Delivery system for a medical device

Abstract

A medical system includes a device receptacle configured to hold an implantable medical device (IMD) (102) within a receptacle volume. The device receptacle is supported by a delivery catheter configured to position the device receptacle within an anatomical volume of a patient, such as a heart chamber. A device tether (120) including a conductive tether supports a tether head (128) configured to engage and / or disengage with the IMD. A tether electrode (129) is configured to receive an intrinsic electrical signal generated by a heart of the patient. The device tether is configured to use the conductive tether to conduct the intrinsic electrical signal from the tether electrode to processing circuitry outside of the patient's body.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 611,599, filed December 18, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to systems for delivering and / or retrieving implantable medical devices. Background Technology

[0003] Various types of implantable medical devices have been implanted to treat or monitor one or more conditions in a patient. These implantable medical devices may be adapted to allow the medical device to monitor and / or treat conditions or functions related to the heart, muscles, nerves, brain, stomach, endocrine organs, or other organs and their associated functions. Implantable medical devices may be implanted at target sites selected to detect a patient's physiological condition and / or deliver one or more therapies. For example, an implantable medical device may be delivered to a location in the atrium or ventricle of the heart to sense intrinsic cardiac signals and deliver pacing or anti-tachyarrhythmic shock therapy.

[0004] Some implantable medical devices are sized to be fully implanted within a chamber of the heart and / or another anatomical volume of the patient to detect physiological conditions and / or deliver one or more therapies. Such implantable medical devices may utilize delivery and / or retrieval systems to allow clinicians to navigate (e.g., across the patient's vascular system) the implantable medical device to a target location and / or retrieve it from the patient. In some examples, the implantable medical device may include one or more anchoring components designed to engage with tissue at the target location (e.g., for implantation) and / or disengage from tissue at the target location (e.g., for retrieval). Summary of the Invention

[0005] This disclosure describes a medical system configured to deliver, position, retrieve, and / or otherwise reorient an implantable medical device (“IMD”) within an anatomical volume (e.g., a chamber of the heart) in a patient's body. The medical system includes a device tether comprising a conductive tether supporting a head of the tether configured to engage and / or disengage with the IMD. The medical system may also include a delivery catheter supporting a device receiver configured to retain the IMD within a receiver volume. The conductive tether extends through the lumen of the delivery catheter to allow the tether head to engage and / or disengage with the IMD within the receiver volume.

[0006] A tether electrode, supported by at least one of a tether head and / or a conductive tether, is configured to receive an inherent electrical signal generated by the patient's heart. For example, the tether electrode may be at least a portion of the outer surface region of the tether head and / or the conductive tether. The tether electrode is configured to receive the inherent electrical signal when the tether head and the IMD are within the receptacle volume of the device receptacle. Thus, the tether electrode can receive a signal when the walls of the device receptacle defining the receptacle volume are used to at least partially shield one or more device electrodes of the IMD to prevent sufficient reception of the inherent electrical signal. In some examples, the tether electrode may contact a conductive portion of the IMD (e.g., a conductive portion of the IMD's housing) and may receive the inherent signal via that conductive portion of the IMD.

[0007] The device tether (e.g., tether head and tether) is configured to conduct inherent electrical signals from the tether electrodes to processing circuitry outside the patient's body. Therefore, the device tether enables signal reception and processing when the device electrodes are substantially shielded and / or the IMD is substantially de-energized. For example, when the device electrodes are substantially shielded and / or the IMD is substantially de-energized, the device tether allows medical systems and / or clinicians to assess whether the device receptacle holding the IMD is located within the atrium, ventricle, coronary sinus, or some other part of the heart. In some examples, the device tether allows for assessment of the location and / or orientation of the receptacle and / or IMD relative to target tissue of the heart.

[0008] In one example, a medical system includes: a device tether comprising: a tether electrode configured to receive inherent electrical signals generated by a patient's heart; a tether head configured to engage an implantable medical device within a cavity of the heart; and a conductive tether including a distal portion and a proximal portion, the distal portion being configured within the patient's body, and the proximal portion being configured outside the patient's body when the distal portion and the tether head are within the body. The tether head is attached to a distal portion of the tether, wherein at least one of the tether head or the distal portion of the tether supports a tether electrode, wherein the tether electrode is configured to conduct an inherent electrical signal to the distal portion of the tether, wherein the distal portion of the tether is configured to conduct an inherent electrical signal to a proximal portion of the tether; and a processing circuit configured to receive the inherent electrical signal using a first electrode and a second electrode, the first electrode being configured to be electrically connected to the proximal portion of the tether, and the second electrode being configured to be electrically connected to a portion of the patient.

[0009] In one example, a medical system includes: a device tether comprising: a tether electrode configured to receive an inherent electrical signal generated by a patient's heart; a tether head configured to engage an implantable medical device within a cavity of the heart; and a conductive tether including a distal portion and a proximal portion, the distal portion being configured to be within the patient's body, and the proximal portion being configured to be outside the patient's body when the distal portion and the tether head are within the body, wherein the tether head is attached to the distal portion, wherein at least one of the tether head or the distal portion supports the tether electrode, and wherein the tether electrode is configured to conduct the inherent electrical signal to... The tether includes a distal portion, configured to conduct an inherent electrical signal to a proximal portion; a handle supported by the proximal portion, configured to disengage the tether head from an implantable medical device in a ventricle of the heart; a first electrode configured to be electrically connected to the proximal portion, configured to receive the inherent electrical signal from the proximal portion; a second electrode configured to be electrically connected to the patient's skin; processing circuitry configured to receive the inherent electrical signal using the first and second electrodes; and a display device communicating with the processing circuitry, configured to use the communication to provide a visual indication of the inherent electrical signal.

[0010] In one example, a method includes: receiving an inherent electrical signal generated by a patient's heart using a tether electrode of a device tether, the device tether including a tether head and a conductive tether located within a chamber of the heart, wherein the tether head is configured to engage an implantable medical device within the chamber of the heart, wherein the tether electrode is electrically connected to a distal portion of the conductive tether, wherein the distal portion of the tether is electrically connected to a proximal portion of the conductive tether, wherein the proximal portion of the tether is outside the patient's body; and receiving the inherent electrical signal using processing circuitry, using a first electrode electrically connected to the proximal portion of the tether and a second electrode electrically connected to a portion of the patient.

[0011] In one example, a method includes: positioning an implantable medical device in a ventricle of a patient's heart using a device receptacle supported by a delivery catheter, wherein the device receptacle defines a receptacle volume for holding the implantable medical device and defines a receptacle opening configured to allow the implantable medical device to pass through therein; supporting a tether head within the receptacle volume using a distal portion of a conductive tether extending through a catheter lumen defined by the delivery catheter, wherein the implantable medical device is located between the tether head and the receptacle opening; and using a conductive tether head or distal portion of the tether... The tether electrode, supported by at least one of the electrodes, receives the intrinsic electrical signal generated by the heart; the tether electrode is used to conduct the intrinsic electrical signal to a distal portion of the tether; the distal portion of the tether is used to conduct the intrinsic electrical signal to a proximal portion of the conductive tether, wherein the proximal portion of the tether is outside the patient's body; a processing circuit supported by an external device outside the patient's body receives the intrinsic electrical signal using a first electrode electrically connected to the proximal portion of the tether and a second electrode electrically connected to a portion of the patient's body; and a display device communicating with the processing circuit provides a visual indication of the intrinsic electrical signal.

[0012] Details of one or more examples are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages will be apparent from the specification, drawings, and claims. Attached Figure Description

[0013] Figure 1 This is a conceptual diagram illustrating an example medical system and device container within the heart.

[0014] Figure 2 This is a perspective view of an example delivery catheter and device tether.

[0015] Figure 3 It is a schematic diagram of the device fasteners, the first electrode, the second electrode, and the processing circuit.

[0016] Figure 4 This is a plan view of the head of an example fastener.

[0017] Figure 5 An example technique for receiving signals using tethered electrodes is illustrated.

[0018] Figure 6 An example technique for receiving signals using tethered electrodes and processing circuitry is illustrated.

[0019] Figure 7A This is a schematic cross-sectional view of the head of an example fastener, where the cutting plane passes through the axis of the device and is cut parallel to the page.

[0020] Figure 7B It is in a disengaged configuration. Figure 7AA schematic cross-sectional view of the head of the fastener, wherein the cutting plane passes through the axis of the device and is cut parallel to the page.

[0021] Figure 7C It is in a joint configuration Figure 7A and Figure 7B A schematic cross-sectional view of the head of the fastener, wherein the cutting plane passes through the axis of the device and is cut parallel to the page.

[0022] Figure 8 This is a schematic block diagram of an implantable medical device. Detailed Implementation

[0023] This disclosure describes a medical system configured to deliver, locate, and / or retrieve an implantable medical device (“IMD”) within an anatomical volume (e.g., a chamber of the heart) within a patient’s body. In various examples, the medical system is configured to deliver the IMD to a target site within the patient’s body and (e.g., using processing circuitry) transmit signals indicating the location and / or proximity of the IMD relative to the target site, indicating the suitability of the target site, indicating the deployment of the IMD, and / or for other reasons.

[0024] The medical system includes a device tether comprising a conductive tether supporting a tether head configured to engage and / or disengage with an IMD. The medical system may also include a delivery catheter supporting a device receiver configured to retain the IMD within a receiver volume. The device receiver defines a receiver opening opening into the receiver volume and is configured to allow the IMD to pass through it. In various examples, the walls of the device receiver define the boundaries of the receiver volume. The conductive tether extends through the lumen of the delivery catheter to allow the tether head to engage and / or disengage with the IMD within the receiver volume.

[0025] A tether electrode, supported by at least one of a tether head and / or a conductive tether, is configured to receive an inherent electrical signal generated by the patient's heart. For example, the tether electrode may be at least a portion of the outer surface region of the tether head and / or the conductive tether. The tether electrode is configured to receive the inherent electrical signal when the tether head and the IMD are within the receptacle volume of the device receptacle. Thus, the tether electrode can receive a signal when the wall of the device receptacle defining the receptacle volume is used to at least partially shield one or more device electrodes of the IMD to prevent sufficient reception of the inherent electrical signal. The device tether is configured to use the conductive tether to conduct the inherent electrical signal from the tether electrode to processing circuitry outside the patient's body. Thus, the device tether enables signal reception and processing when the device electrode is substantially shielded and / or the IMD is substantially de-energized. For example, when the device electrodes are substantially shielded and / or the IMD is substantially de-energized, the medical system can use the device tether to assess and / or allow clinicians to assess whether the device receptacle holding the IMD is located in the atrium, ventricle, coronary sinus, or some other part of the heart 101.

[0026] The conductive tether includes a distal portion and a proximal portion, the distal portion being configured within the patient and the proximal portion being configured outside the patient (e.g., when the conductive tether extends through the lumen of a delivery catheter). The distal portion supports the tether head. The device tether is configured to conduct inherent electrical signals received by the tether electrodes to the distal portion. The conductive tether is configured to conduct inherent electrical signals from the distal portion to the proximal portion.

[0027] The medical system includes processing circuitry configured to receive inherent electrical signals sensed by the tether electrodes. The processing circuitry can be located outside the patient's body. For example, when the tether head, distal portion of the tether, device housing, and / or IMD 102 are inside the patient's body, the processing circuitry can be mechanically supported by an external device configured to be outside the patient's body. When the IMD is positioned within the housing volume of the device housing, using external processing circuitry instead of or supplementing the IMD processing circuitry carried by the IMD can improve the reception and / or processing of the inherent electrical signals.

[0028] The processing circuitry is configured to receive inherent electrical signals using a first electrode and a second electrode. The first electrode is configured to be electrically connected to a proximal portion of the tether. The second electrode is configured to be electrically connected to a portion of the patient, such as the patient's skin. In various examples, the first electrode is configured to be electrically connected to and / or electrically isolated from the proximal portion of the tether. For example, the first electrode may include a clamp, a mechanically mating plug and socket, a switch, a circuit breaker, or some other device configured to be electrically connected to the proximal portion of the tether. In some examples, the second electrode is a skin electrode attached to the patient's skin. The first and second electrodes are configured to be displaced outside the patient and / or otherwise from the device receiver and / or IMD.

[0029] In various examples, the processing circuitry of the external device is configured to have a higher gain compared to the IMD processing circuitry. For example, the processing circuitry may be configured to increase the power and / or amplitude of the inherent electrical signal received using the first and / or second electrodes compared to when the IMD processing circuitry uses one or more device electrodes supported by the IMD to receive the inherent electrical signal. Higher gain can result in improved resolution and / or fidelity of the waveform indicating the received inherent electrical signal when, for example, the IMD is within the receptacle volume of a device receptacle and the device electrodes of the IMD are substantially shielded by the device receptacle, and / or when the IMD is substantially de-energized (e.g., before energizing the IMD in preparation for implantation). Improved resolution and / or fidelity can enhance the information content and / or the usefulness to clinicians observing the waveform and / or other circuitry receiving the waveform. For example, using a device tether to receive the inherent electrical signal can improve the ability to determine the location of the device receptacle and / or the IMD during delivery of the IMD to the chambers of the heart (e.g., when the IMD can be substantially within the receptacle volume and / or substantially de-energized).

[0030] In each example, the medical system can be used to position the IMD within a cavity of the heart using a device receptacle and a delivery catheter. A tether head engages the IMD within the receptacle volume of the device receptacle. A distal portion of the conductive tether supports the tether head and extends through a delivery lumen defined by the delivery catheter.

[0031] When the IMD is within the receptacle volume of the device receptacle, the tether electrode can be used to receive inherent electrical signals generated by the heart. In each example, the tether electrode receives inherent electrical signals when the IMD is positioned substantially between the receptacle opening leading to the receptacle volume and the tether head. When the device receptacle, IMD, tether electrode, and distal portion of the tether are inside the patient, the tether electrode can conduct inherent electrical signals to the distal portion of the tether. When the proximal portion of the tether is outside the patient, the distal portion of the tether can conduct inherent electrical signals to the proximal portion of the tether.

