Muscle impedance measurement for hemodynamic stability and automatic therapy programming

Abstract

An implantable medical device includes processing circuitry, the computing apparatus configured to communicate with a plurality of implantable electrodes to sense and pace a patient's heart. The plurality of electrodes include a conduction system pacing electrode positioned in a myocardium of the patient's heart. The computing apparatus is configured to monitor local muscle impedance of the patient's heart using the cardiac conduction system electrode and adapt cardiac therapy deliverable by the implantable device based on the local muscle impedance.

Description

MUSCLE IMPEDANCE MEASUREMENT FOR HEMODYNAMIC STABILITY AND AUTOMATIC THERAPY PROGRAMMING

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 559,528, filed February 29, 2024, the entire content of which is incorporated herein by reference.SUMMARY

[0002] An implantable medical device includes processing circuitry, the computing apparatus configured to communicate with a plurality of implantable electrodes to sense and pace a patient’s heart. The plurality of electrodes include a conduction system pacing electrode positioned in a myocardium of the patient’s heart. The computing apparatus is configured to monitor local muscle impedance of the patient’s heart using the cardiac conduction system electrode and adapt cardiac therapy deliverable by the implantable device based on the local muscle impedance.

[0003] A system includes a plurality of implantable electrodes to sense and pace a patient’s heart, wherein the plurality of electrodes include a cardiac conduction system electrode positionable within a myocardium of the patient’s heart. A computing apparatus includes processing circuitry. The computing apparatus is operably coupled to the plurality of implantable electrodes. The computing apparatus is configured to monitor local muscle impedance of the patient’s heart using the cardiac conduction system electrode and initiate delivery of a therapeutic electrical pulse to the patient’s heart based on the local muscle impedance.

[0004] A method includes monitoring local muscle impedance of a patient’s heart using a cardiac conduction system electrode positionable within a myocardium of the patient’s heart. Delivery of cardiac therapy to the patient’s heart is initiated based on the local muscle impedance.

[0005] The above summary is not intended to describe each embodiment or every implementation of the present disclosure. A more complete understanding will become apparent and appreciated by referring to the following detailed description and claims taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. l is a schematic diagram of a heart of patient.

[0007] FIG. 2A is a conceptual diagram illustrating an illustrative therapy system that is configured to provide cardiac conduction system pacing therapy to the His bundle using a lead placed in the right atrium.

[0008] FIG. 2B is a more detailed conceptual diagram showing the illustrative therapy system of FIG. 2 A.

[0009] FIG. 2C is a detailed conceptual diagram showing the illustrative therapy system of FIG. 2A but only including two leads.

[0010] FIG. 2D is a detailed conceptual diagram showing the illustrative therapy system of FIG. 2 A but only including a single lead.

[0011] FIG. 3 A is a conceptual diagram illustrating an illustrative therapy system that is configured to provide cardiac conduction system pacing therapy to the left bundle branch using a lead placed in the right ventricle.

[0012] FIG. 3B is a close-up view of the lead in the patient’s heart of FIG. 3 A.

[0013] FIG. 4A is a conceptual diagram an illustrative therapy system that is configured to provide cardiac conduction system pacing therapy to the left and / or right bundle branches using a lead placed in the right ventricle.

[0014] FIG. 4B is a detailed conceptual diagram showing the illustrative therapy system of FIG. 4A but only including two leads.

[0015] FIG. 5 is a functional block diagram illustrating an example of a configuration of an implantable medical device of FIGS. 2A-2D.

[0016] FIG. 6 shows an illustrative method for adapting cardiac therapy based on local muscle impedance that may be utilized by the devices of FIGS. 1-5.

[0017] FIG. 7 shows another illustrative method for adapting cardiac therapy based on local muscle impedance that may be utilized by the devices of FIGS. 1-5.

[0018] FIG. 8 illustrates local muscle impedance and arterial blood pressure according to examples described herein.DETAILED DESCRIPTION

[0019] In the following detailed description of illustrative embodiments, reference is made to the accompanying figures of the drawing which form a part hereof,and in which are shown, by way of illustration, specific embodiments which may be practiced. It is to be understood that other embodiments may be utilized, and structural changes may be made without departing from (e.g., still falling within) the scope of the disclosure presented hereby.

[0020] Illustrative devices and methods shall be described with reference to FIGS. 1-8. It will be apparent to one skilled in the art that elements or processes from one embodiment may be used in combination with elements or processes of the other embodiments, and that the possible embodiments of such devices and methods using combinations of features set forth herein is not limited to the specific embodiments shown in the Figures and / or described herein. Further, it will be recognized that the embodiments described herein may include many elements that are not necessarily shown to scale. Still further, it will be recognized that timing of the processes and the size and shape of various elements herein may be modified but still fall within the scope of the present disclosure, although certain timings, one or more shapes and / or sizes, or types of elements, may be advantageous over others.

[0021] FIG. 1 depicts a schematic diagram of a heart 12 and FIGS. 2-4 depict conceptual diagrams showing illustrative therapy systems that may be used to provide therapy to the heart 12 of a patient 14. The patient 14 ordinarily, but not necessarily, will be a human. As shown in FIGS. 2A-2B, the therapy system 10 may include an implantable medical device (IMD) 16, which is coupled to three leads 18, 20, 23, and a programmer 24. The IMD 16 may be, for example, an implantable pacemaker, cardioverter, and / or defibrillator that provides electrical pulses to the heart 12 via electrodes coupled to one or more of the leads 18, 20, 23. Further non-limiting examples of the IMD 16 include the following: a pacemaker with a medical lead, an implantable cardioverter-defibrillator (ICD), an intracardiac device, a leadless pacing device (LPD), a subcutaneous ICD (S-ICD), and a subcutaneous medical device (e.g., nerve stimulator, inserted monitoring device, etc.).

[0022] The leads 18, 20, 23 may extend into the heart 12 of the patient 14 to sense electrical activity of the heart 12 and / or deliver electrical stimulation to the heart 12. In the example shown in FIG. 2A, the right ventricular lead 18 extends through one or more veins (not shown), the superior vena cava (not shown), and the right atrium 26, and into the right ventricle 28. The left ventricular coronary sinus lead 20 extendsthrough one or more veins, the vena cava, the right atrium 26, and into the coronary sinus 30 to a region adjacent to the free wall of the left ventricle 32 of the heart 12. The cardiac conduction system pacing therapy lead 23 (e.g., left bundle branch pacing lead, right bundle branch pacing lead, His-bundle pacing lead, etc.) extends through one or more veins and the vena cava, and into the right atrium 26 of heart 12 to pace the cardiac conduction system (e.g., through triangle of Koch region). While FIGS. 2A-2D illustrate cardiac conduction system pacing therapy lead 23 positioned with in the right atrium 26, the cardiac conduction system pacing therapy lead or electrode may be positioned at other locations such within the right ventricle (RV) along the interventricular wall so that a cardiac conduction system pacing electrodes is positioned proximate and / or in direct contact with the left bundle branch 8a, proximate and / or in direct contact with the right bundle branch 8b, proximate and / or in direct contact with the His bundle 13, etc.. In some embodiments, the cardiac conduction system pacing therapy lead 23 or respective electrode may be positioned within about 1 millimeter of a portion of the cardiac conduction system such as, e.g., the His bundle 13, or along the RV interventricular septal wall near one of both of the left bundle branch (LBB) 8a, the right bundle branch 8b, etc. In one or more embodiments, a cardiac conduction system therapy lead may be further positioned, or located, through the tricuspid valve into the right ventricle 28 and implanted in the interventricular septum (VS), e.g., about 1 to 2 centimeters in an apical direction as will be described further herein with reference to FIGS. 3A-3B and 4A-4B. One example of a cardiac conduction system pacing therapy lead (e.g., a His lead) can be the SELECT SECURE™ 3830. A description of the SELECTSECURE™ 3830 is found in the Medtronic model SELECTSECURE™ 3830 manual (2013), incorporated herein by reference in its entirety. The SELECTSECURE™ 3830 includes two or more conductors with or without lumens.

