CN116726398A

CN116726398A - Lead of cardiac conduction system with defibrillation function

Info

Publication number: CN116726398A
Application number: CN202310828468.9A
Authority: CN
Inventors: 谢文冕; 斯科特·海登; 张永幸; 刘恩焘; 瑞恩·鲍尔; 平利川
Original assignee: Wushuang Medical Usa Co ltd
Current assignee: Wushuang Medical Usa Co ltd
Priority date: 2022-07-08
Filing date: 2023-07-07
Publication date: 2023-09-12

Abstract

A lead for a cardiac conduction system. The wire includes a wire body; the distal end includes a first electrode configured to be inserted into a portion of a ventricular septum; the second electrode is connected with the lead body; the fixation element is configured to fix the lead to a portion of the ventricular septum; a proximal portion. The lead further includes a shock coil connected to the lead body and spaced apart from the second electrode.

Description

Lead of cardiac conduction system with defibrillation function

Cross reference

The disclosure is a partial continuation-in-progress application claiming to enjoy the benefits of U.S. application Ser. No. 17/804,705, filed on 5/31 of 2022, incorporated herein by reference.

Technical Field

The present disclosure relates to lead systems, methods, and designs for cardiac conduction system pacing. More particularly, the present disclosure relates to systems and designs of cardiac conduction system pacing leads with defibrillation capabilities, and to methods of implanting leads within the ventricular septum and right ventricle using delivery systems including catheters.

Background

An Implantable Pulse Generator (IPG) (e.g., implantable pacemaker, implantable defibrillator, etc.) is a battery-powered medical device that contains electronic circuitry with a controller and delivers and regulates electrical pulses to an organ or system, such as the heart, nervous system, etc. A lead is an elongated, flexible wire that connects a device such as an IPG to a target such as an organ or system, transmits electrical pulses (e.g., an energy array) from the device to the target, and/or senses or measures the potential or voltage of the target. A catheter is a tubular medical device for insertion into a passageway, vessel, channel or body cavity, typically to keep the passageway open to facilitate delivery of a single lead or multiple leads during a surgical procedure. The process of catheterization is known as "catheterization". The conduction system of the heart consists of cardiomyocytes and conduction fibres, which are dedicated to the generation and conduction of impulses into the heart. The cardiac conduction system produces a normal cardiac cycle, coordinates the retraction of the heart chambers, and causes the heart to have an autonomous rhythm. Conduction System Pacing (CSP) is a pacing technique that involves implantation of pacing leads at different sites or paths of the cardiac conduction system and includes his bundle pacing, left bundle branch pacing, right bundle branch pacing and/or bilateral pacing (simultaneous pacing of left and right bundle branches).

Disclosure of Invention

In one embodiment, a cardiac conduction system pacing lead having defibrillation capabilities is disclosed. The wire includes a wire body. The lead also includes a distal end including a first electrode configured to be inserted into the ventricular septum portion and a shock coil mounted on the lead body and positioned a distance from a second electrode positioned in the right ventricle. The lead also includes a proximal end. In one embodiment, the lead may further include a second electrode and a fixation element for securing the lead to the ventricular septum portion.

In one embodiment, a method of implanting a lead using a delivery system is disclosed. The method includes inserting a catheter to reach the septum, inserting the catheter against the ventricular septum, inserting a guidewire through the catheter shaft, extending the guidewire from the distal end of the catheter to the proximal end of the catheter, rotating the guidewire body of the guidewire to connect the spiral electrode of the guidewire with the ventricular septum, and removing the catheter.

Embodiments disclosed herein may provide a lead that may be "deep" implanted into the ventricular septum (e.g., inserted a suitable distance into the ventricular septum, e.g., with the lead body portion located within the ventricular septum tissue) to electrically capture the cardiac conduction system (e.g., to a path to the LBB from the right ventricular chamber, etc.). Embodiments disclosed herein may also provide a catheter and guidewire that are more atraumatic and easier to deliver to a desired location. Embodiments disclosed herein may also provide a catheter and guidewire that minimizes trauma to cardiac tissue and has stable electrical performance.

Other features and aspects will become apparent by consideration of the following detailed description and accompanying drawings.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate embodiments of the systems and methods described in this disclosure.

Fig. 1A-1E are side views of a wire according to one embodiment.

Fig. 2 is a side view of a wire according to another embodiment.

Fig. 3 is a side view of a wire according to another embodiment.

Fig. 4 illustrates a wire for fixation according to one embodiment.

Fig. 5 illustrates a lead implanted in the ventricular septum and the right ventricle according to one embodiment.

Specific embodiments of the present disclosure are described herein with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure, which can be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. In this document and in the drawings, like reference numerals designate like elements that may perform the same, similar or equivalent functions.

Detailed Description

The present disclosure relates to systems, methods, and designs of leads for cardiac conduction system pacing. More particularly, the present disclosure relates to systems and designs for pacing leads of cardiac conduction systems with defibrillation capabilities, and to methods of implanting the leads into the ventricular septum and right ventricle using a delivery system that includes a catheter.

