Patent Description:
The present disclosure pertains to medical devices, and methods for manufacturing and/or using medical devices. More particularly, the present disclosure pertains to leadless cardiac devices and methods, such as leadless cardiac pacing devices and methods, and delivery and retrieval devices and methods for such leadless devices.

A wide variety of medical devices have been developed for medical use, for example, cardiac use. Some of these devices include catheters, leads, pacemakers, and the like, and delivery devices and/or systems used for delivering such devices. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices, delivery systems, and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and delivery devices as well as alternative methods for manufacturing and using medical devices and delivery devices.

<CIT> Al discusses a catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.

<CIT> Al discusses a catheter system having a snare assembly to capture the leadless pacemaker. The catheter system includes sheaths extending distally from a shaft, and the snare assembly includes several snare legs, such as segments of snare loops, that extend from one sheath to connect to another sheath.

An implantation and/or retrieval device for a leadless cardiac pacing device comprises: a first elongate shaft including a lumen; a second elongate shaft slidably disposed within the lumen of the first elongate shaft; an end cap assembly fixedly attached to a distal end of the first elongate shaft; and a plurality of wires attached to the second elongate shaft and extending distally from the end cap assembly, the plurality of wires being movable relative to the end cap assembly. The plurality of wires is configured to engage a proximal hub of the leadless cardiac pacing device. The plurality of wires forms a plurality of wire loops extending distally from the end cap assembly.

In addition, the end cap assembly includes an insert secured within an outer housing, the outer housing being fixedly attached to the distal end of the first elongate shaft.

In addition, the insert includes a plurality of bores extending through the insert, wherein the plurality of bores is configured to receive the plurality of wires.

It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the claimed invention. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate example embodiments of the claimed invention. However, in the interest of clarity and case of understanding, while every feature and/or element may not be shown in each drawing, the feature(s) and/or element(s) may be understood to be present regardless, unless otherwise specified. Embodiments, which are in contradiction to the subject-matter of claim <NUM>, are not part of the invention.

Cardiac pacemakers provide electrical stimulation to heart tissue to cause the heart to contract and thus pump blood through the vascular system. Conventional pacemakers typically include an electrical lead that extends from a pulse generator implanted subcutaneously or sub-muscularly to an electrode positioned adjacent the inside or outside wall of the cardiac chamber. As an alternative to conventional pacemakers, self-contained or leadless cardiac pacemakers have been proposed. Leadless cardiac pacemakers are small capsules typically fixed to an intracardiac implant site in or around a cardiac chamber. The small capsule typically includes bipolar pacing/sensing electrodes, a power source (e.g., a battery), and associated electrical circuitry for controlling the pacing/sensing electrodes, and thus provide electrical stimulation to heart tissue and/or sense a physiological condition. In some cases, the leadless cardiac pacemakers may include a proximal and/or a distal extension extending from the small capsule, where the extension(s) may include one or more pacing/sensing electrodes. The capsule may be delivered to the heart using a delivery device which may be advanced through a femoral vein, into the inferior vena cava, into the right atrium, and into the coronary sinus and vessels extending through and/or to the coronary sinus. Accordingly, it may be desirable to provide cardiac pacing devices and delivery devices which facilitate advancement through the vasculature.

The leadless cardiac pacing device described herein may detect and treat cardiac arrhythmias, and more particularly, deliver electrical stimulation therapy to a right atrium, left atrium, right ventricle, and/or a left ventricle of a heart of a patient. For instance, one or more devices may be implanted on or within a patient's heart, and the one or more devices may be configured to deliver electrical stimulation therapy to one or more chambers of the patient's heart in accordance with one or more therapy programs and/or to treat one or more types of detected cardiac arrhythmias. Some example electrical stimulation therapies include bradycardia therapy, cardiac resynchronization therapy (CRT), anti-tachycardia pacing (ATP) therapy, defibrillation and/or cardioversion therapy, and the like. Some example cardiac arrhythmias include atrial fibrillation or atrial flutter, ventricular fibrillation, and tachycardia.

Although various features of a leadless cardiac pacing device are described herein, alternative and/or additional features of an example leadless cardiac pacing device are discussed in <CIT>; and <CIT>.

<FIG> is a conceptual diagram of an illustrative system for delivering electrical stimulation therapy to a patient's heart, including delivering electrical stimulation therapy to a right atrium, left atrium, right ventricle, and/or a left ventricle of the patient's heart. <FIG> shows an illustrative leadless cardiac pacing device <NUM> implanted in and around heart <NUM>. Heart <NUM> of <FIG> is depicted showing a right atrium <NUM>, a left atrium <NUM>, a right ventricle <NUM>, a left ventricle <NUM>, a coronary sinus <NUM>, a coronary sinus ostium <NUM>, a great cardiac vein <NUM>, and a septum <NUM>. In <FIG>, the coronary sinus <NUM> and the great cardiac vein <NUM> are depicted in broken lines as these features are on the posterior side of the heart <NUM> and would not typically be viewable from the view of <FIG>. Although the leadless cardiac pacing device <NUM> is shown implanted and extending into the coronary sinus <NUM> and at least part of the leadless cardiac pacing device <NUM> typically would not be viewable from the view of <FIG>. an entirety of the leadless cardiac pacing device <NUM> is depicted in solid lines for clarity purposes. In some instances, about <NUM>% of the length of the body <NUM> of the leadless cardiac pacing device <NUM> is inserted into the coronary sinus <NUM>. with the proximal end region of the body <NUM> positioned in the right atrium <NUM>. In some instance about <NUM>%-<NUM>% of the distalmost portion of the length of the body <NUM> of the leadless cardiac pacing device <NUM> may be inserted into the coronary sinus <NUM>, with the remaining proximal end region of the body <NUM> positioned in the right atrium <NUM>.

In the example of <FIG>, the leadless cardiac pacing device <NUM> includes a body <NUM> having a proximal end and a distal end and a distal extension <NUM> extending distally of the distal end of the body <NUM>. However, in some instances, the distal extension <NUM> may not be included and/or one or more other distal and/or proximal extensions may be included. The body <NUM> need not have the same cross-sectional shape along its entire length When implanted, the body <NUM> may be fully or partially disposed within the coronary sinus <NUM> of the patient's heart <NUM>, while the distal extension <NUM> may be fully or partially disposed within a vessel extending from the coronary sinus <NUM> (e.g., the great cardiac vein <NUM>, an anterior interventricular vein, another laterally descending vessel, etc.).

The body <NUM> may have any dimension suitable for implantation at a target location within the heart <NUM> of a patient. In one example, the body <NUM> may have a cross-sectional diameter or area sufficient to fit within the coronary sinus <NUM>, which may vary between about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>). A diameter of the body <NUM> may range, in different embodiments, between about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>). The body <NUM> may be sized to be implanted within different sized coronary sinuses while still allowing sufficient blood flow through the coronary sinus <NUM>.

In some embodiments, the leadless cardiac pacing device <NUM> may include one or more electrodes. In one example, the body <NUM> of the leadless cardiac pacing device <NUM> may support a first electrode <NUM> and a second electrode <NUM>, while the distal extension <NUM> may support a distal electrode. In some cases, the distal extension <NUM> may include a plurality of electrodes (e.g.. a first proximal ring electrode <NUM>, a second proximal ring electrode <NUM>. a third proximal ring electrode <NUM>, a distal ring electrode <NUM>, and/or one or more other electrodes). Although the electrodes described may be indicated as being ring electrodes, other electrode types may be utilized depending on the application.

In some cases, the first electrode <NUM> may be formed on, along, and/or from the body <NUM> and the second electrode <NUM> may be formed on, along, and/or from a fixation member <NUM> (discussed in greater detail below) extending from the body <NUM>. In one example, the body <NUM> may be at least partially formed from an electrically conductive material and an exposed surface of such electrically conductive material may form, at least in part, the first electrode <NUM>. Additionally, or alternatively, the second electrode <NUM> may be formed from one or more exposed electrically conductive surface portions of the fixation member <NUM> that may be exposed to cardiac tissue of the patient. Various arrangements for the electrodes <NUM>, <NUM>, including location, shape, material(s), etc. are contemplated. Alternative and/or additional electrode configurations for a leadless cardiac pacing device <NUM> are discussed in the references mentioned herein.

When provided, the electrodes of the leadless cardiac pacing device <NUM> may be used to deliver electrical stimulation to heart <NUM>, and/or sense one or more physiologic signals. In some cases, the leadless cardiac pacing device <NUM> may use one or more of the electrodes (e.g., electrodes <NUM>-<NUM> or other electrodes) to communicate with one or more other devices, such as, but not limited to, one or more other leadless cardiac pacemakers and/or an implantable cardioverter defibrillator. In some instances, the leadless cardiac pacing device <NUM> may communicate using conducted communication techniques and may deliver and/or receive communication signals through one or more of the electrodes (e.g., the electrodes <NUM>-<NUM> or other electrodes). In some embodiments, the leadless cardiac pacing device <NUM> may include one or more communication wires configured to operate as antenna for wireless communication with and/or to receive electrical energy from one or more other devices.

