VFA delivery and implantation site detection

Abstract

This invention discloses a method comprising locating a Koch triangle region in the right atrium of a patient's heart; securing at least one electrode of an implantable lead or device from the Koch triangle region to cardiac tissue for delivery of atrium-to-ventricle (VfA) cardiac therapy; and testing the position or depth of the at least one electrode to configure the VfA cardiac therapy. Locating the target implantation area in the Koch triangle region may include detecting atrial slow path potentials (ASP) or atrial pacing outputs.

Description

[0001] This technology relates as a whole to implantable medical systems, and more specifically to the delivery of implantable medical systems.

[0002] The cardiac conduction system includes the sinoatrial (SA) node, atrioventricular (AV) node, His bundle, bundle branches, and Purkinje fibers. The heartbeat is initiated in the SA node, which can be described as the heart's natural "pacemaker." Electrical impulses generated by the SA node cause the atrial myocardium to contract. The signal is conducted to the ventricles via the AV node, which inherently delays conduction to allow the atria to stop contracting before the ventricles begin to contract, thus providing proper AV synchronization. Electrical impulses are conducted from the AV node to the ventricular myocardium via the His bundle, bundle branches, and Purkinje fibers.

[0003] Implantable medical devices (IMDs), such as pacemakers or implantable cardioverter-defibrillators (ICDs), deliver therapeutic stimuli to a patient's heart. Patients with conduction system abnormalities, such as poor AV junction conduction or SA junction dysfunction, may receive IMDs (such as pacemakers) to restore a more normal heart rhythm and AV synchronization. Some types of IMDs (such as pacemakers, implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) devices) deliver therapeutic electrical stimulation to a patient's heart via electrodes positioned in or near the heart on one or more implanted endocardial, epicardial, or coronary venous leads. The therapeutic electrical stimulation can be delivered to the heart in the form of pulses or shocks for pacing, cardioversion, or defibrillation. In some cases, IMDs sense the heart's inherent depolarization and deliver therapeutic stimuli to the heart based on sense control.

[0004] Delivering therapeutic electrical stimulation directly to the heart can be used to address potential cardiac conditions such as ventricular asynchrony. Ventricular asynchrony can be described as a lack of synchronization or difference in systolic timing between different ventricles of the heart. Significant differences in systolic timing can reduce cardiac efficiency. CRT delivered to the heart by IMD can enhance cardiac output by resynchronizing the electromechanical activity of the heart's ventricles. CRT is sometimes referred to as "tri-chamber pacing" because it delivers pacing to three chambers: the right atrium, right ventricle, and left ventricle.

[0005] In addition to cardiac pacing, arrhythmias can be treated, for example, by delivering electrical shocks from an ICD (Integrated Cardiac Device) to cardioversion or defibrillation of the heart. This ICD senses the patient's heart rhythm and classifies it according to an arrhythmia detection protocol to detect episodes of tachycardia or fibrillation. Detected arrhythmias can include ventricular tachycardia (VT), rapid ventricular tachycardia (FVT), ventricular fibrillation (VF), atrial tachycardia (AT), and atrial fibrillation (AT). Antitachycardia pacing (ATP) is a painless therapy used to treat ventricular tachycardia (VT) to essentially terminate many monomorphic rapid rhythms. While ATP is painless, it may not be an effective treatment for all types of VT. For example, ATP may be ineffective against polymorphic VT, which has variable morphology. Polymorphic VT and ventricular fibrillation (VF) can be more fatal and may require rapid treatment via electrical shock.

[0006] Dual-chamber medical devices are available, comprising a transvenous atrial lead carrying an electrode that can be placed in the right atrium and a transvenous ventricular lead carrying an electrode that can be placed in the right ventricle via the right atrium. The dual-chamber medical device itself is typically implanted in a subcutaneous pouch, and the transvenous lead is tunneled into the pouch. The dual-chamber medical device senses both atrial and ventricular electrical signals and can provide both atrial and ventricular pacing as needed to promote normal heart rhythm and AV synchronization. Some dual-chamber medical devices can treat both atrial and ventricular arrhythmias.

[0007] Intracardiac medical devices, such as leadless pacemakers, have been introduced or proposed for complete implantation within a patient's heart, eliminating the need for transvenous leads. Leadless pacemakers may include one or more electrodes on their external housing to deliver therapeutic electrical signals and / or sense the heart's inherent depolarization. Intracardiac medical devices can provide cardiac therapeutic functions, such as sensing and pacing, within a single chamber of a patient's heart. Single-chamber intracardiac devices can also treat atrial or ventricular arrhythmias, or atrial or ventricular fibrillation. Some leadless pacemakers are not intracardiac and can be positioned externally, and in some examples, can be anchored to the heart wall via a fixation mechanism. Summary of the Invention

[0008] The techniques disclosed herein generally relate to the delivery of implantable medical systems for atrium-to-ventricle (VfA) cardiac therapy. These techniques facilitate the accurate delivery of implantable medical systems through the Koch triangle region in the right atrium for pacing the left ventricle. Specifically, at least one electrode of the implantable lead or device can be advanced from the Koch triangle region through the right atrial endocardium and central fibrous tissue into the left ventricular myocardium of the patient's heart to deliver cardiac therapy to the left ventricle or sense electrical activity of the left ventricle in the basal region, septal region, or baso-septal region of the left ventricular myocardium. Atrial slow path potentials (ASPs) can be used to determine the suitability of pacing location or depth for VfA cardiac therapy.

[0009] In one aspect, the method includes locating a Koch triangle region in the right atrium of a patient's heart; securing at least one electrode of an implantable lead or device from the Koch triangle region to cardiac tissue for delivery of atrium-to-ventricle (VfA) cardiac therapy; and testing the position or depth of the at least one electrode to configure the VfA cardiac therapy. Atrial slow path potentials (ASPs) can be used to determine the suitability of pacing location or depth for VfA cardiac therapy. The method can be performed using a delivery system that includes a mapping analyzer.

[0010] Details of one or more aspects of this disclosure are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages of the technology described in this disclosure will be apparent from the specification, drawings, and claims. Attached Figure Description

[0011] Figure 1 This is a flowchart illustrating an example of a method for delivering an implantable medical system comprising leads or devices for VfA cardiac therapy.

[0012] Figure 2 It shows that it can be used with, for example Figure 1 The flowchart shows an example of a method used in conjunction with other methods to provide an inlet path to the right atrium of a patient's heart.

[0013] Figure 3 It shows that it can be used with, for example Figure 1 The flowchart shows a first example of a method used in conjunction with other methods to locate the Koch triangle region in a patient's heart.

[0014] Figure 4 It shows that it can be used with, for example Figure 1 The flowchart shows a second example of a method used in conjunction with other methods to locate the Koch triangle region in a patient's heart.

[0015] Figure 5 It shows that it can be used with, for example Figure 1A flowchart illustrating an example of a method used in conjunction with the Koch triangle region to test the location or depth of at least one electrode attached to cardiac tissue.

[0016] Figure 6 It is shown in relation to, for example Figures 1-5 The method is used together with a conceptual diagram of the electrode implantation location mapped relative to the patient's heart in a standard 17-segment view for reference.

[0017] Figure 7 It is shown that, for example, Figures 1-5 A perspective view of an implantable medical system that uses the same method, including implantable leads and delivery sheaths.

[0018] Figure 8 It is shown that, for example, Figures 1-5 A perspective view of an implantable device used in conjunction with the method.

[0019] Figure 9 Is with, for example Figure 7 The system Figure 8 The device and Figures 1-5 The method is used in conjunction with external devices including electrode devices, display devices, and computing devices.

[0020] Figure 10 It is a diagram showing the various structures of a patient's heart.

[0021] Figure 11 This is a diagram showing the specific electrical pathways in a patient's heart that can be used to detect atrial slow path potentials (ASP).

[0022] Figure 12 It is shown that, for example, Figures 1-5 Methods Figure 7 The system Figure 8 The device and Figure 9 A conceptual diagram of a delivery component that can be used to detect ASPs and is used in conjunction with devices.

[0023] Figure 13 This is a graph showing the EGM signal, including the ASP characteristic waveform that can be used to determine the target implantation area.

[0024] Figure 14 It is a graph showing the ECG signal in response to high and low pacing outputs from an EGM pacing pulse that can be used to determine the target implantation area. Detailed Implementation

[0025] This disclosure provides techniques for delivering implantable medical systems for VfA cardiac therapy. These techniques facilitate the accurate delivery of the implantable medical system through the Koch triangle region in the right atrium (RA) for pacing the left ventricle (LV). Specifically, at least one electrode of the implantable lead or device can be advanced from the Koch triangle region through the RA endocardium and central fibrous tissue into the LV myocardium of the patient's heart to deliver cardiac therapy to the LV or sense electrical activity of the LV in the basal region, septal region, or baso-septal region of the LV myocardium.

[0026] As used herein, the term "or" is generally used in its inclusive sense, such as meaning "and / or," unless the context clearly specifies otherwise. The term "and / or" means one or all of the listed elements or a combination of at least two of the listed elements.

[0027] The terms “connection” or “link” refer to elements being directly attached to each other (i.e., in direct contact with each other) or indirectly attached (i.e., having one or more elements between and attaching the two elements). Either term may be modified by the interchangeable terms “operationally” and “operably” to describe a connection or link configured to allow components to interact to perform functions described in this disclosure or known to those skilled in the art who benefit from this disclosure.