As defined herein, the term "distal" may refer to remote from the point of connection (e.g., an implantable pulse generator or like device) or remote from the operator (e.g., doctor, user, etc.). The distal end of the wire or catheter refers to the end of the wire or catheter that is distal to the operator or to the point of connection with the IPG.

As defined herein, the term "proximal" may refer to near a point of connection (e.g., an implantable pulse generator, etc. device) or near an operator (e.g., a doctor, user, etc.). The proximal end of the wire or catheter refers to the end of the wire or catheter that is near the operator or near the point of connection to the IPG.

As defined herein, the term "French" may refer to a unit of size (e.g., diameter, etc.) for a measurement device, such as a catheter, guidewire, etc. For example, a 1Fr round catheter or guide wire has an outer diameter of 1/3 mm. For example, if Fr size is 9, the diameter is 9/3=3.0 millimeters.

As defined herein, the term "spiral" may refer to (e.g., an object) having a three-dimensional shape similar to a wire wound around a cylinder or cone (e.g., in a single layer), such as a spiral bottle opener or spiral stair. And the term "linear" may refer to being aligned or extending in a straight line or nearly straight line.

As defined herein, the term "conductive" may refer to electrical conductivity.

As defined herein, the term "spacing" may refer to the portion separating two chambers, such as between heart chambers. The interval may be an atrial interval and/or a ventricular interval. The term "ventricular septum" or "inter-ventricular septum" (IVS) may refer to the portion separating two ventricular chambers. The term "right ventricular interval" may refer to the ventricular interval at which the RBB is located, and the term "left ventricular interval" may refer to the ventricular interval at which the LBB is located.

As defined herein, the term "pacing" may refer to delivering (e.g., at a desired voltage and a desired interval) pulses to the heart by a device (e.g., a pulse generator) via a lead, through the myocardium, or directly through a cardiac conduction system, resulting in depolarization of the atria or ventricles. While the term "sensing" may refer to the detection of intrinsic electrical signals of the atrium, ventricle, or conduction system by the device through the leads. It will be appreciated that each electrode described herein may be configured as a pacing electrode and/or a sensing electrode and/or a combination of both. It will also be appreciated that each electrode described herein may be configured as an anode and/or a cathode and/or a combination of both.

As defined herein, "conduction system pacing" or "CSP" may refer to a therapy that involves placement of pacing leads at different sites or pathways to electrically capture the cardiac conduction system for treatment of atrioventricular conduction system lesions and delays, thereby providing a more synchronous dual-chamber activation pacing solution. Lead positioning for cardiac Conduction System Pacing (CSP) may be performed for the region of the his bundle, known as His Bundle Pacing (HBP), for the region of the Left Bundle Branch (LBB), known as left Shu Zhiqi pacing (LBBP), or for the region of the right bundle branch, known as Right Bundle Branch Pacing (RBBP), or for both the right and left bundle branch regions, known as Bilateral Bundle Branch Pacing (BBBP). Compared to traditional right ventricular pacing (RV pacing) or biventricular (RV and Left Ventricular (LV)) pacing, which implants RV apex pacing leads and/or LV epicardial pacing leads, leads for CSP are positioned by spacing in the heart, e.g., closer to the his bundle, left bundle branch, and/or right bundle branch. Thus, the design, function, and purpose of the leads used for pacing of the cardiac conduction system are different from the leads used for RV and/or LV pacing. Notably, ventricular pacing (e.g., RV pacing, etc.) can be non-physiological and can lead to adverse consequences of mitral and/or tricuspid valve regurgitation, atrial fibrillation, heart failure, and/or pacing-induced cardiomyopathy, among others. CSP may be physiological pacing and may achieve electro-mechanical synchronization to alleviate chronic clinical adverse consequences, including pacing-induced cardiomyopathy, and the like. It will also be appreciated that indications for CSP may include, for example, conditions where high-load ventricular pacing is required (e.g., sustained atrial fibrillation with atrioventricular block, slow-conducting atrial fibrillation, pacing-induced cardiomyopathy, atrioventricular node ablation, etc.); sick sinus syndrome, while conducting disease in the presence of the atrioventricular node; and/or as an alternative to bibundle branch block, prolongation of QRS and PR intervals, biventricular pacing non-responsiveness, or cardiac resynchronization therapy escalation where a patient requires biventricular pacing in a heart failure patient, or the like.

Some embodiments of the present application are described in detail by referring to the accompanying drawings so that those skilled in the art can more easily understand the advantages and features of the present application. The terms "near", "far", "top", "bottom", "left", "right", and the like as described herein are defined in terms of typical viewing angles and convenience for those skilled in the art. These terms are not limited to a particular orientation.