In some instances, the leadless cardiac pacing device <NUM> may include a neck portion extending longitudinally from the body <NUM> to a proximal hub <NUM> (e.g., a docking hub or other member) disposed generally proximal of the body <NUM>. During implantation, the proximal hub <NUM> may be releasably coupled to an implantation and/or retrieval device (not shown in <FIG>). When coupled, movement of the implantation and/or retrieval device may translate to the leadless cardiac pacing device <NUM> and/or the body <NUM>. thereby allowing a user, such as a physician, to maneuver the leadless cardiac pacing device <NUM> and/or the body <NUM> into position within the heart <NUM>, for example into or proximate the coronary sinus <NUM>. The implantation and/or retrieval device may be capable of longitudinally and/or rotationally manipulating the leadless cardiac pacing device <NUM>.

In some instances, the leadless cardiac pacing device <NUM> may be delivered from a delivery catheter (not shown in <FIG>), and the portion of the delivery catheter surrounding the body <NUM> may conform to the body <NUM> to create a secure connection between the delivery catheter and the body <NUM>. When the leadless cardiac pacing device <NUM> is in position, the delivery catheter may be retracted, or the implantation and/or retrieval device may be used to push the body <NUM> out of the delivery catheter and/or otherwise adjust a position of the leadless cardiac pacing device <NUM>. In some embodiments, the implantation and/or retrieval device may apply rotational torque to the body <NUM> to anchor the leadless cardiac pacing device <NUM> to cardiac tissue.

Although the distal extension <NUM> is depicted in <FIG>, in some instances, the leadless cardiac pacing device <NUM> may not include the distal extension <NUM>. Where the leadless cardiac pacing device <NUM> includes the distal extension <NUM>. the distal extension <NUM> may extend distally from the distal end of the body <NUM>. Further, when included, the distal extension <NUM> may extend into the coronary sinus <NUM> and be secured within the coronary sinus <NUM>. In some cases, the distal extension <NUM> may extend through the coronary sinus <NUM> and into the great cardiac vein <NUM>, as depicted in <FIG>, or one or more other vessels extending from the coronary sinus <NUM> or great cardiac vein <NUM>.

The distal extension <NUM> may include a proximal end 24a and a distal end 24b. The distal end 24b of the distal extension <NUM> may include one or more engaging members, but this is not required. The engaging members, when included, may help secure the distal end 24b of the distal extension <NUM> within the coronary sinus <NUM> or the great cardiac vein <NUM>, and/or may include one or more electrodes or wire loops and may act as an antenna to communicate with and/or receive electrical energy from one or more other devices. For example, the leadless cardiac pacing device <NUM> may receive an energy transfer and/or communicate using inductive and/or conductive communication techniques through electrodes and/or wire loops of the engaging member.

In some embodiments, the electrodes <NUM>-<NUM> on the distal extension <NUM> may be used to deliver electrical stimulation to the heart <NUM>. For example, the leadless cardiac pacing device <NUM> may deliver electrical stimulation to the left ventricle <NUM> of heart <NUM> through a set of one or more of electrodes (e.g., a set from the electrodes <NUM>-<NUM> or other electrodes). In some embodiments, the leadless cardiac pacing device <NUM> may deliver electrical stimulation to the left ventricle <NUM> of the heart <NUM> using two or more of the electrodes <NUM>-<NUM> either simultaneously or with a delay (e.g. via multi-electrode pacing). In some embodiments, the leadless cardiac pacing device <NUM> may use one or more of the electrodes <NUM>-<NUM> to communicate with one or more other devices (e.g.. the electrodes <NUM>-<NUM> may act as an antenna). For example, the leadless cardiac pacing device <NUM> may receive an energy transfer and/or communicate using inductive or conductive communication techniques through one or more of the electrodes <NUM>-<NUM>.

The electrodes <NUM>-<NUM> and/or other electrodes on the leadless cardiac pacing device <NUM> may be able to sense electrical signals, provide electrical stimulation signals, or sense electrical signals and provide electrical stimulation signals. Signal processing, communication, and/or therapy pulse generation may take place at any portion of the leadless cardiac pacing device where the appropriate processing modules may be located. In one example, signal processing, communication, and therapy pulse generation for the electrodes (e.g., electrodes <NUM>-<NUM> and/or other electrodes) of the leadless cardiac pacing device <NUM> may take place in modules within or supported by the body <NUM>.

In some embodiments, the leadless cardiac pacing device <NUM> may be implanted as a single device (e.g., without additional leadless cardiac pacing devices or one or more implantable cardioverter defibrillators), which may provide electrical stimulation to the right atrium <NUM>. the left atrium <NUM>, right ventricle <NUM>, and/or the left ventricle <NUM>. as desired. For example, the leadless cardiac pacing device <NUM> may be configured to deliver electrical stimulation in accordance with a therapy program to treat atrial fibrillation or atrial flutter. In other cases, the leadless cardiac pacing device <NUM> may be implanted with other leadless cardiac pacing devices and/or one or more implantable cardioverter defibrillators implanted at one or more locations in and/or around the heart <NUM>.

<FIG> is a schematic diagram of the illustrative leadless cardiac pacing device <NUM>. In some embodiments, the body <NUM> may generally include a biocompatible material, such as a biocompatible metal and/or polymer, and may hermetically seal the components of the leadless cardiac pacing device <NUM> against fluid intrusion. The body <NUM> depicted in <FIG> may have a generally straight elongated shape extending along a central longitudinal axis. In some instances, the body <NUM> may be substantially cylindrical. The body <NUM>, however, may take on one or more other suitable shapes including, but not limited to, having a bent or angled portion to facilitate engaging tissue of the heart <NUM> with electrodes of the leadless cardiac pacing device <NUM>. Additional or alternative shape configurations for the body <NUM> are discussed in the references mentioned herein.

As discussed above, the leadless cardiac pacing device <NUM> may have one or more electrodes, such as electrodes <NUM>. <NUM> and/or other electrodes, which in the example shown, are supported by the body <NUM> as described herein. It is contemplated in some cases that the body <NUM> may have a different number of electrodes, or no electrodes at all.

In some embodiments, the leadless cardiac pacing device <NUM> may include a neck portion <NUM> extending from a proximal end of the body <NUM> to the proximal hub <NUM>. In some cases, the neck portion <NUM> may have a first outer extent and a proximal end of the neck portion <NUM> may be connected to the proximal hub <NUM> having a second outer extent. In some examples, the second outer extent of the proximal hub <NUM> may be greater than the first outer extent of the neck portion <NUM>. Other configurations are also contemplated.

During implantation, as discussed in greater detail below with respect to <FIG>, an implantation and/or retrieval device (e.g., <FIG>) may releasably engage with and/or couple to the proximal hub <NUM>. When coupled, movement of the implantation and/or retrieval device may transfer to the body <NUM>, thereby allowing a user to longitudinally position and/or rotate the leadless cardiac pacing device <NUM> during implantation. In some cases, instead of or in addition to the neck portion <NUM> and the proximal hub <NUM>, the leadless cardiac pacing device <NUM> may include one-half of an interlocking mechanism, and the implantation and/or retrieval device may have the second half of the interlocking mechanism, which may releasably couple to the interlocking mechanism of the leadless cardiac pacing device <NUM>. Interlocking mechanisms may be configured to create a magnetic connection, a keyed connection, and/or other suitable connections. Additional and/or alternative interlocking mechanisms are described in the references mentioned herein.

In some instances, the body <NUM> may include the fixation member <NUM> and/or the fixation member <NUM> may extend from the body <NUM> opposite the proximal hub <NUM>. In some embodiments, the fixation member <NUM> may be a helical fixation member and may include a distal tip <NUM>, as depicted in <FIG>, and may be configured to maintain the leadless cardiac pacing device <NUM> within the coronary sinus <NUM> when the leadless cardiac pacing device <NUM> is implanted within the coronary sinus <NUM> of the heart <NUM>. In some instances, the fixation member <NUM> is a helical coil that may have an outer diameter in the range of about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>) and a pitch of about <NUM> (<NUM>) to about <NUM> inches (<NUM>) for at least one revolution around the helical coil, but in some embodiments, the helical fixation member <NUM> may take on one or more different diameters and/or a different suitable pitch. The fixation member <NUM> may be formed from a material having a diameter suitable for penetrating and engaging tissue of a heart, conducting electricity, and/or for being flexible or bendable. Additional dimensions and/or features of the fixation member <NUM> are described in the references mentioned herein.

The fixation member <NUM> may be secured to the body <NUM> in any suitable manner. In one example, a proximal portion of the fixation member <NUM> (e.g., a proximal portion of the helical coil) may be embedded (e.g., molded) within the body <NUM> and a distal portion (e.g., a distal portion of the helical coil) of the fixation member <NUM> may extend from the body <NUM> and may be configured to engage cardiac tissue of the patient when the leadless cardiac pacing device is positioned in the patient. The distal portion of the fixation member <NUM> may be configured to extend about <NUM> revolutions to about <NUM> revolutions (or any amount therebetween) about the body <NUM>. The fixation member <NUM> may be configured, at least in part, from a material that is configured to penetrate and engage tissue of a heart, that is electrically conductive, that is radiopaque, and/or that is flexible and/or has shape memory properties. Some suitable but non-limiting examples of materials for the fixation member <NUM> are described below.

