Delivery and retrieval system for a medical device

Abstract

A medical system including a assembly configured to cause a tether head to engage with or disengage from an implantable medical device. The assembly includes handle device having a distal portion and a proximal portion. The handle device is configured such that the movement of the proximal portion relative to the distal portion causes the handle device to exert a force on an elongate body. The elongate body may transfer the force to the tether head, causing the tether head to transition between an engagement configuration and a disengagement configuration. In examples, the proximal portion is configured to rotate relative to the distal portion to cause the handle device to exert the force on the elongate body.

Description

Docket No: A0012371W001 / 2222-587W001DELIVERY AND RETRIEVAL SYSTEM FOR A MEDICAL DEVICE

[0001] This application claims priority from and the benefit of U.S. Provisional Patent Application No. 63 / 687,539, filed on August 27, 2024, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] This disclosure relates generally to medical devices, and, more particularly, to systems for delivering medical devices.BACKGROUND

[0003] Various types of implantable medical devices have been implanted for treating or monitoring one or more conditions of a patient. Such implantable medical devices may be adapted to allow medical devices to monitor and / or treat conditions or functions relating to heart, muscle, nerve, brain, stomach, endocrine organs or other organs and their related functions. The implantable medical devices may be implanted at target locations selected to detect a physiological condition of the patient and / or deliver one or more therapies. For example, implantable medical devices may be delivered to locations within an atrium or ventricle of a heart to sense intrinsic cardiac signals and deliver pacing or antitachyarrhythmia shock therapy.

[0004] Some implantable medical devices are sized to be completely implanted within one of the chambers of the heart and / or another anatomical volume of the patient to detect a physiological condition and / or deliver one or more therapies. Such implantable medical devices may utilize delivery and / or retrieval systems to allow a clinician to navigate the implantable medical device (e.g., through vasculature of the patient) to the target location, and / or to retrieve the implantable medical device from the patient. In some examples, the implantable medical device may include one or more anchoring components intended to engage tissues at the target location (e.g., for implantation) and / or disengage from tissue at the target location (e.g., for retrieval).SUMMARY

[0005] In an example, an assembly for a medical system comprises: a distal portion defining a boundary portion, the boundary portion defining a clearance gap; a proximal portion defining a stop member at a distal section of the proximal portion, wherein the stop member is configured to position in a blocked position relative to the boundary portion when the proximal portion is positioned in a first position relative to the distal portion, wherein the stop member is configured to position in a clearance position relative to the boundary portion when the proximal portion isDocket No: A0012371W001 / 2222-587W001 positioned in a second position relative to the distal portion, and wherein the boundary portion is configured to limit movement of the stop member within the clearance gap in a first direction when the stop member is in the blocked position and configured to permit movement of the stop member within the clearance gap in the first direction when the stop member is in the clearance position; and an elongate body configured to couple to the proximal portion and extending substantially in a second direction opposite the first direction, wherein the proximal portion is configured to exert a force in the first direction on the elongate body when the stop member moves within the clearance gap.

[0006] In an example, an assembly for a medical device comprises: a distal portion defining a boundary portion; a proximal portion configured to rotate relative to the distal portion about a longitudinal axis defined by the distal portion; an elongate body coupled to the proximal portion, wherein the proximal portion is configured to exert a force in a proximal direction on the elongate body when the proximal portion rotates relative to the distal portion; and a tether head configured to receive the force from the elongate body, wherein the tether head is configured to engage an implantable medical device in an engagement configuration and configured to disengage from the implantable medical device in the disengagement configuration, and wherein the tether head is configured to transition between the engagement configuration and the disengagement configuration when the tether head receives the force; and a tether including a tether body, wherein the tether body defines a proximal tether portion coupled to the distal portion and a distal tether position coupled to the tether head, wherein the tether body defines a tether lumen extending from the proximal tether portion to the distal tether portion, and wherein the elongate body is configured to extend through the tether lumen when the tether head receives the force.

[0007] In an example, an assembly for a medical device comprises: a distal portion of a handle; a proximal portion of a handle, wherein the proximal portion is configured to move in a first direction relative to the distal portion and configured to move in a second direction relative to the distal portion, wherein the second direction is substantially opposite the first direction, and wherein the proximal portion includes a housing defining a receptacle; and an elongate body including an engagement portion configured to position within the receptacle when the elongate body extends substantially in the second direction from the receptacle, wherein the engagement portion is configured to translate within the receptacle in the first direction relative to the proximal portion when the proximal portion translates in the second direction relative to the distal portion, and wherein the proximal portion is configured to exert a force in the first direction on the engagement portion when the proximal portion translates in the first direction relative to the distal portion.Docket No: A0012371W001 / 2222-587W001

[0008] In an examples, a method comprises: moving, relative to a distal portion of a handle device, a proximal portion of the handle device from a first position to a second position, wherein the distal portion defines a boundary portion defining a clearance gap, wherein the boundary portion is configured to limit movement of the proximal portion through the clearance gap when the proximal portion is in the first position and configured to permit movement of the proximal portion within the clearance gap when the proximal portion is in the second position; and exerting a force, using the proximal portion, on an elongate body coupled to the proximal portion when the proximal portion stop member moves within the clearance gap.

[0009] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. l is a conceptual drawing illustrating portions of patient anatomy including potential implant sites for an implantable medical device (IMD).

[0011] FIG. 2 is a schematic illustration depicting an example medical device delivery system for delivering an IMD to a location within a heart.

[0012] FIG. 3 is a schematic illustration of an IMD within a receptacle volume of a device receptacle supported by a delivery catheter, with the device receptacle and delivery catheter shown as transparent for clarity.

[0013] FIG. 4 is a perspective view of a handle device in a first configuration.

[0014] FIG. 5 is a perspective view of the handle device in a second configuration.

[0015] FIG. 6 is a perspective view of the handle device and a locking device.

[0016] FIG. 7 is a perspective view of a handle device including a stop member in a blocked position, with a portion of a housing of the handle device shown as transparent for clarity.

[0017] FIG. 8 is a perspective view of the handle device with the stop member in a clearance position, with the portion of a housing of the handle device shown as transparent for clarity.

[0018] FIG. 9 is a perspective view of the handle device with the stop member having translated within a clearance gap of a boundary portion, with the portion of a housing of the handle device shown as transparent for clarity.

[0019] FIG. 10A is schematic illustration of an example stop member illustrated in accordance with the X-Y-Z axes shown.

[0020] FIG. 10B is schematic illustration of the stop member of FIG. 10A illustrated in accordance with the X-Y-Z axes shown.

[0021] FIG. 10C is schematic illustration of the stop member of FIG. 10A and FIG. 10BDocket No: A0012371W001 / 2222-587W001 illustrated in accordance with the X-Y-Z axes shown.

[0022] FIG. 11 is a schematic cross-sectional plan view of a proximal portion of a handle device, depicted with reference to the X-Y-Z axes shown, the cross-section taken with a cutting plane C-C’ of FIG. 7.

[0023] FIG. 12 is a schematic cross-sectional top view of the proximal portion of FIG. 11, depicted with reference to the X-Y-Z axes shown, the cross-section taken with a cutting plane E- E’ shown in FIG. 7.

[0024] FIG. 13 is a schematic cross-sectional plan view of the proximal portion of FIG. 11 having moved relative to a distal portion of the handle device.

[0025] FIG. 14 is a schematic cross-sectional top view of the proximal portion of FIG. 13.

[0026] FIG. 15 is an exploded perspective view of a handle device including an outer section and an insertion section, depicted with reference to the X-Y-Z axes shown.

[0027] FIG. 16 is a schematic cross-sectional plan view of proximal portion of a handle device with an insertion portion positioned within an outer section, depicted with reference to the X-Y-Z axes shown, the cross-section taken with a cutting plane F-F’ of FIG. 15.

[0028] FIG. 17 is a schematic cross-sectional top view of the proximal portion of FIG. 16, depicted with reference to the X-Y-Z axes shown, the cross-section taken with a cutting plane G- G’ shown in FIG. 15 and FIG. 16.

[0029] FIG. 18 is a schematic cross-sectional top view of the proximal portion of FIG. 16 and FIG. 17, depicted with reference to the X-Y-Z axes shown, the cross-section taken with a cutting plane H-EF shown in FIG. 15 and FIG. 16.

[0030] FIG. 19 is a schematic illustration depicting a tether head.

[0031] FIG. 20 illustrates an example technique for operating a handle assembly.DETAILED DESCRIPTION

[0032] This disclosure describes a medical system configured to deliver, position, and / or retrieve an medical device (e.g., an implantable medical device) within an anatomical volume (e.g., a chamber of a heart) within a patient. In general, this disclosure is directed to examples of medical systems using tether assemblies and techniques of using such tether assemblies. The medical system includes a handle assembly configured to cause a tether head device to engage with and / or disengage from a medical device, e.g., an intracardiac device. The handle assembly includes one or more components configured to transmit a driving force to the tether head device via an elongate body (e.g., a pull cable) to cause the tether head device to engage with and / or disengage from the medical device. In examples, the tether head device is configured to engage the medical device in an engagement configuration and configured to disengage from the medicalDocket No: A0012371W001 / 2222-587W001 device in a disengagement configuration. The tether handle assembly may be configured to transmit the driving force via the elongate body and / or cease transmitting the driving force via the elongate body to cause the tether head device to transition between the engagement configuration and the disengagement configuration.

[0033] The handle assembly includes a distal portion and a proximal portion configured to move (e.g., to rotate) relative to the distal portion. The handle assembly is configured such that the movement of the proximal portion relative to the distal portion (e.g., by a clinician) causes the handle assembly to exert the driving force on the elongate body, causing the elongate body to transfer the driving force to the tether head device. The transfer of the driving force by the elongate body causes, in some examples, the tether head device to transition away from the engagement configuration (and, in some examples, transition to the disengagement configuration). In some examples, the transfer of the driving force by the elongate body causes the tether head device to transition away from the disengagement configuration (and, in some examples, transition to the engagement configuration). Hence, the handle assembly is configured such that a clinician may cause the tether head device to disengage from and / or engage with the IMD by the moving (e.g., a rotating) the proximal portion relative to the distal portion. The movement of the proximal portion relative to the distal portion may enhance control of the engagement and / or disengagement of a medical device during an implantation process.

[0034] In examples, the distal portion of the handle assembly includes a boundary portion defining a clearance gap. The proximal portion may define a stop member (e.g., at a proximal section of the proximal portion). The handle assembly may be configured such that a passage of the stop member into the clearance gap (e.g., due to movement of the proximal portion relative to the distal portion) causes the handle assembly to exert the driving force on the elongate body, and causes the tether head device to transition between the engagement configuration and the disengagement configuration. The boundary portion may be configured to block passage of the stop member into the clearance gap when the proximal portion is in a first position (e.g., a first rotational position) relative to the distal portion and configured to allow the stop member to pass into the clearance gap (e.g., to cause exertion of the driving force) when the proximal portion is in a second position (e.g., a second rotational position) relative to the distal portion. Hence, the handle assembly may be configured such that exertion of the driving force on the elongate body (e.g., to cause transition of the tether head device) is substantially dependent on a movement (e.g., by the clinician) of the proximal portion relative to the distal portion.

[0035] In examples, the handle assembly is configured to assist in ensuring that the tether head device remains in a particular configuration (e.g., in the engagement configuration or disengagement configuration) as the tether assembly is navigated (e.g., by a clinician) throughDocket No: A0012371W001 / 2222-587W001 vasculature of a patient to a target site within the patient (e.g., for implantation or retrieval of the medical device at the target site). For example, in some examples, the handle assembly may include a locking device configured to substantially maintain the distal portion in a particular position relative to the distal portion, such that the distal portion is constrained from causing the handle assembly to exert the driving force on the tether head device. The handle assembly may be configured such that, prior to moving the distal portion relative to the distal portion, the locking device must first be disengaged (e.g., by a clinician). Thus, the handle assembly may be configured to provide additional assurance (e.g., to the clinician) that the tether head assembly will remain in the specific configuration (e.g., in the engagement configuration or the disengagement configuration) until the locking device is manipulated (e.g., by the clinician) from a locked configuration to an unlocked configuration.

[0036] In examples, the tether head device is configured to engage an attachment member of the medical device in the engagement configuration and disengage from the attachment member in the disengagement configuration. For example, the tether head device may be configured to define an aperture to receive the attachment member. The tether head device may be configured to define a passageway leading to the aperture, such that the attachment member may be received within the aperture via the passageway. In examples, the tether head device is configured to vary a size of the passageway to engage with and / or disengage from the medical device. For example, in the engagement configuration, the tether head device may be configured such that the passageway is too narrow to permit the attachment member to pass through the passageway to exit (and / or enter) the aperture. In the disengagement configuration, the tether head device may be configured such that the passageway is wide enough to permit the attachment member to pass through the passageway to exit (and / or enter) the aperture.

[0037] Hence, as the medical device and tether head device transit through vasculature to a target site within a patient, the tether head device may engage the attachment member with the tether head device in the engagement configuration (e.g., such that the attachment member is substantially trapped within the aperture). In proximity to the target site, with the tether head in the engagement configuration, the tether head device may transfer forces (e.g., axial driving forces and / or rotational torques) to the medical device via the attachment member to engage the medical device with tissue, disengage the medical device from tissue, reposition and / or relocate the medical device, and / or for other reasons. A clinician may cause the tether head device to transition from the engagement configuration to the disengagement configuration (e.g., by moving the proximal portion of the handle assembly relative to the distal portion of the handle assembly) to cause the tether head device to disengage from the medical device (e.g., to allow theDocket No: A0012371W001 / 2222-587W001 attachment member to exit the aperture via the passageway), allowing withdrawal of the tether head device from the vasculature as the medical device remains implanted at the target site.

[0038] Likewise, the tether head device may be configured to capture a medical device to remove and / or reposition the medical device within vasculature. For example, with the tether head device in the disengagement configuration, the tether head device may be moved relative to the medical device to place the tether head device in a position where transitioning to the engagement configuration causes the tether head device to engage the attachment member. For example, the tether head device may be moved to a position causing the attachment member to enter the aperture via the passageway. A clinician may cause the tether head device to transition from the disengagement configuration to the engagement configuration (e.g., by moving the proximal portion of the handle assembly relative to the distal portion of the handle assembly) to cause the tether head device to engage the attachment member (e.g., to cause the tether head device to substantially trap the attachment member within the aperture). With the tether head in the engagement configuration, the tether head device may transfer driving forces (e.g., axial driving forces and / or rotational torques) to the medical device via the attachment member to disengage the medical device from tissue, engage the medical device with tissue, reposition and / or relocate the medical device, and / or for other reasons. The clinician may cause the tether head device to subsequently transition back to the disengagement configuration (e.g., by moving the proximal portion of the handle assembly relative to the distal portion of the handle assembly) such that movement of the tether head device relative to the medical device causes the attachment member to exit the aperture via the passageway.

[0039] The tether head device is configured to transition between the engagement configuration and the disengagement configuration (e.g., from the engagement configuration to the disengagement configuration) in response to the driving force exerted on the tether head device. The medical system further includes an elongate body (e.g., a braided cable ) configured to exert the driving force on the tether head device. In examples, the elongate body includes a distal portion (“distal body portion”) configured to exert the driving force on the tether head device and a proximal portion (“proximal body portion”) opposite the distal body portion. The proximal body portion may be coupled (e.g., mechanically coupled) to the tether handle assembly. The tether handle assembly may be configured to exert the driving force on the proximal body portion to cause the distal body portion to exert the driving force on the tether head device.

[0040] As used herein, when the elongate body exerts a driving force on the tether head device, this may refer to a force sufficient to cause the tether head device to depart from the engagement configuration and / or disengagement configuration, and / or transition between theDocket No: A0012371W001 / 2222-587W001 engagement configuration and the disengagement configuration. In examples, the driving force may refer to a difference between a first force exerted on the tether head device by the elongate member when an actuation member is in an actuation position and a second force exerted on the tether head device when the actuation member is in a rest position. It is understood that the medical system may be configured such that the elongate body exerts other forces either intentional or incidental on the tether head device instead of or in addition to the driving force.

[0041] The tether head device may be configured to hold (e.g., position in) one of the engagement configuration or the disengagement configuration as the elongate body exerts the driving force on the tether head device. For example, when the elongate body exerts the driving force on the tether head device and causes the tether head device to transition from a first configuration (e.g., one of the engagement configuration or the disengagement configuration) to a second configuration (e.g., the other of the engagement configuration or the disengagement configuration), the tether head device may be configured to hold the second configuration as long as the elongate body continues to exert the driving force on the tether head device.

[0042] In examples, the tether head device is biased to the first configuration (e.g., the engagement configuration). For example, the tether head device may be configured to transition from the second configuration (e.g., the disengagement configuration) to the first configuration when the elongate body ceases to exert the driving force on the tether head device. Stated similarly, the tether head device may be biased such that, in the absence of the driving force exerted on the tether head device, the tether head device tends to assume the first configuration. In some examples, the tether head device includes an elastic member configured to cause the tether head device to assume the first configuration in the absence of the driving force exerted by the elongate body.