The process may include one or more operations, acts or functions represented by one or more blocks. It will be understood that the operations, acts, or functions described in the different blocks, while depicted as discrete blocks, may be further divided into more blocks, combined into fewer blocks, or eliminated, depending on the desired embodiment. Features described in any one embodiment may be combined or combined/applied with other embodiments and vice versa. The scope of the present disclosure is to be determined by the appended claims and their legal equivalents, rather than by the examples given herein. For example, the steps recited in any method claims may be performed in any order and are not limited to the order recited in the claims. Furthermore, no element is necessary to practice an embodiment of the present disclosure unless explicitly described as "critical" or "essential" herein.

As described above, conduction System Pacing (CSP) is a pacing technique that involves implanting pacing leads at different sites or paths to electrically capture the cardiac conduction system, and includes, for example, his bundle pacing, left bundle branch pacing, right bundle branch pacing, and/or bilateral pacing (pacing both left and right bundle branches). CSP may be physiological pacing, enabling electromechanical synchronization to alleviate chronic clinical adverse consequences such as pacing-induced cardiomyopathy. However, existing CPS leads do not have defibrillation capabilities and are not able to treat certain conditions, such as tachyarrhythmias. While devices with defibrillation capabilities, such as cardiac resynchronization therapy defibrillator (CRT-D) devices, these devices are complex in design and require positioning of the lead at a specific location to pace the left ventricle in the location of the anterior ventricular vein or other branch. Not only are existing CRT-D devices complicated to locate, due to the different anatomy of the patient, these devices may not provide the patient with proper therapy, e.g., 25% of patients do not respond to the therapy of the CRT-D device.

Thus, in embodiments of the present disclosure, a lead for pacing of a cardiac conduction system is provided that includes a defibrillation coil that provides the lead with defibrillation functionality and/or adjustability of the pacing vector, e.g., allowing for different pacing, sensing, defibrillation, etc. configurations. Thus, the improved lead is easier to use for heart failure patients using CRT-D devices and/or cardiac resynchronization therapy devices, and provides additional benefits to those in need of cardiac resynchronization therapy.

Fig. 1A-1E exemplarily depict a lead with a defibrillation coil according to one embodiment. It will be appreciated that while the lead in fig. 1A-1E depicts the first electrode as a linear electrode and the second electrode as a spiral electrode, the description of the lead is not intended to limit the scope of the present disclosure, but is provided as an illustration. In practice, the leads may take other configurations, for example, as disclosed in U.S. application Ser. No. 17/804,705 (filed by Singular Medical Inc. at 2022, month 5, 31), which is incorporated herein by reference. For example, in one embodiment, the lead further includes a distal end having an electrode (e.g., a spiral electrode or similar structure). The lead body includes a non-conductive spacer adjacent the spiral electrode, an outer electrode (e.g., a ring electrode surrounding the lead body, which may be of titanium, platinum iridium alloy, etc., and coated to increase surface area, or with a fractal coating such as TiN or IrOx), an electrode coil (e.g., a coil of ring electrode, which may be made of MP35N and/or silver) extending to the proximal end of the lead and connected to a connector (not shown) at the proximal end of the lead body, and an inner electrode (e.g., a coupler, etc.) connected to the electrode coil to the outer electrode.

As shown in fig. 1A-1E, a lead 100 for pacing of a cardiac conduction system has a defibrillation function including a lead body 110 and a distal end including a first electrode 160 configured to be inserted into a ventricular septum portion. Lead 100 also includes a defibrillation coil 180 mounted on the lead body and spaced distally therefrom. The lead 100 also includes a proximal end, not shown in the figures. At the proximal end of lead 100, an Implantable Pulse Generator (IPG) may be provided for generating pulses of energy for treating the heart, such as pacing and/or defibrillation. In one embodiment, as shown in fig. 1A-1E, the lead 100 further includes a second electrode 120 coupled to the lead body 110, as discussed further below. It will be appreciated that the terms such as connecting, mounting, and the like are not intended to limit the scope of the present disclosure, but rather broadly refer to the different mechanisms that connect the different components of the wire, directly and/or indirectly. For example, the components may be joined mechanically, chemically, such as by biocompatible adhesives, welding, ultrasonic welding, and the like.

The lead body 110 includes an outer layer 111 and an outer winding 122, the windings of which are spaced apart from each other. The outer layer 111 may be a multi-layer structure comprising one or more layers including an electrical insulator or insulation layer, a braid or grip layer for rotating the wire 100, an electrically conductive layer, for example connected to an electrical coil or cable. The outer layer 111 may be made of silicon, polyurethane, tetrafluoroethylene, polytetrafluoroethylene, and/or other suitable biocompatible materials. The windings of the outer winding 122 are connected to or adjacent the inner surface of the outer layer 111. The lead body 110 has a distal end 118. The outer winding 122 extends from the proximal end of the lead body 110 to a location near or near the distal tip of the distal end of the lead body.

