JP2012505054A - Single-chamber pacing using a dual-chamber pacing device - Google Patents

Abstract

Various embodiments of the present invention are directed to systems, methods and devices for cardiac applications, including cardiac applications associated with pacing devices. One such device is a cardiac rhythm therapy (CRT) device designed for dual chamber pacing, which uses two pacing signals, each having a positive and negative component, modified for single chamber pacing. set to target. The device has a first output connected to the pacing lead, a second output connected to the pacing lead, a third output connected to the reference point, and a second electrical connection to the first output. And an electrical circuit element connecting the third electrical connection to the second output and the first and fourth electrical connections to the third output.

Description

The present invention relates generally to systems, devices, and methods related to cardiac monitoring and treatment, such as ventricular pacing. A more specific aspect of the present invention is a cardiac rhythm therapy that improves cardiac function by pacing a patient's left and right ventricles by providing a pacing signal to one or more electrodes present in the patient's right ventricle. Regarding the use of the mechanism.
(Claiming priority)
This application is incorporated herein by reference, “METHODS, DEVICES AND SYSTEMS FOR SYSTEMS SINGLE-CHAMBER PACING USING A DUAL-CHAMBER PACING”, which is incorporated herein by reference. Claims the priority of Zhu et al. US application Ser. No. 12 / 249,508, filed Oct. 10, 2008, entitled “DEVICE)”.

  A pacemaker is probably the best known device that provides long-lasting electrical stimulation, such as cardiac rhythm management. Modern pacemakers are designed to be implanted in patients undergoing medical treatment. Other examples of cardiac stimulators include implantable cardiac defibrillators (ICDs) and implantable devices that can perform pacing and defibrillation functions. Such implantable devices provide electrical stimulation to selected portions of the heart to treat heart rhythm disorders. Implantable pacemakers pace the heart with timed pacing pulses. The pacing pulse can be timed relative to other pacing pulses or sensed (endogenous) electrical activity. When functioning properly, the pacemaker forces a minimum heart rate to compensate for the heart's inability to pace itself with an appropriate rhythm for metabolic demand. Some pacing devices synchronize pacing pulses delivered to different regions of the heart to coordinate contractions. Coordinated contractions allow the heart to pump efficiently to provide sufficient cardiac output. Clinical data show that cardiac resynchronization achieved through synchronized biventricular pacing results in significant improvement in cardiac function. Cardiac resynchronization therapy improves cardiac function in patients with heart failure. Heart failure patients have reduced autonomic balance associated with increased LV (left ventricular) dysfunction and increased mortality.

  A commonly treated condition is associated with the heart beating too fast or too late. When the heart beats too slowly (often resulting in a condition called bradycardia), pacing can be used to increase the intrinsic heart rate and cure the condition. When the heart beats too quickly (often resulting in a condition called tachycardia), the intrinsic electrical stimulation of the heart itself is in the presence of certain myocardial matrix modifiers (ie, infarcted or non-conducting regions) A circuit may be found that allows the reformer to re-enter the original activation circuit and induce a new activation. These reentrant circuits can result in very fast heart rates that are undesirable and even more lethal. To cure this condition, a rate of anti-tachycardia pacing that is higher than the tachyarrhythmia rate can be used to restore control of the heart rhythm by using special pulse sequences and pulse trains. A system that delivers anti-tachyarrhythmia fast pacing, once acquiring heart control, gradually reduces the pacing rate, expecting normal sinus rhythm to regain control and reduce intrinsic heart rate . Anti-tachycardia pacing is generally used in combination with an implantable defibrillator because pacing bursts can accelerate tachycardia and cause ventricular fibrillation.

  When pacing for bradycardia, a pacing electrode placed subcutaneously is generally placed in the right chamber (right atrium or right ventricle) of the heart. Access to these cavities is readily available through the superior vena cava, right atrium, tricuspid valve and then into the right ventricle. Pacing for both the right atrium and the right ventricle has been developed. Such dual chamber pacing resulted in better hemodynamic output compared to right ventricular only pacing. In addition to treating bradycardia, dual chamber pacing maintained synchronization between the chambers.

  Electrode placement in the left ventricle is usually avoided if access is not as direct as in right ventricular placement. Furthermore, the risk of embolization in the left ventricle is higher than in the right ventricle. Emboli that can arise in the left ventricle due to the placement of the electrode have direct access to the brain via the ascending aorta from the left ventricle. This presents a considerable risk of stroke.

  Recent clinical evidence suggests that traditional ventricular pacing from the right ventricle produces asynchronous left and right ventricular contractions, thereby resulting in poor mechanical contraction and reduced hemodynamic performance is doing. Long-term right ventricular pacing has been found to be associated with an increased risk of generating and / or worsening heart failure.

  The present invention, in some examples, can help to overcome one or more of the above or other challenges. The present invention is illustrated in various embodiments and applications, many of which include tools and methods that are useful or particularly suitable for a number of cardiac conditions that can benefit from ventricular pacing. Aspects of the present invention are illustrated by right and left ventricular pacing from leads in the right ventricle. Embodiments may be used to facilitate mechanically and / or electrically synchronous contractions for resynchronization, or to maintain synchronization during ventricular pacing, among other applications May be. Particular embodiments relate to such pacing for the treatment of bradycardia.

  According to one embodiment, the patient is treated by directly stimulating the normal physiological conduction system of the heart to induce a conduction sequence. The conduction sequence follows the conduction sequence found in the normal heart both spatially and temporally. The degree to which the conduction sequence follows that of a normal heart is generally determined by the state of cardiomyocytes, the current composition of the extracellular matrix, the size, number and distribution of scar tissue due to infarction, and coronary occlusion for cardiac blood flow. Can be affected by the area of ischemia due to, as well as the condition of the myocardial matrix.

  Aspects of the present invention have two electrodes, also called XSTIM waveforms, that have two opposite polarity waveforms (pulse widths between 0.01 ms and 5 ms) simultaneously or nearly simultaneously (within 1-20 ms) ) Based on discoveries related to applying. It has been discovered that it is possible not only to penetrate the root of the His bundle but also to reach multiple areas of the His after branching of the bundle. Penetration for multiple bundles produces a relatively normal conduction response through the right ventricle, left ventricle, and septum. This allows for electrical activation of the distal bundle in that it allows the bypass of many conduction defects in the normal physiological conduction system of the ventricle.

  One embodiment of the present invention is a cardiac rhythm therapy for biventricular pacing using two pacing signals, each having a positive and negative component, modified for single ventricular pacing. (CRT) directed to a method, system, or device (also known as a biventricular pacing device) (if the device is a dual chamber biventricular device with atrial sensing and pacing capabilities, that aspect of the device remains Can be made). A first output is provided for connecting to the pacing lead, a second output is provided for connecting to the pacing lead, and a third output is connected to the reference point. Provided. The reference point can be the conductive can of the device or can be an electrode on any other lead connected to the device. For example, the reference point can be the distal or proximal defibrillation coil of the defibrillation lead and the defibrillator device has been modified to implement the XSTIM right ventricular waveform configuration. An electrical circuit element for connecting the second electrical connection to the first output, the third electrical connection to the second output, and the first and fourth electrical connections to the third output; Provided. If the device has the ability to sense and pace the atrium, the atrial sensing and pacing output may remain connected to the atrial lead.

  Aspects of the invention are directed to a pacing system having a signal generator that provides a first pacing signal and a second pacing signal, each pacing signal having positive and negative signal components. The pacing lead paces the heart from a single chamber of the heart, and the pacing lead has a first electrode and a second electrode. The circuit element connects the positive component of the first pacing signal and the negative component of the second pacing signal to a common reference, and also converts the negative component of the first pacing signal to the first component. At least a portion of the signal components of the two pacing signals are routed to the pacing lead by connecting the positive component of the second pacing signal to the second electrode to one electrode.

  Aspects of the invention provide a biventricular cardiac resynchronization therapy (CRT) device that provides biventricular pacing using a first pacing signal and a second pacing signal, each pacing signal having positive and negative signal components. Can be used in connection with The second and third outputs are connected to the reference point. The first and fourth outputs are connected to respective inputs of the pacing lead. A positive component of the first pacing signal is provided at the first output, a negative component of the first pacing signal is provided at the second output, and a positive component of the second pacing signal is provided at the third output. And the negative component of the second pacing signal is provided to the fourth output.

  According to an exemplary embodiment of the present invention, a cardiac resynchronization therapy (CRT) device is improved. An unmodified CRT device provides biventricular pacing using a first pacing signal for one chamber of the heart and a second pacing signal for another chamber of the heart. A CRT device uses a circuit element that references a common reference component for each pacing signal and a single chamber using a negative component from one pacing signal and a positive component from the other pacing signal to pace the single chamber. Improved by adding a pacing lead for using the CRT device to provide pacing, the pacing signal includes a negative pulse and a positive pulse, each referenced to a common reference component.

  Aspects of the present invention provide a first pacing signal having a positive component provided to a first electrical connection and a negative component provided to a second electrical connection, and a third electrical connection. For use with a cardiac resynchronization therapy (CRT) device designed for biventricular pacing using a second pacing signal having a positive component provided and a negative component provided to a fourth electrical connection The circuit for this is intended. The circuit includes a first output connected to the pacing lead, a second output connected to the pacing lead, a third output connected to the reference point, and a second electrical connection to the first output. An electrical circuit element configured to connect, connect a third electrical connection to the second output, and connect the first and fourth electrical connections to the third output.

