Patent Application
20250108221
Embodiments described herein generally relate dual chamber leadless pacemaker (LP) systems and methods for use therewith.
Conventional pacemakers typically include a housing (aka “can”), which houses a controller (e.g., processor), and one or more intravascular leads that extend from the housing. Each of the leads includes one or more electrodes that can be used for sensing cardiac electrical activity and for delivering pacing stimulation. Such conventional pacemakers can support single-chamber operating modes (e.g., VVI, AAI) and coordinated dual chamber operating modes (e.g., DDD, VDD, DDI, VDI, or DOO), depending upon how many leads are used and how the conventional pacemakers are programmed. It is noted that when such a pacemaker is supporting an operating mode, it can equivalently be said that the pacemaker is providing a type of operation. For example, saying a pacemaker is supporting a VVI operating mode is the same as saying the pacemaker is providing the VVI operation. It is also noted that the terms operating mode and pacing mode are often used interchangeably. For example, saying a pacemaker is operating in a VVI pacing mode is the same as saying the pacemaker is providing the VVI operation, or saying the pacemaker is supporting VVI operation.
Over the past few years, physicians have started implanting leadless pacemakers (LPs) in place of conventional pacemakers because LPs eliminate the need for implanting leads. This is beneficial because leads may fail and/or migrate more often than desired. Initially an LP was only implanted in a single cardiac chamber, e.g., the right ventricular (RV) chamber, and was only capable of being used to support single-chamber operating modes (e.g., VVI).
There is now a desire to start implanting LPs in two cardiac chambers, e.g., in the RV chamber and in the right atrial (RA) chamber, to provide for a dual chamber LP system that is capable of supporting coordinated dual chamber operating modes (e.g., DDD, VDD, DDI, VDI, or DOO). An LP that is implanted in (or on), or configured to be implanted in (or on), the RV chamber may be referred to herein as a ventricular LP, or a vLP. An LP that is implanted in (or on), or configured to be implanted in (or on), the RA chamber may be referred to herein as an atrial LP, or an aLP.
In order for a dual chamber LP pacing system to provide for coordinated dual chamber operation, e.g., of the RV chamber and the RA chamber, the aLP and the vLP may coordinate their activities via beat-to-beat implant-to-implant (i2i) communication, directly with one another, or via a third implantable medical device (IMD) that acts as a communication hub for the LPs. Such beat-to-beat i2i communication between the aLP and the vLP can be achieved using conductive communication, where the same electrodes that an LP uses for delivering pacing pulses are also used for transmitting i2i communication pulses to another LP, as well for receiving i2i communication pulses from the other LP. Such beat-to-beat i2i communication between the aLP and the vLP can alternatively be achieved using another type of communication besides conductive communication, such as radio frequency (RF) communication or inductive communication. Regardless of the type of i2i communication that is used, beat-to-beat i2i communication (i.e., i2i communication that occurs each and every cardiac cycle) consumes a substantial amount of power, and thus, reduces the longevity of the aLP and the vLP by depleting their respective power sources (e.g., batteries) thereof faster than would occur if i2i communication were not used at all, or were used less frequently than every beat. For example, where conductive i2i communication is used on a beat-by-beat basis, the overall longevity of an LP may be significantly reduced compared to if no conductive i2i communication were used by the LP.
Certain embodiments of the present technology relate to a method for use with a dual chamber leadless pacemaker (LP) system including an atrial leadless pacemaker (aLP) and a ventricular leadless pacemaker (vLP). The method comprises the aLP providing AAI operation, during which the aLP performs atrial pacing when an intrinsic atrial event is not detected within a specified AA interval following a previous paced or intrinsic atrial event, performs atrial sensing, and inhibits the atrial pacing when the intrinsic atrial event is detected within the specified AA interval following the previous paced or intrinsic atrial event. The method also comprises the vLP providing VVI operation, during which the vLP performs ventricular pacing when an intrinsic ventricular event is not detected within a specified VV interval following a previous paced or intrinsic ventricular event, performs ventricular sensing, and inhibits the ventricular pacing when the intrinsic ventricular event is detected within the specified VV interval following the previous paced or intrinsic ventricular event. In this method, the aLP providing the AAI operation, and the vLP providing the VVI operation, occurs during a same first period of time and independent of one another. During this first period of time the aLP and the vLP of the dual chamber LP system collectively provide what is referred to herein as AAI+VVI operation.
In accordance with certain embodiments, each LP, of the aLP and the vLP, includes a respective transmitter that enables the LP to transmit i2i messages (to the other LP, or to a third IMD that acts as a communication hub for the LPs), includes a respective receiver that enables the LP to receive i2i messages (from the other LP, or from the third IMD that acts as a communication hub for the LPs), and includes a respective power source (e.g., battery) used to power the transmitter and the receiver of the LP. In certain such embodiments, the method further comprises, during the same first period of time that the aLP provides the AAI operation and the vLP provides the VVI operation independent of one another, the aLP abstaining from transmitting any i2i messages that are intended to be used to coordinate operation of the vLP with the aLP, and the vLP abstaining from transmitting any i2i messages that are intended to be used to coordinate operation of the aLP with the vLP. This conserves power and thereby increases the longevity of the LPs.
In accordance with certain embodiments, the specified AA interval is shorter than the specified VV interval to cause an atrial rate of the atrial pacing performed by the aLP to be faster than a ventricular rate of the ventricular pacing performed by the vLP.
In accordance with certain embodiments, the aLP includes a sensor that enables the aLP to monitor an activity level of a patient within which the aLP and the vLP are implanted. In certain such embodiments, while the aLP is providing the AAI operation and the vLP is providing the VVI operation, the aLP adjusts an atrial rate of the atrial pacing performed by the aLP by adjusting the specified AA interval based on the activity level of the patient as detected using the sensor of the aLP, and the vLP does not adjust a ventricular rate of the ventricular pacing performed by the vLP, wherein such an embodiment can be referred to more specifically as AAIR+VVI operation. In other embodiments, while the aLP is providing the AAI operation and the vLP is providing the VVI operation, the aLP adjusts an atrial rate of the atrial pacing performed by the aLP by adjusting the specified AA interval based on the activity level of the patient as detected using the sensor of the aLP, and the vLP adjusts a ventricular rate of the ventricular pacing performed by the vLP by adjusting the VV interval based on the activity level of the patient as detecting using the sensor of the vLP, wherein such an embodiment can be referred to more specifically as AAIR+VVIR operation. In such embodiments, the vLP also includes a sensor that enables the vLP to monitor the activity level of the patient.
In accordance with certain embodiments, each LP, of the aLP and the vLP, includes a respective sense amplifier, wherein the sense amplifier of the aLP is configured to sense an atrial electrogram (aEGM) used to detect intrinsic atrial events, and the sense amplifier of the vLP is configured to sense a ventricular electrogram (vEGM) used to detect intrinsic ventricular events. In certain such embodiments, while the aLP is providing the AAI operation and the vLP is providing the VVI operation, the method further comprises the aLP monitoring for possible crosstalk that may be caused by the vLP performing the ventricular pacing and initiating providing crosstalk protection for a first crosstalk protection period, in response to the aLP detecting possible crosstalk that may be caused by the vLP performing the ventricular pacing. Additionally, or alternatively, the method can include the vLP monitoring for possible crosstalk that may be caused by the aLP performing the atrial pacing and the vLP initiating providing crosstalk protection for a second crosstalk protection period, in response to the vLP detecting possible crosstalk that may be caused by the aLP performing the atrial pacing. The second crosstalk protection period may have a same duration as, or a different duration than, the first crosstalk protection period, depending upon the implementation.
In accordance with certain embodiments, the method further comprises the vLP determining whether or not a first specified criterion is satisfied, and the vLP, during a first period of time when the first specified criterion is not satisfied, abstaining from using the transmitter of the vLP to transmit any i2i messages that are intended to be used to coordinate operation of the aLP with the vLP. While the vLP abstains from using its transmitter to transmit any i2i messages that are intended to be used to coordinate operation of the aLP with the vLP, the vLP may also disable or at least partially disable its receiver to further conserver power. The method also comprises the vLP, during a second period of time that begins in response to the first specified criterion being satisfied, using the transmitter of the vLP to transmit a mode switch type of i2i message to the aLP, which if successfully received by and acknowledged by the aLP, causes aLP and the vLP to transition (from respectively providing the AAI operation and the VVI operation) to collectively providing coordinated dual chamber operation (which can be any one of DDD, VDD, DDI, VDI, and DOO operation), during which i2i messages are transmitted by the aLP and the vLP (to support the coordinated dual chamber operation). In specific embodiments, the coordinated dual chamber operation is DDD operation, during which the aLP and the vLP transmit i2i messages (e.g., on a beat-to-beat basis) to enable coordinated dual chamber pacing, and during which the vLP performs ventricular pacing when an intrinsic ventricular event is not detected within a specified atrioventricular (AV) delay following a previous paced or intrinsic atrial event, performs ventricular sensing, and inhibits the ventricular pacing when the intrinsic ventricular event is detected within the specified AV delay following the previous paced or intrinsic atrial event. In accordance with other embodiments, the coordinated dual chamber operation comprises one of VDD, DDI, VDI, or DOO operation.
In accordance with certain embodiments, the method includes the aLP normally disabling at least a portion of the respective receiver of the aLP that enables the aLP to receive one or more i2i messages to thereby conserve power of the power source (e.g., battery) of the aLP compared to if the at least the portion of the respective receiver of the aLP was enabled. In certain such embodiments, the method further comprises the aLP from time to time temporarily enabling at least the portion of the receiver of the aLP that enables the aLP to receive one or more i2i messages from the vLP (or from a third IMD that acts as a communication hub for the LPs), to thereby enable the aLP to monitor for the mode switch type of i2i message. The method also includes the aLP receiving the mode switch type of i2i message from the vLP (or a third IMD that acts as a communication hub for the LPs) and in response thereto transmitting a mode switch acknowledgement message and collectively providing with the vLP the coordinated dual chamber operation during which i2i messages transmitted by the aLP and the vLP (to support the coordinated dual chamber operation).
In certain such embodiments, the method further comprises the aLP abstaining from using its transmitter to transmit any i2i messages that are intended to be used to coordinate operation of the vLP with the aLP until the aLP receives a mode switch type of i2i message.
In accordance with certain embodiments, the first specified criterion, which the vLP determines whether or not is satisfied, comprises the vLP having provided at least a first specified threshold amount of ventricular pacing within a first specified duration. The first specified threshold amount can be a first specified number, or a first specified percentage, but is not limited thereto. It is also possible that the first specified criterion, which the vLP determines whether or not is satisfied, comprises the vLP having delivered ventricular pacing during at least X of the Y most recent cardiac cycles, wherein X and Y are predetermined values and X<Y. Other variations are also possible and within the scope of the embodiments described herein.