[0023] As used herein, cardiac conduction system pacing therapy refers to any pacing therapy configured to deliver pacing therapy (e.g., pacing pulses, electrical stimulation, etc.) to the cardiac conduction system including, e.g., the His bundle 13, the left bundle branch 8a (e.g., LBB area pacing (LBBAP)), the right bundle branch 8b, LBB optimized cardiac resynchronization therapy (LOT-CRT), etc. As used herein, the term “activation” refers to a sensed or paced event. For example, an atrial activation may refer to an atrial sense or event (As) or an atrial pace or artifact of atrial pacing(Ap). As will be described herein, an atrial sense may be detected, or identified, in one or more various signals monitored using one or more various devices or sensors located in one or more various locations. For example, an atrial sense may be detected in a near-field electrical signal from an electrode positioned in the right atrium. Further, for example, an atrial sense may be detected in a far-field electrical signal from an electrode positioned outside of the right atrium such as in the right ventricle or ventricular septum. Still, for example, an atrial sense may be detected in a far-field signal from a mechanical cardiac activation sensor such as an accelerometer or microphone (e.g., a heart sound sensor) positioned in the right atrium or positioned outside of the right atrium such as in the right ventricle or ventricular septum or another portion of the patient’s body. Similarly, a ventricular activation may refer to a ventricular sense or event (Vs) or a ventricular pace or artifact of ventricular pacing (Vp), which may be described as ventricular stimulation pulses. In some embodiments, an activation interval can be detected from As or Ap to Vs or Vp, as well as Vp to Vs. In particular, activation intervals may include a pacing (Ap or Vp) to ventricular interval (left ventricular or right to indicate that t ventricular sense) or an atrial-sensing (As) to ventricular-sensing interval (left ventricular or right ventricular).

[0024] Illustrative IMDs may be described as delivering one or both of conventional pacing therapy and cardiac conduction system pacing therapy. Conventional, or traditional, pacing therapy may be described as delivering pacing pulses into myocardial tissue that is not part of the cardiac conduction system of the patient’s heart such that, e.g., the pacing pulses trigger electrical activation that propagates primarily from one myocardial cell to another myocardial cell (also referred to as “cell-to-cell”) as opposed to propagating within the cardiac conduction system prior to the myocardial tissue. For instance, conventional pacing therapy may deliver pacing pulses directly into the muscular heart tissue (e.g., myocardial tissue) that is to be depolarized to provide the contraction of the heart. For example, conventional left ventricular pacing therapy may utilize a left ventricular coronary sinus lead 20 that is implanted so as to extend through one or more veins, the vena cava, the right atrium 26, and into the coronary sinus 30 to a region adjacent to the free wall of the left ventricle 32 of the heart 12 so as to deliver pacing pulses to the myocardial tissue of the free wall of the left ventricle 32.

[0025] An illustrative left ventricular lead 20 with a set of spaced apart electrodes is shown in U.S. Pat. Pub. No. WO 2019 / 104174 Al, filed on May 4, 2012, by Ghosh et al., which is incorporated by reference in its entirety herein. Illustrative electrodes on leads to form pacing vectors are shown and described in U.S. Pat. No. 8,355,784 B2, and U.S. Pat. No. 8,126,546, each of which are incorporated by reference in their entireties.

[0026] Additionally, the pacing therapy leads 18, 20, 23 may be utilized to deliver left ventricle or left ventricular septal pacing to the ventricular septal wall. At least one of pacing therapy leads 18, 20, 23 may extend through one or more veins, the vena cava, right atrium 26, and into the coronary sinus 30 to a region adjacent to the septal wall of left ventricle 32 of heart 12.

[0027] Illustrative cardiac conduction system pacing therapy may be described in, for example, U.S. Pat. App. Pub. No. 2019 / 0111270 Al entitled “His Bundle and Bundle Branch Pacing Adjustment” published on April 18, 2019, which is incorporated herein by reference in its entirety. Illustrative left ventricular septal pacing may be described in, for example, U.S. Pat. App. Ser. No. 16 / 521,000 entitled “AV Synchronous Septal Pacing” filed on July 24, 2019, which is incorporated herein by reference in its entirety.

[0028] One or more elongated conductors of any of the leads 18, 20, 23 may extend through a hermetic feedthrough assembly, and within an insulative tubular member of the respective lead, and may electrically couple an electrical pulse generator (contained within housing) to one or more electrodes such as, e.g., ring electrodes, tips electrodes, helical electrodes, etc. The conductors may be formed by one or more electrically conductive wires comprising, for example, MP35N alloy known to those skilled in the art, in a coiled or cabled configuration, and the insulative tubular member may be any suitable medical grade polymer, for example, polyurethane, silicone rubber, or a blend thereof. According to one or more illustrative embodiments, the flexible lead body may extend a pre-specified length (e.g., about 10 centimeters (cm) to about 20 cm, or about 15 to 20 cm) from a proximal end to a distal end. The lead body may be less than about 7 French (FR) but typically in the range of about 3 FR to 4 FR in size. In one or more embodiments, about 2 FR size to about 3 FR size lead body is employed.

[0029] Cardiac conduction system pacing may include at least one of His bundle pacing and left and / or right bundle branch pacing. Bundle branch pacing may bypass the pathological region and may have a low and stable pacing threshold. In some embodiments, only one of the left bundle branch or the right bundle branch may be paced using one or more pacing leads. In further embodiments, both bundle branches may be paced at the same time (e.g., dual bundle branch pacing), which may mimic intrinsic activation propagation via the His bundle-Purkinje conduction system, e.g., paced activation propagates via both bundle branches to both ventricles for synchronized contraction. His bundle pacing, on the other hand, typically paces the His bundle proximal to the bundle branches. In some embodiments, the IMD 16 may include one, two, or more electrodes located in one or more bundle branches configured for bundle branch pacing.

[0030] In some embodiments, the IMD 16 may be an intracardiac pacemaker or leadless pacing device (LPD) configured to pace one or more portions of the cardiac conduction system such as the His bundle. As used herein, “leadless” refers to a device being free of a lead extending out of the heart 12. In other words, a leadless device may have a lead that does not extend from outside of the heart to inside of the heart. Some leadless devices may be introduced through a vein, but once implanted, the leadless devices are free of, or may not include, any transvenous lead and may be configured to provide cardiac therapy without using any transvenous lead. In one or more embodiments, an illustrative LPD for bundle pacing does not use a lead to operably connect to an electrode disposed proximate to the septum when a housing of the device is positioned in the atrium. A leadless electrode may be leadlessly coupled to the housing of the medical device without using a lead between the electrode and the housing.

[0031] The IMD 16 may sense electrical signals attendant to the depolarization and repolarization of the heart 12 via various electrodes as shown in FIG. 2B coupled to at least one of leads 18, 20, 23. In some examples, the IMD 16 provides pacing pulses to the heart 12 based on the electrical signals sensed within the heart 12. The configurations of the electrodes used by the IMD 16 for sensing and pacing may be unipolar or bipolar.

[0032] The IMD 16 may also provide defibrillation therapy and / or cardioversion therapy via electrodes located on at least one of the leads 18, 20, 23. For example, the IMD 16 may detect atrial arrhythmias of heart 12, such as atrial fibrillation of the atria 26, 33, and then may deliver defibrillation therapy to the heart 12 in the form of electrical pulses. Also, the IMD 16 may detect ventricular arrhythmias of the heart 12, such as ventricular fibrillation of the ventricles 28, 32, and then may deliver defibrillation therapy to the heart 12 in the form of electrical pulses. In some examples, the IMD 16 may be programmed to deliver a progression of therapies, e.g., pulses with increasing energy levels, until fibrillation of the heart 12 is stopped. The IMD 16 may detect fibrillation employing one or more fibrillation detection techniques known in the art.

