Systems and methods for wireless endocardial stimulation of the left ventricular septum

Abstract

The present technology is generally directed to medical implants, such as stimulation assemblies, for stimulating the septum of a human patient's heart, and associated methods. In some embodiments, the stimulation assembly includes a body, circuitry positioned at least partially within the body, an electrode, and an anchor coupled to the body. The anchor can be secured to the septum such that the body is positioned within the left ventricle of the heart and the electrode engages tissue of the septum. The circuitry can be configured to receive acoustic energy and convert the acoustic energy into electrical energy, and the electrode can deliver the electrical energy to the tissue of the septum to stimulate the tissue.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 111,512, filed November 9, 2020, entitled "SYSTEMS AND METHODS FOR WIRELESS ENDOCARDIAL STIMULATION OF THE LEFT VENTRICULAR SEPTAL WALL," which is incorporated herein by reference in its entirety.

[0002] (Technical field) The present technology relates generally to systems for stimulating cardiac tissue, and more particularly to systems and methods for wirelessly stimulating (e.g., pacing) the left ventricular septum of a human patient. [Background technology]

[0003] The atrioventricular bundle has two branches: the left and right bundle branches, both of which lie along the interventricular septum. The left bundle branch further divides into the left anterior and left posterior bundles. These structures connect to a thin network of structures known as Purkinje fibers, which play an important role in the cardiac electrical conduction system by transmitting cardiac action potentials to the Purkinje fibers.

[0004] When a bundle branch or fascicle is damaged (e.g., by underlying heart disease, myocardial infarction, or cardiac surgery), it can cease to conduct electrical impulses properly, resulting in an altered pathway for ventricular depolarization, a condition known as bundle branch block.

[0005] Pacing to the left ventricular septum has been theoretically viewed as a way to directly stimulate the conduction system and exert a normalizing effect on ventricular depolarization. This effect may restore normal ventricular synchrony and increase cardiac pump function from diseased states. Summary of the Invention [Means for solving the problem]

[0006] The present invention provides, for example, the following items. (Item 1) 1. A stimulation assembly implantable within a patient's heart, the stimulation assembly comprising: The main body and circuitry positioned at least partially within the body and configured to receive acoustic energy from an external source and convert the acoustic energy into electrical energy; an electrode configured to receive the electrical energy; an anchor coupled to the body; Equipped with the anchor is coupled to the body and configured to (a) be positioned within a first ventricle of the heart separated from a second ventricle of the heart by a septum, and (b) engage a septum of the heart such that the electrode engages tissue of the septum; The electrode is further configured to deliver the electrical energy to the tissue of the septum. (Item 2) Item 10. The stimulation assembly of item 1, wherein the anchor has a corkscrew shape. (Item 3) Item 3. The stimulation assembly of item 2, wherein the electrode is positioned on the anchor. (Item 4) Item 4. The stimulation assembly of item 3, wherein the electrode is one of a pair of bipolar electrodes positioned on the anchor, each of the electrodes configured to receive a portion of the electrical energy and deliver the portion of the electrical energy to the tissue of the septum. (Item 5) Item 1. The stimulation assembly of item 1, wherein the first ventricle is a left ventricle of the heart, the body has a distal surface configured to be positioned adjacent the septum within the left ventricle, and the anchor comprises a needle extending from the distal surface. (Item 6) 6. The stimulation assembly of claim 5, wherein the electrode is one of a plurality of electrodes, the electrodes being positioned on the needle, each of the electrodes being configured to receive a portion of the electrical energy and deliver the portion of the electrical energy to the tissue of the septum. (Item 7) Item 6. The stimulation assembly of item 5, wherein the electrodes are positioned linearly along the needles, the needles are configured to be implanted within the tissue of the septum, and the circuitry is further configured to selectively deliver the electrical energy to targeted ones of the electrodes. (Item 8) 2. The stimulation assembly of claim 1, wherein the electrode is one of a plurality of electrodes positioned on the body, each of the electrodes configured to receive a portion of the electrical energy and deliver the portion of the electrical energy to the tissue of the septum. (Item 9) 9. The stimulation assembly of claim 8, wherein the circuitry is further configured to selectively deliver the portion of the electrical energy to the electrodes according to a selected stimulation pattern. (Item 10) Item 10. The stimulation assembly of item 1, wherein the first ventricle is a left ventricle of the heart and the second ventricle is a right ventricle of the heart. (Item 11) Item 10. The stimulation assembly of item 1, wherein the first ventricle is a right ventricle of the heart and the second ventricle is a left ventricle of the heart. (Item 12) 1. A stimulation assembly implantable within a patient's heart, the stimulation assembly comprising: The main body and circuitry positioned at least partially within the body and configured to receive acoustic energy from an external source and convert the acoustic energy into electrical energy; an electrode configured to receive the electrical energy; a plurality of tines extending from the body; Equipped with the tines are configured to move from an at least partially compressed delivery position to an expanded deployed position; In the compressed delivery position, the tines extend generally parallel to one another; In the expanded, deployed position, the tines are configured to engage a septum of the heart and secure the electrode in contact with tissue of the septum; The electrode is further configured to deliver the electrical energy to the tissue of the septum. (Item 13) Item 13. The stimulation assembly of item 12, wherein in the expanded, deployed position, the tines are configured to engage the septum such that the body is positioned within a left ventricle of the heart. (Item 14) Item 13. The stimulation assembly of item 12, wherein in the expanded, deployed position, the tines are configured to engage the septum such that the body is positioned within a right ventricle of the heart. (Item 15) Item 13. The stimulation assembly of item 12, wherein the electrode is one of a plurality of electrodes, each of the electrodes coupled to a corresponding one of the tines, and each of the electrodes configured to receive a portion of the electrical energy and deliver the portion of the electrical energy to the tissue of the septum. (Item 16) Item 16. The stimulation assembly of item 15, wherein in the expanded, deployed position, the electrode is configured to be positioned within tissue of the septum. (Item 17) Item 16. The stimulation assembly of item 15, wherein in the expanded deployed position, the electrode is configured to be positioned on a surface of the septum. (Item 18) Item 18. The stimulation assembly of item 17, wherein the surface is a right ventricular surface of the septum and the body is configured to be positioned within the left ventricle. (Item 19) Item 18. The stimulation assembly of item 17, wherein the surface is a left ventricular surface of the septum and the body is configured to be positioned within the right ventricle. (Item 20) Item 13. The stimulation assembly of item 12, wherein in the expanded, deployed position, the tines are configured to extend through the septum from a first ventricle of the heart to a second ventricle of the heart. (Item 21) Item 13. The stimulation assembly of item 12, wherein in the expanded, deployed position, the tines are configured to be embedded within the septum. (Item 22) In the compressed delivery position, the tines extend generally parallel to an axis; Item 13. The stimulation assembly of item 12, wherein in the expanded, deployed position, at least a portion of each of the tines is configured to deflect away from the axis. (Item 23) 1. A stimulation assembly implantable within a patient's heart, the stimulation assembly comprising: a body having a distal surface configured to be positioned adjacent a septum of the heart within a first chamber of the heart; circuitry positioned at least partially within the body and configured to receive acoustic energy from an external source and convert the acoustic energy into electrical energy; an electrode configured to receive the electrical energy; an elongate member extending from the distal surface and configured to extend through the septum from the first ventricle to a second ventricle of the heart; an anchor member secured to a needle within a second ventricle of the heart and configured to secure the electrode in contact with tissue of the septum; Equipped with The electrode is further configured to deliver the electrical energy to the tissue of the septum. (Item 24) 24. The stimulation assembly of claim 23, wherein the anchor member and the distal surface of the body are configured to exert a compressive force on the septum. (Item 25) 24. The stimulation assembly of claim 23, wherein the electrode is positioned on the distal surface of the body. (Item 26) 26. The stimulation assembly of claim 25, wherein the body has a longitudinal axis extending perpendicular to the distal surface, the longitudinal axis coinciding with the elongated member, and the electrodes are positioned away from the longitudinal axis. (Item 27) 24. The stimulation assembly of claim 23, wherein the electrodes are positioned on the elongated member. (Item 28) 24. The stimulation assembly of claim 23, wherein the elongated member comprises an electrode material, and the stimulation assembly further comprises an insulating coating on the electrode material, the insulating coating having an opening that defines the electrode. (Item 29) 24. The stimulation assembly of claim 23, wherein the first ventricle is a left ventricle of the heart and the second ventricle is a right ventricle of the heart. (Item 30) 24. The stimulation assembly of claim 23, wherein the first ventricle is a right ventricle of the heart and the second ventricle is a left ventricle of the heart. (Item 31) 1. A method of implanting a stimulation assembly at a target site in a septum of a patient's heart, the stimulation assembly including an elongate member and an electrode, the septum separating a first ventricle of the heart from a second ventricle of the heart, the method comprising: passing a suture through the septum adjacent to the target site from the first ventricle to the second ventricle; Attaching a first end portion of the suture to the stimulation assembly; pulling the suture to retract the stimulation assembly into the first ventricle so that the elongate member extends through the septum from the first ventricle to the second ventricle; securing an anchor member to the elongate member within the second ventricle to secure the electrode in contact with tissue of the septum; delivering electrical energy to tissue of the septum with the electrodes; A method comprising: (Item 32) 32. The method of claim 31, wherein the first ventricle is the left ventricle of the heart and the second ventricle is the right ventricle of the heart. (Item 33) 32. The method of claim 31, wherein the first ventricle is the right ventricle of the heart and the second ventricle is the left ventricle of the heart. (Item 34) 32. The method of claim 31, wherein passing the suture through the septum includes positioning a loop of the suture within the second ventricle, the method further including capturing the loop of the suture with a hook mechanism. (Item 35) 32. The method of claim 31, wherein pulling the suture comprises retracting the hook mechanism and the suture loop through a sheath. (Item 36) 32. The method of claim 31, further comprising: (a) before securing the anchor member to the elongate member and (b) after pulling the suture so that the elongate member extends through the septum, rotating the stimulation assembly to move the electrode along the septum. Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 is a schematic diagram of a tissue stimulation system in accordance with an embodiment of the present technology.