[0043] Hence, the medical system is configured such that a clinician may control the configuration and / or configuration transitions of the tether head device through operation of the handle assembly (e.g., by movement of the proximal portion relative to the distal portion). For example, the clinician may cause the tether head device to transition to and / or hold the second configuration (e.g., the disengagement configuration) by moving the proximal portion relative to the distal portion such that the elongate body exerts the driving force on the tether head device. The clinician may cause the tether head device to transition to and / or hold the first configuration (e.g., the engagement configuration) by moving the proximal portion relative to the distal portion such that the elongate body to ceases or otherwise fails to exert the driving force on the tether head device.

[0044] In examples, the medical system includes a tether assembly including a tether body. The tether head device may be configured to couple to a distal portion of the tether body (“distalDocket No: A0012371W001 / 2222-587W001 tether portion”). The tether handle assembly may be configured to couple to a proximal portion of the tether body (“proximal tether portion”). In examples, the tether body defines a lumen having a proximal opening in the proximal tether portion and a distal opening in the distal tether portion. The elongate body may extend through the lumen (e.g., from the proximal tether opening to the distal tether opening). The tether body may be configured to transfer an axial force (e.g., in the distal direction or the proximal direction) from the tether handle assembly to the tether head device and / or transfer a rotational torque from the tether handle assembly to the tether head device.

[0045] FIG. 1 is a conceptual diagram illustrating an example medical system 100 within a right atrium (“RA”) of a heart 101. Medical system 100 is configured to deliver and / or retrieve an implantable medical device 102 (“IMD 102”) to and / or from the vicinity of a target site 104 of heart 101. Although described herein in the context of delivering IMD 102 into the vasculature, e.g., heart 101, the devices, systems, and techniques of this disclosure may be used to deliver an IMD or other medical device to any anatomical location.

[0046] In some examples, medical system 100 includes a delivery catheter 106 supporting a device receptacle 108. Device receptacle 108 is configured to hold IMD 102 during delivery, deployment, and / or retrieval of IMD 102. Device receptacle 108 includes a receptacle wall 110 defining a receptacle volume 112 configured to hold and / or support IMD 102 during the delivery, deployment, and / or retrieval of IMD 102. In examples, device receptacle 108 defines a distal opening 109 (“receptacle opening 109”) which opens into receptacle volume 112. Receptacle opening 109 may be configured to allow at least IMD 102 to pass therethrough. In examples, medical system 100 is configured to deploy IMD 102 from device receptacle 108 (e.g., from a position within receptacle volume 112) and through receptacle opening 109 to cause IMD 102 to engage tissues within target site 104. In examples, medical system 100 is configured to cause IMD 102 to disengage from tissues within target site 104 to, for example, retrieve IMD 102 from and / or reposition IMD 102 within heart 101.

[0047] Delivery catheter 106 is configured to deliver device receptacle 108 and / or IMD 102 to an anatomical volume of the patient (e.g., the RA). Optionally, such delivery can be performed with IMD 102 “preloaded” or present within device receptacle 108 during advancement of delivery catheter 106 to the anatomical volume, or IMD 102 can be advanced to device receptacle 108 after delivery catheter 106 including device receptacle 108 has been advanced to the anatomical volume. Optionally, delivery catheter 106 may be advanced to the anatomical volume of the patient through a surrounding tubular member (e.g., introducer 140 (FIG. 2)), such as a sheath or guide catheter, which may be placed with its distal end in the anatomical volume before delivery catheter 106 is advanced through the surrounding tubular member. In examples,Docket No: A0012371W001 / 2222-587W001 delivery catheter 106 is configured to retrieve device receptacle 108 and / or IMD 102 from the anatomical volume of the patient. Delivery catheter 106 may include a distal portion 114 (“delivery catheter distal portion 114”) configured to be intracorporeal to the patient and a proximal portion 116 (“delivery catheter proximal portion 116”) which may be extracorporeal to the patient when delivery catheter distal portion 114 is intracorporeal. Delivery catheter distal portion 114 may support (e.g., be attached to and / or be a substantially unitary component with) device receptacle 108. In examples, delivery catheter 106 is configured to deliver and / or retrieve device receptacle 108 and / or IMD 102 using vasculature of a patient, such as an inferior vena cava (IVC), superior vena cava (SVC) or other vasculature leading to the anatomical volume. Delivery catheter 106 may define a lumen 118 (“delivery lumen 118”) which opens to receptacle volume 112.

[0048] In examples, medical system 100 includes a tether system 120 configured to engage IMD 102 when, for example, IMD 102 is positioned within receptacle volume 112. Tether system 120 can be used to, e.g., advance IMD 102 distally from device receptacle 108, through receptacle opening 109, to deploy IMD 102 into the anatomical volume. Tether system 120 can also be used to, e.g., extract and / or retract IMD 102 from the anatomical volume, through receptacle opening 109, into device receptacle 108. Tether system 120 includes a tether body 122 which defines a distal portion 124 (“tether distal portion 124”) configured to be intracorporeal to the patient and a proximal portion 126 (“tether proximal portion 126”) which may be extracorporeal to the patient when tether distal portion 124 is intracorporeal. Tether system 120 and / or component(s) thereof, such as tether distal portion 124 and / or tether proximal portion 126, can comprise any suitable catheter, elongate member, and / or inner member (e.g., relative to delivery catheter 106). Tether system 120 and / or tether body 122 can possess sufficient column strength or ’’pushability” to advance IMD 102 distally from device receptacle 108, e.g., in the process of deployment, and / or, in some embodiments, to advance IMD 102, or tether system 120 itself without IMD 102 attached thereto, along the length of delivery catheter 106 including proximal portion 116 and distal portion 114 thereof. Tether system 120 and / or tether body 122 may possess sufficient tensile strength to extract and / or retract IMD 102 from the anatomical volume, through receptacle opening 109, into device receptacle 108, and / or, in some embodiments, through the length of delivery catheter 106 including proximal portion 116 and distal portion 114 thereof. Tether system 120 and / or tether body 122 may possess sufficient torque transmission capability to screw and / or unscrew IMD 102 into target tissue in the anatomical volume. Where IMD 102 is attached to target tissue without need for screwing or rotating (e.g. where IMD 102 is fixated via one or more tines), or where other component(s)Docket No: A0012371W001 / 2222-587W001 perform the screwing / unscrewing function, tether system 120 and / or tether body 122 need not possess this capability.

[0049] Tether distal portion 124 supports and / or is attached to a tether head 128. Tether head 128 may be configured to engage IMD 102. At least tether body 122 may be configured to translate (e.g., slidably translate) and / or rotate within delivery lumen 118 (e.g., translate and / or rotate relative to delivery catheter 106). Tether system 120 may be configured such that the translation and / or rotation of tether body 122 causes tether body 122 and / or tether head 128 to impart translational and / or rotational forces on IMD 102 (e.g., when tether head 128 is engaged with IMD 102), such that IMD 102 translates and / or rotates relative to receptacle wall 110. For example, tether system 120 may be configured to translate within delivery lumen 118 to impart (e.g., via tether head 128) a translational force on IMD 102 causing IMD 102 to translate (e.g., within receptacle volume 112) in the proximal direction P or the distal direction D relative to receptacle wall 110. Tether system 120 may be configured to rotate within delivery lumen 118 to impart (e.g., via tether head 128) a rotational force on IMD 102 causing IMD 102 to rotate (e.g., within receptacle volume 112) about a device axis LD defined by IMD 102. In some examples, tether head 128 and tether body 122 may be substantially separate components. In some examples, tether head 128 may be substantially contiguous with tether body 122, such that tether head 128 and tether body 122 define a unified component. In FIG. 1, portions of tether body 122, tether head 128, and IMD 102 positioned within delivery lumen 118 and / or receptacle volume 112 are depicted with dashed lines.

[0050] Although IMD 102 is depicted in FIG. 1 as partially within receptacle volume 112, in some examples, IMD 102 and / or device receptacle 108 may be configured such that IMD 102 may position wholly within receptacle volume 112. For example, IMD 102 and / or device receptacle 108 may be configured such that one or more of a distal end 113 defined by a housing of IMD 102 (“IMD distal end 113”), a first distal electrode 103, a second distal electrode 105 (e.g., an atrial electrode), and / or an attachment member 132 may be proximal to receptacle opening 109, distal to receptacle opening 109, and / or substantially even with receptacle opening 109. Tether system 120 is configured to cause IMD 102 to translate in the proximal direction P or the distal direction D within receptacle volume 112 to position IMD distal end 113, second distal electrode 105, first distal electrode 103, and / or attachment member 132 proximal to receptacle opening 109, distal to receptacle opening 109, and / or substantially even with receptacle opening 109. In some examples, at least one of tether head 128 or tether distal portion 124 supports an electrode 129 (“tether electrode 129”). In some examples, tether electrode 129 comprises at least a portion of a body comprising tether head 128 and / or tether distal portion 124 (“device tether body”).Docket No: A0012371W001 / 2222-587W001

[0051] In examples, IMD 102 includes processing circuitry 133 (“IMD processing circuitry 133”). Medical system 100 may be configured to use IMD processing circuitry 133 to sense an intrinsic electrical signal generated by heart 101 to, for example, assess electrical activity in proximity of IMD 102 (e.g., in proximity to attachment member 132), conduct pace mapping to determine a suitable placement of IMD 102, evaluate a suitability of pacing delivered by IMD 102 at a particular location, evaluate a position of IMD 102 during an implantation, evaluate a placement of a device electrode relative to a vessel wall, and / or for other reasons. In examples, IMD processing circuitry 133 is mechanically supported by a housing of IMD 102, such that IMD processing circuitry 133 is intracorporeal to the patient when, for example, tether distal portion 124, tether head 128, device receptacle 108 and / or IMD 102 are intracorporeal to the patient.

[0052] IMD processing circuitry 133 may be configured to sense the intrinsic electrical signal using electrodes supported by IMD 102 and / or medical system 100, such as first distal electrode 103, second distal electrode 105, a proximal electrode 107 (e.g., a return electrode), and / or other electrodes of IMD 102 and / or medical system 100. IMD processing circuitry 133 may be configured to process and / or condition a signal sensed by electrodes 103, 105, 107 and / or other electrodes within medical system 100. In examples, one or more electrode (e.g., proximal electrode 107) may be configured to be positioned with receptacle volume 1 12 when IMD 102 resides at least partially within receptacle volume 112.

[0053] Tether head 128 and / or tether system 120 may comprise any suitable mating interface or abutment coupled to, or formed on or in tether system 120, The mating interface may be configured to mate with, receive and / or abut some portion of IMD 102 (e.g., a proximal portion of IMD 102). Tether head 128 and / or tether system 120 may, but need not, possess the ability to transmit torque to IMD 102 for the purpose of screwing or unscrewing it to or from target tissue; this may depend on whether IMD 102 is fixated via a helix, or tines, a combination thereof, or through some other fixation component(s). The tether head 128 and / or tether system 120 may be further implemented via one or more releasable, removable, retractable or severable string(s), filament(s), thread(s), etc., or one or more snare(s), e.g., along with a mating interface or abutment as described herein, to provide a releasable attachment of IMD 102 to tether system 120. Such string(s), filament(s), thread(s), snare(s), etc. can grip, loop through, anchor within, or otherwise interact with a proximal portion of IMD 102 to facilitate such releasable attachment.

[0054] Tether head 128 may be any device configured to mate with, receive and / or abut IMD 102. In examples, tether head 128 is configured such that, when tether head 128 is engaged with IMD 102 (e.g., in the engagement configuration) and tether head 128 receives (e.g., is subjected to) a force and / or a torque, tether head 128 transfers the force and / or the torque to IMD 102.Docket No: A0012371W001 / 2222-587W001Tether head 128 may be configured such that, when tether head 128 is engaged with IMD 102 (e.g., in the engagement configuration) and IMD 102 receives (e.g., is subjected to) the force and / or the torque, IMD 102 transfers the force and / or the torque to tether head 128. In some examples, tether head 128 is configured such that, when tether head 128 is disengaged from IMD 102 (e.g., in the disengagement configuration) and tether head 128 receives (e.g., is subjected to) the force and / or the torque, tether head 128 limits the transfer of and / or fails to transfer the force and / or the torque to IMD 102. Tether head 128 may be configured such that, when tether head 128 is disengaged from IMD 102 (e.g., in the disengagement configuration) and IMD 102 receives (e.g., is subjected to) the force and / or the torque, IMD 102 limits the transfer of and / or fails to transfer the force and / or the torque to tether head 128. In some examples, tether head 128 is configured such that, when tether head 128 is engaged with IMD 102 (e.g., in the engagement configuration), an axial or rotational movement of tether head 128 causes an axial or rotational movement of IMD 102. Tether head 128 may be configured such that, when tether head 128 is disengaged from IMD 102 (e.g., in the disengagement configuration), an axial or rotational movement of tether head 128 limits and / or fails to cause an axial or rotational movement of IMD 102.

[0055] Medical system 100 is configured to position IMD 102 in proximity to target site 104 such that IMD 102 may be anchored to tissues within target site 104. In examples, attachment member 132 is configured to engage tissues within target site 104. For example, delivery catheter 106 may be configured to (e.g., under the influence of a clinician) traverse vasculature of the patient to position device receptacle 108 and IMD 102 in proximity to target site 104. Medical system 100 (e.g., tether body 122 and / or tether head 128) is configured to (e.g., when attachment member 132 is a helical member) impart a torque to IMD 102 to cause attachment member 132 to engage tissues (e.g., tissue within target site 104) when attachment member 132 is within or in proximity to target site 104. In examples, medical system 100 (e.g., tether body 122 and / or tether head 128) is configured to impart a force in the distal direction D to IMD 102 to cause attachment member 132 to engage tissues and / or impart a force in the proximal direction P to IMD 102 to cause attachment member 132 to disengage from tissues (e.g., when attachment member 132 includes one or more tines). Medical system 100 is configured such that tether body 122 and / or tether head 128 may be disengaged from IMD 102 as IMD 102 remains anchored to tissues within or in proximity to target site 104. Delivery catheter 106, device receptacle 108, and tether system 120 may subsequently be withdrawn from the patient (e.g., via vasculature of the patient).

[0056] FIG. 2 is a plan drawing illustrating a portion of an example medical system 100 for delivering an IMD 102 within a receptacle volume 112 to a location within heart 101. FIG. 3 is aDocket No: A0012371W001 / 2222-587W001 schematic illustration of device receptacle 108 supported by delivery catheter distal portion 114 and tether system 120 extending through delivery lumen 118. In FIG. 3, device receptacle 108 and delivery catheter 106 are shown as transparent for clarity.

[0057] Medical system 100 may include an introducer 140, delivery catheter 106, and tether system 120. In examples, introducer 140 is an elongate member defining an interior lumen. Introducer 140 is configured to be inserted (e.g., by a clinician), into vasculature of a patient to provide a channel, via the interior lumen, through which to insert a medical instrument, a device, or other therapy.

[0058] Delivery catheter 106 is configured to be inserted through the interior lumen of introducer 140 to deliver IMD 102 within the vasculature. Delivery catheter 106 includes delivery catheter distal portion 114 and delivery catheter proximal portion 116. Delivery catheter 106 may include a delivery catheter handle 142 and device receptacle 108. Delivery catheter handle 142 may be disposed substantially at a proximal end of delivery catheter proximal portion 116. In examples, delivery catheter handle 142 includes one or more elements (such as buttons, switches, etc.) configured to control a motion of (e.g., steer) delivery catheter 106 (e.g., delivery catheter distal portion 114) and / or device receptacle 108.

[0059] Device receptacle 108 is supported by delivery catheter distal portion 114. In examples, device receptacle 108 is disposed substantially at a distal end 154 of delivery catheter distal portion 114 (“delivery catheter distal end 154”). In examples, receptacle wall 110 defines a hollow, substantially cylindrical body defining receptacle volume 112. Device receptacle 108 is configured to house and support IMD 102 (as depicted in FIG. 3) within receptacle volume 112 as IMD 102 is being transported to and / or implanted within a vasculature of a patient. For example, a clinician may insert device receptacle 108 and delivery catheter distal portion 114 through the interior lumen of introducer 140 when introducer is disposed within a vasculature of a patient. Once device receptacle 108 has extended through introducer 140, the clinician may navigate delivery catheter 106 (e.g., using delivery catheter handle 142) through the vasculature to an implant site (e.g., in proximity to target site 104 (FIG. 1) within heart 101 of the patient. The clinician may cause IMD 102 to extend from and / or distal to receptacle opening 109 using tether system 120. The clinician may cause tether head 128 to disengage from IMD 102 (e.g., using handle 142) and proximally withdraw delivery catheter 106 and tether system 120 through introducer 140.