[0033] In some examples, the programmer 24 as shown in FIG. 2A may be a handheld computing device or a computer workstation or a mobile phone. The programmer 24 may include a user interface that receives input from a user. The user interface may include, for example, a keypad and a display, which may for example, be a cathode ray tube (CRT) display, a liquid crystal display (LCD) or light emitting diode (LED) display. The keypad may take the form of an alphanumeric keypad or a reduced set of keys associated with particular functions. The programmer 24 can additionally or alternatively include a peripheral pointing device, such as a mouse, via which a user may interact with the user interface. In some embodiments, a display of the programmer 24 may include a touch screen display, and a user may interact with the programmer 24 via the display. Through the graphical user interface on the programmer 24, a user may configure one or more pacing therapies, select one or more pacing modes, etc.

[0034] Additionally, various pacing settings may be adjusted, or configured, based on various sensed signals. For example, various near-field and far-field signals may be sensed by one or more of the electrodes of the IMD 16 and / or other devices operatively coupled thereto. For example, P-wave-to-R-wave interval may be monitored or measured within a near-field or far-field signal and then may be used to adjust, configure, and select cardiac conduction system pacing therapy. Further, for example, QRS width may be monitored or measured within a near-field or far-field signal and then may be used to adjust, configure, and select cardiac conduction systempacing therapy. Still further, for example, one or more of P-wave-to-R-wave interval consistency, T-wave-to-P-wave interval consistency, and P-wave morphology consistency may be monitored or measured within a near-field or far-field signal and then may be used to adjust, configure, and select cardiac conduction system pacing therapy.

[0035] The illustrative therapy systems described herein such as IMD 16 may be utilized to deliver cardiac conduction system pacing therapy according to a variety of different modes such as, e.g., inhibited pacing mode, ventricular fusion pacing mode, atrioventricular synchronous pacing mode, atrial fibrillation pacing mode, etc.

[0036] The ventricular fusion pacing mode may be configured to deliver cardiac conduction system pacing therapy to provide effective ventricular fusion. Effective ventricular fusion may be described as synchronizing the timing of the left ventricular activation with the activation on the right ventricle. For example, in a fusion pacing configuration, a medical device may deliver one or more pacing pulses in order to pre-excite the left ventricle and synchronize the depolarization of the left ventricle with the depolarization of the earlier contracting right ventricle. The ventricular activation of the left ventricle may “fuse” (or “merge”) with the ventricular activation of the right ventricle that is attributable to intrinsic conduction of the heart. In this way, the intrinsic and pacing-induced excitation wave fronts may fuse together such that the depolarization of the left ventricle is resynchronized with the depolarization of the right ventricle.

[0037] As used herein, the term “far-field” electrical signal refers to the result of measuring cardiac activity using a sensor, such as an electrode, positioned outside of an area of interest. For example, a far-field electrical signal representing electrical activity of a chamber of interest of the patient’s heart may be measured from an electrode positioned in an adjacent chamber (i.e., a chamber different from than that of the chamber of interest that is next to or near the chamber of interest). More specifically, for example, atrial electrical activity, or electrical activity originating one or more both atria, representative of depolarization of the one or both atria may be monitored in a far-field electrical signal measured using an electrode positioned outside of the right atrium such as in the right or left ventricle, or in the ventricular septum. As used herein, the term “near-field” electrical signal refers to the result of measuringcardiac activity using a sensor, such as an electrode, positioned near an area of interest. For example, an electrical signal measured from an electrode positioned on the left side of the patient’s ventricular septum is one example of a near-field electrical signal of the patient’s LV.

[0038] P-wave timing is the time at which a P-wave is detected. Typically, P- wave timing includes using the maximal first derivative of a P-wave upstroke (or the time of the maximal P-wave value). P-wave timing is also used in the device marker channel to indicate the time of the P-wave or the time of atrial activation. P-wave timing may be determined using near-field signals obtained by sensors (e.g., electrodes, accelerometers, heart sound sensors, etc.) positioned in the atria (e.g., the right atrium) and / or far-field near-field signals obtained by sensors (e.g., electrodes, accelerometers, heart sound sensors, etc.) positioned outside of the atria (e.g., the right atrium) such as in the right ventricle and / or ventricular septum.

[0039] R-wave timing is the time at which the QRS complex is detected. Typically, R-wave timing includes using the maximal first derivative of an R-wave upstroke (or the time of the maximal R-wave value). R-wave timing is also used in the device marker channel to indicate the time of the R-wave or the time of ventricular activation.

[0040] A user, such as a physician, technician, or other clinician, may interact with the programmer 24 to communicate with the IMD 16. For example, the user may interact with the programmer 24 to retrieve physiological or diagnostic information from the IMD 16. Additionally, a user may also interact with the programmer 24 to program the IMD 16, e.g., select values for operational parameters of the IMD 16. The IMD 16 and programmer 24 may communicate via wireless communication using any techniques known in the art. Examples of communication techniques may include, for example, low frequency or radiofrequency (RF) telemetry, but other techniques are also contemplated. In some examples, the programmer 24 may include a programming head that may be placed proximate to the patient’s body near the IMD 16 implant site in order to improve the quality or security of communication between the IMD 16 and the programmer 24.

[0041] FIG. 2B is a conceptual diagram illustrating the IMD 16 and the leads 18, 20, 23 of the therapy system 10 in greater detail. The triple-chamber IMD 16 maybe used for cardiac rhythm therapy and defibrillation or cardioversion therapy (CRT- D). The leads 18, 20, 23 may be electrically coupled to a stimulation generator, a sensing module, or other modules of IMD 16 via connector block 34. In some examples, proximal ends of leads 18, 20, 23 may include electrical contacts that electrically couple to respective electrical contacts within the connector block 34. In addition, in some examples, the leads 18, 20, 23 may be mechanically coupled to the connector block 34 with the aid of set screws, connection pins, or another suitable mechanical coupling mechanism.

[0042] Each of the leads 18, 20, 23 includes an elongated, insulative lead body, which may carry any number of concentric coiled conductors separated from one another by tubular, insulative sheaths. In the illustrated example, an optional pressure sensor 38 and bipolar electrodes 40 and 42 are located proximate to a distal end of the right ventricular lead 18. In addition, the bipolar electrodes 44 and 46 are located proximate to a distal end of the left ventricular lead 20 and bipolar electrodes 48 and 50 are located proximate to a distal end of cardiac conduction pacing lead 23. The cardiac conduction system pacing electrode 50 may be used for pacing and / or sensing of the cardiac conduction system tissue (e.g., His bundle or bundle branch tissue).

[0043] In FIG. 2B, the pressure sensor 38 is disposed in right ventricle 28 and may respond to an absolute pressure inside right ventricle 28. The pressure sensor 38 may be, for example, a capacitive or piezoelectric absolute pressure sensor. In other examples, the pressure sensor 38 may be positioned within other regions of the heart 12 and may monitor pressure within one or more of the other regions of the heart 12, or the pressure sensor 38 may be positioned elsewhere within or proximate to the cardiovascular system of the patient 14 to monitor cardiovascular pressure associated with mechanical contraction of the heart. Optionally, a pressure sensor in the pulmonary artery can be used that is in communication with the IMD 16.

[0044] The electrodes 40, 44 and 48 may take the form of ring electrodes, and the electrodes 42, 46 and 50 may take the form of extendable and / or fixed helix tip electrodes mounted within the insulative electrode heads 52, 54 and 56, respectively. Each of the electrodes 40, 42, 44, 46, 48 and 50 may be electrically coupled to a respective one of the coiled conductors within the lead body of its associated lead 18,20, 23, and thereby coupled to respective ones of the electrical contacts on the proximal end of the leads 18, 20 23.

