Septal perforation for cardiac conduction system pacing

Abstract

The present disclosure includes a lead, a lead delivery system, and a method. The lead delivery system includes a lead body, at least one left bundle branch (LBB) electrode, and an anchor apparatus. The lead body extends from a proximal end to a distal end, where a penetration portion of the lead body is adjacent the distal end and is configured to extend through and perforate a ventricular septum of a patient's heart to position the distal end adjacent a left ventricular endocardium of the patient's heart. The LBB electrode is coupled to the lead body adjacent the distal end of the lead body and configured to pace an LBB area. The anchor apparatus is adjacent the distal end of the lead body and configured to secure the lead body to the ventricular septum, where the anchor apparatus is configured to adapt from a delivery configuration to an anchored configuration.

Description

SEPTAL PERFORATION FOR CARDIAC CONDUCTION SYSTEM PACINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from U.S. Provisional Patent Application 63 / 599,024 filed 15 November 2023, the entire content of which is incorporated herein by reference.BACKGROUND

[0002] The present disclosure relates generally to perforating the ventricular septum of a patient’s heart to, for example, optimize cardiac conduction system (CCS) pacing delivered to a patient and secure a lead within the ventricular septum that will avoid dislodgement over time. Implantable medical devices (IMDs), such as cardiac pacemakers or implantable cardioverter defibrillators, deliver therapeutic stimulation to patients’ hearts thereby improving the lives of millions of patients living with heart conditions. One common conventional therapeutic pacing technique that treats irregular heart rhythm, for example, includes cardiac resynchronization therapy (CRT). CRT may involve delivering an electrical pulse to a patient’s cardiac tissue to induce normal heart beat or rhythm. For example, in response to the electrical pulse, both the right and left ventricles may contract. However, the heartbeat process may be significantly delayed because the pulse travels from the right ventricle through the left ventricle. The electrical pulse passes through the muscle cells that are referred to as myocytes. Myocyte-to-myocyte conduction may be very slow. Delayed electrical pulses can cause the left ventricle to be unable to maintain synchrony with the right ventricle.

[0003] In some patients, heart failure can develop such that the heart’s ability to effectively pump blood to the body decreases. Heart failure may be a devastating diagnosis since, for example, fifty percent of heart failure patients have a life expectancy of five years or less. A possible cause of heart failure is due to atrial fibrillation, which is an irregular and often very rapid heart rhythm or arrhythmia. During atrial fibrillation, the atria of the heart can beat out of sync with the ventriclesof the heart because of the arrythmia of the atria, which can lead to blood clots in the heart and increase the risk of stroke or heart failure, for example.

[0004] CRT devices have been used to help improve cardiac function and help mitigate or improve systems of heart failure. While conventional CRT therapy has shown effectiveness, some physicians have considered alternative pacing methods that involve leveraging the body’s natural CCS to improve pacing therapies. Pacing the CCS (also known as conduction system pacing) may quickly conduct electrical pulses use a portion of heart’s natural conduction system as opposed to conventional pacing techniques that use the cardiac muscle, or myocardial, tissue for signal propagation. The CCS pacing may allow for quick pulse signal propagation within cardiac tissue (for example, akin to a car driving on a highway to traverse a city as opposed to using local roads).SUMMARY

[0005] This disclosure generally relates to perforating the ventricular septum of a patient’s heart to, for example, optimize CCS pacing delivered to a patient. It can be difficult to implant a lead close enough or in proximity to the left bundle branch (LBB), right bundle branch (RBB), or His bundle (or elsewhere in the CCS) to effectively pace the LBB, RBB, or His bundle, respectively. Further, implanted lead(s) may dislodge over time due to natural movement or due to injury. Additionally, patient anatomy, lead geometry (e.g., helix tip length, device width affecting tissue plug hole, etc.), medical professional dependent procedures, torque used, amount of lead rotation used, accidental perforation, lead dislodgement during implantation and post-implantation, and other variables may all contribute to optimizing lead placement and CCS pacing.

[0006] As described herein, perforation of the ventricular septum and anchoring of a lead to the ventricular septum may advantageously secure the lead proximate the LBB, RBB, and / or His bundle and may optimize pacing to the LBB, RBB, and / or His bundle, respectively. Purposefully perforating the ventricular septum may advantageously negate many of the above factors, thereby making implantation easier and making implantation and long-term positioning more efficient, secure, and safer, and may lead to more optimized pacing delivered to the patient.

[0007] In particular, illustrative devices and methods are described herein that include an implantable medical device including a lead body with a penetration portion configured to extend through the ventricular septum to position a distal end of the lead body proximate the left ventricular (LV) endocardium, an LBB electrode proximate LBB to deliver cardiac conduction system pacing thereto, and an anchor apparatus proximate tissue (e.g., septal tissue, LV endocardial tissue, etc.) to secure the lead body in place. Additionally, illustrative device and methods may include, among other things, a piercing apparatus, and RBB electrode, at least one tine, a removable stylet, a sleeve, and a catheter as will be described further herein.

[0008] In one embodiment, an implantable medical lead delivery system can include a lead. The lead can include a lead body, at least one LBB electrode, and an anchor apparatus. The lead body can extend from a proximal end to a distal end. A penetration portion of the lead body can be adjacent the distal end and can be configured to extend through and perforate a ventricular septum of a patient’s heart to position the distal end adjacent a left ventricular endocardium of the patient’s heart. The at least one LBB electrode can be coupled to the lead body adjacent the distal end of the lead body. The at least one LBB electrode can be configured to pace an LBB area when the penetration portion of the lead body is positioned extending through the ventricular septum and the distal end is positioned adjacent the left ventricular endocardium. The anchor apparatus can be adjacent the distal end of the lead body. The anchor apparatus can be configured to secure the lead body to the ventricular septum. The anchor apparatus can be configured to adapt from a delivery configuration to an anchored configuration when the penetration portion of the lead body is positioned extending through the ventricular septum. In the anchored configuration, the anchor apparatus can contact a left ventricular endocardial wall and resist movement of the lead in a proximal direction.

[0009] In one embodiment, a method of perforating a ventricular septum and delivering pacing using an implantable medical device (IMD) can include: advancing a lead into a right ventricle and through a ventricular septum to position a distal end of the lead adjacent a left ventricular endocardium of the patient’s heart. The method can further include securing the lead within the ventricular septum. The method can further include delivering pacing to one or more of an RBB area and an LBB area using at least one electrode of the lead.

[0010] In one embodiment, a lead can include a lead body, at least one LBB electrode, an anchor apparatus, and a sleeve. The lead body can extend from a proximal end to a distal end. A penetration portion of the lead body can be adjacent the distal end. The penetration portion can be configured to extend through and perforate a ventricular septum of a patient’s heart to position the distal end adjacent a left ventricular endocardium of the patient’s heart. The at least one LBB electrode can be coupled to the lead body adjacent the distal end of the lead body. The at least one LBB electrode can be configured to pace an LBB area when the penetration portion of the lead body is positioned extending through the ventricular septum and the distal end is positioned adjacent the left ventricular endocardium. The anchor apparatus can be adjacent the distal end of the lead body. The anchor apparatus can be configured to secure the lead body to the ventricular septum. The anchor apparatus can be configured to adapt from a delivery configuration to an anchored configuration when the penetration portion of the lead body is positioned extending through the ventricular septum. The anchor apparatus can define a pre-formed geometry configured to secure the lead body to the ventricular septum. The sleeve can circumferentially surround at least a portion of the anchor apparatus. The anchor apparatus can be configured to be disposed within the sleeve during delivery of the lead and to extend beyond a distal end of the sleeve when the penetration portion of the lead body is positioned extending through the ventricular septum.

[0011] The above summary is not intended to describe each embodiment or every implementation of the present disclosure. A more complete understanding will become apparent and appreciated by referring to the following detailed description and claims taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. l is a schematic diagram of a heart and conduction system of a patient.

[0013] FIG. 2A is a conceptual diagram of an illustrative therapy system that is configured to provide CCS pacing to the left and / or right bundle branches using a lead placed in the right ventricle.

[0014] FIG. 2B is a detailed conceptual diagram showing the illustrative therapy system of FIG. 2 A but only including two leads.

[0015] FIG. 3 A is a conceptual diagram illustrating an illustrative therapy system that is configured to provide CCS pacing to the left bundle branch using a single lead placed in the right ventricle.

[0016] FIG. 3B is a close-up view of the lead in the patient’s heart of FIG. 3A.

[0017] FIG. 4A is a schematic lead that may be utilized by the devices ofFIGS. 2-3.

[0018] FIG. 4B is another schematic lead that may be utilized by the devices of FIGS. 2-3.

[0019] FIG. 5A is a diagrammatic perspective view of an illustrative system including a portion of a catheter approaching a ventricular septum.

[0020] FIG. 5B is a diagrammatic perspective view of the portion of the catheter of FIG. 5 A and a piercing apparatus therein.

[0021] FIG. 5C is a diagrammatic perspective view of the portion of the catheter and piercing apparatus of FIG. 5B being advanced into the ventricular septum.

[0022] FIG. 5D is a diagrammatic perspective view of the portion of the catheter and piercing apparatus of FIG. 5B with the piercing apparatus being removed from the ventricular septum.

[0023] FIG. 5E is a diagrammatic perspective view of the portion of the catheter of FIG. 5 A and a lead advanced through the catheter and through the ventricular septum.

[0024] FIG. 5F is a diagrammatic perspective view of the portion of the catheter and lead of FIG. 5E with the lead secured within the ventricular septum.

[0025] FIG. 5G is a diagrammatic perspective view of the portion of the catheter and lead of FIG. 5E with the catheter being removed.

[0026] FIG. 6A is a diagrammatic perspective view of an illustrative system including a portion of a catheter advanced to a ventricular septum and a lead advanced through the ventricular septum.

[0027] FIG. 6B is a diagrammatic perspective view of the portion of the catheter and lead of FIG. 6 A with lead being configured into an anchoring configuration.

[0028] FIG. 6C is a diagrammatic perspective view of the portion of the catheter and lead of FIG. 6A with the lead secured within the ventricular septum.

[0029] FIG. 6D is a diagrammatic perspective view of the portion of the catheter and lead of FIG. 6 A with the catheter being removed.

[0030] FIG. 7A is a diagrammatic perspective view of an illustrative system including portions of a catheter and a lead with the lead extending beyond the catheter and the lead perforating a ventricular septum.

[0031] FIG. 7B is a diagrammatic perspective view of the portions of the lead of FIG. 7A with the lead secured within the ventricular septum.

[0032] FIG. 7C is a diagrammatic perspective view of the portions of the lead of FIG. 7 A alone and a diagrammatic perspective view of the portions of the lead of 7A with the lead secured within the ventricular septum, where the lead has insulated portions.

[0033] FIG. 7D is a diagrammatic perspective view of the portions of the lead of FIG. 7 A alone and a diagrammatic perspective view of the portions of the lead of 7A with the lead secured within the ventricular septum, where the lead has a different insulated portion.

[0034] FIG. 8A is a diagrammatic perspective enlarged view of a portion of an illustrative system including a catheter and a lead with a side helix extending beyond the catheter.

[0035] FIG. 8B is a diagrammatic perspective enlarged cutaway view of a portion of the catheter circumferentially surrounding the lead with a side helix of FIG. 8A.

[0036] FIG. 8C is a diagrammatic perspective enlarged view of the portions of the catheter and the lead of FIG. 8 A perforating through a ventricular septum.

[0037] FIG. 8D is a diagrammatic perspective enlarged view of the portions of the catheter and the lead of FIG. 8 A with the catheter being retracted.

[0038] FIG. 8E is a diagrammatic perspective enlarged view of the portions of the catheter and the lead with a side helix of FIG. 8 A with the lead secured within the ventricular septum.

[0039] FIG. 9A is a perspective exploded view of an illustrative system including a lead, a removable stylet, and enlarged portions of the lead.

[0040] FIG. 9B is a perspective view of portions of the components of FIG.9A assembled together in a sleeve.

[0041] FIG. 9C is a perspective view of the portions of the components and sleeve of FIG. 9B with the lead extending from the sleeve.

[0042] FIG. 9D is a perspective view of the components and sleeve of FIG. 9B.

[0043] FIG. 9E is an enlarged perspective view of a portion of the sleeve and lead of FIG. 9D.

[0044] FIG. 9F is a diagrammatic perspective view of the components and sleeve of FIG. 9D advancing toward a ventricular septum.

[0045] FIG. 9G is a diagrammatic perspective view of the components and sleeve of FIG. 9F partially surrounded by a catheter.

[0046] FIG. 9H is a diagrammatic perspective view of portions of the components and sleeve of FIG. 9F penetrating through the ventricular septum.

[0047] FIG. 91 is a diagrammatic perspective view of portions of the components and sleeve of FIG. 9F with the lead extending beyond the sleeve.

[0048] FIG. 9J is a diagrammatic perspective view of portions the components and sleeve of FIG. 9F with the lead secured within the ventricular septum.