[0028] Reference will now be made to the accompanying drawings, which depict one or more aspects described in this disclosure. However, it should be understood that other aspects not depicted in the drawings fall within the scope of this disclosure. The same numbers used in the drawings refer to the same parts, steps, etc. However, it should be understood that the use of reference characters to designate elements in a given drawing is not intended to limit elements in another drawing labeled with the same reference characters. Furthermore, the use of different reference characters to designate elements in different drawings is not intended to indicate that elements referenced differently cannot be the same or similar.

[0029] Figures 1-5 Various methods for delivering implantable leads or devices for VFA cardiac therapy are shown. Figure 1 The entire method is shown, and Figures 2-5 Details of some parts of the overall method are shown. Some or all of these steps can be performed by a physician or other qualified medical professional, who may be, for example, relative to... Figures 7-9 The various systems and devices described in this article are used to assist. Figure 6 The image shows some examples of the implantation sites targeted by these various methods.

[0030] Figure 1This is a flowchart illustrating an example of a method 100 for delivering an implantable medical system including a lead or device for VfA cardiac therapy. Typically, VfA cardiac therapy may include single-chamber or multi-chamber pacing (e.g., dual-chamber or triple-chamber pacing), atrioventricular (AV) synchronous pacing, asynchronous pacing, triggered pacing, cardiac resynchronization pacing, or tachycardia-related therapy. In some embodiments, VfA cardiac therapy utilizes at least one electrode that is coupled from the Koch triangle region of the RA through the RA endocardium and central fibrous tissue to an implantable lead or device implanted in the basal region, septal region, or basal-septal region (basal and septal regions) of the LV myocardium in the patient's heart. The electrode may be described as a tissue puncture electrode. The basal region, septal region, and basal-septal region are relative to... Figure 6 A more detailed description. The Koch triangle region relative to... Figures 7-8 To describe in more detail.

[0031] Method 100 may include providing an introduction pathway from outside the patient's body to the RA of the patient's heart 102 to deliver at least one electrode to the RA of the patient's heart. Typically, the introduction pathway to the RA includes a vein leading to the RA near the surface of the patient's body.

[0032] Method 100 may also include locating the Koch's triangle region in the right atrium of the patient's heart 104. In some cases, the Koch's triangle region can be found relative to specific anatomical structures, such as the tricuspid valve and the coronary sinus ostium (CSO) and AV node, which may also be described as reference anatomical structures. In other words, the tricuspid valve or CSO can be used as a starting point to locate the Koch's triangle region.

[0033] Furthermore, the method 100 may include securing at least one electrode of an implantable lead or device of an implantable medical system to cardiac tissue via a Koch triangle region to deliver atrium-to-ventricle (VfA) cardiac therapy 106. Securing at least one electrode may include selecting a specific location, depth, or orientation of the implantable lead or device to properly position at least one electrode. Typically, securing at least one electrode of an implantable lead or device to cardiac tissue via a Koch triangle region does not position one or more electrodes within the blood volume of the patient's left ventricle (LV).

[0034] Additionally, method 100 may include testing the position or depth of at least one electrode to configure the VfA cardiac therapy 108. If the initial position or depth of at least one electrode is insufficient for the desired VfA cardiac therapy, the electrode can be repositioned in position or depth, for example, by adjusting the position, depth, or orientation of the implanted lead or device. Any suitable technique can be used to test the position or depth of at least one electrode to configure the VfA cardiac therapy 108, such as relative to... Figure 13The description provides an example of using atrial slow path potentials (ASP) to identify the location or depth of VfA cardiac therapy.

[0035] Method 100 may also include preparing the VfA cardiac therapy 110 for the patient. Typically, any guides or components unnecessary for the delivery of the VfA cardiac therapy can be removed from the patient's body after the implantable medical system has been delivered. For example, the catheter may be cut open, the guide may be removed, the lead may be secured (if present) and connected to a device (such as a pacemaker) placed in a bag, and the bag may be closed.

[0036] Figure 2 This is a flowchart illustrating an exemplary method 102a for providing an access pathway to the RA of a patient's heart 102. Method 102 may include locating a vein 120 leading to the RA of the patient's heart. A physician may palpate the patient's body to locate the vein leading to the patient's RA. In some embodiments, the subclavian vein may be used. However, any suitable vein leading to the patient's right atrium may be used. For example, the right atrium may be accessed via a transvenous catheter placed through the femoral vein in the groin and through the superior vena cava such as the subclavian vein, brachiocephalic vein, or jugular vein.

[0037] Method 102a may also include creating an access passage to vein 122. In some embodiments, a physician may insert a needle and syringe into the vein.

[0038] Method 102a may also include confirming entry into a vein 124. For example, a physician may check that the needle has entered the subclavian vein. In some embodiments, the physician may retract or pull back the syringe to aspirate fluid from the entry channel. If the blood drawn into the syringe is purple, the physician can determine that the needle has entered the subclavian vein or another suitable vein.

[0039] Additionally, method 102a may include inserting a guide into vein 126 through an inlet channel. Typically, a guide can be used to introduce various components of an implantable medical system or delivery system into the RA through an inlet channel. An example of a guide is a sheath, which can be placed in the inlet channel via a syringe and needle, through the subclavian vein, and into the RA. The sheath can extend from outside the patient's body into the RA. An implantable lead or device can be advanced from outside the patient's body, through the sheath, and into the RA.

[0040] Figure 3This is a flowchart illustrating a first exemplary method 104a for locating a region of the Koch triangle in a patient's heart 104. Method 104a may include monitoring the delivery of at least one electrode using imaging 140. For example, imaging devices or systems, such as X-ray imaging systems or echocardiography systems, may be used to view one or more components advanced into the RA. In some embodiments, components of the delivery system or implantable leads or devices may include imaging agents, such as radiopaque materials, to provide contrast and visibility when viewed using an X-ray imaging system. Alternatively, other imaging agents, such as fluorescent transillumination contrast dyes, may be used.

[0041] Method 104a may also include advancing an implantable lead or device into the RA 142. When a guide (such as a sheath) is used, the implantable lead or device can be advanced through the guide into the RA. The implantable lead or delivery system for the device can be maneuverable. A core may be coupled to the device's lead or delivery system to provide the physician with control to guide the lead toward the implantation site through the patient's body.

[0042] Method 104a may also include locating the tricuspid valve of the patient's heart using an implantable lead or device 144. In some embodiments, the physician may locate the tricuspid valve, for example, by allowing the implantable lead or device to fall into the RV or by sliding the device along the RA endocardium until the implantable lead or device falls into the RV. The ridge of the tricuspid valve may be located above the septal leaflet of the tricuspid valve, near the septal wall of the right atrium. In some embodiments, the physician may locate the ridge of the tricuspid valve by moving the distal end of the implantable lead or device along the tricuspid valve until the physician detects a tactile response to the ridge.

[0043] Additionally, method 104a may include, for example, moving an implantable lead or device partially toward the CSO and AV nodes of the patient's heart to reach the Koch's triangle region 146 after positioning the tricuspid valve. In some embodiments, the distal end of the implantable lead or device may be moved a certain distance along the endocardium of the RA before reaching the Koch's triangle region. For example, the distal end of the implantable lead or device may be moved between 3 mm and 5 mm in the direction toward the CSO and AV nodes. This distance is shorter than the distance required to reach the CSO or AV node.

[0044] Figure 4 This is a flowchart illustrating a second exemplary method 104b for locating the Koch triangle region in a patient's heart 104. Method 104b is similar to method 104a, and method 104b may include using imaging 140 to monitor the delivery of at least one electrode and advancing an implantable lead or device into the RA 142. Typically, both methods 104a and 104b use an implantable lead or device to locate anatomical structures that facilitate the location of the Koch triangle region.

[0045] Unlike method 104a, method 104b includes locating the CSO using an implantable lead or device 148. In some embodiments, locating the CSO may include advancing the implantable lead or device into the coronary sinus (CS) of the patient's heart, which can be described as cannulating the CS. The implantable lead or device may be retracted from the CS until the distal end of the implantable lead or device reaches the CSO just outside the CS based on fluoroscopic markings. An imaging agent may be used to highlight the CSO and the tricuspid valve.

[0046] Method 104b may further include partially moving the implantable lead or device toward the tricuspid valve and AV node to reach the Koch triangle region 150. In some embodiments, the distal end of the implantable lead or device may be moved a certain distance along the endocardium of the RA before reaching the Koch triangle region. For example, the distal end of the implantable lead or device may be moved between 3 mm and 5 mm in the direction toward the tricuspid valve and AV node. This distance is shorter than the distance required to reach the tricuspid valve or AV node.

[0047] Figure 5 This is a flowchart illustrating an exemplary method 106a for testing the location or depth of at least one electrode attached to cardiac tissue from the Koch triangle region 106. Testing the location or depth of at least one electrode can help ensure that the electrode is suitable for delivery of VfA cardiac therapy.

[0048] Method 106a may include determining an initial implantation location through the Koch triangle region 160. For example, the initial implantation location may be based on moving the distal end of the implantable lead or device a specific distance from the tricuspid valve or CSO.

[0049] Method 106a may further include orienting the implantable lead or device at the initial implantation site 162. In some embodiments, orienting the implantable lead or device may include pointing the distal end of the implantable lead or device toward the apex of the left ventricular (LV) of the patient's heart. The implantable lead or device may be defined using a longitudinal axis extending along the elongated lead or device. In some embodiments, orienting the implantable lead or device may include aligning the longitudinal axis of the implantable lead or device, or the longitudinal axis of the distal end portion of the implantable lead or device, orthogonal to (or perpendicular to) the surface of the Koch triangle region at the initial implantation site.

