronous delivery of the next ventricular pulse at a delay following the end of the ATP train. Upon determination of AT, an algorithm is used to calculate if a ventricular pacing interval can be found that meets maximum and minimum pacing criteria and also provides that the next ventricular pace pulse following the end of the ATP train will follow the last atrial pulse of the train by a suitable AV delay. If such a suitable pacing interval is found, the ventricular pacing interval is set to a temporary value and the train is delivered. If such a pacing interval cannot be initially determined the system waits for one more atrial sense and then repeats the determination to find such a suitable ventricular pacing interval.
This application claims priority to provisional U.S. application Ser. No. 60/439,460 filed 13 Jan. 2003.
This invention relates to implantable cardiac pacing devices that incorporate atrial anti-tachycardia control, and in particular dual chamber pacing devices with atrial anti-tachy control that optimize synchronous ventricular pacing.
Modern implantable cardiac pacing devices are designed for efficient dual or multiple chamber pacing as well as detection and treatment of dangerous cardiac arrhythmias. A dual chamber pacing device provides the capability of synchronous pacing, whereby the ventricle is paced in synchrony with the just preceding atrial beat (intrinsic or paced), thereby approximating the normal healthy coordination between the atrium and the ventricle and thus optimizing cardiac output. However, if the atrium is seized with an arrhythmia, such synchronous pacing cannot be resumed until after the arrhythmia abates or is somehow reverted. In the case of atrial tachycardia (AT), a malignant arrhythmia, pacemakers can respond with normally effective atrial pacing schemes to arrest or stop the AT, after which the pacemaker can resume synchronous pacing when the cardiac condition is stabilized. The problem is that the atrium remains vulnerable to a recurring episode of tachycardia following AT treatment, particularly if the two chambers are not operating in an efficient synchronous manner. What is important, then, and a main feature of this invention, is enabling the pacemaker or other implantable device (ipg) to resume such synchronous pacing as quickly as possible after the conclusion of the AT response.
The advantage of synchronous pacing is well established. For a patient at rest, AV synchrony improves cardiac output by about 20-25%; the improvement decreases with exercise. The intrinsic atrial rate, however, is not always reliable for control of ventricular pacing. Pacemaker patients are, by definition, in a class that is subject to cardiac abnormalities. In particular, AT is a concern, and the pacemaker or ipg must be able to detect AT and provide an appropriate response to terminate the AT. As used here, AT means an abnormally high atrial rate, e.g., a rate of intrinsic atrial beats above 120-150 bpm. The definition of AT may be programmed into the device by a physician, and may be set at a value within a range of, for example, 100-180 bpm. Most pacing devices have a programmable upper rate limit above which the ventricle will not be paced, and this limit may serve to define tachy senses. In a typical arrangement, when such high rate tachy senses occur consecutively or in predominance over a given time period, AT is recognized and an anti-tachy pacing (ATP) mode automatically takes over to stop the AT.
There are many different ATP schemes illustrated in the patent art. Table 1 below lists representative patent and literature references that show different forms of ATP.
Patent/Doc. No. Inventor(s) Issue/Pub Date
4,280,502 Baker, Jr. et al. Jul. 28, 1981
4,390,021 Spurrell et al. Jun. 28, 1983
4,398,536 Nappholz et al. Aug. 16, 1983
4,406,287 Nappholz et al. Sep. 27, 1983
4,408,606 Spurrell et al. Oct. 11, 1983
4,467,810 Vollmann Aug. 28, 1984
4,574,437 Segerstad et al. Mar. 11, 1986
4,577,633 Berkovitz et al. Mar. 25, 1986
4,587,970 Holly et al. May 13, 1986
4,593,695 Wittkampf Jun. 10, 1986
4,491,471 Mehra Jul. 17, 1990
All patents listed in Table 1 above are hereby incorporated by reference herein in their respective entireties. As those of ordinary skill in the art will appreciate readily upon reading the Summary of the Invention, Detailed Description of the Preferred Embodiments and Claims set forth below, many of the devices and methods disclosed in the patents of Table 1 may be modified advantageously by using the teachings of the present invention.
A common form of ATP is to deliver a train of pulses to the atrium immediately after AT is declared. In delivering an ATP train, or burst, different sequences of atrial pulses can be used, with the timing being adjusted for maximum interruption of the tachycardia. Atrial tachycardia is thought to be characterized by a re-entry feedback loop in the atrium, whereby each atrial conduction induces another beat before the natural pacemaker triggers the next normal beat. The timing of the feedback conduction can be variable, such that it is difficult to determine the best time to deliver a reverting pulse that can interrupt the arrhythmia. The basic idea of the train is to deliver a series of pulses before the next tachy occurrence, to enhance the possibility of interruption. It is thought that each successive pulse of the sequence enlarges the area of the atrium that is conditioned to respond to a pacing pulse, such that by the end of the train the entire atrium is in condition to be captured by an atrial pulse (AP). The sequence, whether called a train or burst or whatever, can be programmed for each patient, and may even vary based on history. As used herein, ATP refers to any sequence of atrial pulses delivered for the purpose of interrupting atrial tachycardia or like arrhythmias. However, the various ATP trains have in common the features that atrial sensing is abolished while the ATP pulses are being delivered, and once the train is started the order and timing of the ATP pulses is set, i.e., the train is irrevocable.