In accordance with certain embodiments, the method further comprises, after the vLP has mode switched from providing the VVI operation to collectively providing with the aLP the coordinated dual chamber operation during which i2i messages transmitted by the aLP and the vLP (to support the coordinated dual chamber operation), the vLP determining whether or not a second specified criterion is satisfied. In certain such embodiments, the vLP, during a third period of time that begins in response to the second specified criterion being satisfied, using the transmitter of the vLP to transmit a further mode switch type of i2i message, which if successfully received by and acknowledged by the aLP causes the aLP to mode switch from collectively providing with the vLP the coordinated dual chamber operation to the aLP again providing the AAI operation independent of the vLP, and causes the vLP to mode switch from collectively providing with the aLP the coordinated dual chamber operation to the vLP again providing the VVI operation independent of the aLP. In other words, the second specified criterion when satisfied causes a transition from the coordinated dual chamber operation back to the AAI+VVI operation.
In accordance with certain embodiments, the second specified criterion, which the vLP determines whether or not is satisfied, comprises the vLP having provided less than a second specified threshold amount of ventricular pacing within a second specified duration. The second specified threshold amount can be a second specified number, or a second specified percentage, but is not limited thereto. It is also possible that the second specified criterion, which the vLP determines whether or not is satisfied, comprises the vLP having delivered ventricular pacing during less than A of the B most recent cardiac cycles, wherein A and B are predetermined values and A<B. Other variations are also possible and within the scope of the embodiments described herein.
In accordance with certain embodiments of the present technology, while the aLP is providing the AAI operation and the vLP is providing the VVI operation, independent of one another, the aLP monitors for a third specified criterion that when detected by the aLP causes the aLP to send an i2i message to the vLP (or to a third IMD that acts as a communication hub for the LPs), which i2i message instructs the vLP to change (e.g., increase) its base pacing rate, or equivalently instructs the vLP to change (e.g., shorten) its base VV interval. In order for the vLP to be able to receive such an i2i message, the vLP should temporarily enable its receiver from time to time. The aLP can repeatedly send such a message until the aLP receives an ACK message that the vLP received the message. Thereafter, the aLP may monitor for a fourth criterion, e.g., that the atrial rate has fallen below the specified threshold or some further specified threshold. In response to the aLP detecting the fourth criterion, the aLP sends an i2i message to the vLP (or to a third IMD that acts as a communication hub for the LPs), which i2i message instructs the vLP to change (e.g., reduce) its base pacing rate, or equivalently instructs the vLP to change (e.g., increase) its base VV interval. The aLP can repeatedly send such an i2i message until the aLP receives an ACK message that the vLP received the message.
Certain embodiments of the present technology relate to a dual chamber LP system, comprising an atrial leadless pacemaker (aLP) and a ventricular leadless pacemaker (vLP). The aLP is configured to be implanted in or on an atrial cardiac chamber of a patient's heart. The vLP is configured to be implanted in or on a ventricular cardiac chamber of the patient's heart. The aLP is configured to provide AAI operation, and the vLP is configured to provide VVI operation, during a same period of time and independent of one another. While the aLP provides the AAI operation, the aLP performs atrial pacing when an intrinsic atrial event is not detected within a specified AA interval following a previous paced or intrinsic atrial event, performs atrial sensing, and inhibits the atrial pacing when the intrinsic atrial event is detected within the specified AA interval following the previous paced or intrinsic atrial event. While the vLP provides the VVI operation, the vLP performs ventricular pacing when an intrinsic ventricular event is not detected within a specified VV interval following a previous paced or intrinsic ventricular event, performs ventricular sensing, and inhibits the ventricular pacing when the intrinsic ventricular event is detected within the specified VV interval following the previous paced or intrinsic ventricular event.
In accordance with certain embodiments, each LP, of the aLP and the vLP, includes a respective transmitter that enables the LP to transmit i2i messages, includes a respective receiver that enables the LP to receive i2i messages, and includes a respective power source (e.g., battery) used to power the transmitter and the receiver of the LP. In certain such embodiments, during the same first period of time that the aLP provides the AAI operation and the vLP provides the VVI operation independent of one another, the aLP is configured to abstain from transmitting any i2i messages that are intended to be used to coordinate operation of the vLP with the aLP, and the vLP is configured to abstain from transmitting any i2i messages to that are intended to be used to coordinate operation of the aLP with the vLP.
In accordance with certain embodiments, the specified AA interval is shorter than the specified VV interval to cause an atrial rate of the atrial pacing performed by the aLP to be faster than a ventricular rate of the ventricular pacing performed by the vLP.
In accordance with certain embodiments, the aLP includes a sensor that enables the aLP to monitor an activity level of a patient within which the aLP and the vLP are implanted. Further, each LP, of the aLP and the vLP, includes a respective controller. In certain such embodiments, the controller of the aLP is configured to adjust an atrial rate of the atrial pacing performed by the aLP by adjusting the specified AA interval based on the activity level of the patient as detected using the sensor of the aLP while the aLP is providing the AAI operation. Additionally, the controller of the vLP is configured to not adjust a ventricular rate of the ventricular pacing performed by the vLP while the vLP is providing the VVI operation. In other embodiments, the controller of the aLP is configured to adjust an atrial rate of the atrial pacing performed by the aLP by adjusting the specified AA interval based on the activity level of the patient as detected using the sensor of the aLP while the aLP is providing the AAI operation, and the controller of the vLP is configured to adjust a ventricular rate of the ventricular pacing performed by the vLP by adjusting the VV interval based on the activity level of the patient as detected using the sensor of the vLP while the vLP is providing the VVI pacing, wherein such an embodiment can be referred to more specifically as AAIR+VVIR operation. In such embodiments, the vLP includes a sensor that enables the vLP to monitor the activity level of the patient.
In accordance with certain embodiments, the aLP includes a sense amplifier configured to sense an atrial electrogram (aEGM) used by the aLP to detect intrinsic atrial events, and the vLP includes a sense amplifier configured to sense a ventricular electrogram (vEGM) used by the vLP to detect intrinsic ventricular events. Additionally, the aLP includes a controller that is communicatively coupled to the sense amplifier of the aLP, and the vLP includes a controller that is communicatively coupled to the sense amplifier of the vLP. In certain such embodiments, the controller of the vLP is configured to monitor for possible crosstalk that may be caused by the aLP performing the atrial pacing, while the vLP is providing the VVI operation, and initiate providing crosstalk protection for a first crosstalk protection period, in response to the controller of the vLP detecting possible crosstalk that may be caused by the aLP performing the atrial pacing. Additionally, or alternatively, the controller of the aLP is configured to monitor for possible crosstalk that may be caused by the vLP performing the ventricular pacing, while the aLP is providing the AAI operation, and initiate providing crosstalk protection for a second crosstalk protection period, in response to the controller of the aLP detecting possible crosstalk that may be caused by the vLP performing the ventricular pacing.
In accordance with certain embodiments, each LP, of the aLP and the vLP, includes a respective transmitter that enables the LP to transmit i2i messages to the other LP, includes a respective receiver that enables the LP to receive i2i messages from the other LP, and includes a respective battery used to power the transmitter and the receiver of the LP. Additionally, the aLP includes a controller that is communicatively coupled to the transmitter and the receiver thereof and is powered by the battery thereof, and the vLP includes a controller that is communicatively coupled to the transmitter and the receiver thereof and is powered by the battery thereof. In certain such embodiments, the controller of the vLP is configured to determine whether or not a first specified criterion is satisfied, abstain from using the transmitter of the vLP to transmit any i2i messages that are intended to be used to coordinate operation of the aLP with the vLP during a first period of time when the first specified criterion is not satisfied, and cause the transmitter of the vLP to transmit a mode switch type of i2i message in response to the first specified criterion being satisfied. The mode switch type of i2i message, if successfully received by and acknowledged by the aLP, causes the aLP and the vLP to transition (from respectively providing the AAI operation and the VVI operation, independent of one another) to collectively providing coordinated dual chamber operation during a second period of time, during which i2i messages are transmitted by the aLP and the vLP (to support the coordinated dual chamber operation). In certain embodiments, collectively providing coordinated dual chamber operation, during which i2i messages are transmitted by the aLP and the vLP, comprises collectively providing DDD operation. In other words, in specific embodiments the coordinated dual chamber operation is DDD operation. The aLP and the vLP collectively providing coordinated dual chamber operation, during which i2i messages are transmitted by the aLP and the vLP (to support the coordinated dual chamber operation), can alternatively comprise collectively providing VDD, DDI, VDI, or DOO operation.
In accordance with certain embodiments, the controller of the aLP is configured to normally disable at least a portion of the receiver of the aLP that enables the aLP to receive one or more i2i messages to thereby conserve power of the power source (e.g., battery) of the aLP compared to if the at least the portion of the receiver of the aLP were enabled. Additionally, the controller of the aLP is configured to from time to time temporarily enable the at least the portion of the receiver of the aLP, that enables the aLP to receive one or more i2i messages, to thereby enable the aLP to monitor for the mode switch type of i2i message that causes the aLP to mode switch from providing the AAI operation to collectively providing with the vLP the coordinated dual chamber operation, during which i2i messages are transmitted by the aLP and the vLP (to support the coordinated dual chamber operation). The controller of the aLP is also configured to cause the aLP to mode switch from providing the AAI operation to collectively providing with the vLP the coordinated dual chamber operation, in response to the aLP receiving and acknowledging the mode switch type of i2i message. In certain such embodiments, the controller of the aLP causes the aLP to abstain from using its transmitter to transmit any i2i messages that are intended to be used to coordinate operation of the vLP with the aLP until the aLP receives a mode switch type of i2i message from the vLP.
In accordance with certain embodiments, the first specified criterion, which the controller of the vLP is configured to determine whether or not is satisfied, comprises the vLP having provided at least a first specified threshold amount of ventricular pacing within a first specified duration.
In accordance with certain embodiments, the controller of the vLP is configured to determine whether or not a second specified criterion is satisfied, after the vLP has mode switched from providing the VVI operation to collectively providing with the aLP the coordinated dual chamber operation. The controller of the vLP is also configured to, during a third period of time that begins in response to the second specified criterion being satisfied, use the transmitter of the vLP to transmit a further mode switch type of i2i message to the aLP, which if successfully received by and acknowledged by the aLP causes the aLP to mode switch from collectively providing with the vLP the coordinated dual chamber operation to the aLP again providing the AAI operation independent of the vLP, and causes the vLP to mode switch from collectively providing with the aLP the coordinated dual chamber operation to the vLP again providing the VVI operation independent of the aLP. In other words, the second specified criterion when satisfied causes a transition from the coordinated dual chamber operation back to the AAI+VVI operation.