[0050] Method 106a may further include attaching an implantable lead or device to an initial implantation site 164. The implantable lead or device may be attached in any suitable manner, depending on the type of fixation mechanism included. In some embodiments, the implantable lead or device includes a helical fixation assembly, which may be part of a tissue-penetrating assembly including one or more electrodes. The implantable lead or device may be attached by rotating or twisting the implantable lead or device clockwise or counterclockwise to advance at least one electrode toward the LV into the cardiac tissue forming the Koch triangle region. In some embodiments, the implantable lead or device includes a fixation element that is detachable from the tissue-penetrating assembly including one or more electrodes. The fixation element may be in the form of teeth that engage with the cardiac tissue forming the Koch triangle region.

[0051] Method 106a may also include testing the initial implantation location or depth 166. Any suitable test can be performed to verify the ability of at least one electrode to deliver VfA cardiac therapy. In some embodiments, the test may include monitoring electrical activity using one or more electrodes from the implanted lead or device. The test may also include monitoring mechanical activity using a motion sensor from the implanted lead or device. Furthermore, the test may include delivery using one or more electrodes from the implanted lead or device that can be delivered by an external electrode device (such as relative to...). Figure 9 The device (described) detects test pulses. Various pacing configurations or parameters can be tested at each location and depth.

[0052] Additionally, method 106a may include updating the initial implantation location or depth in response to test 168. The initial implantation location or depth can be changed if the test indicates that at least one electrode is not properly positioned to deliver VfA cardiac therapy. In one example, the implantable lead or device may be retracted from the cardiac tissue and reoriented at the same implantation location. In another example, the implantable lead or device may be retracted from the cardiac tissue and repositioned to another implantation site via the Koch triangle region. In yet another example, the implantable lead or device may be further inserted into the cardiac tissue at the same implantation location. The depth can be adjusted, for example, by rotating the implantable lead or device when using a helical fixation assembly.

[0053] The various steps of method 106a can be repeated until a test indicates that at least one electrode is correctly positioned to deliver the VfA cardiac therapy. In some cases, updating the initial implantation location or depth 168 can only be performed if at least one electrode is not correctly positioned to deliver the VFA cardiac therapy.

[0054] Figure 6This is a two-dimensional (2D) ventricular mapping 200 (e.g., top view) of a patient's heart showing the left ventricle (LV) 202 and right ventricle (RV) 204 in a standard 17-segment view. Mapping 200 includes multiple regions 208 corresponding to different areas of the human heart. As shown, regions 208 are numerically labeled 1-17 (which, for example, correspond to the standard 17-segment model of the human heart, the 17 segments corresponding to the left ventricle, etc.). Regions 208 of mapping 200 may include the anterior basal region 1, the anterior basal septal region 2, the infrabasal septal region 3, the subbasal region 4, the lateral basal region 5, the anterolateral basal region 6, the anterior midline region 7, the anterior midline septal region 8, the inframedial midline septal region 9, the inframedial midline region 10, the inframedial midline region 11, the anterolateral midline region 12, the anterior apical region 13, the apical septal region 14, the infraapical region 15, the lateral apical region 16, and the apical region 17. The inferior septal region and preseptal region of right ventricle 204, as well as the right bundle branch (RBB) and left bundle branch (LBB), are also shown.

[0055] In some implementations, the tissue puncture electrode may be implanted in a targeted implantation area in the basal region, septal region, or baso-septal region of the LV myocardium of a patient's heart, for example, through or from the Koch triangle region via the RA endocardium and central fibrous body. Referring to Figure 200, the basal region includes one or more of the following: pre-basal region 1, pre-basal septal region 2, sub-basal septal region 3, sub-basal region 4, pre-intermediate region 7, pre-intermediate septal region 8, sub-intermediate septal region 9, and sub-intermediate region 10. Referring to Figure 200, the septal region includes one or more of the following: pre-basal septal region 2, pre-basal septal region 3, pre-intermediate septal region 8, sub-intermediate septal region 9, and apical septal region 14. The baso-septal region may include one or more of the following: pre-basal septal region 2, sub-basal septal region 3, pre-intermediate septal region 8, and sub-intermediate septal region 9.

[0056] In some implementations, the target implantation area may include at least a portion of the subbasal septal region 3, the intermediate subbasal septal region 9, at least a portion of the preseptal region 2 near the subbasal septal region, and at least a portion of the intermediate preseptal region 8 near the intermediate subbasal septal region.

[0057] In some implementations, upon implantation, the tissue puncture electrode can be positioned in the upper / posterior baso-septal region of the LV myocardium. The upper / posterior baso-septal region of the LV myocardium may include a portion of at least one of the subbasal septal region 3 and the intermediate subseptal region 9. For example, the upper / posterior baso-septal region may include region 206, which is typically shown as a dashed boundary. As illustrated, the dashed boundary represents the approximate location of the upper / posterior baso-septal region and may vary slightly in shape or size depending on the specific application. Without being bound by any particular theory, intraventricular synchronous pacing or activation may result from stimulation of the septal ventricular myocardium due to the functional electrical connection between the subendocardial Purkinje fibers and the ventricular myocardium.

[0058] Figure 7 This is an example of an implantable medical system or cardiac treatment system 300 used with patient 2 to deliver VfA cardiac therapy, which uses... Figures 1-5 The method of delivery. System 300 may include one or more implantable medical leads or devices (which may be referred to as IMDs). In the illustrated embodiment, system 300 includes an implantable lead 302, which may also be described as a leaded medical device or implantable medical lead, which may be configured for single-chamber or multi-chamber therapy and implanted in the patient's heart 8. The implantable lead 302 may be advanced into the RA via a guide 304, which may include a sheath extending through the subclavian vein into the RA.

[0059] An implantable lead 302 is shown implanted in the RA of the patient's heart 8 within the target implantation area 4. A tissue puncture electrode 306 can be advanced through this implantable lead across the target implantation area to the target implantation site in the LV myocardium. In the illustration, the LV is located behind the RV (see [reference]). Figure 10 (Different perspective views of RV614 and LV 618). Specifically, the implantable lead 302 may include a tissue puncture electrode 306 that can be implanted from the Koch triangle region of the right atrium through the right atrial endocardium and central fibrous body into the high basal and / or septal region of the left ventricular myocardium 14 of the patient's heart. In some embodiments, the tissue puncture electrode 306 may include or form part of a helical fixation assembly. The implantable lead 302 may be described as an atrial-to-ventricular (VfA) lead or device that senses or delivers therapy to one or both ventricles (e.g., right ventricle, left ventricle, or both ventricles, depending on the environment), and is typically positioned in RA.

[0060] The implantable lead 302 may include one or more fixing members (such as...) Figure 8The fixation member 20 abuts against the distal end of the atrial endocardial anchoring implantable lead 302 in the target implantation region 4. The target implantation region 4 may be located between the His bundle 5 and the coronary sinus ostium 3, and may be adjacent to the left ridge 7 of the tricuspid valve 6.

[0061] One or more IMDs of system 300 may include leadless or led IMDs. As used herein, a “leadless” device means a device that does not have leads extending out of the patient’s heart 8. In other words, a leadless device may have leads that do not extend from the outside of the patient’s heart 8 into the inside of the patient’s heart. Some leadless devices can be introduced via a vein, but once implanted, the device does not contain or may not include any transvenous leads and can be configured to deliver cardiac therapy without the use of any transvenous leads. In one example, specifically, when the housing of a leadless device implanted in an RA is positioned in the RA, the leadless device does not use leads to be operatively connected to electrodes in the RA or LV.

[0062] System 300 may include one or more intracardiac IMDs, such as implantable device 400 ( Figure 8 As used herein, an "intracardiac" device refers to a device configured to be implanted entirely within the heart. An intracardiac IMD may include optional leads that do not extend beyond the patient's heart.

[0063] In some embodiments, system 300 may include multiple electrodes. A first electrode of system 300 may be configured to sense the electrical activity of a lower LV of the patient's heart 8 or to deliver cardiac therapy to a lower LV of the patient's heart. A second electrode of system 300 may be configured to sense the electrical activity of a lower RA of the patient's heart 8 or to deliver cardiac therapy to a lower RA of the patient's heart.

[0064] One or more leadless electrodes may be coupled to the housing of the IMD. An IMD having only leadless electrodes can be described as a leadless IMD. As used herein, a "leadless" electrode is an electrode operatively coupled to the device that has no leads or does not use leads, extending between the electrode and the housing of the device.

[0065] The motion sensor of system 300 can be configured to sense the mechanical activity of the patient's heart 8. In some cases, the motion sensor can be configured to sense at least the mechanical activity of the atria of the patient's heart 8. The motion sensor used can be in conjunction with motion sensor 11 ( Figure 8 The same or similar. The controller of system 300 (which may include processing circuitry) can be operatively coupled to one or more electrodes and to a motion sensor. Operable coupling can be performed using wired or wireless connections.

[0066] In the illustrated embodiment, system 300 includes an implantable lead 302. The implantable lead 302 can be configured to sense the electrical activity of the heart 8 and deliver pacing therapy, such as CRT. The implantable lead 302 can be attached to the inner wall of the heart 8 via one or more fixation elements that penetrate tissue (such as…). Figure 12 (AV septum 662 shown). These fixation elements secure the implantable lead 302 to cardiac tissue and hold electrodes (e.g., cathodes or anodes) on the housing of the first medical device in contact with cardiac tissue such as the endocardium or myocardium. In addition to delivering pacing pulses, the implantable lead 302 can be configured to sense or monitor electrical activity in the form of one or more electrical signals using electrodes carried on the housing of the implantable lead 302. The electrical activity can be generated by the myocardium and indicates depolarization and repolarization of the heart 8 at different times during the cardiac cycle.