[0045] The electrodes 40, 42, 44, 46, 48 and 50 may sense electrical signals attendant to the depolarization and repolarization of the heart 12. The electrical signals are conducted to the IMD 16 via the respective leads 18, 20, 23. In some examples, the IMD 16 also delivers pacing pulses via the electrodes 40, 42, 44, 46, 48, 50 to cause depolarization of cardiac tissue of heart 12. In some examples, as illustrated in FIG. 2B, the IMD 16 may include one or more housing electrodes, such as housing electrode 58, which may be formed integrally with an outer surface of a hermetically sealed housing 60 of the IMD 16 or otherwise coupled to the housing 60. In some examples, the housing electrode 58 may be defined by an uninsulated portion of an outward facing portion of the housing 60 of the IMD 16. Other divisions between insulated and uninsulated portions of housing 60 may be employed to define two or more housing electrodes. In some examples, the housing electrode 58 includes substantially all of the housing 60. Any of the electrodes 40, 42, 44, 46, 48, 50 may be used for unipolar sensing or pacing in combination with the housing electrode 58 or for bipolar sensing with two electrodes in the same pacing lead. In one or more embodiments, the housing 60 may enclose a stimulation generator (see FIG. 5) that generates cardiac pacing pulses and defibrillation or cardioversion shocks, as well as a sensing module for monitoring the patient’s heart rhythm.

[0046] The leads 18, 20, 23 may also include elongated electrodes 62, 64, 66, respectively, which may take the form of a coil. The IMD 16 may deliver defibrillation shocks to the heart 12 via any combination of the elongated electrodes 62, 64, 66, and the housing electrode 58. The electrodes 58, 62, 64, 66 may also be used to deliver cardioversion pulses to the heart 12. The electrodes 62, 64, 66 may be fabricated from any suitable electrically conductive material, such as, but not limited to, platinum, platinum alloy or other materials known to be usable in implantable defibrillation electrodes.

[0047] The pressure sensor 38 may be coupled to one or more coiled conductors within the lead 18. In FIG. 2B, the pressure sensor 38 is located more distally on the lead 18 than elongated electrode 62. In other examples, the pressure sensor 38 may be positioned more proximally than the elongated electrode 62, ratherthan distal to the electrode 62. Further, the pressure sensor 38 may be coupled to another one of the leads 20, 23 in other examples, or to a lead other than the leads 18, 20, 23 carrying stimulation and sense electrodes. In addition, in some examples, the pressure sensor 38 may be self-contained device that is implanted within the heart 12, such as within the ventricular septum separating the right ventricle 28 from the left ventricle 32, or the atrial septum separating the right atrium 26 from the left atrium 33. In such an example, the pressure sensor 38 may wirelessly communicate with the IMD 16.

[0048] FIGS. 2C-2D are conceptual diagrams illustrating additional examples of a dual-chamber therapy system 70 and a single-chamber therapy system 71, respectively. The therapy system 70 is similar to therapy system 10 of FIGS. 2A-2B, but includes two leads 18, 23, rather than three leads. The therapy system 70 may utilize the IMD 16 configured to deliver, or perform, dual-chamber pacing. The leads 18, 23 are implanted within the right ventricle 28 and the right atrium 26 to pace one or more portions of the cardiac conduction system such as the His bundle or one or both bundle branches, respectively. The therapy system 71 is similar to therapy system 10 of FIGS. 2A-2B, but includes a single lead 23, rather than three leads. The therapy system 71 may utilize the IMD 16 configured to deliver, or perform, single-chamber pacing. The lead 23 is implanted the right atrium 26 to pace one or more portions of the cardiac conduction system such as the His bundle or one or both bundle branches, respectively.

[0049] The cardiac conduction system pacing lead 23 may be include an electrode 50 in the form of a helix (also referred to as a helical electrode) that may be positioned proximate to, near, adjacent to, or in, area or portions of the cardiac conduction system such as, e.g., ventricular septum, triangle of Koch, the His bundle, left right bundle branch tissues, and / or right bundle branch tissue. The cardiac conduction system pacing lead 23 may be configured as a bipolar lead or as a quadripolar lead that may be used with a pacemaker device, a CRT-P device, or a CRT- ICD.

[0050] FIGS. 3A-3B show the patient’s heart 12 implanted with an implantable medical electrical lead 723 coupled to an IMD 716 to deliver bundle branch pacing according to one example of an IMD system 710. FIG. 3B is a close-up view of lead 723 in the patient’s heart 12 of FIG. 3A. In some embodiments, the electrical lead 723may be the only lead implanted in the heart 12. In other embodiments as discussed herein, there may be multiple leads implanted in the heart 12. The one or more implantable electrodes may include a pacing electrode implantable proximate the cardiac conduction system or may be implantable in the ventricular septum (VS), to deliver cardiac conduction system pacing therapy, for examples.

[0051] In one embodiment, the lead 723 may be configured for dual bundle branch pacing, and the lead 723 may be the same as or similar to lead 23 shown in FIGS. 2A-2B) except that the lead 723 is implanted near the bundle branches in the ventricular septum (VS) from the right ventricle 28 instead of, for example, the His bundle 13. As illustrated, the lead 723 is implanted in the septal wall, or ventricular septum, from the right ventricle 28 toward the left ventricle 32. The lead 723 may not pierce through the wall of the left ventricle 32 or extend into the left ventricular chamber. An electrode 752 and a tissue-piercing electrode 761 may be disposed on a distal end portion of the lead 723, which may also be described as a shaft. The electrode 752 and the tissue-piercing electrode 761 may be the same as or similar to electrode and tissue-piercing electrode 50 shown in FIG. 2B except that the electrode 752 is configured as a cathode electrode to sense or pace the right bundle branch and the electrode 761 is configured to sense or pace the left bundle branch, for example, during dual bundle branch pacing. Accordingly, the electrode 752 may be implanted near right bundle branch 8b, and the electrode 761 may be implanted near the left bundle branch 8a. The electrode 761 may be described as a unipolar cathode electrode, which may be implanted on the left side of the patient’s ventricular septum. The electrode 752 may be described as a unipolar cathode electrode, which may be implanted on the right side of the patient’s ventricular septum.

[0052] During dual bundle branch pacing, both the electrode 752 and the electrode 761 may each deliver a cathodal pulse to achieve synchronized activation, or excitation, of the right bundle branch 8b and the left bundle branch 8a, which may result in synchronized activation of the right ventricle 28 and the left ventricle 32. In some embodiments, the pulses may be delivered at the same time to achieve synchrony. In other embodiments, the pulses may be delivered with a delay to achieve synchrony.

[0053] Although the lead 723 as shown in configured for dual bundle branch pacing using the electrodes 752, 761, it is to be understood that the lead 723 or leadssimilar thereto are considered herein that may only include one of the electrode 752 and the electrode 761, and thus, only configured to deliver cardiac conduction system pacing therapy to one of the right bundle branch and the left bundle branch.

[0054] Additionally, the lead 723 may include a right atrial electrode 770 disposed more proximal to the electrode 752 and the electrode 761 along the lead 723. The right atrial electrode 770 may be positioned in or near the right atrium 26 and may function as an anode for cathodal pulses from the electrode 752 and / or the electrode 761. Further, the right atrial electrode 770 may provide atrial sensing to, e.g., sense atrial depolarizations or activations, to sense or detect atrial fibrillation, etc. Although the lead 723 as shown includes the right atrial electrode 770, it is to be understood that the lead 723 may not include the right atrial electrode 770, and instead, only include one or both of the electrode 752 and the electrode 761.

[0055] Additionally, the device system 710 may include a mechanical cardiac activation sensor 751 coupled to the lead 723 as shown in FIG. 3B. As shown in this embodiment, when the distal end of the lead 723 is implanted through the right ventricle 28 into the ventricular septum, the mechanical cardiac activation sensor 751 may be positioned in the right ventricle 28. The mechanical cardiac activation sensor 751 may be a motion sensor (e.g., an accelerometer) and / or a heart sound sensor (e.g., a microphone) that may be used to determined atrial activation or depolarization (e.g., atrial kick) so as to be used to deliver atrioventricular timed cardiac conduction system pacing therapy. In other words, the device system 710 may be configured to monitor mechanical activity of the patient’s heart using the mechanical cardiac activation sensor, determine atrial activation based on the monitored mechanical activity, and deliver cardiac conduction system pacing using the cardiac conduction system pacing electrode based on the determined atrial activation. Additionally, in one or more embodiments, the mechanical cardiac activation sensor 751 may be located in a housing of the IMD 716, which not be located within the heart of the patient. For example, the house of the IMD 716 may be positioned subcutaneously with the body of the patient. Furthermore, if the device system 710 includes a leadless device, the mechanical cardiac activation sensor 751 may be located in a housing of the leadless device implanted in the right ventricle 28.