  Another embodiment of the present invention connects the pacing lead to a cardiac rhythm therapy (CRT) device designed for dual chamber pacing that uses two pacing signals, each having a positive and negative signal component. With respect to the device, the positive component of the first pacing signal is provided at the first output, the negative component of the first pacing signal is provided at the second output, and the positive component of the second pacing signal is Provided to the third output, the negative component of the second pacing signal is provided to the fourth output, and in the case of dual chamber pacing, the first and second outputs are used by the first lead And the third and fourth outputs are for use by the second lead. The interface includes a connector housing that physically fits into the two interfaces of the CRT device. The first interface provides first and second outputs, the second interface provides third and fourth outputs, and each interface is arranged to physically fit a pacing lead. The The device includes electrical connections from the second and third outputs to the reference point and from the first and fourth outputs to respective inputs of the single pacing lead, thereby providing a single pacing lead. The line is used to allow single chamber pacing.

  Aspects of the invention provide a pacing system from a cardiac rhythm therapy (CRT) device having a signal generator that provides a first pacing signal and a second pacing signal, each pacing signal having positive and negative signal components. Targeting how to make. A pacing lead is provided for delivering pacing to a chamber of the heart and has a first electrode and a second electrode. The signal components of the two pacing signals are obtained by connecting the positive component of the first pacing signal and the negative component of the second pacing signal to the common reference, and the negative component of the first pacing signal. The first electrode is connected to the pacing lead by connecting the positive component of the second pacing signal to the second electrode.

  Embodiments of the present invention are directed to a method of manufacturing a pacing system. A signal generator is produced that provides a first pacing signal and a second pacing signal, each pacing signal having positive and negative signal components. A pacing lead having a first electrode and a second electrode for delivering pacing to a chamber of the heart is produced. By connecting the positive component of the first pacing signal and the negative component of the second pacing signal to the common reference, and the negative component of the first pacing signal to the first electrode, By connecting the positive component of the pacing signal to the second electrode, a circuit element is produced that routes the signal components of the two pacing signals to the pacing lead.

  Aspects of the present invention provide signal routing for connecting pacing leads to a cardiac rhythm therapy (CRT) device designed for dual chamber pacing, using two pacing signals each having a positive and negative signal component. Intended for the matrix, the positive component of the first pacing signal is provided at the first output, the negative component of the first pacing signal is provided at the second output, and the positive component of the second pacing signal. The component is provided at the third output, the negative component of the second pacing signal is provided at the fourth output, and in the case of dual chamber pacing, the first and second outputs are provided by the first pacing lead The third and fourth outputs are for use by the second pacing lead. The signal routing matrix includes electrical connections from the second and third outputs to the reference point, and from the first and fourth outputs to the respective inputs of the single pacing lead, so that A single pacing lead is used to allow single chamber pacing.

  Example 1 may include a pacing system for use with a lead that includes a first electrode and a second electrode for pacing the heart from a single chamber of the heart. The pacing system may comprise a signal generator configured to provide first and second pacing signals each having a positive and negative signal component. The configurable routing circuit routes the positive component of the first pacing signal and the negative component of the second pacing signal to the common signal reference, and the negative component of the first pacing signal is the first component. The electrode can be configured to route the positive component of the second pacing signal to the second electrode.

  In Example 2, the subject matter of Example 1 may optionally include a first capacitive component that provides a first pacing signal and a second capacitive component that provides a second pacing signal.

In Example 3, the subject matter of any one of Examples 1-2 may optionally include a lead that includes a first electrode and a second electrode for pacing the heart from a single chamber of the heart.
In Example 4, the subject matter of any one of Examples 1-3 can optionally include an interface that electrically connects the first and second outputs of the signal generator, where the first and second outputs are Each provides a respective one of the first and second pacing signals for the lead.

In Example 5, the subject matter of any one of Examples 1-4 may optionally further include a third output configured to provide a pacing signal.
In Example 6, the subject matter of any one of Examples 1-5 may optionally include a sense input that detects a cardiac electrical signal.

In Example 7, the subject matter of any one of Examples 1-6 may optionally include pacing control circuitry that modifies the first and second pacing signals.
In Example 8, the subject matter of any one of Examples 1-7 can optionally include a lead configured to sense atrial activity.

  In Example 9, the subject is a biventricular cardiac resynchronization therapy configured to provide biventricular pacing using a first pacing signal and a second pacing signal, each having a positive and negative signal component. (CRT) device, wherein a positive component of the first pacing signal is provided at the first output, a negative component of the first pacing signal is provided at the second output, and the second pacing signal For use with a biventricular cardiac resynchronization therapy (CRT) device, a positive component is provided at the third output and a negative component of the second pacing signal is provided at the fourth output. Any one of examples 1-8 to include a method comprising connecting a third output to a signal reference and connecting the first and fourth outputs to respective inputs of the lead. May include subject or optional In-option may be combined with any one of the subject Examples 1-8.

  In Example 10, the subject matter of any one of Examples 1-9 is optionally placed on the lead in relation to the left ventricle of the heart and carried on the first and fourth outputs. Providing an electrical signal to the left ventricle of the heart may be included.

  In Example 11, the subject matter of any one of Examples 1-10 optionally includes placing a lead in association with the left ventricle of the heart and transmitting electrical signals carried on the first and fourth outputs of the heart. Providing to the left ventricle, monitoring cardiac function in response to provided electrical signals, evaluating efficacy as a function of monitored cardiac function, and in response to evaluation, lead placement or Adjusting one or more characteristics of the electrical signal may be included.

  In Example 12, any one of the subjects of Examples 1-11, optionally, iteratively repeating the providing, monitoring, and adjusting steps, and in response to multiple evaluations, long-term It may include selecting one or more characteristics of the lead placement or electrical signal for use in continuous pacing.

  In Example 13, the subject matter of any one of Examples 1-12 is optionally in response to sensing atrial activity and sensing atrial activity and atrioventricular (AV) delay, Providing an electrical signal carried on the fourth output to the left ventricle of the heart.

In Example 14, the subject matter of any one of Examples 1-13 can optionally include modifying AV delay as a function of cardiac response to the provided electrical signal.
Example 15 provides cardiac resynchronization therapy (CRT) using a first pacing signal for one chamber of the heart and a second pacing signal for another chamber of the heart when providing biventricular pacing. ) To include a device, can include the subject matter of any one of Examples 1-14, or, optionally, can be combined therewith, the CRT device can include each of the first and second pacing signals A CRT to provide single-chamber pacing using a negative component from one pacing signal and a positive component from the other pacing signal to pace a single lumen A pacing output configured to be coupled to a lead for use with the device, wherein the pacing signal is a negative pulse, each referenced to a common reference component. And a positive pulse.

In Example 16, the subject matter of any one of Examples 1-15 can optionally include pacing control circuitry that modifies at least one characteristic of the first and second pacing signals.
In Example 17, the subject matter of any one of Examples 1-16 may optionally include a sensing circuit that generates a signal indicative of synchrony of heart contractions.

In Example 18, the subject matter of any one of Examples 1-17 can optionally include a circuit element that provides a third pacing signal.
In Example 19, the subject matter of any one of Examples 1-18 can optionally include sense circuitry that detects a cardiac atrial activity signal.

  Example 20 is provided for a first pacing signal having a positive component provided to the first electrical connection and a negative component provided to the second electrical connection, and a third electrical connection. For use with a cardiac resynchronization therapy (CRT) device designed for biventricular pacing using a second pacing signal having a positive component and a negative component provided to a fourth electrical connection A first output connected to the pacing lead, a second output connected to the pacing lead, a third output connected to the reference point, and a second electrical connection to the first An electrical circuit element configured to connect the third electrical connection to the second output and the first and fourth electrical connections to the third output at the output of To include any one of the subjects of Examples 1-19 Or optionally, the same may be combined.

  In Example 21, the subject matter of any one of Examples 1-20 is optionally that the first and second outputs are any electrical connections of the first, second, third, or fourth electrical connections. An electrical circuit that can be programmed to be connected to the unit can be included.

In Example 22, the subject matter of any one of Examples 1-21 can optionally include first and second pacing signals that are generated using independently referenced signal sources.
In Example 23, the subject matter of any one of Examples 1-22 can optionally include first and second capacitive sources that each include positive and negative terminals, respectively, The positive and negative terminals of the capacitive source correspond to the first and second electrical connections, respectively, and the positive and negative terminals of the second capacitive source correspond to the third and fourth electrical connections, respectively. Corresponding respectively, the first and second pacing signals are each provided by one of the first and second capacitive sources referenced independently from the other of the first and second capacitive sources.

Example 24 illustrates a cardiac rhythm therapy (CRT) device designed for dual chamber pacing that uses two leads, each providing first and second pacing signals, each having a positive and negative signal component. A device that connects a single lead to a positive component of the first pacing signal is provided to the first output, a negative component of the first pacing signal is provided to the second output, and The positive component of the second pacing signal is provided at the third output, the negative component of the second pacing signal is provided at the fourth output, and in the case of dual chamber pacing, the first and second outputs are: In order to include a device for use by a first lead and the third and fourth outputs are for use by a second lead of Examples 1-23 Including any one subject Or optionally combined with it, the device is a connector configured to physically fit into two interfaces of the CRT device, the first interface being the first And a second output, a second interface providing a third and a fourth output, each interface being arranged for physically mating with a respective lead, Electrical connections from the second and third outputs to the signal reference, and from the first and fourth outputs to the respective inputs of the single lead, thereby using a single lead In Example 25, the subject matter of any one of Examples 1-24 optionally includes a device configured to physically fit into a third interface of the CRT device. U .