[0008] [Figure 2]FIG. 2 is a side view of a pair of receiver-stimulator devices secured to the septum and the left ventricle of a patient's heart in accordance with an embodiment of the present technology.

[0009] [Figure 3] 3A and 3B are side and cross-sectional views, respectively, of a receiver-stimulator device secured to the septum within the left ventricle in accordance with an embodiment of the present technology.

[0010] [Figure 4] FIG. 4 is a side view of a receiver-stimulator device positioned within the left ventricle in accordance with an embodiment of the present technology.

[0011] [Figure 5] FIG. 5A is an isometric view of a receiver-stimulator device secured to the septum within the left ventricle in accordance with an embodiment of the present technology, and FIG. 5B is a side view of the receiver-stimulator device.

[0012] [Figure 6] FIG. 6A is a side view of a receiver-stimulator device secured to the septum in accordance with an embodiment of the present technology, and FIG. 6B is a front view of the receiver-stimulator device from inside the right ventricle.

[0013] [Figure 7] FIG. 7A is a side view of a receiver-stimulator device secured to the septum in accordance with an embodiment of the present technology, and FIG. 7B is a front view of the receiver-stimulator device from inside the right ventricle.

[0014] [Figure 8] FIG. 8A is a side view of a receiver-stimulator fixed to the septum in accordance with an embodiment of the present technology, and FIG. 8B is a front view from the inside of a right ventricular receiver-stimulator.

[0015] [Figure 9] FIG. 9 is a side view of a receiver-stimulator device secured to a bulkhead in accordance with an embodiment of the present technology.

[0016] [Figure 10]FIG. 10 is a side view of a receiver-stimulator device secured to a bulkhead in accordance with an embodiment of the present technology.

[0017] [Figure 11A] FIG. 11A is a side view of a distal portion of a delivery system configured to implant a receiver-stimulator device in a patient's heart according to an embodiment of the present technology, and FIG. 11B is an enlarged side view of the distal portion of delivery system 11A according to an embodiment of the present technology. [Figure 11B] FIG. 11A is a side view of a distal portion of a delivery system configured to implant a receiver-stimulator device in a patient's heart according to an embodiment of the present technology, and FIG. 11B is an enlarged side view of the distal portion of delivery system 11A according to an embodiment of the present technology.

[0018] [Figure 12] FIG. 12 is a side view of a distal portion of a delivery system configured to implant a receiver-stimulator device within a patient's heart in accordance with an embodiment of the present technology.

[0019] [Figure 13] FIG. 13 is a side view of a portion of a delivery system configured to implant a receiver-stimulator device within a patient's heart in accordance with an embodiment of the present technology.

[0020] [Figure 14] FIG. 14 is a side view of a portion of a delivery system configured to implant the receiver-stimulator device of FIG. 13 within a patient's heart in accordance with an embodiment of the present technology.

[0021] [Figure 15-1] 15A-15I and 15K are side views of the distal portion of a delivery system during different stages of a procedure for implanting a receiver-stimulator according to an embodiment of the present technology within the septum of a patient's heart, and FIG. 15J is a rear view from inside the left ventricle of a receiver-stimulator implanted in the septum according to an embodiment of the present technology. [Figure 15-2]15A-15I and 15K are side views of the distal portion of a delivery system during different stages of a procedure for implanting a receiver-stimulator according to an embodiment of the present technology within the septum of a patient's heart, and FIG. 15J is a rear view from inside the left ventricle of a receiver-stimulator implanted in the septum according to an embodiment of the present technology. [Figure 15-3] 15A-15I and 15K are side views of the distal portion of a delivery system during different stages of a procedure for implanting a receiver-stimulator according to an embodiment of the present technology within the septum of a patient's heart, and FIG. 15J is a rear view from inside the left ventricle of a receiver-stimulator implanted in the septum according to an embodiment of the present technology. [Figure 15-4] 15A-15I and 15K are side views of the distal portion of a delivery system during different stages of a procedure for implanting a receiver-stimulator according to an embodiment of the present technology within the septum of a patient's heart, and FIG. 15J is a rear view from inside the left ventricle of a receiver-stimulator implanted in the septum according to an embodiment of the present technology. [Figure 15-5] 15A-15I and 15K are side views of the distal portion of a delivery system during different stages of a procedure for implanting a receiver-stimulator according to an embodiment of the present technology within the septum of a patient's heart, and FIG. 15J is a rear view from inside the left ventricle of a receiver-stimulator implanted in the septum according to an embodiment of the present technology. [Figure 15-6] 15A-15I and 15K are side views of the distal portion of a delivery system during different stages of a procedure for implanting a receiver-stimulator according to an embodiment of the present technology within the septum of a patient's heart, and FIG. 15J is a rear view from inside the left ventricle of a receiver-stimulator implanted in the septum according to an embodiment of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0022] Aspects of the present disclosure are directed to systems and methods for implanting a stimulation assembly (which may be referred to as a receiver-stimulator, stimulation electrode, pacing electrode, etc.) at, within, and / or adjacent to a cardiac septum (e.g., a left ventricular (LV) septum) of a patient, such as a human patient. In some of the embodiments described below, for example, the stimulation assembly includes a body, circuitry positioned at least partially within the body, an electrode, and an anchor coupled to the body. The anchor can be secured to the septum such that the body is positioned within the left ventricle of the heart and the electrode engages tissue of the septum. The circuitry can be configured to (i) receive acoustic energy from a remote wireless controller-transmitter and (ii) convert the acoustic energy into electrical energy. The electrode can deliver electrical energy to tissue of the septum to stimulate the tissue.

[0023] In some embodiments, the anchor can be secured to the septum by rotating the anchor. In other embodiments, the anchor can be secured to the septum by a push-to-seat method or a pull-back-to-deploy-and-push-to-seat method. The electrode can comprise one or more electrodes, and in some embodiments, can be bipolar, tripolar, or quadripolar, and can comprise an electrode array adapted to the spatial characteristics of a particular septal pacing application. In some embodiments, the stimulation assembly includes programmable parameters for the electrode array, including, for example, vectors, locations, and / or timing sequences configured to effectively stimulate the left bundle branch, the atrioventricular bundle, and / or other regions of the cardiac conduction system.

[0024] In some embodiments, a delivery system for delivering a stimulation assembly according to the present technology can be configured to accommodate a tight maneuver required to access the conductive structures of the LV septum via an endovascular approach (e.g., an endovascular approach involving a puncture in the septum between the right and left atria through the left atrium and across the mitral valve). For example, the delivery system can include a delivery sheath or catheter that includes a gland or other rotatable component that allows rotation of the distal end of the delivery sheath relative to the septum, facilitating placement of the stimulation assembly in the septum. Similarly, the delivery system can facilitate delivery of the stimulation assembly through the aortic valve from an arterial approach.

[0025] Specific details of some embodiments of the present technology are described herein with reference to FIGURES 1-15K. However, the technology can be practiced without some of these specific details. In some instances, well-known structures and techniques often associated with leadless tissue stimulation systems, cardiac pacing, electronic circuitry, acoustic and radiofrequency transmission and reception, delivery systems and catheters, etc., are not shown in detail so as not to obscure the technology. Furthermore, while many of the embodiments are described below with reference to systems and methods for left ventricular (LV) septal cardiac pacing, other applications and embodiments are within the scope of the technology in addition to those described herein. For example, one skilled in the art will understand that one or more aspects of the present technology are applicable to other implantable devices configured to treat other areas of the human body.

[0026] The terminology used in the description provided below is intended to be interpreted in its broadest reasonable manner, even when used in conjunction with a detailed description of certain specific embodiments of the present disclosure. Certain terms may be further emphasized below; however, any terminology intended to be interpreted in any restrictive manner will be clearly and specifically defined as such in the Detailed Description section.

[0027] The accompanying drawings depict embodiments of the present technology and are not intended to limit its scope. The sizes of various depicted elements are not necessarily drawn to scale, and these various elements may be arbitrarily enlarged to improve legibility. Details of components may be summarized in the drawings when such details are unnecessary for a complete understanding of how to make and use the technology, and details such as the location of components and certain precise connections between such components may be omitted. Many of the details, dimensions, angles, and other features shown in the figures are merely illustrative of particular embodiments of the present disclosure. Thus, other embodiments may have other details, dimensions, angles, and features without departing from the spirit or scope of the present technology.

[0028] With respect to the terms "distal" and "proximal" within this description, unless otherwise specified, the terms may refer to the relative position of portions of a catheter subsystem with reference to an operator and / or location within the vasculature. As used herein, the designations "rearward," "forward," "upward," "downward," etc. are not meant to limit the referenced components to a particular orientation. Such designations refer to the orientation of the referenced components as illustrated in the drawings, and it should be understood that the systems of the present technology can be used in any orientation suitable for the user.