[0060] Tether system 120 (e.g., at least tether distal portion 124 and some portion of tether proximal portion 126) extends through delivery lumen 118 of delivery catheter 106. In examples, tether distal portion 124 is configured to extend through at least delivery catheter distal portion 114 and / or tether proximal portion 126 is configured to extend through at least delivery catheterDocket No: A0012371W001 / 2222-587W001 proximal portion 116. Aportion of tether distal portion 124 within delivery lumen 118 is shown with a dashed line in FIG. 2. In examples, tether proximal portion 126 extends through delivery catheter handle 142.

[0061] Tether head 128 may be supported by tether distal portion 124. In examples, tether head 128 is disposed substantially at a distal end 125 of tether distal portion 124 (“tether distal end 125”) (FIG. 3). Tether head 128 may be attached to and / or affixed to tether distal end 125. In some examples, a body of tether head 128 is contiguous with and / or a substantially unitary body with tether distal portion 124. In some examples, tether head 128 and tether distal portion 124 define substantially separate bodies affixed to (e.g., attached to) each other (e.g. at tether distal end 125).

[0062] In examples, tether system 120 includes a handle assembly 143. Handle assembly 143 may be disposed substantially at a proximal end 127 of tether proximal portion 126 (“tether proximal end 127”). In examples, handle assembly 143 may be configured to cause tether head 128 to engage with and / or disengage from IMD 102. In examples, handle assembly 143 includes a handle device 149 configured to cause tether head 128 to engage with and / or disengage from IMD 102. In some examples, handle device 149 includes a distal portion 145 and a proximal portion 147. The proximal portion 147 may be configured to move (e.g., to rotate) relative to distal portion 145. Handle device 149 may be configured to cause tether head 128 to disengage from and / or engage with IMD 102 when proximal portion 147 is moved (e.g., by a clinician) relative to distal portion 145.

[0063] As used herein, in some examples, when proximal portion 147 moves (e.g., rotates) relative to distal portion 145, this may mean that proximal portion 147 moves relative to a coordinate system defined by a body of distal portion 145. The movement of proximal portion 147 relative to distal portion 145 may be caused by moving (e.g., by a clinician) proximal portion 147 as distal portion 145 remains substantially stationary relative to, for example, a portion of delivery catheter handle 142 or another portion of medical system 100. For example, the movement of proximal portion 147 relative to distal portion 145 may be caused by a rotation of proximal portion 147 in a first rotational direction W1 around a longitudinal axis L defined by handle assembly 143 as distal portion 145 remains substantially stationary. The movement of proximal portion 147 relative to distal portion 145 may be caused by moving (e.g., by a clinician) distal portion 145 as proximal portion 147 remains substantially stationary relative to, for example, the portion of delivery catheter handle 142 or other portion of medical system 100. For example, the movement of proximal portion 147 relative to distal portion 145 may be caused by a rotation of distal portion 145 in a second rotational direction W2 opposite first rotational direction W1 around longitudinal axis L as proximal portion 147 remains substantially stationary.Docket No: A0012371W001 / 2222-587W001The movement of proximal portion 147 relative to distal portion 145 may be caused by moving (e.g., by a clinician) both proximal portion 147 and distal portion 145 relative to the portion of delivery catheter handle 142 or other portion of medical system 100 to cause proximal portion 147 to move relative to distal portion 145. For example, the movement of proximal portion 147 relative to distal portion 145 may be caused by a rotation of proximal portion 147 in first rotational direction W1 and a movement of distal portion 145 in second rotational direction W2. In other examples, handle device 149 may include one or more of a button, switch, and / or other device configured to cause tether head 128 to engage with and / or disengage from IMD 102 (e.g., when manipulated by a clinician).

[0064] Referring mainly to FIG. 3, delivery catheter 106 includes a body 148 (“delivery catheter body 148”) defining delivery lumen 118. Delivery lumen 118 may extend from a distal lumen opening 150 defined by delivery catheter body 148 to a proximal lumen opening 152 defined by delivery catheter body 148. In examples, distal lumen opening 150 opens into receptacle volume 112. In examples, delivery catheter body 148 defines distal lumen opening 150 substantially at delivery catheter distal end 154”). Delivery catheter body 148 may define proximal lumen opening 152 substantially at a proximal end 156 of delivery catheter body 148 (“delivery catheter proximal end 156”). Tether system 120 (e.g., tether body 122) is configured to translate (e.g., slidably translate) in the distal direction D and / or in the proximal direction P within delivery lumen 118. In examples, tether distal portion 124 and / or tether head 128 are configured to pass through distal lumen opening 150 as tether body 122 translates within delivery lumen 118. In some examples, tether proximal portion 126 is configured to pass through proximal lumen opening 152 as tether body 122 translates within delivery lumen 118. In some examples, tether distal portion 124 and / or tether head 128 are configured to pass through proximal lumen opening 152 as tether body 122 translates within delivery lumen 118 (e.g., such that tether head 128 may be withdrawn in its entirety from delivery lumen 118 via proximal lumen opening 152).

[0065] Delivery catheter body 148 may define and / or support a body 158 of delivery catheter handle 142 (“catheter handle body 158”). In some examples, catheter handle body 158 is a contiguous with and / or a substantially unitary body with delivery catheter body 148. In some examples, delivery catheter body 148 and catheter handle body 158 are substantially separate bodies affixed to (e.g., attached to) each other (e.g. at delivery catheter proximal end 156). In examples, catheter handle body defines a passage 160 (“catheter handle passage 160”) configured to open into delivery lumen 118 (e.g., through proximal lumen opening 152). Tether system 120 (e.g., tether body 122) may be configured to translate (e.g., slidably translate) in the distal direction D and / or in the proximal direction P within catheter handle passage 160 (e.g., asDocket No: A0012371W001 / 2222-587W001 tether body 122 translates within delivery lumen 118). In some examples, tether distal portion 124 and / or tether head 128 are configured to pass through catheter handle passage 160 (e.g., such that tether head 128 may be withdrawn in its entirety from delivery lumen 118 via catheter handle passage 160).

[0066] Tether body 122 may extend from handle device 149 to tether head 128. Tether head 128 may be attached to and / or affixed to tether distal end 125. In examples, handle device 149 (e.g., distal portion 145) is attached to and / or affixed to a proximal end 127 of tether body 122 (“tether proximal end 127”). In examples, tether body 122 defines a lumen 172 (“tether lumen 172”) extending from tether proximal portion 126 to tether distal portion 124. In examples, tether lumen 172 may extend from a distal tether lumen opening 174 defined by tether distal portion 124 (e.g., tether distal end 125) to a proximal tether lumen opening 176 defined by tether proximal portion 126 (e.g., tether proximal end 127”). In examples, proximal tether lumen 176 opens into an inner volume 178 defined by handle assembly 143 (e.g., handle device 149).

[0067] Tether head 128 is configured to engage IMD 102 in an engagement configuration and disengage from IMD 102 in a disengagement configuration. In examples, tether system 120 includes an elongate body 180 (e.g., a cable) configured to exert a force on tether head 128 to cause tether head 128 to transition between the engagement configuration and the disengagement configuration. For example, in some examples, elongate body 180 is configured to exert the force to cause tether head 128 to transition from the engagement configuration to the disengagement configuration. In some examples, elongate body 180 is configured to exert the force to cause tether head 128 to transition from the disengagement configuration to the engagement configuration. In examples, elongate body 180 is configured to cause tether head 128 to substantially maintain the engagement configuration or the disengagement configuration. For example, elongate body 180 may be configured to exert the force to cause tether head 128 to substantially maintain one of the engagement configuration or disengagement configuration. Elongate body 180 may be configured such that, when elongate body 180 ceases to or otherwise does not exert the force, tether head 128 substantially maintains the other of the engagement configuration or disengagement configuration.

[0068] Elongate body 180 may be configured to extend through tether lumen 172. In examples, elongate body 180 includes a distal portion 182 (“elongate body distal portion 182”) configured to attach and / or affix to tether head 128 and / or a proximal portion 184 (“elongate body proximal portion 184”) configured to attach and / or affix to handle device 149 (e.g., proximal portion 147”). In examples, elongate body 180 (e.g., elongate body proximal portion 184) extends through proximal tether lumen opening 176 and / or into inner volume 178. Elongate body 180 (e.g., elongate body distal portion 182) may extend at least to distal tether lumenDocket No: A0012371W001 / 2222-587W001 opening 174 and / or to tether head 128. Elongate body 180 may be configured to slidably translate within tether lumen 172 when elongate body 180 exerts or ceases to exert the force on tether head 128.

[0069] Handle assembly 143 (e.g., handle device 149) is configured to cause elongate body 180 to exert the force on tether head 128. For example, handle assembly 143 may be configured to exert the force on elongate body 180 in a first direction (e.g., proximal direction P). Elongate body 180 may be configured to transfer the force to tether head 128. Handle assembly 143 may be configured to cease exerting the force on elongate body 180 in the first direction, such that elongate body 180 ceases to transfer the force to tether head 128. Hence, handle assembly 143 may be configured to cause tether head 128 (e.g., using elongate body 180) to transition between the engagement configuration and the disengagement configuration, and / or to substantially maintain one of the engagement configuration or the disengagement configuration. A clinician may thus use handle assembly 143 (e.g., handle device 149) to cause tether head 128 to engage with and / or disengage from IMD 102 to affect, for example, an implantation or retrieval of IMD 102.

[0070] Handle device 149 may be configured to cause elongate body 180 to exert the force on tether head 128 when proximal portion 147 is moved (e.g., by a clinician) relative to distal portion 145. In examples, handle device 149 is configured to cause elongate body 180 to exert the force on tether head 128 when proximal portion 147 is rotated relative to distal portion 145. The movement of proximal portion 147 relative to distal portion 145 to cause elongate body 180 to exert the force on tether head 128, such that tether head 128 transitions between the engagement configuration and the disengagement configuration, may enhance control of the engagement and / or disengagement of IMD 102 during the implantation or retrieval of IMD 102 within an anatomical volume of a patient (e.g., a chamber defined by heart 101 (FIG. 1)).

[0071] As an example, FIG. 4 is a perspective view of a handle device 149 in a first configuration. Handle assembly 143 includes handle device 149 comprising distal portion 145 and proximal portion 147. In FIG. 4, tether body 122 (e.g., tether proximal portion 126) is illustrated as transparent and in dashed lines for clarity, with elongate body 180 extending through tether lumen 172. FIG. 5 is a perspective view of handle device 149 in a second configuration, with proximal portion 147 having moved (e.g., rotated) relative to distal portion 145. Handle device 149 is configured to exert a force F on an elongate body 180 in a first direction (e.g., distal direction D) when handle device 149 is in the second configuration. For example, handle device 149 may be configured to exert the force F when proximal portion 147 is moved relative to distal portion 145 and handle device 149 transitions from the first configuration (FIG. 4) to the second configuration (FIG. 5). FIG. 6 is a perspective view of handle device 149Docket No: A0012371W001 / 2222-587W001 engaged with a locking device 220 configured to substantially hold handle device 149 in the first configuration.

[0072] Note that, in some examples, handle device 149 may be configured such that the force F causes an alteration in a force already present on elongate body 180 (e.g., a tensioning or compression force). Stated similarly, tether system 120 (e.g., handle device 149 and / or tether head 128) may be configured such that, when handle device 149 is in the first configuration, elongate body 180 experiences an initial force (and, in some examples, transfers that initial force to tether head 128). Tether system 120 may be configured such that, when handle device 149 shifts from the first configuration (FIG. 4) to the second configuration (FIG, 5), force F acts to increase or decrease the initial force. In other examples, tether system 120 may be configured such that, when handle device 149 is in the first configuration, elongate body 180 is substantially in a relaxed state (e.g., such that tensioning or compressive forces are substantially absent).

[0073] Handle device 149 includes proximal portion 147 is configured to move (e.g., be moved by a clinician) relative to distal portion 145. In examples, proximal portion 147 is configured to rotate about longitudinal axis L when proximal portion 147 moves relative to distal portion 145. For example, proximal portion 147 may be configured to rotate relative to distal portion 145 over at least 30 degrees in some examples, at least 60 degrees in some examples, and / or at least 90 degrees in some examples. In examples, distal portion 145 defines longitudinal axis L. In some examples, longitudinal axis L extends through distal portion 145 and proximal portion 147. Handle device 149 may be configured such that rotation of proximal portion 147 relative to distal portion 145 causes handle device 149 to transition from the first configuration (FIG. 4) to the second configuration (FIG. 5), such that handle device exerts force F on elongate body 180.

[0074] Elongate body 180 may be configured to transfer force F to tether head 128 (FIG. 3) to cause tether head 128 to one of transition from the engagement configuration to the disengagement configuration or transition from the disengagement configuration to the engagement configuration. In examples, handle device 149 is configured to exert force F on elongate body 180 in proximal direction P. In some examples, tether head 128 is configured to transition from the engagement configuration (wherein tether head 128 engages IMD 102) to the disengagement configuration (wherein tether head 128 disengages from IMD 102) when handle device 149 exerts force F on elongate body 180 in proximal direction P. Hence, handle device 149 may be configured to cause tether head 128 to transition between the engagement configuration and the disengagement configuration when proximal portion 147 moves (e.g., is moved by a clinician) relative to distal portion 145.

[0075] In some examples, distal portion 145 includes a housing 188 (“distal portion housingDocket No: A0012371W001 / 2222-587W001188”) defining a distal point PD. Proximal portion 147 may include a housing 190 (“proximal portion housing 190”) defining a proximal point PP. Handle device 149 may be configured such that proximal point PP moves relative to distal point PD when proximal portion 147 (e.g., proximal portion housing 190) moves relative to distal portion 145 (e.g., distal portion housing 188). In examples, handle device 149 is configured such that proximal point PP rotates around longitudinal axis L relative to distal point PD when proximal portion 147 moves relative to distal portion 145 (e.g., when proximal portion 147 rotates around longitudinal axis L relative to distal portion 145).

[0076] In some examples, handle device 149 is configured such that causing a movement (e.g., a rotation) of proximal portion 147 relative to distal portion 145 requires exertion of a first force Fl on proximal portion 147 while a substantially equal and opposite force F2 (e.g., a reaction force) is exerted on distal portion 145. In examples, handle device 149 is configured such that first force Fl causes a first torque (e.g., in first rotational direction Wl) around longitudinal axis L and / or second force Fl causes a second torque (e.g., in second rotational direction W2) around longitudinal axis L Hence, handle device 149 may be configured such movement of proximal portion 147 relative to distal portion 145 substantially requires a clinician to exert first force Fl with a first hand and hold and / or exert second force F2 with a second hand. Thus, handle device 149 may be configured such that movement of proximal portion 147 relative to distal portion 145 is substantially a two-handed operation. This may tend to mitigate handle device 149 against inadvertent manipulations that might act to cause unintended and / or inadvertent movement of proximal portion 147 relative to distal portion 145.

[0077] In some examples, handle device 149 includes a proximal actuation member 192 configured to transfer first force Fl and / or a torque caused by first force Fl to proximal portion 147 (e.g., to proximal portion housing 190). In examples, proximal portion 147 (e.g., proximal portion housing 190) defines proximal actuation member 192. In examples, proximal actuation member 192 defines a proximal bearing surface 194 (e.g., FIG. 5) configured to cause proximal portion 147 to move relative to distal portion 145 when first force Fl is exerted on proximal bearing surface 194. Proximal bearing surface 194 may be configured to transfer first force Fl and / or a torque caused by first force Fl to proximal portion 147 (e.g., proximal portion housing 190). In some examples, instead of or in addition to proximal bearing surface 194, proximal portion 147 (e.g., proximal portion housing 190) may include a proximal handling surface 196 (e.g., FIG. 5) configured to receive first force Fl. Proximal handling surface 196 may be configured to cause proximal portion 147 to move relative to distal portion 145 when first force Fl is exerted on proximal handling surface 196. In some examples, proximal handling surface 196 defines a depression in proximal portion housing 190 configured to receive some portion of aDocket No: A0012371W001 / 2222-587W001 hand (e.g., one or more fingers) when the portion of the hand exerts first force Fl.

[0078] Handle device 149 may include a distal actuation member 198 configured to transfer second force F2 and / or a torque caused by second force F2 to distal portion 145 (e.g., to distal portion housing 188). In examples, distal portion 145 (e.g., distal portion housing 188) defines distal actuation member 198. In examples, distal actuation member 198 defines a distal bearing surface 202 configured to cause and / or assist proximal portion 147 in moving relative to distal portion 145 when second force F2 is exerted on distal bearing surface 202. Distal bearing surface 202 may be configured to transfer second force F2 and / or a torque caused by second force F2 to distal portion 145 (e.g., distal portion housing 188). In some examples, instead of or in addition to distal bearing surface 202, distal portion 145 (e.g., distal portion housing 188) may include a distal handling surface 204 configured to receive second force F2. Distal handling surface 204 may be configured to cause and / or assist proximal portion 147 in moving relative to distal portion 145 when second force F2 is exerted on distal handling surface 204. In some examples, distal handling surface 204 defines a depression in distal portion housing 188 configured to receive some portion of a hand (e.g., one or more fingers) when the portion of the hand exerts second force F2.