As stated above, it is important to continue with synchronous pacing as soon as possible after an AT episode. In fact, establishing synchronous pacing quickly after an abnormal episode is crucial, due to the possibility of mediating or permitting re-establishment of the tachycardia. By way of example, following a premature atrial contraction (PAC) it is known to deliver an atrial sync pulse (ASP) that is timed to enable the pacer to re-establish snychrony with the next delivered ventricular pulse. This is done in order to prevent pacemaker mediated tachycardia. Likewise, following an AT episode, there is a danger of a new AT episode if the next ventricular pace pulse is not synchronized to the last atrial pulse of the ATP. An asynchronous ventricular pulse could put stress on the atrium, which increases the vulnerability to AT or AF. Or, such an asynchronous pulse could lead to retrograde conduction back to the atrium which could induce AT or AF. Moreover, these two mechanisms could stimulate the localized source of polarization that gave rise to the AT or AF in the first place. Thus, while the ATP has presumably stopped the feedback mechanism in the atrium that was admitting the AT, the atrium remains vulnerable following AT and a following asynchronous ventricular pulse can cause either electrical or mechanical interference capable of destabilizing the atrial tissue. This presents a serious problem that has not been addressed by the pacemaker art.
It is an object of the invention to provide an implantable pacing device, and method of operation, that can sense and respond to atrial tachycardias, deliver an ATP train of atrial pulses, and deliver the next ventricular pulse in synchrony with the last atrial pulse of the train.
It is another object of the invention to provide an implantable pacing system capable of detecting a high rate atrial arrhythmia and responding to such arrhythmia with a fixed sequence of atrial pulses designed to revert the arrhythmia, and to deliver the very next ventricular pacing pulse that is due following the sequence in synchrony with the last atrial pulse of such sequence.
It is another object of the invention to provide a method of responding to a sensed atrial tachycardia or the like by delivering a planned ATP scheme of atrial pulses while delivering ventricular pulses without interruption and regaining synchronous ventricular pacing directly after such delivery.
In accord with the above objectives, there is provided a pacing system and method adapted for an implanted cardiac device, whereby an atrial anti-tachy pacing sequence is delivered to the patient's atrium upon sensing of AT, and where the next ventricular beat that follows the ATP is synchronized to the last atrial beat of the sequence. When AT is declared by the system, timing of an ATP is initiated referenced to the atrial sense (AS). At the same time, the pacing system determines whether the first ventricular pacing pulse after the end of the sequence can be delivered at the current ventricular pacing interval (PI) with an acceptable AV interval. If so, the ventricular pacing interval is not changed. If not, then the pacing system determines whether PI can be adapted to a value within predetermined maximum and minimum criteria in order to provide a ventricular pacing pulse with an acceptable AV interval following the last atrial pulse of the sequence. If so, the PI is lengthened or shortened appropriately. Upon determination of an acceptable ventricular PI, one or more ventricular pacing pulses may be delivered asynchronously during the duration of the ATP sequence, and the first ventricular pacing pulse after the end of the ATP train is delivered at an acceptable AV delay following the last atrial pulse of the sequence. In the event that the ventricular PI cannot be so adapted for synchrony when the determinations are first made, the system waits for the next atrial sense, determines a workable PI, and then delivers the ATP train and adapts ventricular PI appropriately.
In carrying out the method of the invention, the ATP sequence is delivered followed by a ventricular pacing pulse that is synchronized to the last atrial pulse. The prior ventricular PI is then restored, and the device determines whether the atrial rhythm is a normal sinus rhythm, i.e., whether AT has been reverted. If AT is again detected, the device repeats delivery of the ATP in the same manner until sinus rhythm is detected, again adapting ventricular PI in order to synchronize the ventricular pulse following the ATP sequence. Ventricular pacing is not interrupted, since one or more ventricular pace pulses, depending on the length of the ATP sequence, will be delivered asynchronously during the ATP sequence. But as soon as the ATP sequence is finished, and a normal sinus rhythm hopefully restored, ventricular pacing is immediately restored in a synchronous mode.
[0014]FIG. 1 is a simplified schematic view of one embodiment of an implantable medical device that can be employed in the present invention.
[0015]FIG. 2 is a graphic representation of an implantable medical device interconnected with a human or mammalian heart, illustrating the device connector portion and the leads between the device and the heart.
[0016]FIG. 3 is a functional schematic diagram showing the primary constituent components of an implantable medical device in accordance with an embodiment of this invention.