  In Example 26, the subject matter of any one of Examples 1-25 can optionally include a device in which the electrical connection further includes a connection between the sense signal of the third interface and a single lead.

In Example 27, any one of the subjects of Examples 1-26 can optionally include a device in which the electrical connection further includes a connection between the fifth and sixth outputs and the second lead. .
Example 28 includes a method of making a pacing system from a cardiac rhythm therapy (CRT) device having a signal generator that provides a first pacing signal and a second pacing signal, each having a positive and negative signal component, respectively. Can include the subject matter of any one of Examples 1-27, and optionally can be combined with it, the method using a lead for delivering pacing to the heart cavity Wherein the lead includes a first electrode and a second electrode for use and connects the positive component of the first pacing signal and the negative component of the second pacing signal to the common reference And by connecting the negative component of the first pacing signal to the first electrode and the positive component of the second pacing signal to the second electrode, It includes connecting the signal component of the second pacing signal to the leads.

In Example 29, the subject matter of any one of Examples 1-28 can optionally include attaching an electrical interface to the CRT device that provides the connection of signal components.
In Example 30, the subject matter of any one of Examples 1-29 can optionally include configuring a programmable connection array of CRT devices, where the configuration results in the connection of signal components.

In Example 31, the subject matter of any one of Examples 1-30 can optionally include connecting a sense signal component to a lead.
Example 32 can include the subject matter of any one of Examples 1-31 to include a method of manufacturing a pacing system, or can optionally be combined with it, each method being correct Producing a signal generator that provides a first pacing signal and a second pacing signal having respective negative and signal components, and a negative component of the first pacing signal and the negative of the second pacing signal By connecting the component to the common reference, and by connecting the negative component of the first pacing signal to the first electrode and the positive component of the second pacing signal to the second electrode, Producing a circuit element for routing the signal components of the first and second pacing signals to a lead comprising the first and second electrodes.

  Example 33 is for a cardiac rhythm therapy (CRT) device designed for dual chamber pacing using first and second leads, each using two pacing signals having positive and negative signal components, respectively. A means for including or using a signal routing matrix connecting the leads can include any one means of Examples 1-32, or can optionally be combined with the first A positive component of the pacing signal is provided at the first output, a negative component of the first pacing signal is provided at the second output, and a positive component of the second pacing signal is provided at the third output. The negative component of the second pacing signal is provided at the fourth output, and in the case of dual chamber pacing, the first and second outputs are for use by the first pacing lead. , The third and fourth outputs are for use by the second pacing lead, the signal routing matrix from the second and third outputs to the reference point, and the first and An electrical connection from the fourth output to the respective input of the lead is provided, thereby allowing single lumen pacing using the lead.

  In Example 34, the subject matter of any one of Examples 1-33 can optionally include or use a matrix with electrical connections from the output of the lead to the sensing input of the CRT device.

In Example 35, any one of the subjects of Examples 1-34 may optionally include or use an electrical connection from the fifth and sixth outputs to the respective input of the second lead. sell.
As indicated above, the aspects and examples discussed above are not to be construed as limiting the scope or teaching of the disclosure herein. Those skilled in the art will recognize that the present invention can be embodied in many ways, including but not limited to the aspects and examples discussed above, based in part on the various discoveries identified herein. Will do.

  The present invention is more complete in view of the detailed description of various exemplary embodiments set forth in accordance with the invention, presented hereinafter with reference to the following figures, each consistent with the invention. May be understood.

FIG. 2 is a diagram of a modified CRT device consistent with an exemplary embodiment of the present invention. FIG. 9 is a diagram of a CRT device, such as the modified CRT device in FIGS. 1A-8, placed in the heart, consistent with an exemplary embodiment of the present invention. FIG. 3 shows an interface and circuit for providing pacing signals consistent with the present invention. FIG. 3 illustrates an interface and circuitry for providing pacing signals consistent with embodiments of the present invention. 1 is a diagram of a modified dual chamber pacemaker (DDD) device consistent with an exemplary embodiment of the present invention. FIG. 1 is a diagram of a modified dual chamber pacemaker (DDD) device consistent with an exemplary embodiment of the present invention. FIG. FIG. 2 is a diagram of a modified DDD device consistent with an exemplary embodiment of the present invention. FIG. 2 is a diagram of a modified DDD device consistent with an exemplary embodiment of the present invention. FIG. 2 is a dual chamber DDD CRT device consistent with an exemplary embodiment of the present invention.

  While the invention is susceptible to various modifications and alternative forms, various embodiments have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention.

The present invention is believed to be applicable to a variety of different types of devices and techniques, and the present invention is based on a lead in the right ventricle having an electrode placed behind the root of the septal cusp of a tricuspid valve. It has been found to be particularly suitable for maintaining and reestablishing normal conduction of the ventricular activation sequence, both its spatial and temporal distribution. The exact spot depends on the location of the block that needs to be bypassed. This spot may depend on the location of the fiber bundle that blocks the conduction circuit and produces an abnormality. In many patients, this location is close to the septal cusp of the tricuspid valve and the fibrous atrioventricular and ventricular septum.
While the present invention is not necessarily limited to such applications, various aspects of the invention may be understood through the description of various embodiments using this context.

  Various aspects of the present invention, including methods and devices, have been discovered to facilitate deep penetration into hispanic roots and distal bundles. This penetration may include the left bundle and its branches, the right bundle and its branches, and the septal bundle. This includes various types of leg blocks (e.g., right bundle block RBBB (proximal and distal), left leg block LBBB (proximal and distal), left leg Left anterior hemiblock LAHB (proximal and distal), left foot hemiblock LPHB (proximal and distal), intraventricular conduction defect IVCD, RBBB with left-axis bias, and , Many other types of complex conduction defects) may be particularly useful. One such aspect of the present invention is directed to the ability and use of waveforms such as XSTIM to penetrate deeply into the conduction system near the His bundle. For example, the use of an XSTIM waveform can be useful in creating large virtual electrodes and overcoming body capacitance compared to other waveforms.

  The conduction system near the His bundle can be thought of as a group of electrical conductors each surrounded by an electrical insulator. Thus, pacing introduced into the conduction system can be provided by capacitance between electrical conductors. Electrical conductors can transmit electrical impulses from cell to cell in the longitudinal direction, but within the bundle there is very little conductivity in the lateral direction. However, strategically placed bridges between cells are thought to allow electrical stimulation to jump from one bundle to another. This mechanism is believed to provide some degree of redundancy if a particular bundle stops work due to, for example, an infarct or microinfarct. As the bundle travels toward its destination in Purkinje fibers, it branches into a set of conductive fibers. The set of fibers is electrically isolated from the rest of the myocardium by special tissue, and the electrical pulse passes through a special conduction system, so that the surrounding distributed capacitor network (at its transverse cut, the His bundle is a cardiomyocyte) Electrical depolarization) is prevented. It is believed that the combination of electrical conductor and insulator effectively creates an intermediate portion of at least two series capacitors. Since the cell membrane of the His bundle is also an insulator, the intracellular fluid inside the His bundle cell is still placed inside another capacitor.

  The XSTIM waveform provides a relatively large virtual electrode, and its asymmetric dogbone shape will be affected by the polarity of the waveform, and therefore the penetration of the waveform is the relative polarity applied to the two electrodes. It becomes possible to adjust by correcting. The XSTIM waveform also provides high frequency stimulation energy that can bypass the capacitor. Therefore, it is considered that the XSTIM waveform can penetrate deeply into the His bundle. Even when two opposite polarity pulses are separated by a few milliseconds (0-20 ms), the waveform appears to penetrate the bundle and even reach the distal bundle that was previously considered unreachable.

  Furthermore, it has been discovered through experimental data that there is no single capture threshold for myocardium and His bundles. In fact, many patient responses change as the pacing voltage increases. As the XSTIM amplitude gradually increases from a sub-threshold value, an initial capture (prior art) threshold is found that triggers a depolarization sequence that activates the ventricles. In many patients, this involves a second threshold that triggers the capture of some fibers of the His bundle. In patients with ventricular conduction defects, successive changes in the electrocardiogram (ECG), QRS width, fractionation level, and 12-lead ECG vector are observed as the XSTIM amplitude further increases. At some point, the saturation point is reached and little or no further improvement is seen. With careful positioning and selection of amplitude levels, pacing stimuli can reach the farthest blocked fibers of the conduction system, and thus improve contraction coordination to near normal levels.

  The ability to achieve a normal conduction response includes infarcts, cardiomyocyte numbers, degeneration, mitochondrial availability, blood supply, presence of interstitial fibrosis, reduced matrix metalloproteinases, etc. Can depend on the health of the substrate without limitation. The extraordinary meaning of these and other discoveries is achieved using a variety of wave shapes and electrode configurations designed to allow similar effects to pass through a capacitive network (eg, by high frequency signal components). That is. The effective capacitance is low for high frequency components, including frequency components that are sufficient to induce action potentials (0.01-20 ms). Some waveforms are less efficient and use more energy to achieve similar results, but the present invention is not limited to the most efficient application of waveforms.