In some cases, the fixation member <NUM> may be able to straighten or elongate from the helical configuration when the fixation member <NUM> is engaging tissue and an axial force is applied to the leadless cardiac pacing device <NUM>. In some instances, the fixation member <NUM> may be plastically deformed and elongated into a straightened configuration from its helical configuration when subjected to an axial force. Such a configuration of the fixation member <NUM> may facilitate removal of the leadless cardiac pacing device <NUM> and may reduce risk causing damage to the patient due to perforation or bruising.

Although one fixation member <NUM> is depicted on the body <NUM> in the Figures, the body <NUM> may support one or more additional fixation members that are axially spaced from the fixation member <NUM>. In other instances, the body <NUM> may not include a fixation member <NUM>. In some cases, as discussed above, the fixation member <NUM> may include or form one or more electrodes (e.g., the second electrode <NUM> or other suitable electrode) and/or may act as an antenna to communicate with and/or receive electrical energy from one or more other devices. For example, the leadless cardiac pacing device <NUM> may receive an energy transfer and/or communicate using inductive and/or conductive communication techniques through electrodes of the fixation member <NUM>.

In at least some cases, the body <NUM> may have a guide wire port <NUM> extending through and/or opening out to a side of the body <NUM>, where the side extends from a first end to a second end of the body <NUM>. In some cases, the guide wire port <NUM> may be configured to receive a guide wire. Where the leadless cardiac pacing device <NUM> includes the distal extension <NUM>, the distal extension <NUM> may include a corresponding guide wire port at a distal tip of the distal end 24b of the distal extension <NUM>. In such instances, a guide wire may be placed down the great cardiac vein <NUM> (or other vessel in communication with the coronary sinus <NUM>). The leadless cardiac pacing device <NUM> may be tracked over the guide wire by threading the distal extension <NUM> over a proximal end of the guide wire, and then advancing the leadless cardiac pacing device <NUM> over the guide wire until in position. In embodiments where the leadless cardiac pacing device <NUM> does not include the distal extension <NUM>, the body <NUM> may include a second guide wire port.

When included, the distal extension <NUM> may extend from the body <NUM> at any suitable angle. In some cases, the distal extension <NUM> may extend from the body <NUM> at an angle relative to a central longitudinal axis of the body <NUM>. In some embodiments, the angle may be an oblique angle, such that the distal extension <NUM>, while in an unconstrained state with no extemal forces applied to bend or flex the distal extension <NUM>, extends from the body <NUM> at a non-parallel angle to the central longitudinal axis of the body <NUM>. In some instances, the oblique angle may be in the range of <NUM> degrees to <NUM> degrees. In some cases, the distal extension <NUM> may extend distally from the body <NUM> toward a circumferential side of the body <NUM> opposite from the guide wire port <NUM>.

The distal extension <NUM> may be a thin, elongated, and flexible member, particularly in relation to the body <NUM>. For instance, the distal extension <NUM> may be between two and ten times the length of the body <NUM>. In some embodiments, the electrodes <NUM>-<NUM> and/or other electrodes may be disposed proximate the distal end 24b of the distal extension <NUM> or may be spread out along the length of distal extension <NUM> (e.g., longitudinally spaced from one another), as shown in <FIG>. Other arrangements and/or configurations of electrodes on the distal extension <NUM> are contemplated and may be utilized. In one example arrangement, each of the electrodes may be ring electrodes and the electrode <NUM> (e.g., a distal ring electrode) may be disposed on the distal extension <NUM> near a distal tip of the distal extension <NUM>. the electrode <NUM> (e.g., a third proximal ring electrode) may be spaced forty (<NUM>) millimeters proximal of the electrode <NUM>, the electrode <NUM> (e.g., a second proximal ring electrode) may be spaced ten (<NUM>) millimeters proximal of the electrode <NUM>, and the electrode <NUM> (e.g., a first proximal ring electrode) may be spaced ten (<NUM>) millimeters proximal of the electrode <NUM>. Such a configuration of electrodes <NUM>-<NUM> may align with the left atrium <NUM> when the distal extension <NUM> is inserted into the great cardiac vein <NUM> or other vessel to allow the leadless cardiac pacing device <NUM> to sense and/or pace the left atrium <NUM> of the heart <NUM>. In some cases, the distal extension <NUM> may be biased to form a shape such as a helical coil or one or more loops.

<FIG> illustrates aspects of a system for implantation and/or retrieval of the leadless cardiac pacing device <NUM>. In some embodiments, the system may include a catheter <NUM> (e.g., <FIG>) having a lumen extending therethrough. In some embodiments, the catheter <NUM> may be a delivery sheath, a retrieval sheath, or a combination thereof. In some embodiments, the system and/or selected components thereof may be referred to as an implantation and/or retrieval device for a leadless cardiac pacing device. Accordingly, any reference to the system, except as will be apparent, may also apply to an implantation and/or retrieval device, and vice versa. In some embodiments, not all elements described herein are necessary for the disclosed system to properly function. For example, the catheter <NUM> may be considered an optional element and/or feature in some embodiments.

A system <NUM> may include a first elongate shaft <NUM> including a lumen extending therethrough and extending distally from a proximal handle <NUM>. The first elongate shaft <NUM> may be a tubular member and/or may be annular with a wall defining the lumen extending therethrough. The first elongate shaft <NUM> may be slidably disposed within the lumen of the catheter <NUM>. The proximal handle <NUM> may include one or more actuation elements <NUM> configured to deflect and/or steer a distal end of the first elongate shaft <NUM>, from side to side for example. In one example configuration, movement and/or translation (e.g., longitudinal, rotational, etc.) of the one or more actuation elements <NUM> may change tension characteristics applied to the first elongate shaft <NUM>, such as by a pull wire or other suitable means. Other means of steering the first elongate shaft <NUM> are also contemplated. Some suitable, but non-limiting, examples of materials for the proximal handle <NUM>, the first elongate shaft <NUM>. and/or the one or more actuation elements <NUM> are discussed below.

In some embodiments, the system <NUM> may include an elongate member <NUM> slidably disposed within the lumen of the first elongate shaft <NUM>. In <FIG>, only a proximal end of the elongate member <NUM> is visible. The elongate member <NUM> may be tubular in construction and may include a lumen extending therethrough. The elongate member <NUM> may be sized and configured to extend distally through the proximal handle <NUM> and into the first elongate shaft <NUM>. In some embodiments, a distal end of the elongate member <NUM> may be positioned proximate the distal end of the first elongate shaft <NUM>. Since the elongate member <NUM> is slidable relative to the first elongate shaft <NUM>, the exact positioning of the elongate member <NUM> with respect to the first elongate shaft <NUM> may be varied according to need. In some embodiments, the elongate member <NUM> may serve as a stiffening device within the first elongate shaft <NUM>. In some embodiments the elongate member <NUM> may reduce and/or prevent axial collapse, shortening, prolapse, and/or compression of the first elongate shaft <NUM> and/or another element that may be slidably disposed within the lumen of the elongate member <NUM> (such as the second elongate shaft described herein) when it is under tension, torque, compression, etc. In some embodiments, the elongate member <NUM> may have a greater column strength and/or a greater axial and/or lateral stiffness than the first elongate shaft <NUM> and/or another element slidably disposed within the elongate member <NUM> (e.g., the second elongate shaft). Some suitable, but non-limiting, examples of materials for the elongate member <NUM> are discussed below.

In some embodiments, the system <NUM> may include one or more irrigation ports. In one example, the system <NUM> may include a first irrigation port I <NUM> fluidly connected to the proximal handle <NUM> and configured to irrigate and/or flush the lumen of the first elongate shaft <NUM>. With the elongate member <NUM> in place within the lumen of the first elongate shaft <NUM>, the first irrigation port <NUM> may be configured to irrigate and/or flush between an outer surface of the elongate member <NUM> and an inner surface of the lumen of the first elongate shaft <NUM>. In some embodiments, the system <NUM> may include a second irrigation port <NUM> fluidly connected to the elongate member <NUM> and configured to irrigate and/or flush the lumen of the elongate member <NUM>. In at least some embodiments, both the first irrigation port <NUM> and the second irrigation port <NUM> may be present and/or utilized. In some embodiments, neither of the first irrigation port <NUM> and the second irrigation port <NUM> may be present and/or utilized. Additional and/or other irrigation ports may be added and/or used as needed. In some embodiments, the system <NUM> may include a proximal port <NUM>. In some embodiments, the proximal port <NUM> may be and/or may include a sealing structure configured to prevent fluid communication with an interior of the proximal handle <NUM> and/or the lumen of the first elongate shaft <NUM>, and/or fluid leakage therefrom. Some suitable, but non-limiting, examples of materials for the first irrigation port <NUM>, the second irrigation port <NUM>, and/or the proximal port <NUM> are discussed below.