[0029] The headings provided herein are for convenience only and should not be construed as limiting the disclosed subject matter. To the extent that any material incorporated by reference herein does not contradict this disclosure, the present disclosure shall control.

[0030] I. SELECTED EMBODIMENTS OF THE TISSUE STIMULATION SYSTEM FIG. 1 is a schematic diagram of a tissue stimulation system 100 (“system 100”) in accordance with an embodiment of the present technology. In the illustrated embodiment, system 100 is configured to stimulate a heart 102 within a human patient's body 104. System 100 can include one or more receiver-stimulators 110 (shown in FIG. 1 , which may also be referred to as a stimulator, stimulation assembly, ultrasound receiver, stimulation-generating electrode, stimulation electrode, pacing electrode, acoustic receiver, etc.) in operative communication (e.g., wireless and / or wireless communication) with a controller-transmitter 120 (which may also be referred to as an ultrasound transmitter, pulse generator, acoustic transmitter, etc.). Controller-transmitter 120 can include a battery module 122 and a transmitter module 124 operatively coupled to and powered by battery module 122. In some embodiments, both receiver-stimulator 110 and controller-transmitter 120 are configured to be implanted within the human patient's body 104. For example, the receiver-stimulator 110 can be implanted in and / or adjacent to the heart 102 (e.g., in the left ventricle, right ventricle, or adjacent area) to deliver stimulation pulses to the heart 102, while the controller-transmitter 120 can be positioned elsewhere remote from the heart 102 (e.g., in the thoracic area). In a particular embodiment, the receiver-stimulator 110 is positioned within the left ventricle and configured to stimulate endocardial tissue of the septum. The transmitter module 124 of the controller-transmitter 120 can direct energy (e.g., acoustic energy, ultrasonic energy) toward the receiver-stimulator 110, which can receive the energy and deliver one or more electrical pulses (e.g., stimulation pulses, pacing pulses) to the heart 102.

[0031] In some embodiments, the system 100 can further include a programmer 130 in operative communication with the controller-transmitter 120. The programmer 130 can be positioned outside the body 104 and can be operable to program various parameters of the controller-transmitter 120 and / or receive diagnostic information from the controller-transmitter 120. In some embodiments, the system 100 further includes a co-implanted device 132 (e.g., an implantable cardioverter-defibrillator (ICD) or pacemaker) coupled to a pacing lead 134 for delivering stimulation pulses to one or more portions of the heart 102 other than the area stimulated by the receiver-stimulator 110. In other embodiments, the co-implanted device 132 can be a leadless pacemaker, which is implanted directly into the heart 102, eliminating the need for a separate pacing lead 134. The co-implanted device 132 and the controller-transmitter 120 can work in conjunction to deliver stimulation signals to the heart 102 and induce synchronized heartbeats. In some embodiments, the controller-transmitter 120 receives signals (e.g., electrocardiogram signals) from the heart 102 and determines information related to the heart 102, such as heart rate, heart rhythm, etc. (including the output of pacing leads 134 located within the heart 102). In some embodiments, the controller-transmitter 120 alternatively or additionally receives information (e.g., diagnostic signals) from the receiver-stimulator 110. The received signals can be used to adjust the ultrasound energy signals delivered to the receiver-stimulator 110.

[0032] The receiver-stimulator 110, controller-transmitter 120, and / or programmer 130 may include machine-readable (e.g., computer-readable) or controller-readable media containing instructions for generating, transmitting, and / or receiving suitable signals (e.g., stimulation signals, diagnostic signals). The receiver-stimulator 110, controller-transmitter 120, and / or programmer 130 may include one or more processors, memory units, and / or input / output devices. Thus, the process of providing stimulation signals and / or performing other associated functions may be implemented by computer-executable instructions contained thereon or in computer-readable media located on the receiver-stimulator 110, controller-transmitter 120, and / or programmer 130. Additionally, the receiver-stimulator 110, controller-transmitter 120, and / or programmer 130 may include dedicated hardware, firmware, and / or software for executing computer-executable instructions that, when executed, implement any one or more methods, processes, and / or subprocesses described herein. Dedicated hardware, firmware, and / or software may also act as the "means" for implementing the methods, processes, and / or sub-processes described herein.

[0033] In some embodiments, the system 100 can include some features similar to or the same as those of the leadless tissue stimulation systems generally disclosed in (i) U.S. Patent No. 7,610,092, filed December 21, 2005, and entitled "LEADLESS TISSUE STIMULATION SYSTEMS AND METHODS," (ii) U.S. Patent No. 8,315,701, filed September 4, 2009, and entitled "LEADLESS TISSUE STIMULATION SYSTEMS AND METHODS," and / or (iii) U.S. Patent No. 8,718,773, filed May 23, 2007, and entitled "OPTIMIZING ENERGY TRANSMISSION IN A LEADLESS TISSUE STIMULATION SYSTEM."

[0034] II. SELECTED EMBODIMENTS OF THE RECEIVER-STIMULATOR 2-10 illustrate various receiver-stimulators configured in accordance with embodiments of the present technology. The receiver-stimulators can operate within the environment of FIG. 1 and, in some embodiments, can be implantable within the left ventricle and / or configured to stimulate the septum of a human heart. For example, the receiver-stimulator can be implanted in the heart 102, receive acoustic energy (e.g., ultrasound energy) from the controller-transmitter 120, and deliver one or more electrical pulses to the heart 102 based on the received acoustic energy. The various receiver-stimulators shown and described in detail with reference to FIGS. 2-10 can include some features that are, at least generally, similar or identical in structure and function to each other. In some embodiments, aspects of various embodiments can be combined. In some embodiments, similar or identical elements are identified by reference numbers having the same last two digits. For example, elements 210 and 310 can include some features that are, at least generally, similar or identical in structure and function to each other.

[0035] 2 is a side view of a pair of receiver-stimulators 210 (individually identified as a first receiver-stimulator 210a and a second receiver-stimulator 210b) secured to the septum SW of a patient's heart and within the left ventricle LV of the heart in accordance with an embodiment of the present technology. The septum SW separates the left ventricle LV from the right ventricle RV of the heart. In the illustrated embodiment, the receiver-stimulators 210 are identical and each include a body 212 and an anchor 214 extending from the body 212. In some embodiments, each of the bodies 212 has a generally cylindrical shape, although in other embodiments, the body 212 can have other shapes (e.g., including rectangular, square, polygonal, rectilinear, irregular, and / or other cross-sectional shapes). Each of the anchors 214 extends into the septum SW and can secure the receiver-stimulator 210 thereto, and each can support one or more electrodes 216 (such as a pair of bipolar pacing electrodes). In some embodiments, each of the anchors 214 has a corkscrew-like shape. As described in detail above with reference to FIG. 1, each of the receiver-stimulators 210 can include circuitry positioned within the body 212, the circuitry configured to (i) receive energy (e.g., directed acoustic energy) from the controller-transmitter 120 (FIG. 1), (ii) convert the energy to electrical energy, and (iii) output the electrical energy via the electrodes 216 to stimulate tissue of the septum SW adjacent the electrodes 216.

[0036] In some embodiments, the receiver-stimulator 210 may be any device disclosed in any of the following: (i) U.S. Patent No. 7,848,815, filed September 4, 2009, entitled "IMPLANTABLE TRANSDUCER DEVICES," (ii) U.S. Patent No. 7,606,621, filed December 21, 2005, entitled "IMPLANTABLE TRANSDUCER DEVICES," (iii) U.S. Patent No. 7,610,092, filed December 21, 2005, entitled "LEADLESS TISSUE STIMULATION SYSTEMS AND METHODS," (iv) U.S. Patent No. 9,616,237, filed September 30, 2013, entitled "SYSTEMS, DEVICES, AND METHODS FOR SELECTIVELY LOCATING IMPLANTABLE DEVICES," (v) U.S. Patent No. 9,616,237, filed October 15, 2015, entitled "METHOD OF MANUFACTURING IMPLANTABLE DEVICES," (vi) U.S. Patent No. 9,616,237, filed October 15, 2015, entitled "METHOD OF MANUFACTURING IMPLANTABLE DEVICES," (vii) U.S. Patent No. 9,616,237, filed October 15, 2015, entitled "METHOD OF MANUFACTURING IMPLANTABLE DEVICES," (vii) U.S. Patent No. 9,616,237, filed December ... No. 9,343,654, entitled "WIRELESS ACOUSTIC STIMULATORS WITH HIGH ENERGY CONVERSION EFFICIENCIES," and / or (vi) U.S. Pat. No. 9,283,392, filed September 24, 2010, entitled "TEMPORARY ELECTRODE CONNECTION FOR WIRELESS PACING SYSTEMS," each of which is incorporated herein by reference in its entirety.

[0037] Various conducting cardiac structures (such as the atrioventricular bundle, left bundle branch, right bundle branch, etc.) can extend through the septum SW. In some embodiments, one of the receiver-stimulators 210 (e.g., a first receiver-stimulator 210a) can be positioned near the atrioventricular bundle, and another of the receiver-stimulators 210 (e.g., a second receiver-stimulator 210b) can be positioned below the first receiver-stimulator 210a, near the left bundle branch. Alternatively, additional receiver-stimulators 210 (not shown) can also be positioned within the region. In some aspects of the present technology, the receiver-stimulator 210 can be relatively smaller and have a lower pacing output than some known receiver-stimulators because the pacing stimulation is delivered in close proximity to the targeted conducting structure (e.g., the atrioventricular bundle, left bundle branch) and therefore does not require as much energy as elsewhere in the heart.