[0017]FIG. 4 is a graphic representation of an embodiment of this invention showing an implantable PCD device interconnected with a heart, the system of this embodiment providing pacing, cardio version and defibrillation.
[0018]FIG. 5 is a functional schematic diagram of an implantable PCD embodiment of this invention.
[0019]FIG. 6A is a timing diagram illustrating an ATP sequence and ventricular pacing with an unchanged ventricular pacing interval.
[0020]FIG. 6B is a timing diagram illustrating an ATP sequence and ventricular pacing with a shortened ventricular pacing interval.
[0021]FIG. 6C is a timing diagram illustrating an ATP sequence and ventricular pacing with a lengthened ventricular interval.
[0022]FIG. 7 is a flow diagram showing the primary steps taken by the system of the invention in responding to sensed AT, adapting ventricular pacing interval as necessary, delivering an ATP sequence, pacing the ventricle asynchronously during the ATP sequence and following the sequence with a ventricular pace pulse synchronously timed to the last atrial pulse of the ATP sequence.
[0023]FIG. 8 is a flow diagram illustrating the preferred algorithm for determining the best ventricular pacing interval for use with an ATP sequence.
[0024]FIG. 1 is a simplified schematic view of one embodiment of implantable medical device (“IMD”) 10 of the present invention. IMD 10 shown in FIG. 1 is a pacemaker comprising at least one of pacing and sensing leads 16 and 18 attached to hermetically sealed enclosure 14 and implanted near human or mammalian heart 8. Pacing and sensing leads 16 and 18 sense electrical signals attendant to the depolarization and re-polarization of the heart 8, and further provide pacing pulses for causing depolarization of cardiac tissue in the vicinity of the distal ends thereof. Leads 16 and 18 may have unipolar or bipolar electrodes disposed thereon, as is well known in the art. Examples of IMD 10 include implantable cardiac pacemakers disclosed in U.S. Pat. No. 5,158,078 to Bennett et al., U.S. Pat. No. 5,312,453 to Shelton et al. or U.S. Pat. No. 5,144,949 to Olson, all hereby incorporated by reference herein, each in its respective entirety.
[0025]FIG. 2 shows connector module 12 and hermetically sealed enclosure 14 of IMD 10 located in and near human or mammalian heart 8. Atrial and ventricular pacing leads 16 and 18 extend from connector header module 12 to the right atrium and ventricle, respectively, of heart 8. Atrial electrodes 20 and 21 disposed at the distal end of atrial pacing lead 16 are located in the right atrium. Ventricular electrodes 28 and 29 at the distal end of ventricular pacing lead 18 are located in the right ventricle.
[0026]FIG. 3 shows a block diagram illustrating the constituent components of IMD 10 in accordance with one embodiment of the present invention, where IMD 10 is pacemaker having a microprocessor-based architecture. IMD 10 is shown as including activity sensor or accelerometer 11, which is preferably a piezoceramic accelerometer bonded to a hybrid circuit located inside enclosure 14. Activity sensor 11 typically (although not necessarily) provides a sensor output that varies as a function of a measured parameter relating to a patient's metabolic requirements. For the sake of convenience, IMD 10 in FIG. 3 is shown with lead 18 only connected thereto; similar circuitry and connections not explicitly shown in FIG. 3 apply to lead 16.
IMD 10 in FIG. 3 is most preferably programmable by means of an external programming unit (not shown in the Figures). One such programmer is the commercially available Medtronic Model 9790 programmer, which is microprocessor-based and provides a series of encoded signals to IMD 10, typically through a programming head which transmits or telemeters radio-frequency (RF) encoded signals to IMD 10. Such a telemetry system is described in U.S. Pat. No. 5,312,453 to Wyborny et al., hereby incorporated by reference herein in its entirety. The programming methodology disclosed in Wybomy et al.'s '453 patent is identified herein for illustrative purposes only. Any of a number of suitable programming and telemetry methodologies known in the art may be employed so long as the desired information is transmitted to and from the pacemaker.
Electrical components shown in FIG. 3 are powered by an appropriate implantable battery power source 76 in accordance with common practice in the art. For the sake of clarity, the coupling of battery power to the various components of IMD 10 is not shown in the Figures. Antenna 56 is connected to input/output circuit 54 to permit uplink/downlink telemetry through RF transmitter and receiver telemetry unit 78. By way of example, telemetry unit 78 may correspond to that disclosed in U.S. Pat. No. 4,566,063 issued to Thompson et al., hereby incorporated by reference herein in its entirety, or to that disclosed in the above-referenced '453 patent to Wybomy et al. It is generally preferred that the particular programming and telemetry scheme selected permit the entry and storage of cardiac rate-response parameters. The specific embodiments of antenna 56, input/output circuit 54 and telemetry unit 78 presented herein are shown for illustrative purposes only, and are not intended to limit the scope of the present invention.