[0049] FIG. 10 is a flowchart method of securing a lead body within the ventricular septum and delivering pacing to at least one of the LBB area and the RBB area.DETAILED DESCRIPTION

[0050] In the following detailed description of illustrative embodiments, reference is made to the accompanying figures of the drawing which form a part hereof, and in which are shown, by way of illustration, specific embodiments which may be practiced. It is to be understood that other embodiments may be utilized, and structural changes may be made without departing from (e.g., still falling within) the scope of the disclosure presented hereby.

[0051] Illustrative systems, devices, and methods shall be described with reference to FIGS. 1-10. It will be apparent to one skilled in the art that elements or processes from one embodiment may be used in combination with elements or processes of the other embodiments, and that the possible embodiments of such systems, devices, and methods using combinations of features set forth herein is not limited to the specific embodiments shown in the Figures and / or described herein. Further, it will be recognized that the embodiments described herein may include many elements that are not necessarily shown to scale. Still further, it will be recognized that timing of the processes and the size and shape of various elementsherein may be modified but still fall within the scope of the present disclosure, although certain timings, one or more shapes and / or sizes, or types of elements, may be advantageous over others.

[0052] Conventional pacing techniques involve pacing one or more of the four chambers of a patient’s heart 12 as illustrated in FIG. 1, including the left atrium (LA) 33, the right atrium (RA) 26, the left ventricle (LV) 32 and the right ventricle (RV) 28. The CCS includes the sinoatrial (SA) node 1, atrial intemodal tracts 2, 4, 5 (i.e., anterior internodal 2, middle intemodal 4, and posterior intemodal 5), atrioventricular (AV) node 3, His bundle 13 (also known as the atrioventricular bundle or bundle of His), LBB 8a, and RBB 8b as shown in FIG. 1. The arch of aorta 6 and the Bachman’s bundle 7 are also shown in FIG. 1. The sinoatrial node 1, located at the junction of the superior vena cava and right atrium, is considered to be the natural pacemaker of the heart as it continuously and repeatedly emits electrical impulses. The electrical impulses spread through the muscles of RA 26 to LA 33 to cause synchronous contraction of the atria. The electrical impulses are also carried through atrial intemodal tracts to the atrioventricular node 3 — the sole connection between the atria and the ventricles. The conduction through the atrioventricular node or atrioventricular nodal tissue takes longer than through the atrial tissue, which results in a delay between the atrial contractions and the start of the ventricular contractions. The atrioventricular (AV) delay, which is the delay between atrial contractions and ventricular contractions, allows the atria to empty blood into the ventricles. Then, the valves between the atria and ventricles close in conjunction with ventricular contraction via branches of the bundle of His. The bundle of His, or His bundle, 13 is located in the membranous atrioventricular septum near the annulus of the tricuspid valve. The His bundle 13 splits into the left and right bundle branches 8a, 8b and are formed of specialized fibers called “Purkinje fibers” 9. The Purkinje fibers 9 may be described as being capable of rapidly conducting an action potential down the ventricular septum (VS), spreading the depolarization wavefront quickly through the remaining ventricular myocardium, and producing a coordinated contraction of the ventricular muscle mass.

[0053] Additionally, many variables affect proper placement of a lead for LBB, RBB, and / or His bundle pacing such as, for example, patient anatomy, lead geometry (e.g., helix tip length, device width affecting tissue plug hole, etc.), medical professional dependent procedure, torque used, amount of lead rotation used,accidental perforation, lead dislodgement during implantation and post-implantation, etc.

[0054] FIG. 1 depicts a schematic diagram of a heart 12 and FIGS. 2-3 depict conceptual diagrams showing illustrative therapy systems that may be used to provide therapy to the heart of a patient. The patient ordinarily, but not necessarily, will be a human. As shown in FIGS. 2A-2B, the therapy system 10 may include IMD 16, which is coupled to three leads 18, 20, 23, and a programmer 24. The IMD 16 may be, for example, an implantable pacemaker, cardioverter, and / or defibrillator that provides electrical pulses to the heart via electrodes coupled to one or more of the leads 18, 20, 23. Further non-limiting examples of the IMD 16 include the following: a pacemaker with a medical lead, an implantable cardioverter-defibrillator (ICD), an intracardiac device, a leadless pacing device (LPD), a subcutaneous ICD (S-ICD), and a subcutaneous medical device (e.g., nerve stimulator, inserted monitoring device, etc.).

[0055] One example of an LPD can be the MICRATM MC1VR01 or the MICRATM MC1AVR1. A description of the MICRATM MC1VR01 is found in the Medtronic model MICRATM MC1VR01 manual (2020), incorporated herein by reference in its entirety. The MICRATM MC1VR01 includes a pacing cathode and a pacing anode, and is a single chamber transcatheter pacing system configured to provide bipolar sensing and pacing in the RV. A description of the MICRATM MC1AVR1 is found in the Medtronic model MICRATM MC1AVR1 manual (2020), incorporated herein by reference in its entirety. The MICRATM MC1AVR1 includes a pacing cathode and a pacing anode, and is a dual chamber transcatheter pacing system configured to provide AV synchronous pacing and bipolar sensing and pacing in the right ventricle.

[0056] The leads 18, 20, 23 may extend into the heart of the patient to sense electrical activity of the heart and / or deliver electrical stimulation to the heart. In the example shown in FIG. 2A, the right atrial (RA) lead 23 extends through one or more veins (not shown), the superior vena cava (not shown), and into the RA 26. The RA lead 23 may be positioned for positioning electrodes 40, 42 near, adjacent, on, within, or around the RA for sensing electrocardiogram signals and pacing the right atrial myocardium. The RA lead 23 is shown with a ring electrode 40 and a helix tip electrode 42 that may be selected in various bipolar pacing electrode pairs for pacing the right atrial myocardial tissue and for sensing right atrial epicardialelectrocardiogram signals. One of the electrodes 40, 42 may be selected in combination with IMD housing 60 or a coil electrode 62 for delivering unipolar right atrial myocardial pacing and / or sensing unipolar atrial electrocardiogram signals.

[0057] The left ventricular coronary sinus lead 20 extends through one or more veins, the vena cava, the right atrium 26, and into the coronary sinus 30 to a region adjacent to the free wall of the LV 32. The left ventricular coronary sinus lead 20 may be positioned for positioning electrodes 94a, 94b, 94c, 94d (collectively “94”) epicardially along the left ventricular myocardium for sensing electrocardiogram signals and pacing the left ventricular myocardium. The left ventricular coronary sinus lead 20 is shown as a quadripolar lead carrying four electrodes 94a-94d that may be selected in various bipolar pacing electrode pairs for pacing the left ventricular myocardial tissue and for sensing left ventricular epicardial electrocardiogram signals. One of the electrodes 94 may be selected in combination with IMD housing 60 or a coil electrode 64 for delivering unipolar left ventricular myocardial pacing and / or sensing unipolar ventricular electrocardiogram signals.

[0058] One example of an LV transvenous lead can be the ATTAIN ABILITYTM 4195. A description of the ATTAIN ABILITYTM 4196 is found in the Medtronic model ATTAIN ABILITYTM 4196 manual (2016), incorporated herein by reference in its entirety. The ATTAIN ABILITYTM 4196 includes two electrodes and an anchoring sleeve.

[0059] In one embodiment, the CCS lead 18 (e.g., left bundle branch pacing lead, right bundle branch pacing lead, His-bundle pacing lead, etc.) extends through one or more veins and the vena cava, the RA 26, through the tricuspid valve and into the RV 28 of the heart to pace the CCS (e.g., within the ventricular septal wall, proximate and / or in direct contact with the LBB 8a, proximate and / or in direct contact with the RBB 8b, proximate and / or in direct contact with the His bundle 13, etc.). In some embodiments, the CCS lead 18 may be positioned within about 1 millimeter of a portion of the CCS such as, e.g., the His bundle 13, the LBB 8a, the RBB 8b, etc. The CCS lead 18 may be positioned for positioning electrodes 48, 50 near, adjacent, on, within, or around the RBB, LBB, respectively, for sensing electrocardiogram signals and pacing the CCS. The CCS lead 18 is shown with a ring electrode 48 and a tip electrode 50 that may be selected in various bipolar pacing electrode pairs for pacing the RBB and the LBB, respectively, and for sensing RBB and LBB electrocardiogram signals, respectively. An LBB area may be described as any area within theventricular septum that is sufficiently proximate the LBB such that delivery of cardiac conduction system pacing pulses to such area will effectively initiate, or trigger, cardiac conduction system activation within the LBB. In other words, the LBB area may be described as an area around or adjacent to the LBB. The RBB area may be described as any area within the ventricular septum that is sufficiently proximate the RBB such that delivery of cardiac conduction system pacing pulses to such area will effectively initiate, or trigger, cardiac conduction system activation within the RBB. In other words, the RBB area may be described as the area around or adjacent to the RBB. In one or more embodiments, the tip electrode 50 may take a non-helical form, for example, a ring electrode, a surface tip electrode, etc. One of the electrodes 48, 50 may be selected in combination with IMD housing 60 or a coil electrode 66 for delivering unipolar RBB and LBB pacing and / or sensing unipolar RBB and LBB electrocardiogram signals. In alternative embodiments, the CCS lead 18 is also used to pace the RA using an electrode 75 (shown in FIGS. 3 A-B) in addition to the CCS, such as in a two lead configuration which does not include the RA lead 23.

[0060] One example of a CCS lead (e.g., a His bundle pacing lead) can be the SELECTSECURE™ 3830. A description of the SELECTSECURE™ 3830 is found in the Medtronic model SELECTSECURE™ 3830 manual (2013), incorporated herein by reference in its entirety. The SELECTSECURE™ 3830 includes two conductors without lumens.

[0061] As used herein, CCS pacing refers to any techniques that are configured to deliver pacing (e.g., pacing pulses, electrical stimulation, etc.) to the CCS including, e.g., the His bundle 13, the LBB 8a, the RBB 8b, etc., in order to initiate ventricular activation. As used herein, the term “activation” refers to a sensed or paced event. For example, an atrial activation may refer to an atrial sense or event (As) or an atrial pace or artifact of atrial pacing (Ap). As will be described herein, an atrial sense may be detected, or identified, in one or more various signals monitored using one or more various devices or sensors located in one or more various locations. For example, an atrial sense may be detected in a near-field electrical signal using an electrode positioned in the right atrium with a respective reference electrode (e.g., an electrode on the housing of the implantable medical device). Further, for example, an atrial sense may be detected in a far-field electrical signal using electrodes positioned outside of the right atrium such as in the right ventricle or ventricular septum and a respective reference electrode. Still, for example, an atrial sense may be detected in afar-field signal using a mechanical cardiac activation sensor such as an accelerometer or microphone (e.g., a heart sound sensor) positioned outside of the right atrium such as in the right ventricle or ventricular septum or another portion of the patient’s body (e.g., within the can or housing of an IMD positioned outside of the patient’s heart). Similarly, a ventricular activation may refer to a ventricular sense or event (Vs) or a ventricular pace or artifact of ventricular pacing (Vp), which may be described as ventricular stimulation pulses. In some embodiments, an activation interval can be detected from As or Ap to Vs or Vp, as well as Vp to Vs. In particular, activation intervals may include a pacing (Ap or Vp) to ventricular interval (left ventricular or right ventricular sense) or an atrial-sensing (As) to ventricular-sensing interval (left ventricular or right ventricular).

[0062] Illustrative IMDs may be described as delivering CCS pacing, and additionally may also deliver conventional pacing. Conventional, or traditional, pacing may be described as delivering pacing pulses into myocardial tissue that is not part of the CCS of the patient’s heart such that, e.g., the pacing pulses trigger electrical activation that propagates primarily from one myocardial cell to another myocardial cell (also referred to as “cell-to-cell”) as opposed to propagating within the CCS prior to the myocardial tissue. For instance, conventional pacing may deliver pacing pulses directly into the muscular heart tissue (e.g., myocardial tissue) that is to be depolarized to provide the contraction of the heart. For example, conventional left ventricular pacing may utilize a left ventricular coronary sinus lead 20 that is implanted so as to extend through one or more veins, the vena cava, the right atrium 26, and into the coronary sinus 30 to a region adjacent to the free wall of the left ventricle 32 of the heart so as to deliver pacing pulses to the myocardial tissue of the free wall of the left ventricle 32.

[0063] An illustrative left ventricular lead 20 with a set of spaced apart electrodes is shown in U.S. Pat. Pub. No. WO 2019 / 104174 Al, filed on May 4, 2012, by Ghosh et al., which is incorporated by reference in its entirety herein. Illustrative electrodes on leads to form pacing vectors are shown and described in U.S. Pat. No. 8,355,784 B2, and U.S. Pat. No. 8,126,546, each of which are incorporated by reference in their entireties.

[0064] Additionally, the pacing leads 18, 20, 23 may be utilized to deliver left ventricle or left ventricular septal pacing to the ventricular septal wall. At least one of pacing leads 18, 20, 23 may extend through one or more veins, the vena cava, rightatrium 26, and into the coronary sinus 30 to a region adjacent to the septal wall of left ventricle 32 of the heart.