[0038] In some embodiments, each of the receiver-stimulators 210 can have a different operating code and can be uniquely addressed by a controller-transmitter (e.g., controller-transmitter 120 of FIG. 1). Thus, the receiver-stimulators 210 can operate to pace the septum SW of the left ventricle LV simultaneously, one at a time, and / or in a staggered fashion (e.g., separated by a programmable delay). For example, the pacing output for the two receiver-stimulators 210 shown in FIG. 2 can be programmed for (i) only a single pacing output (e.g., by the first receiver-stimulator 210a positioned near the atrioventricular bundle), (ii) simultaneous pacing output by both receiver-stimulators 210, and / or (iii) a first pacing output by the first receiver-stimulator 210a (e.g., positioned nearest the atrioventricular bundle) followed by a second pacing output after a programmable time delay by the second receiver-stimulator 210b (e.g., positioned nearest the left bundle branch). Although two receiver-stimulators 210 are shown in FIG. 2, any number of unique receiver-stimulators can be used together as a multi-receiver-stimulator system. In some embodiments, the pacing output from the receiver-stimulator 210 includes neuromodulation pulses to stimulate neural structures within the septal SW. In some embodiments, the neuromodulation pulses have a pulse width of 100 microseconds and / or an amplitude of 1 to 1.5 volts.

[0039] In some embodiments, the receiver-stimulators 210 are delivered to the septum SW using a delivery catheter inserted through a curved sheath. For example, the receiver-stimulators 210 can be delivered to the septum SW using any of the delivery systems described in detail below with reference to FIGS. 11A-15K, e.g., and more specifically, FIGS. 11A-12. In some embodiments, the anchors 214 for each of the receiver-stimulators 210 are secured within the septum SW by rotating the associated delivery catheter and "twisting" the anchors 214 into the septum SW. In other embodiments, the anchors 214 for each of the receiver-stimulators 210 are secured within the septum SW by a push-to-settling method or a pull-back-to-deploy-to-settling method.

[0040] 3A and 3B are side and cross-sectional views, respectively, of a receiver-stimulator 310 secured to the septum SW within the left ventricle LV in accordance with an embodiment of the present technology. Referring to FIG. 3A, in the illustrated embodiment, the receiver-stimulator 310 includes a body 312 having multiple electrodes 316 attached thereto and / or integrally formed therein. The receiver-stimulator 310 may further include multiple anchors 314 (e.g., individually identified as proximal anchor 314a and distal anchor 314b) that may be inserted at least partially into the septum SW and secure the electrodes 316 in contact with the septum SW. In the illustrated embodiment, the anchors 314 do not include electrodes thereon, although in other embodiments, the anchors 314 may include electrodes thereon.

[0041] The receiver-stimulator 310 can include circuitry configured to (i) receive energy (e.g., directed acoustic energy) from the controller-transmitter 120 (FIG. 1), (ii) convert the energy to electrical energy, and (iii) output the electrical energy via electrodes 316 to stimulate tissue of the septum SW adjacent to the electrodes 316. In some embodiments, the electrodes 316 form a tetrapolar electrode array (e.g., a single linear tetrapolar electrode array) in contact with the septum SW. Referring to FIG. 3B, in some embodiments, the receiver-stimulator 310 has a circular cross-sectional shape and is formed from an electrode material. The receiver-stimulator 310 can include a masking or coating 311 overlying the electrode material, the masking or coating 311 including an opening that defines the electrode 316. The coating 311 can be non-conductive (e.g., formed from an electrically insulating material), such that the electrode 316 is exposed only adjacent to the septum SW to provide a direct stimulation path into the septum SW. For example, coating 311 can comprise a polymer (e.g., parylene) and can be positioned around approximately 270 degrees of the circumference of electrode 316. In some aspects of the present technology, coating 311 can help ensure that the majority of the pacing electrical energy is delivered into the septum SW where electrode 316 contacts the septum SW.

[0042] In some embodiments, the receiver-stimulator 310 has a programmable electrode configuration to provide several combinations of pacing vectors, for example, along the septum SW. For example, the electrodes 316 can be spatially programmable in the same or similar manner as the electrodes 216 described in detail above with reference to FIG. 2. Many programming combinations are possible, and in some embodiments, timing delays can also be programmed. The receiver-stimulator 310 can include an application-specific integrated circuit (ASIC) configured to enable this programmability.

[0043] In some embodiments, the receiver-stimulator 310 is delivered to the septum SW using a delivery catheter such that the distal anchor 314b is inserted into the septum SW first. Then, with some lateral movement from the delivery catheter, the catheter can insert the proximal anchor 314a into the septum SW to secure the receiver-stimulator 310 in place. In some aspects of the present technology, this anchoring technique and placement of the electrodes 316 allows the receiver-stimulator 310 to be positioned in a parallel orientation relative to the septum SW rather than the vertical orientation shown in FIG. 3A .

[0044] 4 is a side view of a receiver-stimulator 410 positioned within the left ventricle LV in accordance with an embodiment of the present technology. In the illustrated embodiment, the receiver-stimulator includes a body 412 and a plurality of elongated legs 418 (individually identified as first through third legs 418a-c, respectively) extending from the body 412. The receiver-stimulator 410 may further include a plurality of electrodes 416 (including individually identified first and second electrodes 416a-b) supported by the legs 418. For example, in the illustrated embodiment, the first leg 418a supports the first electrode 416a, and the second leg 418b supports the second electrode 416b. The electrodes 416 can be a unipolar or bipolar electrode set. The legs 418 can be extendable from a compressed delivery position (shown in phantom in FIG. 4) to an expanded, deployed position shown in FIG. 4, in which the legs 418 form a tripod. In some embodiments, the receiver-stimulator 410 includes a spring mechanism 419 (e.g., that can be pushed and / or pulled by an associated delivery system) that is actuable to allow the legs 418 to expand to the deployed position. In some embodiments, the legs 418 can be deployed from the compressed delivery position to the expanded, deployed position by another actuation mechanism on the delivery catheter used to deliver the receiver-stimulator 410 to the left ventricle LV.

[0045] In the deployed position, the distal portions of the legs 418 contact the wall of the left ventricle LV, (i) securing the receiver-stimulator 410 in place within the left ventricle LV, and (ii) placing the electrode 416 in contact with the septum SW. More specifically, the first and second legs 418a-b (e.g., active electrode legs) can drive the electrode 416 into contact with the septum SW, while the third leg 418 (e.g., stabilizing leg) contacts the wall opposite the septum SW (e.g., the lateral free wall of the left ventricle LV) to provide stabilization. The legs 418 can be secured to the respective walls of the left ventricle LV by outward spring force and / or by one or more anchoring mechanisms (not shown). The electrodes 416 can have a programmable electrode configuration, as described in detail above.

[0046] FIG. 5A is an isometric view of a receiver-stimulator 510 secured to the septum SW in the left ventricle LV in accordance with an embodiment of the present technology, and FIG. 5B is a side view of the receiver-stimulator 510. Referring to FIGS. 5A and 5B, in the illustrated embodiment, the receiver-stimulator 510 includes a body 512 and an elongated member or needle 540 extending from the body 512. The needle 540 can have a pointed tip 541 configured to penetrate the septum SW. In the illustrated embodiment, the needle 540 supports one or more electrodes 516 and one or more anchors 514. In some embodiments, the body 512 can be positioned in either the left ventricle LV or the right ventricle RV, and the needle 540 can penetrate the septum SW. That is, the receiver-stimulator 510 can be delivered through either the right ventricle RV or the left ventricle LV. The anchors 514 can be barbs, tines, hooks, and / or other members that extend away from the needles 540 and are configured (e.g., shaped and sized) to secure the needles 540 within the septum SW. In some embodiments, the body 512 includes a proximal surface 513a spaced from the septum SW and an opposite distal surface 513b adjacent the septum SW. The needles 540 can extend from the distal surface 513b, and the proximal surface 513a can support a non-contact electrode 542. In some embodiments, the electrodes 516 on the needles 540 are pacing cathode electrodes, and the non-contact electrode 542 is an anode that can be in electrical communication with one or more of the pacing cathode electrodes 516. In some embodiments, the needles 540 can have a variable length that allows more or fewer of the electrodes 516 to be selectively positioned within the septum SW to provide a desired stimulation pattern. In some embodiments, energy can be selectively applied to electrodes 516 to provide stimulation at different depths within the septum SW.

[0047] FIG. 6A is a side view of a receiver-stimulator 610 secured to the septum SW in accordance with an embodiment of the present technology, and FIG. 6B is a front view (e.g., facing proximally) of the receiver-stimulator 610 from inside the right ventricle RV. In the illustrated embodiment, the receiver-stimulator 610 includes a body 612 and a transseptal anchoring system comprising a plurality of tines 644 (e.g., bendable members, anchors, fixation members), each supporting a corresponding one of a plurality of electrodes 616 at its distal portion. The tines 644 can extend from the body 612 in the left ventricle LV through the septum SW into the right ventricle RV. In the right ventricle RV, the tines 644 can bend parallel to the septum SW and / or curve back toward the septum SW to (i) secure the electrode 616 in contact with the surface of the septum SW within the right ventricle RV and (ii) secure the receiver-stimulator 610 relative to the septum SW. In other embodiments, the body 612 of the receiver-stimulator 610 can be positioned within the right ventricle RV, and the tines 644 can extend through the septum SW into the left ventricle LV to secure the electrode 616 in contact with the surface of the septum SW within the left ventricle LV.