[0056] Furthermore, atrial activations determined using the mechanical cardiac activation sensor 751 may be used in conjunction with atrial activations determined using near-field or far-field electrical activity. In at least one embodiment, the atrial activations determined using the mechanical cardiac activation sensor 751 may be used to confirm atrial activations determined using near-field or far-field electrical activity, or vice versa.

[0057] FIG. 4A is a conceptual diagram of an illustrative system 801 including an IMD, or pacemaker, 814 configured as a multi-chamber pacemaker, a right atrial pacing and sensing lead 919, a coronary sinus lead 992, and a cardiac conduction system pacing lead 918 configured for delivering bundle branch pacing. The IMD 814 is shown coupled to the right atrial lead 919 carrying a pacing tip electrode 936 and a proximal ring electrode 938 that may be used for sensing right atrial signals and delivering atrial pacing to the right atrium. The coronary sinus lead 992 may be advanced into the RA, through the coronary sinus ostium and into a cardiac vein of the left ventricle for positioning electrodes 94a, 94b, 94c, 94d (collectively “CS electrodes 94”) epicardially along the left ventricular myocardium for sensing electrocardiogram signals and pacing the left ventricular myocardium. The coronary sinus lead 992 is shown as a quadripolar lead carrying four electrodes 94a-94d that may be selected in various bipolar pacing electrode pairs for pacing the left ventricular myocardial tissue and for sensing left ventricular epicardial electrocardiogram signals. One of the CS electrodes 94 may be selected in combination with pacemaker housing 815 or a coil electrode 935 for delivering unipolar left ventricular myocardial pacing and / or sensing unipolar ventricular electrocardiogram signals.

[0058] In this example, the IMD 814 may be capable of delivering high voltage cardioversion / defibrillation shock therapies for cardioverting or defibrillating the heart in response to detecting a ventricular tachyarrhythmia. As such, the lead 918 is shown carrying a coil electrode 935 for delivering high voltage shock pulses. One or more coil electrodes may be included along one or more of leads 918, 919 or 992 in various examples. A coil electrode such as coil electrode 935 may be selected in a unipolar pacing electrode vector with any of the lead-based tip or ring electrodes 932, 934, 936, 938 or 94 for sensing unipolar electrocardiogram signals for analysis and determination of ventricular conduction conditions. In some instances, the coil electrode 935 may beused with the housing 815 for sensing a near-field electrocardiogram signal for use in determining atrial depolarizations or activations, etc.

[0059] When the pacing lead 918 is positioned for delivering bundle branch pacing, of one or both bundle branches, cardiac conduction system pacing therapy may be combined with traditional ventricular myocardial pacing of the left ventricle using the coronary sinus lead 992 to correct a left ventricular conduction delay and achieve electrical and mechanical synchrony of the left and right ventricles. As such, in some examples, one or more processors, one or more processing circuits, or a computing apparatus of the IMD 814 may select a cardiac conduction system pacing therapy plus traditional left ventricular myocardial pacing therapy that includes, for example, single or bilateral bundle branch pacing, e.g., using the lead 918, combined with left ventricular myocardial pacing using the coronary sinus lead 992. FIG. 4B is a conceptual diagram of another illustrative therapy system 802 that is substantially similar to the illustrative therapy system 801 of FIG. 4 A except that the system 802 does not includes coronary sinus lead 992.

[0060] The configuration of therapy system 10 illustrated in FIGS. 2-4 are merely examples. In other examples, a therapy system may include epicardial leads and / or patch electrodes instead of or in addition to the transvenous leads 18, 20, 23 illustrated in FIGS. 2-4 or other configurations shown or described herein or incorporated by reference. Further, the IMDs 16, 716, 814 need not be implanted within patient 14. As such, it is to be understood that the illustrative therapy systems described herein may include any suitable number of leads coupled to IMDs 16, 716, 814, and each of the leads may extend to any location within or proximate to the heart 12. For example, illustrative therapy systems may include three transvenous leads located as illustrated in FIGS. 2A-2C and 4 A, a single transvenous lead located as illustrated in FIGS. 3 A-3B, or two transvenous leads located as illustrated in FIGS. 2D and 4B.

[0061] FIG. 5 is a functional block diagram of one example configuration of the IMD 16. Although the IMD 16 of FIG. 5 is described in terms of the systems shown in FIGS. 2A-2D, it is to be understood that the IMDs 716, 814 may be substantially similar to the IMD 16, and as such, the IMDs 716, 814 may include any or all of the described functionality with respect to the functional block diagram of IMD 16.

[0062] The IMD 16 includes a processor 80, a memory 82, a stimulation generator 84 (e.g., electrical pulse generator or signal generating circuit), a sensing module 86 (e.g., sensing circuit), a telemetry module 88, and a power source 90. One or more components of the IMD 16, such as the processor 80, may be contained within a housing of the IMD 16 (e.g., within a housing of a pacemaker). The telemetry module 88, the sensing module 86, or both the telemetry module 88 and the sensing module 86 may be included in a communication interface. The memory 82 includes computer- readable instructions that, when executed by the processor 80, cause the IMD 16 and the processor 80 to perform various functions attributed to the IMD 16 and the processor 80 herein. The memory 82 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random-access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, or any other digital media.

[0063] The processor 80 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or integrated logic circuitry. In some examples, processor 80 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functions attributed to processor 80 herein may be embodied as software, firmware, hardware, or any combination thereof. The processor 80 controls the stimulation generator 84 to select a therapy mode (e.g., select one or more of an inhibited pacing mode, ventricular fusion pacing mode, atrioventricular synchronous pacing mode, atrial fibrillation pacing mode, etc.) and deliver stimulation therapy to the heart 12 according to the selected pacing mode, which may be stored in the memory 82, and various sensing (e.g., atrial depolarizations or activations, ventricular atrial depolarizations or activations, heartrate, P-wave-to-R-wave intervals, etc.). Specifically, the processor 80 may control the stimulation generator 84 to deliver electrical pulses with amplitudes, pulse widths, frequency, or electrode polarities specified by the selected one or more therapy programs and therapy modes.

[0064] In some embodiments, the lead 23 may be operably coupled to the electrode 61, which may be used to monitor or pace the right atrium. The stimulationgenerator 84 may be electrically coupled to the electrodes 40, 42, 44, 46, 48, 50, 58, 61, 62, 64, and 66, e.g., via conductors of the respective lead 18, 20, 23 or, in the case of housing electrode 58, via an electrical conductor disposed within the housing 60 of the IMD 16. The stimulation generator 84 may be configured to generate and deliver electrical stimulation therapy to the heart 12. For example, the stimulation generator 84 may deliver defibrillation shocks to the heart 12 via at least two of the electrodes 58, 62, 64, 66. The stimulation generator 84 may deliver pacing pulses via the ring electrodes 40, 44, 48 coupled to the leads 18, 20, 23, respectively, and / or the helical electrodes 42, 46, 50 of the leads 18, 20, or 23, respectively. The cardiac conduction system pacing therapy can be delivered through the cardiac conduction system lead 23 that is connected to an atrial, right ventricular, or left ventricular connection port of the connector block 34. In some embodiments, the cardiac conduction system pacing therapy can be delivered through the leads 18 and / or 23. In some examples, the stimulation generator 84 delivers pacing, cardioversion, or defibrillation stimulation in the form of electrical pulses. In other examples, the stimulation generator 84 may deliver one or more of these types of stimulation in the form of other signals, such as sine waves, square waves, or other substantially continuous time signals.

[0065] The stimulation generator 84 may include a switch module and the processor 80 may use the switch module to select, e.g., via a data / address bus, which of the available electrodes are used to deliver defibrillation shocks or pacing pulses. The switch module may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable to selectively couple stimulation energy to selected electrodes.