  Aspects of the invention relate to the discovery that the distal block of the His bundle can be bypassed using proximal stimulation of the bundle. For example, such a block can be bypassed by applying appropriate electrical energy (pacing pulses) to the area of the His bundle. This region is located proximal to the tricuspid annulus and passes just behind the septal cusp of the tricuspid valve on the right ventricular side. This same region can be reached from the right atrium to the atrial side of the tricuspid valve by the root of the tricuspid valve.

  Another aspect of the invention relates to the use of large amplitude (20-36 volts) monopolar or bipolar pulses applied to the region. For example, a monopolar pulse can be applied between two electrodes located in the region of hiss, allowing penetration that is deep enough to activate many fibers of the conduction system. In general, the required voltage is on average much higher than the energy required for XSTIM pacing signals. Furthermore, human studies have suggested that these high voltage pulses can be felt by the patient and in some cases can lead to undesirable muscle contractions.

  Aspects of the invention can be found in existing devices (eg, devices used for bradycardia (pacemakers), devices used for tachyarrhythmias (alone or in combination with CRT, ICD, or CRT + ICD)). Defibrillator-ICD) and devices used for heart failure (cardiac resynchronizer-CRT delivering cardiac resynchronization therapy) to devices that can implement XSTIM waveforms and electrical bypass therapy set to target.

  Typically, the ventricular activation sequence begins on the atrial side of the atrioventricular node and propagates to the root of the His bundle where the His bundle branches into a number of small bundles grouped into right and left bundles. The fibers in each bundle are generally insulated from each other. However, there are places that exhibit low insulation at predetermined intervals along the bundle. These bundles are electrically isolated from the surrounding tissue and terminate in Purkinje cells that are responsible for transmitting electrical activation to cardiomyocytes. A normal heart conducts electrical signals from the His bundle through the entire ventricle in about 60-70 ms. Conduction abnormalities, such as those due to infarctions or microinfarcts, can prevent or block the conduction of electrically activated impulses through special His fibers. Such a block results in Purkinje cells that do not receive an electrical activation impulse through the conductive fiber. Thus, cardiomyocytes normally stimulated by these Purkinje cells are not stimulated in the normal manner. Instead, these cardiomyocytes are stimulated from electrical signals that propagate through the cardiomyocytes that actually receive the electrical activation pulse from the conduction fiber. The conduction velocity between cardiomyocytes is much slower than that of conduction fibers. For example, conductive fibers have a conduction velocity of about 2 m / s, while the cardiomyocyte cell-to-cell conduction velocity is about 0.5 m / s. Thus, these blocks can significantly distort both the spatial and temporal distribution of ventricular electrical activation. These temporal and spatial activation sequence distributions introduce mechanical asynchrony that can adversely affect cardiac hemodynamics. Such mechanical asynchrony is a set of progressive mal-adaptive compensatory processes in the slow activation region, dilation among the processes, especially fibroblast proliferation, local proto-oncogene activity. , Compensatory local hypertrophy, and increased sympathetic / parasympathetic balance. These processes can result in heart failure that may be delayed or prevented if conduction abnormalities were not initially present there. Thus, according to aspects of the present invention, maintaining and re-establishing a normal conduction sequence has the considerable advantage of delaying, stopping, or even reversing the progression of the pathology towards heart failure. Yes.

  For other forms of resynchronization therapy, the activation sequence is initiated from two sites in the right and left ventricles to stimulate cardiomyocytes directly rather than using the normal conduction system. This results in an odd activation sequence. In one embodiment, the physician is instructed to place at least one lead in the epicardium of the left ventricle (eg, by placing the lead in the coronary venous system of the left ventricle). . This placement creates a further type of asynchrony because the activation sequence is not only slow but also reversed with respect to the normal / healthy sequence. Despite these problems with such treatments, this type of cell-to-cell activation sequence (without activation of the conduction system) is better than other applications of CRT. The success rate of CRT using dual chamber pacing is limited to only about 60-70% of patients, and the raw activation sequence is “worse” than the new artificial sequence generated by biventricular pacing.

  Accordingly, aspects of the present invention are useful for providing a modality that resynchronizes the ventricles and can be easily implemented. For example, embodiments of the present invention relate to a method that does not require placing a lead in the LV through the coronary sinus and into the LV cardiac vein or something, which is only for high-complexity facilities. In addition, it can only be achieved by highly specialized physicians after long-term expensive training. Furthermore, embodiments of the present invention provide pacing benefits safely (eg, one less lead may fail or cause problems) for patients who would otherwise not have viable treatment options Yes.

  In some embodiments, the present invention is intended to facilitate mechanically and / or electrically synchronous contractions for resynchronization (possibly due to conduction abnormalities such as a left leg block (LBBB)). Used and in response to aspects of the present invention, the left ventricle restores the ability of the left ventricle to rapidly contract and / or synchronize the septal myocardium and each free wall (s). did. While the invention is not necessarily limited to such applications, various aspects of the invention may be understood through the description of various embodiments using the context.

  Consistent with the specific embodiments and various discoveries realized in connection with the present invention, cardiac function can be improved by pace-mapping and / or by delivering pulses to the heart site. Cardiac function is indicated or measured using various techniques. Typical examples are QRS width narrowing, reduced level of QRS fragmentation in 12-lead ECG, normalization or improvement of 12-lead ECG vector angle, reduced slow LV activation timing, free wall and bulkhead machinery Improvement of dynamic synchrony, improvement of left ventricular pressure increase rate, improvement of hemodynamics indirectly evaluated from right ventricular pressure measurement, reduction of left ventricular end-diastolic pressure, improvement of effective pressure, improvement of heart sound, heart sound Loss of S3 component, improved cardiac acceleration profile evaluated using accelerometer, improved efficiency of contraction (amount of energy expended for 100 ml of released blood), evaluated using impedance or other techniques Improving patient respiratory profile or patient minute ventilation, increasing parasympathetic / sympathetic balance, improving heart rate change profile, patient active Improvement of the percentage of time that an improvement of the level of pulmonary edema is assessed by impedance techniques, and / or comprising it / detecting measuring any combination thereof, but is not limited thereto. In certain implementations, pacing can be implemented using XSTIM waveforms in the target pacing region.

  Various sensing devices can be used to evaluate the effectiveness of the pacing signal and location. Examples of suitable sensors are dP / dt max (maximum rate of increase in left ventricular pressure measured directly from echo technique or right ventricular pressure measurement or derived indirectly), to assess cardiac output Sensors that can be used, including but not limited to, QRS narrowing, electrocardiographs that can be used to quantify the reduction in the level of QRS fragmentation in 12-lead ECGs. Other examples include, but are not limited to, the following devices or cardiac function sensing. That is, a vector electrocardiograph or body surface mapping device is used to evaluate normalization or improvement of the vector angle of 12-lead ECG, reduction of late LV activation timing, improvement of free wall and septum mechanical synchrony Many methods and devices exist to assess directly or indirectly the improvement in the rate of increase in left ventricular pressure, and implantable or external sensors are indirectly derived from right ventricular pressure. A microphone and heart sound quantification device that can be used to evaluate hemodynamic improvement and / or evaluate left ventricular end-diastolic pressure reduction and / or evaluate effective pressure improvement Can be used to improve heart sound, assess the disappearance of the S3 component of heart sound, embedded inside the patient (ie, at the tip of the lead), or An accelerometer on the surface of the body can be used to assess the improvement in the acceleration profile of the heart, where the intracardiac temperature improves the efficiency of contraction (the amount of energy expended for 100 ml of released blood). Intrathoracic impedance measurement or intracardiac lead impedance measurement can be used to evaluate improvement in patient respiratory profile or patient minute ventilation, Heart rate change analysis can be used to assess an increase in parasympathetic / sympathetic balance and / or overall improvement in heart rate change profile, and implantable accelerometers are active in patients Can be used to assess improvement in the percentage of time, intrathoracic or lead impedance is an improvement in the level of lung edema It can be used to evaluate the, and / or may be any combination thereof is used. These other aspects are measured directly, or use an increase in systolic pressure or a decrease in diastolic pressure, and the goal is that there is no change in systolic pressure. It can be measured using indirect non-invasive measurements such as cuff-based estimation of diastolic arterial pressure. Another indirect estimation method involves extrapolating relevant hemodynamic information from right ventricular pressure.

  Aspects of the invention are directed to locating and / or pacing a target pacing region. In one embodiment, the target pacing region is at or near the His bundle. In certain embodiments, locating the target pacing region may be aided by determining possible locations for blocked fibers. This can be accomplished using anatomical knowledge and extrapolation for two-dimensional fluoroscopy. The pacing catheter can be placed near a determined location for delivery of pacing signals. Sensors such as a 12-lead ECG that detect possible improved / normal QRS and activation vectors for the patient are used to locate the optimal application site.

  According to one embodiment of the invention, a preformed sheath or steerable or deflectable sheath having a pair of electrodes at its tip is used for pace-mapping. Once the optimal application site has been determined, the permanent pacing catheter is introduced into the site identified by the sheath without moving its tip, and the catheter is then moved into place, for example by screwing into the septum. Fixed. Atrioventricular delay (time from sensed atrial event to release of pacing stimulus at optimal site), pacing (eg, XSTIM) amplitude, interpulse distance (-20 ms for first pulse to second opposite polarity pulse) ~ + 20 ms), the polarity of the pulse (-to tip or + to tip), and the order of polarity (-is first or + is first) when the interpulse distance is greater than zero, in one embodiment, in the embedded lead Can be optimized using indirectly derived electrocardiograms obtained from existing electrodes (see above for other sensors that can be used for site optimization). For background information on such implant procedures, please refer to “Wireless ECG in Implantable Devices” issued November 20, 2007, which is incorporated herein by reference in its entirety. Reference may be made to US Pat. No. 7,299,086, assigned to the name McCabe et al.