[0048] 6B , in some embodiments, the receiver-stimulator 610 includes four of the tines 644 configured to be deployed at 90 degrees relative to one another. In other embodiments, the receiver-stimulator 610 can include more or fewer of the tines 644, and / or individual ones of the tines 644 can include more or fewer of the electrodes 616. The electrodes 616 can be programmed to provide a desired pacing pattern to the septum SW. For example, the pacing power and timing of each of the electrodes 616 can be individually controllable.

[0049] In some embodiments, the receiver-stimulator 610 can be delivered through either the right ventricle RV or the left ventricle LV in a compressed configuration in which the tines 644 are oriented generally parallel to each other and to a common axis. In some embodiments, the tines 644 are formed or otherwise configured from a shape memory material to deflect outward from the compressed delivery configuration to the deployed configuration shown in FIGS. 6A and 6B. More specifically, in the deployed configuration, at least a portion (e.g., a distal portion) of each of the tines 644 can be configured to deflect away from the common axis and toward a surface of the septum SW. In some embodiments, the receiver-stimulator 610 can be delivered using any of the delivery systems and / or methods described in detail below with reference to FIGS. 11A-15K, e.g., more specifically, FIGS. 13 and 14.

[0050] 7A is a side view of a receiver-stimulator 710 anchored to the septum SW in accordance with an embodiment of the present technology, and FIG. 7B is a front view (e.g., facing proximally) of the receiver-stimulator 710 from inside the right ventricle RV. In the illustrated embodiment, the receiver-stimulator 710 includes a body 712, a needle 740 extending from the body 712, and an anchoring system including multiple tines or anchors 714 extending from the needle 740. Each of the anchors 714 can support a corresponding one of multiple electrodes 716. In some embodiments, the anchors 714 extend into the septum SW to (i) contact and secure the electrode 716 within the septum SW, and (ii) secure the receiver-stimulator 710 relative to the septum SW. In the illustrated embodiment, the body 712 is positioned within the left ventricle LV, and the needle 740 and a portion of the anchor 714 extend completely through the septum SW into the right ventricle RV. In other embodiments, the receiver-stimulator 710 can be positioned in an inverted fashion with the body 712 within the right ventricle RV, and / or the needle 740 and anchor 714 need not traverse the entire septum SW (e.g., can be positioned completely within the septum SW).

[0051] 7B , in some embodiments, the receiver-stimulator 710 includes four of the anchors 714 configured to be deployed at 90 degrees relative to one another. In other embodiments, the receiver-stimulator 710 can include more or fewer of the anchors 714, and / or individual ones of the anchors 714 can include more or fewer of the electrodes 716. The electrodes 716 can be programmed to provide a desired pacing pattern output to the septum SW. For example, the pacing output and timing of each of the electrodes 716 can be individually controllable.

[0052] In some embodiments, the receiver-stimulator 710 can be delivered through either the right ventricle RV or the left ventricle LV in a compressed configuration in which the anchors 714 are oriented generally parallel to one another. In some embodiments, the anchors 714 are formed or otherwise configured from a shape memory material so as to bias outward from the compressed delivery configuration to the deployed configuration shown in FIGS. 7A and 7B. In some embodiments, the receiver-stimulator 710 can be delivered using any of the delivery systems and / or methods described in detail below with reference to FIGS. 11A-15K, e.g., and more specifically, FIGS. 13 and 14.

[0053] 8A is a side view of a receiver-stimulator 810 anchored to the septum SW in accordance with an embodiment of the present technology, and FIG. 8B is a front view (e.g., facing proximally) of the receiver-stimulator 810 from inside the right ventricle RV. In the illustrated embodiment, the receiver-stimulator 810 includes a body 812 and an anchoring system including a plurality of tines 844 and anchors 814 extending from the body 812. Each of the anchors 814 can support a corresponding one of a plurality of electrodes 816. In other embodiments, the tines 844 (e.g., a distal portion of the tines 844) can alternatively or additionally support a corresponding one of the electrodes 816.

[0054] The tines 844 can extend from the body 812 in the left ventricle LV through the septum SW into the right ventricle RV. In the right ventricle RV, the tines 844 can be parallel to the septum SW and / or curve back toward the septum SW to help secure the receiver-stimulator 810 relative to the septum SW. The anchors 814 can extend into the septum SW to (i) contact and secure the electrodes 816 within the septum SW and (ii) help secure the receiver-stimulator 810 relative to the septum SW. In other embodiments, the receiver-stimulator 810 can be positioned in an inverted manner, with the body 812 in the right ventricle RV, such that the tines 844 extend from the right ventricle RV through the septum SW into the left ventricle LV.

[0055] 8B , in some embodiments, the receiver-stimulator 810 includes four of the anchors 814 configured to be deployed at 90 degrees relative to each other and four of the tines 844 configured to be deployed at 90 degrees relative to each other. The anchors 814 can further be interspersed / alternated among the tines 844 (e.g., offset 45 degrees relative to each other). In other embodiments, the receiver-stimulator 810 can include more or fewer anchors 814 and / or tines 844, and / or the anchors 814 and tines 844 can be positioned differently relative to each other. In some embodiments, the receiver-stimulator 810 can be delivered through either the right ventricle RV or the left ventricle LV in a compressed configuration in which the anchors 814 and tines 844 are oriented generally parallel to each other and to a common axis. In some embodiments, anchor 814 and tines 844 are formed or otherwise configured from a shape memory material so as to bias outward (e.g., away from a common axis) from a compressed delivery configuration to the deployed configuration shown in Figures 8A and 8B. In some embodiments, receiver-stimulator device 810 can be delivered using any of the delivery systems and / or methods described in detail below with reference to Figures 11A-15K, e.g., and more specifically, Figures 13 and 14.

[0056] 9 is a side view of a receiver-stimulator 910 secured to a septum SW in accordance with an embodiment of the present technology. In the illustrated embodiment, the receiver-stimulator 910 includes a body 912 and an elongate member or needle 940 extending from the body 912. The body 912 includes a proximal surface 913a spaced from the septum SW and a distal surface 913b adjacent the opposite septum SW. The needle 940 can extend from the distal surface 913b, and the receiver-stimulator 910 can include an electrode mounted to the distal surface 913b. In some embodiments, the electrode 916 is eccentrically mounted to the distal surface 913b such that rotation of the receiver-stimulator 910 changes the position of the electrode 916 along the septum SW (e.g., to provide adjustment after anchoring). That is, for example, body 912 can include a longitudinal axis extending perpendicular to distal surface 913b and coincident with needle 940, and electrode 916 can be positioned on distal surface 913b offset from (e.g., away from) the longitudinal axis. In some embodiments, electrode 916 is a cathodic pacing electrode. In some embodiments, electrode 916 is separated from needle 940 and / or anchor member 946, for example, to provide a minimal fibrous cap and a low pacing threshold.

[0057] In some embodiments, the body 912 is positioned within the left ventricle LV, and the needle 940 extends from the left ventricle LV through the septum SW and into the right ventricle RV. In the illustrated embodiment, the receiver-stimulator 910 is positioned within the right ventricle RV and further includes an anchor member 946, such as a bushing, secured to the needle 940 (e.g., at a distal portion of the needle 940). In some embodiments, the needle 940 can be threaded, and the anchor member 946 can include corresponding threads such that the anchor member 946 can be threadably attached onto the needle 940. The anchor member 946 can (i) secure the electrode 916 in contact with a surface of the septum SW (e.g., by pulling the electrode 916 toward the septum SW) and (ii) secure the receiver-stimulator 910 relative to the septum SW. Thus, in some aspects of the present technology, the receiver-stimulator 910 is firmly attached to the septum SW by compression rather than stretching of the septum SW. In other embodiments, the receiver-stimulator device 910 can be positioned in an inverted fashion, with the body 912 in the right ventricle RV and the anchor member 946 in the left ventricle LV.

[0058] In some embodiments, the body 912 and needle 940 are delivered through the septum SW into the left ventricle LV, and then the anchor member 946 is delivered into the right ventricle RV and secured to the needle 940. In some embodiments, the receiver-stimulator device 910 can be delivered using any of the delivery systems and / or methods described in detail below with reference to Figures 11A-15K, e.g., and more particularly, Figures 15A-15K.

[0059] FIG. 10 is a side view of a receiver-stimulator 1010 anchored to the septum SW of the left ventricle LV in accordance with an embodiment of the present technology. In the illustrated embodiment, the receiver-stimulator 1010 generally includes several features similar to those of the receiver-stimulator 910 described in detail above with reference to FIG. 9 , such as a body 1012, a needle 1040, and an anchor member 1046. However, in the illustrated embodiment, the body 1012 is positioned within the right ventricle RV, the anchor member 1046 is positioned within the left ventricle LV, and the needle 1040 includes the electrode 1016 (e.g., rather than the body 1012 including a separate electrode mounted thereto). The electrode 1016 can be positioned along the needle 1040 such that the receiver-stimulator 1010, when implanted as shown in FIG. 10 , is positioned proximate to the left ventricle LV (e.g., on and / or proximate to the surface of the septum SW within the left ventricle LV). In some embodiments, the needle 1040 can comprise an electrode material and can be coated with an insulating material 1011 with an opening that defines the electrode 1016 .