[0065] Illustrative CCS pacing therapy may be described in, for example, U.S. Pat. App. Pub. No. 2019 / 0111270 Al entitled “His Bundle and Bundle Branch Pacing Adjustment” published on April 18, 2019, which is incorporated herein by reference in its entirety. Illustrative left ventricular septal pacing may be described in, for example, U.S. Pat. No. 11,633,607 entitled “AV Synchronous Septal Pacing” filed on July 24, 2019, which is incorporated herein by reference in its entirety.

[0066] One or more elongated conductors may extend through a hermetic feedthrough assembly of the IMD, may electrically couple an electrical pulse generator (contained within housing) to one or more electrodes such as, e.g., ring electrodes, tips electrodes, helical electrodes, etc. The conductors may be formed by one or more electrically conductive wires comprising, for example, MP35N alloy known to those skilled in the art, in a coiled or cabled configuration, and the insulative tubular member may be any suitable medical grade polymer, for example, polyurethane, silicone rubber, or a blend thereof.

[0067] According to one or more illustrative embodiments, the flexible lead body may extend a pre-specified length (e.g., about 10 centimeters (cm) to about 20 cm, or about 15 to 20 cm) from a proximal end 17 to a distal end 19 (FIG. 2A). A penetration portion of the CCS lead 18 may be proximate the distal end 19, and further may be configured to extend through the ventricular septum of the patient’s heart to position the distal end 19 proximate the LV endocardium of the patient’s heart as will described further herein with respective to FIGS. 5-10. The lead body may be less than about 7 French (FR) but typically in the range of about 3 FR to 4 FR in size. In one or more embodiments, about 2 FR size to about 3 FR size lead body is employed.

[0068] CCS pacing may include at least one of His bundle pacing, LBB pacing, and RBB pacing. Bundle branch pacing may bypass the pathological region and may have a low and stable pacing threshold. In some embodiments, only one of the LBB or the RBB may be paced using one or more pacing leads. In further embodiments, both bundle branches may be paced at the same time (e.g., dual bundle branch pacing), which may mimic intrinsic activation propagation via the His bundle- Purkinje conduction system, e.g., paced activation propagates via both bundle branches to both ventricles for synchronized contraction. His bundle pacing, on theother hand, typically paces the His bundle proximal to the bundle branches. In some embodiments, the IMD 16 may be coupled to one, two, or more electrodes located in one or more bundle branches configured for bundle branch pacing.

[0069] In some embodiments, the IMD 16 may be an intracardiac pacemaker or leadless pacing device (LPD) configured to pace one or more portions of the CCS such as one or both of the bundle branches. As used herein, “leadless” refers to a device being free of a lead extending out of the heart 12. In other words, a leadless device may have a lead that does not extend from outside of the heart to inside of the heart. Some leadless devices may be introduced through a vein, but once implanted, the leadless devices are free of, or may not include, any transvenous lead and may be configured to provide cardiac therapy without using any transvenous lead. In one or more embodiments, an illustrative LPD for bundle pacing does not use a lead to operably connect to an electrode disposed proximate to the septum when a housing of the device is positioned in the atrium. A leadless electrode may be leadlessly coupled to the housing of the medical device without using a lead between the electrode and the housing. If a leadless pacing device is used, the “lead” described therein with respect to FIGS. 5-10 may be a leadlet or extension from the leadless pacing.

[0070] The IMD 16 may sense electrical signals attendant to the depolarization and repolarization of the heart via various electrodes as shown in FIG.2 A coupled to at least one of leads 18, 20, 23. In some examples, the IMD 16 provides pacing pulses to the heart based on the electrical signals sensed within the heart. The configurations of the electrodes used by the IMD 16 for sensing and pacing may be unipolar or bipolar.

[0071] The IMD 16 may also provide defibrillation therapy and / or cardioversion therapy via electrodes located on at least one of the leads 18, 20, 23. For example, the IMD 16 may detect atrial arrhythmias of heart, such as atrial fibrillation of the atria 26, 33, and then may deliver defibrillation therapy to the heart in the form of electrical pulses. Also, the IMD 16 may detect ventricular arrhythmias of the heart, such as ventricular fibrillation of the ventricles 28, 32, and then may deliver defibrillation therapy to the heart in the form of electrical pulses. In some examples, the IMD 16 may be programmed to deliver a progression of therapies, e.g., pulses with increasing energy levels, until fibrillation of the heart is stopped. The IMD 16 may detect fibrillation employing one or more fibrillation detection techniques known in the art.

[0072] In some examples, the programmer 24 as shown in FIGS. 2A-B may be a handheld computing device or a computer workstation or a mobile phone. The programmer 24 may include a user interface that receives input from a user. The user interface may include, for example, a keypad and a display, which may for example, be a cathode ray tube display, a liquid crystal display (LCD) or light emitting diode (LED) display. The keypad may take the form of an alphanumeric keypad, or a reduced set of keys associated with particular functions. The programmer 24 can additionally or alternatively include a peripheral pointing device, such as a mouse, via which a user may interact with the user interface. In some embodiments, a display of the programmer 24 may include a touch screen display, and a user may interact with the programmer 24 via the display. Through the graphical user interface on the programmer 24, a user may configure one or more pacing therapies, select one or more pacing modes, etc.

[0073] Additionally, various pacing settings may be adjusted, or configured, based on various sensed signals. For example, various near-field and far-field signals may be sensed by one or more of the electrodes coupled to the IMD 16 and / or other devices operatively coupled thereto. For example, right ventricular depolarization and left ventricular depolarization intervals may be monitored or measured within a near- field or far-field signal and then may be used to adjust, configure, and select CCS pacing. Further, for example, QRS morphology (e.g., QRS peak, various QRS intervals) may be monitored or measured within a near-field or far-field signal and then may be used to adjust, configure, and select CCS pacing. Still further, for example, one or more of right ventricular depolarization and left ventricular depolarization interval consistency, and QRS morphology consistency may be monitored or measured within a near-field or far-field signal and then may be used to adjust, configure, and select CCS pacing.

[0074] The illustrative therapy systems described herein such as IMD 16 may be utilized to deliver CCS pacing according to a variety of different modes such as, e.g., inhibited pacing mode, ventricular fusion pacing mode, atrioventricular synchronous pacing mode, atrial fibrillation pacing mode, etc. The ventricular fusion pacing mode may be configured to deliver CCS pacing to provide effective ventricular fusion. Effective ventricular fusion may be described as synchronizing the timing of the left ventricular activation with the activation on the right ventricle. For example, in a fusion pacing configuration, a medical device may deliver one or morepacing pulses in order to pre-excite the left ventricle and synchronize the depolarization of the left ventricle with the depolarization of the earlier contracting right ventricle. The ventricular activation of the left ventricle may “fuse” (or “merge”) with the ventricular activation of the right ventricle that is attributable to intrinsic conduction of the heart. In this way, the intrinsic and pacing-induced excitation wave fronts may fuse together such that the depolarization of the left ventricle is resynchronized with the depolarization of the right ventricle.

[0075] As used herein, the term “far-field” electrical signal refers to the result of measuring cardiac activity using a sensor, such as an electrode, positioned outside of an area of interest. For example, a far-field electrical signal representing electrical activity of a chamber of interest of the patient’s heart may be measured from an electrode positioned in an adjacent chamber (i.e., a chamber different from than that of the chamber of interest that is next to or near the chamber of interest). More specifically, for example, atrial electrical activity, or electrical activity originating one or more both atria, representative of depolarization of the one or both atria may be monitored in a far-field electrical signal measured using an electrode positioned outside of the right atrium such as in the right or left ventricle, or in the ventricular septum. As used herein, the term “near-field” electrical signal refers to the result of measuring cardiac activity using a sensor, such as an electrode, positioned near an area of interest. For example, an electrical signal measured using an electrode positioned proximate the LBB in the ventricular septum is one example of a near-field electrical signal of the patient’s LBB.

[0076] P-wave timing is the time at which a P-wave is detected. Typically, P- wave timing includes using the maximal first derivative of a P-wave upstroke (or the time of the maximal P-wave value). P-wave timing is also used in the device marker channel to indicate the time of the P-wave or the time of atrial activation. P-wave timing may be determined using near-field signals obtained by sensors (e.g., electrodes, accelerometers, heart sound sensors, etc.) positioned in the atria (e.g., the right atrium) and / or far-field near-field signals obtained by sensors (e.g., electrodes, accelerometers, heart sound sensors, etc.) positioned outside of the atria (e.g., the right atrium) such as in the right ventricle and / or ventricular septum.

[0077] R-wave timing is the time at which the QRS complex is detected. Typically, R-wave timing includes using the maximal first derivative of an R-wave upstroke (or the time of the maximal R-wave value). R-wave timing is also used in thedevice marker channel to indicate the time of the R-wave or the time of ventricular activation.

[0078] A user, such as a physician, technician, or other clinician, may interact with the programmer 24 to communicate with the IMD 16. For example, the user may interact with the programmer 24 to retrieve physiological or diagnostic information from the IMD 16. Additionally, a user may also interact with the programmer 24 to program the IMD 16, e.g., select values for operational parameters of the IMD 16. The IMD 16 and programmer 24 may communicate via wireless communication using any techniques known in the art. Examples of communication techniques may include, for example, low frequency or radiofrequency (RF) telemetry, but other techniques are also contemplated. In some examples, the programmer 24 may include a programming head that may be placed proximate to the patient’s body near the IMD 16 implant site in order to improve the quality or security of communication between the IMD 16 and the programmer 24.

[0079] The three chamber IMD 16 may be used for cardiac resynchronization therapy and defibrillation or cardioversion therapy (CRT-D). The leads 18, 20, 23 may be electrically coupled to a stimulation generator, a sensing module, or other modules of IMD 16 via connector block 34. In some examples, proximal ends of leads 18, 20, 23 may include electrical contacts that electrically couple to respective electrical contacts within the connector block 34. In addition, in some examples, the leads 18, 20, 23 may be mechanically coupled to the connector block 34 with the aid of set screws, connection pins, or another suitable mechanical coupling mechanism.

[0080] While the CCS lead 18 is shown and described with respect to FIGS. 2A, 2B, 3 A, and 3B as being placed in the RV along the intraventricular septal wall, in other examples, the CCS lead 18 may be placed in the right atrium within the triangle of Koch region (not shown) with the corresponding electrodes 48, 50 tunneled through the septal tissue to perforate the septum and to be positioned proximate the RBB and LBB, respectively. In such examples, the system may not contain a lead positioned within the RV, yet still obtain the benefit of LBB or RBB pacing and sensing as described herein. Additionally or alternatively, the system in such examples may include an additional lead or electrode(s) (e.g., RA lead 23 or electrode(s) 40, 42) positioned in the RA configured to pace the RA that may be different from the CCS lead 18 or the respective LBB and RBB electrodes.

[0081] Each of the leads 18, 20, 23 includes an elongated, insulative lead body, which may carry any number of conductors. In the illustrated example, an optional pressure sensor 38 and bipolar electrodes 48 and 50 are located proximate to the distal end 19 of the CCS lead 18. The pressure sensor 38 may respond to an absolute pressure inside RV, or may be positioned within other regions of the heart or elsewhere within or proximate to the cardiovascular system of the patient to monitor cardiovascular pressure associated with mechanical contraction of the heart. In addition, in some examples, the pressure sensor 38 may be self-contained device that is implanted within the heart and wirelessly correspond with the IMD 16. In addition, the bipolar electrodes 94a-94d (collectively referred to as reference number 94) are located proximate to a distal end of the left ventricular lead 20 and bipolar electrodes 40 and 42 are located proximate to a distal end of RA lead 23. The electrodes 48, 50 may be used for pacing and / or sensing of the CCS tissue (e.g., His bundle or bundle branch tissue).

[0082] The electrodes 40, 94a-c and 48 may take the form of ring electrodes, and the electrodes 42, 94d and 50 may take the form of extendable and / or fixed tip electrodes mounted within the insulative electrode heads 52, 54 and 56, respectively. Each of the electrodes 40, 42, 94, 48 and 50 may be electrically coupled to a respective one of the coiled conductors within the lead body of its associated lead 23, 20, 18, and thereby coupled to respective ones of the electrical contacts on the proximal end of the leads 23, 20, 18.

[0083] The electrodes 40, 42, 94, 48 and 50 may sense electrical signals attendant to the depolarization and repolarization of the heart. The electrical signals are conducted to the IMD 16 via the respective leads 23, 20, 18. In some examples, the IMD 16 also delivers pacing pulses via the electrodes 40, 42, 94, 48, 50 to cause depolarization of cardiac tissue of heart. In some examples, as illustrated in FIG. 2A, the IMD 16 may include one or more housing electrodes, such as housing electrode 58, which may be formed integrally with an outer surface of a hermetically sealed housing 60 of the IMD 16 or otherwise coupled to the housing 60. In some examples, the housing electrode 58 may be defined by an uninsulated portion of an outward facing portion of the housing 60 of the IMD 16. Other divisions between insulated and uninsulated portions of housing 60 may be employed to define two or more housing electrodes. In some examples, the housing electrode 58 includes substantially all of the housing 60. Any of the electrodes 40, 42, 94, 48, 50 may be used forunipolar sensing or pacing in combination with the housing electrode 58 or for bipolar sensing with two electrodes in the same pacing lead. In one or more embodiments, the housing 60 may enclose a stimulation generator (see FIG. 4) that generates cardiac pacing pulses and defibrillation or cardioversion shocks, as well as a sensing module for monitoring the patient’s heart rhythm.