In accordance with certain embodiments, the second specified criterion, which the controller of the vLP is configured to determine whether or not is satisfied, comprises the vLP having provided less than a second specified threshold amount of ventricular pacing within a second specified duration.
Certain embodiments of the present technology relate to a method for use with a dual chamber leadless pacemaker (LP) system including an atrial leadless pacemaker (aLP) and a ventricular leadless pacemaker (vLP). The method comprises, during a same first period of time, during which the aLP and the vLP abstain from communicating with one another, the aLP providing AAI operation and the vLP providing VVI operation independent of one another. The method also comprises, during a second period of time, that begins in response to a first specified criterion being satisfied, the vLP and the aLP communicating with one another and mode switching, from the aLP providing AAI operation and the vLP providing VVI operation independent of one another, to the aLP and the vLP collectively providing one of DDD, VDD, DDI, VDI, or DOO operation.
In accordance with certain embodiments, the method further comprises, during a third period of time that begins in response to a second specified criterion being satisfied, the aLP and the vLP mode switching back from collectively providing the one of DDD, VDD, DDI, VDI, or DOO operation, to the vLP again providing the VVI operation and vLP again providing the VVI operation independent of one another.
In accordance with certain embodiments, the first specified criterion is satisfied when the vLP provides at least a first specified threshold amount of ventricular pacing within a first specified duration, and the second specified criterion is satisfied when the vLP provided less than a second specified threshold amount of ventricular pacing within a second specified duration.
This summary is not intended to be a complete description of the embodiments of the present technology. Other features and advantages of the embodiments of the present technology will appear from the following description in which the preferred embodiments have been set forth in detail, in conjunction with the accompanying drawings and claims.
Embodiments of the present technology relating to both structure and method of operation may best be understood by referring to the following description and accompanying drawings, in which similar reference characters denote similar elements throughout the several views:
As noted above, in order for a dual chamber LP pacing system to provide for coordinated (aka synchronized) dual chamber operation, an aLP and a vLP may coordinate their activities via beat-to-beat i2i communication. However, such beat-to-beat i2i communication (i.e., i2i communication that occurs each and every cardiac cycle) consumes a substantial amount of power, and thus, reduces the longevity of the aLP and the vLP by depleting their respective power supplies (e.g., batteries) thereof faster than would occur if i2i communication were not used at all, or if i2i communication were used less frequently than every beat.
In a dual chamber LP system configured to collectively provide DDD operation, a potential disadvantage of relying on beat-to-beat i2i communications to coordinate pacing of the RA and RV chambers is that such a system may be designed to withhold atrial pacing when i2i communication from the vLP to the aLP is unsuccessful (for a single beat, or across multiple consecutive cardiac cycles), which has the effect of causing the dual chamber LP system to collectively provide VDD operation, rather than collectively providing the programmed DDD operation. This behavior (of collectively providing VDD operation when the programmed DDD operation is not possible) is a design mitigator to prevent the two LPs from potentially causing symptomatic harm to a patient by pacing in a desynchronized (aka uncoordinated) rhythm. While withholding atrial pacing may be acceptable for some patients, there are other patients for which reliable atrial-based pacing is important, and sometimes imperative. For example, for patients that have sinus node dysfunction (SND), atrial-based pacing is the primary therapeutic support needed. Furthermore, most patients with SND have an intact and fully functional atrioventricular (AV) node, so they are able to natively maintain AV synchrony via normal AV conduction followed by intrinsic ventricular activation, with minimal-to-no need for ventricular pacing support.
Certain embodiments of the present technology relate to a new operating mode for a dual chamber LP system, which new operating mode can be referred to herein as an AAI+VVI (AAI “plus” VVI) operating mode, or more succinctly as AAI+VVI mode or AAI+VVI operation, or even more succinctly as AAI+VVI. The primary use case for utilizing this new AAI+VVI mode is with patients having SND who generally have intact AV node conduction, with potentially a rare-to-occasional need for intermittent ventricular pacing support, e.g., due to transient AV block, but not limited thereto. In this context, when a dual chamber LP system is utilizing the new AAI+VVI operating mode, the primary role of the vLP is to provide backup ventricular safety pacing support, which optimally minimizes ventricular pacing to be only when needed by the patient and when pacemaker-mediated atrioventricular (AV) synchrony is not a clinical necessity. That is, the vLP is generally used to provide backup ventricular safety pacing support when the new the AAI+VVI operating mode is being provided.
In accordance with certain embodiments of the present technology, the AAI+VVI operation is achieved by operating the aLP in AAI mode, and operating the vLP in VVI mode, without requiring that the aLP and the vLP perform beat-to-beat i2i communication (i.e., without requiring that the aLP and the vLP attempt to communicate with one another every cardiac cycle). In other words, the AAI+VVI operating mode is achieved by the aLP providing AAI operation and the vLP providing VVI operation during a same period of time.
When the aLP provides the AAI operation (aka, when the aLP provides AAI mode pacing), the aLP performs atrial pacing in response to an intrinsic atrial event not being detected within a specified AA interval following a previous (e.g., an immediately preceding) paced or intrinsic atrial event, performs atrial sensing (to sense for an intrinsic atrial event prior to the end of the specified AA interval), and inhibits the atrial pacing in response to the intrinsic atrial event being detected within the specified AA interval following the previous paced or intrinsic atrial event.
When the vLP provides the VVI operation (aka, when the vLP provides VVI mode pacing), the vLP performs ventricular pacing in response to an intrinsic ventricular event not being detected within a specified VV interval following a previous (e.g., an immediately preceding) paced or intrinsic ventricular event, performs ventricular sensing (to sense for an intrinsic ventricular event prior to the end of the specified VV interval), and inhibits the ventricular pacing in response to the intrinsic ventricular event being detected within the specified VV interval following the previous paced or intrinsic ventricular event.
In accordance with certain embodiments, the programmable pacing rate for the aLP is restricted to always being greater than the programmable pacing rate for the aLP. This constraint ensures that the aLP is driving overall cardiac electromechanical functionality, and therein mitigates against vLP rate superseding aLP rate, which can result in undesirable retrograde AV node conduction. This constraint is achieved, in accordance with certain embodiments, by programming the AA interval (that is used by the aLP) to be shorter than the VV interval (that is used by the vLP), which has the effect of causing an atrial rate of the atrial pacing performed by the aLP to be faster than a ventricular rate of the ventricular pacing performed by the vLP. In certain such embodiments, the aLP provides for rate responsive pacing, i.e., the AAI operation is provided by AAIR operation, while the vLP provides for non-rate responsive VVI pacing. More specifically, in certain embodiments the ability to utilize an activity (e.g., temperature or motion) sensor for modulating pacing rate is restricted to the aLP, e.g., by enabling rate responsive pacing by the aLP, and not made available to the vLP, e.g., by disabling rate responsive pacing by the vLP. This constraint is consistent with the intended use case, where atrial-based pacing is the primary need and the ventricular function tracks intrinsically via intact AV node conduction, with ventricular pacing only intended for backup safety support when needed. In still other embodiments, each of the aLP and the vLP provides for rate responsive pacing, i.e., the aLP provides AAIR operation and the vLP provides VVIR operation.
When referring to various types of operating schemes (aka pacing modes or operations) herein, three letters are typically used to refer to the type of operation. In other words, a three position pacemaker code is often used, with the following nomenclature followed: the first position refers to the cardiac chamber paced; the second position refers to the cardiac chamber sensed; and the third position refers to the response to a sensed event. In the first and second positions, the letter O means none, the letter A means Atrium, the letter V means Ventricle, and the letter D means Dual (i.e., A and V). In the third position the letter O means none, the letter I means Inhibited, the letter T means Triggered (aka Tracked), and the letter D means Dual (i.e., T+I). The below Table 1 summarizes this pacemaker nomenclature. Where an R is included in a fourth position, that means the pacing that is provided is rate responsive.
DDD and DDDR operation, as is known in the art, provides for synchronized dual chamber pacing. More specifically, DDD operation provides for atrial and ventricular pacing, atrial and ventricular sensing, and the ability to both inhibit or trigger pacing following a sensed event. DDDR operation is DDD operation that is rate responsive, i.e., the pacing rate is adjusted based on the patient's activity level, e.g., as detected using a motion sensor and/or a temperature sensor. The term DDD operation, as used herein, also encompasses DDDR operation, unless stated otherwise. Similarly, the term AAI operation, as used herein, also encompasses AAIR operation, unless stated otherwise; and the term VVI operation, as used herein, also encompasses VVIR pacing mode, unless stated otherwise.
While neither the aLP nor the vLP can individually perform DDD operation, the aLP and the vLP can be configured to collectively provide for DDD operation (including DDDR operation) when there is successful beat-to-beat bidirectional i2i communication, i.e., when the vLP successfully receives i2i messages from the aLP, and the aLP successfully receives i2i messages from the vLP. In certain embodiments, when the aLP and the vLP collectively provide for DDD operation, they communication with one another each cardiac cycle, i.e., on a beat-to-beat basis.
However, for various different reasons, there may be periods of time during which bidirectional i2i communication fails, because the vLP fails to successfully receive one or more atrial-to-ventricular (a2v) i2i messages from the aLP, and/or the aLP fails to successfully receive one or more ventricular-to-atrial (v2a) i2i messages from the vLP. Such failures in i2i communication may occur, e.g., due to noise, the relative orientations of the aLP and vLP, and/or the distances between the aLP and the vLP, but not limited thereto.
A dual chamber LP system may have safeguards in place to reduce asynchronous pacing in the event of loss of i2i communication in one or both directions, as outlined in the Table 2 below.
As can be appreciated from Table 2 above, in a dual chamber LP system including an aLP and vLP that are configured to collectively provide DDD operation, if v2a communication is lost (i.e., one or more v2a i2i messages transmitted by the vLP are not successfully received by the aLP), then the aLP withholds pacing, and the dual chamber LP system effectively provides VDD operation. If a2v i2i communication is lost (i.e., one or more of the a2v i2i messages transmitted by the aLP are not successfully received by the vLP, then tracking is lost and the dual chamber LP system effectively provides DDI operation. If i2i communication is simultaneously lost in both directions (i.e., v2a i2i messages transmitted by the vLP are not successfully received by the aLP, and a2v i2i messages transmitted by the aLP are not successfully received by the vLP), both mitigations take effect, and the dual chamber LP system effectively provides VDI operation. These transmission receipt safeguards act to guarantee RV pacing while maintaining RA tracking and RA pacing whenever possible. However, when the dual chamber LP system effectively provides for VDD or VDI operation, there is no pacing of the atrium.