[0066] The sensing module 86 monitors signals from at least one of the electrodes 40, 42, 44, 46, 48, 50, 58, 61, 62, 64 or 66 in order to monitor electrical activity of the heart 12, e.g., via electrical signals, such as electrocardiogram (ECG) signals and / or electrograms (EGMs). The sensing module 86 may also include a switch module to select which of the available electrodes are used to sense the heart activity. In some examples, the processor 80 may select the electrodes that function as sense electrodes via the switch module within the sensing module 86, e.g., by providing signals via a data / address bus. In some examples, the sensing module 86 includes one or more sensing channels, each of which may include an amplifier. In response to thesignals from the processor 80, the switch module may couple the outputs from the selected electrodes to one of the sensing channels.

[0067] In some examples, one channel of the sensing module 86 may include an R-wave amplifier that receives signals from the electrodes 44, 46, which are used for pacing and sensing proximate to the left ventricle 32 of the heart 12. Another channel may include another R-wave amplifier that receives signals from the electrodes 40, 42, which are used for pacing and sensing in the right ventricle 28 of the heart 12. In some examples, the R-wave amplifiers may take the form of an automatic gain-controlled amplifier that provides an adjustable sensing threshold as a function of the measured R- wave amplitude of the heart rhythm.

[0068] In addition, in some examples, one channel of the sensing module 86 may include a P-wave amplifier that receives signals from electrodes the 48, 50, which are used for pacing and sensing in the right atrium 26 of heart 12. In some examples, the P-wave amplifier may take the form of an automatic gain-controlled amplifier that provides an adjustable sensing threshold as a function of the measured P-wave amplitude of the heart rhythm. Examples of R-wave and P-wave amplifiers are described in U.S. Patent No. 5,117,824 to Keimel et al., which issued on June 2, 1992, and is entitled, “APPARATUS FOR MONITORING ELECTRICAL PHYSIOLOGIC SIGNALS,” and is incorporated herein by reference in its entirety. Other amplifiers may also be used. Furthermore, in some examples, one or more of the sensing channels of the sensing module 86 may be selectively coupled to the housing electrode 58, or the elongated electrodes 62, 64, or 66, with or instead of one or more of the electrodes 40, 42, 44, 46, 48 or 50, e.g., for unipolar sensing of R-waves or P-waves in any of the chambers 26, 28, or 32 of the heart 12.

[0069] In some examples, the sensing module 86 includes a channel that includes an amplifier with a relatively wider pass band than the R-wave or P-wave amplifiers or a high-resolution amplifier with relatively narrow-pass band for His bundle or bundle branch potential recording. Signals from the selected sensing electrodes that are selected for coupling to this wide-band amplifier may be provided to a multiplexer, and thereafter converted to multi-bit digital signals by an analog-to- digital converter for storage in the memory 82 as an electrogram (EGM). In some examples, the storage of such EGMs in the memory 82 may be under the control of adirect memory access circuit. The processor 80 may employ digital signal analysis techniques to characterize the digitized signals stored in memory 82 to detect and classify the patient’s heart rhythm from the electrical signals. The processor 80 may detect and classify the heart rhythm of the patient 14 by employing any of the numerous signal processing methodologies known in the art.

[0070] If the IMD 16 is configured to generate and deliver pacing pulses to the heart 12, the processor 80 may include pacer timing and control module, which may be embodied as hardware, firmware, software, or any combination thereof. The pacer timing and control module may include a dedicated hardware circuit, such as an ASIC, separate from other the processor 80 components, such as a microprocessor, or a software module executed by a component of the processor 80, which may be a microprocessor or ASIC. The pacer timing and control module may include programmable counters which control the basic time intervals associated with DDD, VVI, DVI, VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR and other modes of single and dual chamber pacing. In the aforementioned pacing modes, “D” may indicate dual chamber, “V” may indicate a ventricle, “I” may indicate inhibited pacing (e.g., no pacing), and “A” may indicate an atrium. The first letter in the pacing mode may indicate the chamber that is paced, the second letter may indicate the chamber in which an electrical signal is sensed, and the third letter may indicate the chamber in which the response to sensing is provided.

[0071] Intervals defined by the pacer timing and control module may include atrial and ventricular pacing escape intervals, refractory periods during which sensed P- waves and R-waves are ineffective to restart timing of the escape intervals, and the pulse widths of the pacing pulses. As another example, the pace timing and control module may define a blanking time period and provide signals from sensing module 86 to blank one or more channels, e.g., amplifiers, for a period during and after delivery of electrical stimulation to the heart 12. The durations of these intervals may be determined by the processor 80 in response to stored data in the memory 82. The pacer timing and control module may also determine the amplitude of the cardiac pacing pulses.

[0072] During pacing, escape interval counters within the pacer timing / control module may be reset upon sensing of R-waves and P-waves. The stimulation generator84 may include pacer output circuits that are coupled, e.g., selectively by a switching module, to any combination of the electrodes 40, 42, 44, 46, 48, 50, 58, 61, 62, or 66 appropriate for delivery of a bipolar or unipolar pacing pulse to one of the chambers of the heart 12. The processor 80 may reset the escape interval counters upon the generation of pacing pulses by stimulation generator 84, and thereby control the basic timing of cardiac pacing functions, including anti -tachyarrhythmia pacing.

[0073] In some examples, the processor 80 may operate as an interrupt driven device and is responsive to interrupts from pacer timing and control module, where the interrupts may correspond to the occurrences of sensed P-waves and R-waves and the generation of cardiac pacing pulses. Any necessary mathematical calculations to be performed by the processor 80 and any updating of the values or intervals controlled by the pacer timing and control module of the processor 80 may take place following such interrupts. A portion of the memory 82 may be configured as a plurality of recirculating buffers, capable of holding series of measured intervals, which may be analyzed by the processor 80 in response to the occurrence of a pace or sense interrupt to determine whether the patient’s heart 12 is presently exhibiting atrial or ventricular tachyarrhythmia.

[0074] The telemetry module 88 includes any suitable hardware, firmware, software, or any combination thereof for communicating with another device, such as the programmer 24. Under the control of the processor 80, the telemetry module 88 may receive downlink telemetry from and send uplink telemetry to the programmer 24 with the aid of an antenna, which may be internal and / or external. The processor 80 may provide the data to be uplinked to the programmer 24 and the control signals for the telemetry circuit within the telemetry module 88, e.g., via an address / data bus. In some examples, the telemetry module 88 may provide received data to the processor 80 via a multiplexer.

[0075] The various components of the IMD 16 are coupled to the power source 90, which may include a rechargeable or non-rechargeable battery. A non-rechargeable battery may be selected to last for several years, while a rechargeable battery may be inductively charged from an external device, e.g., on a daily or weekly basis.

[0076] Many patients are treated with an implantable cardioverter-defibrillator for either primary or secondary prevention of ventricular arrhythmias. Despite thelifesaving benefit, ICD therapy has some challenges that make it difficult for a more extended adoption. Among others, some of the challenges of ICD therapy are related to the delivery of a high-voltage shock. Having ways to differentiate lethal arrhythmias (hemodynamically unstable) from those that are not (hemodynamically stable) may facilitate reducing the number of inappropriate shocks and improve patient outcomes.

[0077] Examples described herein relate to the use of local impedance measurements as a way to discriminate hemodynamically stable arrhythmias. While the impedance concept has been explored in far-field vectors, it has not been used inside the heart muscle to characterize mechanical contraction. While far-field vectors can capture many things between the tip and the can, measured impedance using far-field vectors is driven mainly by fluid changes such as blood volume. Local impedance measurements taken within the heart muscle can capture muscle movement and will therefore be able to measure contractability. Contractability measurements can help to determine whether an arrhythmia is stable or unstable. This will bring a new dimension to the discrimination between stable and unstable arrhythmias. Blood pressure and / or cardiac perfusion can be derived from the local impedance measurements and the blood pressure and / or perfusion can be used to adjust cardiac therapy. For example, blood pressure can be used to determine hemodynamic stability, which would help in reducing the number of ICD shocks by detecting those arrhythmias that are hemodynamically unstable.