[0067] Processing circuitry, sensing circuitry, and other circuitry configured to perform the techniques described herein with respect to implantable lead 302 may be housed within a corresponding hermetically sealed housing (not shown) operatively coupled to the implantable lead. The housing (or a portion thereof) may be conductive to serve as an electrode for pacing or sensing, or as an active electrode during defibrillation. Thus, the housing of the IMD may be described as including housing electrodes or housing-based electrodes.

[0068] Figure 8 An example of the anatomy of an intracardiac or leadless implantable medical device 400 and a patient's heart 8 is shown, which can be used with a leadless cardiac treatment system. Device 400 can be used as a lead 302 ( Figure 7 An alternative to ) . In other words, device 400 and lead 302 can be functionally interchangeable so as to deliver VfA cardiac therapy once implanted.

[0069] The intracardiac device 400 may include a housing 30. The housing 30 may define a hermetically sealed cavity in which internal components of the device 400 reside, such as sensing circuitry, therapy delivery circuitry, control circuitry, memory, telemetry circuitry (or communication interface), other optional sensors, and a power source. The housing 30 may be at least partially formed of a conductive material. Alternatively, the housing 30 may be at least partially formed of a non-conductive material.

[0070] The housing 30 can be described as extending in a generally cylindrical shape between a distal end region 32 and a proximal end region 34 for ease of delivery. The housing 30 may include, for example, a delivery tool interface member 26 at the proximal end 34 for engagement with a delivery tool during implantation of the device 400. For example, the delivery tool interface member 26 may be used when advancing the device 400 toward the target implantation region 4 using a delivery catheter. The delivery tool or catheter can be manipulated to guide the device 400 toward the target implantation region 4.

[0071] All or part of the housing 30 can be used as an electrode during cardiac therapy, such as in sensing and / or pacing. In the example shown, the housing-based electrode 24 is shown as a proximal portion of the outer housing 30. When the housing 30 comprises a conductive material (e.g., formed of a conductive material), portions of the housing 30 can be electrically insulated by a non-conductive material (such as a coating), thereby exposing one or more discrete regions of the conductive material to define the housing-based proximal electrode 24. When the housing 30 comprises a non-conductive material (e.g., formed of a non-conductive material), a conductive coating or layer can be applied to one or more discrete regions of the housing 30 to form the housing-based proximal electrode 24. In other examples, the housing-based proximal electrode 24 can be a component mounted or assembled onto the housing 30, such as a ring electrode. When the housing 30 comprises a non-conductive material, the housing-based proximal electrode 24 can be electrically connected to the internal circuitry of the device 400, for example, via the conductive housing 30 or an electrical conductor.

[0072] In the example shown, the housing-based electrode 24 is positioned closer to the proximal end region 34 of the housing than the distal end region 32 of the housing, and can therefore be described as a proximal housing-based electrode. However, in other examples, the housing-based electrode 24 may be located at other locations along the housing 30, for example, relatively more distally than the location shown.

[0073] At the distal end region 32, the device 400 may include a distal fixation and electrode assembly 36, which may include one or more fixation members 20 in addition to one or more dart electrodes 12 of equal or unequal length. The one or more dart electrodes 12 of the assembly 36 may be described as tissue puncture electrodes. In other embodiments (not shown), the distal fixation and electrode assembly 36 may include a helical or spiral electrode. The dart electrode or spiral electrode may also be described as a tissue puncture electrode.

[0074] As depicted, the device 400 includes a single dart electrode 12, which may include a shaft 40 extending distally away from the distal end region 32 of the housing, and may include one or more electrode elements, such as a tip electrode element 42 at or near the free distal end region of the shaft 40. The tip electrode element 42 may have a conical or hemispherical distal tip with a relatively narrow tip diameter (e.g., less than about 1 millimeter (mm)) for penetration into and through the tissue layer without using a sharp or needle-like tip with a pointed or slanted edge.

[0075] The shaft 40 of the dart electrode 12 can be a normally straight member and can be rigid. In other embodiments, the shaft 40 can be described as relatively rigid but still having limited flexibility (e.g., elastic or semi-rigid) in the lateral direction. The dart electrode 12 can be configured to pierce one or more tissue layers to position the tip electrode element 42 within a desired tissue layer (e.g., ventricular myocardium). Thus, the length or height 47 of the shaft 40 can correspond to the intended pacing site depth. If a second dart electrode 12 is used, its length or height may not be equal to the intended pacing site depth and can be configured to act as an independent electrode for delivering pacing energy to the tissue.

[0076] One or more fixation members 20 may be described as one or more “teeth” having a normal bending position. The teeth may be held in a distally extended position within the delivery tool. The distal tip of the teeth may penetrate cardiac tissue to a limited depth before elastically bending proximally back to the normal bending position (shown) upon release from the delivery tool.

[0077] In some examples, the distal fixation and electrode assembly 36 includes a housing-based distal electrode 22. When the device 400 is used as a pacemaker for multi-chamber pacing (e.g., dual-chamber or triple-chamber pacing) and sensing, the tip electrode element 42 can be used as a cathode electrode paired with the housing-based proximal electrode 24, which serves as a return anode electrode. Alternatively, the housing-based distal electrode 22 can be used as a return anode electrode paired with the tip electrode element 42 for sensing ventricular signals and delivering ventricular pacing pulses. In other examples, the housing-based distal electrode 22 can be a cathode electrode for sensing atrial signals and delivering pacing pulses to the atrial myocardium in the target implantation region 4. When the housing-based distal electrode 22 is used as an atrial cathode electrode, the housing-based proximal electrode 24 can be used as a return anode paired with the tip electrode element 42 for ventricular pacing and sensing, and as a return anode paired with the housing-based distal electrode 22 for atrial pacing and sensing.

[0078] As illustrated, in some pacing applications, the target implantation region 4 is along the atrial endocardium 18, typically below the AV node 15 and His bundle 5. The dart electrode 42 may define the length or height 47 of its axis 40 for penetration through the atrial endocardium 18 in the target implantation region 4, through the central fiber body 16, and into the ventricular myocardium 14, without penetrating through the ventricular endocardial surface 17. When the length or height 47 of the dart electrode 12 is fully advanced into the target implantation region 4, the tip electrode element 42 may rest or be positioned within the ventricular myocardium 14, and the distal electrode 22, based on the housing, may be positioned in close contact with or very close to the atrial endocardium 18.

[0079] Device 400 may include a motion sensor 11 or a motion detector within housing 30. Motion sensor 11 may be used to monitor mechanical activity, such as atrial mechanical activity (e.g., atrial contraction) and / or ventricular mechanical activity (e.g., ventricular contraction). In some embodiments, motion sensor 11 may be used to detect RA mechanical activity. Non-limiting examples of motion sensor 11 include an accelerometer. In some embodiments, the mechanical activity detected by motion sensor 11 may be used to supplement or replace electrical activity detected by one or more electrodes of device 400. For example, motion sensor 11 may be used in addition to, or as an alternative to, the housing-based proximal electrode 24.

[0080] The mechanical activity detected by motion sensor 11 can correspond to various heart sounds. Typically, heart sounds are associated with the mechanical vibrations of the patient's heart and the flow of blood through the heart valves, and therefore can be highly correlated with pressure gradients and blood pressure across the heart valves. Heart sounds may be due not only to vibrations and pressure within the heart, but also to the entire cardiac circulatory system, such as blood, the heart, aorta, etc. Heart sounds can be reproduced with each cardiac cycle and are separated and classified according to the activity associated with the vibration.

[0081] The device 400 can be implanted such that the electrode 12 is positioned to sense electrical activity or deliver pacing therapy to a specific portion of the patient's LV myocardium. For example, the electrode 12 can be implanted in the basal region, septal region, or baso-septal region of the LV.

[0082] Figure 9 An example of an external device is shown, which can be used to facilitate the implantation or configuration of an implantable lead or device. Figure 9 An example of a system 500 depicting an external device used with a patient 520 is shown, the external device including an electrode device 510, a display device 530, and a computing device 540.

[0083] As shown in the figure, electrode device 510 includes a plurality of electrodes 512, which are combined or included within a band wrapped around the chest or torso of a patient 520. In other embodiments, electrode device 510 may include a vest to which the plurality of electrodes 512 may be attached, or the electrodes 512 may be coupled to the vest. Electrode device 510 is operatively coupled to computing device 540 (e.g., via a wired or wireless connection) to provide computing device 540 with electrical signals from each of the electrodes for analysis, evaluation, etc. Electrode device is described in U.S. Patent No. 9,320,446, entitled “Bioelectric Sensor Device and Methods,” published April 26, 2016.

[0084] Although not described herein, system 500 may also include an imaging device (not shown). The imaging device can be any type of imaging device configured to non-invasively image or provide an image of at least a portion of a patient. For example, in addition to non-invasive tools such as imaging agents, the imaging device may provide an image of the patient without using any parts or components that may be located within the patient's body. It should be understood that the systems, methods, and interfaces described herein can be further used to provide non-invasive assistance to a user (e.g., a physician) to calibrate and / or deliver cardiac pacing therapy, to locate and place devices for delivery of cardiac pacing therapy, and / or to locate or select pacing electrodes or pacing vectors proximal to the patient's heart for cardiac pacing therapy in conjunction with an assessment of cardiac pacing therapy.