[0032] The processing circuitry, supported by an external device, can receive intrinsic electrical signals using a first electrode electrically connected to the proximal portion of the tether and a second electrode electrically connected to a portion of the patient. In each example, the display of the display device provides a visual indication of the intrinsic electrical signals. Clinicians can use the visual indications to assess the position of the device receptacle and / or the IMD during delivery of the IMD to the chambers of the heart (e.g., when the IMD can be substantially within the receptacle volume and / or substantially de-energized).

[0033] Therefore, the medical system is configured to detect the intrinsic electrical signals of the heart using a tether electrode supported by at least one of a tether head and / or a conductive tether. The tether electrode is configured to receive the intrinsic electrical signals when the tether head and the IMD are within the receptacle volume of the device receptacle. The tether electrode can receive signals when the walls of the device receptacle, which define the receptacle volume, are used to at least partially shield one or more device electrodes of the IMD to prevent sufficient reception of the intrinsic electrical signals. Thus, the device tether enables signal reception and processing when the device electrodes are substantially shielded and / or the IMD is substantially de-energized. For example, when the device electrodes are substantially shielded and / or the IMD is substantially de-energized, the medical system can utilize the device tether to assess and / or allow clinicians to assess whether the device receptacle holding the IMD is located within the atrium, ventricle, coronary sinus, or some other part of the heart 101.

[0034] Figure 1 This is a conceptual diagram illustrating an example medical system 100 within the right atrium (“RA”) of heart 101. Medical system 100 is configured to deliver an implantable medical device 102 (“IMD 102”) to and / or retrieve from a target site 104 of heart 101. Although described herein in the context of delivering IMD 102 to a vascular system (e.g., heart 101), the devices, systems, and techniques disclosed herein can be used to deliver IMDs or other medical devices to any anatomical location.

[0035] Medical system 100 includes a delivery catheter 106 that supports a device receiver 108. Device receiver 108 is configured to retain IMD 102 during delivery, deployment, and / or retrieval. Device receiver 108 includes a receiver wall 110 defining a receiver volume 112 configured to retain and / or support IMD 102 during delivery, deployment, and / or retrieval. In various examples, device receiver 108 defines a distal opening 109 (“receiver opening 109”) opening into receiver volume 112. Receiver opening 109 may be configured to allow at least IMD 102 to pass through it. In various examples, medical system 100 is configured to deploy IMD 102 from device receiver 108 (e.g., from positioning within receiver volume 112) and through receiver opening 109 to engage tissue within target site 104. In various examples, the medical system 100 is configured to disengage the IMD 102 from the tissue within the target site 104, for example, to retrieve the IMD 102 from the heart 101 and / or to reposition the IMD 102 within the heart.

[0036] Delivery catheter 106 is configured to deliver device receiver 108 and / or IMD 102 into the patient's anatomical volume (e.g., RA). Optionally, during the advancement of delivery catheter 106 into the anatomical volume, such delivery may be performed with the IMD 102 "pre-loaded" or present within the device receiver 108, or the IMD 102 may be advanced into the device receiver 108 after delivery catheter 106, including device receiver 108, has been advanced into the anatomical volume. Optionally, delivery catheter 106 may be advanced into the patient's anatomical volume via a surrounding tubular member (not shown) (such as a sheath or guide catheter) that may place its distal end in the anatomical volume before delivery catheter 106 is advanced through the surrounding tubular member. In various examples, delivery catheter 106 is configured to retrieve device receiver 108 and / or IMD 102 from the patient's anatomical volume. The delivery catheter 106 may include a distal portion 114 (“delivery catheter distal portion 114”) and a proximal portion 116 (“delivery catheter proximal portion 116”), the distal portion being configured to be inside the patient and the proximal portion being outside the patient while the delivery catheter distal portion 114 is inside the patient. The delivery catheter distal portion 114 may support the device receiver 108 (e.g., attached to the device receiver and / or a component substantially integral with the device receiver). In various examples, the delivery catheter 106 is configured to deliver and / or retrieve the device receiver 108 and / or IMD 102 using the patient’s vascular system (such as the inferior vena cava (IVC), superior vena cava (SVC), or other vascular system leading to the anatomical volume). The delivery catheter 106 may define a lumen 118 (“delivery lumen 118”) leading to the receiver volume 112.

[0037] In various examples, the medical system 100 includes a device tether 120 configured to engage the IMD 102 when, for example, the IMD 102 is positioned within the receptacle volume 112. The device tether 120 can be used, for example, to advance the IMD 102 distally from the device receptacle 108 through a receptacle opening 109 to deploy the IMD 102 into the anatomical volume. The device tether 120 can also be used, for example, to withdraw the IMD 102 from the anatomical volume and / or retract it back into the device receptacle 108 through the receptacle opening 109. The device tether 120 includes a conductive tether 121 comprising a tether body 122. The tether body 122 may include a distal portion 124 (“tether distal portion 124”) and a proximal portion 126 (“tether proximal portion 126”), the distal portion being configured to be inside the patient and the proximal portion being outside the patient when the tether distal portion 124 is in the body. The device tether 120 and / or its components (such as tether 121 and tether body 122) may include any suitable catheter or elongated member, or internal member (e.g., relative to delivery catheter 106). Device tethers 120, 121, and / or tether body 122 may have sufficient column strength or "pushability" to advance the IMD 102 distally from the device receiver 108, for example, during deployment, and / or, in some embodiments, to advance the IMD 102 or the device tether 120 (without the IMD 102 attached thereto) itself along the length of the delivery catheter 106, including its proximal portion 116 and distal portion 114. Device tethers 120, 121, and / or tether body 122 may have sufficient tensile strength to withdraw the IMD 102 from the anatomical volume and / or retract it back into the device receiver 108 through the receiver opening 109, and / or, in some embodiments, along the length of the delivery catheter 106, including its proximal portion 116 and distal portion 114. The device tether 120, tether 121, and / or tether body 122 may have sufficient torque transmission capacity to screw the IMD 102 into and / or unscrew it from the target tissue in the anatomical volume. This capability is not required when the IMD 102 is attached to the target tissue without tightening or rotation (e.g., when the IMD 102 is secured via one or more teeth), or when other components perform the screwing-in and / or unscrewing function.

[0038] The distal portion 124 of the tether supports and / or attaches to a tether head, such as a tether head 128, configured to engage the IMD 102. At least the tether body 122 may be configured to translate (e.g., slidably translate) and / or rotate (e.g., translate and / or rotate relative to the delivery catheter 106) within the delivery lumen 118. The device tether 120 may be configured such that translation and / or rotation of the tether body 122 causes the tether body 122 and / or the tether head 128 to apply translational and / or rotational forces on the IMD 102, such that the IMD 102 translates and / or rotates relative to the receiver wall 110. For example, the device tether 120 may be configured to translate within the delivery lumen 118 to apply a translational force to the IMD 102 (e.g., via the tether head 128), thereby translating the IMD 102 relative to the receiver wall 110 (e.g., within the receiver volume 112) in a proximal direction P or a distal direction D. The device tether 120 may be configured to rotate within the delivery lumen 118 to apply a rotational force to the IMD 102 (e.g., via the tether head 128), thereby rotating the IMD 102 (e.g., within the receiver volume 112) about a device axis LD defined by the IMD 102. In some examples, the tether head 128 and the tether body 122 may be substantially separate components. In some examples, the tether head 128 may be substantially abutted against the tether body 122, such that the tether head 128 and the tether body 122 define an integral component. Figure 1 In the image, dashed lines are used to depict the various parts of the tether body 122, tether head 128, and IMD 102 located within the delivery lumen 118 and / or the container volume 112.

[0039] Despite IMD 102 in Figure 1While depicted as partially within the receiver volume 112, in some examples, the IMD 102 and / or device receiver 108 may be configured such that the IMD 102 can be completely positioned within the receiver volume 112. For example, the IMD 102 and / or device receiver 108 may be configured such that one or more of the distal end 113 (“IMD distal end 113”) defined by the housing of the IMD 102, the first distal electrode 103, the second distal electrode 105 (e.g., an atrial electrode), and / or attachment member 132 may be proximal to, distal to, and / or substantially flush with the receiver opening 109. The device fastener 120 is configured to translate the IMD 102 within the container volume 112 in the proximal direction P or the distal direction D to position the distal end 113 of the IMD, the second distal electrode 105, the first distal electrode 103, and / or the attachment member 132 proximal to the container opening 109, distal to the container opening 109, and / or substantially flush with the container opening 109.

[0040] At least one of the tether head 128 or the distal portion 124 of the tether supports the electrode 129 (“tether electrode 129”). The tether head 128 or the distal portion 124 of the tether may support the tether electrode 129 such that when the tether head 128 or the distal portion 124 of the tether moves in the distal direction D, moves in the proximal direction P, and / or rotates about the axis defined by the device tether 120, the tether electrode 129 remains substantially stationary relative to at least some portion of the tether head 128 or the distal portion 124 of the tether. For example, when the tether head 128 or the distal portion 124 of the tether (e.g., using the tether body 122) is positioned within the delivery lumen 112, within the container volume 112, or distal to the container opening 109, respectively, the tether electrode 129 may be configured to be positioned at least within the delivery lumen 112, within the container volume 112, or distal to the container opening 109, respectively.

[0041] In some examples, the tether electrode 129 includes at least a portion of a body that includes a tether head 128 and / or a distal tether portion 124 (“device tether body”). For example, the tether electrode 129 may include the body of the tether head 128 (e.g., tether head body 177). Figure 4 At least a portion of and / or the outer surface of the head 128 of the tethering member (e.g., the outer surface 179 of the head) Figure 4At least a portion of the device tether electrode 129. In some examples, the tether electrode 129 includes a surface (e.g., defined by the device tether body). For example, the device tether body may be a conductive material configured to be covered by an insulating material. The tether electrode 129 may be a portion of the surface defined by the device tether body, wherein the insulating cover is substantially removed. In some examples, the device tether body may be substantially entirely uncovered by any insulating material, such that the tether electrode 129 substantially includes the entire tether head body. In some examples, the tether electrode 129 may be a substantially separate component attached to, attached to, and / or otherwise supported by the device tether body.

[0042] As Figure 4 In alternative configurations shown and described herein, the tether head or tether tip may include any suitable mating interface or abutment that is coupled to or formed on or therein the tether 121 or the distal portion 124 of the tether, and configured to mate with, receive, and / or abut the proximal portion of the IMD 102. The tether head or tether tip may, but need not, have the ability to transmit torque to the IMD 102 for screwing it into or out of the target tissue; this may depend on whether the IMD 102 is secured via a helix, or teeth, a combination thereof, or by some other securing component. The tether head or tether tip may be further realized via one or more releasable, removable, retractable, or cutable ropes, filaments, threads, etc., or one or more snares (e.g., together with mating interfaces or abutments as described herein) to provide a releasable attachment of the IMD 102 to the device tether 120. Such ropes, filaments, threads, snares, etc., may grip, circumnavigate, anchor within, or otherwise interact with the proximal portion of the IMD 102 to facilitate such releasable attachment. In any of these configurations, the tether electrode 129 may be supported by or formed thereon on or therein by the tether head, the tether tip, or any portion of the distal portion 124 of the tether.

[0043] Medical system 100 is configured to position IMD 102 near target site 104 such that IMD 102 can be anchored to tissue within target site 104. In various examples, IMD 102 includes attachment member 132 configured to engage tissue within target site 104. For example, delivery catheter 106 may be configured (e.g., under the influence of a clinician) to traverse a patient's vascular system to position device receiver 108 and IMD 102 near target site 104. Medical system 100 (e.g., tether body 122 and / or tether head 128) is configured (e.g., when attachment member 132 is a helical member) to apply torque to IMD 102 when attachment member 132 is within or near target site 104 to cause attachment member 132 to engage tissue (e.g., tissue within target site 104). In various examples, the medical system 100 (e.g., the tether body 122 and / or the tether head 128) is configured to apply force to the IMD 102 in a distal direction D to cause the attachment member 132 to engage with tissue and / or to apply force to the IMD 102 in a proximal direction P to disengage the attachment member 132 from tissue (e.g., when the attachment member 132 includes one or more serrations). The medical system 100 is configured such that the tether body 122 and / or the tether head 128 can disengage from the IMD 102 while the IMD 102 remains anchored to or near the tissue at the target site 104. Subsequently, the delivery catheter 106, device receiver 108, and device tether 120 can be withdrawn from the patient (e.g., via the patient's vascular system).

[0044] In various examples, IMD 102 includes delivery circuitry 133 (“IMD processing circuitry 133”). Medical system 100 may be configured to use IMD processing circuitry 133 to sense inherent electrical signals generated by heart 101, for example, to assess electrical activity in the vicinity of IMD 102 (e.g., in the vicinity of attachment member 132), to perform pacing mapping to determine the appropriate placement of IMD 102, to evaluate the suitability of pacing delivered by IMD 102 at a specific location, to evaluate the positioning of IMD 102 during implantation, to evaluate the placement of device electrodes relative to the vessel wall, and / or for other reasons. In various examples, IMD processing circuitry 133 is mechanically supported by the housing of IMD 102 such that IMD processing circuitry 133 is in the patient's body when, for example, the distal portion 124 of the tether, the head 128 of the tether, the device receiver 108, and / or IMD 102 are in the patient's body.

[0045] In various examples, the IMD processing circuitry 133 is configured to sense inherent electrical signals using electrodes supported by the IMD 102 (e.g., the housing of the IMD 102). For example, the IMD processing circuitry 133 may be configured to sense inherent electrical signals using two or more device electrodes 111 (such as a first distal electrode 103, a second distal electrode 105, a proximal electrode 107 (e.g., a return electrode), and / or other device electrodes of the IMD 102). The device electrodes 111 may be configured to communicate with the IMD processing circuitry 133. The IMD processing circuitry 133 may be configured to process and / or modulate signals sensed by the device electrodes 111 and / or other electrodes within the medical system 100. In various examples, one or more device electrodes of the device electrodes 111 (e.g., the proximal electrode 107) may be configured to be positioned together with the receptacle volume 112 when the IMD 102 is at least partially residing within the receptacle volume 112.