[0078] The processor 80 may include impedance circuitry that discriminates hemodynamically stable arrhythmias from hemodynamically unstable arrhythmias using local impedance measurements. The processor 80 may use the local impedance measurements and / or the discrimination to adapt or provide therapy. In some examples, the processor 80 changes device settings based on the local impedance measurements.

[0079] Examples described herein may be used to fine-tune of CRT and / or CRT-D devices using the conduction system lead. For example, device programming can be automatically adapted to maximize left ventricular pressure using the local impedance measurements without input from an operator of the IMD.

[0080] FIG. 6 shows an illustrative method for adapting cardiac therapy based on local muscle impedance that may be utilized by the devices of FIGS. 1-5. Local impedance is monitored 610 using at least two implantable electrodes positionable inmyocardium tissue of the heart such as the septum wall of a heart of a patient. For example, a tip and a ring electrode may be positionable in myocardium tissue of the heart. In some examples, the electrodes for measuring the local muscle impedance could be shared with the existing pacing and sensing electrodes on the lead assuming that these electrodes could be completely embedded inside the heart tissue. In some examples, one or both of the electrodes used to measure the local impedance are dedicated electrodes for local impedance measurements that are connected to impedance measurement circuitry.

[0081] In some configurations, the implantable electrode is a conduction system electrode. According to various examples, a conduction system pacing lead having a ring and a tip electrode and both the ring and the tip electrodes are positionable within the septum. The monitoring may occur continuously or may occur periodically or may occur in response to a detected cardiac event. For example, a dyssynchrony (e.g., an interventricular dyssynchrony) may be detected and the local muscle impedance may be measured to determine whether the dyssynchrony warrants a cardiac therapy. The cardiac therapy may include defibrillation therapy and / or pacing therapy, for example.

[0082] A cardiac therapy may be adapted 620 and / or initiated based on the monitored local muscle impedance. For example, the IMD may be configured to deliver one or more electrical shocks to the patient’s heart based on the monitored local muscle impedance. In some configurations, adapting the cardiac therapy may involve automatically updating IMD settings based on the monitored muscle impedance. For example, the IMD setting may be updated to increase a blood pressure (e.g., a left ventricular pressure) using the measured local muscle impedance. For example, the local impedance measurements may be used to optimize or change the IMD settings. One or more IMD settings may be changed based on the monitored local impedance. For example, one or more of pacing delays, pacing vectors, pacing amplitudes, and atrioventricular (AV) delays may be changed or optimized. The AV delay represents the delay between atrial contraction and ventricular contraction. The IMD settings may be changed or optimized to increase the blood pressure to a predefined level.

[0083] FIG. 7 shows another illustrative method for adapting cardiac therapy based on local muscle impedance that may be utilized by the devices of FIGS. 1-5 Local impedance is monitored 710 using an implantable electrode positionable in amyocardium of a heart of a patient. In some configurations, the implantable electrode is a conduction system electrode. The implantable electrode may be positionable in a septum wall of the patient’s heart.

[0084] IMD 16 may receive an indication of a suspected arrhythmia. The arrhythmia may be initially detected using one or more of an ECG, an EGM, or any other suitable mechanism. The arrhythmia is confirmed 720 based on the local muscle impedance. A processor of the IMD determines 730 whether the arrhythmia is hemodynamically stable based on the local muscle impedance. This can be done by looking at the peak-to-peak variation and / or the peak amplitude in the local muscle impedance during the suspected arrhythmia event. The peak-to-peak amplitudes may be measured over one or both of a cardiac cycle and a breathing cycle. In some examples, the peak-to-peak amplitude is determined over a predefined time window (for example, 3 seconds). Variations in the peak magnitudes over time may be used to determine the stability of any potential arrhythmia.

[0085] Determining a peak magnitude or peak maximum helps to determine higher contractility when compared to lower magnitude amplitudes. A higher contractility may point to more stable conditions. If the peak-to-peak variation is significant at the high or maximum amplitude, this provides information on the amount of organization in the rhythm. If the peak-to-peak variability is organized, there is a higher chance to meet the oxygen demands from the body. Therefore, if the peak-to- peak variability is small, it may be determined that the arrhythmia is hemodynamically stable.

[0086] The system may determine that the peak-to-peak variation is organized by comparing the variability to a predefined threshold. For example, the system may determine if the peak-to-peak variation is greater than or equal to a predefined threshold. If the peak-to-peak variation is greater than or equal to the predefined threshold, then it is determined that the arrhythmia is hemodynamically stable. The peak-to-peak variation may be calculated with two peaks or may be calculated using more than two peaks using a mean or median of the peak-to-peak variation, for example. When an arrhythmia is hemodynamically unstable such as during ventricular fibrillation, there is little or no muscle contractability, so the peak-to-peak variation in local muscle impedance would be small. Therefore, if the peak-to-peak variation is lessthan the predefined threshold, it may be determined that the arrhythmia is hemodynamically unstable.

[0087] If it is determined 730 that the arrhythmia is hemodynamically stable, the system continues to monitor 710 local muscle impedance. If it is determined 730 that the arrhythmia is not hemodynamically stable, cardiac therapy is provided 740 to the patient’s heart. For example, IMD 16 may deliver defibrillation therapy to the patient’s heart. In some configurations, the system is configured to provide one or more electrical pulses to the patient’s heart based on the determination 730 that the arrhythmia is hemodynamically unstable.

[0088] The local impedance measurements could be used to adjust automatic CRT programming. For example, blood pressure and / or cardiac perfusion may be derived from the local impedance measurements. These measurements may be used to determine programming settings that help optimize by, for example, increasing or maximizing blood pressure. For example, a programming setting may be determined that increases left ventricular pressure. For example, the local impedance measurements may be used to automatically optimize one or more of pacing delays, pacing vectors, pacing amplitudes, and atrioventricular (AV) delays. These settings may be programmed to increase or maximize muscle impedance values automatically, without input from an operator or user.

[0089] FIG. 8 illustrates local muscle impedance and arterial blood pressure according to examples described herein. As can be observed, muscle contraction is associated with a decrease in impedance. There is a clear decrease in the impedance signal associated with the left ventricular contraction. The impedance signal shown in FIG. 8 also illustrates the closure of the aortic valve, which can be useful for adapting device therapy.ILLUSTRATIVE EXAMPLES

[0090] While the present disclosure is not so limited, an appreciation of various aspects of the disclosure will be gained through a discussion of the specific illustrative examples provided below. Various modifications of the illustrative examples, as well as additional examples of the disclosure, will become apparent herein.

[0091] Example 1 : An implantable medical device comprising: a computing apparatus comprising processing circuitry, the computing apparatus configured to communicate with a plurality of implantable electrodes to sense and pace a patient’s heart, the plurality of electrodes comprising a conduction system pacing electrode positioned in a myocardium of the patient’s heart, wherein the computing apparatus is configured to: monitor local muscle impedance of the patient’s heart using the cardiac conduction system electrode; and adapt cardiac therapy deliverable by the implantable device based on the local muscle impedance.

[0092] Example 2: The implantable medical device of Example 1, wherein the computing apparatus is configured to determine one or both of cardiac perfusion and cardiac pressure based on the local muscle impedance.

[0093] Example 3: The implantable medical device of Example 1 or Example 2, wherein the conduction system electrode comprises a tip electrode and a ring electrode.

[0094] Example 4: The implantable medical device of Example 3, wherein both of the tip electrode and the ring electrode are positionable within the myocardium of the patient’s heart.

[0095] Example 5: The implantable medical device of any of Example 1 through Example 4, wherein the computing apparatus is configured to detect hemodynamic instability based on the local muscle impedance.

[0096] Example 6: The implantable medical device of Example 5, comprising an implantable cardioverter defibrillator (ICD) and wherein the computing apparatus is configured to initiate delivery of a therapeutic electrical pulse to the patient’s heart based on the detection of the hemodynamic instability.