[0085] For example, systems, methods, and interfaces can provide image-guided navigation that can be used to navigate leads, including leadless devices, electrodes, leadless electrodes, radio electrodes, catheters, etc., within a patient, while also providing non-invasive cardiac therapy assessments, including determining whether pacing settings are optimal, or whether one or more selected parameters are optimal, such as selected location information (e.g., location information for electrodes targeting a specific location in the left ventricle). Systems and methods using imaging devices and / or electrode devices are described in U.S. Patent No. 9,877,789, entitled "Implantable Electrode Location Selection," published January 30, 2018; U.S. Patent No. 10,251,555, entitled "Implantable Electrode Location Selection," published April 9, 2019; U.S. Patent No. 9,924,884, entitled "Systems, Methods, and Interfaces for Identifying Effective Electrodes," published March 27, 2018; and U.S. Patent No. 10,064,567, entitled "Systems, Methods, and Interfaces for Identifying Optical-Electrical Vectors," published September 4, 2018.

[0086] Imaging devices can be configured to capture X-ray images and / or any other alternative imaging modalities. For example, imaging devices can be configured to capture images or image data using isocentric fluoroscopy, biplane fluoroscopy, ultrasound, computed tomography (CT), multi-slice computed tomography (MSCT), magnetic resonance imaging (MRI), high-frequency ultrasound (HIFU), optical coherence tomography (OCT), intravascular ultrasound (IVUS), two-dimensional (2D) ultrasound, three-dimensional (3D) ultrasound, four-dimensional (4D) ultrasound, intraoperative CT, intraoperative MRI, etc. Furthermore, it should be understood that imaging devices can be configured to capture multiple consecutive images (e.g., sequentially) to provide video frame data. In other words, multiple images captured by the imaging device over time can provide video frame or motion picture data. Additionally, images can be acquired and displayed in two, three, or four dimensions. In more advanced forms, four-dimensional surface rendering of the heart or other areas of the body can also be achieved by combining cardiac data or other soft tissue data from mapping or preoperative image data captured from MRI, CT, or echocardiographic modalities. Image datasets from mixed modalities (such as positron emission tomography (PET) combined with CT, or single-photon emission computed tomography (SPECT) combined with CT) can also provide functional image data superimposed on anatomical data, for example, to navigate therapeutic devices toward a target location (e.g., within the heart or other regions of interest).

[0087] Systems and / or imaging devices that can be used in conjunction with the exemplary systems and methods described herein are listed in the following U.S. Patent Application Publication No. 2005 / 0008210, issued to Evron et al., published January 13, 2005; U.S. Patent Application Publication No. 2006 / 0074285, issued to Zakh et al., published April 6, 2006; U.S. Patent No. 8,731,642, issued to Zakh et al., published May 20, 2014; U.S. Patent No. 8,861,830, issued to Brada et al., published October 14, 2014; U.S. Patent No. 6,980,675, issued to Evron et al., published December 27, 2005; and U.S. Patent No. 23, 2007. U.S. Patent No. 7,286,866 to Okerlund et al., issued on December 11, 2011; U.S. Patent No. 7,308,297 to Reddy et al., issued on December 11, 2011; U.S. Patent No. 7,308,299 to Burrell et al., issued on December 11, 2011; U.S. Patent No. 7,321,677 to Evron et al., issued on January 22, 2008; U.S. Patent No. 7,346,381 to Okerlund et al., issued on March 18, 2008; U.S. Patent No. 7,454,248 to Burrell et al., issued on November 18, 2008; and U.S. Patent No. 7,454,248 to V, issued on March 3, 2009. U.S. Patent No. 7,499,743 to Vass et al., issued July 21, 2009; U.S. Patent No. 7,565,190 to Okerlund et al., issued September 8, 2009; U.S. Patent No. 7,587,074 to Zakh et al., issued September 8, 2009; U.S. Patent No. 7,599,730 to Hunter et al., issued October 6, 2009; U.S. Patent No. 7,613,500 to Vass et al., issued November 3, 2009; U.S. Patent No. 7,742,629 to Zakh et al., issued June 22, 2010; and U.S. Patent No. 7,642,629 to Okerlund et al., issued June 29, 2010. U.S. Patent No. 747,047 to Evron et al., issued August 17, 2010; U.S. Patent No. 7,778,685 to Vass et al., issued August 17, 2010; U.S. Patent No. 7,813,785 to Okerlund et al., issued October 12, 2010; U.S. Patent No. 7,996,063 to Vass et al., issued August 9, 2011; U.S. Patent No. 8,060,185 to Hunter et al., issued November 15, 2011; and U.S. Patent No. 8,401,616 to Verard et al., issued March 19, 2013, are described in U.S. Patent No. 7,778,685 to Evron et al., issued August 17, 2010; U.S. Patent No. 7,778,686 to Vass et al., issued August 17, 2010; U.S. Patent No. 7,813,785 to Okerlund et al., issued October 12, 2010; U.S. Patent No. 7,996,063 to Vass et al., issued August 9, 2011; U.S. Patent No. 8,060,185 to Hunter et al., issued November 15, 2011; and U.S. Patent No. 8,401,616 to Verard et al., issued March 19, 2013.

[0088] Display device 530 and computing device 540 may be configured to display and analyze data such as electrical signals (e.g., electrocardiogram data), cardiac information representing one or more of mechanical and electrical cardiac functions (e.g., mechanical cardiac function only, electrical cardiac function only, or both mechanical and electrical cardiac functions), etc. The cardiac information may include information on electrical heterogeneity or electrical asynchrony generated using electrical signals acquired, monitored, or collected using electrode device 510, alternative electrical activation information, or data, etc. Computing device 540 may be a server, personal computer, or tablet computer. Computing device 540 may be configured to receive input from input device 542 and transmit output to display device 530. In addition, the computing device 540 may include a data storage device that allows access to processes or routines and / or one or more other types of data, such as for calibrating and / or delivering pacing therapy to drive a graphical user interface configured to non-invasively assist a user in targeting a pacing device, and / or for evaluating pacing therapy at that location (e.g., the location of an implantable electrode for pacing, the location of pacing therapy delivered by a specific pacing vector, etc.).

[0089] Computing device 540 can be operatively coupled to input device 542 and display device 530 to, for example, transmit data to and from each of the input device 542 and display device 530. For example, computing device 540 can be electrically coupled to each of the input device 542 and display device 530 using, for example, analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, internet-based connections, etc. As further described herein, a user can provide input to input device 542 to manipulate or modify one or more graphic depictions displayed on display device 530 and view and / or select one or more pieces of information related to cardiac therapy.

[0090] Although the input device 542 is depicted as a keyboard, it should be understood that the input device 542 may include any device capable of providing input to the computing device 540 for performing the functions, methods, and / or logic described herein. For example, the input device 542 may include a mouse, trackball, touchscreen (e.g., capacitive touchscreen, resistive touchscreen, multi-touch touchscreen, etc.), etc. Similarly, the display device 530 may include any device capable of displaying information to a user, such as a graphical user interface 532, including cardiac information, text commands, graphical depictions of electrical activation information, graphical depictions of the anatomy of the human heart, images or graphical depictions of a patient's heart, images or graphical depictions of a leadless pacemaker for calibrating and / or delivering pacing therapy, graphical depictions of a leadless pacemaker positioned or placed to provide cardiac pacing therapy, graphical depictions of the location of one or more electrodes, graphical depictions of the human torso, images or graphical depictions of a patient's torso, graphical depictions of a patient's torso, images or graphical depictions of a human torso, graphical depictions or actual images of implanted electrodes and / or leads, etc. In addition, the display device 530 may include a liquid crystal display, an organic light-emitting diode screen, a touch screen, a cathode ray tube display, etc.

[0091] The processing programs or routines stored and / or executed by the computing device 540 may include programs or routines for: computational mathematics, matrix mathematics, dispersion determination (e.g., standard deviation, variance, range, interquartile range, mean absolute difference, mean absolute deviation, etc.), filtering algorithms, maximum value determination, minimum value determination, threshold determination, moving window algorithms, decomposition algorithms, compression algorithms (e.g., data compression algorithms), calibration algorithms, image construction algorithms, signal processing algorithms (e.g., various filtering algorithms, Fourier transform, fast Fourier transform, etc.), normalization algorithms, comparison algorithms, vector mathematics, or any other processing required to implement one or more of the methods and / or processes described herein. The data stored and / or used by the computing device 540 may include, for example, electrical signal / waveform data from the electrode device 510, scattered signals, windowed scattered signals, parts or portions of various signals, electrical activation times from the electrode device 510, graphics (e.g., graphic elements, icons, buttons, windows, dialog boxes, drop-down menus, graphic areas, graphic regions, 3D graphics, etc.), graphical user interfaces, results from one or more processing procedures or routines employed in accordance with the disclosure herein (e.g., electrical signals, cardiac information, etc.), or any other data necessary to perform one or more of the processes or methods described herein.

[0092] The electrical activation time of a patient's heart can be used to assess the patient's cardiac condition and / or calibrate, deliver, or evaluate cardiac therapies to be delivered or being delivered to the patient. Alternative electrical activation information or data for one or more regions of the patient's heart can be monitored or determined using electrode device 510. Electrode device 510 can be configured to measure the body surface potential of patient 520, and more specifically, to measure the trunk surface potential of patient 520.

[0093] Electrodes 512 can be configured to surround the heart of the patient 520 and to record or monitor electrical signals associated with the depolarization and repolarization of the heart after a signal has propagated through the torso of the patient 520. Each electrode 512 can be used in a monopolar configuration to sense torso surface potentials reflecting cardiac signals. Interface / amplifier circuitry 516 can also be coupled to return electrodes or unrelated electrodes (not shown) that can be combined with each electrode 512 for monopolar sensing. In some examples, approximately 12 to approximately 50 electrodes 512 may be spatially distributed around the patient's torso. Other configurations may have more or fewer electrodes 512.