Continuing to refer to FIG. 3, VREF and Bias circuit 82 most preferably generates stable voltage reference and bias currents for analog circuits included in input/output circuit 54. Analog-to-digital converter (ADC) and multiplexer unit 84 digitizes analog signals and voltages to provide “real-time” telemetry intracardiac signals and battery end-of-life (EOL) replacement functions. Operating commands for controlling the timing of IMD 10 are coupled by data bus 72 to digital controller/timer circuit 74, where digital timers and counters establish the overall escape interval of the IMD 10 as well as various refractory, blanking and other timing windows for controlling the operation of peripheral components disposed within input/output circuit 54.
In some preferred embodiments of the present invention, IMD 10 may operate in various non-rate-responsive modes, including, but not limited to, DDD, DDI, VVI, VOO and VVT modes. In other preferred embodiments of the present invention, IMD 10 may operate in various rate-responsive, including, but not limited to, DDDR, DDIR, VVIR, VOOR and VVTR modes. Some embodiments of the present invention are capable of operating in both non-rate-responsive and rate responsive modes. Moreover, in various embodiments of the present invention IMD 10 may be programmably configured to operate so that it varies the rate at which it delivers stimulating pulses to heart 8 only in response to one or more selected sensor outputs being generated. Numerous pacemaker features and functions not explicitly mentioned herein may be incorporated into IMD 10 while remaining within the scope of the present invention.
[0038]FIGS. 4 and 5 illustrate one embodiment of IMD 10 and a corresponding lead set of the present invention, where IMD 10 is a PCD. In FIG. 4, the ventricular lead takes the form of leads disclosed in U.S. Pat. Nos. 5,099,838 and 5,314,430 to Bardy, and includes an elongated insulative lead body 1 carrying three concentric coiled conductors separated from one another by tubular insulative sheaths. Located adjacent the distal end of lead 1 are ring electrode 2, extendable helix electrode 3 mounted retractably within insulative electrode head 4 and elongated coil electrode 5. Each of the electrodes is coupled to one of the coiled conductors within lead body 1. Electrodes 2 and 3 are employed for cardiac pacing and for sensing ventricular depolarizations. At the proximal end of the lead is bifurcated connector 6 which carries three electrical connectors, each coupled to one of the coiled conductors. Defibrillation electrode 5 may be fabricated from platinum, platinum alloy or other materials known to be usable in implantable defibrillation electrodes and may be about 5 cm in length.
[0042]FIG. 5 is a functional schematic diagram of one embodiment of implantable PCD 10 of the present invention. This diagram should be taken as exemplary of the type of device in which various embodiments of the present invention may be embodied, and not as limiting, as it is believed that the invention may be practiced in a wide variety of device implementations. IMD 10 is provided with an electrode system. If the electrode configuration of FIG. 4 is employed, the correspondence to the illustrated electrodes is as follows. Electrode 25 in FIG. 5 includes the uninsulated portion of the housing of PCD 10. Electrodes 25, 15, 21 and 5 are coupled to high voltage output circuit 27, which includes high voltage switches controlled by CV/defib control logic 29 via control bus 31.
Switches disposed within circuit 27 determine which electrodes are employed and which electrodes are coupled to the positive and negative terminals of the capacitor bank (which includes capacitors 33 and 35) during delivery of defibrillation pulses.
In the event that generation of a cardioversion or defibrillation pulse is required, microprocessor 51 may employ an escape interval counter to control timing of such cardioversion and defibrillation pulses, as well as associated refractory periods. In response to the detection of atrial or ventricular fibrillation or tachyarrhythmia requiring a cardioversion pulse, microprocessor 51 activates cardioversion/defibrillation control circuitry 29, which initiates charging of the high voltage capacitors 33 and 35 via charging circuit 69, under the control of high voltage charging control line 71. The voltage on the high voltage capacitors is monitored via VCAP line 73, which is passed through multiplexer 55 and in response to reaching a predetermined value set by microprocessor 51, results in generation of a logic signal on Cap Full (CF) line 77 to terminate charging. Thereafter, timing of the delivery of the defibrillation or cardioversion pulse is controlled by pacer timing/control circuitry 63. Following delivery of the fibrillation or tachycardia therapy microprocessor 51 returns the device to a cardiac pacing mode and awaits the next successive interrupt due to pacing or the occurrence of a sensed atrial or ventricular depolarization.
Continuing to refer to FIG. 5, delivery of cardioversion or defibrillation pulses is accomplished by output circuit 27 under the control of control circuitry 29 via control bus 31. Output circuit 27 determines whether a monophasic or biphasic pulse is delivered, the polarity of the electrodes and which electrodes are involved in delivery of the pulse. Output circuit 27 also includes high voltage switches which control whether electrodes are coupled together during delivery of the pulse. Alternatively, electrodes intended to be coupled together during the pulse may simply be permanently coupled to one another, either exterior to or interior of the device housing, and polarity may similarly be pre-set, as in current implantable defibrillators. An example of output circuitry for delivery of biphasic pulse regimens to multiple electrode systems may be found in the above cited patent issued to Mehra and in U.S. Pat. No. 4,727,877, hereby incorporated by reference herein in its entirety.