[0084] The leads 23, 20, 18 may also include elongated electrodes 62, 64, 66, respectively (shown in FIG. 2 A), which may take the form of a coil. The IMD 16 may deliver defibrillation shocks to the heart via any combination of the elongated electrodes 62, 64, 66, and the housing electrode 58. The electrodes 58, 62, 64, 66 may also be used to deliver cardioversion pulses to the heart. The electrodes 62, 64, 66 may be fabricated from any suitable electrically conductive material, such as, but not limited to, platinum, platinum alloy or other materials known to be usable in implantable defibrillation electrodes.

[0085] The elongated electrodes may be selected in a unipolar electrode vector with any of the lead-based tip or ring electrodes for sensing unipolar electrocardiogram signals for analysis and determination of ventricular conduction conditions. In some instances, the elongated electrodes may be used with the housing 60 for sensing a far-field electrocardiogram signal for use in determining atrial depolarizations or activations, etc. The pressure sensor 38 may be coupled to one or more coiled conductors within the lead 18.

[0086] FIGS. 2B-3B are conceptual diagrams illustrating additional examples of a dual chamber therapy system 70 and a single chamber therapy system 71. The therapy system 70 is similar to therapy system 10 of FIG. 2A, but includes two leads 18, 23, rather than three leads. The therapy system 70 may utilize the IMD 16 configured to deliver, or perform, dual chamber pacing. The leads 18, 23 are implanted within the RV and the RA to pace one or more portions of the CCS such as the His bundle or one or both bundle branches, and to pace the RA, respectively. The therapy system 71 is similar to therapy system 10 of FIG. 2A, but includes a single CCS lead 18, rather than three leads. The therapy system 71 may utilize the IMD 16 configured to deliver, or perform, single chamber pacing. The CCS lead 18 is implanted the RV to pace one or more portions of the CCS such as one or both bundle branches.

[0087] The CCS lead 18 may be configured to perforate, or extend through, the ventricular septum of the patient’s heart to position the distal end 19 proximate theLV endocardium of the patient’s heart. The CCS lead 18 may be include an electrode 50 in the form of a tip electrode (as described herein) or a helix (not shown), etc., that may perforate the ventricular septum and that may be positioned proximate to, near, adjacent to, or in, area or portions of the CCS such as, e.g., ventricular septum, triangle of Koch, the His bundle, left bundle branch tissues, and / or right bundle branch tissue. The CCS lead 18 may be configured as a bipolar lead that may be used with a pacemaker device, a CRT-P device, or a CRT-ICD.

[0088] FIGS. 3A-3B show the patient’s heart implanted with CCS lead 18 to deliver bundle branch pacing according to one example of the single chamber therapy system 71. The CCS lead 18 is positioned, or located, through the tricuspid valve into the RV and has perforated through the ventricular septum from the RV 28 into the LV 32, and is implanted in the interventricular septum. FIG. 3B is a close-up view of the CCS lead 18 in the patient’s heart of FIG. 3A. In some embodiments, the CCS lead 18 may be the only lead implanted in the heart. In other embodiments as discussed herein, there may be leads in addition to the CCS lead 18 implanted in the heart. The one or more implantable electrodes of the CCS lead 18 may include a pacing electrode implantable proximate the CCS to deliver CCS pacing.

[0089] As illustrated, the CCS lead 18 is implanted in the septal wall, or ventricular septum, from the RV toward the LV, and further perforates the ventricular septum (e.g., creates a pathway from the RV endocardium to the LV endocardium). The electrodes 48 and 50 may be disposed proximate the distal end 19 of the CCS lead 18 as discussed herein at least with respect to FIG. 2A. The electrodes 48 and 50 may be the same as or similar to electrode 48 and electrode 50 shown in FIG. 2A and the electrode 48 is configured to sense or pace the right bundle branch (e.g., RBB electrode) and the electrode 50 is configured to sense or pace the left bundle branch (e.g., LBB electrode), for example, during dual bundle branch pacing. Accordingly, the electrode 48 may be implanted near right bundle branch 8b, and the electrode 50 may be implanted near the left bundle branch 8a. The RBB electrode 48 may be disposed proximal to the LBB electrode 50. The electrode 50 may be implanted towards the left side of the patient’s ventricular septum, or may be implanted along the endocardial wall in the LV adjacent the ventricular septum. The electrode 48 may be implanted towards the right side of the patient’s ventricular septum. In one embodiment, the electrode 50 may be a tip electrode, and the electrode 48 may be a ring electrode.

[0090] During dual bundle branch pacing, both the electrodes 48 and 50 may each deliver a pulse to achieve synchronized activation, or excitation, of the RBB 8b and the LBB 8a, which may result in synchronized activation of the RV and the LV. In some embodiments, the pulses may be delivered at the same time to achieve synchrony. In other embodiments, the pulses may be delivered with a delay to achieve synchrony.

[0091] Although the CCS lead 18 as shown in configured for dual bundle branch pacing using the electrodes 48, 50, it is to be understood that the CCS lead 18 or leads similar thereto are considered herein that may only include one of the electrode 48 and the electrode 50, and thus, only configured to deliver CCS pacing to one of the right bundle branch and the left bundle branch. In alternative embodiments, both electrodes 48 and 50 may be located on the CCS lead 18, but the IMD 16 may use just one of electrodes 48, 50 to pace only one bundle branch. Additionally, the CCS lead 18 may include an RA electrode 75 disposed more proximal to the electrodes 48, 50 along the CCS lead 18. Although the CCS lead 18 as shown includes the RA electrode 75, it is to be understood that the CCS lead 18 may not include the RA electrode 75, and instead, only include one or both of the electrode 48 and the electrode 50.

[0092] When the CCS lead 18 is positioned for delivering bundle branch pacing, of one or both bundle branches, CCS pacing may be combined with traditional ventricular myocardial pacing of the left ventricle using the coronary sinus lead 20 to correct a left ventricular conduction delay and achieve electrical and mechanical synchrony of the left and right ventricles. As such, in some examples, one or more processors, one or more processing circuits, or a computing apparatus of the IMD 16 may select a CCS pacing therapy plus traditional left ventricular myocardial pacing therapy that includes, for example, single or bilateral bundle branch pacing, e.g., using the CCS lead 18, combined with left ventricular myocardial pacing using the coronary sinus lead 20.

[0093] If the IMD 16 is configured to generate and deliver pacing pulses to the heart, a processor (not shown) may include pacer timing and control module, which may be embodied as hardware, firmware, software, or any combination thereof. The pacer timing and control module may include programmable counters which control the basic time intervals associated with DDD, VVI, DVI, VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR and other modes of single and dualchamber pacing. In the aforementioned pacing modes, “D” may indicate dual chamber, “V” may indicate a ventricle, “I” may indicate inhibited pacing (e.g., no pacing), and “A” may indicate an atrium. The first letter in the pacing mode may indicate the chamber that is paced, the second letter may indicate the chamber in which an electrical signal is sensed, the third letter may indicate the chamber in which the response to sensing is provided, and the fourth letter may indicate rate adaptiveness (e.g., “R” may indicate rate adaptiveness).

[0094] The various components of the IMD 16 are coupled to a power source, which may include a rechargeable or non-rechargeable battery. A non-rechargeable battery may be selected to last for several years, while a rechargeable battery may be inductively charged from an external device, e.g., on a daily or weekly basis.

[0095] The illustrative devices and methods described herein may provide adaptive CCS pacing therapy that may select an appropriate CCS pacing therapy mode based on one or more conditions or parameters measured from the patient.

[0096] The illustrative devices and methods described herein may provide and use monitored electrical activity (e.g., ECG, EGM, etc.) to determine various cardiac events and to provide effective pacing for use in cardiac therapy such as, for example, cardiac resynchronization therapy (CRT), biventricular pacing, LBB pacing (with or without atrial pacing), LBB block mode pacing, RBB pacing, RBB block mode pacing, etc. Illustrative pacing may be delivered using the devices as described in FIGS. 2-4.

[0097] For example, the single chamber device may include a single lead extending through the right atrium into the RV, perforate the ventricular septum and extend into the LV, as shown in FIGS. 3A-3B. The dual chamber device may include one or more leads or leadless devices. For example, the dual chamber device may include a first lead extending into the right atrium and a second lead extending into the LV as shown in FIG. 2B. The three-chamber device may include multiple leads or leadless devices. For example, the three-chamber device may include a first lead extending into the LV, a second lead extending into the coronary sinus to a region adjacent to the free wall of the LV, and a third lead extending into the right atrium, as shown in FIG. 2A.

[0098] Two illustrative leads 100, 109 that may be utilized by the devices of FIGS. 2-3 to perforate the ventricular septum and pace the LBB area are depicted in FIGS. 4A and 4B. Generally, the lead 100 of FIG. 4A is substantially similar to thelead 109 of FIG. 4B except the location of the anchoring apparatus 108 and the addition of an RBB electrode 107, which will be described further herein.

[0099] The lead 100 may be similar to the lead 18 as described herein with respect to FIGS. 2-3, or may be similar to the leadless or leadlet devices as described herein. The lead 100 may include, among other things, a lead body 101, at least one LBB electrode 106 coupled to the lead body 101, and an anchor apparatus 108. In one or more embodiments, the lead body 101 may include the anchor apparatus 108. In alternative embodiments, the anchor apparatus 108 may be coupled to the lead body 101.

[0100] The lead body 101 extends from a proximal end 102 to a distal end 104. The distal end 104 may be configured to be positioned in a patient’s heart to provide cardiac therapy. The proximal end 102 of the lead body 101 may be positioned outside of the patient’s heart and proximal to an operator controlling the lead 100 during implantation and may be connected to an IMD such as IMD 16 described herein with respect to FIGS. 2-4. The distal end 104 of the lead body 101 may be distal to the operator controlling the lead 100 during implantation and may be moved through the ventricular septum to be positioned for implantation or securement in a portion or region of the patient’s heart such that it perforates from the RV endocardium to the LV endocardium and traverses, or extends through, the entirety of the ventricular septum.

[0101] The lead body 101 may define, or include, a penetration portion 103 that extends along the lead body 101. The penetration portion 103 may be characterized as the portion of the lead body 101 that is configured to extend through (e.g., perforate) the ventricular septum of a patient’s heart to position the distal end 104 adjacent or proximate the LV endocardium of the patient’s heart after implantation of the lead. That is, the penetration portion 103 may be characterized as the portion of the lead body 101 that perforates through the ventricular septum when the distal end 104 is positioned adjacent or proximate to the LV endocardium after implantation of the lead, and the penetration portion 103 contacts and is bounded by both the RV and the LV. The penetration portion 103 may include the distal end 104. For example, the penetration portion 103 may be proximate (e.g., adjacent) the distal end 104 once the lead 100 is securely implanted. In alternative embodiments, the penetration portion 103 may not include the distal end 104. In one or more embodiments, the penetration portion 103 may define a length that is greater than orequal to the width, or thickness, of the ventricular septum of the patient’s heart. For example, the penetration portion 103 may be between about 10 millimeters (mm) and 20 mm. In one embodiment, the penetration portion is 15 mm.

[0102] The penetration portion 103 may include the at least one LBB electrode 106, the RBB electrode 107, and / or the anchor apparatus 108. Further, the penetration portion 103 may include any of those elements 106-108 during and / or after lead implantation in various embodiments as described herein. For example, the LBB electrode 106 may be coupled to the lead body 101 within the penetration portion 103 during and after lead implantation such that the LBB electrode 106 is located within the ventricular septum during and after lead implantation.Alternatively, the LBB electrode 106 may be coupled to the lead body 101 within the penetration portion 103 after lead implantation (e.g., during lead implantation, the LBB electrode 106 may extend into the LV 32 and may not be located within the ventricular septum). In some embodiments, the penetration portion 103 may include the distal end 104. In alternative embodiments, the penetration portion 103 may not include the distal end 104.

[0103] The lead 100 may include at least one left bundle branch (LBB) electrode 106 (e.g., electrode 50 as described herein) coupled to the lead body 101 within the penetration portion 103. The LBB electrode 106 may be configured (e.g., positioned along the lead body 101) to pace an LBB area of the patient’s heart (see FIGS. 5-9) when the penetration portion 103 of the lead body 101 is positioned extending through the ventricular septum and the distal end 104 is positioned proximate the LV endocardium. In one or more embodiments, the LBB electrode 106 may include a tip electrode positioned at the distal end 104 of the lead body 101 as shown, e.g., in FIGS. 4A, 5E-5G, 7A, and 9A-9E. In such embodiments, for example, the LBB electrode 106 may be configured to provide LBB pacing to the LBB (e.g., direct pacing or LBB area pacing). Such embodiments may advantageously allow the LBB electrode 106 to be positioned close to the LBB and effectively and reliably pace the LBB, which may allow for more flexible, or larger, implantation tolerances.