[0094] The computing device 540 can record and analyze electrical activity sensed by the electrodes 512 (e.g., trunk-surface potential signals). The computing device 540 can be configured to analyze signals from the electrodes 512 to provide, as anterior and posterior electrode signals and alternative cardiac electrical activation times, such as actual or local electrical activation times representing one or more regions of the patient's heart, as will be further described herein. The computing device 540 can also be configured to analyze signals from the electrodes 512 to provide, as anterior-septal electrode signals and alternative cardiac electrical activation times, such as actual or local electrical activation times representing one or more anterior-septal regions of the patient's heart, as will be further described herein, for example, for calibration, delivery, and / or evaluation of pacing therapy. Furthermore, the electrical signal measured at the left anterior surface of the patient's trunk can be a representative or substitute for the electrical signal of the left anterior ventricular region of the patient's heart; the electrical signal measured at the left lateral surface of the patient's trunk can be a representative or substitute for the electrical signal of the left left ventricular region of the patient's heart; the electrical signal measured at the left posterolateral surface of the patient's trunk can be a representative or substitute for the electrical signal of the posterolateral left ventricular region of the patient's heart; and the electrical signal measured at the posterior surface of the patient's trunk can be a representative or substitute for the electrical signal of the left posterior ventricular region of the patient's heart. The measurement of activation time can be performed by measuring the time interval between the onset of cardiac depolarization (e.g., the onset of the QRS complex) and an appropriate reference point (such as peak, minimum, minimum slope, maximum slope, zero crossover, threshold crossover, etc.).

[0095] Additionally, the computing device 540 may be configured to provide a graphical user interface depicting the alternative electrical activation time obtained using the electrode device 510. Systems, methods, and / or interfaces may non-invasively use the electrical information collected using the electrode device 510 to assess a patient's cardiac condition and / or calibrate, deliver, or evaluate cardiac pacing therapies to be delivered or being delivered to a patient.

[0096] As described herein, electrode device 510 can be configured to measure electrical information (e.g., electrical signals) representing different regions of a patient's heart. For example, the activation time of different regions of the patient's heart can be approximated by the activation time of a surface electrocardiogram (ECG) measured using a surface electrode near a surface region corresponding to a different region of the patient's heart. In at least one example, the activation time of the anterior-middle septum region of the patient's heart can be approximated by the surface ECG activation time measured using a surface electrode near a surface region corresponding to the anterior-middle septum region of the patient's heart. That is, a portion, and not the entire group, of a set of electrodes 512 can be used to generate the activation time corresponding to a specific location of the patient's heart corresponding to that portion of the set of electrodes.

[0097] The system, method, and interface can be used to provide non-invasive assistance to the user in assessing a patient’s cardiac health or condition and / or in assessing cardiac therapies such as CRT using electrode device 510 (e.g., cardiac therapy is currently being delivered to the patient during or after implantation). Furthermore, the system, method, and interface can be used to assist the user in the configuration or calibration of cardiac therapies (such as CRT) to be delivered or being delivered to the patient.

[0098] Multiple external electrodes, such as electrode 512, can be used to monitor electrical activity. Electrical activity can be monitored via multiple electrodes during or in the absence of pacing therapy. The monitored electrical activity can be used to evaluate pacing therapy for the patient. Electrical activity monitored using the described ECG band can be used to evaluate at least one pacing setting for cardiac pacing therapy. As an example, the pacing setting can be any single parameter or combination of parameters, including but not limited to electrode location, pacing polarity, pacing output, pacing pulse width, timing of ventricular pacing relative to atrial timing delivery, pacing rate, etc. Furthermore, as an example, the location of the leadless device or pacing lead can include a location in the right ventricle, left ventricle, or right atrium.

[0099] Furthermore, during or without pacing therapy, monitored electrical activity can be used to construct a surface isochronous map of ventricular activation. The monitored electrical activity and / or the map of ventricular activation can be used to generate electrical heterogeneity information (EHI). EHI may include measures that determine electrical heterogeneity. Measures of electrical heterogeneity may include a measure of the standard deviation (SDAT) of activation time of electrodes on the left side of the patient's trunk and / or a measure of the mean left ventricular activation time (LVAT) of electrodes on the left side of the patient's trunk. LVAT can be determined by electrodes on the anterior and posterior surfaces, which are closer to the left ventricle. Measures of electrical heterogeneity information may include a measure of the mean right ventricular activation time (RVAT) of electrodes on the right side of the patient's trunk. RVAT can be determined by electrodes on the anterior and posterior surfaces, which are closer to the right ventricle. Measures of electrical heterogeneity may include a measure of the mean total activation time (mTAT) obtained from multiple electrode signals from both sides of the patient's trunk, or may include other measures (e.g., standard deviation, interquartile range, difference between the most recent and earliest activation times) reflecting the range or dispersion of activation times on multiple electrodes located on the right or left side of the patient's trunk, or a combination of both. Measures of electrical heterogeneity information may include a measure of the anterior septal activation time (ASAT) of electrodes on the trunk adjacent to the anterior septum of the heart.

[0100] Electrical heterogeneity information (EHI) can be generated during the delivery of pacing therapy in one or more pacing settings. Measured electrical heterogeneity can be used to generate EHI. As an example, the measure of electrical heterogeneity may include one or more of SDAT, LVAT, RVAT, mTAT, and ASAT. In another example, only ASAT may be determined and further used, and / or ASAT may be weighted more heavily than other values.

[0101] One or more pacing settings associated with pacing therapy can be evaluated. Pacing settings may include multiple pacing parameters. Multiple pacing parameters may be optimal if the patient's cardiac condition improves, if the pacing therapy effectively captures the desired portion of the RA, RV, or LV, and / or if a measure of electrical heterogeneity improves by a certain threshold compared to the baseline rhythm or therapy. Determining whether a pacing setting is optimal may be based on at least one measure of electrical heterogeneity generated from electrical activity during pacing (and in some cases, during natural conduction, or in the absence of pacing). At least one measure may include one or more of SDAT, LVAT, RVAT, mTAT, and ASAT.

[0102] Furthermore, multiple pacing parameters may be optimal if the measure of electrical heterogeneity is greater than or less than a specific threshold, and / or if the location of the pacing therapy used to stimulate the left ventricle causes a specific firing pattern in the myofiber fibers of the heart. Additionally, multiple pacing parameters may be optimal if the measure of electrical heterogeneity indicates correction for left bundle branch block (LBBB), and / or if the measure of electrical heterogeneity indicates complete engagement of the Purkinje system, etc. As an example, measures of electrical heterogeneity of ASAT less than or equal to a threshold (e.g., a threshold of 30 ms) and LVAT less than or equal to a threshold (e.g., a threshold of 30 ms) can indicate correction for LBBB, and therefore, the pacing setting is optimal. As an example, measures of electrical heterogeneity of RVAT less than or equal to a threshold (e.g., a threshold of 30 ms), ASAT less than or equal to a threshold (e.g., a threshold of 30 ms), and LVAT less than or equal to a threshold (e.g., a threshold of 30 ms) can indicate complete engagement of the Purkinje system, and therefore, the pacing setting can be optimal.

[0103] In response to the acceptance and benefit of pacing therapy using a pacing setting, indicating complete engagement of the patient's natural cardiac conduction system, indicating correction of ventricular conduction disorders (e.g., left bundle branch block), etc., the pacing setting can be determined to be optimal. A pacing setting may include one or more of the following: pacing electrode position (including one or more of the depth, angle, rotation, etc. of a screw-based fixation mechanism), voltage, pulse width, intensity, pacing polarity, pacing vector, pacing waveform, timing of pacing delivery relative to an inherent or pacing atrial event or relative to an inherent His bundle potential, and / or pacing location. A pacing vector may include any two or more pacing electrodes for delivering pacing therapy, such as a tip-to-can electrode, a tip-to-ring electrode, etc. A pacing location may refer to the position of any one of one or more pacing electrodes located using a leaded, leadless device, and / or any device or apparatus configured to deliver pacing therapy.

[0104] The pacing settings used for therapy can be adjusted. The pacing settings can be adjusted in response to the pacing settings not being optimal. Even if the pacing settings are within the optimal range, they can be adjusted to determine if they are positioned within the optimal range for greater benefit, usefulness, or functionality in pacing therapy. The pacing settings can be adjusted to find the optimal measure of electrical heterogeneity.

[0105] Determining whether the pacing setting is optimal can be based on a specific measure of the electrical heterogeneity of the ECG band. In at least one example, the pacing setting can be adjusted at intervals related to changes in the electrical heterogeneity measure until the electrical heterogeneity measure is at or near a specific value. For example, the pacing setting can be adjusted so that the electrical heterogeneity measure is close to a specific threshold measure, and the rate at which the pacing setting is adjusted can be slowed down as the measure approaches the specific threshold. In other words, the pacing setting can be adjusted more quickly when the electrical heterogeneity measure is far from the specific threshold measure, and more slowly when the electrical heterogeneity measure is closer to the specific threshold measure, until the electrical heterogeneity measure is at the specific threshold measure.

[0106] During implantation, various techniques can be used to determine whether the correct target implantation area 4 has been reached within the Koch triangle region before attempting to implant the IMD. In some embodiments, the target implantation area 4 can be identified using a slow path signal measured with the tip of a mapping electrode of the delivery component or delivery catheter. In some embodiments, the target implantation area 4 can be identified by testing the pacing output with the tip of the mapping electrode of the delivery component or delivery catheter and gradually decreasing the pacing output until a virtual ventricle-to-atrial pacing ECG pattern is detected. Using such techniques to properly identify the target implantation area 4 before introducing the IMD can facilitate the entire implantation process.