Inside the outer layer 111, near the distal tip of the distal end 118, the second electrode 120 has windings 121 to fix the position of the spiral electrode. The windings of the second electrode 120 extend to the outside of the lead body 110, and the winding portions of the second electrode 120 may have a variable or identical winding pitch at the outside of the lead body 110. The second electrode 120 includes a first portion extending distally from the lead body and a second portion extending distally from the first portion. In one embodiment, the winding diameter of the second electrode 120 is greater than the winding diameter of the outer winding 122. In one embodiment, the length of the second electrode 120 ranges from about 2.2 millimeters to about 2.6 millimeters, preferably about 2.4 millimeters, which is longer than the length of a conventional spiral electrode by about 1.8 millimeters. In another embodiment, the length of the second electrode 120 may be about 4 millimeters. In one embodiment, the proximal portion of the second electrode 120 may be coated with a non-conductive material. In another embodiment, the proximal portion of the second electrode 120 is not coated with a non-conductive material. In one embodiment, the outer winding 122 is electrically connected to the second electrode 120 to deliver electrical pulses (e.g., energy arrays) to the second electrode 120 through the outer winding 122, and/or a sense signal may be detected at the second electrode 120 and transmitted to/from the device to/from an IPG (not shown) through the outer winding 122.

In one embodiment, the lead 100 may include a fixation element for securing the lead to the ventricular septum portion. In the illustrated embodiment, it is understood that the second electrode 120 includes a fixation element for securing the lead to the ventricular septum. For example, because the second electrode 120 is connected to the lead body (e.g., via windings 121) and includes a helical winding, rotating the lead 100 or the lead body 110 may extend the entire lead 100 distally to or retract proximally from the ventricular septum portion, e.g., by relatively rotating the second electrode 120, the second electrode 120 is configured to connect to or retract from heart tissue. In other embodiments, the fixation element may be a separate component of the wire, such as a fixation wing, clip, hook, screw, or the like.

The first electrode 160 extends from the lead body 110, and may include a tapered tip, a stem portion integrally connected with the tapered tip, and a spacer 150 connected to the first electrode 160. Thus, the first electrode 160 may be a linear electrode for insertion into a portion of the ventricular septum to electrically capture the cardiac conduction system. In other embodiments, the first electrode 160 may be a spiral electrode or the like.

The intermediate layer 119 extends from the proximal end of the lead body 110 to the distal end portion of the lead body 110. The intermediate layer 119 is connected to or located on the inner surface of the external coil 122. The housing 113 is located inside the winding 121 of the second electrode 120 in the lead body 110 and the external coil 122. The proximal portion of the housing 113 is located between the intermediate layer 119 and the inner coil 115. The middle portion of the housing 113 is located between the outer coil 122, the winding 121 and the inner coil 115. The distal portion of the housing 113 is located between the winding 121 and the spacer 150 or shaft of the first electrode 160. In one embodiment, the housing 113 is made of plastic or biocompatible material.

The inner coil 115 extends from the proximal end of the lead body 110 to a location near the distal end of the lead body 110. In one embodiment, the internal coil 115 is electrically connected to the first electrode 160 to transmit electrical pulses (e.g., energy arrays) to the first electrode 160 through the internal coil 115 and/or to detect sensing signals of the first electrode 160 through the internal coil 115 and to transmit signals to/from an implantable pulse generator (not shown). The inner coil 115 is attached to or adjacent to the inner surface of the intermediate layer 119 and a portion of the inner surface of the housing 113. Between the proximal portion of the housing 113 and the windings of the inner coil 115, a set of drive members (e.g., drive "teeth") are disposed and fixedly attached to the inner surface of the proximal portion of the housing 113. The drive component is configured to enable the inner coil 115 to extend distally or retract proximally of the spacer 150 and the first electrode 160 connected to the spacer 150. In one embodiment, a terminal pin (not shown) or any suitable control mechanism may be provided at the proximal end of the lead 100 for rotationally driving the inner coil 115 to distally extend or proximally retract the spacer 150 and the first electrode 160 connected to the spacer 150.

In one embodiment, the spacer 150 may be integral to the first electrode 160 as an electrode (e.g., unipolar or bipolar, made of metal or similar materials). In such embodiments, the electrode portion of the spacer 150 may be coated (e.g., by an electrically non-conductive layer) while the portion of the first electrode 160 or the distal tip portion of the electrode is not coated for delivering stimulation pacing (e.g., delivering electrical pulses) and/or sensing.

The spacer 150 and the first electrode 160 pass through the cavity in the housing 113, through the space in the outer coil 122, and through the space in the second electrode 120. The length of the spacer 150 ranges from about 4 millimeters to about 12 millimeters. In one embodiment, the spacer 150 may have different lengths (about 4 mm, about 6 mm, about 8 mm, about 12 mm, etc. to accommodate spiral electrodes to electrically capture the LBB and the RBB) to accommodate ventricular intervals of different thicknesses. In such an embodiment, ultrasound or similar ultrasound may measure the thickness of the ventricular septum and determine and/or select a desired spacer length during surgery. It is understood that the "retracted state" of the lead may refer to a state of the lead fully or partially retracted proximally of the spacer 150 and the first electrode 160 (e.g., the distal end of the first electrode 160 is proximal of the distal end of the second electrode 120). The "extended state" of the lead refers to the spacer 150 and the first electrode 160 extending fully or partially distally (e.g., the distal end of the first electrode 160 is distal to the distal end of the second electrode 120).