As noted above, while withholding atrial pacing may be acceptable for some patients, there are other patients for which reliable atrial-based pacing is important, and sometimes imperative. For example, for patients that have SND, atrial-based pacing is the primary therapeutic support needed. As noted above, certain embodiments of the present technology relate to a new AAI+VVI operating mode. Additional details of such embodiments are provided herein. However, before providing addition details of the specific embodiments of the present technology mentioned above, an exemplary system in or with which embodiments of the present technology can be used will first be described with reference to
In certain embodiments, LPs 102a and 102b communicate with one another, and/or with an ICD 106, by conductive communication through the same electrodes that are used for sensing and/or delivery of pacing therapy. The LPs 102a and 102b may also be able to use conductive communication to communicate with an external device, e.g., a programmer 109, having electrodes placed on the skin of a patient within with the LPs 102a and 102b are implanted. The LPs 102a and 102b can each alternatively, or additionally, include an antenna that would enable them to communicate with one another, the ICD 106 and/or an external device, using RF communication. Alternatively, or additionally, it is possible that the LPs 102a, 102b utilize another type of communication, such as inductive communication, in which case the LPs 102a, 102b can each include a respective inductive communication coil. While only two LPs are shown in
Each LP 102 uses two or more electrodes located within, on, or within a few centimeters of the housing of the pacemaker, for pacing and sensing at the cardiac chamber. Where the LPs 102 communication using conductive communication, the electrodes of the LPs 102 can also be used for bidirectional conductive communication with one another, as well as with the programmer 109, and the ICD 106.
Referring to
In
The receivers 120 and 122 can also be referred to, respectively, as a low frequency (LF) receiver 120 and a high frequency (HF) receiver 122, because the receiver 120 is configured to monitor for one or more signals within a relatively low frequency range (e.g., below 100 KHz) and the receiver 122 is configured to monitor for one or more signals within a relatively high frequency range (e.g., above 100 KHz). In certain embodiments, the receiver 120 (and more specifically, at least a portion thereof) is always enabled and monitoring for a wakeup notice, which can simply be a wakeup pulse, within a specific low frequency range (e.g., between 1 KHz and 100 KHz); and the receiver 122 is selectively enabled by the receiver 120. The receiver 120 is configured to consume less power than the receiver 122 when both the first and second receivers are enabled. Accordingly, the receiver 120 can also be referred to as a low power receiver 120, and the receiver 122 can also be referred to as a high power receiver 122. In certain embodiments, while the aLP and the vLP are collectively providing the AAI+VVI operation, the lower power receiver 120 and the high power receiver 120 of the aLP are both normally disable, and the lower power receiver 120 is enabled from time to time to monitor for a mode switch type of i2i message from the vLP. Alternatively, while the aLP and the vLP are collectively providing the AAI+VVI operation, the aLP always powers its low power receiver 120, and only powers its high power receiver 122 in response to receiving a wakeup pulse from the vLP, wherein the wakeup pulse can be part of an i2i message from the vLP that is a mode switch i2i message. Other variations are also possible and within the scope of the embodiments described herein. In certain such embodiments, the aLP abstains from using its transmitter to transmit any i2i messages, that are intended to be used to coordinate operation of the vLP with the aLP, until the aLP receives a mode switch type of i2i message.
The low power receiver 120 is incapable of receiving signals within the relatively high frequency range (e.g., above 100 KHz), but consumes significantly less power than the high power receiver 122. This way the low power receiver 120 is capable of always monitoring for a wakeup notice without significantly depleting the battery (e.g., 114) of the LP. In accordance with certain embodiments, the high power receiver 122 is selectively enabled by the low power receiver 120, in response to the low power receiver 120 receiving a wakeup notice, so that the high power receiver 122 can receive the higher frequency signals, and thereby handle higher data throughput needed for effective i2i communication without unnecessarily and rapidly depleting the battery of the LP (which the high power receiver 122 may do if it were always enabled).
Since the receivers 120, 122 are used to receive conductive communication messages, the receivers 120, 122 can also be referred to as conductive communication receivers. In certain embodiments, each of the LPs 102 includes only a single conductive communication receiver.
In accordance with certain embodiments, when one of the LPs 102a and 102b senses an intrinsic event or delivers a paced event, the corresponding LP 102a, 102b transmits an implant event message to the other LP 102a, 102b. For example, when an atrial LP 102a senses/paces an atrial event, the atrial LP 102a transmits an implant event message including an event marker indicative of a nature of the event (e.g., intrinsic/sensed atrial event, paced atrial event). When a ventricular LP 102b senses/paces a ventricular event, the ventricular LP 102b transmits an implant event message including an event marker indicative of a nature of the event (e.g., intrinsic/sensed ventricular event, paced ventricular event). In certain embodiments, each LP 102a, 102b transmits an implant event message to the other LP 102a, 102b preceding the actual pace pulse so that the remote LP can blank its sense inputs (or provide some other type of crosstalk protection) in anticipation of that remote pace pulse (to prevent inappropriate crosstalk sensing). The above describe implant event messages are examples of i2i messages.
The implant event messages may be formatted in various manners. As one example, each event message may include a leading trigger pulse (also referred to as an LP wakeup notice, wakeup pulse or wakeup signal) followed by an event marker. The notice trigger pulse (also referred to as the wakeup notice, wakeup pulse or wakeup signal) is transmitted over a first channel (e.g., with a pulse duration of approximately 10 us to approximately 1 ms and/or within a fundamental frequency range of approximately 1 KHz to approximately 100 KHz). The notice trigger pulse indicates that an event marker is about to be transmitted over a second channel (e.g., within a higher frequency range). The event marker can then be transmitted over the second channel.
The event markers may include data indicative of one or more events (e.g., a sensed intrinsic atrial activation for an atrial located LP, a sensed intrinsic ventricular activation for a ventricular located LP). The event markers may include different markers for intrinsic and paced events. The event markers may also indicate start or end times for timers (e.g., an AV interval, a blanking interval, etc.). Optionally, the implant event message may include a message segment that includes additional/secondary information.
Optionally, the LP (or other IMD) that receives any i2i communication message from another LP (or other IMD) or from an external device may transmit a receive acknowledgement (ACK) indicating that the receiving LP (or other IMD) received the i2i communication message. In certain embodiments, where an IMD expects to receive an i2i communication message within a window, and fails to receive the i2i communication message within the window, the IMD may transmit a failure-to-receive acknowledgement indicating that the receiving IMD failed to receive the i2i communication message. The failure-to-receive acknowledgement message can also be referred to as a negative acknowledgement (NACK) message. An LP can receive a message from another LP that includes an indicator (e.g., an error code) in its payload, or header, that indicates to the LP that the other LP failed to receive an expected message from the LP. Other variations are also possible and within the scope of the embodiments described herein.
The event messages enable the LPs 102a, 102b to deliver synchronized therapy and additional supportive features (e.g., measurements, etc.). To maintain synchronous therapy, each of the LPs 102a and 102b is made aware (through the event messages) when an event occurs in the chamber containing the other LP 102a, 102b. Some embodiments described herein provide efficient and reliable processes to maintain synchronization between LPs 102a and 102b without maintaining continuous communication between LPs 102a and 102b. In accordance with certain embodiments herein, low power event messages/signaling may be maintained between LPs 102a and 102b synchronously or asynchronously.
For synchronous event signaling, LPs 102a and 102b may maintain synchronization and regularly communicate at a specific interval. Synchronous event signaling allows the transmitter and receivers in each LP 102a, 102b to use limited (or minimal) power as each LP 102a, 102b is only powered for a small fraction of the time in connection with transmission and reception. For example, LP 102a, 102b may transmit/receive (Tx/Rx) communication messages in time slots having duration of 10-20 μs, where the Tx/Rx time slots occur periodically (e.g., every 10-20 ms). Such synchronous event signaling may be used, e.g., when the LPs 102a and 102b collectively provide coordinated dual chamber operation during which i2i messages are transmitted by the aLP and the vLP (to support the coordinated dual chamber operation), but is not limited thereto.
LPs 102a and 102b may lose synchronization, even in a synchronous event signaling scheme. As explained herein, features may be included in LPs 102a and 102b to maintain device synchronization, and when synchronization is lost, LPs 102a and 102b undergo operations to recover synchronization. Also, synchronous event messages/signaling may introduce a delay between transmissions which causes a reaction lag at the receiving LP 102a, 102b. Accordingly, features may be implemented to account for the reaction lag.
During asynchronous event signaling, LPs 102a and 102b do not maintain communication synchronization. During asynchronous event signaling, one or more of receivers 120 and 122 of LPs 102a and 102b may be “always on” (always awake) to search for incoming transmissions. However, maintaining LP receivers 120, 122 in an “always on” (always awake) state presents challenges as the received signal level often is low due to high channel attenuation caused by the patient's anatomy. Further, maintaining the receivers awake will deplete the battery 114 more quickly than may be desirable.
In accordance with certain embodiments, the first receiver 120 may maintain the first channel active (awake) at all times (including when the second channel is inactive (asleep)) in order to listen for messages from a remote LP. The second receiver 122 may be assigned a second activation protocol that is a triggered protocol, in which the second receiver 122 becomes active (awake) in response to detection of trigger events over the first receive channel (e.g., when the incoming signal corresponds to the LP wakeup notice, activating the second channel at the local LP). The terms active, turned on, awake and enabled are used interchangeably herein.
Still referring to
The controller 112 and the pulse generator 116 may be configured to transmit event messages, via the electrodes 108, in a manner that does not inadvertently capture the heart in the chamber where LP 102a, 102b is located, such as when the associated chamber is not in a refractory state. In addition, an LP 102a, 102b that receives an event message may enter an “event refractory” state (or event blanking state) following receipt of the event message. The event refractory/blanking state may be set to extend for a determined period of time after receipt of an event message in order to avoid the receiving LP 102a, 102b from inadvertently sensing another signal as an event message that might otherwise cause retriggering. For example, the receiving LP 102a, 102b may detect a measurement pulse from another LP 102a, 102b or the programmer 109.
Since the conductive communication receivers 120, 122 (or alternatively, just a single conductive communication receiver) and the pulse generator 116 are used to perform conductive communication, these components can be considered parts of a conductive communication transceiver 124. The conductive communication transceiver 124 can alternatively include alternative and/or additional components that enable an LP, or other type of IMD, to transmit and receive conductive communication messages with another IMD and/or with an external device, such as the programmer 109. For an example, while the same pulse generator 116 can be used to produce pacing pulses (for use in pacing a patient's heart) and conductive communication pulses (for use in communicating with another IMD or an external device), it would also be possible that the conductive communication transceiver 124 can include its own dedicated pulse generator. For another example, as noted above, it would also be possible for the conductive communication transceiver 124 to include only a single receiver, rather than both receivers 120, 122. Other variations are also possible and within the scope of the embodiments described herein.