[0046] In some examples, such as when at least one of the device electrodes 111 is positioned within the container volume 112, the body of the container wall 110 and / or IMD 102 may reduce the reception of signals (e.g., inherent electrical signals) by at least one of the device electrodes 111. For example, when a given device electrode (e.g., proximal electrode 107) is positioned within the container volume 112, the body of the container wall 110 and / or IMD 102 may be used to at least partially shield the given device electrode from sufficient signal reception, to attenuate the signal, and / or to otherwise interfere with the signal as it travels through the signal path to the given device electrode. In some cases, the body of the container wall 110 and / or IMD 102 may at least partially block the signal path from the fluid environment (e.g., the patient's blood) surrounding the device container 108 to the given device electrode, such that the body of the container wall 110 and / or IMD 102 serves to at least partially reduce the signal strength of the signal reaching the given device electrode. For example, when a given device electrode positioned within the receiver volume 112 typically relies on a signal path to advance through the receiver opening 109 to receive a signal, portions of the IMD 102 substantially positioned between the receiver opening 109 and the given device electrode can be used to attenuate, at least partially shield, and / or otherwise interfere with the signal before it is received by the given device electrode. This attenuation, shielding, and / or interference can reduce the ability of the IMD processing circuitry 133 to process and / or modulate the sensed signal, potentially affecting the usefulness of the sensed signal to clinicians.

[0047] Medical system 100 is configured to use device tether 120 in place of or as a supplement to device electrodes 111 to receive sensing signals (e.g., intrinsic electrical signals) to, for example, enhance the sensing and / or processing of intrinsic electrical signals generated by heart 101. Medical system 100 may use device tether 120 to receive sensing signals when, for example, other device electrodes in proximal electrode 107 and / or device electrodes 111 are substantially shielded by a portion of receptacle wall 110 and / or IMD 102. For example, medical system 100 may be configured to use device tether 120 to receive intrinsic electrical signals when IMD 102 is positioned such that one or more device electrodes in device electrodes 111 (e.g., proximal electrode 107) are substantially within receptacle volume 112. In various examples, medical system 100 is configured to use tether electrode 129 to receive sensing signals. The conductive tether 121 (e.g., tether body 122) is configured to conduct signals from the tether electrode 129 to the proximal portion 126 of the tether, such that the signals can be processed by processing circuitry outside the patient.

[0048] Medical system 100 may be configured to receive inherent electrical signals via tether electrode 129 when tether electrode 129 is positioned within receptacle volume 112 and / or delivery lumen 118. Medical system 100 may be configured to receive inherent electrical signals via tether electrode 129 when IMD 102 is positioned within receptacle volume 112 (e.g., when tether head 128 engages with IMD 102 within receptacle volume 112). Medical system 100 may be configured to receive inherent electrical signals via tether electrode 129 when IMD 102 is within receptacle volume 112 and substantially between device tether 128 and receptacle opening 109. Therefore, medical system 100 may receive inherent electrical signals via tether electrode 129, rather than via one or more of device electrodes 111 (or otherwise). Therefore, when the IMD 102 is positioned (e.g., within the container volume 112) such that the container wall 110 and / or a portion of the IMD 102 substantially shield one or more device electrodes (such as the proximal electrode 107) in the device electrodes 111, the medical system 100 can receive inherent signals via the tether electrode 129.

[0049] The conductive tether 121 (e.g., tether body 122) is configured to conduct inherent signals from the tether electrode 129 and the distal portion 124 of the tether. The distal portion 124 of the tether is configured to conduct the inherent electrical signals from the distal portion 124 of the tether to the proximal portion 126 of the tether. In various examples, the tether electrode 129 is supported and / or defined by a portion of the tether head 128. In some examples, instead of being supported and / or defined by the tether head 128, or as a supplement to being supported and / or defined by the tether head, the tether electrode 129 may be supported and / or defined by a portion of the conductive tether 121 (e.g., tether body 122). The conductive tether 121 may be configured (e.g., via the distal portion 124 of the tether) to conduct inherent electrical signals substantially from the tether head 128 to the proximal portion 126 of the tether.

[0050] The medical system 100 includes processing circuitry 134 configured to receive inherent electrical signals sensed by the tether electrode 129. Processing circuitry 134 is configured to be mechanically supported by an external device 136 and / or another device of the medical system 100. External device 136 and / or processing circuitry 134 may be configured to be outside the patient's body and / or otherwise displaced from the device housing 108 and / or IMD 102, for example, when the distal portion 124 of the tether, the head 128 of the tether, the device housing 108, and / or IMD 102 are inside the patient's body. When the IMD 102 is at least partially located within the housing volume 112, using processing circuitry 134, either in place of or as a supplement to the IMD processing circuitry 133 (e.g., via the device tether 120), can improve the reception and / or processing of inherent electrical signals.

[0051] Processing circuitry 134 may be configured to receive sensing signals using a first electrode 138 and a second electrode 139. The first electrode 138 is configured to be electrically connected to the proximal portion 126 of the tether. In various examples, the first electrode 138 is configured to contact the proximal portion 126 of the tether to establish an electrical connection with it. The first electrode 138 may be configured to displace from the proximal portion 126 of the tether to electrically isolate it from the proximal portion 126 (e.g., disconnect the electrical connection to the proximal portion). In various examples, the first electrode 138 is configured to be manipulated by a clinician to electrically connect and / or isolate the first electrode 138 from the proximal portion 126 of the tether. For example, the first electrode 138 may include a clamp, a mechanically engaged plug and socket, a switch, a circuit breaker, or some other device configured to contact and displace from the proximal portion 126 of the tether.

[0052] The second electrode 139 is configured to be electrically connected to a portion of the patient, such as the patient's skin. In various examples, the second electrode 139 is an external electrode configured to be outside the patient and / or otherwise displaced from the device housing 108 and / or IMD 102. For example, in various examples, the second electrode 139 is a skin electrode attached to the patient's skin. In various examples, the medical system 100 is configured to use one or more conductive links, such as conductive link 135 between the first electrode 138 and processing circuitry 134 and / or conductive link 137 between the second electrode 139 and processing circuitry 134, to convey (e.g., conduct) signals from the first electrode 138 and / or the second electrode 139.

[0053] In some examples, processing circuitry 134 is configured to have a higher gain compared to IMD processing circuitry 133. For example, processing circuitry 134 may be configured to increase the power and / or amplitude of the inherent electrical signal received via the first electrode 138 and / or the second electrode 139 compared to when IMD processing circuitry 133 uses device electrode 111 to receive the inherent electrical signal. Higher gain can result in improved resolution and / or fidelity of the waveform indicating the received inherent electrical signal, making the waveform more informative and / or more useful, for example, to a clinician observing the waveform and / or to other circuitry receiving the waveform. For example, when the IMD 102 is positioned within the device housing 108 such that one or more device electrodes 111 (e.g., return electrode 107) are substantially shielded by the housing wall 110, the processing circuitry 134 can be configured to generate a waveform indicating the inherent electrical signal received via the device tether 120, having a higher resolution and / or fidelity than the waveform generated by the IMD 102 indicating the inherent electrical signal received by the device electrodes 111. This improved resolution and / or fidelity can enhance the information content and / or the usefulness to the clinician observing the waveform and / or to other circuitry receiving the waveform.

[0054] In some examples, the device tether 120 (e.g., tether head 128 and / or tether body 122) is configured such that the tether electrode 129 has a reduced impedance to the reception of an inherent electrical signal compared to one or more device electrodes in the device electrodes 111. For example, the device tether 120 may be configured such that the tether electrode 129 has a first impedance to the inherent electrical signal when positioned within the receptacle volume 112 and / or delivery lumen 118. The IMD 102 may be configured such that one of the device electrodes 111 (e.g., proximal electrode 107) has a second impedance to the inherent electrical signal when one of the device electrodes 111 is positioned within the receptacle volume 112. The first impedance may be less than the second impedance. In various examples, the first impedance is less than the second impedance when the tether electrode 129 and one of the device electrodes 111 are in contact with a common conductive medium (such as the patient's blood) for the inherent electrical signal. In some examples, the tether electrode 129 defines a first contact area configured to contact and / or be electrically connected to a common conductive medium, and one of the device electrodes 111 defines a second contact area configured to contact and / or be electrically connected to a common conductive medium, and the first contact area is larger than the second contact area.

[0055] Using the device tether 120 to receive inherent electrical signals improves the ability to determine the location of the device receptacle 108 and / or the IMD 102 during delivery of the IMD 102 into the chamber of the heart 101 (e.g., using processing circuitry 134). For example, during delivery of the IMD 102 into the heart 101 using the device receptacle 108 (e.g., where the IMD 102 is at least partially located within the receptacle volume 112), the medical system 100 may be configured to utilize the device tether 120 and processing circuitry 134 to assess and / or allow a clinician to assess whether the device receptacle 108 is within the atrium, ventricle, coronary sinus, or some other part of the heart 101. In some examples, processing circuitry 134 is configured to use inherent electrical signals obtained via the device tether 120 to assess the location of the device receptacle 108 and / or the IMD 102 during delivery of the IMD 102 into the chamber of the heart 101. In the various examples, the device tether 120 allows the reception of inherent electrical signals when the IMD 102 (and, for example, the IMD processing circuitry 133) is substantially de-energized (e.g., in an off state). Therefore, the device tether 120 allows the IMD 102 to remain in the off state until the medical system 100 positions the IMD 102 within the ventricle of the heart 101 and / or near the target site 104.

[0056] In various examples, the medical system 100 includes a display device 141, which includes a display 151. The display device 141 may be configured to receive data from processing circuitry 134 and use the display 151 to display information to a user (e.g., a clinician). For example, the display device 141 may be configured to use the display 151 to display a waveform indicating a sensed signal (e.g., an inherent electrical signal of the heart 101). In various examples, the waveform indicates a sensed signal (e.g., an inherent electrical signal) received by processing circuitry 134 using device tether 120. The medical system 100 may be configured to use one or more communication links (such as communication link 157) to transmit data indicating the waveform and / or other information related to the waveform from processing circuitry 134 to the display device 141. In various examples, the display 151 is a liquid crystal display, an organic light-emitting diode screen, a touchscreen, a cathode ray tube display, or other types of displays configured to display information to a user. In some examples, the medical system 100 is configured to use one or more communication links (such as communication link 161) to transmit data indicating a waveform to a display device 141, the waveform indicating a sensed signal (e.g., an inherent electrical signal) received by the IMD processing circuitry 133. In some examples, the medical system 100 is configured to transmit data indicating a waveform to a different display device than display device 141, the waveform indicating a sensed signal received by the IMD processing circuitry 133. In some examples, display device 141 and external device 136 may be part of a single computing device (e.g., display device 141 and external device may be supported by a common housing of a single computing device).

[0057] In various examples, the medical system 100 is configured to use the processing circuitry 134 when the IMD 102 and / or the IMD processing circuitry 133 is substantially off (e.g., when the IMD 102 and / or the IMD processing circuitry 133 is substantially de-energized) and / or when one or more of the device electrodes 111 are substantially within the device housing 112. For example, during delivery of the IMD 102 to a chamber of the heart, the medical system 100 may be configured to use the processing circuitry 134 to sense signals using the tethering electrode 129 (e.g., to determine the position of the device housing 108 and the IMD 102 during IMD delivery). The medical system 100 may use the processing circuitry 134 and the tethering electrode 129 to evaluate, for example, whether the device housing 108 and the IMD 102 are in the patient's atrium or ventricle. The medical system 100 can be configured to use the IMD processing circuit 133 when the IMD 102 and IMD processing circuit 133 are substantially on (e.g., when the IMD 102 and / or IMD processing circuit 133 are at least partially energized), and one or more of the device electrodes 111 can adequately receive inherent electrical signals (e.g., when one or more of the device electrodes 111 are distal to the receiver opening 109). For example, during pacing mapping and / or implantation of the IMD 102 within the heart chamber, the medical system 100 can be configured to use the IMD processing circuit 133 to sense signals using the first distal electrode 103, the second distal electrode 105, and / or the proximal electrode 107. Using the IMD processing circuit 133, which receives signals substantially from the electrodes of the IMD 102, can provide more precise signals during, for example, pacing mapping, implantation of the IMD 102, or other procedures.

[0058] In some examples, the device tether 120 is configured to engage with a portion of the IMD 102 (e.g., the IMD retrieval structure 192, the IMD housing 196, and / or the proximal electrode 107). Figure 3 Electrical connectivity is provided to assist IMD 102 in receiving sensed signals for delivery to IMD processing circuitry 133. For example, IMD retrieval structure 192 may include one or more conductive portions configured to electrically contact tether electrode 129 when tether head 128 engages IMD 102. IMD retrieval structure 192 may be electrically connected to proximal electrode 107 (e.g., via IMD housing 196). Electrical connection between tether electrode 129 and proximal electrode 107 or another conductive portion of IMD 102 can increase the effective area of ​​tether electrode 129 to improve signal acquisition and quality. Additionally, medical system 100 may be configured to utilize the electrical connection between tether electrode 129 and proximal electrode 107 when medical system 100 uses processing circuitry 133 of IMD 102 to sense inherent electrical signals of heart 101.

[0059] For example, when the first distal electrode 103, the second distal electrode 105, and / or another device electrode in the device electrode 111 are distal to the receiver opening 109 (e.g., outside the receiver volume 112) and the proximal electrode 107 is proximal to the receiver opening 109 (e.g., inside the receiver volume 112), the IMD processing circuit 133 can sense an inherent electrical signal using the electrical connection between the tether electrode 129 and the proximal electrode 107. The medical system 100 can use the IMD processing circuit 133 to sense an inherent electrical signal between a first conductive path including the first distal electrode 103, the second distal electrode 105, and / or another device electrode in the device electrode 111 distal to the receiver opening 109, and the second conductive path including the proximal electrode 107 and the tether electrode 129. The first conductive path may extend between, for example, the first distal electrode 103, the second distal electrode 105, and / or another device electrode 111 distal to the receptacle opening 109 and the processing circuitry 133. The second conductive path may extend from, for example, the processing circuitry 133 via a clamp or other connection between the conductive path 137 and the proximal portion 126 of the tether, through the proximal electrode 107 and the tether electrode 129, through the distal portion 124 of the tether, through the proximal portion 126 of the tether, and to the second electrode 139. Thus, the medical system 100 may be configured to use the device tether 120 to enable the IMD processing circuitry 133 to sense the inherent electrical signal of the heart 101 when the proximal electrode 107 is proximal to the receptacle opening 109 (e.g., within the receptacle volume 112) using the device electrode distal to the receptacle opening 109 (e.g., the first distal electrode 103). For example, the device tether 120 allows the IMD processing circuitry 133 to use the first distal electrode 103 and / or the second distal electrode 105 to perform pacing mapping and / or assess the implantation of the IMD 102 before withdrawing the device receiver 108 and the device tether 120 proximally away from the IMD 102.