The system <NUM> may include a second elongate shaft <NUM> slidably disposed within the lumen of the first elongate shaft <NUM> and/or the elongate member <NUM>. In some embodiments, the second elongate shaft <NUM> may include a first proximal handle <NUM> disposed proximal of the proximal port <NUM> and/or the proximal handle <NUM>. In some embodiments, the second elongate shaft <NUM> may include a second proximal handle <NUM> disposed proximal of the first proximal handle <NUM>. In some embodiments, the second proximal handle <NUM> may be fixedly attached to the second elongate shaft <NUM> at and/or proximate a proximal end of the second elongate shaft <NUM>. The first proximal handle <NUM> may be slidable on the second elongate shaft <NUM> and may selectively lockable to the second elongate shaft <NUM> at a variable position along the second elongate shaft <NUM> selected by the user. In some embodiments, locking the first proximal handle <NUM> to the second elongate shaft <NUM> may limit axial movement of the second elongate shaft <NUM> relative to the handle <NUM>, the first elongate shaft <NUM>, the elongate member <NUM>, and/or the proximal port <NUM>. For example, when the first proximal handle <NUM> is locked to the second elongate shaft <NUM>, the first proximal handle <NUM> may contact and/or interfere with the proximal port <NUM> (or a proximal surface of the proximal handle <NUM> and/or the elongate member <NUM>, where present), thereby preventing further distal translation of the second elongate shaft <NUM> relative to the handle <NUM>, the first elongate shaft <NUM>. the elongate member <NUM>, and/or the proximal port <NUM>. Additional and/or other reasons for locking the first proximal handle <NUM> to the second elongate shaft <NUM> will become apparent. In at least some embodiments, the second elongate shaft <NUM> may be a tubular member, such as a hypotube or other similar structure, having a lumen extending therethrough. In some embodiments, the second elongate shaft +<NUM> may be a solid shaft or wire devoid of any lumens disposed therein. Some suitable, but non-limiting, examples of materials for the second elongate shaft <NUM>, the first proximal handle <NUM>, and/or the second proximal handle <NUM> are discussed below.

The system <NUM> includes an end cap assembly <NUM> disposed at a distal end of the first elongate shaft <NUM>. The end cap assembly <NUM> includes an outer housing <NUM> fixedly attached to the distal end of the first elongate shaft <NUM> and an insert <NUM> secured within the outer housing <NUM>, as shown in <FIG>. In some embodiments, a distalmost surface of the insert <NUM> is flush with a distalmost end surface of the outer housing <NUM>. In some embodiments, the distalmost surface of the insert <NUM> is parallel and/or coplanar with the distalmost end surface of the outer housing <NUM>. The insert includes a plurality of bores <NUM> extending through the insert <NUM>. In some embodiments, the plurality of bores <NUM> may be oriented and/or may extend generally longitudinally through the insert <NUM>. In at least some embodiments, the plurality of bores <NUM> may open distally and/or through the distalmost surface of the insert <NUM>. Some suitable, but non-limiting, examples of materials for the end cap assembly <NUM>, the outer housing <NUM>, and/or the insert <NUM> are discussed below.

The system <NUM> may include a plurality of wires <NUM> attached to the second elongate shaft <NUM> and extending distally from the end cap assembly <NUM>. While not explicitly shown, the plurality of wires <NUM> may be attached (e.g., fixedly attached, welded, bonded, etc.) to the second elongate shaft <NUM> at a location within the lumen of the first elongate shaft <NUM> and/or the elongate member <NUM>. In some embodiments, the location may be proximate the distal end of the first elongate shaft <NUM> and/or the elongate member <NUM>. In some embodiments, the location may be along a middle portion (e.g., from about <NUM>/<NUM> to about <NUM>/<NUM> of an overall length) of the first elongate shaft <NUM> and/or the elongate member <NUM>. The plurality of wires <NUM> may be movable relative to the end cap assembly <NUM> via translation and/or movement of the second elongate shaft <NUM> relative to the first elongate shaft <NUM> and/or the elongate member <NUM>. In some embodiments, the plurality of wires <NUM> may be movable and/or translatable through the end cap assembly <NUM> between a first position (e.g., <FIG>) and a second position (e.g., <FIG>) distal of the first position. Some suitable, but non-limiting, examples of materials for the plurality of wires <NUM> are discussed below.

The plurality of wires <NUM> may be configured to engage the proximal hub <NUM> of the leadless cardiac pacing device <NUM>. In some embodiments, the plurality of wires <NUM> may form a plurality of wire loops <NUM> distal of and/or extending distally from the end cap assembly <NUM>. In some embodiments, the plurality of wire loops <NUM> may be translatable between a first position and a second position distal of the first position In some embodiments, the plurality of wire loops <NUM> may be configured to engage the proximal hub <NUM> of the leadless cardiac pacing device <NUM> in the first position. In some embodiments, the plurality of wire loops <NUM> may be configured to secure the proximal hub <NUM> of the leadless cardiac pacing device <NUM> relative to the end cap assembly <NUM> in the first position. In some embodiments, the plurality of wire loops <NUM> may be configured to secure the proximal hub <NUM> of the leadless cardiac pacing device <NUM> against the distalmost surface of the insert <NUM> in the first position. The plurality of bores <NUM> may be configured to receive the plurality of wires <NUM>. In some embodiments, the plurality of wires <NUM> may extend through the plurality of bores <NUM>. In some embodiments, the plurality of wires <NUM> may be movable and/or translatable through the plurality of bores <NUM> via translation and/or longitudinal movement of the second elongate shaft <NUM> relative to the first elongate shaft <NUM> and/or the second proximal handle <NUM> relative to the first proximal handle <NUM>. In some embodiments, the second proximal handle <NUM> may be spaced proximally apart from the first proximal handle <NUM> when the plurality of wires <NUM> and/or the plurality of wire loops <NUM> is in the first position (e.g., <FIG>). In some embodiments, the plurality of wires <NUM> and/or the plurality of wire loops <NUM> is configured to transfer rotational motion of the first elongate shaft <NUM> to the proximal hub <NUM> in the first position for implantation and/or retrieval of the leadless cardiac pacing device <NUM>.

In at least some embodiments, the configuration of <FIG> may be seen and/or utilized before and/or during delivery of the leadless cardiac pacing device <NUM>. wherein the proximal hub <NUM> of the leadless cardiac pacing device <NUM> is secured relative to and/or against the end cap assembly <NUM> for navigation to the target site. In some embodiments, the configuration shown in <FIG> may be seen and/or utilized during retrieval of the leadless cardiac pacing device <NUM>, wherein the leadless cardiac pacing device <NUM> has been re-captured.

<FIG> illustrates a cross-section taken along line <NUM>-<NUM> in <FIG>. In some embodiments, each of the plurality of wire loops <NUM> may include and/or define a distal end segment <NUM>. In some embodiments, the distal end segment <NUM> may extend between a pair (e.g., two) of the plurality of bores <NUM>. In some embodiments, the distal end segment <NUM> may be substantially straight. In some embodiments, the distal end segment <NUM> may extend generally parallel to the distalmost surface of the insert <NUM> and/or the distalmost end surface of the outer housing <NUM>. In some embodiments, the distal end segment <NUM> may extend generally perpendicular to the central longitudinal axis of the first elongate shaft <NUM> and/or the end cap assembly <NUM>.

In some embodiments, in the first position, the plurality of wire loops <NUM> may include three or more intersecting distal end segments <NUM> forming a bounded opening <NUM> receiving the neck portion <NUM> of the leadless cardiac pacing device <NUM> therethrough. In some embodiments, in the first position, the bounded opening <NUM> may have a smallest radial extent measured perpendicular to the central longitudinal axis of the end cap assembly <NUM> that is greater than a greatest radial extent of the neck portion <NUM> measured perpendicular to the central longitudinal axis of the leadless cardiac pacing device <NUM>, and the bounded opening <NUM> may have a greatest radial extent measured perpendicular to the central longitudinal axis of the end cap assembly <NUM> that is less than a smallest radial extent of the proximal hub <NUM> measured perpendicular to the central longitudinal axis of the leadless cardiac pacing device <NUM>.

In some embodiments, circumferentially adjacent wire loops and/or distal end segments of the plurality of wire loops <NUM> crisscross (e.g., cross over and/or under) each other when viewed axially along the central longitudinal axis of the end cap assembly <NUM>. In some embodiments, when the plurality of wires <NUM> and/or the plurality of wire loops <NUM> is in the first position, circumfcrentially adjacent wire loops of the plurality of wire loops <NUM> crisscross (e.g., cross over and/or under) each other when viewed axially along the central longitudinal axis of the end cap assembly <NUM>. In some embodiments, when the plurality of wires <NUM> and/or the plurality of wire loops <NUM> is in the second position, circumferentially adjacent wire loops of the plurality of wire loops <NUM> crisscross (e.g., cross over and/or under) each other when viewed axially along the central longitudinal axis of the end cap assembly <NUM>.