As used in this specification and the appended claims, the term “ATP train” refers to a sequence of pulses delivered to the patient's atrium for the purpose of interrupting, or stopping a detected episode of atrial tachycardia. Techniques of detecting AT and delivering ATP trains are well known in the art, as discussed above.
The algorithm used to provide for AV synchrony following an ATP train can be understood with reference to the timing diagram of FIG. 6A, and the following definitions in the table below.
ATP interval (duration between y seconds
pulses of the train)
ATP traind total duration of an ATP train
(nominally n * y, where the
train has n intervals)
Pacing Interval the current ventricular cycle
Minimum pacing interval the minimum allowed cycle
length to obtain
Maximum pacing interval the maximum allowed cycle
AV_min the minimum allowed AV
AV_max the maximum allowed AV
V_ATPi the interval between the last
ventricular event and the atrial
tachy sense i
X round up [(V_ATPi + ATP
traind + AV_min)/Pacing
Interval], where any fractional
value is rounded up to the next
[0061]FIG. 6A illustrates a series of high rate atrial senses, with ventricular pace pulses being delivered at a certain pacing interval. In a conventional detection algorithm, AT is deemed to be sensed when a given number of senses occur at a rate above a tachy thershold and continue over a given duration of senses or time. As illustrated, AT is declared at Atrial Tachy Sense i, which occurs V_ATPi after the last ventricular pace pulse. In this situation if the temporary PI is maintained as the current PI, a ventricular pace pulse would be scheduled for delivery following the last pulse of the ATP train by more than AV_min but less than AV_max. Any ventricular pulse delivered within this timeframe would be properly synchronized, as seen in FIG. 6A. Thus, the first step of the sync algorithm is to determine if this condition is met: IF (X*pacing interval−V_ATPi ) is <=(ATP Traind+AV_max), then deliver the ATP train and set the temporary (adapted) pacing interval to Pacing Interval (the current PI). This will achieve re-synchronization since the next VP will fall between AV_min and AV_max after the end of the train. In this situation, then, the PI remains unchanged.
If the above condition is not met, then it must be determined whether the ATP train can be delivered along with an adapted pacing interval that will permit the desired synchronous pacing after the end of the ATP train. FIG. 6B illustrates a Short Pacing Interval, and FIG. 6C illustrates a Long Pacing Interval, as determined in accord with this invention. The logic is:
[0063]0190
Examples of selecting short and long Pacing Intervals are seen in FIGS. 6B and 6C respectively. If both short and long pacing intervals qualify, the one that places the temporary Pacing Interval closest to the initial Pacing Interval is chosen. If only the short Pacing Interval qualifies, it is selected. FIG. 6B illustrates a Short Pacing Interval, where the first ventricular pulse after the end of the train occurs just before the time corresponding to AV_max. In FIG. 6C, the Long Pacing Interval produces a ventricular pace pulse at an AV delay that follows the end of the train by just about AV_min. In both cases, the ventricular pacing Interval then returns to Pacing Interval, and synchronous pacing is continued (assuming a normal sinus rhythm).
[0065]FIG. 7 is a flow diagram showing the primary steps taken in carrying out the specific features of this invention. At block 301, the sinus rhythm is examined, by looking at successive intervals between sinus (atrial) beats. The sinus beats, or atrial senses, are determined in a well known manner. An example of an over-all flow diagram for event determination in a dual chamber pacemaker, including determining atrial senses, is presented at FIG. 4, U.S. Pat. No. 6,029, 087, assigned to the assignee of this invention and incorporated herein by reference. See also FIG. 2 of U.S. Pat. No. 6,128,532, also incorporated herein by reference in its entirety. As stated above, in a typical tachy detection scheme, senses are classified as tachy senses if the rate corresponding to the interval is above a predetermined threshold. If such tachy beats are sensed, at block 302 the pacemaker monitors to see if the tachy beats continue for a duration as to constitute AT. If so, AT is determined, and an atrial tachy sense i (as seen in FIGS. 6A-C) signal is sent to block 303. At block 303 the implanted device performs the above logic steps to determine if an ATP train can be delivered along with a Pacing Interval adapted to resynchronize after the train. If not, which is statistically not probable but will occur occasionally, the pacer waits, returning to block 302 where upon the next atrial beat an Atrial Tachy Sense i signal is generated and sent to decision block 303. Upon determining an available temporary Pacing Interval (the current PI, Short PI or Long PI), the Pacing Interval is adapted as shown at block 305. At 306, the ATP train is delivered while ventricular pacing is continued asynchronously. At the end of the ATP train, the pacer waits to deliver the next ventricular pulse, as shown at block 308. After such synchronous delivery, the ventricular pacing interval is restored to Pacing Interval. At 310, the pacer determines whether the atrial rhythm is a normal sinus rhythm or a tachycardia. If a normal sinus rhythm is detected, the pacer goes back to examining the sinus rhythm, as at block 301. However, if the AT has not been interrupted, the pacer returns to decision block 303, and prepares to deliver another ATP train along with an adapted Pacing Interval.