[0107] refer to Figure 10 Pacing techniques typically involve pacing one or more of the four chambers of the patient's heart 8, including the right atrium (RA) 612, right ventricle (RV) 614, left ventricle (LV) 616, and left atrium (LA) 618, all of which are shown in a frontal view of the frontal portion of the patient's heart 8. Some therapeutic pacing techniques involve the cardiac conduction system. The cardiac conduction system (e.g., a "superhighway") can be described as conducting electrical impulses rapidly, while pacing myocardial tissue conducts electrical impulses slowly (e.g., "traveling on a dirt road"). The cardiac conduction system includes the SA node 620, the internodal bundles 622, 623, and 624 (i.e., the anterior internodal 622, the middle internodal 623, and the posterior internodal 624), the AV node 15, the His bundle 5 (also known as the atrioventricular bundle or His bundle), and bundle branches including the left bundle branch (LBB) 630 and the right bundle branch (RBB) 632. Figure 10 Aortic arch 634 and Bachman bundle 636 are also shown.

[0108] The SA node 15, located at the junction of the superior vena cava (SVC) 638 and RA 612, is considered the heart's natural pacemaker because it continuously and repetitively fires electrical impulses. These impulses travel through the muscle of RA 612 to LA 618 to induce synchronized atrial contractions. The impulses are also delivered via the internodal tract to the AV node 15—the only connection between the atria and ventricles.

[0109] Conduction through the tissue at AV junction 15 takes longer than through the atrial tissue, resulting in a delay between the onset of atrial and ventricular contractions. This AV delay allows the atria to empty blood into the ventricles; it is the delay between atrial and ventricular contractions. The valves between the atria and ventricles then close before ventricular contraction is initiated by the branches of His bundle 5.

[0110] The His bundle 5 is located in the membranous atrioventricular septum near the tricuspid annulus. The tricuspid valve 6 is located between RA 612 and RV 614. The His bundle 5 splits into LBB 630 and RBB 632 and is formed by specialized fibers called "Purkinje fibers" 640. Purkinje fibers 640 can be described as rapidly conducting action potentials downward along the ventricular septum, causing the depolarization wavefront to rapidly expand through the remaining ventricular myocardium and producing coordinated contraction of the ventricular muscle mass.

[0111] Figure 11 This is a diagram illustrating a specific electrical path of a patient's heart 8 and an example of a target implantation region 4 suitable for VfA cardiac therapy. In the illustrated embodiment, the patient's heart 8 defines a fast path 650 from the AV junction 15 to the target implantation region 4, which can be described as part of the conduction system of the heart 8. The patient's heart 8 also defines a slow path 652 from the target implantation region 4 to the AV junction 15, which can also be described as part of the cardiac tissue. The target implantation region 4 can also be described as a slow path region. The target implantation region 4 can be determined to be suitable based on an electrical signal indicating the detection of an ASP. The detection of the ASP can indicate that the electrode has reached the target implantation region 4 within the Koch triangle region 654.

[0112] Figure 12 This is a conceptual diagram illustrating an example of a delivery assembly 660 fixed to the AV septum 662 of a patient's heart 8, which can be used for implantation of a leaded or leadless IMD. The delivery assembly 660 can be described as a delivery catheter. The delivery assembly 660 may include a mapping electrode 664 that can be inserted into the AV septum 662 through a target implantation region 4 in a Koch triangle region 106. The mapping electrode 664 can be used to test the location and depth of potential implantation sites within the AV septum 662, for example, until an ASP is detected.

[0113] In some embodiments, the mapping electrode 664 is disposed on the guidewire 666. The guidewire 666 may be described as a mapping guidewire. Alternatively or additionally, the delivery assembly 660 may include a conductive fixing element on the sheath, which may be used to provide the mapping electrode 668.

[0114] Mapping electrodes 664 and 668 may each be electrically coupled to a separate conductor extending between the distal and proximal portions of the delivery assembly 660. The conductor may be coupled to a proximal contact, such as a proximal end loop, which may be connected to analyzer 670 for mapping. Specifically, analyzer 670 may be any suitable electrophysiological (EP) analyzer configured to analyze electrogrammography (EGM) and / or ECG signals for mapping selected by a person skilled in the art who benefits from this disclosure. The analyzer may include a controller with processing circuitry and memory.

[0115] Generally, any suitable delivery component can be used to deliver leaded or leadless IMDs. Examples of delivery components that can be used include those described in U.S. Provisional Application No. 62 / 914,937 (Hine et al.), filed October 14, 2019, and U.S. Provisional Application No. 62 / 948,366 (Hine et al.), filed December 16, 2019.

[0116] Figure 13 This is a graph 680 illustrating an example of an electrophysiological (EP) mapping signal, or EGM signal 682, that can be measured using an EP analyzer. Specifically, the EGM signal 682 can be measured using a mapping electrode implanted in the target implantation region. It can be seen, particularly in the exploded view of region 684, that the detection of the ASP characteristic waveform 686 in the EGM signal 682 can indicate that the mapping electrode has been properly implanted in the appropriate target implantation region within the Koch triangle region.

[0117] In some implementations, the ASP characteristic waveform 686 can be identified as having multiple deflections. As shown, the ASP characteristic waveform 686 may include four “peaks” (local maxima) and three “troughs” (local minima). In general, the local maxima and minima can be described as deflection points. As shown, the ASP characteristic waveform 686 includes seven deflection points. Typically, the ASP waveform 686 may include larger local maxima and minima than other waveforms detectable in the EGM signal 682.

[0118] Other ECG and EGM signals are shown for reference. In the illustrated embodiment, various ECG signals 688 (V1, I, and II) and other EGM signals, such as the His bundle electrode signal 690 and the proximal coronary sinus electrode signal 692, are shown. The EGM signal 682 can also be described as an RA electrode signal.

[0119] Figure 14A graph 700 is an example of a mapped signal or EGM signal 702 and various ECG signals 708, which include the delivery of a test pacing, and which can be used to measure the response to the pacing signal using an EP analyzer. In some embodiments, a test pacing pulse may be provided to a potential implantation site starting with a higher pacing output (such as 10 volts (V)) for 1 ms, and then reduced to a lower pacing output (such as 0.5 V) for 1 ms. In response to the detection of a virtual ventricle-to-atrium pacing delivery ECG pattern in the ECG signal 708, the potential implantation site can be identified as a suitable target implantation site.

[0120] In graph 700, a test pacing with high pacing output around time window 704 is shown relative to the measured EGM signal 702 and the corresponding ECG signal 708, indicating ventricular pacing. A test pacing with lower pacing output around time window 706 is shown relative to the measured EGM signal 702 and the corresponding ECG signal 708, indicating a virtual ventricle-to-atrium pacing ECG pattern. Generally, higher pacing output can pace both the ventricles and atria, while lower pacing output capable of pacing only the atria may be suitable as a target implantation area.

[0121] Exemplary Implementation

[0122] While this disclosure is not limited thereto, an understanding of various aspects of this disclosure will be gained through discussion of the specific illustrative embodiments provided below. Various modifications to the exemplary embodiments and additional embodiments of this disclosure will become apparent herein.

[0123] In implementation scheme A1, the method includes locating a Koch triangle region in the right atrium of a patient's heart; securing at least one electrode of an implantable lead or device from the Koch triangle region to the heart tissue to deliver an atrium-to-ventricle (VfA) cardiac therapy; and testing the position or depth of at least one electrode to configure the VfA cardiac therapy.

[0124] In implementation scheme A2, the method includes the method according to implementation scheme A1, and further includes providing an introduction path to deliver at least one electrode to the right atrium of a patient's heart.

[0125] In implementation scheme A3, the method includes the method according to implementation scheme A2, wherein providing an introduction pathway to the right atrium includes one or more of the following:

[0126] Locate the vein leading to the right atrium of the patient's heart;

[0127] Create an entry channel into the vein;

[0128] Confirm the entry point into the vein; and

[0129] The catheter is inserted into the vein through the inlet channel.

[0130] In implementation scheme A4, the method includes the method according to any implementation scheme A, wherein locating the Koch triangle region includes one or more of the following:

[0131] Imaging is used to monitor the delivery of at least one electrode;

[0132] The implantable lead or device is advanced into the right atrium;

[0133] The patient's tricuspid valve is located using an implantable lead or device; and

[0134] The implanted lead or device is moved partially toward the coronary sinus ostium and atrioventricular node of the patient's heart to reach the Koch triangle region.

[0135] In implementation scheme A5, the method includes the method according to implementation scheme A4, wherein positioning the tricuspid valve includes positioning the ridge of the tricuspid valve above the septal leaflet of the tricuspid valve near the septal wall of the right atrium.

[0136] In implementation scheme A6, the method includes the method according to any one of implementation schemes A1-A3, wherein locating the Koch triangle region includes one or more of the following:

[0137] Imaging is used to monitor the delivery of at least one electrode;

[0138] The implantable lead or device is advanced into the right atrium;

[0139] Positioning the coronary sinus ostium using an implantable lead or device; and

[0140] The implanted lead or device is partially moved toward the tricuspid valve and atrioventricular node to reach the Koch triangle region.

[0141] In implementation scheme A7, the method includes the method according to implementation scheme A6, wherein locating the coronary sinus ostium includes:

[0142] To advance an implantable medical lead or device into the coronary sinus of a patient's heart; and

[0143] Retract the implanted medical lead or device until the distal end of the implanted medical lead or device reaches the coronary sinus ostium.