  In some embodiments, optimization may be performed by implanting a right ventricular pressure sensor that senses a right ventricular pressure direct measurement. Such a sensor can detect right ventricular systolic pressure. This detection can be used to extrapolate left ventricular response such as left ventricular systolic pressure or preferably dP / dt max or left ventricular end diastolic pressure (LVEDP). In order to ensure hemodynamic stability, these measurements can be performed while the patient is at rest. When the atrial rate can be monitored and it is discovered that a low and stable rate period is occurring, other sensors (ie, the patient is at rest or has minimal movement) An accelerometer) can be used. These measurements made during a stable rate are then used to adjust the parameters and / or placement of the pulse generator. Parameter adjustment can be performed automatically by the device after the implantation is finished, for example, parameter adjustment is a standard where the starting point is the previous point and the parameter is adjusted by 10-30% up Can be achieved by a simple dichotomy. If no different effects are seen, the parameters are adjusted 10-30% below. If a beneficial effect is seen, the parameter is then adjusted further by 10-30% below, eventually a deleterious effect is seen, at which point the last adjustment is cut in half and the parameter is Adjusted by 5-15% above and the measurement is taken again. If the effect is still harmful, the parameters are adjusted by 2.5-7.5% above until a beneficial effect is seen. The adjustment will then naturally converge to the optimal parameters.

  According to another embodiment, in a patient with an expanded heart, the physician prefers the heart as an organ rather than the rest of the body to facilitate heart healing and reverse remodeling You may choose as follows. To that end, left ventricular preload can be reduced while maintaining cardiac synchrony using pacing such as XSTIM at the optimal site. This is part of the method discussed herein, where the parameters were adjusted to find the optimal left ventricular function to find the functional point at which the heart was providing the body with a high level of cardiac output. Different. However, this type of optimization can be suboptimal in terms of effects on the heart. Aspects of the invention allow maintenance of ventricular synchrony for a variety of different AV delays. For example, the ability of XSTIM CRT to maintain synchrony at various AV delays allows the use of AV delays that are beneficial for dilated hearts even when the AV delay is suboptimal for left ventricular preload. Thus, for patients with extremely dilated hearts, the AV delay can be set to a very short delay. AV delay can be determined by reducing AV delay after mitral valve closure until left atrial contraction begins to occur. This event represents the shortest possible AV delay that does not compromise lung function by increasing pulmonary capillary wedge pressure. At the same time, this AV delay allows the heart to function at the lowest possible end diastolic pressure and preload. These measurements can be easily made using current art Doppler echocardiography. Optimizing AV delay with the methods taught in this disclosure may allow the heart to work with low preload to increase the likelihood of reverse remodeling. After the heart exhibits an improvement / inverse remodeling, the AV delay can be increased to a setting that is set according to the techniques described previously (eg, ECG, RV pressure, LV dP / dt, ECG measurement, LVEDP, etc.).

  In certain embodiments of the invention, the AV delay setting is initiated with a very low AV delay determined by the implanting physician using estimates, patient symptoms, or Doppler echocardiography as described above. After a predetermined amount of time (ranging from weeks to months programmable by the physician), the device is set to automatically switch the AV delay of the implantable device to improve the overall hemodynamic function. sell. Alternatively, uncomplicated devices can be programmed with an initial short delay. The device is also programmed with a long AV delay target that slows the AV delay from a short value to a long value determined by the physician within a period established by the physician using clinical judgment. Obtained by increasing.

  Some methods and specific aspects consistent with these and other embodiments of the present invention include guiding a catheter-type device that delivers a pulse to a cardiac site in need of improved cardiac function, To improve, determine pacing (voltage) thresholds beyond the capture threshold, deliver pulses of opposite polarity to achieve such improved cardiac function, pulses of opposite polarity to sites near the His bundle Delivering, electrode-based hispacing without necessarily penetrating into the His bundle, generating and / or delivering multiple pacing profiles (eg, pacing profile delivering opposite polarity pulses and another pacing RV (by repeating different pacing profiles, including profiles), The distal BBB (leg block) and / or by delivering a pacing profile to generate a synchronized contraction of the LV septum and free wall from the pacing site and at a site near the root of the His bundle Or relates to treating one or more of the diffuse BBB.

  Various embodiments of the present invention include stimulation catheters, systems, and methods that use two or three electrodes. In certain embodiments of the invention, the two most distal electrodes are located at the tip of the catheter. According to a particular embodiment, the distal two electrodes are separated by 4 mm and the electrodes are implemented at the tip of the catheter as a 2 mm thick ring and a 4 mm diameter hemisphere of a 4 French catheter. An optional third electrode may be located at several locations, such as on the lead body at some distance from the first pair, or even between the pairs. Transvenous localization for a reference electrode can be used when the time to separate two opposite polarity pulses is not zero. This can be useful to reduce the possibility of pocket stimulation.

  As a specific example of unexpected results, treat patients with various cardiac abnormalities previously considered unsuitable for His bundle pacing (eg, large QRS complex with distal left bundle block or diffuse left bundle block) Thus, it has been discovered that His bundle pacing and / or para-Hisian pacing can be used. It has also been discovered that the complexity of implantation (eg, duration and / or invasiveness) can be beneficially influenced by the use of specific devices, systems and placement methods.

  According to an exemplary embodiment of the invention, a special stimulation profile is used to capture the left and right ventricular synchronous contractions. This stimulation profile is provided to the lead in the right ventricle. This lead placement and stimulation profile is selected as a function of the sensed cardiac function during pacing. In particular, lead placement and stimulation profiles are determined based on more information (eg, QRS width or slow activation site timing) than whether the placement / profile provides capture. In some examples, this is a pacing voltage / profile that would otherwise not be desirable (eg, a voltage derived from criteria other than the capture threshold, and / or that the pacing lead penetrates the surrounding (fibrous) tissue. Without his bundle pacing).

  An understanding of the various embodiments of the present invention can be facilitated by a description of existing pacing, implantation, and associated procedures and devices. While there are a number of differences between the various embodiments of the present invention and such existing pacing, the present invention does not exclude embodiments that include existing pacing aspects. Conversely, aspects of the present invention are particularly useful for implementation with existing pacing methods and devices. Thus, some embodiments of the present invention provide the flexibility of being useful when combined with existing implementations.

  Aspects of the present invention facilitate the use of existing CRT device architectures produced by several manufacturers to function for use with newly discovered inventions in the underlying patent documents. These inventions include the use of an XSTIM waveform (two opposite polarity pulses used to capture a single contraction of the heart) that provides resynchronization therapy from a lead located in the right ventricle, It is not limited.

  Current art biventricular CRT (cardiac resynchronization therapy) devices have two independent ventricular channels: one channel for RV and the other channel for LV. Such CRT devices are often configured to provide two opposite polarity pulses with programmable amplitude, pulse width, and relative time delay. Aspects of the invention facilitate the output of two opposite polarity pulses having programmable amplitude, pulse width, and relative time delay (including no delay).

  In accordance with one embodiment of the present invention, a modification is made to a dual chamber CRT device having a flexible analog / digital chip design architecture to enable on-chip reconnection between different output terminals and output circuit elements. It becomes possible. For example, an XSTIM capable device can be produced through a reprogramming switch / multiplexer that is used to define electrical connections to one or more pacing leads.

  FIG. 1A shows a diagram of one such modified CRT device consistent with an exemplary embodiment of the present invention. FIG. 1A shows two pacing capacitors C1 and C2 that provide pacing output signals for the ventricular channel. Pace controllers 102 and 104 provide various functions for pacing delivery, including but not limited to timing control, amplitude setting, and pulse duration. Connection grid 100 provides a selectable connection between pacing capacitors C 1, C 2 and various outputs 120. The solid box of the connection grid 100 shows the connection between the capacitors C1, C2 and the output directly above. Thus, the positive signal component of C1 and the negative component of C2 are connected together to a reference such as a can of a CRT device. The negative signal component of C1 is connected to one part of the right ventricular (RV) lead and the positive signal component of C2 is connected to another part of the right ventricular lead. In this configuration, the right ventricular lead will be used to provide a pacing signal. It should be noted that although a similar configuration may be implemented for what is conventionally considered as a left ventricular lead, pacing will still preferably be applied to the patient's right ventricle.

  Therefore, according to the aspect of the present invention, the first electrical connection (C1-) is the first output (RV-), the second electrical connection (C2 +) is the second output (RV +), and the third A dual chamber CRT device configured to connect the electrical connection (C1 +) and the fourth electrical connection (C2-) to a third output / reference.

  FIG. 1A shows a connection grid 100 that can be configured in response to a connection control circuit. The connection grid 100 shown in FIG. 1A is a relatively simple connection grid that allows each terminal to select between five different outputs. More complex or simple connection grids can also be implemented, including connection grids that allow the choice of applying pacing controls to either or both terminals of capacitors C1 and C2.

  The particular circuit shown in FIG. 1A represents only any number of configurable circuits that can be implemented in accordance with the present invention. For example, the power source for the pacing signal need not be capacitive per se, but can be provided by various power supply circuits and electrical elements.

  Although not shown, the atrial channel can also be included as part of the device. However, it remains essentially the same between the dual chamber CRT device and the modified embodiment discussed herein.