Still referring to
The RF communication transceiver 134 consumes more battery power than the conductive communication transceiver 124. More generally, it is more power efficient from an LP 102 (or other type of IMD) to use conductive communication than to use RF communication to communicate with another LP 102 (or other type of IMD). Accordingly, in accordance with certain embodiments of the present technology, the LP 102 (or other type of IMD) is configured to primarily transmit and receive messages using conductive communication, and RF communication is used as a backup or auxiliary type of communication that can be used when conductive communication is deactivated (aka turned off) or is unsuccessful or otherwise deficient, as will be described in additional detail below.
It is possible that the LPs 102a, 102b are only capable of utilizing conductive communication for communicating with one another and/or other devices (such as a programmer 109 and/or ICD 106), in which case the antenna 118 and the RF communication transceiver 134 may be eliminated. It may also be the case that the LPs 102a, 102b are only configured to communicate using RF communication, and to not utilize conductive communication, in which case certain circuitry may be eliminated, such as the receivers 120, 122. Alternatively, or additionally, it is possible that the LPs 102a, 102b utilize another type of communication, such as inductive communication, in which case the LPs 102a, 102b can each include a respective inductive communication coil.
In accordance with certain embodiments herein, the programmer 109 may communicate over a programmer-to-LP channel, with LP 102a, 102b utilizing the same communication scheme. The external programmer 109 may listen to the event message transmitted between LP 102a, 102b and synchronize programmer to implant communication such that programmer 109 does not transmit communication messages 17 until after an i2i messaging sequence is completed.
In some embodiments, each individual LP 102 can comprise a hermetic housing 110 configured for placement on or attachment to the inside or outside of a cardiac chamber and at least two leadless electrodes 108 proximal to the housing 110 and configured for bidirectional communication with at least one other device (e.g., an ICD 106) within or outside the body.
The electrodes 108 can be configured to communicate bidirectionally among the multiple leadless cardiac pacemakers and/or the implanted ICD 106 to coordinate pacing pulse delivery and optionally other therapeutic or diagnostic features using messages that identify an event at an individual pacemaker originating the message and a pacemaker receiving the message react as directed by the message depending on the origin of the message. An LP 102a, 102b that receives the event message reacts as directed by the event message depending on the message origin or location. In some embodiments or conditions, the two or more leadless electrodes 108 can be configured to communicate bidirectionally among the one or more leadless cardiac pacemakers 102 and/or the ICD 106 and transmit data including designated codes for events detected or created by an individual pacemaker. Individual pacemakers can be configured to issue a unique code corresponding to an event type and a location of the sending pacemaker.
In some embodiments, an individual LP 102a, 102b can be configured to deliver a pacing pulse with an event message encoded therein, with a code assigned according to pacemaker location and configured to transmit a message to one or more other leadless cardiac pacemakers via the event message coded pacing pulse. The pacemaker or pacemakers receiving the message are adapted to respond to the message in a predetermined manner depending on type and location of the event.
Moreover, information communicated on the incoming channel can also include an event message from another leadless cardiac pacemaker signifying that the other leadless cardiac pacemaker has sensed a heartbeat or has delivered a pacing pulse, and identifies the location of the other pacemaker. For example, LP 102b may receive and relay an event message from LP 102a to the programmer. Similarly, information communicated on the outgoing channel can also include a message to another leadless cardiac pacemaker or pacemakers, or to the ICD, that the sending leadless cardiac pacemaker has sensed a heartbeat or has delivered a pacing pulse at the location of the sending pacemaker.
Referring again to
In a further embodiment, a cardiac pacing system 100 comprises at least one LP 102a, 102b configured for implantation in electrical contact with a cardiac chamber and configured to perform cardiac pacing functions in combination with the co-implanted ICD 106. Each LP 102 comprise at least two leadless electrodes 108 configured for delivering cardiac pacing pulses, sensing evoked and/or natural cardiac electrical signals, and transmitting information to the co-implanted ICD 106.
As shown in the illustrative embodiments, an LP 102a, 102b can comprise two or more leadless electrodes 108 configured for delivering cardiac pacing pulses, sensing evoked and/or natural cardiac electrical signals, and bidirectionally communicating with the co-implanted ICD 106.
Each LP 102a, 102b can be configured for operation in a respective particular location and to have a respective particular functionality at manufacture and/or by programming by an external programmer. Bidirectional communication among the multiple leadless cardiac pacemakers can be arranged to communicate notification of a sensed heartbeat or delivered pacing pulse event and encoding type and location of the event to another implanted pacemaker or pacemakers. The LP 102a, 102b receiving the communication decode the information and respond depending on location of the receiving pacemaker and predetermined system functionality.
In some embodiments, the LPs 102a and 102b are configured to be implantable in any chamber of the heart, namely either atrium (RA, LA) or either ventricle (RV, LV). Furthermore, for dual-chamber configurations, multiple LPs may be co-implanted (e.g., one in the RA and one in the RV, one in the RV and one in the coronary sinus proximate the LV). Certain pacemaker parameters and functions depend on (or assume) knowledge of the chamber in which the pacemaker is implanted (and thus with which the LP is interacting; e.g., pacing and/or sensing). Some non-limiting examples include sensing sensitivity, an evoked response algorithm, use of AF suppression in a local chamber, blanking & refractory periods, etc. Accordingly, each LP needs to know an identity of the chamber in (or on) which the LP is implanted, and processes may be implemented to automatically identify a local chamber associated with each LP.
Processes for chamber identification may also be applied to subcutaneous pacemakers, ICDs, with leads and the like. A device with one or more implanted leads, identification and/or confirmation of the chamber into which the lead was implanted could be useful in several pertinent scenarios. For example, for a DR or CRT device, automatic identification and confirmation could mitigate against the possibility of the clinician inadvertently placing the V lead into the A port of the implantable medical device, and vice-versa.
Also shown in
Still referring to
Referring to
In various embodiments, LP 102a, 102b can manage power consumption to draw limited power from the battery, thereby reducing device volume. Each circuit in the system can be designed to avoid large peak currents. For example, cardiac pacing can be achieved by discharging a tank capacitor (not shown) across the pacing electrodes. Recharging of the tank capacitor is typically controlled by a charge pump circuit. In a particular embodiment, the charge pump circuit is throttled to recharge the tank capacitor at constant power from the battery.
In some embodiments, the controller 112 in an LP 102 can access signals on the electrodes 108 and can examine output pulse duration from another LP 102 for usage as a signature for determining triggering information validity and, for a signature arriving within predetermined limits, activating delivery of a pacing pulse following a predetermined delay of zero or more milliseconds. The predetermined delay can be preset at manufacture, programmed via an external programmer, or determined by adaptive monitoring to facilitate recognition of the triggering signal and discriminating the triggering signal from noise. In some embodiments or in some conditions, the controller 112 can examine output pulse waveform from another leadless cardiac pacemaker for usage as a signature for determining triggering information validity and, for a signature arriving within predetermined limits, activating delivery of a pacing pulse following a predetermined delay of zero or more milliseconds.
The housing can also include an electronics compartment 210 within the housing that contains the electronic components necessary for operation of the pacemaker, including, e.g., a pulse generator, transceiver, a battery, and a processor for operation. The hermetic housing 202 can be adapted to be implanted on or in a human heart, and can be cylindrically shaped, rectangular, spherical, or any other appropriate shapes, for example.
The housing can comprise a conductive, biocompatible, inert, and anodically safe material such as titanium, 316L stainless steel, or other similar materials. The housing can further comprise an insulator disposed on the conductive material to separate electrodes 108a and 108b. The insulator can be an insulative coating on a portion of the housing between the electrodes, and can comprise materials such as silicone, polyurethane, parylene, or another biocompatible electrical insulator commonly used for implantable medical devices. In the embodiment of
As shown in
The electrodes 108a and 108b can comprise pace/sense electrodes, or return electrodes. A low-polarization coating can be applied to the electrodes, such as sintered platinum, platinum-iridium, iridium, iridium-oxide, titanium-nitride, carbon, or other materials commonly used to reduce polarization effects, for example. In
Several techniques and structures can be used for attaching the housing 202 to the interior or exterior wall of the heart. A helical fixation mechanism 205, can enable insertion of the device endocardially or epicardially through a guiding catheter. A torqueable catheter can be used to rotate the housing and force the fixation device into heart tissue, thus affixing the fixation device (and also the electrode 108a in
LPs 102a and 102b can utilize implant-to-implant (i2i) communication through event messages to coordinate operation with one another in various manners. The terms i2i event messages and i2i event markers are used interchangeably herein to refer to event related messages and IMD/IMD operation related messages transmitted from an implanted device and directed to another implanted device (although external devices, e.g., a programmer, may also receive i2i event messages). In certain embodiments, LP 102a and LP 102b operate as two independent leadless pacers maintaining beat-to-beat dual-chamber functionality via a “Master/Slave” operational configuration. For descriptive purposes, the ventricular LP 102b shall often be referred to as “vLP” and the atrial LP 102a shall often be referred to as “aLP,” as was noted above. The LP 102 that is designated as the master device (e.g., vLP) may implement all or most dual-chamber diagnostic and therapy determination algorithms. For purposes of the following illustration, it is assumed that the vLP is a “master” device, while the aLP is a “slave” device. Alternatively, the aLP may be designated as the master device, while the vLP may be designated as the slave device. The master device orchestrates most or all decision-making and timing determinations (including, for example, rate-response changes).
As shown in
As with i2i transmission 402, i2i transmission 506 may include an envelope that may include one or more individual pulses. For example, similar to envelope 406, the envelope of i2i transmission 506 may include a low frequency pulse followed by a high frequency pulse train. In certain embodiments, the i2i transmission 506 is transmitted during a refractory period that follows the sensed event.
Optionally, wherein the first LP is located in an atrium and the second LP is located in a ventricle, the first LP produces an AS/AP event marker to indicate that an atrial sensed (AS) event or atrial paced (AP) event has occurred or will occur in the immediate future. For example, the AS and AP event markers may be transmitted following the corresponding AS or AP event. Alternatively, the first LP may transmit the AP event marker slightly prior to delivering an atrial pacing pulse. Alternatively, wherein the first LP is located in an atrium and the second LP is located in a ventricle, the second LP initiates an atrioventricular (AV) interval after receiving an AS or AP event marker from the first LP; and initiates a post atrial ventricular blanking (PAVB) interval after receiving an AP event marker from the first LP.
Optionally, the first and second LPs may operate in a “pure” master/slave relation, where the master LP delivers “command” markers in addition to or in place of “event” markers. A command marker directs the slave LP to perform an action such as to deliver a pacing pulse and the like. For example, when a slave LP is located in an atrium and a master LP is located in a ventricle, in a pure master/slave relation, the slave LP delivers an immediate pacing pulse to the atrium when receiving an AP command marker from the master LP.