[0097] Example 7: The implantable medical device of any of Example 1 through Example 6, wherein adapting the cardiac therapy comprises automatically updating device settings based on the monitored muscle impedance.

[0098] Example 8: The implantable medical device of Example 7, wherein automatically updating the device settings comprises automatically updating the device settings to maximize a left ventricular pressure based on the monitored muscle impedance.

[0099] Example 9: The implantable medical device of any of Example 1 through Example 8, wherein the computing apparatus is configured to detect an arrhythmia and discriminate between a hemodynamically unstable arrhythmia and a hemodynamically stable arrhythmia based on the monitored local muscle impedance.

[0100] Example 10: The implantable medical device of Example 9, wherein the computing apparatus is further configured to initiate cardiac therapy based on the discrimination.

[0101] Example 11 : The implantable medical device of any of Example 1 through Example 10, wherein the conduction system electrode is positionable in a septum wall of the patient’s heart.

[0102] Example 12: A system, comprising: a plurality of implantable electrodes to sense and pace a patient’s heart, wherein the plurality of electrodes comprise a cardiac conduction system electrode positionable within a myocardium of the patient’s heart; and a computing apparatus comprising processing circuitry, the computing apparatus operably coupled to the plurality of implantable electrodes, wherein the computing apparatus is configured to: monitor local muscle impedance of the patient’s heart using the cardiac conduction system electrode; and initiate delivery of a therapeutic electrical pulse to the patient’s heart based on the local muscle impedance.

[0103] Example 13: The implantable defibrillator of Example 12, wherein the computing apparatus is configured to determine one or both of cardiac perfusion and cardiac pressure based on the local muscle impedance.

[0104] Example 14: The implantable defibrillator of Example 12 or Example 13, wherein the computing apparatus is configured to detect hemodynamic instability based on the local muscle impedance.

[0105] Example 15: The implantable defibrillator of Example 14, comprising an implantable cardioverter defibrillator (ICD) and wherein the computing apparatus is configured to initiate delivery of the therapeutic electrical pulse to the patient’s heart based on the detection of the hemodynamic instability.

[0106] Example 16: The implantable defibrillator of any of Example 12 through Example 15, further wherein the computing apparatus is configured to detect anarrhythmia and discriminate between a hemodynamically unstable arrhythmia and a hemodynamically stable arrhythmia based on the monitored local muscle impedance.

[0107] Example 17: The implantable defibrillator of any of Example 12 through Example 16, wherein the computing apparatus is further configured to initiate delivery of the therapeutic electrical pulse based on the discrimination.

[0108] Example 18: A method, comprising: monitoring local muscle impedance of a patient’s heart using a cardiac conduction system electrode positionable within a myocardium of the patient’s heart; and initiating delivery of cardiac therapy to the patient’s heart based on the local muscle impedance.

[0109] Example 19: The method of Example 18, further comprising: detecting an arrhythmia; and discriminating between a hemodynamically unstable arrhythmia and a hemodynamically stable arrhythmia based on the monitored local muscle impedance.

[0110] Example 20: The method of Example 19, wherein initiating delivery of cardiac therapy comprises initiating delivery of a therapeutic electrical pulse based on the discrimination.[OHl] This disclosure has been provided with reference to illustrative embodiments and examples and is not meant to be construed in a limiting sense. As described previously, one skilled in the art will recognize that other various illustrative applications may use the techniques as described herein to take advantage of the beneficial characteristics of the devices and methods described herein. Various modifications of the illustrative embodiments and examples will be apparent upon reference to this description.

[0112] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit.Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0113] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0114] All references and publications cited herein are expressly incorporated herein by reference in their entirety for all purposes, except to the extent any aspect directly contradicts this disclosure.

[0115] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are to facilitate understanding of certain terms used frequently herein and are not meant to limit the scope of the present disclosure.

[0116] Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims may be understood as being modified either by the term “exactly” or “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein or, for example, within typical ranges of experimental error.

[0117] The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any range within that range. Herein, the terms “up to” or “no greater than” a number (e.g., up to 50) includes the number (e.g., 50), and the term “no less than” a number (e.g., no less than 5) includes the number (e.g., 5).

[0118] The terms “coupled” or “connected” refer to elements being attached to each other either directly (in direct contact with each other) or indirectly (having one or more elements between and attaching the two elements). Either term may be modified by “operatively” and “operably,” which may be used interchangeably, to describe that the coupling or connection is configured to allow the components to interact to carryout at least some functionality (for example, a mobile user device may be operatively coupled to a cellular network transmit data to or receive data therefrom).

[0119] Reference to “one embodiment,” “an embodiment,” “certain embodiments,” or “some embodiments,” etc., means that a particular feature, configuration, composition, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of such phrases in various places throughout are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, configurations, compositions, or characteristics may be combined in any suitable manner in one or more embodiments.

[0120] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” encompass embodiments having plural referents, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise.

[0121] As used herein, “have,” “having,” “include,” “including,” “comprise,” “comprising” or the like are used in their open-ended sense, and generally mean “including, but not limited to.” It will be understood that “consisting essentially of,” “consisting of,” and the like are subsumed in “comprising,” and the like.

[0122] The term “and / or” means one or all of the listed elements or a combination of at least two of the listed elements.

[0123] The phrases “at least one of,” “comprises at least one of,” and “one or more of’ followed by a list refers to any one of the items in the list and any combination of two or more items in the list.

Claims

CLAIMSWhat is claimed:

1. A system comprising: an implantable medical device configured to be coupled with one or more leads, the implantable medical device comprising: a computing apparatus comprising processing circuitry, the computing apparatus configured to communicate with a plurality of implantable electrodes to sense and pace a patient’s heart, the plurality of electrodes comprising a cardiac conduction system pacing electrode positioned in a myocardium of the patient’s heart, wherein the computing apparatus is configured to: monitor local muscle impedance of the patient’s heart using the cardiac conduction system electrode; and adapt cardiac therapy deliverable by the implantable device based on the local muscle impedance.

2. The system of claim 1, wherein the computing apparatus is configured to determine one or both of a cardiac perfusion and a cardiac pressure based on the local muscle impedance.

3. The system of any of claims 1 or 2, wherein the computing apparatus is configured to detect hemodynamic instability based on the local muscle impedance.

4. The system of claim 3, wherein the computing apparatus is configured to initiate delivery of a therapeutic electrical pulse to the patient’s heart based on the detection of the hemodynamic instability.

5. The system of any of claims 1 through 4, wherein adapting the cardiac therapy comprises automatically updating device settings based on the monitored muscle impedance.

6. The system of claim 5, wherein automatically updating the device settings comprises automatically updating the device settings to increase a left ventricular pressure based on the monitored muscle impedance.

7. The system of any of claims 1 through 6, wherein the computing apparatus is configured to detect an arrhythmia and discriminate between a hemodynamically unstable arrhythmia and a hemodynamically stable arrhythmia based on the monitored local muscle impedance.

8. The system of any of claims 1 through 7 further comprising: one or more leads comprising a plurality of implantable electrodes configured to sense and pace a patient’s heart, the one or more leads comprising a cardiac conduction system lead comprising the cardiac conduction system electrode.

9. The system of claim 8, wherein the cardiac conduction system electrode comprises a ring electrode and a tip electrode both positionable in a myocardium of the patient’s heart.

10. The system of any of claims 8 or 9, wherein the conduction system electrode is positionable in a septum wall of the patient’s heart.

11. The system of any of claims 1 through 10, wherein the implantable medical device comprises an implantable cardioverter defibrillator (ICD).

12. A method, comprising: monitoring local muscle impedance of a patient’s heart using an implantable medical device having a cardiac conduction system electrode positionable within a myocardium of the patient’s heart; and initiating, using the implantable medical device, delivery of cardiac therapy to the patient’s heart based on the local muscle impedance.

13. The method of claim 12, further comprising, using the implantable medical device: detecting an arrhythmia; and discriminating between a hemodynamically unstable arrhythmia and a hemodynamically stable arrhythmia based on the monitored local muscle impedance.

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