[0104] In alternative one or more embodiments, the LBB electrode 106 is or includes an electrode that is at or near the distal end 104 of the lead body 101, but is not covering, or sets proximal to the distal end 104 (e.g., a ring electrode) as shown, e.g., in FIGS. 4B, 6A-6D and 8A-8D. In such embodiments, for example, the LBB electrode 106 may advantageously be positioned close to the LBB, particularly inembodiments where the distal end 104 of the lead body 101 is not immediately adjacent the LBB. For example, the LBB electrode 106 may be between about 0.1 millimeters (mm) and 10 mm from the distal end 104 in a direction proximal to the distal end 104. In one embodiment, the LBB electrode 106 is 0 mm from the distal end. In one embodiment, the LBB electrode 106 is 1 mm from the distal end.

[0105] In some embodiments, perforation of the ventricular septum during and after lead placement also allows for a repeatable placement of another lead, or the same lead 100, 109, within the septum after removing the original lead 100, 109. Repeatable placement may include placement of a second lead such that any electrodes of the second lead are located in approximately the same location of the heart as the electrodes of the first lead were located.

[0106] The lead 100, 109 may further include an anchor apparatus 108. The anchor apparatus 108 may be proximate the distal end 104 of the lead body 101. For example, the anchor apparatus 108 may be operably coupled to the distal end 104 of the lead body 101, as illustrated in FIG. 4 A, which may advantageously allow the anchor apparatus 108 to secure the lead body 101 to the ventricular septum (not shown) and which may also allow the anchor apparatus 108 to assist in covering the perforation through-hole within the ventricular septum. In some embodiments, the anchor apparatus 108 may be configured to adapt from a delivery configuration to an anchored configuration when the penetration portion 103 of the lead body 101 is positioned extending through the ventricular septum. Further, in some embodiments, in the anchored configuration, the anchor apparatus 108 may contact the LV endocardial wall and resist movement of the lead 100, 109 in a proximal direction. Thus, the anchor apparatus 108 may inhibit proximal pulling forces acting on the lead 100, 109 after implantation and prevent removal of the lead 100, 109 from the ventricular septum during regular function of the heart.

[0107] Further, for example, the anchor apparatus 108 may be operably coupled to the penetration portion 103 of the lead body 101 as illustrated in FIG. 4B, which may advantageously allow the anchor apparatus 108 to secure the lead body 101 to the ventricular septum and which may also allow the anchor apparatus 108 to remain within the ventricular septum and avoid entry into the LV. That is, the anchor apparatus 108 may be positioned proximal to the distal end 104 and further may be coupled to the lead body 101 within the penetration portion 103. Avoiding placement of the anchor apparatus 108 within the LV may advantageously avoid build up ofdebris on the anchor apparatus 108 and may better protect the components of the lead 100, 109.

[0108] The anchor apparatus 108 may be configured to secure the lead body 101 to the ventricular septum. The lead body 101 may be secured to the ventricular septum when the lead body 101 will not move or dislodge from its implanted position.

[0109] The lead 109 may further include a right bundle branch (RBB) electrode 107, as shown in FIG. 4B). RBB electrode 107 may include, for example, the electrode 48 as described herein. The RBB electrode 107 may be coupled to the lead body 101. The RBB electrode 107 may be coupled to the lead body 101 within the penetration portion 103. The RBB electrode 107 may be positioned proximal to the LBB electrode 106 and the distal end 104.

[0110] The RBB electrode 107 may be configured to pace the RBB when the penetration portion 103 of the lead body 101 is positioned extending through the ventricular septum to position the distal end 104 proximate the LV endocardium. In one or more embodiments, the RBB electrode 107 includes a ring electrode positioned proximate the RBB. Such embodiments may advantageously allow for RBB pacing or dual bundle branch pacing. In alternative embodiments, the RBB electrode 107 may be positioned proximate the RBB area to provide RBB area pacing. Such alternative embodiments may advantageously allow the RBB electrode 107 to be positioned close to the RBB and effectively and reliably pace the RBB, which may allow for more flexible, or larger, implantation tolerances. For example, the RBB electrode 107 may be between about 3 millimeters (mm) and 23 mm from the distal end 104 in a direction proximal to the distal end 104. In one embodiment, the RBB electrode 107 is 7 mm from the distal end. Further, for example, the RBB electrode 107 may be between about 2 millimeters (mm) and 10 mm from the LBB electrode 106 in a direction proximal to the LBB electrode 106. In one embodiment, the RBB electrode 107 is 5 mm from the LBB electrode 106.

[0111] The LBB and / or RBB pacing electrodes may be the same as or substantially similar to one or more implanted electrodes as discussed herein with respect to FIGS. 1-3. A tip electrode may be an electrode located on, adjacent to, near, or proximate the tip of the CCS lead 18 as described above. A coil electrode may be an electrode shaped in or on a coil and located proximal to the tip of the lead along the lead body. A ring electrode may be an electrode shaped in a ring around the lead body.

[0112] Additionally, it is to be understood that one or both of the LBB and RBB electrodes 106, 107 may not only be used to deliver cardiac conduction system pacing but may also be used to sense cardiac electrical activity. For example, in one embodiment, and as described above, the RBB electrode 107 (e.g., RBB ring to can unipolar implanted electrogram using electrode 48) may be used to monitor electrical activity of the right ventricle along the RBB to produce an electrical signal representative of RBB electrical activity. Further, for example, the LBB electrode 106 (e.g., LBB tip to can unipolar implanted electrogram using electrode 50) may be used to monitor electrical activity of the left ventricle along the LBB to produce an electrical signal representative of LBB electrical activity.

[0113] An illustrative medical lead delivery system 213 and method 214 for implantation of a lead through a ventricular septum 210 of a patient’s heart to position a distal end 204 of the lead proximate a left ventricular endocardium of the patient’s heart is shown in FIGS. 5A-5G. It will be understood the components referenced in the description of FIGS. 5A-5G herein are consistent with the descriptions of the same components described elsewhere herein (e.g., FIGS. 1-3, 4A-4B, 6A-6D, 7A-7D, BASE, 9A-9J, etc.) unless contradictory to the current description or corresponding figures. As shown in FIG. 5 A, the system 213 and the method 214 may include introducing a delivery catheter 230 to an implantation site 218 at or adjacent to ventricular septum 210 from access of RV 28. The delivery catheter 230 may be described as being configured to deliver the lead to the right ventricular endocardium so as to be implanted through the ventricular septum 210 to position a distal end 204 of the lead body 201 proximate a left ventricular endocardium of the patient’s heart, as illustrated in FIGS. 5F and 5G.

[0114] The delivery catheter 230 may extend from a proximal end (not shown) to a distal end 232. In FIG. 5A, only the distal end 232 of the delivery catheter 230 is depicted while the proximal end is located outside of the patient’s body. The delivery catheter 230 defines a delivery lumen 233 extending from the proximal end to the distal end 232 such that the lead or any other element of the system described herein may be delivered or introduced from outside of the patient’s body to the implantation site. The delivery lumen 233 may be configured to receive the lead during delivery of the lead into and through the ventricular septum 210. The delivery lumen 233 may be configured to receive the piercing apparatus (described furtherherein) during delivery of the piercing apparatus into and through the ventricular septum 210.

[0115] The catheter 230 may circumferentially surround at least a portion of the lead body 201, or the delivery lumen 233 may be configured to receive the lead, during delivery of the lead body 201 into and through the ventricular septum 210 (see, e.g., FIGS. 5E-5G), which may advantageously protect the lead body 201 during delivery. The delivery catheter 230 may define an outside diameter of about 2 millimeters (mm) to about 6 mm. In one embodiment, the outside diameter is 4 mm. The delivery catheter 230 may define an inside diameter of about 1 millimeters (mm) to about 4 mm. In one embodiment, the inside diameter is 2 mm. The delivery catheter 230 may include (e.g., be formed of) one or more various materials such as, for example, Polyamide 12 (e.g., Nylon 12), Polyether block amide, and combinations thereof. The delivery catheter 230, however, may include any materials so as to be able to deliver or introduce elements from outside of the patient’s body to the implantation site.

[0116] The delivery catheter 230 may be advanced or moved (e.g., manipulated, rotated, etc.) as indicated by the arrows of FIG. 5 A until the distal end 232 is proximate to or adjacent the implantation site 218 as shown in FIG. 5B. After the distal end 232 of delivery catheter 230 is sufficiently positioned, a piercing apparatus 220 of the system 213 may be advanced or moved to the implantation site 218 using the delivery catheter 230 as shown and indicated by the arrow in FIG. 5B.

[0117] The piercing apparatus 220, as illustrated in FIGS. 5B-5D, may be an optional component of the system. In some embodiments, the ventricular septum may already be pierced and thus no piercing apparatus 220 would be required. Further, in some embodiments the system may include a piercing apparatus 220 separate from the lead, as illustrated in FIGS. 5A-5D. In alternative embodiments, the lead body may include a piercing element that is integral with the lead body (as described further herein). The piercing apparatus 220 may be configured to perforate the ventricular septum 210. Perforation of the ventricular septum and anchoring of a lead to the ventricular septum may, for example, advantageously secure the lead proximate the LBB, RBB, and / or His bundle and may optimize pacing to the LBB, RBB, and / or His bundle, respectively. Purposefully perforating the ventricular septum may advantageously negate many of the above factors, thereby making implantation easier and making implantation and long-term positioning more efficient, secure, and safer,and may lead to more optimized pacing delivered to the patient. Otherwise, variables such as patient anatomy, lead geometry (e.g., helix tip length, device width affecting tissue plug hole, etc.), medical professional dependent procedures, torque used to secure the lead in the ventricular septum, amount of lead rotation used in a lateral direction, accidental perforation of the ventricular septum, lead dislodgement during implantation and post-implantation, etc., are important to optimize lead placement and to optimize CCS pacing.

[0118] The catheter 230 may circumferentially surround the piercing apparatus 220, or in other words the lumen 233 may be configured to receive the lead, during delivery of the piercing apparatus 220 into and through the ventricular septum 210 (see, e.g., FIGS. 5A-5D), which may advantageously protect the piercing apparatus 220 during delivery. The piercing apparatus 220 may include, for example, a needle or piercing tip. The piercing apparatus 220 may be a standalone component, as illustrated in FIGS. 5A-5D. In alternative embodiments and as described further herein, the piercing apparatus may be integral with the lead, as illustrated in FIGS. 8 and 9. In embodiments where the piercing apparatus 220 is a standalone component, as illustrated in FIG. 5, the piercing apparatus 220 may advantageously only be temporarily operated within the patient’s heart, and then may be removed, saving space and avoiding damage to the component.

[0119] The piercing apparatus 220 may be advanced or moved (e.g., manipulated, rotated, etc.) as indicated by the arrows of FIG. 5B until the piercing apparatus 220 is proximate to or adjacent the LV endocardium as shown in FIG. 5C. Next, the piercing apparatus 220 may be retracted or moved (e.g., manipulated, rotated, etc.) as indicated by the arrows of 5D until the piercing apparatus 220 is removed from the system 213. As illustrated in 5D, the piercing apparatus 220 creates a through-hole 225 through the septum 210.

[0120] The lead may further include an anchor apparatus 208, as illustrated in FIGS. 5E-5G. The anchor apparatus 208 may be proximate or adjacent the distal end 204 of the lead body 201. For example, the anchor apparatus 208 may be operably coupled to the distal end 204 of the lead body 201, or the anchor apparatus 208 may include the distal end 204. The anchor apparatus 208 may be advanced or moved (e.g., manipulated, rotated, etc.) as indicated by the arrows of FIG. 5E until the anchor apparatus 208 is within the LV and contacts the LV endocardial wall as shown in FIGS. 5E-5F. In some embodiments, the anchor apparatus 208 may be configured toadapt from a delivery configuration to an anchored configuration when the penetration portion 203 of the lead body 201 is positioned extending through the ventricular septum. Further, in some embodiments, in the anchored configuration, the anchor apparatus 208 may contact the LV endocardial wall and resist movement of the lead in a proximal direction. Thus, the anchor apparatus 208 may inhibit proximal pulling forces acting on the lead after implantation and prevent removal of the lead from the ventricular septum during regular function of the heart.

[0121] In one or more embodiments, the anchor apparatus includes at least one retaining flange 211. The retaining flange(s) 211 may be positioned proximate the distal end 204 of the lead body 201, as illustrated in FIGS. 5E-5G. The flange(s) 211 may be positioned distal to the LBB electrode 206. The flange(s) 211 may be configured to expand from a delivery configuration (FIG. 5E) to an anchor configuration (FIGS. 5F and 5G). The flange(s) 211 may be advanced or moved (e.g., manipulated, rotated, etc.) until the tine(s) have expanded to the anchor configuration such that the flange(s) 211 are flush against the LV endocardium as shown in FIG. 5F. In the delivery configuration, the flange(s) 211 may be more flush with the lead body 201 as compared to the anchor configuration. In one embodiment, the flange (s) 211 are flush against the lead body 201 in the delivery configuration. In the anchor configuration, the flange(s) 211 may be held at an angle relative to a centerline, C, of the lead body 201.