The shock coil 180 is mounted on the lead body 110, for example, mechanically, by being embedded in or attached to the outer surface of the lead body 110. Feed coil 185 extends from the proximal end of lead body 110 to a position near or adjacent to shock coil 180. In one embodiment, the feed coil 185 is electrically connected to the shock coil 180 such that electrical pulses (e.g., energy arrays) may be delivered to the shock coil 180 through the feed coil 185, and/or a sense signal may be detected at the shock coil 180 and transmitted to/from an implantable pulse generator (not shown) device through the feed coil 185. In one embodiment, feed coil 185 may be located between the outer surface of outer coil 122 and outer layer 111. An electrically insulating layer may be provided between feed coil 185 and outer coil 122. In another embodiment, feed coil 185 may be disposed at any suitable location within lead body 110. The shock coil 180 may be made of a biocompatible alloy (e.g., tantalum, titanium, platinum, and/or Pt/Ir or alloys thereof, etc.) to achieve electrical conduction and high voltage shock, e.g., for defibrillation. The wire diameter of the shock coil 180 may be between about 0.1 mm and about 0.3 mm, with a length of about 40 mm to 100 mm. Although not limited to this range, to provide an example, the wire diameter of the shock coil 180 is about 0.2 mm and the length is about 57 mm.

The outer diameter of the shock coil 180 may be greater than, less than, or equal to the outer diameter of other portions of the outer surface of the lead body 110, such as the retention portion of the lead body. In one embodiment, the outer diameter of the lead body 110 may be between about 2.0Fr to about 9.0Fr, preferably between about 5 to about 9Fr, and the diameter of the shock coil 180 is preferably between about 5 to about 9 Fr. It will be appreciated that since the amount of energy that can be released by the shock coil 180 can depend on the available surface area of the shock coil, the length of the shock coil can increase as the diameter of the shock coil decreases. Thus, in one embodiment, the surface area of the shock coil 180 is between about 350mm2 and about 650mm2, preferably about 500mm2 or so, depending on the length and diameter of the shock coil, for example, a smaller diameter coil may require a longer length to have the same surface area.

It will be appreciated that, unlike the discussion above, the shock coil 180 is disposed on a wire and may have a different configuration and electrical connection to the IPG. For example, fig. 2 shows another embodiment of a lead 200 having a single electrode 220 at a distal end. The wire 200 may include the same or similar features as the wire 100 of fig. 1, for which no detailed discussion is provided in fig. 2. The lead 200 in fig. 2 includes a shock coil 280 disposed or placed around the lead body 210 and a feed coil (or coil conductor) 285 electrically connected to the shock coil 280. Feed coil 285 may be added as a separate circuit, for example, using coil conductors around the lead body, so that shock coil 280 and feed coil 285 may be added to existing CSP lead designs. In other embodiments, feed coil 285 and shock coil 280 are integral with lead body 210. In one embodiment, outer insulation layer 286 is provided around feed coil 285. The outer insulation layer 286 may be a multi-layer structure including one or more layers including an electrically insulating layer, an insulating layer, a braid or grip layer for rotating wires, an electrically conductive layer, such as an electrically conductive layer connected to an electrical coil or cable, or the like. The outer insulating layer 286 may be made of silicon, polyurethane, or other suitable biocompatible material.

The electrode 220 is electrically connected to the IPG, for example, by an inner conductor 222, which may be disposed within the lead body 210. Inner conductor 222 and/or feed coil 285 may be made of MP35N and/or silver (multi-core) coils or cables, and may be coated with an ETFE coating or other suitable conductive material. Inner conductor 222 may be isolated from feed coil 285 by inner insulating layer 211. It is understood that the inner insulating layer 211 may be the outer layer (e.g., outer layer 111) of the existing CSP wire design described above. The inner insulating layer 211 may be made of silicon, polyurethane, or other suitable biocompatible material. Inner conductor 222 and inner insulating layer 211 are disposed or located within the inner diameters of feed coil 285 and shock coil 280. Thus, the lead 200 may be configured to rotate to provide the necessary contact to insert the electrodes into the ventricular septum or other tissue to make electrical connection with the cardiac conduction system. In one embodiment, a core (e.g., a cone assembly, not shown) may be placed within the spiral space of the second electrode 220. In another embodiment, the second electrode 220 may have no core in the spiral space. The core may be conductive or non-conductive.