  FIG. 1B shows a diagram of a CRT device as modified in FIGS. 1A-8, placed in the heart, consistent with an exemplary embodiment of the present invention. A heart H showing a right ventricle RV and a left ventricle LV divided by a septum S is shown in cross section. The catheter is provided in the right ventricle RV, the distal electrode 12 is fixed to the septum, and the proximal electrode 14 is in the right ventricle. The right hand side of the figure shows the catheter 10 enlarged and energized by the pacemaker 1 to generate two monopolar pulse waves between the electrodes 12, 14 and the pacemaker 1. A pulse wave including but not limited to phase, duration, amplitude, and polarity configuration can be modified as discussed herein.

  As discussed in US Patent Application Serial No. 11 / 300,242, aspects of the present invention relate to methods of application and methods that facilitate implantation and avoid catheter 10 connection and disconnection. The sense circuit 2 can be used to check for proper placement and pulse wave configuration. In certain embodiments, a deflectable sheath having electrodes at its edges may be used. The deflectable sheath allows a stimulus to be applied to check proper placement of the catheter (eg, in response to a signal received by the sense circuit 2) and also allows the catheter to be placed in the proper location. Allows fixation (eg, screwing into the heart). If used, the sheath can then be removed and is ultimately disposable.

As discussed herein, the sense circuit 2 may be implemented in response to any number of different sensing signals indicative of cardiac function due to pacing signals delivered by a pacing generator.
According to a particular embodiment of the present invention, the pacemaker and application method are implemented as follows.

  The pulse generator (single or dual chamber) has a programmable configuration and has at least two superimposed polar inversions between each other with respect to a neutral reference point It has a ventricular output that includes a monopolar pulse wave. The neutral reference point may be, for example, a third electrode implemented as a pacemaker metal box or a tripolar catheter.

• Active-fixation ventricular catheter.
A deflectable and / or preformed sheath having a distal tip with electrodes.
Use a sheath to determine the stimulation location within the right ventricular septum (or otherwise near the His bundle).

  The determined stimulation location can be used to stimulate left ventricular stimulation, such as by applying an electrical alternative circuit principle or electrical bypass, from which pacing reestablishes physiological conduction in a damaged (eg, conduction abnormal) heart. It is such that it allows greater interventricular synchrony, making it easier.

The general aspects of FIG. 1B may be implemented in combination with one or more of the various embodiments disclosed herein, including but not limited to the aspects discussed in connection with each of the figures.
FIG. 2 shows an interface and circuit for providing pacing signals consistent with the present invention. Header / connector 200 is a circuit and interface that connects the output of CRT device 202 to a single pacing lead 204 (which may also include an atrial channel). Connection lines between the outputs (RV +/− and LV +/−) of the CRT device 202 and the header 200 indicate the connection functions provided by the connector circuit 200. Thus, one positive component of the RV and LV signals is connected to the pacing lead 204, and the other negative component of the RV and LV signals is similarly connected to the pacing lead 204.

  A reference electrode 206 placed on the pacing lead 204 is an optional component. Another option is to use the can of the CRT device as a reference (alone or in combination with one or more reference points / electrodes). One or both of the other signal components (eg, LV− or RV +) are connected to a reference component such as a can of CRT device 202 and / or to reference electrode 206 of pacing lead 204. In this particular embodiment, the CRT is configured to provide the RV signal as a unipolar pacing signal and the LV signal as a bipolar pacing signal (since RV (+) is not connected to the can or electrode 206). The Unipolar pacing signals use a single signal component that can be referenced to the device can, delivered to the pacing site, while bipolar pacing signals are referenced to other neighboring electrodes delivered to the pacing site. Signal components to be used. In monopolar mode, the device internal logic connects the (+) side of the signal to the can and the negative side to the tip of the intracardiac lead (for LV leads) or the active electrode of the ring.

  According to another embodiment (not shown), the connections of the RV and LV leads are inverted. The RV lead is then configured for bipolar pulses and the LV lead is configured for monopolar pulses.

  As shown by the signal waveform, pacing lead 204 can be configured to deliver two opposite polarity pulses, which can be delivered simultaneously or with an offset between the pulses. Can be sent out. This offset can be achieved using the device's programmable interventricular delay.

  FIG. 3 illustrates an interface and circuit for providing pacing signals consistent with embodiments of the present invention. Connector / interface 302 includes circuitry for routing signal components from CRT device 312. Optionally, an atrial component 304 can be implemented. For example, atrial component 304 can be used to connect electrode 308, which can be located on pacing lead 306 or a separate pacing lead, to atrial port A. RV + and LV- are shown as connecting to each lead for sending pacing signals. The polarities of the RV and LV signal components are exemplary only and can be inverted. RV− and LV + are shown as connecting to a reference such as electrode 310. Optionally, the reference portion can be a can of CRT device 312, a remote reference point, or both. As discussed in connection with FIG. 2, CRT device 312 may be configured to have one of an RV or LV signal that provides a unipolar signal. In such embodiments, the reference component (eg, LV +) can be left unconnected.

  FIG. 3 may also include a connector housing that is constructed to physically interface with two or more lead outputs of the CRT device 312. Specifically, the RV and LV outputs of CRT device 312 are designed to interface with each lead. However, the connector / interface 302 may connect to multiple lead outputs of the CRT device and provide a single lead output that may include connections to multiple outputs of the CRT device 312. As such, CRT device 312 is designed to interface with two or three pacing leads, but can be used as a single pacing lead with little or no modification. Similarly, pacing leads can be implemented using standard connection types if so desired.

  Although not shown, the polarity of the ring and tip can be reversed. This can be useful for changing the shape of the virtual electrode around the physical electrode. For example, the larger head of the dogbone virtual electrode can be flipped to face the blocked area of the His bundle. This can be particularly useful in correcting small differences between the optimal site specified by the sheath and the actual placement of the implantable electrode. The rotation of the dogbone virtual electrode can be achieved by the relative timing and polarity of the two pulses (negative first, positive first, ring positive, tip positive, and / or interpulse timing).

  Although not explicitly shown, the connector / interface 302 can also be implemented to interface with additional outputs, including additional pacing outputs as described in connection with FIG.

FIG. 4 shows a diagram of a modified dual chamber pacemaker (DDD) device consistent with an exemplary embodiment of the present invention. FIG. 4 conventionally shows two pacing capacitors C1 and C2 that provide pacing output signals for the atrial and ventricular chambers, respectively. Pace controls 402 and 404 provide various functions for pacing delivery, including but not limited to timing control, amplitude setting, and pulse duration. Connection grid 400 provides a selectable connection between pacing capacitors C 1, C 2 and various outputs 420. The solid box of the connection grid 400 shows the connection between the capacitors C1, C2 and the output directly above. Thus, the positive signal component of C1 and the negative component of C2 are connected together to a reference such as a can of a DDD device. The negative signal component of C1 is connected to one part of the right ventricular (RV) lead and the positive signal component of C2 is connected to another part of the right ventricular lead. In such a configuration, the right ventricular lead is used to provide a pacing signal, and the atrial lead can remain disconnected. It should be noted that although a similar configuration may be implemented for what is conventionally considered as a left ventricular lead, pacing will still preferably be applied to the patient's right ventricle.
Therefore, according to the aspect of the present invention, the first electrical connection (C1-) is the first output (RV-), the second electrical connection (C2 +) is the second output (RV +), and the third A DDD device configured to connect the first electrical connection (C1 +) and the fourth electrical connection (C2-) to the third output / reference unit.

  FIG. 4 shows a connection grid 400 that can be configured in response to a connection control circuit. The connection grid 400 shown in FIG. 4 is a relatively simple connection grid that allows each terminal to select between five different outputs. More complex or simple connection grids can also be implemented, including connection grids that allow the choice of applying pacing controls to either or both terminals of capacitors C1 and C2.

  The particular circuit shown in FIG. 4 only represents any number of configurable circuits that can be implemented in accordance with the present invention. For example, the power source for the pacing signal need not be capacitive per se, but can be provided by various power supply circuits and electrical elements.

  FIG. 5 is similar to FIG. However, the reference electrode (s) are connected to the negative of capacitor C1 and the positive of capacitor C2, while the positive of C1 and the negative of C2 are connected to the RV lead.

FIG. 6 shows a diagram of a modified DDD device consistent with an exemplary embodiment of the present invention. FIG. 6 shows two pacing capacitors C1 and C2 and a sense amplifier 605 that provide pacing output signals for the ventricular channel. For simplicity, ventricular channel sense amplifiers are not shown. However, if a sense amplifier is implemented, the sense amplifier will have an RV channel between RV (−) and RV (+) for -2 pole detection and RV ( -) And cans can be attached. Pace controllers 602 and 604 provide various functions for pacing delivery, including but not limited to timing control, amplitude setting, and pulse duration. Connection grid 600 provides a selectable connection between pacing capacitors C 1, C 2 and various outputs 620. The solid box of the connection grid 600 shows the connection between the capacitors C1, C2 and the output directly above. Thus, the negative signal component of C1 and the positive component of C2 are connected together to a reference such as a can of a DDD device. The positive signal component of C1 is connected to one part of the right ventricular (RV) lead and the negative signal component of C2 is connected to another part of the right ventricular lead. In this configuration, the right ventricular lead will be used to provide a pacing signal.
Therefore, according to the aspect of the present invention, the first electrical connection (C1 +) is the first output (RV +), the second electrical connection (C2-) is the second output (RV-), and the third A DDD device configured to connect the first electrical connection (C1-) and the fourth electrical connection (C2 +) to the third output / reference section.