[0122] The angle between the flange(s) 211 and the centerline C of the lead body 201 may be between about 1 degree and about 179 degrees. In at least one embodiment, the angle between the flange(s) 211 and the centerline C of the lead body 201 is 90 degrees. In other embodiments, the angle between the flange(s) 211 and the centerline C of the lead body 201 may be greater than or equal to 10 degrees, greater than or equal to 20 degrees, greater than or equal to 30 degrees, greater than or equal to 40 degrees, greater than or equal to 50 degrees, greater than or equal to 60 degrees, greater than or equal to 70 degrees, greater than or equal to 80 degrees, greater than or equal to 90 degrees, etc. and / or less than or equal to 95 degrees, 85 degrees, 75 degrees, 65 degrees, 55 degrees, 45 degrees, 35 degrees, 25 degrees, 15 degrees, 5 degrees, etc.

[0123] The flange(s) 211 may be configured to expand to the anchor configuration when the penetration portion 203 of the lead body 201 is positioned extending through the ventricular septum 210. Further, the flange(s) 211 may beconfigured to expand to the anchor configuration when an operator retracts the distal end 204 of the lead body 201 towards the ventricular septum 210 (e.g., when the lead body 101 is pulled proximally, or in a proximal direction). For example, as an operator retracts the distal end 204 of the lead body 201 towards the ventricular septum 210, the flange(s) 211 may expand from the delivery configuration to the anchor configuration such that the flange(s) are expanded to be flush with the LV endocardium, as illustrated in FIGS. 5F and 5G. In alternative embodiments, the flange(s) 211 may expand to the anchor configuration such that the flange(s) 211 are expanded to be secured fully within the septum 210 (as opposed to flush against the septum).

[0124] As illustrated in FIGS. 5F and 5G, the flange(s) 211 may advantageously extend over an LV opening 226 of the through-hole 225 through the ventricular septum 210 when in the anchor configuration. Such extension over the LV opening 226 may aid in patient recovery and assist in maintaining proper blood flow through the patient’s heart. The anchor apparatus 208 may be configured to secure the lead body 201 to the ventricular septum 210. The lead body 201 may be secured to the ventricular septum 210 such that the lead body 201 will not move or dislodge from its implanted position.

[0125] Next, the catheter 230 may be retracted or moved (e.g., manipulated, rotated, etc.) as indicated by the arrows of 5G until the catheter 230 is removed from the system 213. The lead may be used to pace the LBB area using the LBB electrode 206 and as described herein. In alternative embodiments, the lead may include an RBB electrode 207 (FIG. 5G) which may be used to pace the RBB area as described herein.

[0126] An illustrative system 313 and method 314 for implantation of a lead through a ventricular septum 310 of a patient’s heart to position a distal end 304 of the lead proximate a left ventricular endocardium of the patient’s heart is shown in FIGS. 6A-6D. It will be understood the components referenced in the description of FIGS. 6A-6D herein are consistent with the descriptions of the same components described elsewhere herein (e.g., FIGS. 1-3, 4A-4B, 5A-5G, 7A-7D, 8A-8E, 9A-9J, etc.) unless contradictory to the current description or corresponding figures. As shown in FIG. 6 A, the system 313 and the method 314 may include introducing a delivery catheter 330 to an implantation site 318 at or adjacent to the septum 310, and as described herein with respect to FIG. 5 A. The system 313 and the method 314 may includeintroducing a piercing apparatus (not shown) to the implantation site 318 and through the septum 310, and as described herein with respect to FIGS. 5B-5D. In alternative embodiments, and as discussed further herein, the lead may include a piercing element, and the piercing apparatus is not required. As illustrated in 6A, the piercing apparatus created a through-hole 325 through the septum 310.

[0127] The lead may further include an anchor apparatus 308. The anchor apparatus 308 may be proximate the distal end 304 of the lead body 301. For example, the anchor apparatus 308 may define the distal end 304 of the lead body 301, as illustrated in FIGS. 6B-6D. Further, for example, the anchor apparatus 308 may be distal, or adjacent to, to the penetration portion 303 of the lead body 301. As illustrated, the anchor apparatus 308 may advantageously secure the lead body 301 to the ventricular septum 310 and assist in covering the perforation through-hole 325 within the ventricular septum 310.

[0128] The anchor apparatus 308 may be configured to secure the lead body 301 to the ventricular septum 310. The lead body 301 may be secured to the ventricular septum 310 such that the lead body 301 remains secure in the implanted position and can resist pushes or pulls in the proximal direction, distal direction, or both during the normal operation of the lead within the patient’s heart.

[0129] The anchor apparatus 308 may proximally extend from the distal end 304 to a point along the lead body 301. The anchor apparatus 308 may define a length between about 1% and about 20% of the total length of the lead body 301. In at least one embodiment, the anchor apparatus 308 is 10% of the total length of the lead body 301. In other embodiments, the anchor apparatus 308 may be greater than or equal to 1%, greater than or equal to 2%, greater than or equal to 5%, greater than or equal to 7%, greater than or equal to 9%, greater than or equal to 10%, greater than or equal to 12%, greater than or equal to 15%, greater than or equal to 20%, etc. and / or less than or equal to 25%, 18%, 14%, 11%, 8%, 6%, 4%, 3%, etc. of the total length of the lead body 101. In one or more embodiments, the anchor apparatus 308 of the lead body 301 may define a pre-formed geometry, as illustrated in FIGS. 6B-6D. The preformed geometry may include one or more of a hook-shape, a bend, or any shape which may help press the anchor apparatus 308 against the LV endocardium within the LV chamber to help secure the lead body 301 within the ventricular septum 310 and inhibit a proximal pull of lead body 301 back through the septum 310. In such embodiments, the pre-formed geometry defining the anchor apparatus 308 may beconfigured to expand from a delivery configuration (FIG. 6A) to an anchor configuration (FIGS. 6B-6D). In the delivery configuration, the pre-formed geometry defining the anchor apparatus 308 may be held in a more linear configuration relative to a longitudinal axis of lead body 301 than in the delivery configuration. Such a linear configuration may advantageously allow the lead body 301 to be easily maneuvered through the through-hole 325.

[0130] In some examples, lead body 301 may be biased into the delivery configuration due to delivery catheter 330. Additionally, or alternatively, in one or more embodiments, the lead may further include a removable stylet 350, as illustrated in FIG. 6B to aid in the delivery of lead. The removable stylet 350 may be disposed within the lead body 301. The removable stylet 350 may have a diameter of about 0.2mm, 0.4 mm, 0.5 mm, etc. The removable stylet 350 may be constructed of, for example, MP35N, metals, plastics, or any combination thereof. The removable stylet 350 may advantageously provide increased stiffness to the lead body 301 during implantation of the lead. For example, the removable stylet 350 may have a stiffness (as defined using Young’s Modulus measured in gigapascals) of about 5GPa, 25 GPa, 35 GPa, 45 GPa, 105 GPa, 205 GPa, 305 GPa, 405 GPa, etc. The removable stylet 350 may advantageously provide sufficient stiffness to hold the lead body 301 in a delivery configuration, for example, in a linear shape, during implantation of the lead body 301.

[0131] The removable stylet 350 may be retracted or moved (e.g., manipulated, rotated, etc.) until the removable stylet 350 is removed from the system 313 as shown in FIG. 6B. Once the lead body 301 is implanted and the removable stylet 350 is removed, without the increased stiffness from the removable stylet 350, the lead body 301 may take a pre-formed shape as illustrated in FIG. 6B. In one or more embodiments where the anchor apparatus 308 defines a pre-formed geometry, the removable stylet 350 may be configured to resist the pre-formed geometry and maintain an approximately linear lead body geometry of the anchor apparatus 308 when disposed within the lead body 301 and anchor apparatus 308. Such embodiments may advantageously allow for the use of a pre-formed geometry without requiring a large cross-sectional through-hole in the ventricular septum 310.

[0132] The pre-formed geometry defining the anchor apparatus 308 may be configured to expand to the anchor configuration when the penetration portion 303 of the lead body 301 is positioned extending through the ventricular septum 310.Further, the pre-formed geometry defining the anchor apparatus 308 may be configured to expand to the anchor configuration when an operator retracts the distal end 304 of the lead body 301 towards the ventricular septum 310, as illustrated using the arrow of FIG. 6C. Still further, the pre-formed geometry defining the anchor apparatus 308 may advantageously extend over the through-hole through the ventricular septum 310 when in the anchor configuration, which may aid in patient recovery and assist in maintaining proper blood flow through the patient’s heart.

[0133] Next, the catheter 330 may be retracted or moved (e.g., manipulated, rotated, etc.) as indicated by the arrows of 6D until the catheter 330 is removed from the system 313. The lead may be used to pace the LBB area using the LBB electrode(s) 306 and as described herein. In alternative embodiments, the lead may include an RBB electrode 307 (FIG. 6D) which may be used to pace the RBB area as described herein.

[0134] An illustrative system 413 and method 414 for implantation of a lead through a ventricular septum 410 of a patient’s heart to position a distal end 404 of the lead proximate a left ventricular endocardium of the patient’s heart is shown in FIGS. 7A-7D. It will be understood the components referenced in the description of FIGS. 7A-7D herein are consistent with the descriptions of the same components described elsewhere herein (e.g., FIGS. 1-3, 4A-4B, 5A-5G, 6A-6D, 8A-8E, 9A-9J, etc.) unless contradictory to the current description or corresponding figures. As shown in FIG. 7 A, the system 413 and the method 414 may include introducing a delivery catheter 430 to an implantation site 418 at or adjacent to the septum 410, and as described herein with respect to FIG. 5 A. The system 413 and the method 414 may include introducing a piercing apparatus (not shown) to the implantation site 418 and through the septum 410, and as described herein with respect to FIGS. 5B-5D. The system 413 and the method 414 may include a pre-formed geometry defining an anchor apparatus 408, and as described with respect to FIGS. 6B-6D.

[0135] As illustrated in FIGS. 7A-7B, the entire pre-formed geometry defining an anchor apparatus 408 may be insulated and may not provide a pacing pulse to surrounding tissue. An LBB electrode 406 may provide pacing to the LBB area as described herein. An RBB electrode 407 (FIG. 7B) may provide pacing to the RBB area as described herein.

[0136] As illustrated in FIGS. 7C and 7D, the pre-formed geometry defining an anchor apparatus 408 may be only partially insulated, and any un-insulatedportions of the anchor apparatus 408 may be used as an LBB electrode 406. This may advantageously provide stronger LBB pacing, as the LBB area is paced from multiple locations. Additionally, different un-insulated portions may be tested to determine the un-insulated portion(s) that provide optimal response to LBB pacing. In alternative embodiments, the un-insulated portions of the anchor apparatus 408 may be used to pace the LV endocardium.

[0137] An illustrative system 513 and method 514 for implantation of a lead through a ventricular septum 510 of a patient’s heart to position a distal end 504 of the lead body 501 proximate a left ventricular endocardium of the patient’s heart is shown in FIGS. 8A-8E. It will be understood the components referenced in the description of FIGS. 8A-8E herein are consistent with the descriptions of the same components described elsewhere herein (e.g., FIGS. 1-3, 4A-4B, 5A-5G, 6A-6D, 7A-7D, 9A-9J, etc.) unless contradictory to the current description or corresponding figures. As shown in FIG. 8A, the system 513 and the method 514 may include introducing a delivery catheter 530 to an implantation site 518 at or adjacent to the septum 510, and as described herein with respect to FIG. 5 A.

[0138] The system 513 and the method 514 may include introducing a piercing element 520 to the implantation site 518 and through the septum 510. As illustrated in FIGS. 8A-8E, the piercing element 520 is integral with the lead body 501. The piercing element 520 may advantageously save operation time during implantation because the piercing element 520 does not need to be removed prior to lead insertion, which may also avoid contamination during an operation. In embodiments where the lead body 501 includes the piercing element 520, the piercing element 520 may be proximate the distal end 504 of the lead body 501, and may define the distal end 504 of the lead body 501. Additionally, the piercing element 520 may include the LBB electrode 506. For example, the piercing element 520 may define the LBB electrode 506.

[0139] The piercing element 520 may further include a ridge 521 (FIG. 8 A). The ridge 521 may help anchor the lead against the LV endocardial wall, and thus may also help resist movement of the lead in a proximal direction and / or inhibit proximal pull of the lead after implantation of the lead.

[0140] In one or more embodiments, the anchor apparatus 508 defines a fixation helix disposed around a circumference of the lead body 501, as illustrated in FIGS. 8A, 8B, 8D, and 8E. The anchor apparatus 508 may be advanced or moved(e.g., manipulated, rotated, etc.) as indicated by the arrows of 8D until the piercing element 520 has pierced through the ventricular septum 510 and the anchor apparatus 508 has secured the lead within the ventricular septum 510, as illustrated in FIG. 8E. Further, the anchor apparatus 508 may be positioned proximal to the distal end 504 and proximal to the LBB electrode 506. The anchor apparatus 508 may be engaged with tissue within the ventricular septum to secure the lead in place. The anchor apparatus 508 may be coupled to the lead body 501 within the penetration portion 503 (e.g., may be coupled to the penetration portion 503 of the lead body 501). The anchor apparatus 508 / fixation helix may also help anchor the lead against the LV endocardial wall (in addition to and separately from the ridge 521), and thus may also help resist movement of the lead in a proximal direction and / or inhibit proximal pull of the lead after implantation of the lead.