In accordance with some embodiments, communication and synchronization between the aLP and vLP is implemented via conducted communication of markers/commands in the event messages (per i2i communication protocol). As explained above, conducted communication represents event messages transmitted from the sensing/pacing electrodes at frequencies outside the RF (e.g., Wi-Fi or BLE) frequency range. Alternatively, the event messages may be conveyed over communication channels operating in the RF frequency range. The figures and corresponding description below illustrate non-limiting examples of markers that may be transmitted in event messages. The figures and corresponding description below also include the description of the markers and examples of results that occur in the LP that receives the event message. Table 3 represents example event markers sent from the aLP to the vLP, while Table 4 represents example event markers sent from the vLP to the aLP. In the master/slave configuration, AS event markers are sent from the aLP each time that an atrial event is sensed outside of the post ventricular atrial blanking (PVAB) interval or some other alternatively-defined atrial blanking period. The AP event markers are sent from the aLP each time that the aLP delivers a pacing pulse in the atrium. The aLP may restrict transmission of AS markers, whereby the aLP transmits AS event markers when atrial events are sensed both outside of the PVAB interval and outside the post ventricular atrial refractory period (PVARP) or some other alternatively-defined atrial refractory period. Alternatively, the aLP may not restrict transmission of AS event markers based on the PVARP, but instead transmit the AS event marker every time an atrial event is sensed.
As shown in Table 3, when an aLP transmits an event message that includes an AS event marker (indicating that the aLP sensed an intrinsic atrial event), the vLP initiates an AV interval timer. If the aLP transmits an AS event marker for all sensed events, then the vLP would preferably first determine that a PVAB or PVARP interval is not active before initiating an AV interval timer. If however the aLP transmits an AS event marker only when an intrinsic signal is sensed outside of a PVAB or PVARP interval, then the vLP could initiate the AV interval timer upon receiving an AS event marker without first checking the PVAB or PVARP status. When the aLP transmits an AP event marker (indicating that the aLP delivered or is about to deliver a pace pulse to the atrium), the vLP initiates a PVAB timer and an AV interval time, provided that a PVARP interval is not active. The vLP may also blank its sense amplifiers to prevent possible crosstalk sensing of the remote pace pulse delivered by the aLP.
As shown in Table 4, when the vLP senses a ventricular event, the vLP transmits an event message including a VS event marker, in response to which the aLP may initiate a PVARP interval timer. When the vLP delivers or is about to deliver a pace pulse in the ventricle, the vLP transmits VP event marker. When the aLP receives the VP event marker, the aLP initiates the PVAB interval timer and also the PVARP interval timer. The aLP may also blank its sense amplifiers to prevent possible crosstalk sensing of the remote pace pulse delivered by the vLP. The vLP may also transmit an event message containing an AP command marker to command the aLP to deliver an immediate pacing pulse in the atrium upon receipt of the command without delay.
The foregoing event markers are examples of a subset of markers that may be used to enable the aLP and vLP to maintain full dual chamber functionality. In one embodiment, the vLP may perform all dual-chamber algorithms, while the aLP may perform atrial-based hardware-related functions, such as PVAB, implemented locally within the aLP. In this embodiment, the aLP is effectively treated as a remote ‘wireless’ atrial pace/sense electrode. In another embodiment, the vLP may perform most but not all dual-chamber algorithms, while the aLP may perform a subset of diagnostic and therapeutic algorithms. In an alternative embodiment, vLP and aLP may equally perform diagnostic and therapeutic algorithms. In certain embodiments, decision responsibilities may be partitioned separately to one of the aLP or vLP. In other embodiments, decision responsibilities may involve joint inputs and responsibilities.
Messages that are transmitted between LPs (e.g., the aLP and the vLP) can be referred to herein generally as i2i messages, since they are implant-to-implant messages. As noted above, such messages can include event markers that enable one LP to inform the other LP of a paced event or a sensed event. For example, in certain embodiments, whenever the aLP 102a senses an atrial event or paces the right atrium, the aLP will transmit an i2i message to the vLP 102b to inform the vLP of the sensed or paced event in the atrium. In response to receiving such an i2i message, the vLP 102b may start one or more timers that enable the vLP to sense or pace in the right ventricle. Similarly, the vLP may transmit an i2i message to the aLP 102a whenever the vLP senses a ventricular event or paces the right ventricle.
The i2i messages that are sent between LPs may be relatively short messages that simply allow a first LP to inform a second LP of an event that was sensed by the first LP or caused (paced) by the first LP, and vice versa. Such i2i messages can be referred to herein as event marker i2i messages, or more succinctly as event i2i messages. The i2i messages that are sent between LPs, in certain instances, can be extended i2i messages that include (in addition to an event marker) an extension. In certain embodiments, an extended i2i message includes an event marker (e.g., 9 bits), followed by an extension indicator (e.g., 2 bits), followed by an extended message payload portion (e.g., 17 bits), followed by a cyclic redundancy check (CRC) code (e.g., 6 bits) or some other type of error detection and correction code. Other variations are also possible.
As explained above, certain embodiments of the present technology relate to a new AAI+VVI operating mode for use by a dual chamber LP system. As also explained above, a primary use case for utilizing this new AAI+VVI operation is with patients having SND who generally have intact AV node conduction, with potentially a rare-to-occasional need for intermittent ventricular pacing support, e.g., due to transient AV block, but not limited thereto.
The AAI+VVI operation is achieved by operating the aLP in AAI mode, and operating the vLP in VVI mode, without requiring that the aLP and the vLP perform i2i communication (i.e., without requiring that the aLP and the vLP attempt to communicate with one another every cardiac cycle, every other cardiac cycle, or even less frequently). In other words, the AAI+VVI operating mode is achieved by the aLP providing AAI operation and the vLP independently providing VVI operation during a same period of time.
When the aLP provides the AAI operation, the aLP performs atrial pacing in response to an intrinsic atrial event not being detected within a specified AA interval following a previous (e.g., an immediately preceding) paced or intrinsic atrial event, performs atrial sensing (to sense for an intrinsic atrial event prior to the end of the specified AA interval), and inhibits the atrial pacing in response to the intrinsic atrial event being detected within the specified AA interval following the previous paced or intrinsic atrial event.
When the vLP provides the VVI operation, the vLP performs ventricular pacing in response to an intrinsic ventricular event not being detected within a specified VV interval following a previous (e.g., an immediately preceding) paced or intrinsic ventricular event, performs ventricular sensing (to sense for an intrinsic ventricular event prior to the end of the specified VV interval), and inhibits the ventricular pacing in response to the intrinsic ventricular event being detected within the specified VV interval following the previous paced or intrinsic ventricular event.
In accordance with certain embodiments, the programmable pacing rate for the aLP is restricted to always being greater than the programmable pacing rate for the vLP. This constraint ensures that the aLP is driving overall cardiac electromechanical functionality, and therein mitigates against the vLP rate superseding the aLP rate, which can result in undesirable retrograde AV node conduction. This constraint is achieved, in accordance with certain embodiments, by programming the AA interval (that is used by the aLP) to be shorter than the VV interval (that is used by the vLP), which has the effect of causing an atrial rate of the atrial pacing performed by the aLP to be faster than a ventricular rate of the ventricular pacing performed by the vLP. Additionally or alternatively, in accordance with certain embodiments, the programmable pacing rate for the vLP is restricted to always being less than the programmable pacing rate for the aLP. This constraint similarly ensures that the aLP is driving overall cardiac electromechanical functionality, and therein mitigates against the vLP rate superseding the aLP rate, which can result in undesirable retrograde AV node conduction. This constraint is achieved, in accordance with certain embodiments, by programming the VV interval (that is used by the vLP) to be longer than the AA interval (that is used by the aLP), which has the effect of causing a ventricular rate of the ventricular pacing performed by the vLP to be slower than an atrial rate of the atrial pacing performed by the aLP.
In accordance certain embodiments, the aLP provides for rate responsive pacing, i.e., the AAI operation is provided by AAIR operation, while the vLP provides for non-rate responsive VVI pacing. More specifically, the aLP can utilize a temperature sensor (e.g., 152) thereof and/or a motion sensor (e.g., accelerometer 154) thereof to detect patient activity, and modulate its pacing rate based on the detected patient activity. In certain such embodiments, while the aLP is providing rate responsive AAI operation, i.e., AAIR operation, the vLP provides its VVI operation utilizing a constant programmed ventricular rate. In other words, the VVI operation provided by the vLP is not rate responsive. This can be because the vLP disables its temperature sensor (e.g., 152) and/or its motion sensor (e.g., accelerometer 154), ignores the outputs thereof, or turns off its rate responsive feature. Such one or more constraints is/are consistent with the intended use case, where atrial-based pacing by the aLP is the primary need and the ventricular function provided by the vLP tracks intrinsically via intact AV node conduction, with ventricular pacing by the vLP only intended for backup safety support when needed. In other embodiments, while the aLP is providing rate responsive AAI operation, i.e., AAIR operation, the vLP is providing rate responsive VVI operation, i.e., VVIR operation, which can be referred to more specifically as AAIR+VVIR operation. In certain embodiments, when the dual chamber LP system is providing AAIR+VVIR operation, a sensitivity of the temperature sensor and/or motion sensor of the vLP is less than a sensitivity of the temperature sensor and/or motion sensor of the aLP, so that an increase in the atrial pacing rate provided by aLP is greater than a corresponding increase in the ventricular pacing rate provided by vLP. Such a configuration keeps the AA interval shorter than the VV interval to thereby cause an atrial rate of the atrial pacing performed by the aLP to remain faster than a ventricular rate of the ventricular pacing performed by the vLP.
Additional details of the AAI+VVI operation according to certain embodiments of the present technology are described below with reference to the high level flow diagrams of
Referring to
Still referring to
In accordance with certain embodiments, steps 602 and 604 are performed by the aLP during a same period of time that steps 632 and 634 are performed by the vLP. In certain such embodiments, in order to conserve power and thereby increase longevity of the aLP and the vLP, the aLP abstains from transmitting any i2i messages that are intended to be used to coordinate operation of the vLP with the aLP while the vLP is providing the VVI operation, and the vLP abstains from transmitting any i2i messages that are intended to be used to coordinate operation of the aLP with the vLP while the aLP is providing the AAI operation, while steps 604 and 634 are being performed. In other words, AAI+VVI operation is achieved without requiring any i2i messages being sent from the aLP to the vLP (directly, or via a third IMD that acts as a communication hub), and vice versa.