[0144] In embodiment A8, the method includes the method according to any embodiment A, wherein at least one electrode of the implantable lead or device is secured from the Koch triangle region to the cardiac tissue to deliver VfA cardiac therapy, comprising one or more of the following:

[0145] Determine the initial implantation location through the Koch triangle region;

[0146] Orient the implantable lead or device at the initial implantation site;

[0147] Attach the implantable lead or device to the initial implantation site;

[0148] Testing the initial implantation location and depth; and

[0149] Update the initial implantation location or depth in response to tests.

[0150] In implementation scheme A9, the method includes the method according to implementation scheme A8, wherein the orientation of the implantable lead or device includes pointing the distal end of the implantable lead or device toward the apex of the left ventricle of the patient's heart.

[0151] In implementation scheme A10, the method includes the method according to implementation scheme A8 or A9, wherein testing the initial implantation site includes one or more of the following:

[0152] One or more electrodes using implanted leads or devices are used to monitor electrical activity;

[0153] Motion sensors using implanted leads or devices monitor mechanical activity; and

[0154] One or more electrodes, using implanted leads or devices, deliver test pulses that can be detected by external electrode devices.

[0155] In implementation scheme A11, the method includes the method described according to any A implementation scheme, and further includes preparing VfA cardiac therapy for the patient.

[0156] In implementation scheme A12, the method includes the method according to any A implementation scheme, wherein securing at least one electrode of the implantable lead or device to cardiac tissue via the Koch triangle region does not position one or more electrodes into the blood volume of the left ventricle of the patient's heart.

[0157] In implementation scheme A13, the method includes the method according to any implementation scheme A, wherein securing at least one electrode of an implantable lead or device to cardiac tissue via the Koch triangle region includes advancing at least one electrode from the Koch triangle region through the right atrial endocardium and central fibrous body into the left ventricular myocardium of the patient's heart to deliver cardiac therapy to the left ventricle or sense electrical activity of the left ventricle in the basal region, septal region, or baso-septal region of the left ventricular myocardium.

[0158] In implementation scheme A14, the method includes the method according to any A implementation scheme, wherein locating the Koch triangle region in the right atrium of the patient's heart includes testing whether an atrial slow path potential (ASP) is detected at the potential target implantation site using at least one electrode of the delivery component.

[0159] In embodiment A15, the method includes the method according to embodiment A14, wherein testing whether an ASP is detected includes determining whether electrical activity detected by at least one electrode includes a deflection pattern indicating an ASP.

[0160] In implementation scheme A16, the method includes the method according to any A implementation scheme, wherein locating the Koch triangle region in the right atrium of the patient's heart includes testing, using at least one electrode of the delivery component, whether the pacing output at the potential target implantation site paces the atrium but not the ventricles of the patient's heart.

[0161] In implementation scheme A17, the method includes the method according to implementation scheme A16, wherein testing whether the pacing output at the potential target implantation site includes:

[0162] Delivering pacing output to capture ventricular pacing; and

[0163] Reduce pacing output until atrial pacing is captured while ventricular pacing is not.

[0164] In implementation scheme B1, the delivery component includes:

[0165] Mapping electrodes, configured to be advanced into a potential target implantation region within the Koch triangle region; and

[0166] A mapping analyzer, operatively coupled to a mapping electrode, is configured to use the mapping electrode to determine whether an atrial slow path potential (ASP) is detected at a potential target implantation area.

[0167] In implementation scheme C1, the delivery component includes:

[0168] Mapping electrodes, configured to be advanced into a potential target implantation region within the Koch triangle region; and

[0169] A mapping analyzer operatively coupled to a mapping electrode, the mapping analyzer being configured to determine, using at least one electrode of the delivery component, whether the pacing output at a potential target implantation site paces the atrium without pacing the ventricles of the patient's heart.

[0170] Implementation of B1 or C1, wherein the mapping analyzer is configured to perform the method according to any one of implementations A14 to A17.

[0171] Therefore, various techniques related to VfA delivery are disclosed. It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically presented in the specification and figures. It should also be understood that, depending on the example, certain actions or events of any process or method described herein may be performed in a different order, and may be completely added, combined, or omitted (e.g., performing the described techniques may not require all the described actions or events). Furthermore, although for clarity some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by combinations of units or modules associated with, for example, a medical device.

[0172] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality 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 correspond to tangible media 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 is accessible by a computer).

[0173] The instructions can 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 arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, as used herein, the term "processor" can refer to any of the aforementioned structures or any other physical structures suitable for implementing the described technology. Furthermore, this technology can be fully implemented in one or more circuit or logic elements.

[0174] All references and publications cited herein are expressly incorporated in their entirety by way of citation for all purposes, unless in any respect directly contradicts this disclosure.

[0175] Unless otherwise stated, all scientific and technical terms used herein have their common meaning in the art. The definitions provided herein are intended to facilitate understanding of certain terms frequently used herein and are not intended to limit the scope of this disclosure.

[0176] Orientation-related terms (such as "proximal", "distal", "top", "bottom", "side", and "end") are used to describe the relative positions of components and do not imply an absolute limitation on the orientation of the considered embodiment.

[0177] As used herein, unless otherwise expressly stated in this disclosure, the term “configured as” may be used interchangeably with the terms “suitable” or “structured as”.

[0178] Unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” cover implementations with plural indicators.

[0179] The phrases “at least one of…”, “including at least one of…”, and “one or more of…” accompanying a list refer to any one item in the list or any combination of two or more items in the list.

[0180] As used in this article, "have," "having," "include," "including," "comprise," and "comprising" are used in their open-ended sense and usually mean "including but not limited to." It should be understood that phrases such as "basically composed of" and "composed of" are categorized under "comprising."

[0181] References to “an embodiment,” “an embodiment,” “certain embodiments,” or “some embodiments,” etc., mean that a particular feature, configuration, composition, or characteristic described in connection with that embodiment is included in at least one embodiment of this disclosure. Therefore, the appearance of such shortened terms throughout the document does not necessarily refer to the same embodiment of this disclosure. Furthermore, particular features, configurations, compositions, or characteristics may be combined in any suitable manner in one or more embodiments.

Claims

1. A delivery component, comprising: A mapping electrode, which is configured to be advanced into a potential target implantation region within the Koch triangle region; and A mapping analyzer, operatively coupled to the mapping electrode, is configured to use the mapping electrode to determine whether the pacing output at the potential target implantation site paces the atrium but not the ventricles of the patient's heart.

2. The delivery component of claim 1, wherein, in order to determine whether the pacing output at the potential target implantation region paces the atrium but not the ventricle of the patient's heart, the mapping analyzer is further configured to: The pacing output is delivered to the potential target implantation area to capture ventricular pacing; and Reduce the pacing output until atrial pacing is captured while ventricular pacing is not captured.

3. The delivery assembly of claim 1 or 2, wherein the mapping analyzer is further configured to use the mapping electrode to determine whether an atrial slow path potential (ASP) is detected at the potential target implantation region.

4. The delivery component of claim 3, wherein determining whether an ASP is detected includes determining whether the electrical activity detected by the mapping electrode includes a deflection pattern indicating the ASP.

5. The delivery assembly of claim 1 or 2, wherein the potential target implantation region in the Koch triangle region is located in the left ventricular myocardium via the right atrial endocardium and central fibrous body for delivering cardiac therapy to the left ventricle or sensing electrical activity of the left ventricle in the basal region, septal region, or baso-septal region of the left ventricular myocardium.

6. The delivery assembly of claim 1 or 2, wherein the mapping electrode is capable of being located together with the potential target implantation area, and wherein the mapping analyzer is further configured to test the position or depth of the mapping electrode to configure atrium-to-ventricle (VfA) cardiac therapy.

7. The delivery assembly of claim 1 or 2, wherein the delivery assembly further comprises a guidewire inserted into a vein leading to the right atrium of the patient's heart, wherein the guidewire extends from a proximal end to a distal end, and wherein the mapping electrode is coupled to the distal end of the guidewire.

8. The delivery assembly of claim 1 or 2, wherein the delivery assembly further comprises a sheath inserted into a vein leading to the right atrium of the patient's heart, wherein the sheath extends from a proximal end to a distal end, and wherein the mapping electrode is coupled to the distal end of the sheath.

9. The delivery assembly of claim 8, wherein the sheath is further configured to receive an implantable lead or device in the potential target implantation area and deliver it through the right atrial endocardium and central fibrous body to the left ventricular myocardium of the patient's heart to deliver cardiac therapy to the left ventricle or sense electrical activity of the left ventricle in the basal region, septal region, or baso-septal region of the left ventricular myocardium.

10. The delivery component of claim 9, wherein the mapping analyzer is further configured to: One or more electrodes of the implanted lead or device are used to monitor electrical activity; Motion sensors using the implanted leads or device monitor mechanical activity; and One or more electrodes of the implanted lead or device are used to deliver test pulses that can be detected by an external electrode device.

11. The delivery assembly of claim 1 or 2, wherein the mapping electrode is not positioned within the blood volume of the left ventricle of the patient's heart.

12. The delivery assembly of claim 1 or 2, wherein the mapping electrode is electrically connected to a separate conductor extending between the distal and proximal portions of the delivery assembly.

13. The delivery assembly according to claim 1 or 2, wherein the mapping electrode is disposed on the guidewire.

14. The delivery assembly according to claim 1 or 2, wherein the delivery assembly is capable of including a conductive fixing element on the sheath.

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