[0079] In examples, proximal actuation member 192 may define a second proximal bearing surface 206 and / or proximal portion housing 190 may define a second proximal handling surface 208 configured to receive a force opposite force Fl. Second proximal bearing surface 206 and / or second proximal handling surface 208 may be configured to receive the force opposite force Fl to cause handle device 149 to transition from the second configuration (FIG. 5) to the first configuration (FIG. 4). Distal actuation member 198 may define a second distal bearing surface 210 and / or distal portion housing 188 may define a second proximal handling surface 212 configured to receive a force opposite force F2. Second distal bearing surface 210 and / or second distal handling surface 212 may be configured to receive the force opposite force F2 to cause handle device 149 to transition from the second configuration (FIG. 5) to the first configuration (FIG. 4).

[0080] In some examples, handle device 149 is configured to substantially keep proximal portion 147 and distal portion 145 in the first configuration (FIG. 4) until a threshold force is exerted (e.g., by a clinician) on one of proximal portion 147 or distal portion 145. For example, handle device 149 may include an extending member 214 configured to keep proximal portion 147 and distal portion 145 in the first configuration until the threshold force is exerted. In some examples, extending member 214 is configured to couple (e.g., mechanically couple) proximal portion 147 and distal portion 145. For example, in some examples, extending member 214 may define a proximal portion 216 (“member proximal portion 216”) attached and / or coupled toDocket No: A0012371W001 / 2222-587W001 proximal portion 147 and define a distal portion 218 (“member distal portion 218”) attached and / or coupled to distal portion 145. Extending member 214 may extend continuously (e.g., comprise a substantially contiguous material) from member proximal portion 216 to member distal portion 218. Extending member 214 may be configured such that the continuous extension from member proximal portion 216 to member distal portion 218 causes proximal portion 147 and distal portion 145 to remain in the first configuration when forces on proximal portion 147 or distal portion 145 (e.g., rotational forces around longitudinal axis L) are less than the threshold force. Extending member 214 may be configured to separate (e.g., to break) when forces on proximal portion 147 or distal portion 145 (e.g., rotational forces around longitudinal axis L) provide a resultant force greater the threshold force. Hence, extending member 214 may be configured such that handle device 149 tends to remain in the first configuration until a clinician exerts the threshold force on handle device 149. This may tend to stabilize handle device 149 against inadvertent forces that might act to cause some degree of unintended movement between proximal portion 147 and distal portion 145.

[0081] In some examples, handle device 149 may be configured to provide a feedback (e.g., a mechanical and / or haptic feedback) when proximal portion 147 moves (e.g., is moved by a clinician) relative to distal portion 145. The feedback may serve to provide an indication to a clinician holding and / or manipulating handle device 149 that motion between proximal portion 147 and distal portion 145 is occurring. For example, extending member 214 may extend from one or proximal portion 147 or distal portion 145 and define a member end in contact with the other of proximal portion 147 or distal portion 145. Extending member 214 may be configured such that the member end slidably translates over some portion of the other of proximal portion 147 or distal portion 145 when proximal portion 147 moves relative to distal portion 145. Handle device 149 may be configured such that the sliding translation causes a feedback (e.g., a vibration or a sound) sensible by a clinician (e.g., a clinician causing proximal portion 147 to move relative to distal portion 145). Hence, the feedback provide an indication (e.g., to the clinician) that motion between proximal portion 147 and distal portion 145 is occurring.

[0082] In some examples, handle assembly 143 includes locking device 220 (FIG. 5, FIG. 6). Locking device 220 may be configured to be placed in a locked configuration and an unlocked configuration. In examples, locking device 220 is configured to keep proximal portion 147 and distal portion 145 in the first configuration when locking device is in the locked configuration. Locking device 220 may be configured to allow and / or permit movement (e.g., rotation) of proximal portion 147 relative to distal portion 145 when locking device is in the unlocked configuration.

[0083] For example, as depicted in FIG. 6, locking device 220 may be configured to engageDocket No: A0012371W001 / 2222-587W001 distal portion 145 and proximal portion 147 in the locked configuration to keep handle device 149 is in the first configuration. Locking device 220 may be configured to limit and / or substantially prevent movement of proximal portion 147 relative to distal portion 145 when locking device 220 engages distal portion 145 and proximal portion 147. In examples, locking device 220 is separable from handle device 149 (as depicted in FIG. 5), such that locking device 220 may be disengaged (e.g., by a clinician) from at least one of distal portion 145 and / or proximal portion 147 to establish an unlocked configuration. In some examples, locking device 220 is configured to engage distal portion housing 188 and / or distal actuation member 198 and proximal portion housing 190 and / or proximal actuation member 192 when handle device 149 is in the first configuration.

[0084] In some examples, locking device 220 may comprise a fastening device such as a mechanical latch or other device configured to establish the locked configuration and the unlocked configuration. For example, locking device 220 may comprise a first section and a second section separable from the first section. The first section may be coupled to proximal portion 147 and the second section may be coupled to distal portion 145. The first section and the second section may be configured to mechanically mate to form a substantially unified portion of locking device 220. Locking device 220 may be configured such that mechanically mating the first portion and the second portion causes locking device 220 to establish the locked configuration tending to keep handle device 149 is in the first configuration. Locking device 220 may be configured to establish the unlocked configuration when the first section separates (e.g., is separated by a clinician) from the second section. The first component and the second component may comprise, for example, a stud and a socket (e.g., a snap fastener), a latch and a catch, a barrel bolt and a catch plate, or any other components configured to form a mechanically mated connection with each other.

[0085] In some examples, one of proximal portion 147 or distal portion 145 may define a neck portion 222 which is surrounded at least in part by the other of proximal portion 147 (e.g., proximal portion housing 190) or distal portion 145 (e.g., distal portion housing 188). In some examples, neck portion 222 defines a rotary -type joint with the other of proximal portion 147 or distal portion 145, such that proximal portion 147 may rotate about longitudinal axis L relative to distal portion 145.

[0086] In some examples, handle device 149 is configured to limit a linear displacement (e.g., a displacement substantially parallel to distal direction D and proximal direction P) between distal housing portion 188 (e.g., distal point DP) and proximal housing portion 190 (e.g., proximal point PP). For example, handle device 149 (e.g., neck portion 222) may be configured to allow proximal portion 147 to move in distal direction D toward or in proximal direction PDocket No: A0012371W001 / 2222-587W001 away from distal portion 145 by a particular amount while also limiting a maximum linear displacement between distal housing portion 188 (e.g., distal point DP) and proximal housing portion 190 (e.g., proximal point PP). In examples, handle device 149 is configured such that neck portion 222 is surrounded (e.g., remains surrounded by) the other of proximal portion 147 (e.g., proximal portion housing 190) or distal portion 145 (e.g., distal portion housing 188) when proximal portion 147 is displaced from distal portion 145 by the maximum linear displacement.

[0087] In some examples, handle device 149 is configured such that, in order to move proximal portion 147 relative to distal portion 145, proximal portion 147 must first axially translate (e.g., by axially translated by a clinician) toward distal portion 145 by some amount . Handle device 149 may be configured such that, prior to proximal portion 147 axially translating toward distal portion 145, handle device 149 limits or prevent a movement (e.g., a rotation) of proximal portion 147 relative to distal portion 147 (e.g., prevents a movement which causes handle device 149 to transition from the first configuration (FIG. 4) to the second configuration (FIG. 5)). In examples, handle device 149 is configured such that proximal portion 147 must first axially translate (e.g., move in a direction substantially parallel to longitudinal axis L) in the distal direction D before proximal portion 147 may move (e.g., rotate) relative to distal portion 145. This may tend to stabilize handle device 149 against inadvertent forces that might act to cause some degree of unintended movement between proximal portion 147 and distal portion 145.

[0088] In examples, in some examples, handle device 149 is configured such that the movement (e.g., a rotation) of proximal portion 147 relative to distal direction D causes proximal portion 147 to axially translate (e.g., in proximal direction P) relative to distal portion D. In examples, the axial translation of proximal portion 147 relative to distal portion 145 (e.g., in proximal direction P) causes handle device 149 to exert force F on elongate body 180. For example, in the first configuration (FIG. 4), handle device 149 may be configured such that axial translation of proximal portion 147 relative to distal portion 145 in proximal direction P is blocked by handle device 149 (e.g., blocked by a portion of distal portion housing 188). Handle device 149 may be configured such that, in the second configuration (FIG. 5), handle device 149 (e.g., the a portion of distal portion housing 188) allows the axial translation of proximal portion 147 relative to distal portion 145 (e.g., in proximal direction P), such that handle device 149 exerts force F on elongate body 180. In some examples, handle device 149 is configured to exert a member force (e.g., using a compression member) on proximal portion 147 which causes, in the second configuration, proximal portion 147 to axially translate (e.g., in proximal direction P) relative to distal portion 145. In examples, elongate body 180 may be attached to, affixed to, or otherwise in contact with proximal portion 147, such that handle device 149 exerts force F onDocket No: A0012371W001 / 2222-587W001 elongate body 180 when proximal portion 147 axially translates in the first direction relative to distal portion 145.

[0089] As an example, FIG. 7 is a perspective view of handle device 149 in the first configuration, depicted with reference to an X-Y-Z axes. FIG. 8 is a perspective view of handle device 149 with proximal portion 147 having moved (e.g., rotated) relative to distal portion 145, depicted with reference to the X-Y-Z axes. FIG. 9 is a perspective view of handle device 149 in the second configuration, depicted with reference to the X-Y-Z axes. In FIGS. 7-9, distal portion housing 188 is illustrated as transparent for clarity. FIG. 10A is a schematic illustration of an example stop member 232 of handle device 149, depicted with reference to the X-Y-Z axes, and generally in accordance with a cutting plane A-A’ shown in FIG. 7. Cutting plane A-A’ is substantially parallel to the Y-Z plane of the X-Y-Z axes. FIG. 10B is a schematic illustration of the example stop member 232 of FIG. 10A, depicted with reference to the X-Y-Z axes, and with the X axis proceeding out of the page. FIG. 10C is a schematic illustration of the example stop member 232 of FIG. 10A and 10B, depicted with reference to the X-Y-Z axes, and with the Y axis proceeding out of the page. In FIGS 7-10C, the X-Y-Z axes defines a right-hand coordinate system with the X axis substantially parallel to the proximal direction P and / or the distal direction D.

[0090] Referring largely to FIG. 7, handle device 149 (e.g., distal portion 145) may define and / or include a boundary portion 224 defining a clearance gap 226. For example, boundary portion 224 may define some portion of a boundary B defining clearance gap 226. In examples, boundary portion 224 includes one or more components such as first component 228 and / or second component 230 defining a portion of boundary B. In some examples, handle device 149 (e.g., distal portion 145 and / or distal portion housing 188) is configured to support first component 228 and / or second component 230 to cause first component 228 and / or second component 230 to define the portion of boundary B. In some examples, distal portion 145 (e.g., distal portion housing 188) is configured to maintain first component 228 and / or second component 230 in a position substantially stationary relative to distal portion housing 188, and / or substantially stationary relative to each other. In other examples, distal portion housing 188 may define first component 228 and / or second component 230 such that first component 228 and / or second component 230 are substantially contiguous portions (e.g., extended portions) of a material comprising some portion of distal portion housing 188.

[0091] Boundary portion 224 may be configured such that a passage (e.g., an axial translation) of proximal portion 147 through clearance gap 226 is limited when handle device 149 is in the first configuration. Stated similarly, boundary portion 224 may be configured such that, with handle device 149 in the first configuration, boundary portion 224 prevents (e.g.,Docket No: A0012371W001 / 2222-587W001 block) proximal portion 147 from axially translating in a first direction (e.g., proximal direction P) through clearance gap 226. In examples, boundary portion 224 is configured to cause contact between boundary B of clearance gap 226 and proximal portion 147 to limit axial translation of proximal portion 147 through clearance gap 226 at least in the first direction. Handle device 149 may be configured such that the contact between boundary B and proximal portion 147 substantially arrests (e.g., prevents) the axial translation of proximal portion 147 through clearance gap 226 at least in the first direction.

[0092] Handle device 149, in the first configuration, may be configured to limit and / or prevent axial transition of a stop member 232 to limit and / or prevent axial translation of proximal portion 147 through clearance gap 226. In examples, stop member 232 is defined and / or supported by proximal portion 147. In examples, stop member 232 is configured to be substantially stationary with respect to proximal portion housing 190. For example, stop member 232 may be configured such that a rotation of proximal portion 147 (e.g., proximal portion housing 190) relative to distal portion 145 (e.g., distal portion housing 188) causes a rotation of stop member 232 relative to distal portion 145 (e.g., distal portion housing 188). In examples, stop member 232 is configured to rotate synchronously with proximal portion 147. In examples, stop member 232 is configured to rotate about longitudinal axis L when proximal portion 147 (e.g., proximal portion housing 190) rotates about longitudinal axis L. For example, handle device 149 may be configured such that when proximal point PP rotates about longitudinal axis L relative to distal point PD (e.g., due to rotation of proximal portion 147 by a clinician), a member point PM defined by stop member 232 rotates around longitudinal axis L relative to distal point PD. In examples, member point PM is substantially stationary relative to proximal point PP when proximal point PP and member point PM rotate about longitudinal axis L.

[0093] Stop member 232 may be configured to position in a blocked position relative to boundary portion 224 when handle device 149 is in the first configuration. In examples, stop member 232 is configured to contact boundary portion 224 (e.g., boundary B) to limit and / or prevent proximal portion 147 (e.g., the portion of proximal portion 147 comprising stop member 232) from axially translating in the first direction (e.g., proximal direction P) through clearance gap 226. For example, stop member 232 may define a flange surface 234 configured to contact boundary portion 224 (e.g., first component 228) to limit and / or prevent the axial translation of proximal portion 147 through clearance gap 226 in the first direction. Flange surface 234 may be configured to contact boundary portion 224 when stop member 232 is positioned in the blocked position relative to boundary portion 224 (e.g., when handle device 149 is in the first configuration).

[0094] In some examples, stop member 232 defines a flange surface 235 configured toDocket No: A0012371W001 / 2222-587W001 contact boundary portion 224 (e.g., second component 230) to limit and / or prevent the axial translation of proximal portion 147 through clearance gap 226 in the first direction. In examples, stop member 232 defines flange surface 234 on a first side of stop member 232 and defines flange surface 235 on a second side of stop member 232 opposite the first side. Stop member 232 may be configured such that flange surface 235 contacts boundary portion 224 (e.g., second component 230) when flange surface 234 contacts boundary portion 224 (e.g., first component 228). Stop member 232 may include any number of flange surfaces such as flange surface 234 and flange surface 235. In examples, flange surface 234, flange surface 235, and / or other flange surface of stop member 232 are configured to substantially balance reaction forces exerted on stop member 232 by boundary portion 224 to, for example, limit and / or prevent a rotation of stop member 232 relative to longitudinal axis L that might result from exertion of the reaction forces.

[0095] In some examples, flange surface 234 and / or flange surface 235 are configured to limit a rotation of proximal portion 147 relative to distal portion 145 unless proximal portion 147 is axially translated relative to distal portion 145. For example, flange surface 234 may define a lip portion 236 configured to exert a force on boundary portion 224 (e.g., first component 228) when a torque around longitudinal axis L is placed on proximal portion 147. Flange surface 234 may be configured such that the force exerted by lip portion 236 generates a counter-torque on proximal portion 147 which tends to limit and / or substantially prevent a rotation of proximal portion 147 relative to distal portion 145. For example, the torque around longitudinal axis L placed on proximal portion 147 may cause lip portion 236 to contact and exert the force on boundary portion 224. Boundary portion 224 may exert an equal and opposite reaction force on lip portion 236, such that lip portion 236 exerts a torque around longitudinal axis L substantially equal and opposite to the torque around longitudinal axis L placed on proximal portion 147.

[0096] Handle device 149 may be configured to displace lip portion 236 from boundary portion 224 to allow the rotation of proximal portion 147 relative to distal portion 145. For example, as depicted in FIG. 8, handle device 149 may be configured to allow proximal portion 147 to axially translate in a second direction opposite the first direction (e.g., in distal direction D) to cause the displacement of lip portion 236 from boundary portion 224. Hence, in some examples, handle device 149 may be configured such that an initial axial translation of proximal portion 147 relative to distal portion 145 (e.g., in the second direction) is necessary prior to rotating proximal portion 147 relative to distal portion 145. In some examples, flange surface 234 and / or flange surface 135 may substantially conform to some portion of boundary portion 224 when flange surface 234 and / or flange surface 235 are in contact with boundary portion 224 (e.g., in contact with first component 228 and second component 230 respectively).