In some embodiments, the plurality of wire loops <NUM> may include a first wire loop <NUM> passing through a first pair <NUM> of the plurality of bores <NUM>. In some embodiments, the plurality of wire loops <NUM> may include a second wire loop <NUM> passing through a second pair <NUM> of the plurality of bores <NUM>. In some embodiments, the plurality of wire loops <NUM> may include a third wire loop <NUM> passing through a third pair <NUM> of the plurality of bores <NUM>. In some embodiments, the plurality of wire loops <NUM> may include a fourth wire loop <NUM> passing through a fourth pair <NUM> of the plurality of bores <NUM>. Other configurations and/or arrangements are also contemplated.

In some embodiments, one of the second pair <NUM> of the plurality of bores <NUM> may be disposed circumferentially between the first pair <NUM> of the plurality of bores <NUM>. In some embodiments, one of the third pair <NUM> of the plurality of bores <NUM> may be disposed circumferentially between the second pair <NUM> of the plurality of bores <NUM>. In some embodiments, one of the fourth pair <NUM> of the plurality of bores <NUM> may be disposed circumferentially between the third pair <NUM> of the plurality of bores <NUM>. In some embodiments, one of the first pair <NUM> of the plurality of bores <NUM> may be disposed circumferentially between the fourth pair <NUM> of the plurality of bores <NUM>. Other configurations and/or arrangements are also contemplated.

In the example of <FIG>, the plurality of wire loops <NUM> and/or the distal end segments <NUM> thereof may form an "over-under" pattern with respect to each other. In the illustrated arrangement, the first wire loop <NUM> passes over the fourth wire loop <NUM> and under the second wire loop <NUM>, the second wire loop <NUM> passes over the first wire loop <NUM> and under the third wire loop <NUM>, the third wire loop <NUM> passes over the second wire loop <NUM> and under the fourth wire loop <NUM>, and the fourth wire loop <NUM> passes over the third wire loop <NUM> and under the first wire loop <NUM>. The first wire loop <NUM>, the second wire loop <NUM>, the third wire loop <NUM>, and the fourth wire loop <NUM> may collectively form and/or define the bounded opening <NUM>. In the example of <FIG>, the proximal hub <NUM> includes four "lobes" or corners and has a generally square shape with scalloped sides. In some embodiments, the bounded opening <NUM> may be generally square. Other configurations are also contemplated. In some embodiments, the distal end segment <NUM> of the first wire loop <NUM> may be oriented generally parallel to the distal end segment <NUM> of the third wire loop <NUM>. In some embodiments, the distal end segment <NUM> of the second wire loop <NUM> may be oriented generally parallel to the distal end segment <NUM> of the fourth wire loop <NUM>. In some embodiments, the distal end segment <NUM> of the first wire loop <NUM> and/or the distal end segment of the third wire loop <NUM> may be oriented generally perpendicular to the distal end segment <NUM> of the second wire loop <NUM> and/or the distal end segment <NUM> of the fourth wire loop <NUM>. In some embodiments, adjacent bores of the plurality of bores <NUM> may be spaced apart by a distance less than a width and/or radial extent of the proximal hub <NUM>. As discussed herein, the configuration of <FIG> may be used during delivery of the leadless cardiac pacing device <NUM> and/or may be used during retrieval of the leadless cardiac pacing device <NUM>.

<FIG> illustrates an alternative configuration of the cross-section taken along line <NUM>-<NUM> in <FIG>, which may be substantially the same as the configuration of <FIG> above, except that in the example of <FIG>, the plurality of wire loops <NUM> and/or the distal end segments <NUM> thereof may form an "over-over" and "under-under" pattern with respect to each other. In the illustrated arrangement, the first wire loop <NUM> passes over the fourth wire loop <NUM> and over the second wire loop <NUM>, the second wire loop <NUM> passes under the first wire loop <NUM> and under the third wire loop <NUM>. the third wire loop <NUM> passes over the second wire loop <NUM> and over the fourth wire loop <NUM>, and the fourth wire loop <NUM> passes under the third wire loop <NUM> and under the first wire loop <NUM>. The first wire loop <NUM>, the second wire loop <NUM>, the third wire loop <NUM>, and the fourth wire loop <NUM> may collectively form and/or define the bounded opening <NUM>. In the example of <FIG>, the proximal hub <NUM> includes four "lobes" or corners and has a generally square shape with scalloped sides. In some embodiments, the bounded opening <NUM> may be generally square. In some embodiments, the distal end segment <NUM> of the first wire loop <NUM> may be oriented generally parallel to the distal end segment <NUM> of the third wire loop <NUM>. In some embodiments, the distal end segment <NUM> of the second wire loop <NUM> may be oriented generally parallel to the distal end segment <NUM> of the fourth wire loop <NUM>. In some embodiments, the distal end segment <NUM> of the first wire loop <NUM> and/or the distal end segment of the third wire loop <NUM> may be oriented generally perpendicular to the distal end segment <NUM> of the second wire loop <NUM> and/or the distal end segment <NUM> of the fourth wire loop <NUM>. In some embodiments, adjacent bores of the plurality of bores <NUM> may be spaced apart by a distance less than a width and/or radial extent of the proximal hub <NUM>. As discussed herein, the configuration of <FIG> may be used during delivery of the leadless cardiac pacing device <NUM> and/or may be used during retrieval of the leadless cardiac pacing device <NUM>.

<FIG> illustrates an alternative configuration of the cross-section taken along line <NUM>-<NUM> in <FIG>, which may be substantially the same as the configuration of <FIG> above, except that in the example of <FIG>, there are only three wire loops and three pairs of the plurality of bores <NUM> In the example of <FIG>. the plurality of wire loops <NUM> and/or the distal end segments <NUM> thereof may form an "over-under" pattern with respect to each other. In the illustrated arrangement, the first wire loop <NUM> passes over the third wire loop <NUM> and under the second wire loop <NUM>. the second wire loop <NUM> passes over the first wire loop <NUM> and under the third wire loop <NUM>. and the third wire loop <NUM> passes over the second wire loop <NUM> and under the first wire loop <NUM>. The first wire loop <NUM>, the second wire loop <NUM>, and the third wire loop <NUM> may collectively form and/or define the bounded opening <NUM>. The proximal hub <NUM> includes three "lobes" or corners and has a generally triangular shape with scalloped sides. In some embodiments, the bounded opening <NUM> may be generally triangular. Other configurations are also contemplated. In some embodiments, adjacent bores of the plurality of bores <NUM> may be spaced apart by a distance less than a width and/or radial extent of the proximal hub <NUM>. As discussed herein, the configuration of <FIG> may be used during delivery of the leadless cardiac pacing device <NUM> and/or may be used during retrieval of the leadless cardiac pacing device <NUM>.

<FIG> and <FIG> illustrate selected aspects of the system <NUM> shown in <FIG> and <FIG>. In some embodiments, the second proximal handle <NUM> may be moved closer to and/or into abutment with the first proximal handle <NUM> when the plurality of wires <NUM> and/or the plurality of wire loops <NUM> is in the second position (e.g., <FIG>). <FIG> shows the plurality of wires <NUM> and/or the plurality of wire loops <NUM> in the second position in more detail. When the plurality of wires <NUM> and/or the plurality of wire loops <NUM> is in the second position, the leadless cardiac pacing device <NUM> may be loaded to the implantation and/or retrieval device for delivery and/or implantation to the target site, or the leadless cardiac pacing device <NUM> may be captured at the target site for retrieval and/or removal from the target site. The plurality of wires <NUM> and/or the plurality of wire loops <NUM>, in the second position, may extend radially outward of an outermost circumference of the leadless cardiac pacing device <NUM> and/or the body <NUM>. In the second position, the distal end segment <NUM> of each of the plurality of wire loops <NUM> may be substantially straight. In some embodiments, the distal end segment <NUM> may extend generally parallel to the distalmost surface of the insert <NUM> and/or the distalmost end surface of the outer housing <NUM>. In some embodiments, the distal end segment <NUM> may extend generally perpendicular to the central longitudinal axis of the first elongate shaft <NUM> and/or the end cap assembly <NUM>.

<FIG> is an exploded view of certain elements of the system <NUM>, for example, the end cap assembly <NUM> and the leadless cardiac pacing device <NUM> of <FIG> and/or 5A. As may be seen, the end cap assembly <NUM> includes the outer housing <NUM> and the insert <NUM>. The insert <NUM> may be coaxially received within the outer housing <NUM>. In some embodiments, the insert <NUM> may be fixedly attached to the outer housing <NUM>. such as by adhesive bonding, mechanical attachment, various forms of welding, or other means. In at least some embodiments, the insert <NUM> may be a unitary structure, as seen in <FIG>. The insert <NUM> may include a distalmost surface <NUM> that is substantially flat and/or planar. The distalmost surface <NUM> of the insert <NUM> may be configured to abut and/or contact a proximal surface of the proximal hub <NUM>. In at least some embodiments, the end cap assembly <NUM>, the outer housing <NUM>, and/or the insert <NUM> may be devoid of any structure configured to engage and/or contact a side surface of the proximal hub <NUM>.