Referring back to fig. 1, a shock coil 180 (or 280) is disposed along the lead body 110, spaced from the second electrode 120 or distal end. In one embodiment, the distance between the shock coil 180 and the second electrode 120 or distal end is about 10 millimeters to about 50 millimeters, or more. Thus, when a portion of the lead is implanted into the ventricular septum through the right ventricle, the lead body 110 can be curved, for example, due to the flexibility of the lead body and the length of the slack between the shock coil 180 and the proximal end proximal to the second electrode 120, which curve can be configured to reduce the force exerted on the CSP pacing electrode implanted in the ventricular septum. Thus, when second electrode 120 or electrode 220 is connected to a portion of the ventricular septum, such as at least partially within the right ventricular septum, shock coil 180 is positioned at a different location in the Right Ventricle (RV), such as below second electrode 120 or electrode 220, for example, at the right ventricle and/or along the right ventricular septum wall, as will be discussed further below.

In one embodiment, the lead 100 as shown in fig. 3 and 5 includes a stress relief 190 between the shock coil 180 and the second electrode 120, such as a transition or slack between the electrode coil 180 and the second electrode when implanted. The stress relief portion 190 is configured to relieve stress, such as pressure or force, applied to CSP pacing electrodes, such as the first electrode and the second electrode, implanted in the ventricular septum, such as due to the weight of the RV coil and/or the gravitational effects of the lead body 110 and/or the force caused by movement of the heart during heart beat. Accordingly, the stress relief portion 190 may provide and/or improve long term stability and prevent or reduce dislocation of the first electrode and/or the second electrode to prevent or mitigate the likelihood of tissue perforation.

In one embodiment, the strain relief 190 is made of a softer or more resilient material than the rest of the lead body, such as a flexible polymer or plastic or biocompatible metal, allowing bending between the second electrode and the lead body portion with the shock coil 180 between the shock coil 180 and the second electrode 120. In another embodiment, stress relief portion 190 includes a hinge or hinge-like portion (e.g., with a very soft/resilient and flex fatigue resistant portion) between shock coil 180 and second electrode 120, wherein a pivot is provided that allows flexible bending of lead body 110 at the location without transmitting an unacceptable force to the CSP electrode, such as an unacceptable force causing dislocation of the lead electrode or damage to the myocardium at the implantation site, resulting in an unstable or increased pacing threshold.

In one embodiment, as shown in fig. 3, stress relief portion 190 may be a preformed portion 191 between shock coil 180 and second electrode 120 for providing a specific positioning of shock coil 180, such as a specific location along and "support" of the ventricular septum when the CSP pacing electrode of lead 100 is implanted at the ventricular septum. The proximal end of the lead provides a terminal pin 195 or any suitable control mechanism that can be rotated to drive the inner coil distally to extend or retract the first electrode. The preformed portion 191 is provided at an angle θ of between about 65 degrees and about 105 degrees, with an angle of about 90 degrees being preferred. Thus, when a portion of the lead 100 is connected to the room space by inserting the first lead electrode 160 into the room space and connecting the second lead electrode 120 into the room space, the stress relief portion 190 lessens the force exerted on the CSP electrode to which the distal end of the lead is connected, for example, lessens the downward force caused by the weight of the lead and the shock coil 180. In one embodiment, a fluoroscopic, ultrasound or other imaging mode may be used to measure the length of the ventricular septum and determine and/or select the desired length of the stress-relief portion to position the shock coil 180.

Although specific examples of stress relief portion 190 are discussed herein, these examples are by way of example only and are not intended to limit the scope of the present disclosure. Conversely, other configurations of the strain relief 190 may be used with portions of the lead body 110 and the shock coil 180 in different positions relative to the second electrode 120.

In one embodiment, the outer diameter of the first electrode 160 (linear electrode) may be smaller than the inner diameter of the second electrode 120 (spiral electrode) such that the first electrode 160 and the second electrode 120 are coaxial and/or such that the first electrode 160 is located in the spiral space of the second electrode 120. The length of the first electrode 160 may be about four millimeters. The length of the second electrode 120 may be about four millimeters. Thus, as shown in fig. 1A-1E, the first electrode 160 is disposed within the space inside the second electrode 120 and retracted into the lead body 110 after the second electrode 120 is secured to the compartment, the first electrode 160 may be extended to be further inserted into the compartment so that the lead 100 electrode may reach the corresponding conductive path (e.g., the his bundle, RBB, LBB, etc. of the conductive system).

The implantation and operation of leads for pacing of the cardiac conduction system with defibrillation functionality is discussed below.

As disclosed in U.S. application No. 17/804,705, a catheter may be inserted to reach a specific site of the inter-ventricular septum or other tissue during an implantation procedure. After the desired location is determined, the guide wire 100 may be inserted through an opening extending from the proximal end of the catheter to the distal end of the catheter. A catheter or guidewire may be used to place the distal end of the lead 100 at a desired location. The catheter and/or guidewire may then be removed. In one embodiment, the guide wire 100 may be delivered using, for example, a catheter or catheter sheath, guide wire, and/or guidewire having an inner diameter of 6Fr or greater.

It will be appreciated that positioning the catheter over the ventricular septum may include one or more of the following steps: pulling the first bend wire bends the distal end of the catheter, pulling the second bend wire to further bend the distal end of the catheter, and positioning the tip of the distal end of the catheter perpendicular to the endocardial surface of the ventricular septum.