If the aLP and the vLP were communicating with one another using i2i messages, then the vLP may inform the aLP via an i2i message of a pacing pulse that is about to be delivered by the vLP, in response to which the aLP could blank its sense amplifier (e.g., 132) so that the aLP doesn't mistakenly detect a paced ventricular event as an intrinsic atrial event. However, this is not possible when the aLP and the vLP abstain from sending i2i messages to one another, which increases the probability that the aLP could mistakenly detect a paced ventricular event as an intrinsic atrial event, which in turn would cause the aLP to inhibit atrial pacing for that cardiac cycle, which is undesirable. To reduce the probability of the aLP mistakenly detecting a paced ventricular event as an intrinsic atrial event, at step 606 the aLP monitors for possible crosstalk that may be caused by the vLP performing ventricular pacing. According, in accordance with certain embodiments the aLP is configured to monitor for possible crosstalk that may be caused by the vLP performing ventricular pacing. Example additional details of how such embodiments can be implemented are described below.
Such possible crosstalk monitoring at step 606 can be performed, for example, using one of the techniques described in U.S. Pat. No. 10,182,765, titled “Systems and Methods for Classifying Signals of Interest in a Cardiac Rhythm Management Device,” which is incorporated herein by reference. For example, referring to
Referring again to
As noted above, in certain embodiments, while steps 604 and 634 are being performed to provide the AAI+VVI operation, there is no i2i communication between the aLP and the vLP. In other words, AAI+VVI operation is achieved without requiring any i2i messages be sent from the aLP to the vLP (directly, or via a third IMD that acts as a communication hub), and vice versa. While i2i communication is not being used by the aLP and the vLP, the aLP can normally disable its receiver(s), e.g., 120 and 122, and temporarily enable one or more of its receiver(s) from time to time, to sense for possible crosstalk and/or to determine whether a mode switch message is received from the vLP. More specifically, at step 612 the aLP determines whether or not it is time to temporarily enable its receiver 120 to monitor for a mode switch type of i2i message from the vLP (or a third IMD that acts as a communication hub). If the answer to the determination at step 612 is No, then flow returns to step 604 and the aLP continues to provide AAI operation. If the answer to the determination at step 612 is Yes, then flow goes to step 614 and the aLP temporarily enables its receiver 120 to monitor for a mode switch type of i2i message from the vLP (or a third IMD).
For example, the aLP can at step 614 temporarily enable its receiver 120, once per period of time (e.g., once every 10 seconds, once every minute, once every 5 minutes, or once every 10 minutes, etc.) for a specified duration (e.g., 1 second, 2 seconds, 5 seconds, or 10 seconds, etc.) or for a specified number of cardiac cycles (e.g., 1 cardiac cycle, 2 cardiac cycles, 5 cardiac cycles, or 10 cardiac cycles, etc.). Alternatively, the aLP can temporarily enable its receiver 120, once every specified number of cardiac cycles (e.g., 10 cardiac cycles, 30 cardiac cycles, 60 cardiac cycles, or 120 cardiac cycles, etc.) for a specified duration (e.g., 1 second, 2 seconds, 5 seconds, or 10 seconds, etc.) or for a specified number of cardiac cycles (e.g., 1 cardiac cycle, 2 cardiac cycles, 5 cardiac cycles, or 10 cardiac cycles, etc.). It is also possible that the low power receiver 120 of the aLP is always on and selectively temporarily enables the high power receiver 122 in response to the low power receiver 120 receiving a wakeup pulse of an i2i mode switch message received from the vLP. If the low power receiver 120 of the aLP is already enabled to provide crosstalk protection (in accordance with steps 606, 608, and 610), or is always on (aka always enabled) and is in the process of providing crosstalk protection (by performing one of steps 606, 608, or 610), then at step 612 the aLP can be reconfigured to start listening for and processing possible i2i messages. Such reconfiguring of the aLP could be achieved, for example, by updating low-level i2i communication hardware registers to enable the i2i hardware (e.g., the high power receiver 122) to receive i2i payloads, or it could be a logical reconfiguration, but is not limited thereto.
At step 616, there is a determination of whether or not the aLP received a mode switch type i2i message from the vLP during the period of time that the receiver(s), or a portion thereof, of the aLP is/are enabled. If the answer to the determination at step 616 is No, then flow returns to step 604 and the aLP continues to provide AAI operation. If the answer to the determination at step 616 is Yes, then flow goes to step 618. In certain embodiments, the aLP abstains from transmitting any i2i messages that are intended to be used to coordinate operation of the vLP with the aLP until the aLP receives a mode switch type of i2i message from the vLP (or a third IMD).
At step 618 the aLP transmits a mode switch acknowledgement (ACK) type i2i message to the vLP, and then the aLP changes its mode of operation from providing AAI operation independent of the vLP to collectively providing with the vLP coordinated dual chamber operation (e.g., DDD, VDD, DDI, VDI, or DOO operation) during which i2i messages are transmitted by the aLP and the vLP (to support the coordinated dual chamber operation), as indicated at step 620. While collectively providing the coordinated dual chamber operation, the aLP and the vLP transmit i2i messages to one another (e.g., on a beat-to-beat basis) or to a third IMD that acts as a communication hub for the aLP and the vLP.
At step 622, there is a determination of whether or not the aLP received a further mode switch type i2i message from the vLP. If the answer to the determination at step 622 is No, then flow returns to step 620 and the aLP continues to provide, collectively with the vLP, the coordinated dual chamber operation during which i2i messages are transmitted by the aLP and the vLP (to support the coordinated dual chamber operation). If the answer to the determination at step 622 is Yes, then flow goes to step 624.
At step 624 the aLP transmits a further mode switch acknowledgement (ACK) type i2i message to the vLP, and then flow returns to step 604, and the aLP returns to providing the AAI operation again. At this point the aLP can return to normally disabling its receiver(s), or a portion thereof, because beat-by-beat i2i communication need not be used during the AAI+VVI operation.
Referring now to the steps shown on the right in
To reduce the probability of the vLP mistakenly detecting a paced atrial event as an intrinsic ventricular event, at step 636 the vLP monitors for possible crosstalk that may be caused by the aLP performing atrial pacing. Such possible crosstalk monitoring at step 636 can be performing, for example, using one of the techniques described in U.S. Pat. No. 10,182,765, which was incorporated herein by reference above. At step 638 there is a determination of whether or not the vLP detects possible crosstalk that may be caused by the aLP performing atrial pacing, and more specifically, the aLP delivering a pacing pulse. If the answer to the determination at step 638 is No, then step 640 is skipped and flow goes to step 642. If the answer to the determination at step 638 is Yes, then flow goes to step 640. At step 640 the vLP initiates providing crosstalk protection for a crosstalk protection period, so as to avoid crosstalk caused by an atrial pacing pulse from being mistakenly detected as an intrinsic ventricular event. The crosstalk protection period utilized at instances of step 640 can have the same duration as, or a different duration than, the crosstalk protection period utilized at instance of step 610, depending upon implementation. Such crosstalk protection can be performed in various different manners, examples of which were discussed above with reference to step 610, and thus need not be repeated. Instead of performing blanking at step 640, the vLP (and more specifically its controller) can ignore an intrinsic ventricular event that is detected during the crosstalk protection period, because it can be assumed that such a detected intrinsic ventricular event is actually crosstalk caused by the aLP performing atrial pacing. The blocks corresponding to steps 636, 638, and 640 in
Still referring to
At step 644 there is a determination of whether or not the first specified criterion was satisfied. If the answer to the determination at step 644 is No, then flow returns to step 634 and the vLP continues to provide the VVI operation. This also results in the aLP continuing to provide the AAI operation. If the answer to the determination at step 644 is Yes, then flow goes to step 646. At step 646 that vLP transmits a mode switch type i2i message to the aLP. As part of step 646, or just prior to step 646, the vLP may enable a transmitter thereof (if the transmitter had been disabled to conserve power) to transmit i2i messages to the aLP, and the vLP may also enable one or more of its receiver(s) (if the receiver(s) thereof had been previously disabled to conserve power) to listen for a mode switch ACK i2i message that may be transmitted by the aLP. More generally, at step 644 there is a determination of whether the dual chamber LP system should switch from AAI+VVI operation to coordinated dual chamber operation when a patient's need for ventricular pace support becomes more than just rare or intermittent.
At step 648 that is a determination by the vLP (and more specifically, a controller thereof) of whether or not a mode switch ACK i2i message was received from the aLP by the vLP. If the answer to the determination at step 648 is No, then flow returns to step 646 and the vLP transmits another mode switch i2i message to the aLP. This can continue until the answer to the determination at step 648 is Yes, or until there is some timeout. If the answer to the determination at step 648 is Yes, then flow goes to step 650. At step 650 the vLP changes its mode of operation from providing VVI operation to collectively with the aLP providing coordinated dual chamber operation during which i2i messages are transmitted by the aLP and the vLP (to support the coordinated dual chamber operation). As noted above, while collectively providing the coordinated dual chamber operation, the aLP and the vLP transmit i2i messages (e.g., on a beat-to-beat basis) to enable coordinated dual chamber therapy. The coordinated dual chamber operation collectively provided by the aLP and the vLP at steps 620 and 650 may or may not be rate responsive, depending upon how the dual chamber LP system is programmed.
Still referring to
At step 654 there is a determination of whether or not the second specified criterion was satisfied. If the answer to the determination at step 654 is No, then flow returns to step 650 and the vLP continues to provide the coordinated dual chamber operation collectively with the aLP. If the answer to the determination at step 654 is Yes, then flow goes to step 656. At step 656 that vLP transmits a further mode switch type i2i message to the aLP (or to the third IMD that acts as a communication hub for the LPs). More generally, at step 654 there is a determination of whether the dual chamber LP system should switch from the coordinated dual chamber operation back to the AAI+VVI because the patient's need for ventricular pacing returned to be relatively rare or intermittent.
At step 658 there is a determination by the vLP (and more specifically, a controller thereof) of whether or not a further mode switch ACK i2i message was received from the aLP by the vLP. If the answer to the determination at step 658 is No, then flow returns to step 656 and the vLP transmits another further mode switch i2i message to the aLP. This can continue until the answer to the determination at step 658 is Yes, or until there is some timeout. If the answer to the determination at step 658 is Yes, then flow returns to step 634, and the vLP returns to providing the VVI operation. This also results in the aLP returning to providing the AAI operation, and thus, to the dual chamber LP system (e.g., 100) returning to providing the new AAI+VVI operation. In certain embodiments, in order to conserve power and thereby increase longevity of the aLP and the vLP, once the dual chamber LP system (e.g., 100) has returned to providing the AAI+VVI operation, the aLP abstains from transmitting any i2i messages that are intended to be used to coordinate operation of the vLP with the aLP while the vLP is providing the VVI operation, and the vLP abstains from transmitting any i2i messages that are intended to be used to coordinate operation of the aLP with the vLP while the aLP is providing the AAI operation. In other words, AAI+VVI operation, once returned to, is provided without requiring any i2i messages being sent from the aLP to the vLP (directly, or via a third IMD that acts as a communication hub), and vice versa.