[0060] III. SELECTED EMBODIMENTS OF DELIVERY SYSTEMS, COMPONENTS, AND METHODS 11A-15K illustrate various delivery systems and associated methods for implanting one or more receiver-stimulator devices to stimulate, for example, the left ventricular septum, according to embodiments of the present technology. The delivery systems can be used to deliver one or more of the receiver-stimulator devices described in detail above with reference to FIGS. 2-10. The various receiver-stimulator devices shown and described in detail with reference to FIGS. 11A-15K can include some features that are at least generally similar in structure and function or identical in structure and function relative to each other. In some embodiments, aspects of various embodiments can be combined. In some embodiments, similar or identical elements are identified by reference numbers having the same last two digits. For example, elements 1150 and 1250 can include some features that are at least generally similar in structure and function or identical in structure and function relative to each other.

[0061] 11A is a side view of a distal portion of a delivery system 1150 configured to implant a receiver-stimulator device within a patient's heart in accordance with an embodiment of the present technology. FIG. 11B is an enlarged side view of a distal portion of the delivery system 1150 in accordance with an embodiment of the present technology. Referring to FIGS. 11A and 11B, in the illustrated embodiment, the delivery system 1150 includes an elongate sheath 1152 (which may also be referred to as a first catheter or first elongate member) defining a lumen 1149 and having a proximal segment or portion 1154 that is rotatably coupled to a distal segment or portion 1156 by a rotatable coupling 1155. A delivery catheter 1158 (not visible in FIG. 11A, which may also be referred to as a second elongate sheath or second elongate member) can be advanceable through the lumen 1149 of the sheath 1152. In some embodiments, a receiver-stimulator, such as one or more of the receiver-stimulators described in detail above with reference to Figures 2-10, can be coupled to and / or advanced through a delivery catheter 1158 for implantation at the septum SW within the left ventricle LV of the heart. For example, the receiver-stimulator can be clamped to a distal portion of the delivery catheter 1158.

[0062] The rotatable coupling 1155 can be a bearing, push ring, or other member that allows the distal region 1156 and the proximal region 1154 of the sheath 1152 to rotate relative to one another. In some embodiments, the proximal region 1154 of the sheath 1152 is secured to the distal region 1156 by an interference fit, a snap-fit arrangement, and / or another suitable connection at the rotatable coupling 1155. In some aspects of the present technology, the rotatable coupling 1155 can inhibit or even prevent the distal region 1156 of the sheath 1152 from separating from the proximal region 1154 during retraction of the sheath 1152 under tension. In some embodiments, the rotatable coupling 1155 is configured to allow the distal region 1156 to rotate relative to the proximal region 1154 of the sheath 1152 by more than about 50 degrees, more than about 90 degrees, more than about 180 degrees, and / or more than about 270 degrees about the longitudinal axis of the sheath 1152 (e.g., as shown by arrow A in FIG. 11B ). In some embodiments, the rotatable coupling 1155 can include an outer surface 1160 that is at least partially chamfered or angled to facilitate smooth advancement through the introducer and / or the patient's vasculature.

[0063] 11A , in some embodiments, a sheath 1152 is configured to be advanced transseptally through the septum SW into the patient's left atrium LA, through / across the patient's mitral valve MV, and into the left ventricle LV. In the illustrated embodiment, a proximal region 1154 of the sheath 1152 defines a proximal bend 1151, and a distal region 1156 of the sheath 1152 defines a distal bend 1153. In some embodiments, the proximal bend 1151 has a radius of curvature (e.g., a radius of turn) that is greater than the radius of curvature of the distal bend 1153. In some embodiments, a balloon 1157 (shown in cross-section in FIG. 11A ) can be coupled to a distal end 1159 of the sheath 1152. In some aspects of the present technology, the distal bend 1153 is shaped and sized to help position the balloon 1157 along the septum SW in the left ventricle LV, while the proximal bend 1151 facilitates entry of the delivery system 1150 into the left atrium LA. In some embodiments, the delivery system 1150 can include other components (not shown) in addition to the rotatable sheath 1152 and delivery catheter 1158, such as, for example, a transseptal needle, a transseptal retractor, a transseptal sheath, etc.

[0064] 11A and 11B, during the delivery procedure, a transseptal puncture can be performed superiorly and posteromedially to the fossa ovalis in most patients. The delivery system 1150 can then be advanced through the puncture across the septum between the right and left atria LA at a distance from the annulus of the mitral valve MV, e.g., approximately 3.5 to 4.0 centimeters. In some embodiments, the sheath 1152 can then be rotated by actuating the distal region 1156 of the sheath (e.g., via a cable and knob on the proximal handle of the sheath 1152) and then torquing the delivery catheter 1158 while the receiver-stimulator is still secured thereto. That is, in some embodiments, the delivery catheter 1158 can be torqued to rotate the distal region 1156 of the sheath 1152 while the receiver-stimulator is not released from the delivery catheter 1158 and does not protrude distally outside the balloon 1157. Such rotation can allow the balloon 1157 to be positioned at different target locations along the septum SW, thus allowing a receiver-stimulator device or multiple different receiver-stimulator devices to be delivered and implanted at one of the different locations. For example, in FIG. 11A , delivery system 1150 is positioned to implant a receiver-stimulator device at a first target location 1161 along the septum SW in the left ventricle LV, but can be rotated (as shown in phantom) to implant the receiver-stimulator device at a second target location 1162 along the septum SW and / or other target locations. In some embodiments, multiple delivery catheters can be inserted through the sheath 1152 to implant multiple receiver-stimulator devices at different locations along the septum SW.

[0065] In other embodiments, the delivery system 1150 can be advanced intravascularly into the patient's right ventricle to facilitate delivery of the receiver-stimulator device to the septum SW within the right ventricle, for example. In such embodiments, the distal bend 1153 can be similarly shaped and sized to aid in positioning the balloon 1157 along the septum SW within the right ventricle, and the sheath 1152 can be rotated to position the balloon 1157 at a different target site along the septum SW.

[0066] 12 is a side view of a distal portion of a delivery system 1250 configured to implant a receiver-stimulator 1210 within a patient's heart in accordance with an embodiment of the present technology. In the illustrated embodiment, the delivery system 1250 includes an elongate sheath 1252 defining a lumen 1249 and a delivery catheter 1258 advanceable through the lumen 1249 of the sheath 1252. In some embodiments, the receiver-stimulator 1210 (which may be similar to or the same as the receiver-stimulator 210 described in detail with reference to FIG. 2 ) can be coupled to a distal portion 1264 of the delivery catheter 1258 and / or advanced through the delivery catheter 1258 for implantation at the septum SW within the left ventricle LV of the heart.

[0067] In the illustrated embodiment, the sheath 1252 has a shape that includes a distal bend 1253 and a generally straight distal portion 1265 distal to the distal bend 1253. During a delivery procedure, the sheath 1252 can be advanced over the delivery catheter 1258, and / or the delivery catheter 1258 can be advanced through the sheath 1252 so that (i) the distal bend 1253 contacts the posterior or lateral wall LW of the left ventricle opposite the septum SW, and (ii) the distal portion 1265 faces (e.g., faces generally perpendicular to) the septum SW. Thus, in some aspects of the present technology, the sheath 1252 can adjust relative to the lateral wall LW to apply a forward anchoring force to the receiver-stimulator 1210 (e.g., in the direction indicated by arrow B toward the septum SW) during implantation of the receiver-stimulator 1210 using the delivery catheter 1258. In some embodiments, the generally straight distal portion 1265 has a controllably variable length, for example, allowing for variation of the minimum bend radius of the distal bend 1253, which can facilitate positioning of the delivery system 1250 within the left ventricle LV.

[0068] In some aspects of the present technology, much of the challenge in reaching a target implantation location along the septum SW within the left ventricle LV is the relative inflexibility of the delivery catheter 1258. Thus, in some embodiments, the length of the receiver-stimulator 1210 and / or the associated mechanism for detaching the receiver-stimulator 1210 from the delivery catheter 1258 can be reduced, reducing the corresponding length of the relatively stiff section of the delivery catheter 1258 and further improving the flexibility of the delivery system 1250 and the ability to deliver the receiver-stimulator 1210 to a desired target location along the septum SW. Similarly, in some embodiments, the delivery catheter 1258, the receiver-stimulator 1210, and / or the associated detachment mechanism can include one or more hinges, pivot points, etc., to reduce the stiffness of the delivery system 1250. For example, the receiver-stimulator 1210 can be pivotally coupled to the delivery catheter 1258 to improve flexibility.

[0069] 13 is a side view of a portion of a delivery system 1350 configured to implant a receiver-stimulator 1310 within a patient's heart in accordance with an embodiment of the present technology. In some embodiments, the receiver-stimulator 1310 can be similar to or the same as any of the receiver-stimulators described in detail above with reference to FIGS. 6A-8B. For example, in the illustrated embodiment, the receiver-stimulator 1310 includes a body 1312 and a plurality of tines 1344 that can support one or more stimulation electrodes (not shown).