The logic steps that are carried out at decision block 303 are illustrated in the sub-routine of FIG. 8. At 401, it is determined whether the temporary Pacing Interval (TPI) can be maintained as the current Pacing Interval, by the comparison shown. If yes, at block 402 (part of block 305 in FIG. 7), TPI=PI and the device proceeds to block 306 (FIG. 7) to deliver the ATP train. But if no, then at block 410 the Short Pacing Interval (SPI) and Long Pacing Interval (LPI) are calculated. At 412, it is determined if SPI>=Minimum Pacing Interval AND LPI is<=Maximum Pacing Interval. If yes, at 414 it is determined whether (PI−SPI)<(LPI−PI). If no, TPI is set=LPI at block 416; if yes, then TPI is set=SPI at block 415. Following this, the routine goes to block 306 where the ATP train is delivered.
Returning to block 412, if the answer is NO, the routine goes to block 420 and determines if SPI>=Minimum PI. If YES, TPI is set=SPI at block 421. However, if NO then the routine goes to block 424 and determines if LPI<=Maximum PI. If yes, then TPI is set=LPI at block 425. But if NO, then the train cannot be delivered, and the routine returns to block 302 to wait for the next Atrial Tachy Sense i, after which the sub-routine of FIG. 8 is again entered.
The preferred embodiment of the invention as described meets the objects set forth above, namely to provide re-synchronization of ventricular pacing following delivery of an anti-tachy scheme of atrial pulses designed to interrupt the AT and return the atrium to a normal sinus rhythm. During the ATP sequence, any ventricular pulse that is delivered is an asynchronous pulse at a V-V interval determined by the algorithm. The first ventricular pulse after the end of the train or other ATP scheme follows the last ATP pulse by a delay within the range AV_min to AV_max, and thus is accurately synchronized. It is an important feature of this invention that ventricular pacing is maintained at a rate that meets the criteria that it can't be too slow or too fast. Re-synchronization as such could theoretically be achieved by the simple expedient of timing out a suitable AV delay following the last atrial pulse of the ATP train. However, depending on the timing of the ventricular pace pulses and the duration of the ATP train this would usually result in a V-V interval that was unacceptably short or long. The invention, as seen above, provides for asynchronous pacing at an acceptable rate as well as re-synchronization immediately after the end of the ATP train, thus optimizing conditions for stabilizing the atrium and preventing return of AT or another dangerous atrial arrhythmia. Following re-synchronization, and in the absence of continued AT, the pacing device resumes normal synchronous pacing.
The preceding specific embodiments are illustrative of the practice of the invention. It is to be understood, therefore, that other expedients known to those skilled in the art or disclosed herein, may be employed without departing from the invention or the scope of the appended claims. The present invention is not limited to any particular combination of hardware and software per se, but may find application with any form of software supplementing hardware. Of course, the calculation of a temporary pacing interval is most suitably done with a microprocessor. In the claims, means-plus-function clauses are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Thus, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface, in the environment of fastening wooden parts a nail and a screw are equivalent structures.
1. An implantable cardiac pacing device, comprising:
ventricular pacing means for pacing the patient's ventricle with pace pulses at an adaptable pacing interval;
AT means for determining AT and for determining the timing of the start of an AT episode;
train means for delivering an ATP train in fixed relation to said AT start;
algorithm means activated at said start of an AT episode for determining if ventricular pace pulses can be delivered following a said AT start with an adapted pacing interval whereby a synchronized ventricular pace pulse will be delivered synchronized to the last atrial pulse of a said AT train that has been delivered, said determining including determining said adapted pacing interval subject to predetermined pacing interval and AV criteria;
temporary means for temporarily changing the pacing interval to said adapted value when it is determined that a said adapted pacing interval can be determined; and
initiating means for initiating said train means to deliver a said ATP train upon a said pacing interval determination that a synchronized ventricular pace pulse can be delivered.
2. The device as described in claim 1, comprising rhythm means for determining whether AT remains present following delivery of a said ATP train and a said synchronized ventricular pulse.
3. The device as described in claim 1, comprising repeat means for repeating the operation of said algorithm means when AT is determined to be present following delivery of a said ATP train.
4. The device as described in claim 1, comprising storage means for storing criteria relating to maximum and minimum values of pacing interval and maximum and minimum values of AV delay.
5. The device as described in claim 1, comprising revert means operative after delivery of a synchronized pulse for changing said ventricular pacing interval back to the value it had prior to delivery of a said ATP train.
6. The device as described in claim 1, comprising wait means operative if said determining means determines that a said synchronized pace pulse cannot be delivered for activating said algorithm means after waiting for sensing of another atrial sinus beat.