[0060] Although the examples herein discuss delivery, retrieval, and / or positioning of IMD 102 within the RA of heart 101, medical system 100 may be configured to deliver, retrieve, and / or position the IMD 102 in a manner similar to that described for the RA of heart 101, in any other chamber of heart 101 and / or in other anatomical volumes of the patient. Furthermore, although the examples herein discuss attachment member 132 defining a helical member, attachment member 132 may define other structures, such as one or more elongated serrations extending from, for example, the distal portion 194 of the IMD. Device tethering members 120 (e.g., conductive tethering member 121 and tethering member head 128) may be configured to apply translational force (e.g., in the distal direction D) and / or rotational torque to the IMD 102 to cause attachment member 132 to engage tissue near target site 104. Target site 104 may include an appendage of the RA, or a triangle in the Koch region of the RA, or some other part of the heart 101, or some other location within the patient's body.

[0061] Figure 2 This is a plan view of an example medical system 100 used to deliver an IMD 102 within a container volume 112 to a location within a heart 101. Figure 3 This is a schematic diagram of a device receiver 108 supported by the distal portion 114 of the delivery catheter and a device tether 120 extending through the delivery lumen 118. Figure 3 In the image, for clarity, the device container 108 and the delivery conduit 106 are shown as transparent.

[0062] Medical system 100 may include a guide 140, a delivery catheter 106, and a device tether 120. In various examples, the guide 140 is an elongated member defining an internal lumen. The guide 140 is configured (e.g., by a clinician) to be inserted into a patient's vascular system to provide a channel through which a medical device, apparatus, or other therapy is inserted.

[0063] The delivery catheter 106 is configured to be inserted through the internal lumen of the guide 140 to deliver the IMD 102 within the vascular system. The delivery catheter 106 includes a distal portion 114 and a proximal portion 116. The delivery catheter 106 may include a delivery catheter handle 142 and a device receiver 108. The delivery catheter handle 142 may be substantially located at the proximal end of the proximal portion 116. In various examples, the delivery catheter handle 142 includes one or more elements (such as buttons, switches, etc.) configured to control movement (e.g., steering) of the distal portion 114 and / or the device receiver 108.

[0064] Device receiver 108 is supported by a distal portion 114 of the delivery catheter. In various examples, device receiver 108 is substantially disposed at the distal end 154 (“distal end 154 of delivery catheter”) of the distal portion 114 of the delivery catheter. Device receiver 108 includes a receiver wall 110 defining a receiver volume 112. In various examples, device receiver 108 includes a hollow, substantially cylindrical body defining a receiver volume 112. Device receiver 108 is configured to receive the IMD 102 (e.g., when it is being transported to and / or implanted into the patient’s vascular system) while the IMD 102 is being transported to and / or implanted into the patient’s vascular system. Figure 3 The device 106 (as depicted) is housed and supported within the receptacle volume 112. For example, when the guide is positioned within the patient's vascular system, the clinician can insert the device receptacle 108 and the distal portion 114 of the delivery catheter through the internal lumen of the guide 140. Once the device receptacle 108 has extended through the guide 140, the clinician can (e.g., using the delivery catheter handle 142) navigate the delivery catheter 106 across the vascular system to the implantation site within the patient's heart 101 (e.g., near the target site 104). Figure 1 Clinicians can use the device tether 120 to extend the IMD 102 from and / or distally to the receiver opening 109. Clinicians can (e.g., using the handle 142) disengage the tether head 128 from the IMD 102 and withdraw the delivery catheter 106 and device tether 120 proximally via the guide 140.

[0065] A device tether 120 (e.g., at least a portion of the distal portion 124 and the proximal portion 126 of the tether) extends through the delivery lumen 118 of the delivery catheter 106. In various examples, the distal portion 124 of the tether is configured to extend through at least the distal portion 114 of the delivery catheter, and / or the proximal portion 126 of the tether is configured to extend through at least the proximal portion 116 of the delivery catheter. A portion of the distal portion 124 of the tether is within the delivery lumen 118. Figure 2 The image is shown in dashed lines. In each example, the proximal portion 126 of the tether extends through the handle 142 of the delivery catheter.

[0066] The tether head 128 may be supported by the distal portion 124 of the tether. In various examples, the tether head 128 is substantially located at the distal end 125 (“tether distal end 125”) of the distal portion 124 of the tether. Figure 3The tether head 128 may be attached to and / or connected to the distal end 125 of the tether. In some examples, the body of the tether head is adjacent to and / or substantially integral with the distal portion 124 of the tether. In some examples, the tether head 128 and the distal portion 124 of the tether define (e.g., at the distal end 125 of the tether) substantially separate bodies that are attached (e.g., connected) to each other.

[0067] In various examples, the device tether 120 includes a tether handle 144. The tether handle 144 may be substantially located at the proximal end 127 (“tether proximal end 127”) of the proximal portion 126 of the tether. In various examples, the tether handle 144 includes one or more devices (such as tether handle device 153) configured to engage and / or disengage the tether head 128 from the IMD 102. The tether handle device 153 may be one or more of a button, a switch, and / or other devices configured to engage and / or disengage the tether head 128 from the IMD 102 (e.g., when operated by a clinician). Although Figure 2 and Figure 3 A tether handle assembly 153 is depicted substantially on the side of the housing of the tether handle 144, but the tether handle 144 may support the tether handle assembly 153 and / or a portion thereof at any location on the housing of the tether handle 144. In some examples, the tether handle 144 supports the tether handle assembly 153 and / or a portion thereof substantially in the distal proximal portion and / or proximal end of the housing tether handle 144. In various examples, the device tether 120 includes a pull wire (e.g., a conductor 208). Figures 7A to 7C The pull cord is configured such that the tether head device 153 enables the tether head 128 to engage and / or disengage from the IMD 102.

[0068] Clinicians can use the device tether 120 to extend the IMD 102 from and / or distally thereto from the receiver opening 109. Clinicians can (e.g., using the tether handle 144) disengage the tether head 128 from the IMD 102 and withdraw the delivery catheter 106 and device tether 120 proximally via the guide 140. The conductive tether 121 may be of sufficient length for the clinician to manipulate the tether handle 144 to advance the tether head 128 distally through the receiver opening 109.

[0069] In some examples, with the tether head 128 outside the receiver volume 112 (e.g., distal to the receiver opening 109), a clinician can engage the tether head 128 with the IMD 102. The clinician can then use the device tether 120 (e.g., the tether handle 144 and / or the conduction tether 121) to load the IMD 102 into the receiver volume 112 via the receiver opening 109 and advance the delivery catheter 106, in which the device tether 120 and the IMD 102 are present, through the guide 140 and into the vascular system.

[0070] Main Reference Figure 3 The delivery catheter 106 includes a body 148 (“delivery catheter body 148”) defining a delivery lumen 118. The delivery lumen 118 extends from a distal lumen opening 150 defined by the delivery catheter body 148 to a proximal lumen opening 152 defined by the delivery catheter body 148. The distal lumen opening 150 opens into a receiver volume 112. In various examples, the delivery catheter body 148 defines the distal lumen opening 150 at a distal end 154 (“delivery catheter distal end 154”). The delivery catheter body 148 may define the proximal lumen opening 152 substantially at a proximal end 156 (“delivery catheter proximal end 156”). A device tether 120 (e.g., tether body 122) is configured to translate (e.g., slidably translate) within the delivery lumen 118 in a distal direction D and / or a proximal direction P. In various examples, the distal portion 124 of the tether and / or the head 128 of the tether are configured to pass through the distal lumen opening 150 when the tether body 122 translates within the delivery lumen 118. In various examples, the proximal portion 126 of the tether is configured to pass through the proximal lumen opening 152 when the tether body 122 translates within the delivery lumen 118. In some examples, the distal portion 124 of the tether and / or the head 128 of the tether are configured to pass through the proximal lumen opening 152 when the tether body 122 translates within the delivery lumen 118 (e.g., such that the head 120 can be withdrawn entirely from the delivery lumen 118 via the proximal lumen opening 152).

[0071] The delivery catheter body 148 may define and / or support the body 158 (“catheter handle body 158”) of the delivery catheter handle 142. In some examples, the catheter handle body 158 is adjacent to and / or substantially integral with the delivery catheter body 148. In some examples, the delivery catheter body 148 and the catheter handle body 158 are substantially separate bodies attached (e.g., at the proximal end 156 of the delivery catheter) to each other. In various examples, the catheter handle body defines a channel 160 (“catheter handle channel 160”) configured (e.g., through the proximal lumen opening 152) to the delivery lumen 118. The device tether 120 (e.g., tether body 122) may be configured to translate (e.g., slidably translate) within the catheter handle channel 160 in the distal direction D and / or the proximal direction P (e.g., when the tether body 122 translates within the delivery lumen 118). In some examples, the distal portion 124 of the tether and / or the head 128 of the tether are configured to pass through the catheter stem passage 160 (e.g., such that the head 120 of the tether can be withdrawn entirely from the delivery lumen 118 via the catheter stem passage 160).

[0072] The receiver wall 110 of the device receiver 108 includes a wall body 162 defining an outer surface 164 (“outer wall surface 164”) on a first side of the wall body 162 and an inner surface 166 (“inner wall surface 166”) on a second side of the wall body 162 opposite to the first side. The inner wall surface 166 may define the boundary of the receiver volume 112. A delivery catheter body 148 defines an outer surface 168 (“catheter outer surface 168”) on a first side of the delivery catheter body 148 and an inner surface 170 (“catheter inner surface 170”) on a second side of the delivery catheter body 148 opposite to the first side. The catheter inner surface 170 may define the boundary of the delivery lumen 118.

[0073] At least a portion of the catheter outer surface 168 and the outer wall surface 164 are configured to be in fluid communication with an external environment EO surrounding the device receiver 108 and the distal portion 114 of the delivery catheter. For example, the outer wall surface 164 and the catheter outer surface 168 may be configured to be in fluid communication with the fluid environment within the chambers of the heart 101 when the device receiver 108 and the distal portion 114 of the delivery catheter are positioned (e.g., by a clinician) within the heart 101. In various examples, the external environment EO includes fluids (e.g., the patient's blood).

[0074] The tether electrode 129 is configured to receive signals from the heart 101 transmitted by the external environment EO. Figure 1The inherent electrical signal of the device electrode 129. When the tether electrode 129 is positioned within the receptacle volume 112 and / or delivery lumen 118, the tether electrode 129 can receive the inherent electrical signal transmitted by the external environment EO. ​​The tether electrode 129 is configured to receive the inherent electrical signal via the tether electrode 129 when the IMD 102 is positioned within the receptacle volume 112 (e.g., when the tether head 128 engages with the IMD 102 within the receptacle volume 112). In various examples, the tether electrode 129 is configured to receive the inherent electrical signal when the IMD 102 is within the receptacle volume 112 and substantially between the tether head 128 and the receptacle opening 109. Thus, the medical system 100 can receive the inherent electrical signal via the tether electrode 129 when one or more of the device electrodes 111 (e.g., proximal electrode 107) are substantially shielded from the external environment EO by the receptacle wall 110 and / or a portion of the IMD 102. When the IMD processing circuit 133 is substantially de-energized, the medical system 100 can receive inherent electrical signals via the tether electrode 129.

[0075] The tether electrode 129 is configured to conduct received intrinsic electrical signals to the distal portion 124 of the tether. The distal portion 124 of the tether is configured to conduct intrinsic electrical signals from the distal portion 124 of the tether to the proximal portion 126 of the tether. The processing circuitry 134 is configured to receive the intrinsic electrical signals using a first electrode 138 electrically connected to the proximal portion 126 of the tether and a second electrode 139 electrically connected to a portion of the patient. In various examples, when the tether electrode 129 receives the intrinsic electrical signals, the proximal portion 126 of the tether extends through at least the proximal luminal opening 152. The first electrode 138 may be electrically connected to a portion of the proximal portion 126 of the tether proximal to the proximal luminal opening 152. In some examples, when the tether electrode 129 receives the intrinsic electrical signals, the proximal portion 126 of the tether extends through the catheter stem passage 160. The first electrode 138 may be electrically connected to a portion of the proximal portion 126 of the tether proximal to the catheter stem passage 160. Thus, the tether head 128 may be configured to receive an inherent electrical signal using the tether electrode 129, wherein the tether head 128 is inside the patient, and to conduct the signal to the first electrode 138 and processing circuitry 134 at a location outside the patient using the conductive tether 121. In various examples, the inherent electrical signal is an electrogram (EGM) of the heart 101.

[0076] The first electrode 138 is configured to be electrically connected to the proximal portion 126 of the tethering member (e.g., as shown in the image). Figure 3 (As depicted). In each example, the first electrode 138 is configured to be electrically isolated from the proximal portion 126 of the tether (e.g., as shown). Figure 2(As depicted). For example, the first electrode 138 may include a conductor 172 (“first electrode conductor 172”) configured to contact the proximal portion 126 of the tether to establish an electrical connection with the proximal portion 126 of the tether. The first electrode conductor 172 may be configured to displace from the proximal portion 126 of the tether to electrically isolate it from the proximal portion 126 of the tether. In various examples, the first electrode 138 is configured to be manipulated (e.g., by a clinician) to electrically connect and / or isolate the first electrode conductor 172 from the proximal portion 126 of the tether. In various examples, the first electrode 138 includes a gripping portion 174 configured to be gripped and / or manipulated by a clinician. The gripping portion 174 may be configured such that a force applied (e.g., by a clinician) to the gripping portion 174 electrically connects and / or isolates the first electrode conductor 172 from the proximal portion 126 of the tether. In some examples, the first electrode 138 is configured to establish a first positioning and a second positioning, the first positioning being configured to induce contact between the first electrode conductor 172 and the proximal portion 126 of the tether, and the second positioning being configured to displace the first electrode conductor 172 and the proximal portion 126 of the tether. In various examples, the first electrode 138 (e.g., by means of a biasing element such as a spring, a compressible material, or another biasing element) is biased to transition from the second positioning to the first positioning. In various examples, the first electrode 138 is configured to transition from the first positioning to the second positioning when a force (e.g., by a clinician) is applied to the grip portion 174.