[0070] The receiver-stimulator 1310 is in a compressed delivery configuration in FIG. 13 with the tines 1344 oriented generally parallel to one another. More specifically, the delivery system 1350 can include a sleeve 1368 (shown as transparent in FIG. 13 for clarity) that at least partially surrounds the tines 1344 during delivery of the receiver-stimulator 1310. The sleeve 1368 can maintain the tines 1344 in the compressed delivery configuration during delivery and / or implantation and can be removed after delivery of the receiver-stimulator 1310 to the target implantation location, allowing the tines 1344 to expand and secure the receiver-stimulator 1310 at the target implantation location. In some embodiments, for example, the sleeve 1368 is formed from a biodegradable material (e.g., a rapidly biodegradable material) that degrades after implantation, allowing the tines 1344 to expand, such as within the patient's ventricle, as described in detail above with reference to FIGS. 6A-8B . In other embodiments, the sleeve 1368 can include perforations and / or the delivery system 1350 can include a suture or other device to score the sleeve 1368 and remove the sleeve 1368 from around the tines 1344, allowing the tines 1344 to expand.

[0071] FIG. 14 is a side view of a portion of a delivery system 1450 configured to implant the receiver-stimulator 1310 of FIG. 13 within a patient's heart in accordance with an embodiment of the present technology. The receiver-stimulator 1310 is in a compressed delivery configuration in FIG. 13 , in which the tines 1344 are oriented generally parallel to one another. More specifically, the delivery system 1450 may include a sleeve 1468 that at least partially surrounds the tines 1344 during delivery of the receiver-stimulator 1310. The sleeve 1468 may maintain the tines 1344 in the compressed delivery configuration during delivery and / or implantation and may be removed after delivery of the receiver-stimulator 1310 to the target implantation location, allowing the tines 1344 to expand and secure the receiver-stimulator 1310 at the target implantation location. In the illustrated embodiment, for example, the sleeve 1468 is coupled to a drawstring or pullwire 1469, which may extend proximally to the handle of the delivery system 1450 and / or proximally outside the patient. Once the receiver-stimulator 1310 is positioned at the target location, the pull wire 1469 can be pushed or pulled to move the sleeve 1468 distally from the tines 1344 or proximally toward the body 1312, allowing the tines 1344 to expand.

[0072] 15A-15I and 15K are side views of a distal portion of a delivery system 1550 during different stages of a procedure for implanting a receiver-stimulator 1510 (FIGS. 15F-15K) within the septum SW of a patient's heart according to an embodiment of the present technology. FIG. 15J is a rear view (e.g., facing distally) from within the left ventricle LV of a receiver-stimulator 1510 implanted in the septum SW according to an embodiment of the present technology. In some embodiments, the receiver-stimulator 1510 can be similar to or the same as any of the receiver-stimulators described in detail above with reference to FIGS. 9 and 10. For example, as best shown in FIG. 15K, the receiver-stimulator 1510 can include a body 1512 including an electrode 1516 and having a needle 1540 extending therefrom and configured to penetrate the septum SW. An anchor member 1546 may be coupled to the needle 1540 to secure the receiver-stimulator 1510 and electrode 1516 relative to the septum SW.

[0073] FIG. 15A illustrates the delivery system 1550 after advancement of a first catheter 1570 (e.g., a mapping catheter) through a first sheath 1572 and into the left ventricle LV toward the septum SW. The first sheath 1572 can be positioned at least partially within the left ventricle LV or positioned proximally within the patient's vasculature. In some embodiments, the first catheter 1570 can include a distal tip 1571 including one or more electrodes 1573 configured to electrically map and / or pace the septum SW. Thus, the first catheter 1570 can be used to determine a target site for implantation of a receiver-stimulator 1510 along the septum SW. In some embodiments, the first catheter 1570 can have a size of approximately 7 French or approximately 8 French. The first catheter 1570 and first sheath 1572 can access the left ventricle LV via a transseptal or transaortic intravascular route.

[0074] FIG. 15B illustrates the delivery system 1550 after a puncturing element 1576 (e.g., a needle) has been advanced through the first catheter 1570 into and through the septum SW (e.g., into the right ventricle RV).

[0075] 15C illustrates the delivery system 1550 after the suture 1578 has been advanced through the piercing element 1576 and into the right ventricle RV. In the illustrated embodiment, the suture 1578 forms a loop 1579 that is positioned within the right ventricle RV.

[0076] 15D illustrates the delivery system 1550 after (i) withdrawing the puncturing element 1576 (FIG. 15C) through the first catheter 1570 and (ii) advancing the hook element 1580 through the second sheath 1582 into the right ventricle RV. The second sheath 1582 can be positioned at least partially within the right ventricle RV or positioned proximally within the patient's vasculature. As shown, the hook element 1580 can be used to capture a loop 1579 of the suture 1578 within the right ventricle RV.

[0077] 15E illustrates the delivery system 1550 after (i) retracting the loop 1579 (FIG. 15D) of the suture 1578 into the second sheath 1582 by withdrawing the hook element 1580 (FIG. 15D), and (ii) retracting the first catheter 1570 through the first sheath 1572. Thus, at this stage, the suture 1578 can span between the first and second sheaths 1572, 1582 while extending through the septum SW.

[0078] 15F illustrates the delivery system 1550 during advancement of the receiver-stimulator 1510 over the suture 1578 and through the first sheath 1572. In some embodiments, the receiver-stimulator 1510 (e.g., needle 1540) is attached to the distal end 1583 of the suture 1578. Thus, the receiver-stimulator 1510 can be advanced by withdrawal of the suture 1578 through the second sheath 1582. In some embodiments, the first sheath 1572 can be advanced into the left ventricle LV before and / or during advancement of the receiver-stimulator 1510 through the first sheath 1572.

[0079] 15G illustrates the delivery system 1550 after continued advancement of the receiver-stimulator 1510 toward and into the septum SW. In some embodiments, continued retraction of the suture 1578 into the second sheath 1582 can pull the needle 1540 of the receiver-stimulator 1510 into and through the septum SW, such that (i) the needle 1540 extends from the left ventricle LV into the right ventricle RV, and (ii) the electrode 1516 of the receiver-stimulator 1510 is positioned against the septum SW within the left ventricle LV.

[0080] 15H illustrates the delivery system 1550 after (i) advancement of the anchor mechanism 546 over the suture 1578, through the second sheath 1582, and onto the needle 1540 in the right ventricle RV, and (ii) withdrawal of the first sheath 1572 (FIG. 15G). In some embodiments, a delivery catheter (not shown) can be used to advance the anchor member 1546 over the suture 1578 and onto the needle 1540. In some embodiments, the anchor member 1546 is attached to the needle 1540 (e.g., threaded thereon) and can apply a compressive force to the septum SW to firmly secure the electrode 1516 in contact with the septum SW.

[0081] FIG. 15I illustrates an optional alignment step that may be performed before emplacement of the anchor member 1546 (as shown in FIG. 15H ), in which a second catheter 1584 is (i) advanced through the second sheath 1582 over the suture 1578 (not visible in FIG. 15I ) to engage the needle 1540, and (ii) then rotated to rotate the electrode 1516 and vary the location of the electrode 1516 along the septum SW due to the eccentric or offset positioning of the electrode 1516 along the body 1512 of the receiver-stimulator 1510. In some embodiments, the second catheter 1584 can rotate the receiver-stimulator 1510 until the electrode 1516 is optimally positioned along the septum SW. FIG. 15J illustrates the eccentrically positioned electrode 1516 after being rotated and aligned with a target conductive structure CS, such as a bundle branch within the septum SW.

[0082] Finally, Figure 15K illustrates the receiver-stimulator 1510 after removal of the delivery system 1550 (Figures 15A-15I) from the patient. At this stage, the receiver-stimulator 1510 remains at the target implantation location along the septum SW. Referring together to Figures 15H and 15K, the suture 1578 can be released (e.g., cut) from the needle 1540 of the receiver-stimulator 1510, and the suture 1578 and second sheath 1582 can be withdrawn from the patient.