In the embodiments described above with reference to
In accordance with certain embodiments of the present technology, while the aLP is providing the AAI operation and the vLP is providing the VVI operation, independent of one another, the aLP monitors for a specific criterion (referred to as a third specified criterion) that when detected by the aLP causes the aLP to send an i2i message to the vLP (or to a third IMD that acts as a communication hub for the LPs), which i2i message instructs the vLP to change (e.g., increase) its base pacing rate (e.g., from 40 ventricular beats per minute, to 60 ventricular beats per minute, but not limited thereto), or equivalently instructs the vLP to change (e.g., shorten) its base VV interval. For example, the third specified criterion can be that the aLP has detected that the atrial rate exceeds some specified threshold (e.g., 170 atrial beats per minute, but not limited thereto). In order for the vLP to be able to receive such an i2i message, the vLP should temporarily enable its receiver from time to time, in a similar manner to what the aLP does so at steps 612 and 614. The aLP can repeatedly send such a message until the aLP receives an ACK message that the vLP received the message, in a similar manner that the vLP does at steps 646 and 648. Thereafter, the aLP may monitor for a fourth criterion, e.g., that the atrial rate has fallen below the specified threshold or some further specified threshold (e.g., 130 atrial beats per minute, to provide hysteresis, but not limited thereto). In response to the aLP detecting the fourth criterion, the aLP sends an i2i message to the vLP (or to a third IMD that acts as a communication hub for the LPs), which i2i message instructs the vLP to change (e.g., reduce) its base pacing rate (e.g., from 60 ventricular beats per minute, back to 40 ventricular beats per minute, but not limited thereto), or equivalently instructs the vLP to change (e.g., increase) its base VV interval. The aLP can repeatedly send such an i2i message until the aLP receives an ACK message that the vLP received the message. This is similar to what the vLP does at steps 652, 654656, and 658. A purpose of such an embodiment is to attempt to provide enhanced ventricular pacing support during atrial fibrillation (AF) and/or another type of atrial tachycardia, without requiring beat-to-beat i2i communication during the atrial tachycardia.
In certain embodiments, the aLP and the vLP collectively provide AAI+VVI operation without ever mode switching to collectively providing the coordinated dual chamber operation. The flow diagram in
The steps in
LP 701 has a housing 700 to hold the electronic/computing components. Housing 700 (which is often referred to as the “can”, “case”, “encasing”, or “case electrode”) may be programmably selected to act as the return electrode for certain stimulus modes. The LP is shown as including electrode terminals 702, 704, 706, 708, and 710, however the LP would likely include only two or three electrode terminals, depending upon how many electrodes the LP has.
The terminals may be connected to electrodes that are located in various locations on housing 700 or elsewhere within and about the heart. LP 701 includes a programmable microcontroller 720 that controls various operations of LP 701, including cardiac monitoring and stimulation therapy. Microcontroller 720 includes a microprocessor (or equivalent control circuitry), RAM and/or ROM memory, logic and timing circuitry, state machine circuitry, and I/O circuitry.
LP 701 further includes a pulse generator 722 that generates stimulation pulses and communication pulses for delivery by one or more electrodes coupled thereto. Pulse generator 722 is controlled by microcontroller 720 via control signal 724. Pulse generator 722 may be coupled to the select electrode(s) via an electrode configuration switch 726, which includes multiple switches for connecting the desired electrodes to the appropriate I/O circuits, thereby facilitating electrode programmability. Switch 726 is controlled by a control signal 728 from microcontroller 720.
In the embodiment of
Microcontroller 720 is illustrated as including timing control circuitry 732 to control the timing of the stimulation pulses (e.g., pacing rate, atrio-ventricular (AV) delay, atrial interconduction (AA) delay, or ventricular interconduction (VV) delay, etc.). The AA delay can also be referred to as an AA interval, and the VV delay can also be referred to as the VV interval. Timing control circuitry 732 may also be used for the timing of refractory periods, blanking intervals, noise detection windows, evoked response windows, alert intervals, marker channel timing, and so on. Microcontroller 720 also has an arrhythmia detector 734 for detecting arrhythmia conditions. Microcontroller 720 also has an AV synchrony detector 736 that can be configured to determine an AV synchrony metric in accordance with embodiments of the present technology described herein. Although not shown, the microcontroller 720 may further include other dedicated circuitry and/or firmware/software components that assist in monitoring various conditions of the patient's heart and managing pacing therapies. The microcontroller can include a processor. The microcontroller, and/or the processor thereof, can be used to perform the methods of the present technology described herein.
LP 701 is further equipped with a communication modem (modulator/demodulator) 740 to enable wireless communication with the remote slave pacing unit. Modem 740 may include one or more transmitters and two or more receivers as discussed herein in connection with
LP 701 includes a sensing circuit 744 selectively coupled to one or more electrodes, that perform sensing operations, through switch 726 to detect the presence of cardiac activity in the right chambers of the heart. Sensing circuit 744 may include dedicated sense amplifiers, multiplexed amplifiers, or shared amplifiers. It may further employ one or more low power, precision amplifiers with programmable gain and/or automatic gain control, bandpass filtering, and threshold detection circuit to selectively sense the cardiac signal of interest. The automatic gain control enables the unit to sense low amplitude signal characteristics of atrial fibrillation. Switch 726 determines the sensing polarity of the cardiac signal by selectively closing the appropriate switches. In this way, the clinician may program the sensing polarity independent of the stimulation polarity.
The output of sensing circuit 744 is connected to microcontroller 720 which, in turn, triggers or inhibits the pulse generator 722 in response to the presence or absence of cardiac activity. Sensing circuit 744 receives a control signal 746 from microcontroller 720 for purposes of controlling the gain, threshold, polarization charge removal circuitry (not shown), and the timing of any blocking circuitry (not shown) coupled to the inputs of the sensing circuitry.
In the embodiment of
LP 701 further includes an analog-to-digital (A/D) data acquisition system (DAS) 750 coupled to one or more electrodes via switch 726 to sample cardiac signals across any pair of desired electrodes. Data acquisition system 750 is configured to acquire intracardiac electrogram signals, convert the raw analog data into digital data, and store the digital data for later processing and/or telemetric transmission to an external system 754 (e.g., a programmer, local transceiver, or a diagnostic system analyzer). Data acquisition system 750 is controlled by a control signal 756 from the microcontroller 720.
Microcontroller 720 is coupled to a memory 760 by a suitable data/address bus. The programmable operating parameters used by microcontroller 720 are stored in memory 760 and used to customize the operation of LP 701 to suit the needs of a particular patient. Such operating parameters define, for example, pacing pulse amplitude, pulse duration, electrode polarity, rate, sensitivity, automatic features, arrhythmia detection criteria, and the amplitude, waveshape and vector of each stimulation pulse to be delivered to the patient's heart. The memory 760 can also store instructions for performing at least some of the steps of the methods described above with reference to
The operating parameters of LP 701 may be non-invasively programmed into memory 760 through a telemetry circuit 764 in telemetric communication via communication link 766 with external system 754. Telemetry circuit 764 allows intracardiac electrograms and status information relating to the operation of LP 701 (as contained in microcontroller 720 or memory 760) to be sent to external system 754 through communication link 766.
LP 701 can further include magnet detection circuitry (not shown), coupled to microcontroller 720, to detect when a magnet is placed over the unit. A magnet may be used by a clinician to perform various test functions of LP 701 and/or to signal microcontroller 720 that external system 754 is in place to receive or transmit data to microcontroller 720 through telemetry circuits 764.
LP 701 can further include one or more physiological sensors 770. Such sensors are commonly referred to as “rate-responsive” sensors because they are typically used to adjust pacing stimulation rates according to the exercise state of the patient. However, physiological sensor 770 may further be used to detect changes in cardiac output, changes in the physiological condition of the heart, or diurnal changes in activity (e.g., detecting sleep and wake states). Signals generated by physiological sensors 770 are passed to microcontroller 720 for analysis. Microcontroller 720 responds by adjusting the various pacing parameters (such as rate, AV Delay, VV Delay, etc.) at which the atrial and ventricular pacing pulses are administered. While shown as being included within LP 701, physiological sensor(s) 770 may be external to LP 701, yet still be implanted within or carried by the patient. Examples of physiologic sensors might include sensors that, for example, sense respiration rate, pH of blood, ventricular gradient, activity, position/posture, minute ventilation (MV), and so forth.
A battery 772 provides operating power to all of the components in LP 701. Battery 772 is capable of operating at low current drains for long periods of time. Battery 772 also desirably has a predictable discharge characteristic so that elective replacement time can be detected. As one example, LP 701 employs lithium/silver vanadium oxide batteries.
LP 701 further includes an impedance measuring circuit 774, which can be used for many things, including: lead impedance surveillance during the acute and chronic phases for proper lead positioning or dislodgement; detecting operable electrodes and automatically switching to an operable pair if dislodgement occurs; measuring respiration or minute ventilation; detecting when the device has been implanted; measuring stroke volume; and detecting the opening of heart valves; and so forth. Impedance measuring circuit 774 is coupled to switch 726 so that any desired electrode may be used.
It is to be understood that the subject matter described herein is not limited in its application to the details of construction and the arrangement of components set forth in the description herein or illustrated in the drawings hereof. The subject matter described herein is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, it is noted that the term “based on” as used herein, unless stated otherwise, should be interpreted as meaning based at least in part on, meaning there can be one or more additional factors upon which a decision or the like is made. For example, if a decision is based on the results of a comparison, that decision can also be based on one or more other factors in addition to being based on results of the comparison.
Embodiments of the present technology have been described above with the aid of functional building blocks illustrating the performance of specified functions and relationships thereof. The boundaries of these functional building blocks have often been defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and relationships thereof are appropriately provided. Any such alternate boundaries are thus within the scope and spirit of the claimed invention. For example, it would be possible to combine or separate some of the steps shown in
It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments (and/or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the embodiments of the present technology without departing from its scope. While the dimensions, types of materials and coatings described herein are intended to define the parameters of the embodiments of the present technology, they are by no means limiting and are exemplary embodiments. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the embodiments of the present technology should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. Further, the limitations of the following claims are not written in means-plus-function format and are not intended to be interpreted based on 35 U.S.C. § 112 (f), unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function void of further structure.
This application claims priority to U.S. Provisional Patent Application No. 63/587,508, titled DUAL CHAMBER LEADLESS PACEMAKER SYSTEMS AND METHODS FOR USE THEREWITH, filed Oct. 3, 2023, which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63587508 | Oct 2023 | US |