As shown in fig. 4, lead 100 may be operated to place electrodes at desired locations of the ventricular septum to electrically capture the cardiac conduction system. For example, in one embodiment, the lead 100 may be rotated such that the second electrode 120 (e.g., a spiral electrode) pierces heart tissue (e.g., a ventricular septum) while the first electrode 160 is in a retracted state. For example, in one embodiment, when the second electrode 120 contacts tissue, the lead 100 may be rotated (e.g., clockwise or counterclockwise) to push/deploy the second electrode 120 into the heart tissue.

After the second electrode 120 is inserted into heart tissue, the first electrode 160 (e.g., a linear electrode) of the lead 100 may be inserted into the ventricular septum by extending the first electrode 160 from the lead body 110 from the retracted state to the extended state. In one embodiment, a terminal pin 195 (e.g., an IS-1 pin, DF4, or other type of controller) located at the proximal end of the lead 100 may be rotated to extend and deploy the first electrode 160 into the ventricular septum (e.g., to enable the electrodes of the lead 100 to reach the corresponding conductive pathways of the cardiac conductive system, such as His bundle, RBB, LBB, etc.).

As shown in fig. 5, in one embodiment, first electrode 160 is first implanted deep into the ventricular septum and then second electrode 120 is inserted into the ventricular septum, e.g., to electrically capture the corresponding conductive path, i.e., second electrode 120 corresponds to RBB, first electrode 160 corresponds to LBB, and pressure relief portion 190 is configured such that shock coil 180 is located above or along the surface of the RV ventricular septum and/or in the blood pool in the right chamber. In one embodiment, the pressure relief portion 190 has flexibility such that the weight of the lead 100 and the shock coil 180 causes it to flex at the pressure relief portion 190, for example due to gravity. In another embodiment, the pressure relief portion 190 has a preformed portion 191 so that after the first electrode 160 and the second electrode 120 are connected to the inter-chamber system, the pressure relief portion 190 can position the shock coil 180 at a particular angle, such as 90 degrees, with the shock coil 18 corresponding to or along the surface of the RV chamber interval, or at a particular location in the right chamber. Thus, because at least a portion of the lead 100 including the shock coil 180 is located at a different location, e.g., along the RV chamber separation wall, unlike the first electrode 160 and the second electrode 120, the lead 100 is designed to provide stability and prevent, mitigate tissue dislocation, possibly tearing or perforation due to gravity and/or heart movement (e.g., heart beat).

It will be appreciated that the wire 100 has many beneficial advantages, at least from a structural standpoint of the wire 100, as described herein.

For example, in one embodiment, the configuration of lead 100 is suitable for deep implantation of a first electrode, which may overcome the shortcomings of conventional lead designs in terms of ease of implantation, fixation, and placement into the ventricular septum. Thus, embodiments disclosed herein may help ease wire penetration into the inter-ventricular space (i.e., inter-ventricular space) to locate and find a conductive path such as LBB, may reduce (or create less) cardiac tissue damage, may result in a lower and stable pacing threshold, and may provide a wire connection with long-term stability. That is, the embodiments disclosed herein provide better connection (e.g., when the second electrode 120 is screwed into the compartment) and better electrical performance than conventional leads, and may facilitate easy deep implantation of the lead 100 (deep insertion) and attachment of the lead to the compartment (e.g., the second electrode is at or near the RBB location within the compartment, the first electrode is deep inserted or at the LBB location within the compartment).

In one embodiment, a shock coil 180 is located within the right ventricle, such as an RV coil, for delivering an energy array to the heart to stop the rapid or more rapid beating of the heart, such as ventricular fibrillation.

The CSP lead with defibrillation capabilities may also provide replacement therapy for chronic heart failure patients, particularly for CRT-D therapy patients.

Furthermore, in one embodiment, lead 100 is configured to be adjustable to provide different combinations of pacing vectors, e.g., these components may be used for functions other than those discussed above to provide pacing, sensing, defibrillation, etc. For example, in one embodiment, the shock coil 160 may function as an anode and the second electrode 120 may function as a cathode. Thus, the lead 100 is configured such that the cardiac pacemaker may deliver an energy matrix to the second electrode 120 for pacing or the like.

Various aspects are: it will be appreciated that any one aspect may be used in combination with other aspects.

Aspect 1: a cardiac conduction system pacing lead having defibrillation capabilities, the lead comprising a lead body; the distal end includes a first electrode configured to be inserted into the compartment; the electric shock coil is arranged on the lead body and is separated from the second electrode by a certain distance; and a proximal end.

Aspect 2: the lead according to aspect 1, wherein the first electrode is a linear electrode and the distal end comprises a spacer coupled to the linear electrode, wherein the spacer is adjustable to extend or retract the linear electrode distally or proximally.

Aspect 3: the lead according to aspect 2, wherein the proximal end is configured to be rotatable to adjust the spacer to extend or retract the linear electrode distally or proximally.