<FIG> is a cross-sectional view of the insert <NUM> of <FIG>. As described above, the insert <NUM> includes the plurality of bores <NUM> extending through the insert <NUM>. In some embodiments, the plurality of bores <NUM> may be oriented and/or may extend generally longitudinally through the insert <NUM>. In some embodiments, some and/or each of the plurality of bores <NUM> may curve radially outwardly in a distal direction relative to the central longitudinal axis of the insert <NUM>. In at least some embodiments, the plurality of bores <NUM> may open distally and/or through the distalmost surface <NUM> of the insert <NUM>. The plurality of wires <NUM> (not shown) may extend through the insert <NUM> and/or the plurality of bores <NUM>. A proximal portion of the plurality of wires <NUM> may extend proximally from the insert <NUM> into the first elongate shaft <NUM>. where the proximal portion of the plurality of wires may be fixedly attached and/or joined to a distal end of the second elongate shaft <NUM>.

<FIG> illustrate an alternative configuration of the end cap assembly <NUM> of <FIG>. For reference, in the example of <FIG>, the plurality of wires <NUM> is shown in the second position. In some embodiments, the system <NUM> may include an end cap assembly <NUM>, which may be similar to the end cap assembly <NUM> in many ways, except as expressly described herein. The end cap assembly <NUM> is disposed at the distal end of the first elongate shaft <NUM>. The end cap assembly <NUM> includes an outer housing <NUM> fixedly attached to the distal end of the first elongate shaft <NUM> and an insert <NUM> secured within the outer housing <NUM>, as shown in <FIG>. In some embodiments, a distalmost surface <NUM> of the insert <NUM> is flush with a distalmost end surface of the outer housing <NUM>. In some embodiments, the distalmost surface <NUM> of the insert <NUM> is parallel and/or coplanar with the distalmost end surface of the outer housing <NUM>.

The insert <NUM> includes a plurality of bores <NUM> extending through the insert <NUM>. In some embodiments, the plurality of bores <NUM> may be oriented and/or may extend generally longitudinally through the insert <NUM>. In at least some embodiments, the plurality of bores <NUM> may open distally. Some suitable, but non-limiting, examples of materials for the end cap assembly <NUM>, the outer housing <NUM>. and/or the insert <NUM> are discussed below.

In some embodiments, the insert <NUM> may include a plurality of insert members <NUM> (e.g., <FIG>) and/or an insert member retainer <NUM>. In some embodiments, the insert member retainer <NUM> may include and/or define the distalmost surface <NUM> of the insert <NUM>. In some embodiments, the insert member retainer <NUM> may be disposed distally of the plurality of insert members <NUM>. The insert <NUM> may be coaxially received within the outer housing <NUM>. In some embodiments, the insert <NUM> may be fixedly attached to the outer housing <NUM>, such as by adhesive bonding, mechanical attachment, various forms of welding, or other means. The distalmost surface <NUM> may be substantially flat and/or planar. The distalmost surface <NUM> of the insert <NUM> may be configured to abut and/or contact a proximal surface of the proximal hub <NUM>. in at least some embodiments, the end cap assembly <NUM>, the outer housing <NUM>, the insert <NUM>, and/or the plurality of insert members <NUM> may be devoid of any structure configured to engage and/or contact a side surface of the proximal hub <NUM>.

As seen in <FIG>, each of the plurality of insert members <NUM> may include at least a portion of one or more of the plurality of bores <NUM> extending through the insert <NUM>. In some embodiments, each of the plurality of bores <NUM> may have an ovoid cross-sectional shape. In the example of <FIG>, each of the plurality of bores <NUM> may be configured to receive one or more of the plurality of wires <NUM> therein. For example, each of the plurality of bores <NUM> may be sized, shaped, and/or configured to receive two of the plurality of wires <NUM> therein. In some embodiments, the insert member retainer <NUM> may be configured to cross over and/or separate a distal opening of each bore <NUM> into two apertures, wherein each aperture is configured to receive one of the plurality of wires <NUM> extending therethrough. When the plurality of insert members <NUM> is joined together to collectively form the insert <NUM>. the plurality of insert member <NUM> may join together along and/or at the central longitudinal axis of the insert <NUM>, which may be coaxial with the central longitudinal axis of the outer housing <NUM> in at least some embodiments. In some embodiments, the plurality of insert members <NUM> may be fixedly attached together (e.g., adhesively bonded, welded, etc.,) when assembled to form the insert <NUM>. However, fixed attachment between adjacent insert members <NUM> is not strictly necessary in all cases.

<FIG> illustrates one of the plurality of insert members <NUM> in detail. In some embodiments, the plurality of bores <NUM> may be oriented and/or may extend generally longitudinally through the insert <NUM> and/or the plurality of insert members <NUM>. In some embodiments, some and/or each of the plurality of bores <NUM> may curve radially outwardly in a distal direction relative to the central longitudinal axis of the insert <NUM>. The plurality of wires <NUM> (not shown) may extend through the insert <NUM>, the plurality of insert members <NUM>, and/or the plurality of bores <NUM>. A proximal portion of the plurality of wires <NUM> may extend proximally from the insert <NUM> into the first elongate shaft <NUM>. where the proximal portion of the plurality of wires <NUM> may be fixedly attached and/or joined to a distal end of the second elongate shaft <NUM>.

Each of the plurality of insert members <NUM> may include a first lateral face <NUM> and a second lateral face <NUM>. In some embodiments, the first lateral face <NUM> and the second lateral face <NUM> may be oriented substantially perpendicular to each other. The first lateral face <NUM> may include a recess <NUM> extending into the insert member <NUM> and the second lateral face <NUM> may include a projection <NUM> extending outward therefrom. When the plurality of insert members <NUM> are assembled together, the projection <NUM> may be received within the recess <NUM>. For example, the projection <NUM> of a first insert member <NUM> may be received within the recess <NUM> of a second insert member <NUM>, the projection <NUM> of the second insert member <NUM> may be received within the recess <NUM> of a third insert member <NUM>, the projection <NUM> of the third insert member <NUM> may be received within the recess <NUM> of a fourth insert member <NUM>. and the projection <NUM> of the fourth insert member <NUM> may be received within the recess <NUM> of the first insert member <NUM>. In at least some embodiments, each of the plurality of insert members <NUM> may include a distal recess extending proximally from a distally facing surface of the insert member <NUM> and configured to receive a portion of the insert member retainer <NUM>. In some embodiments, the distally facing surface of the insert member <NUM> may be substantially parallel to and/or coplanar with the distalmost surface <NUM> of the insert member retainer <NUM> when the end cap assembly <NUM> is fully assembled. As may be seen and/or determined from <FIG>, each of the plurality of insert members <NUM> may include approximately one half of each of the plurality of bores <NUM> that extends through it. Accordingly, two adjacent insert members <NUM> form each complete bore of the plurality of bores <NUM> after being assembled together.

<FIG> illustrates aspects of another alternative configuration of the end cap assembly <NUM>. In some embodiments, the system <NUM> may include an end cap assembly <NUM>, which may be similar to the end cap assembly <NUM> in many ways, except as expressly described herein. The end cap assembly <NUM> may be disposed at the distal end of the first elongate shaft <NUM> (not shown). In some embodiments, the end cap assembly <NUM> may include an outer housing <NUM> fixedly attached to the distal end of the first elongate shaft <NUM> and an insert <NUM> secured within the outer housing <NUM>. In some embodiments, a distalmost surface <NUM> of the insert <NUM> is flush with a distalmost end surface of the outer housing <NUM>. In some embodiments, the distalmost surface <NUM> of the insert <NUM> is parallel and/or coplanar with the distalmost end surface of the outer housing <NUM>. In some embodiments, the insert <NUM> may include a plurality of bores <NUM> extending through the insert <NUM>. In some embodiments, the plurality of bores <NUM> may be oriented and/or may extend generally longitudinally through the insert <NUM>. In at least some embodiments, the plurality of bores <NUM> may open distally. In some embodiments, the outer housing <NUM> may include a pair of distally extending extensions <NUM>. The pair of distally extending extensions <NUM> may be configured to engage and/or abut one or more side surfaces of the proximal hub <NUM> to facilitate transfer of rotational motion from the first elongate shaft <NUM> to the proximal hub <NUM>. Some suitable, but non-limiting, examples of materials for the end cap assembly <NUM>, the outer housing <NUM>, and/or the insert <NUM> are discussed below.

<FIG> depict an example use (e.g., implantation and retrieval) of the system <NUM> and the leadless cardiac pacing device <NUM> within the heart <NUM>. Although the depicted method includes obtaining access to the patient's heart <NUM> through the inferior vena cava, access to the heart <NUM> may also or alternatively be obtained through the superior vena cava and/or other approaches. The view of the heart <NUM> in <FIG> is similar to the view depicted in <FIG>. The broken lines depicted in <FIG> depict features that may be covered by one or more other features and that would not ordinarily be viewable from the view depicted. The features in broken lines are shown to assist in describing the disclosed concepts. Further, the features within the coronary sinus <NUM> are depicted in solid lines for clarity purposes although such features would not ordinarily be viewable from the view depicted.