[0097] Referring largely to FIG. 8, stop member 232 may be configured to position in aDocket No: A0012371W001 / 2222-587W001 clearance position relative to boundary portion 224 when handle device 149 is in the second configuration (e.g., when proximal portion 147 has moved (e.g., been rotated by a clinician) relative to distal portion 145. Handle device 149 may be configured to allow axial transition of a proximal portion 147 (e.g., stop member 232) into clearance gap 226 when stop member is in the clearance position. In examples, stop member 232 is configured to transition from the blocked position (e.g., FIG. 7) to the clearance position (e.g., FIG. 8) when handle device 149 transitions from the first configuration (e.g., FIG. 7) to the second configuration (e.g., FIG. 8). Stated similarly, stop member 232 may be configured to transition from the blocked position to the clearance position when proximal portion 147 (e.g. proximal portion housing 190) moves (e.g., rotates) relative to distal portion 145 (e.g., distal portion housing 188) to cause handle device 149 to transition from the first configuration to the second configuration.

[0098] Stop member 232 is configured to move away from and / or displace from boundary portion 224 when stop member 232 transitions from the blocked position to the clearance position. Stop member 232 may be configured such that the movement away from and / or the displacement from boundary portion allows proximal portion 147 (e.g., stop member 232) to axially translate in a first direction (e.g., proximal direction P) relative to boundary portion 224. For example, in examples, stop member 232 is configured to move and / or displace flange surface 234 away from first component 228 and / or move and / or displace flange surface 235 away from first component 228 when stop member 232 transitions (e.g., moves) from the blocked position to the clearance position. In examples, flange surface 234 and / or flange surface 235 are configured to rotate about longitudinal axis L relative to boundary portion 224 when stop member 232 transitions (e.g., moves) from the blocked position to the clearance position.

[0099] Stop member 232 may be configured such that the movement and / or displacement of flange surface 234 from first component 228 and / or flange surface 235 from second component 230 limits (e.g., eliminates) contact between proximal portion 147 (e.g., stop member 232) and boundary portion 224 when stop member axially translates in the first direction (e.g., proximal direction P), such that proximal portion 147 may axially translate in the first direction relative to boundary portion 224. In examples, stop member 232 is configured to at least partially insert into clearance gap 226 when proximal portion 147 axially translates in the first direction (e.g., proximal direction P) relative to boundary portion 224.

[0100] For example, referring largely to FIG. 9, which illustrates handle device 149 in the second configuration, handle device 191 may be configured such that proximal portion 147 may axially translate relative to distal portion 145 (e.g., boundary portion 224) at least over a displacement DI in the first direction (e.g., in proximal direction P) when handle device 149 is in the second configuration. Handle device 149 may be configured such that the axial translation ofDocket No: A0012371W001 / 2222-587W001 proximal portion 147 relative to distal portion 145 causes handle device 149 to exert the force F on elongate body 180. In examples, proximal portion 147 is configured to exert the force F on elongate body proximal portion 184 when proximal portion 147 axially translates relative to distal portion 145 at least over the displacement DI. Elongate body 180 may be configured to transfer the force F from elongate body proximal portion 184 to elongate body distal portion 182 (FIG. 3). Elongate body distal portion 182 may be configured to exert the force F on tether head 128 to, for example, cause tether head 128 to transition between the engagement configuration and the disengagement configuration. In examples, handle device 191 is configured to exert force F in proximal direction P on elongate body 180 when proximal portion 147 axially translates relative to boundary portion 224 in proximal direction P. In examples, handle device 149 is configured to place a tension on or increase a tension of elongate body 180 when handle device 149 exerts force F on elongate body 180.

[0101] In examples, stop member 232 is configured to at least partially insert into clearance gap 226 when proximal portion 147 axially translates in the first direction (e.g., proximal direction P) relative to boundary portion 224. In some examples, stop member 232 is configured to cause flange surface 234 and / or flange surface 235 to transition from a position distal to boundary portion 224 to a position proximal to boundary portion 224 when proximal portion 147 axially translates in proximal direction P relative to boundary portion 224. In examples, elongate body 180 is attached to, affixed to, or otherwise in contact with stop member 232 when proximal portion 147 axially translates in the first direction relative to boundary portion 224, such that the axial translation causes stop member 232 to exert force F on elongate body 180.

[0102] Stop member 232 may define a second flange surface 238 configured to contact boundary portion 224 (e.g., second component 230) to limit and / or prevent further axial translation of proximal portion 147 through clearance gap 226 in the first direction (e.g., proximal direction P). Stop member 232 may be configured such that second flange surface 238 contacts boundary portion 224 (e.g., first component 228 and / or second component 230) to limit and / or prevent further axial translation of proximal portion 147 through clearance gap 226. In examples, second flange surface 238 is configured to contact boundary portion 224 when proximal portion 147 axially translates over the distance DI relative to distal portion 145. Second flange surface 238 may limit and / or prevent further axial translation of proximal portion 147 through clearance gap 226 to ease handling of handle device 149 (e.g., to ensure both distal portion 145 and proximal portion 147 may be handled as a single component by a clinician). Stop member 232 may include any number of second flange surfaces such as second flange surface 238. In examples, second flange surface 238 is configured to contact boundary portion 224 when handle device 149 is in the second configuration.Docket No: A0012371W001 / 2222-587W001

[0103] In examples, proximal portion 147 (e.g., stop member 232) is configured to limit a rotation of proximal portion 147 relative to distal portion 145 when handle device 149 is in the second configuration (e.g., when second flange surface 238 contacts boundary portion 224). For example, proximal portion 147 (e.g., stop member 232) may define a bearing surface 239 configured to exert a force on boundary portion 224 (e.g., first component 228) when a torque around longitudinal axis L is placed on proximal portion 147 (e.g., in first rotational direction Wl). Bearing surface 239 may be configured such that the force exerted by bearing surface 239 generates a counter-torque on proximal portion 147 which tends to limit and / or substantially prevent a rotation of proximal portion 147 relative to distal portion 145. For example, the torque around longitudinal axis L placed on proximal portion 147 may cause bearing surface 239 to contact and exert the force on boundary portion 224. Boundary portion 224 may exert an equal and opposite reaction force on bearing surface 239, such that bearing surface 239 exerts a torque around longitudinal axis L substantially equal and opposite (e.g., in second rotational direction W2) to the torque around longitudinal axis L placed on proximal portion 147. In examples, handle device 149 is configured to displace bearing surface 239 from boundary portion 224 to, for example, permit rotation of proximal portion 147 relative to distal portion 145. For example, proximal portion 147 may be configured to axially translate in the second direction (e.g., distal direction D) relative to proximal portion 147 to displace bearing surface 239 from boundary portion 224.

[0104] In some examples, stop member 232 is configured to extend into an inner volume 240 defined by distal portion housing 188. For example, distal portion housing 188 may define an inner surface 241 bounding (e.g., defining a boundary of) inner volume 240. Proximal portion 147 may be configured such that stop member 232 is positioned within inner volume 240 when handle device 149 is in the first configuration, transitioning between the first configuration and the second configuration, and / or is in the second configuration. In examples, stop member 232 positions within inner volume 240 when distal portion housing 188 at least partially surrounds neck portion 222. In examples, distal housing portion 188 defines and / or supports boundary portion 224 within inner volume 225. In examples, elongate body 180 extends through an opening 242 defined by distal portion housing 188. Opening 242 may open into a passage defined by distal portion housing 188 which extends from an exterior surface of distal portion housing 188 and into inner volume 240. In examples, elongate body 180 (e.g., elongate body proximal portion 184) extends into opening 242 and into inner volume 240.

[0105] In some examples, handle device 149 includes an elastic member 245 (e.g., a spring) configured to exert a member force FM on proximal portion 147 in the first direction (e.g., in proximal direction P). Elastic member 245 may be configured to exert member force FM whenDocket No: A0012371W001 / 2222-587W001 handle device 491 is in the first configuration (FIG. 7), transitioning between the first configuration and the second configuration, and / or in the second configuration (FIG. 9). Elastic member 245 may be configured to exert member force FM when stop member 232 is in the blocked position (FIG. 7), transitioning between the blocked position and the clearance position, and / or in the clearance position (FIG. 9). In FIG. 7 and FIG. 8, elastic member 245 is depicted as a cross-section with a cutting plane taken substantially parallel to longitudinal axis L.

[0106] Elastic member 245 may be configured to exert force FM to cause proximal portion 147 to translate axially relative to distal portion 145 in the first direction (e.g., when stop member 232 is in the clearance position). In examples, elastic member 245 is configured to cause stop member 232 to contact (e.g., substantially seat against) boundary portion 224 when stop member 232 is in the blocked position and / or the clearance position. For example, elastic member 245 may exert force FM to cause flange surface 234 to seat against boundary portion 224 (e.g., first component 228) when stop member 232 is in the blocked position. Elastic member 245 may exert force FM to cause flange surface 238 to seat against boundary portion 224 (first component 228 and / or second component 230) when stop member 232 is in the clearance position.

[0107] Elastic member 245 may be supported by handle device 149 such that when elastic member 245 exerts force FM on proximal portion 147 (e.g., stop member 232) in the first direction, elastic member 245 exerts a second force substantially equal to force FM and in the second direction on distal portion 145 (e.g., distal portion housing 188). In examples, elastic member 245 is positioned within inner volume 240. In some examples, elastic member 245 is supported by inner surface 241. For example, elastic member 245 may be supported such that when elastic member 245 exerts force FM on proximal portion 147, elastic member 245 exerts the second force on inner surface 241.

[0108] Although depicted in FIGS. 7-9 as extending substantially parallel to longitudinal axis L and within inner volume 240, elastic member 245 may be located anywhere and / or act on any portion of proximal portion 147 and / or distal portion 145 sufficient to cause elastic member 245 to exert force FM on proximal portion 147 (e.g., stop member 232). In examples, elastic member 245 includes an elastic member first end and an elastic member second end substantially opposite the elastic member first end. The elastic member first end may be coupled (e.g., mechanically coupled) to distal portion 145. The elastic member second end may be coupled (e.g., mechanically coupled) to proximal portion 147 (e.g., stop member 232). In some examples, elastic member 245 is configured such that force FM varies (e.g., increases) as a displacement between the elastic member first end and the elastic member second end varies (e.g., decreases), although this is not required. In examples, elastic member 245 is configured such that a clinician may overcome force FM using hand force to, for example, cause proximal portion 147 to axiallyDocket No: A0012371W001 / 2222-587W001 translate in the second direction (e.g., the distal direction). In examples, elastic member 245 is configured to compress (e.g., decrease a distance between elastic member first end and elastic member second end) when proximal portion 147 axially translates relative to distal portion 145 in the second direction (e.g., distal direction D). Elastic member 245 may be configured to expand (e.g., increase a distance between elastic member first end and elastic member second end) when proximal portion 147 axially translates relative to distal portion 145 in the first direction (e.g., the proximal direction P).

[0109] Handle device 149 may be configured to reduce and / or cease exerting force F on elongate body 180 when handle device transitions from the second configuration to the first configuration. Handle device 149 may be configured to transition from the second configuration (FIG. 9) to the first configuration (FIG. 7) moving proximal portion 147 relative to distal portion 145 in a direction opposite the direction that proximal portion 147 moved relative to distal portion 145 to transition from the first configuration to the second configuration. For example, handle device 149 may be configured to transition from the second configuration to the first configuration by movement of proximal portion 147 relative to distal portion 145 in second rotational direction W2. Handle device 149 may be configured to displace second flange surface 238 from boundary portion 224 (e.g., by axially translating proximal portion 147 in the second direction (e.g., distal direction D) to permit movement of proximal portion 147 relative to distal portion 145 in second rotational direction W2. Movement of proximal portion 147 in second rotational direction W2 (e.g., with flange surface 234 displaced from boundary portion 224) may cause stop member 232 to transition from the clearance position to the blocked position.Reducing and / or ceasing to exert force F on elongate body 180 may cause tether head 128 to transition from the disengagement configuration to the engagement configuration, or cause tether head 128 to transition from the engagement configuration to the disengagement configuration.

[0110] Hence, handle assembly 143 (e.g., handle device 149) may be configured to exert a force F on elongate body 180 when proximal portion 147 moves (e.g., is moved by a clinician) relative to distal portion 145. In examples, handle assembly 143 is configured to exert force F when proximal portion 147 is rotated (e.g., in first rotational direction Wl) relative to distal portion 145. Elongate body 180 may transfer force F to tether head 128 to cause tether head to transition from one of the engagement configuration or the disengagement configuration to the other of the engagement configuration or the disengagement configuration. Handle assembly 143 (e.g., handle device 149) may be configured to alter (e.g., reduce) and / or cease exerting force F on elongate body 180 when proximal portion 147 when proximal portion 147 is rotated (e.g., in second rotational direction W2) relative to distal portion 145. Elongate body 180 may alter and / or cease transferring exerting force F to cause tether head to transition from the other of theDocket No: A0012371W001 / 2222-587W001 engagement configuration or the disengagement configuration to the one of the engagement configuration or the disengagement configuration.[OHl] FIG. 11 is a cross-sectional plan view of a portion of an example proximal portion 145 of handle device 149, depicted with reference to the X-Y-Z axes shown and generally in accordance with a cutting plane C-C’ shown in FIG. 7. FIG. 12 is a cross-sectional top view of a portion of an example proximal portion 145 of handle device 149, depicted with reference to the X-Y-Z axes shown and generally in accordance with a cutting plane E-E’ shown in FIG. 7. In FIG. 11 and FIG. 12, proximal point PP of proximal portion 145 is displaced from distal point DP of distal portion 147 by a displacement D2. FIG. 13 is a cross-sectional plan view of proximal portion 145 of FIG. 11, with proximal portion 145 having moved in the second direction (e.g., the distal direction) toward distal portion 147, such that proximal point PD is displaced from distal point DP by a displacement D3 less than displacement D2. FIG. 14 is a cross-sectional top view of proximal portion 145 of FIG. 12, with proximal point PD displaced from distal point DP by the displacement D3. Cutting plane C-C’ is substantially parallel to the X-Y plane of the X-Y-Z axes. Cutting plane E-E’ is substantially parallel to the X-Z plane of the X-Y-Z axes.

[0112] In some examples, handle assembly 143 (e.g., handle device 149) is configured such that, when proximal portion 145 moves in the second direction (e.g., distal direction D) toward distal portion 145, proximal portion 145 moves relative to both distal handle 147 and elongate body 180. For example, as stated, FIG. 11 depicts proximal portion 145 such that proximal point PP is displaced from distal point DP of distal portion 147 by displacement D2. As depicted in FIG. 13, proximal portion 145 may move toward distal portion 147 over a displacement D4. FIG. 13 depicted the location of proximal point PP prior to the movement over displacement D4 as point PP’ (e.g., point PP” substantially corresponds to the location of proximal point PP depicted in FIG. 11). Handle assembly 143 may be configured such that movement of proximal portion 145 in the second direction (e.g., toward distal portion 147) also results in movement of proximal portion 145 relative to elongate body 180 in the second direction. For example, when proximal portion 145 moves in the second direction over the displacement D4, proximal portion 145 (e.g., proximal portion housing 190) may move relative to elongate body 180 over a displacement such as displacement D5. In examples, displacement D5 is substantially equal to displacement D4.

[0113] As discussed, proximal portion 145 may be configured to impart force F (FIG. 5) on elongate body 180 when proximal portion 145 moves in the first direction (e.g., proximal direction P) relative to distal portion 147. Elongate body 180 may be configured such that the impartation of force F on elongate body 180 causes elongate body 180 to move in the first direction (e.g., causes elongate body 180 to remain substantially stationary to proximal portionDocket No: A0012371W001 / 2222-587W001145 when proximal portion 145 moves in the first direction relative to distal portion 147).

[0114] For example, as discussed, when handle assembly 143 is in the first configuration (e.g., FIG. 7), proximal portion 145 may be configured to move in the second direction relative to (e.g., towards) distal portion 147 (e.g., to displace lip portion 236 (FIG. 7, FIG. 10C) from boundary portion 224). Proximal point PP may move over displacement D4 (FIG. 13) when handle assembly 143 is in the first configuration and proximal portion 145 moves in the second direction towards distal portion 147. Handle assembly 143 may be configured such that proximal portion 145 also moves in the second direction relative to elongate body 180 when handle assembly 143 is in the first configuration and proximal portion 145 moves in the second direction towards distal portion 147. Proximal portion housing 190 may establish displacement D5 (FIG. 13) from elongate body 180 when proximal portion 145 moves in the second direction toward distal portion 147 with handle assembly 143 is in the first configuration.