Aspect 4: the lead according to any one of aspects 1 to 3, further comprising a second electrode connected to the lead body and a fixing element configured to fix the lead to the inter-chamber portion.

Aspect 5: the lead according to any one of aspects 1 to 4, wherein the second electrode is a spiral electrode and includes a fixing element configured to be fixed to the inter-compartmental portion by rotating the lead to the inter-compartmental portion.

Aspect 6: the lead according to any one of aspects 1 to 5, wherein the lead further comprises a stress relief portion between the shock coil and the distal end, spacing the shock coil from the distal end.

Aspect 7: the lead according to aspect 6, wherein the stress relief portion is flexible such that when connected to the inter-chamber portion, the stress relief portion is configured such that the shock coil is in a different position than the second electrode.

Aspect 8: the lead according to aspect 6, wherein the stress relief portion is a preformed portion such that the shock coil is disposed at an angle to the second electrode.

Aspect 9: the lead according to aspect 8, wherein the angle is between about 65 degrees and about 105 degrees.

Aspect 10: the lead according to aspect 9, wherein the angle is 90 degrees.

Aspect 11: the lead according to any one of aspects 1 to 10, wherein the first electrode is a cathode and the second electrode is an anode.

Aspect 12: the lead according to any one of aspects 1 to 10, wherein the second electrode is a cathode and the shock coil is an anode.

Aspect 13: the lead according to any one of aspects 1 to 12, the shock coil being spaced from the distal end by a distance of between about 10 mm and about 50 mm.

Aspect 14: the lead according to any one of aspects 1 to 13, wherein a diameter of the shocking coil is smaller than a diameter of an outer surface of the lead.

Aspect 15: the lead according to any one of claims 1 to 13, wherein the diameter of the shocking coil is the same as or greater than the diameter of the outer surface of the lead.

Aspect 16: the lead according to any one of aspects 14 to 15, wherein the diameter of the shock coil is between about 5Fr and about 9 Fr.

Aspect 17: the lead according to any of claims 1 to 16, wherein the surface area of the shocking coil is between about 350mm2 and about 650mm 2.

The terminology used in the description is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms "a," "an," and "the" also include plural referents unless the context clearly dictates otherwise. The terms "comprises" and/or "comprising" when used in this specification specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, and/or components.

With respect to the foregoing description, it will be appreciated that modifications may be made in detail, especially in matters of the materials of construction employed as well as the shapes, sizes and arrangement of the components without departing from the scope of the present disclosure. The specification and described embodiments are exemplary only, with a true scope and spirit being indicated by the following claims.

Claims

1. A lead for cardiac conduction system pacing having defibrillation capabilities, the lead comprising: a lead body;

the distal end includes a first electrode configured to be inserted into a portion of a ventricular septum;

an electric shock coil mounted on the lead body and spaced apart from the second electrode by a certain distance; and

a proximal end.

2. The lead of claim 1, wherein the first electrode is a linear electrode and the distal end comprises a spacer coupled to the linear electrode and the spacer is adjustable to extend the linear electrode distally or retract the linear electrode proximally.

3. The lead of claim 2, wherein the proximal end is configured to be rotatable to adjust the spacer to extend the linear electrode distally or retract the linear electrode proximally.

4. The lead of claim 1, further comprising a second electrode coupled to the lead body and a fixation element configured to secure the lead to the portion of the ventricular septum.

5. The lead of claim 4, wherein the second electrode is a spiral electrode and comprises a fixation element configured to be fixed to the ventricular septum portion by threading the lead into the ventricular septum.

6. The lead of claim 1, wherein the lead further comprises a strain relief portion between the shock coil and the distal end such that the shock coil is spaced a distance from the distal end.

7. The lead of claim 6, wherein the strain relief portion is flexible such that when connected to the ventricular spaced portion, the strain relief portion is configured to position the shock coil at a different location relative to the distal end.

8. The lead of claim 6, wherein the strain relief portion is a preformed portion such that the shock coil forms an angle with the distal end.

9. The lead of claim 8, wherein the angle is between about 65 degrees and about 105 degrees.

10. The lead of claim 9, wherein the angle is about 90 degrees.

11. The lead of claim 4, wherein the first electrode is a cathode and the second electrode is an anode.

12. The lead of claim 4, wherein the second electrode is a cathode and the shock coil is an anode.

13. The lead of claim 1, wherein the shock coil is spaced from the distal end a distance of about 10 millimeters to about 50 millimeters.

14. The lead of claim 1, wherein the diameter of the shock coil is less than the diameter of the outer surface of the lead.

15. The lead of claim 1, wherein the diameter of the shock coil is the same as or greater than the diameter of the outer surface of the lead.

16. The lead of claim 13, wherein the diameter of the shock coil is between about 5Fr and about 9 Fr.

17. The lead of claim 1, wherein the surface area of the shock coil is between about 350mm2 and about 650mm 2.