In some embodiments, implanting the leadless cardiac pacing device <NUM> within the heart <NUM> may begin by positioning a guide wire within heart <NUM>, such as a first guide wire <NUM> depicted in <FIG>. The first guide wire <NUM> may have a diameter of <NUM> inches (<NUM>) and/or may have one or more other suitable diameters for gaining access to the heart <NUM>. The first guide wire <NUM> may gain access to the heart <NUM> through an opening in the patient's skin extending into an artery or vein (e.g., the femoral vein or other vessel) that has been dilated with an introducer or other device having a dilation feature (e.g., using a catheter <NUM> and a dilator <NUM> as depicted in <FIG>) and advancing the first guide wire <NUM> to and/or through the inferior vena cava or other body vessel.

In some instances, the first guide wire <NUM> may have one or more radiopaque markers disposed on and/or adjacent to a distal end of the first guide wire <NUM>. Such radiopaque markers may allow for easier viewing of the first guide wire <NUM> through one or more medical imaging systems as the first guide wire <NUM> is maneuvered into position with the heart <NUM>. In some embodiments, the radiopaque markers may be spaced apart from each other by a known distance. In such embodiments, by counting the number of radiopaque markers between two features within the heart <NUM>, a distance may be determined between the two features. In some embodiments, the leadless cardiac pacing device <NUM> may be manufactured in a variety of sizes, or various portions of the leadless cardiac pacing device <NUM>, such as the body <NUM> and the distal extension <NUM>, may be manufactured in various sizes and lengths. By determining a distance between different features of the patient's heart <NUM>, for instance between the coronary sinus ostium <NUM> and the septum <NUM> in the right atrium <NUM>, as depicted in <FIG>, an appropriate sized body <NUM> or distal extension <NUM> may be selected for the particular patient.

After measuring distances between various features of the heart <NUM>, or in embodiments where such measurements are not needed, the catheter <NUM> (e.g., an introducer) and the dilator <NUM> may be maneuvered over the first guide wire <NUM> into the heart <NUM>, as depicted in <FIG>. In some cases, the catheter <NUM> may be steerable and the dilator <NUM> may be located at or adjacent a distal end (e.g., at or adjacent a distal tip) of the catheter <NUM>. The dilator <NUM> may be configured to engage the ostium <NUM> of the coronary sinus <NUM> and dilate and/or cannulate the coronary sinus <NUM> such that the catheter <NUM> and/or the leadless cardiac pacing device <NUM> may be received therein. Alternatively or in addition, the catheter <NUM> may have a pre-formed bend at or adjacent a distal end of the catheter <NUM>. In such cases, the dilator <NUM> may be inserted through the distal end of the catheter <NUM> to straighten the distal end of the catheter <NUM> during insertion of the catheter into the heart <NUM>. Then, when the distal end of the catheter <NUM> is within the heart, such as within the right atrium <NUM>, the dilator <NUM> may be withdrawn such that the distal end of the catheter <NUM> bends to face and/or extend into the coronary sinus <NUM> and/or to direct the first guide wire <NUM> toward and/or into the coronary sinus <NUM>.

<FIG> depicts the catheter <NUM> and the first guide wire <NUM> bent and inserted into the coronary sinus <NUM> after withdrawal of the dilator <NUM> relative to, through, and/or from the catheter <NUM>. In some cases, after the catheter <NUM> is bent toward the coronary sinus <NUM>. the first guide wire <NUM> may be advanced into the coronary sinus <NUM> and the catheter <NUM> may be advanced along the first guide wire <NUM> and into the coronary sinus <NUM>.

The dilator <NUM> may include a conical tapered tip, such that advancing the catheter <NUM> and the dilator <NUM> into the coronary sinus <NUM> expands the inner diameter of the coronary sinus <NUM>. In another example, the dilator <NUM> may be rounded or may have a more abrupt taper than a conical taper. Other dilator configurations are contemplated and any configuration suitable for dilating the coronary sinus <NUM> may be utilized. As such, if the coronary sinus <NUM> needs to be expanded to receive the leadless cardiac pacing device <NUM>, the distal end or distal tip of the catheter <NUM> and/or the dilator <NUM> may be advanced through the ostium <NUM> of the coronary sinus <NUM> to dilate the coronary sinus <NUM> a suitable amount sufficient to receive the leadless cardiac pacing device <NUM>. In addition to or as an alternative to the catheter <NUM> and/or the dilator <NUM>, one or more other catheters, dilators, or introducers may be used to facilitate dilating, cannulating, and/or otherwise entering the coronary sinus <NUM>.

Once the coronary sinus <NUM> has been cannulated and the catheter <NUM> inserted therein, the first guide wire <NUM> may then be removed from the catheter <NUM>, as depicted in <FIG>. In some instances, a second guide wire <NUM> may be inserted into and/or through the catheter <NUM> and maneuvered through coronary sinus <NUM> and into the great cardiac vein <NUM> or other vessel extending from the coronary sinus <NUM>, as depicted in <FIG>. The second guide wire <NUM> may have a diameter of about <NUM> inches (<NUM>) and/or other suitable diameter for navigating vessels of and/or extending around the heart <NUM> (e.g., for navigating the great cardiac vein <NUM> and/or other vessels extending from or to the great cardiac vein <NUM>). In at least some embodiments, the second guide wire <NUM> may have a diameter less than the diameter of the first guide wire <NUM>. Alternatively, in some embodiments, the first guide wire <NUM> may be advanced through the coronary sinus <NUM> and into the great cardiac vein <NUM> or other vessel extending from the coronary sinus <NUM>.

<FIG> depicts the catheter <NUM> and the system <NUM> including the leadless cardiac pacing device <NUM> positioned within the coronary sinus <NUM> with the distal extension <NUM> tracked over the second guide wire <NUM> into the great cardiac vein <NUM> or other cardiac vessel. The second guide wire <NUM> may exit the guide wire port of the body <NUM> and extend along an exterior of the body <NUM>. In some embodiments, the proximal end of the body <NUM> of the leadless cardiac pacing device <NUM> and the proximal hub <NUM> may extend proximally out of the coronary sinus <NUM> into the right atrium <NUM>, with the plurality of wires <NUM> engaged with the proximal hub <NUM>. The leadless cardiac pacing device <NUM> may be advanced to this position by pushing the system <NUM> including the leadless cardiac pacing device <NUM> through the catheter <NUM> and over the second guide wire <NUM> with the plurality of wires <NUM> engaged with the proximal hub <NUM>. Alternatively, only one of the catheter <NUM> or the second guide wire <NUM> may be utilized to position the system <NUM> and/or the leadless cardiac pacing device <NUM>. Further, it is contemplated that the leadless cardiac pacing device <NUM> may be positioned with neither of the catheter <NUM> nor the second guide wire <NUM>.

Once the system <NUM>, the leadless cardiac pacing device <NUM>, and/or the catheter <NUM> have been position within the coronary sinus <NUM> adjacent a target location, the system <NUM>, the first elongate shaft <NUM>, and/or the leadless cardiac pacing device <NUM> may be rotated to position the distal tip <NUM> of the fixation member <NUM> at a desired location for puncturing and engaging tissue of the heart <NUM> and/or the coronary sinus <NUM>. An orientation of the leadless cardiac pacing device <NUM> within the coronary sinus <NUM> and/or within the system <NUM> may be adjusted via interacting with a proximal end of the system <NUM> and/or may be adjusted in a different suitable manner. In some cases, the orientation of the leadless cardiac pacing device <NUM> within the coronary sinus <NUM> and/or within the system <NUM> may be adjusted by adjusting a position of the leadless cardiac pacing device <NUM> in a longitudinal direction and/or by rotating the leadless cardiac pacing device <NUM> in a direction of arrow A and/or arrow B using the system <NUM> and/or aspects thereof.

In some cases, a rotational and/or longitudinal position of the distal tip <NUM> may be known or identifiable from one or more radiopaque markers and the known rotational and/or longitudinal position may be utilized for positioning the distal tip <NUM>. In one example, the distal tip <NUM> may be or may include a radiopaque marker identifiable by one or more imaging systems to facilitate proper alignment of the distal tip <NUM> of the fixation member <NUM> with the tissue of the heart <NUM> and/or the coronary sinus <NUM>. Alternatively or additionally, the fixation member <NUM> may include one or more other radiopaque features and/or the leadless cardiac pacing device <NUM> may include one or more radiopaque markers having a known relationship with the distal tip <NUM> that may be used to position the distal tip <NUM> at the desired location. In one example, the distal tip <NUM> may have a first circumferential position, a tail of the fixation member <NUM> may have a second circumferential position at a predetermined angular orientation from the first circumferential position that may be used to facilitate rotationally aligning the distal tip <NUM> with target tissue of the heart. Rotation of the leadless cardiac pacing device <NUM> to rotationally align the distal tip <NUM> with target tissue of the heart may be performed while the distal tip <NUM> remains within the lumen of the catheter <NUM> to prevent unintentional penetration of the distal tip <NUM> into the tissue, and thereafter the fixation member <NUM> may be deployed out of the distal end of the catheter <NUM>. Alternatively or additionally, the leadless cardiac pacing device <NUM> may be rotated in a counter direction of the helical anchor of the fixation member <NUM> after deploying the distal tip <NUM> of the fixation member <NUM> out of the distal end of the catheter <NUM> to prevent unintentional penetration of the distal tip <NUM> into the tissue.