  FIG. 6 shows a connection grid 600 that can be configured in response to a connection control circuit. The connection grid 600 shown in FIG. 6 is a relatively simple connection grid that allows each terminal to select between five different outputs. More complex or simple connection grids can also be implemented, including connection grids that allow the choice of applying pacing controls to either or both terminals of capacitors C1 and C2.

  The particular circuit shown in FIG. 6 only represents any number of configurable circuits that can be implemented in accordance with the present invention. For example, the power source for the pacing signal need not be capacitive per se, but can be provided by various power supply circuits and electrical elements.

Although not shown, the ventricular sense channel may be implemented using a connection that remains essentially the same between a conventional DDD device and the embodiment of FIG.
FIG. 7 is similar to FIG. However, the signal polarity is such that the positive of capacitor C1 and the negative of capacitor C2 are connected to the reference (can), while the negative of C1 is connected to RV (−) and the positive of C2 is connected to RV (+). Is inverted.

Although not shown, the RV sense channel can be implemented in a manner similar to the connection in the DDD device.
FIG. 8 shows a diagram of a dual chamber DDD CRT device consistent with an exemplary embodiment of the present invention. FIG. 8 shows three pacing capacitors C1, C2, and C3 that provide pacing output signals for the ventricular and atrial channels. Pace controls 802, 804, and 806 provide various functions for pacing delivery, including but not limited to timing control, amplitude setting, and pulse duration. Connection grid 800 provides a selectable connection between pacing capacitors C 1, C 2, C 3 and various outputs 820. The solid box of connection grid 800 shows the connection between capacitors C1, C2, C3 and the output directly above. Thus, the negative signal component of C1 and the positive component of C3 are connected together to a reference such as a can of a CRT device. The positive signal component of C1 is connected to one part of the right ventricular (RV) lead and the negative signal component of C3 is connected to another part of the right ventricular lead. In this configuration, the right ventricular lead will be used to provide a pacing signal.
Therefore, according to the aspect of the present invention, the first electrical connection (C1 +) is the first output (RV +), the second electrical connection (C3-) is the second output (RV-), and the third And a dual chamber CRT device configured to connect the electrical connection (C1-) and the fourth electrical connection (C3 +) to the third output / reference section.

  FIG. 8 shows a connection grid 800 that can be configured in response to a connection control circuit. The connection grid 800 shown in FIG. 8 is a relatively simple connection grid that allows each terminal to select between five different outputs. More complex or simple connection grids can also be implemented, including connection grids that allow the choice of applying pacing controls to either or both terminals of capacitors C1 and C2.

  The particular circuit shown in FIG. 8 only represents any number of configurable circuits that can be implemented in accordance with the present invention. For example, the power source for the pacing signal need not be capacitive per se, but can be provided by various power supply circuits and electrical elements.

  The circuit shown in FIG. 8 uses the special (capacitive) pacing source previously used for atrial pacing to configure the RV channel to provide XSTIM dual pulse therapy. And XSTIM CRT at the same time. This is particularly true for patients with dilated hearts where the stromal lesions are too large (ie, because there is a major infarction that destroyed the His fibers that activate the region of LV) and XSTIM cannot bypass it. Can be useful. As such, a second LV may be required to synchronize a region that is activated late in the LV.

  Cardiac application represents a specific embodiment of the present invention. However, the present invention also includes treatments where high current density spot (s) away from the electrode are beneficial to stimulate targets including but not limited to nerves, muscles, gastrointestinal system, and cortex. Applicable to other treatments. For example, US Pat. No. 5,299,569 issued to Wernicke et al. Issued on Apr. 5, 1994 (also incorporated herein by reference) is intended to treat a variety of disorders. Describes pacing the vagus nerve. The pacing electrode is applied directly to the vagus nerve in the neck, for example. Directly applying an electrode to the vagus nerve creates a risk of mechanical damage to the nerve (eg, compression necrosis). The electrodes are placed subcutaneously near the vagus nerve (VN) in the neck rather than on it (percutaneously or transvenously connected). The reference electrode is placed subcutaneously on the opposite side of the nerve VN (percutaneously or transvenously connected). The electrode and reference electrode are connected to a pulse generator IPG. Using the signals described above, the resulting electric field captures the vagus nerve. The signal may be selected to have amplitude, frequency, and other parameters fully described by the '569 patent. It will be appreciated that other alternative embodiments of using the present invention for pacing organs or nerves will occur to those skilled in the art, with the benefit of the teachings of the present invention.

  Those skilled in the art will recognize that the various aspects discussed in connection with the present invention can be implemented in various combinations and methods. Further, aspects discussed in connection with various references disclosed herein and incorporated herein may be used in combination with aspects of the present invention, including those referenced at the beginning of this document. . In particular, to the extent that the references presented at the beginning of this document include several similar figures and associated descriptions, those skilled in the art will be able to understand the aspects disclosed in the references, even for figures that are not common among documents. You will understand interoperability. The teachings throughout these documents relate to aspects that may be used in combination with embodiments of the present invention. Thus, the document is incorporated in its entirety by reference. For example, a US provisional patent application identified by serial number 61 / 020,511 includes appendices with diagrams showing various pacing electrodes and associated circuit elements, and such embodiment (s) are described in this book. It can be used in combination with aspects of the invention.

  The various embodiments described above are provided by way of illustration only and should not be construed to limit the invention. Based on the foregoing description and illustrations, those skilled in the art will readily recognize that various modifications and changes may be made without strictly following the exemplary embodiments and applications shown and described herein. I will. Such modifications and changes do not depart from the true spirit and scope of the present invention.

The various embodiments described above are provided by way of illustration only and should not be construed to limit the invention. Based on the foregoing description and illustrations, those skilled in the art will readily recognize that various modifications and changes may be made without strictly following the exemplary embodiments and applications shown and described herein. I will. Such modifications and changes do not depart from the true spirit and scope of the present invention.
Appendix
[Appendix 1]
In a cardiac resynchronization therapy (CRT) device that uses a first pacing signal for one chamber of the heart and a second pacing signal for another chamber of the heart in providing biventricular pacing There,
A circuit element that causes each of the first pacing signal and the second pacing signal to be referenced to a common reference component;
A single-chamber pacing configured to be coupled to the lead and using a CRT device using a negative component from one pacing signal and a positive component from the other pacing signal; Pacing output and pacing
And wherein the pacing signal includes a negative pulse and a positive pulse, each of the negative pulse and the positive pulse being referenced to the common reference component.
[Appendix 2]
The device of claim 1, further comprising pacing control circuitry that modifies at least one characteristic of the first pacing signal and the second pacing signal.
[Appendix 3]
The device according to any one of appendices 1 and 2, further comprising a sensing circuit that generates a signal indicative of synchronicity of the heart contraction.
[Appendix 4]
4. The device of any one of appendices 1-3, further comprising a circuit element that provides a third pacing signal.
[Appendix 5]
The device according to any one of appendices 1 to 4, further comprising sense circuitry for detecting the atrial activity signal of the heart.
[Appendix 6]
A first pacing signal having a positive component provided to the first electrical connection and a negative component provided to the second electrical connection, and a positive component provided to the third electrical connection And a circuit for use with a cardiac resynchronization therapy (CRT) device designed for biventricular pacing using a second pacing signal having a negative component provided to a fourth electrical connection The circuit is
A first output configured to connect to a pacing lead;
A second output configured to connect to the pacing lead;
A third output configured to connect to a reference point;
Connecting the second electrical connection to the first output, connecting the third electrical connection to the second output, and connecting the first electrical connection and the fourth electrical connection to the second output; An electrical circuit element configured to connect to the third output;
The device according to any one of appendices 1 to 5, comprising:
[Appendix 7]
The electrical circuit element is programmable such that the first output and the second output are connected to any of the first, second, third, or fourth electrical connections. The device according to appendix 6.
[Appendix 8]
8. The device of any one of clauses 6-7, wherein each of the first pacing signal and the second pacing signal is generated using an independently referenced signal source.
[Appendix 9]
A first capacitive source; and a second capacitive source, each of the first and second capacitive sources including a separate positive terminal and a negative terminal; The positive and negative terminals of the capacitive source correspond to the first and second electrical connections, respectively, and the positive and negative terminals of the second capacitive source are respectively , Respectively corresponding to the third electrical connection and the fourth electrical connection, wherein each of the first pacing signal and the second pacing signal is the first capacitive source and the second capacitive 9. A device according to any one of claims 6 to 8, provided by one of the first capacitive source and the second capacitive source referenced independently from the other of the sources.
[Appendix 10]
A device that connects a single lead to a cardiac rhythm therapy (CRT) device designed for dual chamber pacing using two leads each providing a first pacing signal and a second pacing signal. Each of the first and second pacing signals has a positive component and a negative signal component, and the positive component of the first pacing signal is provided to a first output, the first pacing A negative component of the signal is provided at a second output, a positive component of the second pacing signal is provided at a third output, and a negative component of the second pacing signal is provided at a fourth output. In the case of dual chamber pacing, the first output and the second output are for use by a first lead, and the third output and the fourth output are second Used by lead wire Is of order, said device,
A connector configured to physically fit into two interfaces of the CRT device, wherein a first interface provides the first output and a second output, and a second interface is the first interface. 3 and 4 outputs, wherein each interface is configured to physically mate with a respective lead; and
Electrical connections from the second and third outputs to the signal reference, and from the first and fourth outputs to respective inputs of the single lead;
And thereby enabling single chamber pacing using said single lead.
[Appendix 11]
The device of claim 10, wherein the connector housing is further configured to physically fit into a third interface of the CRT device.
[Appendix 12]
The device according to any one of appendices 10 to 11, wherein the electrical connection further includes a connection between a sense signal of a third interface and the single lead.
[Appendix 13]
The device according to any one of appendices 10 to 12, wherein the electrical connection portion further includes a connection portion between the fifth output and the sixth output and the second lead wire.
[Appendix 14]
A signal routing matrix that connects leads to a cardiac rhythm therapy (CRT) device designed for dual chamber pacing using a first lead and a second lead, respectively, for using two pacing signals The two pacing signals each have a positive signal component and a negative signal component, and the positive component of the first pacing signal is provided to a first output, and the first pacing signal A negative component is provided at the second output, a positive component of the second pacing signal is provided at the third output, a negative component of the second pacing signal is provided at the fourth output, For cavity pacing, the first output and the second output are for use by the first lead, and the third output and the fourth output are the second lead. By line Is intended to be used Te, the signal routing matrix,
Electrical connections from the second output and third output to the signal reference, and from the first output and fourth output to the respective inputs of the lead, thereby providing the lead A matrix that allows single-chamber pacing using lines.
[Appendix 15]
15. The matrix according to appendix 14, further comprising an electrical connection from the output of the lead wire to the sensing input of the CRT device.
[Appendix 16]
The matrix of claim 15, further comprising electrical connections from the fifth output and the sixth output to respective inputs of the second lead.
[Appendix 17]
A pacing system for use with a lead including a first electrode and a second electrode for pacing a heart from a single chamber of the heart,
A signal generator configured to provide a first pacing signal and a second pacing signal, wherein each of the first pacing signal and the second pacing signal is a positive signal component and a negative signal component. The signal generator;
Routing a positive component of the first pacing signal and a negative component of the second pacing signal to a common signal reference, the negative component of the first pacing signal to the first electrode, and A routing circuit configurable to route a positive component of a second pacing signal to the second electrode;
A pacing system comprising:
[Appendix 18]
The pacing system of claim 17, further comprising a first capacitive component that provides the first pacing signal and a second capacitive component that provides the second pacing signal.
[Appendix 19]
The pacing system according to any one of appendices 17 to 18, further comprising the lead wire including the first electrode and the second electrode for pacing the heart from a single chamber of the heart.
[Appendix 20]
And further comprising an interface for electrically connecting the first output and the second output of the signal generator, wherein each of the first output and the second output is connected to the lead with the first pacing signal. 20. A pacing system according to any one of clauses 17-19, wherein each pacing system provides one each of a second pacing signal.
[Appendix 21]
21. A pacing system according to any one of clauses 17 to 20, wherein the signal generator further includes a third output configured to provide a pacing signal.
[Appendix 22]
The pacing system according to any one of appendices 17 to 21, further comprising a sense input for detecting the electrical signal of the heart.
[Appendix 23]
23. A pacing system according to any one of clauses 17-22, further comprising pacing control circuitry that modifies the first pacing signal and the second pacing signal.
[Appendix 24]
24. A pacing system according to any one of clauses 17-23, further comprising a lead configured to detect atrial activity.