7. The device as described in claim 1, wherein said temporary means controls said ventricular pacing means to deliver ventricular pace pulses asynchronously at said temporary pacing interval during said ATP train duration.
8. The device as described in claim 1, wherein said algorithm means comprises second storage means for storing the duration of said ATP train and means for determining the time interval from the last ventricular pace pulse before AT to the start of said ATP train.
9. The device as described in claim 8, comprising calculation means for calculating when said adapted interval can suitably be the same as the pacing interval before delivery of said ATP train.
10. The device as described in claim 8, wherein said calculation means calculates when said adapted interval can suitably be longer than the pacing interval before delivery of said ATP train.
11. An implantable cardiac pacing system, comprising:
ventricular pacing means for pacing the patient's ventricle with pace pulses delivered at an adaptable pacing interval;
AT means for determining the occurrence of AT and for determining a designated time of start of AT;
train means for delivering an ATP train of atrial pulses in fixed relation to said AT start; and
adapting means for adapting the pacing interval of said ventricular pacing means so that the next ventricular pace pulse delivered after the end of said AT train is re-synchronized to the last atrial pulse of said AT train.
12. The system as described in claim 11, wherein said train means comprises means for delivering a sequence of atrial pulses at a constant ATP interval and for delivering the first of said train pulses at said ATP interval following said AT start.
13. The system as described in claim 11, wherein said adapting means comprises storage means for storing AV_min and AV_max allowable values of AV delay and sync means for determining a ventricular pacing interval whereby ventricular pace pulses are delivered asynchronously during the duration of said ATP train and the re-synchronized ventricular pace pulse delivered after the conclusion of said ATP train is timed to follow the last atrial pulse of said train by an interval within the range of AV_min to AV_max.
14. The system as described in claim 13, wherein said adapting means comprises algorithm means for determining if the ventricular pacing interval prior to AT start can be maintained and provide for said re-synchronized pulse.
15. The system as described in claim 13, wherein said algorithm means comprises means for determining when the ventricular pacing interval can be set to a shorter value.
16. The system as described in claim 13, wherein said algorithm means comprises means for determining when the ventricular pacing interval can be set to a longer value.
17. The system as described in claim 11, wherein said adapting means comprises delay means for determining when a suitable pacing interval cannot be calculated at the time of AT start and for then delaying delivery of a said ATP train and calculation of a suitable adapted pacing interval by one atrial cycle.
18. The system as described in claim 11, wherein said train means comprises fixed sequence means for delivering a predetermined group of atrial pulses in a fixed sequence, and wherein said adapting means comprises train storage means for storing the duration of said fixed sequence of pulses.
19. The system as described in claim 11, comprising detection means operative following delivery of a said train for detecting if AT remains, and repeat means for repeating the operation of said train means and said adapting means if AT remains.
20. The system as described in claim 19, comprising reset means for resetting the ventricular pacing interval to its former value following delivery of said re-synchronizing pulse.
21. A method of dual chamber pacing, comprising:
determining the existence of atrial tachycardia (AT) and designating a start of said AT;
storing data concerning an ATP sequence of atrial pulses to be delivered to interrupt an AT;
determining a temporary pacing interval for asynchronously pacing the ventricle after start of AT, wherein said temporary pacing interval meets predetermined rate criteria and is calculated to provide for re-synchronization after the last atrial pulse of said ATP sequence;
delivering said ATP sequence in timed relation to said AT start;
delivering ventricular pace pulses at said temporary pacing interval through the duration of said sequence; and
delivering the next ventricular pulse following the end of said sequence at said temporary pacing interval, whereby said next ventricular pulse is synchronized to the last atrial pulse of said ATP sequence, thereby re-synchronizing ventricular pacing.
22. The method as described in claim 21, comprising storing the ventricular pacing interval just before AT start, and re-setting said ventricular pacing interval to said stored pacing interval after delivery of said next re-synchronizing pulse.
23. The method as described in claim 21, comprising delivering said sequence of atrial pulses at a constant interval and delivering the first of said sequence of pulses at said constant interval following said AT start.
24. The method as described in claim 21, comprising storing AV_min and AV_max allowable values of AV delay, and wherein said determining comprises determining that said next ventricular pulse is delivered within AV_min to AV_max after said last atrial pulse of said ATP sequence.
25. The method as described in claim 24, comprising storing values of minimum and maximum pacing intervals, and wherein said determining comprises determining that said temporary pacing interval is within the range of AV_min to AV_max.
26. The method as described in claim 21, comprising determining the current pacing interval just before AT start and determining when the temporary pacing interval can be set to a value shorter than said current pacing interval.
27. The method as described in claim 21, comprising determining the current pacing interval just before AT start and determining when the temporary pacing interval can be set to a value equal to said current pacing interval.
28. The method as described in claim 21, comprising determining the current pacing interval just before AT start and determining when the temporary pacing interval can be set to a value longer than said current pacing interval.