Once the leadless cardiac pacing device <NUM> is in position, the catheter <NUM> and the second guide wire <NUM> may be retracted and the leadless cardiac pacing device <NUM> may be further rotated using the first elongate shaft <NUM> (e.g., in the direction of arrow A and/or other suitable direction) such that the distal tip <NUM> and the fixation member <NUM> engage tissue of the heart <NUM> and/or the coronary sinus <NUM>. In some instances, the leadless cardiac pacing device <NUM> may be oriented such that the distal tip <NUM> initially penetrates into the left atrial muscle and/or through a wall of the coronary sinus <NUM>. Once the fixation member <NUM> is engaged with the tissue, the system <NUM> (less the leadless cardiac pacing device <NUM>) and the catheter <NUM> may be retracted and, optionally, removed from the heart <NUM>. <FIG> depicts an example of how the leadless cardiac pacing device <NUM> may be positioned after the system <NUM>, the catheter <NUM>, and the second guide wire <NUM> have been retracted and the fixation member <NUM> has engaged the tissue of the heart <NUM>. Although the body <NUM> of the leadless cardiac pacing device <NUM> is depicted as extending along the right atrium <NUM> and the left atrium <NUM> in the coronary sinus <NUM>, the body <NUM> of the leadless cardiac pacing device <NUM> may be entirely positioned along the right atrium <NUM> or entirely along the left atrium <NUM> within the coronary sinus <NUM>. In some instances the body <NUM> of the leadless cardiac pacing device <NUM> may be located along both of the right atrium <NUM> and the left atrium <NUM> such that at least part of the first electrode <NUM> is in contact with tissue of the right atrium <NUM> and at least part of the second electrode <NUM> is in contact with tissue of the left atrium <NUM>. In such instances, the leadless cardiac pacing device <NUM> may be programmed to sense and/or pace one or more of the right atrium <NUM> and left atrium <NUM> with the respective electrodes <NUM>, <NUM> or other electrodes due to the electrodes being bipolar.

In some cases, the implanted leadless cardiac pacing device <NUM> may be removed from the coronary sinus <NUM> and/or the positioning of the implanted leadless cardiac pacing device <NUM> may be adjusted. <FIG> depicts the catheter <NUM> and a retrieval device <NUM> (e.g., a implantation and/or retrieval device, which may be or may not be the system <NUM> or similar to the system <NUM>) inserted into the coronary sinus <NUM>, with the retrieval device <NUM> (e.g., the end cap assembly <NUM> and/or the plurality of wires <NUM> of the system <NUM>) engaging the proximal hub <NUM> of the leadless cardiac pacing device <NUM>. Once the retrieval device <NUM> (e.g., the end cap assembly <NUM> and/or the plurality of wires <NUM> of the system <NUM>) has engaged the proximal hub <NUM> of the leadless cardiac pacing device <NUM>, the retrieval device <NUM> (e.g., the system <NUM>) may apply a force to the leadless cardiac pacing device causing the leadless cardiac pacing device <NUM> to rotate in a direction of arrow B or other suitable direction. Rotation of the leadless cardiac pacing device <NUM> may result in the fixation member <NUM> at least partially withdrawing from engagement with the tissue of the heart <NUM>.

In addition to or as an alternative to rotating the leadless cardiac pacing device <NUM> in the direction of arrow B, a longitudinal and/or axial force may be applied to the leadless cardiac pacing device <NUM> in a direction of arrow C (e.g., a longitudinal direction). When the fixation member <NUM> is still engaged with the tissue of the heart, applying the longitudinal and/or axial force to the leadless cardiac pacing device <NUM> in the longitudinal direction of arrow C may cause the fixation member <NUM> to elongate (e.g., straighten and/or elongate in one or more other suitable manners), as shown in <FIG> and facilitate removing the fixation member <NUM> from tissue of the heart <NUM>. Depending on the material configurations utilized, an axial force in the range of about <NUM>-<NUM> pound-force (1bf), in the range of about <NUM>-<NUM> lbf, at least about <NUM> lbf, at least about <NUM> lbf, at least about <NUM> lbf but less than about <NUM> lbf, and/or other suitable force amount may be utilized to elongate the fixation member <NUM>. In some instances, the fixation member <NUM> may be plastically deformed into a straightened configuration by applying the longitudinal and/or axial force in the direction of arrow C for removal from the tissue of the heart <NUM>.

After the fixation member <NUM> has been completely removed from the tissue of the heart <NUM> as shown in <FIG>, the catheter <NUM> may be advanced over a portion of or an entirety of the leadless cardiac pacing device <NUM> via relative movement of the retrieval device <NUM> (e.g., the system <NUM>) and the catheter <NUM>. Once covered by the catheter <NUM>, the leadless cardiac pacing device <NUM> may be completely withdrawn from the coronary sinus <NUM> and the patient's heart <NUM> by applying a further force in the direction C and/or repositioned (e.g., to improve positioning of electrodes of the leadless cardiac pacing device <NUM> and/or for one or more other suitable reasons) within the coronary sinus <NUM> and/or the vessels in communication with the coronary sinus <NUM> by applying a rotational force in direction A (e.g., <FIG>) to re-engage the fixation member <NUM> with tissue adjacent the coronary sinus <NUM>.

In some cases, the catheter <NUM> may be inserted into the vasculature of the patient (e.g., into the coronary sinus <NUM>) and positioned over at least part of the leadless cardiac pacing device <NUM> and/or the retrieval device <NUM> (e.g., the system <NUM>) to facilitate withdrawing the leadless cardiac pacing device <NUM> from the coronary sinus <NUM>. In such cases, the catheter <NUM> may be positioned at a location covering a proximal end of the leadless cardiac pacing device <NUM> and the retrieval device <NUM> (e.g., the system <NUM>) may be advanced through the catheter <NUM> to the leadless cardiac pacing device <NUM> at least partially covered by the catheter <NUM>. The positioning of the catheter <NUM> over the proximal end of the leadless cardiac pacing device <NUM> may include deflecting a distal end portion of the catheter <NUM> into the coronary sinus <NUM> and steering the catheter <NUM> over the proximal end of the leadless cardiac pacing device <NUM>. The deflection and steering of the catheter <NUM> may be effected by manipulating one or more control features adjacent a proximal end of the catheter <NUM> and/or the catheter <NUM> may have a pre-formed bend configured to bend toward the coronary sinus <NUM>. In some embodiments, the leadless cardiac pacing device <NUM> may be removed using only the retrieval device <NUM> (e.g., the system <NUM>) without the presence of the catheter <NUM>.

Those skilled in the art will recognize that the present disclosure may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. For instance, as described herein, various embodiments include one or more modules described as performing various functions. However, other embodiments may include additional modules that split the described functions up over more modules than that described herein. Additionally, other embodiments may consolidate the described functions into fewer modules.

The materials that can be used for the various components of the system(s) and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion refers to the system. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the first elongate shaft, the second elongate shaft, the end cap assembly, the outer housing, the insert, the plurality of wires, the leadless cardiac pacing device, the handle(s), and/or elements or components thereof.

In some embodiments, the system, and/or components thereof, may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material.

Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example. DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethanc 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example. DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene. Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin. polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, polyurethane silicone copolymers (for example, ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

Some examples of suitable metals and metal alloys include stainless steel, such as 304V, <NUM>, and 316LV stainless steel: mild steel: nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g.. UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like): platinum enriched stainless steel; titanium: platinum; palladium; gold; combinations thereof; or any other suitable material.

In at least some embodiments, portions or all of the system, and/or components thereof, may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the system in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the system to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the system and/or other elements disclosed herein. For example, the system, and/or components or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The system, or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.

In some embodiments, the system and/or other elements disclosed herein may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone)); anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/anti-mitotic agents (such as paclitaxel. <NUM>-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors): anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptidecontaining compound, heparin, anti-thrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin): cholesterol-lowering agents: vasodilating agents; and agents which interfere with endogenous vasoactive mechanisms.

Claim 1:
An implantation and/or retrieval device (<NUM>) for a leadless cardiac pacing device (<NUM>), comprising:
a first elongate shaft (<NUM>) including a lumen;
a second elongate shaft (<NUM>) slidably disposed within the lumen of the first elongate shaft (<NUM>);
an end cap assembly (<NUM>) fixedly attached to a distal end of the first elongate shaft (<NUM>); and
a plurality of wires (<NUM>) attached to the second elongate shaft (<NUM>) and extending distally from the end cap assembly (<NUM>), the plurality of wires (<NUM>) being movable relative to the end cap assembly (<NUM>);
wherein the plurality of wires (<NUM>) is configured to engage a proximal hub of the leadless cardiac pacing device (<NUM>);
wherein the plurality of wires (<NUM>) forms a plurality of wire loops extending distally from the end cap assembly;
characterized in that
the end cap assembly (<NUM>) includes an insert secured within an outer housing (<NUM>), the outer housing (<NUM>) being fixedly attached to the distal end of the first elongate shaft (<NUM>);
wherein the insert includes a plurality of bores (<NUM>) extending through the insert, wherein the plurality of bores (<NUM>) is configured to receive the plurality of wires (<NUM>).