[0077] In various examples, the tether body 122 of the device tether 120 is an elongated body comprising a conductive material (e.g., a conductive material), such as a metal, a conductive polymer, or other conductive material. The tether body 122 may be configured to use the conductive material to conduct a sensed signal (e.g., an inherent electrical signal) from the distal portion 124 of the tether to the distal portion 126 of the tether. In various examples, the conductive material extends from the distal end 125 of the tether to the proximal portion 126 of the tether. In various examples, the conductive material extends from the proximal end 127 of the tether to the distal portion 124 of the tether. A first electrode 138 (e.g., a first electrode conductor 172) may be configured to be electrically connected to the conductive material when the first electrode 138 is electrically connected to the proximal portion 126 of the tether.

[0078] In some examples, the tether body 122 defines an outer surface 176 (“tether outer surface 176”). The tether outer surface 176 may be configured to substantially face the inner surface 170 of the catheter as the conductive tether 121 and / or the tether body 122 extends through the delivery lumen 118. In various examples, the tether outer surface 176 is a surface defined by a conductive material of the tether body 122. A first electrode 138 (e.g., a first electrode conductor 172) may be configured to be electrically connected to the conductive material via the outer surface 176 when the first electrode 138 is electrically connected to the proximal portion 126 of the tether.

[0079] Figure 4 An example tether head 128 is illustrated. The tether head 128 is configured to engage and / or disengage with the IMD 102. The tether head 128 and the components discussed herein are examples of tether heads that can be used by the medical system 100. In other examples, the medical system 100 may use other tether head assemblies with different components. As discussed, the tether electrode 129 may be supported (e.g., mechanically supported) or defined by the tether head 128 and / or the tether body 122. For example, Figure 4 The tether electrode 129 is depicted (in dashed lines) as extending over the tether head 128 and the tether body 122.

[0080] The tether head 128 includes a body 177 (“tether head body 177”) defining an outer surface 179 (“head outer surface 179”). In various examples, the head outer surface 179 is configured to be in fluid communication with the receiver volume 112 when the tether head 128 is positioned (e.g., at least partially positioned) within the receiver volume 112. In various examples, the tether electrode 129 includes at least a portion of the head outer surface 179 of the tether head 128 and / or at least a portion of the tether outer surface 176 of the distal tether portion 124. Thus, the device tether 120 can be configured to receive inherent electrical signals (via the tether electrode 129) using at least a portion of the tether head 128 and / or at least a portion of the distal tether portion 126.

[0081] The tether head 128 may be configured such that when the tether head 128 is positioned within the receiver volume 112 (e.g., when engaged with IMD 102) and / or within the delivery lumen 118, at least a portion of the tether electrode 129 is in fluid communication with the receiver volume 112. For example, the tether head 128 may be configured such that when the tether head 128 is positioned within the receiver volume 112 and / or the delivery lumen 118, a portion of the outer surface 179 of the head defining and / or supporting the tether electrode 129 is in fluid communication with the receiver volume 112. Therefore, the tether electrode 129 may be configured to receive an inherent electrical signal via fluid present within the receiver volume 112. For example, when the patient's blood and / or another fluid (e.g., saline, medical dye, or another fluid) are present within the receiver volume 112, the tether electrode 129 may be configured to receive an inherent electrical signal via the patient's blood and / or another fluid.

[0082] In some examples, the tether electrode 129 is part of the head outer surface 179 and / or the tether outer surface 176. For example, the head outer surface 179 and / or the tether outer surface 176 may include a conductive material configured to be covered by an insulating material. The tether electrode 129 may be a portion of the head outer surface 179 and / or the tether outer surface 176 with the insulating cover removed. In some examples, the head outer surface 179 and / or the tether outer surface 176 may be substantially completely uncovered, such that the tether head 129 substantially comprises the entire head outer surface 179.

[0083] In various examples, the head body 177 is configured to be coupled to and / or coupled to the distal portion 124 of the tether (e.g., the tether body 122). In various examples, the tether electrode 129 is electrically connected to the head body 177. In various examples, the head body 177 is configured to be electrically connected to the tether body 122. Therefore, the device tether 120 can be configured to conduct inherent electrical signals from the tether electrode 129 to the distal portion 124 of the tether via an electrical path including the head body 177 and the tether body 122. In some examples, the outer surface 179 of the head is configured to be electrically connected to the outer surface 176 of the tether. Therefore, the device tether 120 can be configured to conduct inherent electrical signals from the tether electrode 129 to the distal portion 124 of the tether via an electrical path including the outer surface 179 of the head and the outer surface 176 of the tether. In various examples, the head body 177 and the tether body 122 can be substantially separate components. In some examples, the head body 177 may be substantially adjacent to the tether body 122, and the head body 177 and the tether body 122 define an integral part.

[0084] In various examples, the tether head 128 defines an orifice 184 to receive a portion of the IMD 102 (e.g., a portion of the IMD retrieval structure 192). The tether head 128 may be configured to define a passage 185 leading to the orifice 184, such that the portion of the IMD 102 may be received within the orifice 184 via the passage 185. The tether head 128 may be configured to alter the dimensions of the passage 185 to engage and / or disengage with the IMD 102. For example, in an engaged configuration, the tether head 128 may be configured to make the passage 185 too narrow to allow the portion of the IMD 102 (e.g., the portion of the IMD retrieval structure 192) to pass through the passage 185, thereby substantially preventing the portion of the IMD 102 from leaving (and / or entering) the orifice 184. In the disengaged configuration, the tether head 128 may be configured to make the passage 185 wider than in the engaged configuration, such that this portion of the IMD 102 can pass through the passage 185 to exit (and / or enter) the orifice 184. In various examples, the tether handle 144 (e.g., tether handle device 153) is configured to allow the tether head 128 to transition between the engaged and disengaged configurations.

[0085] In various examples, the tether head 128 includes an engaging member 182 configured to increase and / or decrease the size of the passage 185 and / or the orifice 184. The engaging member 182 may be configured to move relative to the engaging section 180 to increase and / or decrease the size of the passage 185 and / or the orifice 184. For example, the engaging member 182 may be configured to move relative to the engaging section 180 in a proximal direction P to increase the size of the passage 185 and / or the orifice 184. The engaging member 182 may be configured to move relative to the engaging section 180 in a distal direction D to decrease the size of the passage 185 and / or the orifice 184. In various examples, the tether handle 144 (e.g., tether handle device 153) is configured to move the engaging member 182 relative to the engaging section 180 to increase and / or decrease the size of the passage 185 and / or the orifice 184.

[0086] The tether head 128 can be configured to surround the device axis LD when the IMD 102 (e.g., IMD retrieval structure 192) is trapped within the orifice 184. Figure 3The device applies a distal guiding force, a proximal guiding force, or a torque. The engagement member 182 may be configured to move relative to the engagement section 180 (e.g., in the proximal direction P) to increase the size of the orifice 184, allowing the tether head 128 to disengage from the retrieval structure 192 (e.g., the IMD retrieval structure 192 can be released from the orifice 184). For example, the engagement member 182 may be moved relative to the engagement section 180 such that a proximal translation of the tether head 128 relative to the IMD 102 disengages the tether head 128 from the IMD retrieval structure 192 (e.g., after using the device tether 120 to implant the IMD 102 into a patient).

[0087] In various examples, the tether head 128 includes a support section 178 that connects to an engagement section 180. The support section 178 may connect to a distal portion 124 of the tether. The engagement section 180 may define an orifice 184. In various examples, the tether head body 177 includes a body of the support section 178 (e.g., support section body 216). Figures 7A to 7C )) and / or the main body of the joining section 180 (e.g., the main body of the joining section 202 ( Figures 7A to 7C At least one of the following. In various examples, the head outer surface 170 includes at least one of an outer surface 186 defined by an engagement section 180 and / or an outer surface 188 defined by a support section 178. In various examples, the tether head 128 is configured such that when the tether head 128 is positioned within the receiver volume 112 and / or delivery lumen 118, at least a portion of the outer surface 186 (e.g., defining and / or supporting a portion of the tether electrode 129) is in fluid communication with the receiver volume 112. In various examples, the tether head 128 is configured such that when the tether head 128 is positioned within the receiver volume 112 and / or delivery lumen 118, at least a portion of the outer surface 188 (e.g., defining and / or supporting a portion of the tether electrode 129) is in fluid communication with the receiver volume 112.

[0088] Main return to Figure 3 Device receiver 108 (e.g., wall body 162) may define receiver opening 109 substantially at the distal end 175 (“receiver distal end 175”) of device receiver 108. Receiver opening 109 may be configured such that IMD 102 can exit from and / or enter receiver volume 112 through receiver opening 109. In various examples, receiver volume 112 is defined at least partially by receiver opening 109. Distal lumen opening 150 is configured to allow at least a portion of tether body 122 to be positioned within receiver volume 112 when another portion of tether body 122 is positioned within delivery lumen 118.

[0089] In various examples, the device receiver 108 defines a receiver axis LR that extends at least through the receiver opening 109. In various examples, the inner wall surface 166 at least partially surrounds the receiver axis LR. In various examples, the receiver axis LR extends through the distal lumen opening 150. In some examples, the receiver volume 112 is at least partially defined by the distal lumen opening 150. In some examples, the receiver volume 112 defines a cross-sectional region perpendicular to the receiver axis LR, wherein the cross-sectional region is defined by a curved, curved, or polygonal boundary (e.g., a boundary defined by the inner wall surface 166). In some examples, the cross-sectional region is defined by a substantially circular boundary. In various examples, at least some portion of the wall body 162 lies between the outer wall surface 164 and the inner wall surface 166. In various examples, the outer wall surface 164 at least partially and / or substantially completely surrounds the receiver axis LR and / or the inner wall surface 166. The outer wall surface 164 can be configured such that the outer wall surface 164 is substantially oriented away from the container axis LR, the inner wall surface 166 and / or the container volume 112.

[0090] In some examples, the medical system 100 (e.g., tether head 128) is configured to engage the proximal portion 190 of the IMD 102 (“IMD proximal portion 190”). The tether head 122 may be configured to transmit torque and / or proximal or distal guiding forces to the IMD 102. The tether body 122 may be configured to receive torque and / or forces (e.g., from a clinician) and transmit torque and / or forces to the tether head 128. In various examples, the IMD proximal portion 190 includes a retrieval structure 192 (“IMD retrieval structure 192”). The IMD retrieval structure 192 may be configured to engage with the medical system 100 and / or another medical device to, for example, implant the IMD 102 within an anatomical volume, retrieve the IMD 102 from the anatomical volume, reposition the IMD 102 within the anatomical volume, and / or reorient the IMD 102 within the anatomical volume. IMD 102 may include a distal portion 194 (“IMD distal portion 194”) opposite the proximal portion 190 of the IMD. In various examples, IMD 102 (e.g., IMD distal portion 194) supports attachment member 132. In some examples, attachment member 132 is configured (e.g., as a helical member) such that rotation of IMD 102 about a device axis LD defined by IMD 102 causes the attachment member to engage and / or disengage tissue within target site 104.

[0091] IMD 102 may support (e.g., mechanically support) device electrodes 111. In various examples, attachment member 132 supports a first distal electrode 103. IMD distal portion 194 may support a second distal electrode 105. IMD proximal portion 190 may support a proximal electrode 107. In various examples, IMD 102 includes a housing 196 (“IMD housing 196”) supporting one or more device electrodes (e.g., the second distal electrode 105 and / or the proximal electrode 107) in device electrodes 111. In various examples, at least one device electrode (e.g., the proximal electrode 107) in device electrodes 111 is configured to be positioned together with the housing volume 112 when IMD 102 is at least partially residing within the housing volume 112. In each example, the IMD 102 is configured such that at least one device electrode of the device electrodes 111 (e.g., at least one of the first distal electrode 103, the second distal electrode 105, and / or the proximal electrode 107) is in fluid communication with the container volume 112 when the IMD 102 is at least partially residing within the container volume 112.

[0092] Figure 5 An example of a technique 500 for receiving inherent electrical signals generated by the heart is illustrated. Although the primary reference is... Figures 1 to 4 and Figures 7A to 8 The medical system 100 describes technology 500, but in other examples, technology 500 may be applied to other medical systems.

[0093] Technique 500 includes receiving inherent electrical signals from a patient's heart 101 using a tether electrode 129 of a device tether 120 (502). At least one of a tether head 128 or a conductive tether 121 of the device tether 120, located within a cavity of the heart 101, can support the tether electrode 129. In various examples, the tether head 128 engages with an implantable medical device 102 within a cavity of the heart 101. The conductive tether 121 includes a distal tether portion 124 within the patient and a proximal tether portion 126 outside the patient. The tether electrode 129 is electrically connected to the distal tether portion 124. The distal tether portion 124 is electrically connected to the proximal tether portion 126.

[0094] Technique 500 includes receiving an intrinsic electrical signal (504) by at least one of processing circuitry 134 or IMD processing circuitry 133 using a first electrode 138 electrically connected to the proximal portion 126 of the tether and a second electrode 139 electrically connected to a portion of the patient. In various examples, technique 500 includes using the tether electrode 129 to conduct the intrinsic electrical signal to the distal portion 124 of the tether. In various examples, technique 500 includes using the distal portion 124 of the tether to conduct the intrinsic electrical signal to the proximal portion 126 of the tether. In various examples, technique 500 includes providing a visual indication of the intrinsic electrical signal using a display device 141 communicating with at least one of processing circuitry 134 or IMD processing circuitry 133. In various examples, the intrinsic electrical signal is an intracardiac electrogram generated by the heart 101. Processing circuitry 134 may be supported by an external device 136 outside the patient's body. In various examples, processing circuitry 133 is supported by IMD 102.