[0141] The fixation helix may have any number of rotations, or partial rotations, around the circumference of the lead body 501. The fixation helix may define a length that is less than or equal to the width of the patient’s ventricular septum 510 (e.g., a length that is less than or equal to a length of the penetration portion 503, illustrated in FIG. 8E). In embodiments where the anchor apparatus 508 includes a fixation helix, the LBB electrode 506 may be positioned distal to the fixation helix. Further, rotation of the lead body 501 may fixate the fixation helix within the ventricular septum 510.

[0142] Next, the catheter 530 may be retracted or moved (e.g., manipulated, rotated, etc.) as indicated by the arrows of 8D until the catheter 530 is removed from the system 513. The lead may be used to pace the LBB area using the LBB electrode 506 and as described herein. In alternative embodiments, the lead may include an RBB electrode 507 (FIG. 8E) which may be used to pace the RBB area as described herein. Additionally, the RBB electrode 507 may be used to the pace the RV endocardium.

[0143] An illustrative system 613 and method 614 for implantation of a lead through a ventricular septum 610 of a patient’s heart to position a distal end 604 of the lead proximate a left ventricular endocardium of the patient’s heart is shown in FIGS. 9A-9J. It will be understood the components referenced in the description of FIGS. 9A-9J herein are consistent with the descriptions of the same components described elsewhere herein (e.g., FIGS. 1-3, 4A-4B, 5A-5G, 6A-6D, 7A-7D, 8A-8E, etc.) unless contradictory to the current description or corresponding figures.

[0144] As shown in FIG. 9 A, the system 613 may include a lead body 601 extending from a proximal end 602 to a distal end 604. The lead body 601 may define, or include, a penetration portion 603 that extends along the lead body 601. In this embodiment, the penetration portion 603 may not include the distal end 604, and instead an anchor apparatus 608 may include the distal end 604 (similar to FIGS. 6-7). The penetration portion 603 is the portion of the lead body 601 that is configured to extend through the ventricular septum of a patient’s heart to position the distal end 604 proximate the LV endocardium of the patient’s heart after implantation of the lead.

[0145] In one or more embodiments, the lead further comprises a sleeve 634 as illustrated in FIGS. 9A-9F and 9H-9J. The sleeve 634 may circumferentially surround at least a portion of the anchor apparatus 608 and at least a portion of the lead body 601 proximate the distal end 604, or in other words a sleeve lumen may be configured to receive at least a portion of the anchor apparatus 608 and the lead body 601 proximate the distal end 604. The sleeve 634 may advantageously provide increased stiffness to the anchor apparatus 608 and the lead body 601 and may protect the components of the lead before, during, and after implantation. Further, the sleeve 634 may advantageously provide sufficient stiffness to hold the anchor apparatus 608 and the lead body 601 in a deformed shape, for example, in a linear shape, during implantation of the lead body 601. In alternative embodiments, the sleeve 634 may be integral with the lead body 601.

[0146] The anchor apparatus 608 may proximally extend from the distal end 604 to a point along the lead body 601. The anchor apparatus 608 may define a length between about 1% and about 20% of the total length of the lead body 601. In at least one embodiment, the anchor apparatus 608 is 10% of the total length of the lead body 601. In other embodiments, the anchor apparatus 608 may be greater than or equal to 1%, greater than or equal to 2%, greater than or equal to 5%, greater than or equal to 7%, greater than or equal to 9%, greater than or equal to 10%, greater than or equal to 12%, greater than or equal to 15%, greater than or equal to 20%, etc. and / or less than or equal to 25%, 18%, 14%, 11%, 8%, 6%, 4%, 3%, etc. of the total length of the lead body 601. In one or more embodiments, the anchor apparatus 608 of the lead body 601 may define a pre-formed geometry, as illustrated in FIGS. 9C-9E and 91-9 J. The pre-formed geometry may include one or more of a hook-shape, a bend, or any shape which may help press the anchor apparatus 608 against the LV endocardium withinthe LV chamber to help secure the lead body 601 within the ventricular septum 610 and inhibit a proximal pull of lead body 601 back through the septum 610. In such embodiments, the pre-formed geometry defining the anchor apparatus 608 may be configured to expand from a delivery configuration (FIG. 9B) to an anchor configuration (FIGS. 9C-9E and 9I-9J). In the delivery configuration, the pre-formed geometry defining the anchor apparatus 608 may be held in a more linear configuration relative to a longitudinal axis of lead body 601 than in the delivery configuration. Such a linear configuration may advantageously allow the lead body 601 to be easily maneuvered through the through-hole.

[0147] In some examples, lead body 601 may be biased into the delivery configuration due to a delivery catheter 630. Additionally, or alternatively, in one or more embodiments, the lead may further include the sleeve 634, as described herein. The sleeve 634 may have an inner diameter between about 1 mm and about 4 mm, and may have an outer diameter between about 2 mm and about 6 mm. The sleeve 634 may be constructed of, for example, silicon, polyurethane, other plastics, or any combination thereof. The sleeve 634 may advantageously provide increased stiffness to the lead body 601 during implantation of the lead. The sleeve 634 may advantageously provide sufficient stiffness to hold the lead body 601 in a delivery configuration, for example, in a linear shape, during implantation of the lead body 601.

[0148] Once the anchor apparatus 608 is expanded beyond or outside of the sleeve 634, without the increased stiffness from the sleeve 634, the anchor apparatus 608 may take a pre-formed shape as illustrated in FIGS. 9C-9E and 91-9 J. In one or more embodiments where the anchor apparatus 608 defines a pre-formed geometry, the sleeve 634 may be configured to resist the pre-formed geometry and maintain an approximately linear lead body geometry of the anchor apparatus 608 when disposed within the sleeve 634. Such embodiments may advantageously allow for the use of a pre-formed geometry without requiring a removable stylet, may allow for the use of a pre-formed geometry without requiring a large cross-sectional through-hole in the ventricular septum 610, etc.

[0149] The pre-formed geometry defining the anchor apparatus 608 may be configured to expand to the anchor configuration when the penetration portion 603 of the lead body 601 is positioned extending through the ventricular septum 610. Further, the pre-formed geometry defining the anchor apparatus 608 may beconfigured to expand to the anchor configuration when an operator advances the distal end 604 of the lead body 601 away from the ventricular septum 610, as illustrated using the arrow of FIG. 91. Still further, the pre-formed geometry defining the anchor apparatus 608 may advantageously extend over the through-hole through the ventricular septum 610 when in the anchor configuration, which may aid in patient recovery and assist in maintaining proper blood flow through the patient’s heart.

[0150] The LBB electrode 606 may be coupled to the anchor apparatus 608 as opposed to the lead body 601, and may be configured to be disposed within the sleeve 634 during delivery of the lead (FIGS. 9B, 9F). The LBB electrode 606 may be configured to extend beyond a distal end of the sleeve 634 when the penetration portion 603 of the lead body 601 is positioned extending through the ventricular septum 610 (FIG. 9J). In alternative embodiments, the sleeve 634 may include the LBB electrode 606 (e.g., a ring electrode as described herein and as illustrated in FIG. 9E).

[0151] Additionally, the lead (and more specifically, the sleeve 634 of the lead) may include a piercing element 620 as illustrated in FIGS. 9A-9F and 9H-9J. In such embodiments, the sleeve 634 may advantageously provide increased stiffness to the piercing element 620 that may result in faster and easier perforation of the ventricular septum 610 and that may further avoid damage to the components and the ventricular septum 610, for example, due to deflection of the components.

[0152] In some examples, sleeve 634 may be configured to house anchoring apparatus 608 during delivery and then deploy anchoring apparatus 608 after penetration across the ventricular septum. In some examples, advancement of anchoring apparatus 608 distally relative to piercing element 620 may be accomplished through mechanical rotation of anchoring apparatus 608 relative to sleeve 634. For example, the sleeve 634 may include an internal threaded surface 660, and the lead may include a connector pin 690 (FIG. 9A) that is operably coupled to a notch 670 configured to travel along the internal threaded surface 660 (FIGS. 9B and 9C). As an operator controls the connector pin 690 by twisting it, the notch 670 travels along the internal threaded surface 660, the distal end 604 of the anchor apparatus 608 comprising the pre-formed geometry may extend beyond the distal end of the sleeve 634, as illustrated in FIG. 9C, 9D, and 91. The connector pin 690 may be located adjacent, proximate to, and / or define, the proximal end 602 of the lead body 601.

[0153] The system 613 may further include a conductor coil 680 (FIGS. 9B, 9C), which may define an elongated electrode that may be connected with LBB electrode 606. The conductor coil 680 may advantageously allow the LBB electrode606 to be connected to a power source located on the opposite end of the sleeve 634 from the LBB electrode 606. As illustrated in FIGS. 9B-9C, the conductor coil 680 may be positioned within the sleeve 634 and around the exterior of the anchor apparatus 608. In alternative embodiments, the conductor coil 680 may be positioned within the anchor apparatus 608.

[0154] Next, the catheter 630 may be retracted or moved (e.g., manipulated, rotated, etc.) until the catheter 630 is removed from the system 613. The lead body 601 may be retracted such that the anchor apparatus secures the lead body 601 within the septum 610, as described herein and as shown using the arrow of FIG. 9 J. The lead may be used to pace the LBB area using the LBB electrode 606 and as described herein (FIG. 9J). In alternative embodiments, the lead may include an RBB electrode607 (FIG. 9J) which may be used to pace the RBB area as described herein.

[0155] An illustrative method 700 of perforating the ventricular septum and pacing the CCS using a lead as described herein (and which method 700 may be utilized by the devices of FIGS. 2-9) is depicted in FIG. 10. The method 700 may include advancing the piercing apparatus through the ventricular septum prior to advancing the lead body through the ventricular septum, noted as step reference number 702. The piercing apparatus may be integral with the lead body or may be a separate component, as described herein, but in either case the piercing apparatus will advance through the ventricular septum prior to advancing the rest of the lead body. The lead may include a lead body as described herein, as well as any other lead components described herein (e.g., a piercing apparatus, a catheter, a removable stylet, a sleeve, etc.).

[0156] The method 700 may further include advancing the lead body into the RV and through the ventricular septum into the LV 704. The lead body may include the proximal end and the distal end as described herein.

[0157] The method 700 may further include securing the lead body within the ventricular septum using the anchor apparatus, noted as step reference number 706. Securing the lead body within the ventricular septum using the anchor apparatus may include at least one of: retracting the lead body towards the ventricular septum,removing the removable stylet from the lead, and advancing the lead body beyond the distal end of the sleeve.

[0158] Retracting the lead body towards the ventricular septum may include a user controlling the lead body and retracting the lead body as described herein. Retracting the lead body towards the ventricular septum may occur after the ventricular septum has been perforated and after the lead body has been extended through the ventricular septum and into the LV. Thus, retracting the lead body towards the ventricular septum may advantageously seal the through-hole through the ventricular septum as the anchor apparatus is pulled flush with the LV endocardium and extends across the through-hole. Further, retracting the lead body towards the ventricular septum may expand the at least one tine (as described herein) of the anchor apparatus from the delivery configuration to the anchor configuration, the configurations also as described herein. The tine(s) of the anchor apparatus may be positioned proximate the distal end of the lead body, as described herein.

[0159] In one or more embodiments, the distal end of the lead body includes the pre-formed geometry defining the anchor apparatus as described herein. In embodiments with the removable stylet as described herein, the removable stylet may be configured to resist the pre-formed geometry and maintain an approximately linear lead body geometry at the distal end. The pre-formed geometry may include at least one of a hook and a bend, as described herein. In embodiments with the sleeve as described herein, the sleeve may be configured to resist the pre-formed geometry and maintain an approximately linear lead body geometry at the distal end. The preformed geometry may re-form when the lead body is extended beyond the distal end of the sleeve, as described herein.

[0160] The method 700 may further include delivering pacing to at least one of an RBB area and an LBB area using at least one electrode 708, and such delivery may be done using the devices as described with respect to FIGS. 2-9.

[0161] Various examples have been described. These and other examples are within the scope of the following claims. For example, a single chamber, dual chamber, or triple chamber pacemakers (e.g., CRT-P) or ICDs (e.g., CRT-D) devices can be used to implement the illustrative methods described herein.ILLUSTRATIVE EXAMPLES

[0162] While the present disclosure is not so limited, an appreciation of various aspects of the disclosure will be gained through a discussion of the specific illustrative examples provided below. Various modifications of the illustrative examples, as well as additional examples of the disclosure, will become apparent herein.

[0163] Example Exl : An implantable medical lead delivery system including a lead. The lead includes a lead body extending from a proximal end to a distal end, where a penetration portion of the lead body is adjacent the distal end and is configured to extend through and perforate a ventricular septum of a patient’s heart to position the distal end adjacent a left ventricular endocardium of the patient’s heart. The lead further includes at least one left bundle branch (LBB) electrode coupled to the lead body adjacent the distal end of the lead body and configured to pace an LBB area when the penetration portion of the lead body is positioned extending through the ventricular septum and the distal end is positioned adjacent the left ventricular endocardium. The lead further includes an anchor apparatus adjacent the distal end of the lead body and configured to secure the lead body to the ventricular septum, where the anchor apparatus is configured to adapt from a delivery configuration to an anchored configuration when the penetration portion of the lead body is positioned extending through the ventricular septum. In the anchored configuration, the anchor apparatus contacts a left ventricular endocardial wall and resists movement of the lead in a proximal direction.