[0115] Handle assembly 143 may be transitioned to the second configuration (e.g., as depicted in FIG. 8), such that proximal portion 145 move in the first direction (e.g., proximal direction P) relative to distal portion 147 over a displacement greater than displacement D5 (e.g., as depicted in FIG. 9). In examples, displacement DI (FIG. 9) is greater than displacement D5 (FIG. 13). Handle assembly 143 (e.g., proximal portion housing 190) may be configured to impart force F (FIG. 5) on elongate body 180 when proximal portion 145 moves in the first direction over the displacement greater than displacement D5. Elongate body 180 may be configured such that the impartation of force F on elongate body 180 causes elongate body 180 to move in the first direction (e.g., causes elongate body 180 to remain substantially stationary to proximal portion 145) at least when the displacement of proximal portion 145 from distal portion 147 is equal to or exceeds displacement D5.

[0116] In examples, elongate body 180 is configured to move in the first direction relative to proximal portion 145 (e.g., proximal portion housing 190) when proximal portion 145 moves in the second direction toward distal portion 147 (e.g., distal portion housing 188). Stated similarly, in examples, elongate body 180 may be configured to move in proximal direction P relative to proximal portion 145 when proximal portion 145 moves in distal direction D toward distal portion 147. For example, when proximal portion 145 moves in the second direction (e.g., distal direction D) relative to distal portion 147 to displace lip portion 236 (FIG. 7, FIG. 10C) from boundary portion 224, elongate body 180 may be configured to move in proximal direction P relative to proximal portion 145 (e.g., to remain substantially stationary relative to distal portion 147).

[0117] In some examples, elongate body 180 includes an engagement portion 260 coupled to a member body 262 of elongate body 180. For example, engagement portion 260 may be coupledDocket No: A0012371W001 / 2222-587W001 to a proximal section 264 of member body 262. In examples, engagement portion 260 is mechanically coupled to member body 262 (e.g., by soldering, welding, an adhesive, a fastener, crimping, or another method). For example, in some examples, engagement portion 260 may be configured to substantially surround a portion 263 of member body 262 (“body portion 263”) (FIG. 11, depicted with dashed line) configured to extend substantially into engagement portion 260 (e.g., into a volume defined by engagement portion 260). Engagement portion 260 may be coupled to body portion 263 by soldering, welding, an adhesive, a fastener, crimping, or another method. In some examples, engagement portion 260 is crimped onto body portion 263 such that engagement portion 260 at least frictionally engages body portion 263. Engagement portion 260 may be configured such that the frictional engagement between engagement portion 260 and body portion 263 causes engagement portion 260 to transfer force F (FIG. 5) to member body 262.

[0118] In some examples, member body 262 and engagement portion 260 are substantially unitary bodies (e.g., substantially contiguous with one another). Engagement portion 260 may be configured to such that elongate body 180 tends to move in the first direction (e.g., proximal direction P) relative to proximal portion 145 when proximal portion 145 moves in the second direction (e.g., distal direction D) toward distal portion 147, and further configured to receive force F from proximal portion 145 when proximal portion 145 moves in the first direction (e.g., the proximal direction P). For example, from the position depicted in FIG. 13 and FIG. 14, engagement portion 260 may be configured to receive force F subsequent to proximal portion 145 moving the in first direction at least over the displacement D4 and / or D5.

[0119] In examples, engagement portion 260 is configured to engage proximal portion housing 190 when proximal portion 145 moves in the first direction (e.g., proximal direction P) relative to distal portion 147 (e.g., subsequent to proximal portion 145 moving the in first direction at least over the displacement D4 and / or D5). For example, proximal portion housing 190 may define a bearing surface 266 configured to contact engagement portion 260 when proximal portion 145 moves in the first direction relative to distal portion 147. Bearing surface 266 may be configured to transfer force F (FIG. 5) to elongate body 180 (e.g., engagement portion 260) when bearing surface 266 contacts engagement portion 260 and proximal portion 145 moves in the first direction relative to distal portion 147. Engagement portion 260 may be configured to transfer force F to member body 262 such that, for example, elongate body transfers force F to tether head 128 (FIG. 3).

[0120] In examples, proximal portion housing 190 is configured to define a receptacle 268. Bearing surface 266 may be configured to define at least a portion of a boundary BP defining receptacle 268. In examples, engagement portion 260 is configured to position within receptacleDocket No: A0012371W001 / 2222-587W001268. Engagement portion 260 may be configured to move within receptacle 268 (e.g., to establish displacement D5) when proximal portion 145 moves in the second direction (e.g., distal direction D) relative to distal portion 147. For example, engagement portion 260 may be configured to translate in the first direction within receptacle 268 and relative to proximal portion housing 190 when proximal portion housing 190 moves in the second direction relative to distal portion housing 188. In examples, member body 262 is configured to extend from receptacle 268 in the second direction (e.g., distal direction D) when engagement portion 260 positions within receptacle 268. In some examples, longitudinal axis L extends through receptacle 268.

[0121] In some examples, member body 262 defines a first cross-sectional dimension Cl (“member dimension Cl”) and engagement portion 260 defines a second cross-sectional dimension C2 (“engagement dimension C2”) (FIG. 14). Engagement portion 260 and / or member body 262 may be configured such that engagement dimension C2 is greater than member dimension Cl. In examples, engagement dimension C2 and / or member dimension Cl are substantially perpendicular to longitudinal axis L. Engagement portion 260 may be configured such that engagement dimension C2 causes engagement portion 260 to contact bearing surface 266 when proximal portion 145 moves in the first direction relative to distal portion 147.

[0122] Proximal portion housing 190 may define a chamber opening 270 which opens into receptacle 268. In examples, chamber opening 270 is defined by a chamber opening boundary BC defined by proximal portion housing 190. Chamber opening 270 may be configured to limit movement of engagement portion 260 through chamber opening 270 in at least the second direction relative to proximal portion housing 190 (e.g., limit movement toward distal portion 147) when proximal portion 145 moves in the first direction relative to distal portion 147 (e.g., moves away from distal portion 147). In examples, chamber opening 270 opens into bearing surface 266. In some examples, bearing surface 266 defines at least a portion of a chamber opening boundary BC. Chamber opening 270 may be configured such that engagement portion 260 (e.g., due to engagement dimension C2) contacts bearing surface 266 when proximal portion 145 moves in the first direction relative to distal portion 147 (e.g., when proximal portion 145 moves over the displacement greater than displacement D4 and / or displacement D5). In examples, chamber opening boundary BC defines a third cross-sectional dimension C3 (“opening dimension C3”) greater than engagement dimension C2. In examples, opening dimension C3 is substantially perpendicular to longitudinal axis L and / or substantially parallel to engagement dimension C2.

[0123] Proximal portion 145 may be configured such that member body 262 extends through chamber opening 270 when engagement portion 260 resides within receptacle 268. Chamber opening 270 may be configured to allow passage of member body 262 through chamber openingDocket No: A0012371W001 / 2222-587W001270 (e.g., when engagement portion 260 is substantially stationary relative to proximal portion housing 190). For example, chamber opening 270 and / or chamber opening boundary BC may be configured such that member body 262 may translate through chamber opening 270 and relative to chamber opening boundary BC in at least the first direction (e.g., when proximal portion 145 moves toward distal portion 147 in the second direction). For example, in some examples, proximal portion housing 190 may be configured such that opening dimension C3 is less than member dimension C2. In some examples, opening dimension C3 may be substantially equal to member dimension C2 (e.g., such that member body 262 may slidably translate against chamber opening boundary BC when member body 262 translates relative to chamber opening boundary BC).

[0124] In examples, chamber opening 270 and / or chamber opening boundary BC are configured to allow member body 262 to translate through chamber opening 270 and relative to chamber opening boundary BC in the first direction when engagement portion 260 translates (e.g., within receptacle 268) in the first direction relative to proximal portion housing 190. Chamber opening 270 and / or chamber opening boundary BC may be configured such that member body 262 may translate through chamber opening 270 and relative to chamber opening boundary BC in the second direction, (e.g., as proximal portion 145 moves away from distal portion 147 in the first direction over a displacement less than displacement D4 and / or displacement D5), and / or configured to allow member body 262 to translate through chamber opening 270 and relative to chamber opening boundary BC in the second direction when engagement portion 260 translates (e.g., within receptacle 268) in the second direction relative to proximal portion housing 190 (e.g., as proximal portion 145 moves away from distal portion 147 in the first direction over the displacement less than displacement D4 and / or displacement D5).

[0125] In some examples, proximal portion housing 190 defines an entry passage 272 configured to allow the passage of member body 262 therethrough. Entry passage 272 may be defined at least in part by a passage boundary BE defined by proximal portion housing 190. In examples, entry passage 272 extends in the second direction (e.g., distal direction D) from chamber opening 270 (e.g., chamber opening boundary BC). Chamber opening 270 (e.g., chamber opening boundary BC) may be configured such that chamber opening 270 opens from entry passage 272 and into receptacle 268 (and, e.g., vice-versa).

[0126] In some examples, proximal portion 145 (e.g., proximal portion housing 190) includes an outer section defining a recess and an insertion section configured to insert into the recess. The outer section and the insertion section may be configured to define any aspects of proximal portion 145 (e.g., proximal portion housing 190) disclosed herein when the insertion section inserts into the recess of the outer section.Docket No: A0012371W001 / 2222-587W001

[0127] As an example, FIG. 15 illustrates an exploded perspective view of handle assembly 143 including an outer section 274 and an insertion section 276. Outer section 274 defines a recess 278 (“outer section recess 278”) configured to receive insertion section 276 (e.g., insertion section 276 is configured to insert into outer section recess 278). In examples, outer section 274 defines a boundary BR which defines outer section recess 278. In some examples, outer section 274 may define proximal actuation member 192, proximal handling surface 196, second proximal handling surface 208, at least portions of entry passage 272, boundary BE, receptacle 268, boundary BP, and / or other portions of proximal portion 145. Insertion section 276 may define at least portions of entry passage 272, boundary BE, receptacle 268, boundary BP, stop member 232, and / or other portions of proximal portion 145.

[0128] FIG. 16 is a cross-sectional plan view of a portion of proximal portion 145 with insertion portion 276 inserted into outer section recess 278, depicted with reference to the X-Y-Z axes shown (with the Z axis proceeding out of the page) and generally in accordance with a cutting plane F-F’ of FIG. 15. Cutting plane F-F’ is substantially parallel to the X-Y plane of the X-Y-Z axes. Cutting plane G-G’ is substantially parallel to the Y-Z plane of the X-Y-Z axes. In examples, insertion section 276 defines a flange portion 280 configured to contact and / or substantially seat against outer section 274 when insertion section 276 is inserted within outer section recess 278. Outer section recess 278 (e.g., boundary BR) may be configured to limit (e.g., to block) passage of flange portion 280 into outer section recess 278 when insertion section 276 is inserted into outer section 274. In examples, insertion section 276 is configured such that entry passage 272 extends through flange portion 280. Proximal portion 145 may be configured such that insertion section 276 may be inserted into (e.g., slidably translate into) outer section 274 in the first direction (e.g., proximal direction P) until flange portion 280 contacts and / or substantially seats against outer section 274. In examples, insertion section 276 is configured to remain substantially stationary relative to outer section 274 when insertion section 276 is inserted within (e.g., positioned) within outer section 274 (e.g., via outer section recess 278). Flange portion 280 may be configured to assist in the support and / or securement of insertion section 276 within outer section 274.

[0129] Outer section 274 may define a support portion 282 configured to engage insertion section 276 when insertion section 276 is positioned within outer section 274. In examples, support portion 282 is configured to assist in the support and / or securement of insertion section 276 within outer section 274. In some examples, support portion 282 defines one of a protrusion or a recess configured to receive the protrusion, and insertion section 276 defines the other of the protrusion or the recess. Support portion 282 may be configured such that the protrusion engages the recess to substantially guide insertion section 276 as insertion section 276 inserts into outerDocket No: A0012371W001 / 2222-587W001 section 274 (e.g., via outer section recess 278) and / or to hold insertion section 276 substantially stationary with respect to outer section 274 when insertion section 276 is positioned within outer section 274. In some examples, insertion portion 276 includes a support element 285 configured to engage outer section 274 when insertion section 276 is positioned within outer section 274 to, for example, provide support and / or securement of insertion section 276 within outer section 274. In examples, support element 285 is one of a second protrusion (e.g., as depicted in FIG. 15) or a second recess configured to receive the second protrusion. Outer section 285 may define the other of the second protrusion or the second recess.

[0130] In some examples, support portion 282 defines a protrusion configured to insert at least partially into entry passage 272 and / or receptacle 268 when insertion section 276 is positioned within outer section 274. In some examples, support portion 282 is configured to define at least some portion of boundary BE or entry passage 272 and / or boundary BP of receptacle 268 when insertion section 276 is positioned within outer section 274. For example, Insertion section 276 may define a first portion of boundary BE and / or boundary BP as a substantially open channel having an upper channel opening 284 defined by an upper surface 286 (FIG. 15) of insertion section 276 (upper surface 286 is depicted as a dashed line in FIG. 16). Support portion 282 may be configured to insert within upper channel opening 284 to define a second portion of boundary BE and / or boundary BP when insertion section 276 is positioned within outer section 274.

[0131] FIG. 17 is a cross-sectional end view of insertion portion 276 inserted into outer section recess 278, depicted with reference to the X-Y-Z axes shown (with the X axis proceeding into the page) and generally in accordance with a cutting plane G-G’ of FIG. 15 and FIG. 16. In FIG. 17, proximal direction P is into the page and distal direction D is out of the page. Cutting plane G-G’ is substantially parallel to the Y-Z plane of the X-Y-Z axes. Engagement portion 260 is positioned within receptacle 268 and member body 262 extends through entry passage 272 defined by boundary BE. Proximal portion housing 188 (e.g., insertion section 276) defines boundary BC of chamber opening 270 (FIGS 11-14). In FIG. 17, engagement portion 260 is depicted as behind boundary BC. Bearing surface 266 (FIG. 17) limits and or blocks movement of engagement portion 260 into entry passage 272, such that proximal portion 145 (e.g., proximal portion housing 188) transfers force F (FIG. 5) to engagement portion 260 when proximal portion 145 moves in the first direction (e.g., proximal direction P) relative to distal portion 147. Support portion 282 is depicted as a protrusion received by upper channel opening 284.

[0132] FIG. 18 is a cross-sectional end view of insertion portion 276 inserted into outer section recess 278, depicted with reference to the X-Y-Z axes shown (with the X axis proceeding out of the page) and generally in accordance with a cutting plane H-EF of FIG. 15 and FIG. 16. InDocket No: A0012371W001 / 2222-587W001FIG. 18, proximal direction P is out of the page and distal direction D is into the page. Cutting plane H-H’ is substantially parallel to the Y-Z plane of the X-Y-Z axes. In FIG. 17, engagement portion 260 is depicted in front of bearing surface 266 and boundary BC. Bearing surface 266 is configured such that engagement portion 260 may translate within receptacle 268 and relative to proximal portion 145 in the first direction (e.g., proximal direction P) when proximal portion 145 moves in the second direction (e.g., distal direction D) toward distal portion 147 (e.g., such that engagement portion 260 and proximal housing portion 190 (e.g., insertion section 276) define displacement D5 (FIG. 13, FIG. 14)).

[0133] FIG. 19 illustrates an example tether head 128. Tether head 128 may be configured to assume the engagement configuration (e.g., to engage IMD 102 (FIG. 3)) and assume the disengagement configuration to disengage from IMD 102. Tether head 128 may be configured to transition between the engagement configuration and the disengagement configuration when elongate body 34 exerts force F on tether head 128. Tether head 128 and the components discussed here are examples of a tether head which may be used by medical system 100. Medical system 100 may use other tether head assemblies having different components in other examples. In FIG. 19, elongate body 180 is shown in dashed lines and extends within tether lumen 172.

[0134] In examples, tether head 128 is configured to vary and / or alter one or more dimensions of a passageway 243 into an aperture 244 when tether head device transitions between the engagement configuration and the disengagement configuration. Tether head 128 may be configured to transition between the engagement configuration and the disengagement configuration when elongate body 180 exerts force F on tether head 128.

[0135] In examples, tether head 128 defines an aperture 244 to receive some portion of IMD 102 (e.g., a portion of an IMD retrieval structure 252 (FIG. 3)). Tether head 128 may be configured to define a passageway 243 leading to aperture 244, such that the portion of IMD 102 may be received within aperture 244 via passageway 243. Tether head 128 may be configured to vary a size of passageway 243 to engage with and / or disengage from IMD 102. For example, in an engagement configuration, tether head 128 may be configured to cause passageway 243 to be too narrow to permit the portion of IMD 102 (e.g., the portion of IMD retrieval structure 252) to pass through passageway 243, substantially preventing the portion of IMD 102 from exiting (and / or entering) aperture 244. In a disengagement configuration, tether head 128 may be configured to cause passageway 243 to be wider than in the engagement configuration, such that the portion of IMD 102 may pass through passageway 243 to exit (and / or enter) aperture 244. Hence, handle device 149 may cause tether head 128 to transition between the engagement configuration and the disengagement configuration using the exertion of force F on elongate body 180.Docket No: A0012371W001 / 2222-587W001

[0136] In examples, tether head 128 includes an engagement member 246 configured to increase and / or decrease a size of passageway 243 and / or aperture 244. Engagement member 246 may be configured to move relative to a body 248 of tether head 128 (“tether head body 248”) to increase and / or decrease a size of passageway 243 and / or aperture 244. For example, engagement member 246 may be configured to move in the proximal direction P relative to tether head body 248 to increase a size of passageway 243 and / or aperture 244. Engagement member 246 may be configured to move in the distal direction D relative to tether head body 248 to decrease a size of passageway 243 and / or aperture 244. In examples, handle assembly 143 (e.g., handle device 149) is configured to cause engagement member 246 to move relative to tether head body 248 to increase and / or decrease a size of passageway 243 and / or aperture 244. In examples, engagement member 246 and a portion of tether head body 248 define aperture 244.