[0095] Technique 500 may include: using the tether electrode 129 to receive an inherent electrical signal when the IMD 102 is at least partially located within the receiver volume 112. In various examples, technique 500 includes: using the tether electrode 129 to receive an inherent electrical signal when one or more device electrodes (e.g., distal electrode 107) of the device electrodes 111 are at least partially located within the receiver volume 112. Technique 500 may include: using processing circuitry 134 to receive a signal when the IMD 102 is at least partially located within the receiver volume 112. In various examples, technique 500 includes: using processing circuitry 134 to receive a signal when one or more device electrodes (e.g., distal electrode 107) of the device electrodes 111 are at least partially located within the receiver volume 112. Technique 500 may include: using the tether electrode 129 to receive inherent electrical signals and / or having inherent electrical signals received by the processing circuit 133 when the IMD 102 and / or processing circuit 134 are substantially de-energized (e.g., substantially in a closed state).

[0096] In various examples, technique 500 includes using processing circuitry 134 to evaluate the location of device housing 108 and / or IMD 102, such as within the atrium, ventricle, coronary sinus, or some other part of heart 101. In some examples, technique 500 includes using processing circuitry 134 to evaluate the location of device housing 108 and / or IMD 102 using inherent electrical signals sensed and / or received by tethering electrodes 129.

[0097] In some examples, technique 500 may include using processing circuitry 133 of IMD 102 to receive inherent electrical signals. Technique 500 may include using a tether head 128 to establish and / or maintain an electrical connection between tether electrode 129 and proximal electrode 107 of IMD 102. In various examples, when tether head 128 establishes and / or maintains the electrical connection between tether electrode 129 and proximal electrode 107, proximal electrode 107 is within the receiver volume 112. In some examples, when tether head 128 establishes and / or maintains the electrical connection between tether electrode 129 and proximal electrode 107, one or more of the first distal electrode 103, the second distal electrode 105, and / or another device electrode of device electrode 111 are distal to the receiver opening 109 (e.g., outside the receiver volume 112).

[0098] Processing circuitry 133 can receive an inherent electrical signal between a first conductive path and a second conductive path, the first conductive path including a first distal electrode 103, a second distal electrode 105, and / or another device electrode among device electrodes 111, the second conductive path including a proximal electrode 107 and a tether electrode 129. In various examples, the first conductive path extends between the first distal electrode 103, the second distal electrode 105, and / or another device electrode among device electrodes 111 and the second electrode 139 or another electrode electrically connected to the patient. In various examples, the second conductive path extends through the proximal electrode 107, the tether electrode 129, the distal portion 124 of the tether, the proximal portion 126 of the tether, and the first electrode 138 or another electrode electrically connected to the proximal portion 126 of the tether. In various examples, technique 500 includes using processing circuitry 133 to perform pacing mapping of the heart 101 and / or evaluation of the implantation of the IMD 102.

[0099] In various examples, technique 500 includes using a conductive tether 121 to extend a proximal portion 126 of the tether through a proximal lumen opening 152 of a delivery lumen 118 defined by a delivery catheter 106. The proximal lumen opening 152 may be outside the patient's body. A first electrode 138 may be electrically connected to a portion of the proximal portion 126 of the tether proximal to the proximal lumen opening 152. In various examples, a device receiver 108 holding the IMD 102 within a receiver volume 112 positions the IMD 102 within a chamber of the heart 101. A distal lumen opening 150 of the delivery lumen 118 may open into the receiver volume 112 of the device receiver 108. Technique 500 may include using the conductive tether 121 to extend at least one of a tether head 128 or a distal portion 124 of the tether through the distal lumen opening 150 as the proximal portion 126 of the tether extends through the proximal lumen opening 152. Technique 500 may include: using a conductive tether 121 to position at least one of the tether head 128 or the tether distal portion 124 within the accommodating volume 112 when the proximal portion 126 of the tether extends through the proximal lumen opening 152.

[0100] Technique 500 may include: using a tether electrode 129 to receive an inherent electrical signal when the tether head 128 is positioned in at least one of a receptacle volume 112 or a delivery lumen 118. When the tether electrode 129 receives the inherent electrical signal, at least a portion of the tether head 128 may be in fluid communication with the receptacle volume 112. In various examples, the tether electrode receives the signal via fluid within the receptacle volume 112. In various examples, the technique includes: at least using a receptacle opening 109 to fill the receptacle volume 112 with fluid (e.g., the patient's blood). In some examples, the tether electrode 129 receives the inherent electrical signal when the IMD 102 is within the receptacle volume 112 and between the tether electrode 129 and the receptacle opening 109.

[0101] In various examples, technique 500 includes supporting the tether electrode 129 using at least a portion of the outer surface 179 of the head defined by the tether head body 177 of the tether head 128. Technique 500 may include using the tether body 122 to position that portion of the outer surface 179 of the head in fluid communication with fluid within the container volume 112 and / or the delivery lumen 118.

[0102] In various examples, technique 500 includes conducting an inherent electrical signal from the tether electrode 129 to the distal portion 124 of the tether. The distal portion 124 of the tether may conduct the inherent electrical signal to the proximal portion 126 of the tether. The proximal portion 126 of the tether may conduct the signal to the first electrode 138. In various examples, when the tether electrode 129 conducts the inherent electrical signal to the distal portion 124 of the tether, at least one of the head outer surface 179 or the tether head body 177 conducts the inherent electrical signal to at least one of the tether outer surface 176 or the tether body 122. In various examples, at least one of the tether outer surface 176 or the tether body 122 conducts the inherent electrical signal from the distal portion 124 of the tether to the proximal portion 126 of the tether. In each example, at least one of the outer surface 176 of the tether or the body 122 of the tether conducts an inherent electrical signal from the proximal portion 126 of the tether to the first electrode 138.

[0103] Technique 500 may include: using a first electrode 138 to contact a first electrode conductor 172 and a proximal portion 126 of the tether to electrically connect the first electrode 138 and the proximal portion 126 of the tether. In various examples, technique 500 includes: using the first electrode 138 to displace the first electrode conductor 172 from the proximal portion 126 of the tether to electrically isolate the first electrode 138 and the proximal portion 126 of the tether. In some examples, biasing of the first electrode 138 maintains electrical contact between the first electrode 138 and the proximal portion 126 of the tether. In some examples, technique 500 includes: using a gripping portion 174 to overcome the biasing of the first electrode 138 to electrically isolate the first electrode 138 and the proximal portion 126 of the tether.

[0104] Figure 6 An example is illustrated by technique 600 for receiving inherent electrical signals generated by the heart using processing circuitry outside the patient's body. Although primarily referenced... Figures 1 to 4 and Figures 7A to 8 The medical system 100 describes technology 600, but in other examples, technology 600 may be applied to other medical systems. Furthermore, any step in technology 600 may be performed in addition to or in lieu of any step in technology 500. Similarly, any step in technology 500 may be performed in addition to or in lieu of any step in technology 600.

[0105] Technique 600 includes: positioning the IMD 102 within a chamber of a patient's heart 101 using a device receiver 108 supported by a delivery catheter 106 (602). The device receiver 108 holds the IMD 102 within a receiver volume 112, between a tether head 128 and a receiver opening 109 of the device receiver 108. A distal tether portion 124 of a conductive tether 121 supports the tether head 128 and extends through a delivery lumen 118 defined by the delivery catheter 106.

[0106] Technique 600 includes: receiving an intrinsic electrical signal generated by the heart 101 using a tether electrode 129 supported by at least one of the tether head 128 or the distal portion 124 of the tether (604). Technique 600 includes: using the tether electrode 129 to conduct the intrinsic electrical signal to the distal portion 124 of the tether (606). Technique 600 includes: using the distal portion 124 of the tether to conduct the intrinsic electrical signal to the proximal portion 126 of the tether, wherein the proximal portion 126 of the tether is outside the patient's body (608).

[0107] Technology 600 includes: a processing circuit 134 supported by an external device 136 outside the patient's body to receive an inherent electrical signal (610) using a first electrode 138 electrically connected to a proximal portion 126 of the tether and a second electrode 139 electrically connected to a portion of the patient. Technology 600 may include: a display 151 of a display device 141 to provide a visual indication of the inherent electrical signal.

[0108] In various examples, technique 600 includes: electrically connecting tether electrode 129 and IMD housing 196 using tether head 128, the IMD housing being electrically connected to proximal electrode 107 of IMD 102. In various examples, at least a portion of IMD housing 196 and the proximal electrode are positioned within a receptacle volume. Technique 600 may include: using IMD housing 196 to conduct inherent electrical signals from tether electrode 129 to proximal electrode 107. In various examples, technique 600 includes: receiving inherent electrical signals via IMD processing circuitry 133 supported by at least one of IMD 102, proximal electrode 107, and first distal electrode 103 and / or second distal electrode 105. Technique 600 may include: using an indicating device to provide a visual indication of the inherent electrical signals received by IMD processing circuitry 133, wherein the indicating device is a display device 141 or another device.

[0109] In some examples, technique 600 includes using IMD processing circuit 133 to receive the inherent electrical signal after using processing circuit 134 to receive the inherent electrical signal.

[0110] Figure 7AThis is a cross-sectional view of the tether head 128 and IMD 102, wherein the tether head 128 defines an orifice 184 and a passage 185 into the orifice 184. IMD 102 includes a retrieval structure 192, which includes an attachment member 198. Figure 7A In the middle, the head 128 of the fastener is in the engagement configuration, and the attachment member 198 is displaced from the orifice 184. Figure 7B It is a cross-sectional view of the tether head 128 and IMD 102, wherein the tether head 128 is in a disengaged configuration and the attachment member 198 is within the orifice 184. Figure 7C This is a cross-sectional view of the tether head 128 and IMD 102, wherein the tether head 128 is in an engaged configuration and the attachment member 198 is within the orifice 184. Figure 7A , Figure 7B and Figure 7C In the middle, the cross section is taken in a plane including the longitudinal axis LT of the tether head 128.

[0111] The tether head 128 can be configured such that the attachment member 198 can be received within the orifice 184 via the passage 185. The tether head 128 can be configured to change the size of the passage 185 to engage and / or disengage with the IMD 102. For example, in Figure 7A In the case where the tether head 128 is in the engaged configuration, the tether head 128 is configured to make the passage 185 too narrow to allow the attachment member 198 to pass through the passage 185, thereby substantially preventing the attachment member 198 from entering the orifice 184. Figure 7B In the case where the tether head 128 is in the disengaged position, the tether head 128 is configured to widen the passage 185, allowing the attachment member 198 to pass through the passage 185 into the orifice 184. Figure 7C In the case where the attachment member 198 is within the orifice 184, the tether head has returned to the engagement configuration (e.g., the narrowed passage 185), such that the attachment member 198 is essentially trapped within the orifice 184. When the tether head 128 is in the engagement configuration and the attachment member 198 is within the orifice 184, as... Figure 4 As illustrated in D, the head of the fastener can be returned to... Figure 7B The disengagement configuration allows the attachment member 198 to exit the orifice 184.

[0112] In each example, the body 202 of the engagement segment 180 (“engagement segment body 202”) may at least partially define the boundary of the orifice 184 and / or the boundary of the passage 185. In each example, the passage 185 extends from the distal end 204 of the engagement segment 180 (“engagement segment distal end 204”) and opens into the orifice 184. In each example, the engagement segment distal end 204 and / or the passage 185 are distal to the orifice 184. The body 206 of the engagement member 182 (“engagement member body 206”) may be configured to change the width of the passage 185 (e.g., to widen or narrow the passage). For example, the engagement member body 206 may be configured to move relative to the engagement segment body 202 (e.g., in the proximal direction P and / or the distal direction D) to change the width of the passage 185. In each example, the engagement member body 206 is configured to move in the proximal direction P relative to the engagement section body 202 when the tether head 128 changes from an engagement configuration to a disengagement configuration (e.g., when the tether head 128 widens the passage 185). The engagement member body 206 may be configured to move in the distal direction D relative to the engagement section body 202 when the tether head 128 changes from a disengagement configuration to an engagement configuration (e.g., when the tether head 128 narrows the passage 185).

[0113] In various examples, the device fastener 120 includes an elongated body or wire 208 (“wire 208”) configured to switch the fastener head 128 between an engaged configuration and a disengaged configuration. In various examples, the wire 208 is configured (e.g., using the fastener handle device 153) such that the fastener handle 144 enables the fastener head 128 to switch between an engaged configuration and a disengaged configuration. In various examples, the fastener head 128 may be configured to apply a driving force F ( ) to the fastener head 128 (e.g., on the engaging member body 206) when the wire 208 applies the driving force F ( ). Figure 7B When the tether head 128 transitions between an engaged configuration and a disengaged configuration, it is used to switch between these configurations. In various examples, the tether head 128 includes an elastic member 210 configured to apply a member force FE to a portion of the tether head 128 (e.g., on the engaging member body 206). Figures 7A to 7CThe conductor 208 is configured to overcome the member force FE when the conductor 208 applies a driving force F. In various examples, the elastic member 210 is configured to cause the tether head 128 to assume a first configuration (e.g., an engaged configuration or a disengaged configuration) when the elastic member 210 applies the member force FE. The conductor 208 may be configured to cause the tether head 128 to assume a second configuration (e.g., an engaged configuration or a disengaged configuration) when the conductor 208 applies a driving force F. In some examples, the elastic member 210 is configured to cause the tether head 128 to assume an engaged configuration when the elastic member 210 applies the member force FE in the absence of the conductor 208 applying the driving force F, and the conductor 208 is configured to cause the tether head 128 to assume a disengaged configuration when the conductor 208 applies a driving force F and overcomes the member force FE.