Claims (24)

In a cardiac resynchronization therapy (CRT) device that uses a first pacing signal for one chamber of the heart and a second pacing signal for another chamber of the heart in providing biventricular pacing There,
A circuit element that causes each of the first pacing signal and the second pacing signal to be referenced to a common reference component;
A single-chamber pacing configured to be coupled to the lead and using a CRT device using a negative component from one pacing signal and a positive component from the other pacing signal; And a pacing output, wherein the pacing signal includes a negative pulse and a positive pulse, each of the negative pulse and the positive pulse being referenced to the common reference component.   The device of claim 1, further comprising a pacing control circuitry that modifies at least one characteristic of the first pacing signal and the second pacing signal.   The device according to claim 1, further comprising a sensing circuit that generates a signal indicative of synchronicity of the heart contraction.   4. The device of any one of claims 1-3, further comprising a circuit element that provides a third pacing signal.   5. The device of any one of claims 1-4, further comprising sense circuitry for detecting the cardiac atrial activity signal. A first pacing signal having a positive component provided to the first electrical connection and a negative component provided to the second electrical connection, and a positive component provided to the third electrical connection And a circuit for use with a cardiac resynchronization therapy (CRT) device designed for biventricular pacing using a second pacing signal having a negative component provided to a fourth electrical connection The circuit is
A first output configured to connect to a pacing lead;
A second output configured to connect to the pacing lead;
A third output configured to connect to a reference point;
Connecting the second electrical connection to the first output, connecting the third electrical connection to the second output, and connecting the first electrical connection and the fourth electrical connection to the second output; 6. A device according to any one of the preceding claims, comprising an electrical circuit element configured to connect to a third output.   The electrical circuit element is programmable such that the first output and the second output are connected to any of the first, second, third, or fourth electrical connections. The device of claim 6.   8. A device according to any one of claims 6 to 7, wherein each of the first pacing signal and the second pacing signal is generated using independently referenced signal sources.   A first capacitive source; and a second capacitive source, each of the first and second capacitive sources including a separate positive terminal and a negative terminal; The positive and negative terminals of the capacitive source correspond to the first and second electrical connections, respectively, and the positive and negative terminals of the second capacitive source are respectively , Respectively corresponding to the third electrical connection and the fourth electrical connection, wherein each of the first pacing signal and the second pacing signal is the first capacitive source and the second capacitive 9. A device according to any one of claims 6 to 8, provided by one of the first capacitive source and the second capacitive source referenced independently from the other of the sources. A device that connects a single lead to a cardiac rhythm therapy (CRT) device designed for dual chamber pacing using two leads each providing a first pacing signal and a second pacing signal. Each of the first and second pacing signals has a positive component and a negative signal component, and the positive component of the first pacing signal is provided to a first output, the first pacing A negative component of the signal is provided at a second output, a positive component of the second pacing signal is provided at a third output, and a negative component of the second pacing signal is provided at a fourth output. In the case of dual chamber pacing, the first output and the second output are for use by a first lead, and the third output and the fourth output are second Used by lead wire Is of order, said device,
A connector configured to physically fit into two interfaces of the CRT device, wherein a first interface provides the first output and a second output, and a second interface is the first interface. 3 and 4 outputs, wherein each interface is configured to physically mate with a respective lead; and
Electrical connections from the second output and the third output to the signal reference and from the first output and the fourth output to the respective inputs of the single lead, thereby A device that allows single chamber pacing using the single lead.   The device of claim 10, wherein the connector housing is further configured to physically mate with a third interface of the CRT device.   12. The device according to any one of claims 10 to 11, wherein the electrical connection further comprises a connection between a sense signal of a third interface and the single lead.   13. The device according to any one of claims 10 to 12, wherein the electrical connection further comprises a connection between a fifth output and a sixth output and a second lead. A signal routing matrix that connects leads to a cardiac rhythm therapy (CRT) device designed for dual chamber pacing using a first lead and a second lead, respectively, for using two pacing signals The two pacing signals each have a positive signal component and a negative signal component, and the positive component of the first pacing signal is provided to a first output, and the first pacing signal A negative component is provided at the second output, a positive component of the second pacing signal is provided at the third output, a negative component of the second pacing signal is provided at the fourth output, For cavity pacing, the first output and the second output are for use by the first lead, and the third output and the fourth output are the second lead. By line Is intended to be used Te, the signal routing matrix,
Electrical connections from the second output and third output to the signal reference, and from the first output and fourth output to the respective inputs of the lead, thereby providing the lead A matrix that allows single-chamber pacing using lines.   The matrix of claim 14, further comprising an electrical connection from an output of the lead to a sensing input of the CRT device.   16. The matrix of claim 15, further comprising electrical connections from the fifth output and the sixth output to respective inputs of the second lead. A pacing system for use with a lead including a first electrode and a second electrode for pacing a heart from a single chamber of the heart,
A signal generator configured to provide a first pacing signal and a second pacing signal, wherein each of the first pacing signal and the second pacing signal is a positive signal component and a negative signal component. The signal generator;
Routing a positive component of the first pacing signal and a negative component of the second pacing signal to a common signal reference, the negative component of the first pacing signal to the first electrode, and A pacing system comprising: a routing circuit configurable to route a positive component of a second pacing signal to the second electrode.   The pacing system of claim 17, further comprising a first capacitive component that provides the first pacing signal and a second capacitive component that provides the second pacing signal.   19. A pacing system according to any one of claims 17 to 18, further comprising the lead including the first electrode and the second electrode for pacing the heart from a single chamber of the heart. .   And further comprising an interface for electrically connecting the first output and the second output of the signal generator, wherein each of the first output and the second output is connected to the lead with the first pacing signal. 20. A pacing system according to any one of claims 17 to 19, which provides a respective one of the second pacing signal and the second pacing signal.   21. A pacing system according to any one of claims 17 to 20, wherein the signal generator further comprises a third output configured to provide a pacing signal.   The pacing system according to any one of claims 17 to 21, further comprising a sense input for detecting the cardiac electrical signal.   23. A pacing system according to any one of claims 17 to 22, further comprising pacing control circuitry that modifies the first and second pacing signals.   24. A pacing system according to any one of claims 17 to 23, further comprising a lead configured to sense atrial activity.

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