[0137] In some examples, for example when tether distal portion 124 is coupled to tether head 128, tether head body 248 is configured to remain substantially stationary relative to a portion of tether distal portion 124 when engagement member 246 moves relative to tether head body 248. For example, tether head body 248 may be coupled to tether distal portion 124 substantially at tether distal end 125. Tether head body 248 may be configured to remain substantially stationary relative to a tether distal end 125 when engagement member 246 moves relative to tether head body 248. Tether head body 248 may be configured to remain substantially stationary relative to a tether distal end 125 when elongate body 180 exerts force F on tether head 128. In examples, tether body 122 is configured such that, when elongate body 180 exerts force F on tether head 128 (e.g., engagement member 246), tether distal end 125 exerts a substantially equal and opposite reaction force FR on tether head 128 (e.g., tether head body 248) to, for example, cause tether head body 248 to remain substantially stationary relative to tether distal end 125.

[0138] Tether head 128 may be configured to exert a torque on IMD 102 around a device axis LD (FIG. 3) when IMD 102 (e.g., IMD retrieval structure 252) is trapped within aperture 244. In examples, tether head 128 is configured to receive the torque from tether body 122 and transfer at least some portion of the torque to IMD 102. Tether body 122 may be configured to receive the torque (e.g., in first rotational direction W1 or second rotational direction W2) from handle device 149 (e.g., when handle device 149 is in the direct configuration or the second configuration). In examples, tether head 128 is configured to exert an axially directed force (e.g., in distal direction D or proximal direction P) on IMD 102 when IMD 102 (e.g., IMD retrieval structure 252) is trapped within aperture 244. In examples, tether head 128 is configured to receive the axially directed force from tether body 122 and transfer at least some portion of the axially directed force to IMD 102. Tether body 122 may be configured to receive the axiallyDocket No: A0012371W001 / 2222-587W001 directed force (from handle device 149 (e.g., when handle device 149 is in the direct configuration or the second configuration).

[0139] Referring largely to FIG. 3, receptacle wall 110 of device receptacle 108 may include a wall body 162 defining an outer surface 164 (“wall outer surface 164”) on a first side of wall body 162 and an inner surface 166 (“wall inner surface 166”) on a second side of wall body 162 opposite the first side of wall body 162. Wall inner surface 166 may define a boundary of receptacle volume 112. Delivery catheter body 148 may defines an outer surface 168 (“catheter outer surface 168”) on a first side of delivery catheter body 148 and an inner surface 170 (“catheter inner surface 170”) on a second side of delivery catheter body 148 opposite the first side of delivery catheter body 148. Catheter inner surface 170 may define a boundary of delivery lumen 118. In examples, device receptacle 108 (e.g., receptacle wall 110) is configured to define receptacle opening 109 at a distal end 111 of device receptacle 108 (“receptacle distal end 111”).

[0140] Wall outer surface 164 and at least some portion of catheter outer surface 168 are configured to be in fluidic communication with an external environment EO surrounding an exterior of device receptacle 108 and delivery catheter distal portion 114. For example, wall outer surface 164 and catheter outer surface 168 may be configured to be in fluid communication with a fluid environment within a chamber of heart 101 when device receptacle 108 and delivery catheter distal portion 114 are positioned (e.g., by a clinician) within heart 101. In examples, external environment EO comprises a fluid (e.g., blood of a patient). A clinician may cause IMD 102 to extend from and / or distal to receptacle opening 109 using tether system 120. The clinician may cause tether head 128 to disengage from IMD 102 (e.g., using handle assembly 143) and proximally withdraw delivery catheter 106 and tether system 120 through introducer 140. Tether body 122 may be of sufficient length such that a clinician may manipulate handle assembly 143 to advance tether head 128 distally through receptacle opening 109. In some examples, with tether head 128 outside of receptacle volume 112 (e.g., distal to receptacle opening 109), a clinician may cause tether head 128 to engage IMD 102. The clinician may then use tether system 120 (e.g., handle assembly 143 and / or conduction tether 121) to load IMD 102 within receptacle volume 112 via receptacle opening 109, and advance delivery catheter 106, with tether system 120 and IMD 102 therein, through introducer 140 and into the vasculature.

[0141] In some examples, medical system 100 (e.g., tether head 128) is configured to engage a proximal portion 250 of IMD 102 (“IMD proximal portion 250”). Tether head 122 may be configured to transfer a torque and / or a proximally directed or distally directed force to IMD 102. Tether body 122 may be configured to receive the torque and / or force (e.g., from a clinician) and transfer the torque and / or force to tether head 128. In examples, IMD proximal portion 190 includes a retrieval structure 252 (“IMD retrieval structure 252”). IMD retrieval structure 252Docket No: A0012371W001 / 2222-587W001 may be configured to engage with medical system 100 and / or another medical device to, for example, implant IMD 102 within an anatomical volume, retrieve IMD 102 from an anatomical volume, re-position IMD 102 within an anatomical volume, and / or re-orient IMD 102 within an anatomical volume. IMD 102 may include a distal portion 254 (“IMD distal portion 254”) opposite IMD proximal portion 250. In examples, IMD 102 (e.g., IMD distal portion 254) supports attachment member 132. In some examples, attachment member 132 is configured (e.g., as a helix) such that rotation of IMD 102 about a device axis LD defined by IMD 102 (e.g., defined by a housing 256 of IMD 102 (“IMD housing 256”)) causes attachment member to engage and / or disengage tissues within target site 104.

[0142] Medical system 100 (e.g., IMD 102) may be configured to use IMD processing circuitry 133 to sense an intrinsic electrical signal generated by heart 101 to, for example, assess electrical activity in proximity of IMD 102 (e.g., in proximity to attachment member 132), conduct pace mapping to determine a suitable placement of IMD 102, evaluate a suitability of pacing delivered by IMD 102 at a particular location, evaluate a position of IMD 102 during an implantation, evaluate a placement of a device electrode relative to a vessel wall, and / or for other reasons. In examples, IMD processing circuitry 133 is mechanically supported by IMD housing 256. IMD housing 256 may enclose IMD processing circuitry 133 and / or other circuitry of IMD 102. IMD housing 256 may be configured to fluidly isolate IMD processing circuitry 133 and / or other circuitry from an environment in contact with an exterior surface of IMD housing 256. In examples, IMD housing 256 is configured to hermetically seal an enclosure defined by IMD 102 and holding IMD processing circuitry 133 and / or other circuitry.

[0143] IMD housing 256 may be configured to define shapes that are easily accepted by the patient's body while minimizing patient discomfort. For example, IMD housing 256 may define a substantially cylindrical shape with cylindrical sidewalls. In other examples, IMD housing 256 may define substantially rectangular or other non-cylindrical shapes. IMD housing 256 may define shapes in which corners and edges are designed with relatively large radii, in order to present a housing having smoothly contoured exterior surfaces. In examples, attachment member132 is coupled to IMD housing 256. In examples, IMD distal portion 254 supports attachment member 132.

[0144] Electrodes 103, 105, 107 may be configured to communicate with processing circuitry (e.g., IMD processing circuitry 133 and / or other processing circuitry). IMD processing circuitry133 may be configured to process and / or condition a signal sensed by electrodes 103, 105, 107 and / or other electrodes within medical system 100. IMD 102 may comprise a pacemaker such as a leadless and / or wholly intracardiac pacemaker. One or more of electrodes 103, 105, 107 may be electrically connected to IMD processing circuitry 133. IMD processing circuitry 133 may beDocket No: A0012371W001 / 2222-587W001 operable connected to operating circuitry configured to deliver therapy to a patient and / or sense physiological signals of the patient using electrodes 103, 105, 107.

[0145] IMD processing circuitry 133 may include fixed function circuitry and / or programmable operating circuitry. In examples, IMD processing circuitry 133 includes circuitry configured to perform one or more functions of operating circuitry, such as therapy delivery circuitry, sensing circuitry, processing circuitry, switching circuitry, communication circuitry, and / or other circuitries. IMD processing circuitry 133, as well as other processors, operating circuitry, controllers, control circuitry, and the like, described herein, may include any combination of integrated circuitry, discrete logic circuity, analog circuitry, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), or field-programmable gate arrays (FPGAs). In some examples, IMD processing circuitry 133 includes multiple components, such as any combination of one or more microprocessors, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry, and / or analog circuitry.

[0146] Functions attributed to IMD processing circuitry 133 may be embodied as software, firmware, hardware or any combination thereof. IMD processing circuitry 133 may include, for instance, a variety of capacitors, transformers, switches, and the like configured to perform the functions of IMD processing circuitry 133. In examples, IMD processing circuitry 133 may be configured to communicate with another device, such as a patient input / output device, a clinician input / output device, and / or others. IMD processing circuitry 133 may include any suitable hardware, firmware, software or any combination thereof for communicating with another device. In addition, IMD processing circuitry 133 may communicate with a networked computing device and a computer network. In examples, IMD processing circuitry 133 and / or other circuitry of medical system 100 is configured to deliver stimulation signals to and / or receive sensing signals from electrodes 103, 105, 107 and / or other electrodes and / or sensors within medical system 100 or external to medical system 100. IMD processing circuitry 133 may be configured to provide electrical signals, e.g., pacing therapy, to electrodes 103. 105, 107 and / or other electrodes within medical system 100. IMD processing circuitry 133 may be configured to receive electrical signals, e.g., sensed cardiac electrical signals, from electrodes 103, 105, 107 and / or other electrodes within medical system 100.

[0147] Medical system 100 (e.g., processing circuitry 224) can also include memory configured to store program instructions, such as software, which may include one or more program modules, which are executable by IMD processing circuitry 133. The program instructions may be embodied in software and / or firmware. The memory can include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memoryDocket No: A0012371W001 / 2222-587W001(RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), ferroelectric RAM (FRAM), flash memory, or any other digital media. In some examples, the memory includes computer-readable instructions that, when executed by IMD processing circuitry 133 cause IMD processing circuitry 133 to perform various functions described herein and / or other functions of IMD processing circuitry 133.

[0148] As used here, when a first portion of a system (e.g., medical system 100) supports a second portion of the system, this means that when the second portion causes a first force to be exerted on the first portion, the first portion causes a second force to be exerted on the second portion in response to the first force. The first force and / or second force may be a contact force and / or an action-at-a-distance force. For example, first force and / or second force may be mechanical force, a magnetic force, a gravitational force, or some other type of force. The first portion of the system may be a portion of the system or a portion of a component of the system. The second portion of the system may be another portion of the system or another portion of the same component or a different component. In some examples, when the first portion of the system supports the second portion of the system, this may mean the second portion is mechanically supported by and / or mechanically connected to the first portion.

[0149] As used here, when a first portion of a system (e.g., medical system 100 and / or handle device 149) is substantially parallel to a second portion of or an axis defined by the system, this may mean the first portion is parallel or nearly parallel to the second portion or the axis to the extent permitted by manufacturing tolerances. In some examples, when the first portion is substantially parallel to the second portion or the axis, this may mean a first vector defined by the first component of the system defines an angle of less than 10 degrees, in some examples less than 5 degrees, and in some examples less than 1 degree, with a second vector defined by the second component or the axis. The first portion may be a first component of the system, a first axis and / or first vector defined by the first system, a first plane defined by the first system, a first area defined by the first system, and / or another portion of the first system. The second portion may be a second component of the system, a second axis and / or second vector defined by the second system, a second plane defined by the second system, a second area defined by the second system, and / or another portion of the second system.

[0150] A technique for conducting a signal to a receptacle volume of a receptacle device is illustrated in FIG. 20. Although the technique is described mainly with reference to medical system 100 of FIGS. 1-19, the technique may be applied to other medical systems in other examples.

[0151] The technique includes moving, relative to a distal portion 145, a proximal portion 147 from a first position to a second position (2002). In examples, a portion of proximal portionDocket No: A0012371W001 / 2222-587W001147 (e.g., stop member 232) moves from a blocked position to a clearance position relative to distal portion 145 when proximal portion 147 moves from the first position to the second position. In examples, stop member 232 moves from the blocked position to the clearance position relative to a boundary portion 224 defined by distal portion 145 when proximal portion 147 moves from the first position to the second position. In examples, proximal portion 147 (e.g., proximal portion housing 190) rotates about a longitudinal axis L relative to distal portion 145 (e.g., distal portion housing 188) when proximal portion 147 moves relative to distal portion 145. In some examples, the technique includes moving proximal portion 145 toward distal portion 147 to move proximal portion 147 from the first position to the second position. In examples, an engagement portion 260 of an elongate body 180 translates relative to proximal portion 145 and within an receptacle 268 when proximal portion 145 moves toward distal portion 147.

[0152] The technique includes exerting a force F, using proximal portion 147, on elongate body 180 coupled to proximal portion 147 when proximal portion 147 moves relative to distal portion 145 (2004). In examples, proximal portion 147 moves (e.g., axially translates substantially parallel to longitudinal axis L) within a clearance gap 226 defined by a boundary portion 224. In examples, distal portion 145 supports and / or defines boundary portion 224. Boundary portion 224 may limit movement of proximal portion 147 (e.g., stop member 232) within clearance gap 226 when proximal portion 147 is in the first position. Boundary portion 224 may permit movement of proximal portion 147 (e.g., stop member 232) within clearance gap 226 when proximal portion 147 is in the second position. In some examples, the movement of proximal portion 147 (e.g., the axial translation) causes proximal portion 147 to exert force F on elongate body 180. In some examples, a bearing surface 266 defines some portion of receptacle 268 transfers force F from proximal portion 145 to elongate body 180.

[0153] Elongate body 180 may transfer force F to a tether head 128. In examples, tether head 128 transitions between an engagement configuration wherein tether head 128 is configured to engage IMD 102 and a disengagement configuration wherein tether head 128 is configured to disengage from IMD 102. In examples, elongate body 180 axially translates within a tether lumen 172 when elongate body 180 transfers force F to tether head 128. Tether head 128 may alter a size of aperture 244 when elongate body 180 transfers force F to tether head 128. In examples, engagement member 246 moves relative to tether head body 248 when elongate body 180 transfers force F to tether head 128.

[0154] In examples, an elastic member 245 exerts a member force FM on proximal portion 147 (e.g., on stop member 232). Elastic member 245 may exert member force FM on proximal portion 147 when proximal portion 147 is in the first position and / or the second position. Elastic member 245 may exert member force FM on proximal portion 147 when stop member 232 is inDocket No: A0012371W001 / 2222-587W001 the blocked position and / or in the clearance position. In examples, elastic member 245 is configured to exert member force FM on proximal portion 147 to cause proximal portion 147 to axially translate (e.g., over distance DI) within clearance gap 226. In examples, member force FM causes flange surface 234, 235 to contact (e.g., to seat on) boundary portion 224 (e.g., first component 228 and / or second component 230) when proximal portion 147 is in the first position (e.g., when stop member 232 is in the blocked position). In some examples, member force FM causes second flange surface 238 contact (e.g., to seat on) boundary portion 224 (e.g., first component 228 and / or second component 230) when proximal portion 147 is in the second position (e.g., when stop member 232 is in the clearance position).

[0155] Various examples of the disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other examples are within the scope of the following claims.

Claims

Docket No: A0012371W001 / 2222-587W001WHAT IS CLAIMED IS:

1. An assembly for a medical system comprising: a distal portion defining a boundary portion, the boundary portion defining a clearance gap; a proximal portion defining a stop member at a distal section of the proximal portion, wherein the stop member is configured to position in a blocked position relative to the boundary portion when the proximal portion is positioned in a first position relative to the distal portion, wherein the stop member is configured to position in a clearance position relative to the boundary portion when the proximal portion is positioned in a second position relative to the distal portion, and wherein the boundary portion is configured to limit movement of the stop member within the clearance gap in a first direction when the stop member is in the blocked position and configured to permit movement of the stop member within the clearance gap in the first direction when the stop member is in the clearance position; and an elongate body configured to couple to the proximal portion and extending substantially in a second direction opposite the first direction, wherein the proximal portion is configured to exert a force in the first direction on the elongate body when the stop member moves within the clearance gap.