[0114] In each example, the elastic member 210 is configured to define a first length L1 when the tether head 128 is in a first configuration, and a second length L2 when the tether head 128 is in a second configuration. For example, as Figure 7A As depicted, when the head of the tether is in the engaged configuration, the elastic member 210 can define a first length L1. For example... Figure 7B As depicted, when the tether head 128 is in a disengaged configuration, the resilient member 210 may define a second length L2. In various examples, the first length L1 and the second length L2 are substantially parallel to the distal direction D and / or the proximal direction P. In some examples, the first length L1 and the second length L2 define the shortest length between the distal end 212 (“resilient member distal end 212”) of the resilient member 210 and the proximal end 214 (“resilient member proximal end 214”) of the resilient member 210 opposite to the resilient member distal end 212. In some examples, the first length L1 and the second length L2 define the lengths along the resilient member 210 between the resilient member distal end 212 and the resilient member proximal end 214. In various examples, the resilient member 210 is configured such that the member force FE increases as the resilient member changes from the first length L1 to the second length L2. In some examples, the resilient member 210 may be configured such that the member force FE increases as the resilient member changes from the second length L2 to the first length L1. In each example, the distal portion of the lead wire 208 applies a driving force F to the tether head 128. The lead wire 208 may include a proximal portion coupled to the tether handle 144. The lead wire 208 may be configured such that increasing the tension of the proximal portion of the lead wire 208 causes the distal portion of the lead wire 208 to apply a driving force F to the tether head 128. In each example, the tether handle 144 is configured to increase the tension of the proximal body of the lead wire 208.

[0115] The tether handle 144 may be configured to cause the lead wire 208 to apply a driving force F to the tether head and / or to stop the lead wire 208 from applying a driving force F to the tether head 128 to control the configuration of the tether head. The tether handle 144 may be configured such that a clinician can cause the tether handle 144 to apply and / or stop applying a driving force F to the tether head 128. In some examples, the tether handle 144 is configured to be substantially locked into a configuration in which a driving force F is applied and / or substantially locked into a configuration in which a driving force F is stopped and / or cannot be applied to the tether head 128, such that the tether head 128 is substantially maintained in one of the engaged or disengaged configurations until (e.g., the locking member of the tether handle 144) is operated (e.g., by a clinician). In each example, the conductive tether 121 (e.g., tether body 122) defines a lumen 218 (“tether lumen 218”) in which a portion of the wire 208 is received. In each example, the tether lumen 218 extends substantially from the distal end 125 of the tether to the proximal end 127 of the tether.

[0116] Figure 8 This is a functional block diagram illustrating an example configuration of a device 218 configured to receive and / or detect inherent electrical signals of the heart 101 using device tether 120. Device 218 may be an example of external device 136 and / or IMD 102. Device 218 may include processing circuitry 220, sensing circuitry 222, therapy delivery circuitry 224, sensor 226, communication circuitry 228, and memory 230. Processing circuitry 220 may be an example of processing circuitry 134 and / or processing circuitry 133. In some examples, memory 230 includes computer-readable instructions that, when executed by processing circuitry 220, cause device 218 and processing circuitry 220 to perform various functions attributed herein to device 218 and processing circuitry 220. The memory 230 may include any volatile, non-volatile, magnetic, optical, or electrical medium, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), ferroelectric RAM (FRAM), flash memory, or any other digital medium.

[0117] Processing circuitry 220 may include fixed-function circuitry and / or programmable processing circuitry. Processing circuitry 220 may include any and more of a microprocessor, controller, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or equivalent discrete or analog logic circuitry. In some examples, processing circuitry 220 may include multiple components, such as one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, and any combination of other discrete or integrated logic circuitry.

[0118] The functions attributable to processing circuitry 220 may be embodied in software, firmware, hardware, or any combination thereof. Processing circuitry 220 may include, for example, various capacitors, transformers, and switches configured to perform the functions of processing circuitry 220. In various examples, processing circuitry 220 may be configured (e.g., via communication circuitry 228) to communicate with another device, such as a patient input / output device, a clinician input / output device, and / or other devices. Processing circuitry 220 may include any suitable hardware, firmware, software, or any combination thereof for communicating with another device. Furthermore, processing circuitry 220 may communicate with networked computing devices and / or computer networks.

[0119] In some examples, processing circuitry 220 may receive, via communication circuitry 228 (e.g., from an external device), the corresponding value of each of a plurality of cardiac sensing parameters, cardiac therapy parameters (e.g., cardiac pacing parameters), and / or electrode vectors. Processing circuitry 220 may store such parameters and / or electrode vectors in memory 230. Therapy delivery circuitry 224 and sensing circuitry 222 are electrically connected to electrodes 232, which may correspond to a first electrode 138, a second electrode 139, a device electrode 111, and / or be electrically connected to device 218 and / or other electrodes supported by that device. Processing circuitry 220 is configured to control therapy delivery circuitry 224 to generate an electrotherapy and deliver the electrotherapy to heart 101 via electrodes 232. The electrotherapy may include, for example, pacing pulses or any other suitable electrical stimulation. Processing circuitry 220 may control therapy delivery circuitry 224 to deliver the electrical stimulation therapy via electrodes 232 according to one or more therapy parameter values ​​that may be stored in memory 230. In some examples, therapy delivery circuitry 224 may include a capacitor, a current source, and / or a regulator.

[0120] Furthermore, processing circuitry 220 is configured to control sensing circuitry 222 to monitor signals from electrode 232 in order to monitor the electrical activity of heart 101. Sensing circuitry 222 may include circuitry for acquiring electrical signals, such as filters, amplifiers, and analog-to-digital circuitry. The electrical signals acquired by sensing circuitry 222 may include inherent and / or pacing cardiac electrical activity, such as atrial depolarization and / or ventricular depolarization. Sensing circuitry 222 may filter, amplify, and digitize the acquired electrical signals to generate raw digital data. Processing circuitry 220 may receive the digitized data generated by sensing circuitry 222. In some examples, processing circuitry 220 may perform various digital signal processing operations on the raw data, such as digital filtering. In some examples, in addition to sensing circuitry 222, device 218 may optionally include sensors 226, which, for example, may be one or more pressure sensors and / or one or more accelerometers. Communication circuitry 228 may include any suitable hardware (e.g., antenna), firmware, software, or any combination thereof for communicating with another device, for example, external to the patient.

[0121] IMD housing 196 may encapsulate processing circuitry 134 and / or other circuitry within medical system 100. IMD housing 196 may be configured to isolate processing circuitry 134 and / or other circuitry from ambient fluids in contact with the outer surface of IMD housing 196. In various examples, IMD housing 196 is configured to hermetically seal the package defined by IMD 102 and retaining processing circuitry 134 and / or other circuitry. IMD housing 196 may be configured to define a shape that is easily accepted by the patient's body while minimizing patient discomfort. For example, IMD housing 196 may define a substantially cylindrical shape with cylindrical sidewalls. In other examples, IMD housing 196 may define a substantially rectangular or other non-cylindrical shape. IMD housing 196 may define a shape in which corners and edges are designed to have relatively large radii to present a housing with an outer surface having a smooth profile. In various examples, attachment member 132 is attached to IMD housing 196.

[0122] Communication links 157 and 161 can be hardwired and / or wireless communication links. In some examples, communication links 157 and 161 may include a portion of control circuitry 220. In some examples, communication links 157 and 161 may include wired connections, wireless internet connections, or direct wireless connections (such as wireless LAN, Bluetooth). ™ Wi-Fi ™ (and / or infrared connections). Communication links 157 and 161 can utilize any wireless or remote communication protocol. Conductive links 135 and 137 can be any component configured to conduct electrical signals through a conductive path.

[0123] As used herein, when a first part of a system (e.g., medical system 100) supports a second part of the system, this means that when the second part causes a first force to be applied to the first part, the first part responds to the first force by causing a second force to be applied to the second part. The first and / or second forces can be contact forces and / or long-range forces. For example, the first and / or second forces can be mechanical forces, magnetic forces, gravity, or some other type of force. The first part of the system can be a portion of the system or a component of the system. The second part of the system can be another part of the system or another part of the same or different components. In some examples, when the first part of the system supports the second part of the system, this can mean that the second part is mechanically supported and / or mechanically connected to the first part.

[0124] Various embodiments of this disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other embodiments are within the scope of the appended claims.

[0125] Example 1. A medical system comprising a device tether, the device tether comprising: a tether electrode configured to receive an inherent electrical signal generated by a patient's heart; a tether head configured to engage an implantable medical device within a cavity of the heart; and a conductive tether comprising a distal tether portion and a proximal tether portion, the distal tether portion being configured within the patient's body, the proximal tether portion being configured outside the patient's body when the distal tether portion and the tether head are in the body, wherein the tether head is attached to the distal tether portion, and wherein at least one of the tether head or the distal tether portion supports the tether electrode.

[0126] Example 2. The medical system according to Example 1, the medical system further includes a processing circuit configured to receive the inherent electrical signal from the proximal portion of the tether, wherein the device tether is configured to conduct the inherent electrical signal to the proximal portion of the tether.

[0127] Example 3. The medical system according to Example 1 or Example 2, the medical system further includes a first electrode and a second electrode, the first electrode being configured to be electrically connected to a proximal portion of the tether, and the second electrode being configured to be connected to a portion of the patient, wherein the processing circuit is configured to use the first electrode and the second electrode to receive the inherent electrical signal.

[0128] Example 4. A medical system according to any one of Examples 1 to 3, the medical system further comprising a display device communicating with the processing circuitry, wherein the display device is configured to use the communication to provide a visual indication of the inherent electrical signal.

[0129] Example 5. A medical system according to any one of Examples 1 to 4, wherein at least a portion of the processing circuitry is supported by an external device configured to be outside the patient when the distal portion of the tether and the head of the tether are inside the body.

[0130] Example 6. A medical system according to any one of Examples 1 to 5, wherein at least a portion of the processing circuitry is supported by the implantable medical device.

[0131] Example 7. A medical system according to any one of Examples 1 to 6, wherein the tether head supports the tether electrode.

[0132] Example 8. A medical system according to any one of Examples 1 to 7, wherein the tether electrode is defined by at least one of a body of the tether head or a body of the distal portion of the tether.

[0133] Example 9. A medical system according to any one of Examples 1 to 8, wherein the inherent electrical signal is an intracardiac electrogram.

[0134] Example 10. A medical system according to any one of Examples 1 to 9, the medical system further comprising a delivery catheter including a distal portion and a proximal portion, wherein the distal portion is configured to be inside the patient and the proximal portion is configured to be outside the patient when the distal portion is inside the patient, wherein the delivery catheter defines a delivery lumen extending between a distal lumen opening defined by the distal portion and a proximal lumen opening defined by the proximal portion, and wherein a distal portion of a tether is configured to pass through the distal lumen opening and a proximal portion of the tether is configured to pass through the proximal lumen opening when the conductive tether is translated within the delivery lumen.

[0135] Example 11. The medical system according to Example 10, the medical system further includes a device receiver including a receiver wall defining a receiver volume, wherein a distal lumen opening opens into the receiver volume, and wherein the device receiver is configured to be positioned within the chamber of the heart.

[0136] Example 12. The medical system according to Example 11, wherein the tether electrode is configured to receive the inherent electrical signal when the tether electrode is positioned in one of the receptacle volume or the delivery lumen.

[0137] Example 13. The medical system according to Example 11 or Example 12, the medical system further includes an implantable medical device, wherein the implantable medical device is configured to be positioned within the recipient volume when the tether head engages with the implantable medical device.

[0138] Example 14. The medical system according to Example 13, wherein the implantable medical device includes a distal electrode and a proximal electrode, wherein the implantable medical device is configured to receive an intrinsic electrode signal using at least one of the proximal electrode or the distal electrode, and wherein the tether electrode is configured to receive the intrinsic electrical signal when at least the proximal electrode is positioned within the receptacle volume.

[0139] Example 15. A medical system according to any one of Examples 1 to 14, wherein the conductive tether defines an outer surface extending from a distal portion of the tether to a proximal portion of the tether, and wherein the distal portion of the tether is configured to use the outer surface to conduct the inherent electrical signal to the proximal portion of the tether.

[0140] Example 16. The medical system according to Example 15, wherein the first electrode according to claim 3 is configured to be electrically connected to the outer surface.

[0141] Example 17. A medical system according to any one of Examples 1 to 16, wherein the first electrode according to claim 3 includes a conductor configured to establish contact with a proximal portion of the tether to electrically connect the first electrode and the proximal portion of the tether, and wherein the first electrode is configured to displace the conductor from the proximal portion of the tether to electrically isolate the first electrode and the proximal portion of the tether.

[0142] Example 18. The medical system according to Example 17, wherein the first electrode includes a clamp configured to cause contact between the conductor and the proximal portion of the tether in a first clamp positioning, and to displace the conductor from the proximal portion of the tether in a second clamp positioning.

[0143] Example 19. The medical system according to Example 18, wherein the clamp is biased to change from the second clamp positioning to the first clamp positioning.

[0144] Example 20. A medical system according to any one of Examples 1 to 19, wherein the tether head is configured to engage the implantable medical device in an engaged configuration and disengage from the implantable medical device in a disengaged configuration, and the medical system further includes a handle configured to allow the tether head to change between the engaged configuration and the disengaged configuration.

[0145] Example 21. The medical system according to Example 20, wherein the conductive tether includes a tether wall defining a tether lumen extending from the shank to the tether head, and the medical system further includes a wire extending through the tether lumen, wherein the wire is configured such that the shank enables the tether head to switch between an engagement configuration and a disengagement configuration.

[0146] Example 22. The medical system according to Example 21, wherein the tether wall is configured to conduct the inherent electrical signal from the distal portion of the tether to the proximal portion of the tether.

[0147] Example 23. The medical system according to any one of Examples 1 to 22, the medical system further comprising a second electrode, wherein the second electrode is configured to be electrically connected to the patient's skin.