[0164] Example Ex2: The lead delivery system of Exl, further including a piercing apparatus configured to perforate the ventricular septum.

[0165] Example Ex3: The lead delivery system of any one of Exl-Ex2, where the lead further includes a piercing element, and where the piercing element is adjacent the distal end of the lead body.

[0166] Example Ex4: The lead delivery system of any one of Exl-Ex3, further including a right bundle branch (RBB) electrode coupled to the lead body proximal to the LBB electrode and configured to pace an RBB area when the penetration portion of the lead body is positioned extending through the ventricular septum to position the distal end adjacent the left ventricular endocardium.

[0167] Example Ex5: The lead delivery system of any one of Exl-Ex4, where the anchor apparatus includes at least one retaining flange positioned adjacent thedistal end of the lead body, where the at least one retaining flange is configured to expand from a delivery configuration to an anchor configuration when the penetration portion of the lead body is positioned extending through the ventricular septum and the distal end of the lead body is pulled proximally.

[0168] Example Ex6: The lead delivery system of any one of Exl-Ex5, where the at least one tine is positioned distal to the LBB electrode.

[0169] Example Ex7: The lead delivery system of any one of Exl-Ex6, further including a removable stylet disposed within the lead body.

[0170] Example Ex8: The lead delivery system of any one of Exl-Ex7, where the anchor apparatus defines a pre-formed geometry, and where the removable stylet is configured to resist the pre-formed geometry and maintain an approximately linear lead body geometry when disposed within the lead body, where the anchor apparatus is located distally from the penetration portion.

[0171] Example Ex9: The lead delivery system of any one of Exl-Ex8, where the anchor apparatus defines a pre-formed geometry, and where the pre-formed geometry comprises one or more of a hook and a bend.

[0172] Example ExlO: The lead delivery system of any one of Exl-Ex9, where the hook or bend is configured to contact the left ventricular endocardial wall and resist movement of the lead in a proximal direction.

[0173] Example Exl 1 : The lead delivery system of any one of Exl-ExlO, where the anchoring apparatus includes the at least one LBB electrode.

[0174] Example Exl2: The lead delivery system of any one of Exl-Exl 1, further including a sleeve circumferentially surrounding at least a portion of the anchor apparatus and at least a portion of the lead body adjacent the distal end, where the LBB electrode is configured to be disposed within the sleeve during delivery of the lead, and where the LBB electrode is configured to extend beyond a distal end of the sleeve when the penetration portion of the lead body is positioned extending through the ventricular septum.

[0175] Example Exl3: The lead delivery system of any one of Exl-Exl2, where the anchor apparatus includes a fixation helix operably coupled to the penetration portion of the lead body and disposed around a circumference of the lead body, where the LBB electrode is positioned distal to the fixation helix, and where rotation of the lead body fixates the fixation helix within the ventricular septum.

[0176] Example Exl4: The lead delivery system of any one of Exl-Exl3 further including a catheter, where the catheter defines a catheter lumen configured to receive the lead during delivery of the lead into and through the ventricular septum.

[0177] Example Exl5: The lead delivery system of any one of Exl-Exl4, further including a piercing apparatus configured to perforate the ventricular septum, where the catheter defines a catheter lumen configured to receive the piercing apparatus during delivery of the piercing apparatus into and through the ventricular septum.

[0178] Example Exl6: A method of perforating a ventricular septum and delivering pacing using an implantable medical device (IMD), the method including advancing a lead into a right ventricle and through a ventricular septum to position a distal end of the lead adjacent a left ventricular endocardium of the patient’s heart. The method further includes securing the lead within the ventricular septum. The method further includes delivering pacing to one or more of a right bundle branch (RBB) area and a left bundle branch (LBB) area using at least one electrode of the lead.

[0179] Example Exl7: The method of Exl6, further including advancing a catheter into the right ventricle and adjacent to an implantation site located adjacent the ventricular septum prior to advancing the lead through the ventricular septum.

[0180] Example Exl8: The method of any one of Exl6-Exl7, further including advancing a piercing apparatus through the ventricular septum prior to advancing the lead through the ventricular septum.

[0181] Example Exl9: The method of any one of Exl6-Exl8, where securing the lead within the ventricular septum further includes one or more of: retracting the lead towards the ventricular septum, removing a removable stylet from the lead, and rotating a fixation helix within the ventricular septum.

[0182] Example Ex20: The method of any one of Exl6-Exl9, where retracting the lead towards the ventricular septum expands at least one tine of the lead from a delivery configuration to an anchor configuration, and where the at least one tine is positioned adjacent the distal end of the lead.

[0183] Example Ex21 : The method of any one of Exl6-Ex20, where the anchor apparatus defines a pre-formed geometry, and where the removable stylet is configured to resist the pre-formed geometry and maintain an approximately linearlead body geometry of the anchor apparatus, and where the pre-formed geometry includes at least one of a hook and a bend.

[0184] Example Ex22: The method of any one of Exl6-Ex21, where the fixation helix is operably coupled to the lead and disposed around a circumference of the lead, and where rotation of the lead fixates the fixation helix within the ventricular septum.

[0185] Example Ex23 : A lead including a lead body extending from a proximal end to a distal end, where a penetration portion of the lead body is adjacent the distal end and is configured to extend through and perforate a ventricular septum of a patient’s heart to position the distal end adjacent a left ventricular endocardium of the patient’s heart. The lead further includes at least one left bundle branch (LBB) electrode coupled to the lead body adjacent the distal end of the lead body and configured to pace an LBB area when the penetration portion of the lead body is positioned extending through the ventricular septum and the distal end is positioned adjacent the left ventricular endocardium. The lead further includes an anchor apparatus adjacent the distal end of the lead body and configured to secure the lead body to the ventricular septum, where the anchor apparatus is configured to adapt from a delivery configuration to an anchored configuration when the penetration portion of the lead body is positioned extending through the ventricular septum, where the anchor apparatus defines a pre-formed geometry configured to secure the lead body to the ventricular septum. The lead further includes a sleeve circumferentially surrounding at least a portion of the anchor apparatus, where the anchor apparatus is configured to be disposed within the sleeve during delivery of the lead and to extend beyond a distal end of the sleeve when the penetration portion of the lead body is positioned extending through the ventricular septum.

[0186] Example Ex24: The lead of Ex23, where the sleeve further includes an internal threaded surface, and the lead further includes a notch configured to travel along the internal threaded surface and extend the anchor apparatus beyond the distal end of the sleeve.

[0187] Example Ex25: The lead of any one of Ex23-Ex24, where the notch is operably connected to and controlled by a connector pin located adjacent the proximate end of the lead.

[0188] This disclosure has been provided with reference to illustrative embodiments and examples and is not meant to be construed in a limiting sense. Asdescribed previously, one skilled in the art will recognize that other various illustrative applications may use the techniques as described herein to take advantage of the beneficial characteristics of the devices and methods described herein. Various modifications of the illustrative embodiments and examples will be apparent upon reference to this description.

[0189] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0190] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0191] All references and publications cited herein are expressly incorporated herein by reference in their entirety for all purposes, except to the extent any aspect directly contradicts this disclosure.

[0192] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are to facilitate understanding of certain terms used frequently herein and are not meant to limit the scope of the present disclosure.

[0193] Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims may be understood as being modified either by the term “exactly” or “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing theteachings disclosed herein or, for example, within typical ranges of experimental error.

[0194] The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any range within that range. Herein, the terms “up to” or “no greater than” a number (e.g., up to 50) includes the number (e.g., 50), and the term “no less than” a number (e.g., no less than 5) includes the number (e.g., 5).

[0195] The terms “coupled” or “connected” refer to elements being attached to each other either directly (in direct contact with each other) or indirectly (having one or more elements between and attaching the two elements). Either term may be modified by “operatively” and “operably,” which may be used interchangeably, to describe that the coupling or connection is configured to allow the components to interact to carry out at least some functionality (for example, a mobile user device may be operatively coupled to a cellular network transmit data to or receive data therefrom).

[0196] Reference to “one embodiment,” “an embodiment,” “certain embodiments,” or “some embodiments,” etc., means that a particular feature, configuration, composition, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of such phrases in various places throughout are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, configurations, compositions, or characteristics may be combined in any suitable manner in one or more embodiments.

[0197] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” encompass embodiments having plural referents, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise.

[0198] As used herein, “have,” “having,” “include,” “including,” “comprise,” “comprising” or the like are used in their open-ended sense, and generally mean “including, but not limited to.” It will be understood that “consisting essentially of,” “consisting of,” and the like are subsumed in “comprising,” and the like.

[0199] The term “and / or” means one or all of the listed elements or a combination of at least two of the listed elements.

[0200] The phrases “at least one of,” “comprises at least one of,” and “one or more of’ followed by a list refers to any one of the items in the list and any combination of two or more items in the list.

Claims

CLAIMS1. An implantable medical lead delivery system comprising: a lead comprising: a lead body extending from a proximal end to a distal end, wherein a penetration portion of the lead body is adjacent the distal end and is configured to extend through and perforate a ventricular septum of a patient’s heart to position the distal end adjacent a left ventricular endocardium of the patient’s heart; at least one left bundle branch (LBB) electrode coupled to the lead body adjacent the distal end of the lead body and configured to pace an LBB area when the penetration portion of the lead body is positioned extending through the ventricular septum and the distal end is positioned adjacent the left ventricular endocardium; and an anchor apparatus adjacent the distal end of the lead body and configured to secure the lead body to the ventricular septum, wherein the anchor apparatus is configured to adapt from a delivery configuration to an anchored configuration when the penetration portion of the lead body is positioned extending through the ventricular septum, wherein in the anchored configuration, the anchor apparatus contacts a left ventricular endocardial wall and resists movement of the lead in a proximal direction.

2. The lead delivery system of claim 1, further comprising a piercing apparatus configured to perforate the ventricular septum.

3. The lead delivery system of claim 1, wherein the lead further comprises a piercing element, and wherein the piercing element is adjacent the distal end of the lead body.

4. The lead delivery system of claim 1, further comprising a right bundle branch (RBB) electrode coupled to the lead body proximal to the LBB electrode and configured to pace an RBB area when the penetration portion of the lead body is positioned extending through the ventricular septum to position the distal end adjacent the left ventricular endocardium.

5. The lead delivery system of claim 1, wherein the anchor apparatus comprises at least one retaining flange positioned adjacent the distal end of the lead body, wherein the at least one retaining flange is configured to expand from a delivery configuration to an anchorconfiguration when the penetration portion of the lead body is positioned extending through the ventricular septum and the distal end of the lead body is pulled proximally.

6. The lead delivery system of claim 5, wherein the at least one retaining flange is positioned distal to the LBB electrode.

7. The lead delivery system of claim 1, further comprising a removable stylet disposed within the lead body.

8. The lead delivery system of claim 7, wherein the anchor apparatus defines a preformed geometry, and wherein the removable stylet is configured to resist the pre-formed geometry and maintain an approximately linear lead body geometry when disposed within the lead body, wherein the anchor apparatus is located distally from the penetration portion.

9. The lead delivery system of claim 1, wherein the anchor apparatus defines a preformed geometry, and wherein the pre-formed geometry comprises one or more of a hook and a bend.

10. The lead delivery system of claim 9, wherein the hook or bend is configured to contact the left ventricular endocardial wall and resist movement of the lead in a proximal direction.

11. The lead delivery system of claim 1, wherein the anchoring apparatus comprises the at least one LBB electrode.

12. The lead delivery system of claim 1, further comprising a sleeve circumferentially surrounding at least a portion of the anchor apparatus and at least a portion of the lead body adjacent the distal end, wherein the LBB electrode is configured to be disposed within the sleeve during delivery of the lead, and wherein the LBB electrode is configured to extend beyond a distal end of the sleeve when the penetration portion of the lead body is positioned extending through the ventricular septum.

13. The lead delivery system of claim 1, wherein the anchor apparatus comprises a fixation helix operably coupled to the penetration portion of the lead body and disposedaround a circumference of the lead body, wherein the LBB electrode is positioned distal to the fixation helix, and wherein rotation of the lead body fixates the fixation helix within the ventricular septum.

14. The lead delivery system of claim 1, further comprising a catheter, wherein the catheter defines a catheter lumen configured to receive the lead during delivery of the lead into and through the ventricular septum.

15. A method of perforating a ventricular septum and delivering pacing using the lead delivery system of claim 1, the method comprising: advancing the lead into a right ventricle and through a ventricular septum to position a distal end of the lead adjacent a left ventricular endocardium of the patient’s heart; securing the lead within the ventricular septum; and delivering pacing to one or more of a right bundle branch (RBB) area and a left bundle branch (LBB) area using at least one electrode of the lead.

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