29. The method as described in claim 21, comprising determining when a temporary pacing interval cannot be calculated that meets predetermined criteria, delaying delivery of said ATP sequence, and sensing the next atrial beat.
30. The method as described in claim 21, comprising detecting if AT remains after delivering a said ATP sequence, and repeating said determining step after sensing said next atrial beat.
31. A pacing system for detecting and treating atrial tachycardia in a patient and re-synchronizing ventricular pacing of the patient directly after the tachycardia treatment, comprising:
AT means for delivering an ATP train of a fixed sequence of pulses to the patient's atrium; and
temporary means for delivering asynchronous ventricular pacing pulses at a temporary pacing interval to the patient's ventricle during said ATP train and for the next ventricular pacing pulse after the last pulse of said sequence, whereby said next ventricular pacing pulse is synchronously timed with respect to said last sequence pulse.
32. The system as described in claim 31, wherein said temporary means comprises calculating means for calculating said temporary pacing interval.
33. The system as described in claim 32, wherein said temporary means comprises storage means for storing a range of acceptable AV delay values and said calculating means comprises means for calculating said temporary pacing interval so that said next ventricular pacing pulse is delivered at a delay following said last pulse, where said delay is within said range.
34. The system as described in claim 33, wherein said temporary means comprises limit means for limiting said temporary pacing interval to a value within a predetermined range of pacing intervals.
35. The system as described in claim 32, comprising storage means for storing PI criteria, and delay means for delaying the operation of said AT means and said temporary means until said calculating means can calculate a temporary pacing interval that meets said stored PI criteria.
36. The system as described in claim 32, wherein said delay means initiates operation of said calculating means after one additional atrial beat is sensed.
37. The system as described in claim 32, wherein said calculating means comprises selection means for selecting a pacing interval from among intervals that are longer and shorter than the pacing interval at time of detecting atrial tachycardia.
38. A method of optimising synchronous pacing of a patient following an episode of atrial tachycardia, comprising:
detecting atrial tachycardia and preparing delivery of an ATP sequence to the patient's atrium;
calculating a temporary pacing interval for asynchronous pacing of the patient's ventricle while said ATP sequence is delivered and which will enable delivery of a next ventricular pace pulse after the end of said sequence that is synchronously timed in relation to the end of the ATP sequence; and
delivering said ATP sequence and asynchronously pacing the ventricle at said temporary pacing interval through and including delivery of a synchronous pace pulse to the ventricle after the end of said sequence.
39. The method as described in claim 38, comprising storing a current pacing interval before detection of atrial tachycardia and resuming synchronous pacing with said current pacing interval after delivery of said one pace pulse.
40. The method as described in claim 38, wherein said calculating comprises calculating a pacing interval that is between a predetermined minimum value and a predetermined maximum value.
41. The method as described in claim 40, wherein said calculating comprises determining that said synchronous pace pulse is delivered within a predetermined AV range following the end of said ATP sequence.
42. The method as described in claim 41, comprising storing values of AV_max and AV_min and delivering said synchronous pace pulse at an AV delay after the end of said ATP sequence that is no less than AV_min and no more than AV_max.
43. The method as described in claim 38 comprising defining the start of atrial tachycardia, and delivering said ATP sequence and said asynchronous pulses in timed relation to said start.
44. The method as described in claim 43, comprising determining if a suitable temporary pacing interval can be used, and if not waiting for a next atrial beat and then calculating said temporary pacing interval.
45. A system of cardiac pacing of a patient, comprising:
AT means for detecting the presence of AT;
ATP means for delivering an ATP sequence of atrial pulses to the patient's atrium in response to detected AT;
ventricular pacing means for pacing the patient's ventricle;
rate criteria means for limiting the rate of ventricular pacing; and
control means for controlling said ventricular pacing means to deliver ventricular pace pulses during said ATP sequence and for a next ventricular pace pulse after the end of said sequence at a rate that meets said rate criteria and provides that said next ventricular pace pulse is in cardiac synchrony with the last atrial pulse of said sequence.
46. The system as described in claim 45, wherein said control means comprises AV means for storing a range of acceptable AV delay values and calculating means for calculating a temporary pacing interval that meets said rate criteria and also provides that said next ventricular pace pulse is delivered following said last atrial pace pulse by an AV interval that is within said range.
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US10435071 US7162300B2 (en) 2003-01-13 2003-05-12 Synchronized atrial anti-tachy pacing system and method
DE200460019713 DE602004019713D1 (en) 2003-01-13 2004-01-12 Apparatus and method for synchronized antitachycardia stimulation
PCT/US2004/000652 WO2004062726A8 (en) 2003-01-13 2004-01-12 Synchronized atrial anti-tachy pacing system and method
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EP20040701517 EP1850908B1 (en) 2003-01-13 2004-01-12 Synchronized atrial anti-tachy pacing system and method
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US10435071 Active 2024-12-03 US7162300B2 (en) 2003-01-13 2003-05-12 Synchronized atrial anti-tachy pacing system and method
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