[0083] IV. ADDITIONAL EXAMPLES The following examples illustrate some embodiments of the present technology. Example 1. A stimulation assembly implantable within a patient's heart, the stimulation assembly comprising: The main body and circuitry positioned at least partially within the body and configured to receive acoustic energy from an external source and convert the acoustic energy into electrical energy; an electrode configured to receive electrical energy; (a) a body positioned within a first ventricle of the heart separated from a second ventricle of the heart by a septum; (b) an anchor configured to engage a septum of the heart, the anchor having an electrode coupled to the body so as to engage tissue of the septum, the electrode further configured to deliver electrical energy to the tissue of the septum; a stimulation assembly comprising: Example 2: The stimulation assembly described in Example 1, wherein the anchor has a corkscrew shape. (Example 3) The stimulation assembly of Example 2, wherein the electrodes are positioned on the anchors. (Example 4) A stimulation assembly as described in Example 3, wherein the electrode is one of a pair of bipolar electrodes positioned on the anchor, each of the electrodes configured to receive a portion of the electrical energy and deliver a portion of the electrical energy to tissue of the septum. (Example 5) A stimulation assembly as described in Example 1, wherein the first ventricle is the left ventricle of the heart, the body has a distal surface configured to be positioned adjacent to the septum within the left ventricle, and the anchor comprises a needle extending from the distal surface. (Example 6) A stimulation assembly as described in Example 5, wherein the electrode is one of a plurality of electrodes, the electrodes being positioned on the needle, and each of the electrodes being configured to receive a portion of the electrical energy and deliver a portion of the electrical energy to tissue of the septum. (Example 7) A stimulation assembly as described in Example 5 or Example 6, wherein the electrodes are positioned linearly along the needles, the needles are configured to be implanted within tissue of the septum, and the circuitry is further configured to selectively deliver electrical energy to targeted ones of the electrodes. (Example 8) A stimulation assembly described in any one of Examples 1-7, wherein the electrode is one of a plurality of electrodes, the electrodes being positioned on the body, and each of the electrodes being configured to receive a portion of the electrical energy and deliver a portion of the electrical energy to tissue of the septum. (Example 9) The stimulation assembly of Example 8, wherein the circuitry is further configured to selectively deliver a portion of the electrical energy to the electrodes according to a selected stimulation pattern. (Example 10) A stimulation assembly described in any one of Examples 1-9, wherein the first ventricle is the left ventricle of the heart and the second ventricle is the right ventricle of the heart. (Example 11) A stimulation assembly described in any one of Examples 1-9, wherein the first ventricle is the right ventricle of the heart and the second ventricle is the left ventricle of the heart. Example 12. A stimulation assembly implantable within a patient's heart, the stimulation assembly comprising: The main body and circuitry positioned at least partially within the body and configured to receive acoustic energy from an external source and convert the acoustic energy into electrical energy; an electrode configured to receive electrical energy; a plurality of tines extending from the body, the tines configured to move from an at least partially compressed delivery position to an expanded deployed position; Equipped with In the compressed delivery position, the tines extend generally parallel to one another; In the expanded, deployed position, the tines are configured to engage a septum of the heart and secure the electrode in contact with tissue of the septum; The electrode is further configured to deliver electrical energy to tissue of the septum. Stimulator assembly. (Example 13) A stimulation assembly as described in Example 12, wherein in the expanded deployed position, the tines are configured to engage the septum so that the body is positioned within the left ventricle of the heart. (Example 14) A stimulation assembly as described in Example 12, wherein in the expanded deployed position, the tines are configured to engage the septum so that the body is positioned within the right ventricle of the heart. (Example 15) A stimulation assembly described in any one of Examples 12-14, wherein the electrode is one of a plurality of electrodes, each of the electrodes is coupled to a corresponding one of the tines, and each of the electrodes is configured to receive a portion of the electrical energy and deliver a portion of the electrical energy to tissue of the septum. (Example 16) A stimulation assembly as described in Example 15, wherein in the expanded deployed position, the electrode is configured to be positioned within the tissue of the septum. (Example 17) A stimulation assembly as described in Example 15, wherein in the expanded deployed position, the electrode is configured to be positioned on the surface of the septum. (Example 18) A stimulation assembly as described in Example 17, wherein the surface is a right ventricular surface of the septum and the body is configured to be positioned within the left ventricle. (Example 19) A stimulation assembly as described in Example 17, wherein the surface is a left ventricular surface of the septum and the body is configured to be positioned within the right ventricle. (Example 20) A stimulation assembly described in any one of Examples 12-19, wherein in the expanded deployed position, the tines are configured to extend through the septum from the first ventricle of the heart to the second ventricle of the heart. (Example 21) A stimulation assembly described in any one of Examples 12-20, wherein in the expanded, deployed position, the tines are configured to be embedded within the septum. Example 22 In the compressed delivery position, the tines extend generally parallel to an axis; 22. The stimulation assembly of any one of Examples 12-21, wherein in the expanded, deployed position, at least a portion of each of the tines is configured to deflect away from the axis. Example 23. A stimulation assembly implantable within a patient's heart, the stimulation assembly comprising: a body having a distal surface configured to be positioned adjacent a cardiac septum within a first ventricle of the heart; circuitry positioned at least partially within the body and configured to receive acoustic energy from an external source and convert the acoustic energy into electrical energy; an electrode configured to receive electrical energy; an elongate member extending from the distal surface and configured to extend through the septum from the first ventricle to the second ventricle of the heart; an anchor member secured to the needle within the second ventricle of the heart and configured to secure the electrode in contact with tissue of the septum; Equipped with The electrode is further configured to deliver electrical energy to tissue of the septum, a stimulation assembly. (Example 24) A stimulation assembly as described in Example 23, wherein the anchor member and the distal surface of the body are configured to exert a compressive force on the septum. (Example 25) A stimulation assembly described in Example 23 or Example 24, wherein the electrode is positioned on the distal surface of the body. (Example 26) A stimulation assembly as described in Example 25, wherein the body has a longitudinal axis extending perpendicular to the distal surface and coinciding with the elongated member, and the electrodes are positioned away from the longitudinal axis. (Example 27) A stimulation assembly described in any one of Examples 23-26, wherein the electrode is positioned on an elongated member. (Example 28) A stimulation assembly described in any one of Examples 23-27, wherein the elongated member comprises an electrode material, and the stimulation assembly further comprises an insulating coating on the electrode material, the insulating coating having openings that define the electrodes. (Example 29) A stimulation assembly described in any one of Examples 23-28, wherein the first ventricle is the left ventricle of the heart and the second ventricle is the right ventricle of the heart. (Example 30) A stimulation assembly described in any one of Examples 23-28, wherein the first ventricle is the right ventricle of the heart and the second ventricle is the left ventricle of the heart. Example 31. A method of implanting a stimulation assembly at a target site in a septum of a patient's heart, the stimulation assembly including an elongate member and an electrode, the septum separating a first ventricle of the heart from a second ventricle of the heart, the method comprising: passing a suture through the septum proximal to the target site from the first ventricle to the second ventricle; Attaching a first end portion of the suture to a stimulation assembly; pulling the suture to retract the stimulation assembly into the first ventricle so that the elongate member extends through the septum from the first ventricle to the second ventricle; securing an anchor member to the elongate member within the second ventricle to secure the electrode in contact with tissue of the septum; delivering electrical energy to the tissue of the septum using an electrode; A method comprising: (Example 32) The method described in Example 31, wherein the first ventricle is the left ventricle of the heart and the second ventricle is the right ventricle of the heart. (Example 33) The method described in Example 31, wherein the first ventricle is the right ventricle of the heart and the second ventricle is the left ventricle of the heart. (Example 34) The method described in any one of Examples 31-33, wherein passing the suture through the septum includes positioning a loop of the suture within the second ventricle, and the method further includes capturing the loop of the suture using a hook mechanism. (Example 35) A method described in any one of Examples 31-34, wherein pulling the suture includes retracting the hook mechanism and the suture loop through the sheath. (Example 36) The method described in any one of Examples 31-35, wherein the method further includes (a) before securing the anchor member to the elongated member, and (b) after pulling the suture so that the elongated member extends through the septum, rotating the stimulation assembly to move the electrode along the septum.

[0084] (V. Conclusion) The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Specific embodiments of the present technology and examples thereof are described above for illustrative purposes, but various equivalent modifications are possible within the scope of the present technology, as those skilled in the art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0085] From the foregoing, it should be understood that, although specific embodiments of the present technology have been described herein for illustrative purposes, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may also include the plural or singular terms, respectively.

[0086] Furthermore, unless the word "or," in reference to a list of two or more items, is expressly limited to mean only a single item exclusively from the other items, the use of "or" in such a list shall be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of items in the list. In addition, the term "comprising" is used throughout to mean including at least the recited features, so as not to exclude any greater number of the same features and / or other features of additional types. Also, while specific embodiments have been described herein for illustrative purposes, it should be understood that various modifications can be made without departing from the present technology. Furthermore, while advantages associated with some embodiments of the present technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to fall within the scope of the present technology. Thus, the present disclosure and related technology may encompass other embodiments not explicitly shown or described herein.

Claims

1. 1. A stimulation assembly implantable within a patient's heart, the stimulation assembly comprising: The main body and circuitry positioned at least partially within the body and configured to receive acoustic energy from an external source and convert the acoustic energy into electrical energy; a plurality of tines extending from the body, the tines configured to move from an at least partially compressed delivery position to an expanded deployed position; In the compressed delivery position, the tines extend generally parallel to one another; a plurality of tines configured to engage a septum of the heart in the expanded, deployed position to secure an electrode in contact with tissue of the septum; a plurality of electrodes, each of the electrodes configured to receive a portion of the electrical energy and deliver the portion of the electrical energy to the tissue of the septum, each of the electrodes coupled to a corresponding one of the tines; a stimulation assembly comprising:

2. 10. The stimulation assembly of claim 1, wherein in the expanded, deployed position, the tines are configured to engage the septum such that the body is positioned within a left ventricle of the heart.

3. 10. The stimulation assembly of claim 1, wherein in the expanded, deployed position, the tines are configured to engage the septum such that the body is positioned within a right ventricle of the heart.

4. The stimulation assembly of claim 1 , wherein in the expanded, deployed position, the electrode is configured to be positioned within the tissue of the septum.

5. The stimulation assembly of claim 1 , wherein in the expanded, deployed position, the electrode is configured to be positioned on a surface of the septum.

6. The stimulation assembly of claim 5 , wherein the surface is a right ventricular surface of the septum and the body is configured to be positioned within a left ventricle of the heart.

7. The stimulation assembly of claim 5 , wherein the surface is a left ventricular surface of the septum and the body is configured to be positioned within a right ventricle of the heart.

8. 10. The stimulation assembly of claim 1, wherein in the expanded, deployed position, the tines are configured to extend through the septum from a first ventricle of the heart to a second ventricle of the heart.

9. The stimulation assembly of claim 1 , wherein in the expanded, deployed position, the tines are configured to be embedded within the septum.

10. In the compressed delivery position, the tines extend generally parallel to an axis; The stimulation assembly of claim 1 , wherein in the expanded, deployed position, at least a portion of each of the tines is configured to deflect away from the axis.

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