2. The assembly of claim 1, wherein the proximal portion is configured to rotate relative to the distal portion about a longitudinal axis extending through the distal portion and the proximal portion when the proximal portion transitions between the first position and the second position.

3. The assembly of claim 1 or claim 2, further comprising an elastic member configured to exert a member force on the proximal portion in the first direction, wherein the elastic member is configured to exert the member force when the stop member is in at least one of the blocked position or the clearance position.

4. The assembly of claim 3, wherein the proximal portion is configured to transfer at least a portion of the member force to the elongate body to exert the force in the first direction on the elongate body.Docket No: A0012371W001 / 2222-587W0015. The assembly of claim 3 or claim 4, wherein the elastic member is supported by one of the distal portion or the proximal portion.

6. The assembly of any of examples 1-5, further comprising a connecting member defining a first portion of the connecting member coupled to a second portion of the connecting member, wherein the first portion is coupled to the proximal portion and the second portion is coupled to the distal portion, and wherein at least one of: the first portion is configured to decouple from the proximal portion when a handling force greater than a threshold force is applied to one or the proximal portion or the distal portion to cause the proximal portion to transition from the first position to the second position, or the second portion is configured to decouple from the distal portion when the handling force greater than the threshold force is applied to the one or the proximal portion or the distal portion to cause the proximal portion to transition from the first position to the second position.

7. The assembly of any of examples 1-6, further comprising a locking device configured to be placed in a locked orientation relative to at least one of the proximal portion or the distal portion and configured to be placed in an unlocked orientation relative to the at least one of the proximal portion or the distal portion, the locking device configured to prevent the proximal portion from transitioning from the first position to the second position in the locked orientation and configured to allow the proximal portion to transition from the first position to the second position in the unlocked configuration.

8. The assembly of example 7, wherein the locking device is configured to engage the proximal portion and the distal portion in the locked orientation, and wherein the locking device is configured to separate from the proximal portion and the distal portion when the locking device is in the unlocked configuration.

9. The assembly of any of claims 1-8, wherein the stop member defines at least one flange surface configured to engage the boundary portion to limit the movement of the stop member within the clearance gap in the first direction.Docket No: A0012371W001 / 2222-587W00110. The assembly of claim 9, wherein the at least one flange surface includes a first flange surface configured to engage the boundary portion when the stop member is in the blocked position to cause the boundary portion to limit movement of the stop member within the clearance gap in the first direction when the stop member is in the blocked position.

11. The assembly of claim 10, wherein the first flange surface is configured to displace from the boundary portion to allow the movement of the stop member within the clearance gap in the first direction when the stop member transitions from the blocked position to the clearance position.

12. The assembly of claim 11, wherein the first flange surface is configured to displace from the boundary portion in the second direction when the proximal portion moves in the second direction relative to the distal portion, and wherein at least one of the first flange surface or the boundary portion us configured to limit the stop member from transitioning from the blocked position to the clearance position until the flange surface displaces from the boundary portion in the second direction.

13. The assembly of any of claims 9-12, wherein the at least one flange surface includes a second flange surface configured to engage the boundary portion when the stop member is in the clearance position to limit the movement of the stop member within the clearance gap.

14. The assembly of any of claims 9-13, wherein the proximal portion is configured to transfer a second portion of the member force to the at least one flange when the proximal portion transfers the first portion of the member force to the elongate body.

15. The assembly of any of claims 1-14, wherein the distal portion comprises a housing defining an inner volume, wherein the housing supports the boundary portion, and wherein the stop member extends into the inner volume.

16. The assembly of any of claims 1-15, wherein the housing defines an opening which opens into a passage extending through the housing and into the inner volume, wherein the elongate body extends through the opening and into the inner volume.Docket No: A0012371W001 / 2222-587W00117. The assembly of any of claims 1-16, wherein the proximal portion includes one or more gripping portions configured to allow a clinician or other person to exert the handling force on the proximal portion to cause the proximal portion to transition from the first position to the second position.

18. The assembly of any of claims 1-17, further comprising a tether system including a tether head, wherein the elongate body is configured to transfer the force in the first direction to the tether head, wherein the tether head is configured to maintain a coupling of the tether head and a medical device in an engagement configuration, wherein the tether head is configured to allow a decoupling of the tether head and the medical device in a disengagement configuration, and wherein the tether head is configured to either transition from the engagement configuration to the disengagement configuration or transition from the disengagement configuration to the engagement configuration when the elongate body transfers the force in the first direction to the tether head.

19. The assembly of claim 18, wherein the tether system includes a tether body defining a lumen, wherein the elongate body is configured to extend through the lumen, and wherein the elongate body is configured to slidably translate within the lumen.

20. The assembly of claim 17 or claim 18, wherein a distal body portion of the tether body is coupled to the tether head and a proximal body portion of the tether body is coupled to the distal portion.

21. The assembly of any of claims 18-21, further comprising a delivery catheter defining a delivery catheter lumen and a device receptacle defining a receptacle volume configured to hold the medical device, wherein the tether body is configured to extend through the delivery catheter lumen when the tether head is positioned within the receptacle volume.

22. An assembly for a medical system comprising: a distal portion of a handle; a proximal portion of a handle, wherein the proximal portion is configured to move in a first direction relative to the distal portion and configured to move in a second direction relativeDocket No: A0012371W001 / 2222-587W001 to the distal portion, wherein the second direction is substantially opposite the first direction, and wherein the proximal portion includes a housing defining a receptacle; and an elongate body including an engagement portion configured to position within the receptacle when the elongate body extends substantially in the second direction from the receptacle, wherein the engagement portion is configured to translate within the receptacle in the first direction relative to the proximal portion when the proximal portion translates in the second direction relative to the distal portion, and wherein the proximal portion is configured to exert a force in the first direction on the engagement portion when the proximal portion translates in the first direction relative to the distal portion.

23. The assembly of claim 22, wherein the engagement portion is configured to engage the housing when the proximal portion moves in the first direction relative to the distal portion.

24. The assembly of claim 23 or claim 24, wherein the elongate body includes a member body coupled to the engagement portion, wherein the member body is configured to extend substantially in the second direction from the receptacle when the engagement portion positions in the receptacle.

25. The assembly of claim 24, wherein the engagement portion is configured to transfer the force in the first direction to the member body when the housing imparts the force in the first direction on the engagement portion.

26. The assembly of claim 24 or claim 25, wherein the housing defines a longitudinal axis substantially parallel to the first direction and the second direction, wherein the member body defines a member dimension substantially perpendicular to a longitudinal axis defined by the housing and the engagement portion defines an engagement dimension substantially perpendicular to the longitudinal axis, wherein the engagement dimension is greater than then member dimension.

27. The assembly of claim 26, wherein the longitudinal axis is substantially parallel to or substantially coincident with at least one of the first direction or the second direction.Docket No: A0012371W001 / 2222-587W00128. The assembly of any of claims 24-27, wherein the housing defines a chamber opening which opens into the receptacle, wherein the chamber opening is configured to limit movement of the engagement portion through the chamber opening in at least the second direction relative to the housing when the proximal portion moves in the first direction relative to the distal portion, and wherein the chamber opening is configured to allow passage of the member body through the chamber opening in at least the first direction relative to the housing when the proximal portion moves in the second direction relative to the distal portion.

29. The assembly of claim 28, wherein the chamber opening opens from an entry passage defined by the housing to the receptacle, wherein the entry passage is configured to allow passage of the member body through the entry passage in at least the first direction relative to the housing when the proximal portion moves in the second direction relative to the distal portion.

30. The assembly of any of claims 22-29, wherein the proximal portion includes an outer section defining an outer section recess and an insertion section configured to insert within the outer section recess, wherein the insertion section is configured to define a least a portion of a boundary defining the receptacle when the insertion section inserts within the outer section recess.

31. The assembly of claim 30, wherein the insertion section is configured to define at least a portion of a passage boundary defining the entry passage when the insertion section inserts within the outer section recess.

32. The assembly of claim 30 or claim 31, wherein the outer section defines one of a protrusion or a recess and the insertion section defines the other of the recess or the protrusion, wherein the recess is configured to receive the protrusion when the insertion section inserts within the outer section recess.

33. The assembly of claim 32, wherein at least one of the protrusion or the recess is configured to limit rotation of insertion portion relative to the outer section when the recess receives the protrusion.

34. The assembly of any of claims 22-33, wherein:Docket No: A0012371W001 / 2222-587W001 the distal portion defines a boundary portion, the boundary portion defining a clearance gap; the proximal portion defines a stop member at a distal section of the proximal portion, wherein the stop member is configured to position in a blocked position relative to the boundary portion when the proximal portion is positioned in a first position relative to the distal portion, wherein the stop member is configured to position in a clearance position relative to the boundary portion when the proximal portion is positioned in a second position relative to the distal portion, wherein the boundary portion is configured to limit movement of the stop member within the clearance gap in a first direction when the stop member is in the blocked position and configured to permit movement of the stop member within the clearance gap in the first direction when the stop member is in the clearance position, and wherein the proximal portion is configured to exert the force in the first direction on the engagement portion when the stop member moves within the clearance gap.

35. The assembly of claim 34, wherein the engagement portion is configured to translate within the receptacle in the first direction relative to the proximal portion when the stop member moves relative to boundary portion in the second direction.

36. The assembly of claim 34 or claim 35, wherein the proximal portion is configured to rotate relative to the distal portion about the longitudinal axis of claim 26, wherein the longitudinal axis of claim 26 extends the through the distal portion when the proximal portion transitions between the first position and the second position.

37. The assembly of any of claims 34-36, further comprising an elastic member configured to exert a member force on the proximal portion in the first direction, wherein the elastic member is configured to exert the member force when the stop member is in at least one of the blocked position or the clearance position.

38. The assembly of claim 37, wherein the elastic member is supported by one of the distal portion or the proximal portion.Docket No: A0012371W001 / 2222-587W00139. The assembly of any of examples 34-38, further comprising a connecting member defining a first portion of the connecting member coupled to a second portion of the connecting member, wherein the first portion is coupled to the proximal portion and the second portion is coupled to the distal portion, and wherein at least one of: the first portion is configured to decouple from the proximal portion when a handling force greater than a threshold force is applied to one or the proximal portion or the distal portion to cause the proximal portion to transition from the first position to the second position, or the second portion is configured to decouple from the distal portion when the handling force greater than the threshold force is applied to the one or the proximal portion or the distal portion to cause the proximal portion to transition from the first position to the second position.

40. The assembly of any of examples 34-39, further comprising a locking device configured to be placed in a locked orientation relative to at least one of the proximal portion or the distal portion and configured to be placed in an unlocked orientation relative to the at least one of the proximal portion or the distal portion, the locking device configured to prevent the proximal portion from transitioning from the first position to the second position in the locked orientation and configured to allow the proximal portion to transition from the first position to the second position in the unlocked configuration.

41. The assembly of any of claims 34-40, wherein the stop member includes a first flange surface configured to engage the boundary portion when the stop member is in the blocked position to cause the boundary portion to limit movement of the stop member within the clearance gap in the first direction when the stop member is in the blocked position, wherein the first flange surface is configured to displace from the boundary portion to allow the movement of the stop member within the clearance gap in the first direction when the stop member transitions from the blocked position to the clearance position, and wherein the engagement portion is configured to translate within the receptacle relative to the proximal portion when the first flange surface displaces from the boundary portion.Docket No: A0012371W001 / 2222-587W00142. The assembly of claim 41, wherein the stop member includes a second flange surface configured to engage the boundary portion when the stop member is in the clearance position to limit the movement of the stop member within the clearance gap.

43. The assembly of any of claims 22-42, wherein the distal portion comprises a distal housing defining an inner volume, wherein the distal housing supports the boundary portion, and wherein the stop member extends into the inner volume.

44. The assembly of any of claims 22-43, wherein the proximal portion includes one or more gripping portions configured to allow a clinician or other person to exert a handling force on the proximal portion to cause the proximal portion to transition from the first position to the second position.

45. The assembly of any of claims 22-44, further comprising a tether system including a tether head, wherein the elongate body is configured to transfer the force in the first direction to the tether head, wherein the tether head is configured to maintain a coupling of the tether head and a medical device in an engagement configuration, wherein the tether head is configured to allow a decoupling of the tether head and the medical device in a disengagement configuration, and wherein the tether head is configured to either transition from the engagement configuration to the disengagement configuration or transition from the disengagement configuration to the engagement configuration when the elongate body transfers the force in the first direction to the tether head.

46. The assembly of claim 45, wherein the tether system includes a tether body defining a lumen, wherein the elongate body is configured to extend through the lumen, and wherein the elongate body is configured to slidably translate within the lumen.

47. The assembly of claim 45 or claim 46, wherein a distal body portion of the tether body is coupled to the tether head and a proximal body portion of the tether body is coupled to the distal portion.Docket No: A0012371W001 / 2222-587W00148. The assembly of any of claims 22-47, further comprising a delivery catheter defining a delivery catheter lumen and a device receptacle defining a receptacle volume configured to hold the medical device, wherein the tether body is configured to extend through the delivery catheter lumen when the tether head is positioned within the receptacle volume.

49. An assembly for a medical device comprising: a distal portion defining a boundary portion; a proximal portion configured to rotate relative to the distal portion about a longitudinal axis defined by the distal portion; an elongate body coupled to the proximal portion, wherein the proximal portion is configured to exert a force in a proximal direction on the elongate body when the proximal portion rotates relative to the distal portion; and a tether head configured to receive the force from the elongate body, wherein the tether head is configured to engage an implantable medical device in an engagement configuration and configured to disengage from the implantable medical device in the disengagement configuration, and wherein the tether head is configured to transition between the engagement configuration and the disengagement configuration when the tether head receives the force; and a tether including a tether body, wherein the tether body defines a proximal tether portion coupled to the distal portion and a distal tether position coupled to the tether head, wherein the tether body defines a tether lumen extending from the proximal tether portion to the distal tether portion, and wherein the elongate body is configured to extend through the tether lumen when the tether head receives the force.

50. The assembly of claim 49, wherein the distal portion defines a boundary portion defining a clearance gap; wherein the proximal portion defines a stop member, wherein the stop member is configured to position in a blocked position relative to the boundary portion, wherein the stop member is configured to position in a clearance position relative to the boundary portion when the proximal portion is rotated relative to the distal portion, andDocket No: A0012371W001 / 2222-587W001 wherein the boundary portion is configured to limit movement of the stop member within the clearance gap in a first direction when the stop member is in the blocked position and configured to permit movement of the stop member within the clearance gap in the first direction when the stop member is in the clearance position.

51. The assembly of claim 50, further comprising an elastic member configured to exert a member force on the proximal portion to cause the proximal portion to engage the boundary portion when the stop member is in the blocked position and when the stop member is in the clearance position.

52. A method, comprising: moving, relative to a distal portion of a handle device, a proximal portion of the handle device from a first position to a second position, wherein the distal portion defines a boundary portion defining a clearance gap, wherein the boundary portion is configured to limit movement of the proximal portion through the clearance gap when the proximal portion is in the first position and configured to permit movement of the proximal portion within the clearance gap when the proximal portion is in the second position; and exerting a force, using the proximal portion, on an elongate body coupled to the proximal portion when the proximal portion moves within the clearance gap.

53. The method of claim 52, further comprising rotating the proximal portion relative to the distal portion to move the proximal portion relative to the distal portion.

54. The method of claim 53, further exerting the force on the elongate body in a proximal direction by axially translating the proximal portion in the proximal direction relative to the distal portion.

55. The method of claim 54, further comprising exerting, using an elastic member, a member force on the proximal portion to cause the proximal portion to axially translate in the proximal direction relative to the distal portion.

56. The method of claim 55, further comprising transferring, using the proximal portion, at least a portion of the member force to the elongate body.

57. The method of any of claims 52-56, further comprising:Docket No: A0012371W001 / 2222-587W001 transferring, using the elongate body, the force to a tether head; and transitioning, using the force, the tether head between an engagement configuration and a disengagement configuration, wherein the tether head is configured to engage an implantable medical device in the engagement configuration and configured to disengage from the implantable medical device in the disengagement configuration.

58. The method of any of claims 52-57, further comprising decoupling a connecting member from one of the distal portion or the proximal portion when the proximal portion moves from the first position to the second position, wherein the connecting member is coupled to the distal portion and the proximal portion when the proximal portion is in the first position.

59. The method of any of claims 52-58, further comprising exerting a handling force on one or more gripping portions of the proximal portion to cause the proximal portion to transition from the first position to the second position.

60. The method of any of claims 52-59, further comprising translating, using the force, the elongate body relative to a tether body when the proximal portion exerts the force on the elongate body, wherein the tether body is coupled to the distal portion and coupled to the tether head, and wherein the elongate body extends through a lumen defined by the tether body.

61. The method of any of claims 57-60, further comprising engaging, using the tether head, the implantable medical device when the implantable medical device is positioned within a receptacle volume of a receptacle device supported by a delivery catheter, wherein the tether body extends through catheter lumen defined by the delivery catheter.

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