[0148] Example 24. A medical system comprising a device tether, the device tether comprising: a tether electrode configured to receive an inherent electrical signal generated by a patient's heart; a tether head configured to engage an implantable medical device within a cavity of the heart; and a conductive tether comprising a distal portion and a proximal portion, the distal portion being configured within the patient's body, the proximal portion being configured to, when the distal portion and the tether head are in the body, [the device tether is described in the original text]. Above the patient, wherein the tether head is attached to a distal portion of the tether, wherein at least one of the tether head or the distal portion of the tether supports the tether electrode, wherein the tether electrode is configured to conduct the inherent electrical signal to the distal portion of the tether, wherein the distal portion of the tether is configured to conduct the inherent electrical signal to a proximal portion of the tether; and a handle supported by the proximal portion of the tether, the handle being configured to disengage the tether head from the implanted medical device in the chamber of the heart.

[0149] Example 25. The medical system according to Example 24, the medical system further comprising: a first electrode configured to be electrically connected to a proximal portion of the tether, wherein the first electrode is configured to receive the inherent electrical signal from the proximal portion of the tether; a second electrode configured to be electrically connected to the patient's skin; a processing circuit configured to use the first electrode and the second electrode to receive the inherent electrical signal; and a display device communicating with the processing circuit, wherein the display device is configured to use the communication to provide a visual indication of the inherent electrical signal.

[0150] Example 26. A medical system according to Example 24 or Example 25, wherein the conductive tether defines an outer surface extending from the tether head to a distal portion of the tether and from the distal portion of the tether to a proximal portion of the tether, wherein the tether head is configured to use the outer surface to conduct the inherent electrical signal to the distal portion of the tether, and wherein the distal portion of the tether is configured to use the outer surface to conduct the inherent electrical signal to the proximal portion of the tether.

[0151] Example 27. The medical system according to Example 26, wherein the first electrode according to claim 25 is configured to be electrically connected to the outer surface.

[0152] Example 28. A medical system according to any one of Examples 24 to 27, the medical system further comprising a delivery catheter, the delivery catheter including a distal portion and a proximal portion, wherein the distal portion is configured to be inside the patient, and the proximal portion is configured to be outside the patient when the distal portion is inside the patient, wherein the delivery catheter defines a delivery lumen extending between a distal lumen opening defined by the distal portion and a proximal lumen opening defined by the proximal portion, and wherein the distal portion of the tether is configured to pass through the distal lumen opening, and the proximal portion of the tether is configured to be outside the patient when the conductive tether is in the patient's body, wherein the delivery catheter defines a delivery lumen extending between a distal lumen opening defined by the distal portion and a proximal lumen opening defined by the proximal portion, and wherein the distal portion of the tether is configured to pass through the distal lumen opening, and the proximal portion of the tether is configured to be outside the patient's body when the conductive tether is in the patient's body, wherein the delivery catheter defines a delivery lumen extending between a distal lumen opening defined by the distal portion and a proximal lumen opening defined by the proximal portion of the tether. The delivery lumen is translated within the proximal lumen opening; a device receiver including a receiver wall defining a receiver volume, wherein the distal lumen opening opens into the receiver volume, wherein the device receiver is configured to be positioned within the chamber of the heart, and wherein the tether electrode is configured to receive the inherent electrical signal when the tether head is positioned in either the receiver volume or the delivery lumen; and an external device supporting the processing circuitry, wherein the external device is configured to be outside the patient when the distal portion of the tether, the tether head, the device receiver, and the distal portion of the catheter are inside the patient.

[0153] Example 29. A method comprising: receiving an inherent electrical signal generated by a patient's heart using a tether electrode of a device tether, the device tether including a tether head and a conductive tether located within a chamber of the heart, wherein the tether head is configured to engage an implantable medical device within the chamber of the heart, wherein the tether electrode is electrically connected to a distal tether portion of the conductive tether, wherein the distal tether portion is electrically connected to a proximal tether portion of the conductive tether, and wherein the proximal tether portion is outside the patient's body; and receiving the inherent electrical signal using the processing circuitry, using a first electrode electrically connected to the proximal tether portion and a second electrode electrically connected to a portion of the patient.

[0154] Example 30. The method according to Example 29, the method further comprising: using the tether electrode to conduct the inherent electrical signal to a distal portion of the tether; and using the distal portion of the tether to conduct the inherent electrical signal to a proximal portion of the tether.

[0155] Example 31. The method according to Example 29 or Example 30, the method further comprising: using a display device in communication with the processing circuit to provide a visual indication of the inherent electrical signal.

[0156] Example 32. The method according to any one of Examples 29 to 31, the method further comprising: using the processing circuit to detect an intracardiac electrogram using the inherent electrical signal.

[0157] Example 33. The method according to any one of Examples 29 to 32, the method further comprising: using an external device outside the patient to support the processing circuit.

[0158] Example 34. The method according to any one of Examples 29 to 33, the method further comprising: using an implantable medical device in the patient's body to support the processing circuit.

[0159] Example 35. The method according to any one of Examples 29 to 34, the method further comprising: using the conductive tether to extend a proximal portion of the tether through a proximal lumen opening of a catheter lumen defined by a proximal portion of a delivery catheter, wherein the proximal portion of the catheter is outside the patient, and wherein the delivery lumen extends from the proximal lumen opening to a distal lumen opening of the catheter lumen; and using the proximal portion of the tether to electrically connect the first electrode to a portion of the proximal portion of the tether proximal to the proximal lumen opening.

[0160] Example 36. The method according to Example 35, the method further comprising: using the delivery catheter to position a device receptacle in the chamber of the heart, wherein the device receptacle includes a receptacle wall defining a receptacle volume, and wherein the distal lumen opening opens into the receptacle volume.

[0161] Example 37. The method according to Example 36, the method further comprising: using the tether electrode to receive the inherent electrical signal when the tether head is positioned in one of the container volume or the delivery lumen.

[0162] Example 38. The method according to Example 36 or Example 37, the method further comprising: using the tether head to engage the implantable medical device when the implantable medical device is within the recipient volume.

[0163] Example 39. The method according to any one of Examples 36 to 38, the method further comprising: using the tether electrode to receive the inherent electrical signal when at least the proximal electrode of the implantable medical device is positioned within the recipient volume.

[0164] Example 40. The method according to Example 38 or Example 39, wherein the processing circuit is a device processing circuit supported by the device housing of the implantable medical device, and the method further includes: using the device processing circuit to receive the inherent electrical signal.

[0165] Example 41. The method according to Example 40, wherein the device processing circuit is configured to receive the inherent electrical signal using at least one of the proximal or distal electrodes of the implantable medical device, and the method further comprises: electrically connecting the tether electrode and at least one of the proximal or distal electrodes using at least the device housing.

[0166] Example 42. The method according to Example 41, the method further comprising: using the device housing to conduct the inherent electrical signal from the tether electrode to at least one of the proximal electrode or the distal electrode.

[0167] Example 43. The method according to any one of Examples 40 to 42, the method further comprising: using the implantable medical device to bring the distal electrode into contact with the patient's blood.

[0168] Example 44. The method according to any one of Examples 36 to 43, the method further comprising: using the device receiver to position the implantable medical device between the tether head and a receiver opening defined by the device receiver.

[0169] Example 45. The method according to any one of Examples 29 to 44, the method further comprising: using the conductive tether, electrically connecting the distal portion of the tether and the proximal portion of the tether using an outer surface extending from the distal portion of the tether to the proximal portion of the tether.

[0170] Example 46. The method according to Example 45, the method further comprising: using the conductive tether to electrically connect the first electrode and the outer surface to electrically connect the first electrode and the proximal portion of the tether.

[0171] Example 47. The method according to any one of Examples 29 to 46, the method further comprising: using the first electrode to contact a conductor of the first electrode with a proximal portion of the tether to electrically connect the first electrode and the proximal portion of the tether; and using the first electrode to displace the conductor from the proximal portion of the tether to electrically isolate the first electrode and the proximal portion of the tether.

[0172] Example 48. The method according to any one of Examples 29 to 47, the method further comprising: using the bias of the first electrode to maintain the electrical contact between the first electrode and the proximal portion of the tether; and using the first electrode to overcome the bias of the first electrode to electrically isolate the first electrode and the proximal portion of the tether.

[0173] Example 49. The method according to any one of Examples 29 to 48, the method further comprising: using a handle to switch the tether head between an engagement configuration and a disengagement configuration, wherein in the engagement configuration the tether head engages the implantable medical device, and in the disengagement configuration the tether head disengages from the implantable medical device.

[0174] Example 50. The method according to Example 49, the method further comprising: using a wire extending through a tether lumen defined by a tether wall of the conductive tether to enable the shank to switch the tether head between the engagement configuration and the disengagement configuration.

[0175] Example 51. The method according to Example 52, the method further comprising: using the tether wall to electrically connect the distal portion of the tether and the proximal portion of the tether.

[0176] Example 52. A method comprising: positioning an implantable medical device in a ventricle of a patient's heart using a device receptacle supported by a delivery catheter, wherein the device receptacle defines a receptacle volume for retaining the implantable medical device and defines a receptacle opening configured to allow the implantable medical device to pass through therein; supporting a tether head within the receptacle volume using a distal portion of a conductive tether extending through a catheter lumen defined by the delivery catheter, wherein the implantable medical device is located between the tether head and the receptacle opening; and using at least one of the tether head or the distal portion of the tether. The system includes: a tether electrode supported by the patient to receive inherent electrical signals generated by the heart; using the tether electrode to conduct the inherent electrical signals to a distal portion of the tether; using the distal portion of the tether to conduct the inherent electrical signals to a proximal portion of the conductive tether, wherein the proximal portion of the tether is outside the patient's body; using a processing circuit supported by an external device outside the patient's body, using a first electrode electrically connected to the proximal portion of the tether and a second electrode electrically connected to a portion of the patient to receive the inherent electrical signals; and using a display device in communication with the processing circuit to provide a visual indication of the inherent electrical signals.

[0177] Example 53. The method according to Example 52, the method further comprising: electrically connecting the tether electrode and the device housing of the implantable medical device using the tether head, wherein the device housing is electrically connected to the proximal electrode of the implantable medical device, and wherein at least a portion of the device housing and the proximal electrode are positioned within the receptacle volume; receiving the inherent electrical signal using device processing circuitry supported by the implantable medical device and the distal electrode of the implantable medical device; and using an indicator device to provide a visual indication of the inherent electrical signal detected by the device processing circuitry, wherein the indicator device is one of the display device or another device.

[0178] Example 54. According to the method of Example 53, the method further includes: after receiving the inherent electrical signal using the processing circuit supported by the external device, using the device processing circuit to receive the inherent electrical signal.

Claims

1. A medical system including a device tether, said device tether comprising: A tethering electrode configured to receive inherent electrical signals generated by the patient’s heart; A tether head configured to engage an implantable medical device within the cavity of the heart; and A conductive tether comprising a distal portion and a proximal portion, the distal portion being configured to be inside a patient, and the proximal portion being configured to be outside the patient when the distal portion and the head of the tether are inside the body. The head of the tether is attached to the distal portion of the tether, and The tether head or the distal portion of the tether supports the tether electrode.

2. The medical system of claim 1, further comprising processing circuitry configured to receive the inherent electrical signal from a proximal portion of the tether, wherein the tether is configured to conduct the inherent electrical signal to the proximal portion of the tether.

3. The medical system of claim 1 or claim 2, further comprising a first electrode and a second electrode, the first electrode being configured to be electrically connected to a proximal portion of the tether, the second electrode being configured to be connected to a portion of the patient, wherein the processing circuitry is configured to use the first electrode and the second electrode to receive the inherent electrical signal.

4. The medical system according to any one of claims 1 to 3, the medical system further comprising a display device communicating with the processing circuitry, wherein the display device is configured to use the communication to provide a visual indication of the inherent electrical signal.

5. The medical system according to any one of claims 1 to 4, wherein at least a portion of the processing circuitry is supported by an external device configured to be outside the patient when the distal portion of the tether and the head of the tether are in the body.

6. The medical system according to any one of claims 1 to 5, wherein at least a portion of the processing circuitry is supported by the implantable medical device.

7. The medical system according to any one of claims 1 to 6, wherein the tether electrode is defined by at least one of the body of the tether head or the body of the distal portion of the tether.

8. The medical system according to any one of claims 1 to 7, wherein the inherent electrical signal is an intracardiac electrogram.

9. The medical system according to any one of claims 1 to 8, further comprising a delivery catheter, the delivery catheter comprising a distal portion and a proximal portion, The distal portion of the catheter is configured to be inside the patient, and the proximal portion of the catheter is configured to be outside the patient when the distal portion of the catheter is inside the patient. The delivery catheter defines a delivery lumen that extends between a distal lumen opening defined by a distal portion of the catheter and a proximal lumen opening defined by a proximal portion of the catheter. When the conductive tether is translated within the delivery lumen, the distal portion of the tether is configured to pass through the distal lumen opening, and the proximal portion of the tether is configured to pass through the proximal lumen opening.

10. The medical system of claim 9, further comprising a device receiver including a receiver wall defining a receiver volume, wherein a distal lumen opening opens into the receiver volume, and wherein the device receiver is configured to be positioned within the chamber of the heart.

11. The medical system of claim 10, further comprising the implantable medical device, wherein the implantable medical device includes a distal electrode and a proximal electrode, wherein the implantable medical device is configured to receive an intrinsic electrode signal using at least one of the proximal electrode or the distal electrode, and wherein the tether electrode is configured to receive the intrinsic electrical signal when at least the proximal electrode is positioned within the receptacle volume.

12. The medical system of any one of claims 1 to 11, wherein the conductive tether defines an outer surface extending from a distal portion of the tether to a proximal portion of the tether, and wherein the distal portion of the tether is configured to use the outer surface to conduct the inherent electrical signal to the proximal portion of the tether.

13. The medical system according to any one of claims 1 to 12, wherein the tether head is configured to engage the implantable medical device in an engaged configuration and disengage from the implantable medical device in a disengaged configuration, and the medical system further includes a handle configured to allow the tether head to change between the engaged configuration and the disengaged configuration.

14. The medical system of claim 13, wherein the conductive tether includes a tether wall defining a tether lumen extending from the shank to the tether head, and the medical system further includes a wire extending through the tether lumen, wherein the wire is configured such that the shank enables the tether head to switch between the engagement configuration and the disengagement configuration.

15. The medical system of claim 14, wherein the tether wall is configured to conduct the inherent electrical signal from the distal portion of the tether to the proximal portion of the tether.

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