Tether assembly for medical device delivery system

Abstract

A tether handle assembly comprising: a first element coupled to a proximal end of a pull shaft and comprising: an elongate body; one or more first features; and a second element configured to hold the elongate body, the second element comprising: a housing defining a recess; and one or more second features disposed within the recess, wherein the first element is configured to rotate to transition between a locked orientation and an unlocked orientation, wherein when in the locked orientation, the one or more first features are configured to interface with the one or more second features to inhibit movement of the first element relative to the second element, wherein when in the unlocked orientation, the first element is configured to move relative to the second element along the longitudinal axis and apply a force along the pull shaft.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 594,611, filed October 31, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates generally to medical devices, and more specifically to systems for delivering medical devices. Background Technology

[0003] Some types of implantable medical devices (IMDs), such as pacemakers or implantable cardioverter-defibrillator systems, can be used to provide cardiac sensing and therapy to a patient via one or more electrodes. As an example, some IMDs include an implantable pulse generator comprising a housing enclosing electronic components, which can be configured for subcutaneous implantation in a patient's chest or within a chamber of the patient's heart. IMDs with a pulse generator configured for implantation within a chamber of the heart can be referred to as intracardiac devices or leadless implantable medical devices. Medical device delivery systems including delivery catheters can be used to deliver intracardiac devices intravenously to the implantation site within the patient's heart and release the device after it has been secured at the implantation site. The medical device delivery system can then be withdrawn from the patient. Summary of the Invention

[0004] Generally, this disclosure relates to systems, apparatus, and methods for inserting a medical device into a patient via a medical device delivery system. The medical device delivery system may include a tether assembly comprising a tether handle assembly and a tether head assembly. The tether head assembly and the tether handle assembly may be coupled via a pull shaft. A medical device (e.g., an intracardiac device) may be releasably coupled to the tether head assembly. A clinician may actuate the tether handle assembly to release the medical device, for example, within the patient's body. The tether handle assembly described herein may include a first element configured to engage with a second element. A clinician may manipulate the first element to hold or release the medical device using the tether handle assembly. The clinician may rotate the first element relative to the second element from a locked orientation to an unlocked orientation and move the first element in the unlocked orientation to manipulate the tether head assembly to release or hold the medical device.

[0005] The apparatus, systems, and methods described herein offer several advantages over other tether assemblies used in medical device delivery systems. The tether assemblies described herein require a clinician to manipulate the tether handle assembly with two separate movements to release the medical device (e.g., by rotating the first element to the unlocking orientation and by moving the first element in the unlocking orientation). This requirement for two separate movements prevents accidental release of the medical device from the patient's medical device delivery system and simplifies the release process. In some examples described herein, features on the first and second elements of the tether handle assembly limit the range of movement and / or rotation of the first element relative to the second element, which facilitates consistent and repeatable movement of the first element relative to the second element to manipulate the tether head assembly. In some examples, the limitation of the range of rotation reduces the torque applied from the tether handle assembly to the tether head assembly, thereby suppressing torsion of the tether assembly.

[0006] In some examples, this disclosure describes a tether assembly for a medical device delivery system, the tether assembly including: a tether head assembly; and a tether handle assembly connected to the tether head assembly via a pull shaft, the tether handle assembly including: a first element connected to a proximal end of the pull shaft, the first element including: a movable body; one or more first features disposed on the movable body of the first element; and a second element configured to retain at least a portion of the movable body of the first element, the second element including: a housing defining a recess sized to receive at least a portion of an elongated body. A portion; and one or more second features disposed within a recess, wherein a first element is configured to rotate about a longitudinal axis of the tether handle assembly to switch between a locking orientation and an unlocking orientation, wherein when the first element is in the locking orientation relative to a second element, the one or more first features are configured to engage with the one or more second features to inhibit movement of the first element relative to the second element along the longitudinal axis, wherein when the first element is in the unlocking orientation relative to the second element, the first element is configured to move relative to the second element along the longitudinal axis and apply force along a pull axis, and wherein the tether head assembly is configured to release the medical device in response to a force along the pull axis.

[0007] In some examples, this disclosure describes a method comprising: advancing a tether head assembly of a tether assembly and a medical device to a target location within a patient's body lumen, wherein an attachment member of the medical device is held between an outer retainer and an inner retainer of the tether head assembly; implanting the medical device into tissue at the target location in the patient; rotating a first element of a tether handle assembly relative to a second element of the tether handle assembly from a locked orientation to an unlocked orientation, wherein the tether handle assembly is coupled to the tether head assembly via a pull shaft, wherein at least a portion of a movable body of the first element is disposed within a recess defined by a housing of the second element, and wherein one or more first features disposed on the movable body abut against one or more second features within the recess to inhibit movement of the first element relative to the second element along a longitudinal axis of the tether handle assembly when the first element is in the locked orientation; and retracting the first element proximally relative to the second element along the longitudinal axis when the first element is in the unlocked orientation, such that the pull shaft retracts the inner retainer proximally and releases the attachment member from the tether head assembly.

[0008] In some examples, this disclosure describes a tether handle assembly comprising: a first element coupled to a proximal end of a pull rod, the first element including: a movable body; one or more first features disposed on the movable body; and a second element configured to retain at least a portion of the movable body of the first element, the second element including: a housing defining a recess sized to receive the at least a portion of the movable body; and one or more second features disposed within the recess, wherein the first element is configured to rotate about a longitudinal axis to switch between a locking orientation and an unlocking orientation, wherein when the first element is in the locking orientation relative to the second element, the one or more first features are configured to abut against the one or more second features to inhibit movement of the first element relative to the second element along the longitudinal axis of the tether handle assembly, wherein when the first element is in the unlocking orientation relative to the second element, the first element is configured to move relative to the second element along the longitudinal axis and apply a proximal force along the pull rod.

[0009] The present invention is intended to provide an overview of the subject matter described herein. It is not intended to provide an exclusive or exhaustive interpretation of the devices and methods described in detail in the following drawings and description. Further details of one or more examples are set forth in the following drawings and description. Attached Figure Description

[0010] Figure 1 This is a conceptual diagram illustrating a portion of the patient's anatomy, including potential implantation sites for implantable medical devices (IMDs).

[0011] Figure 2 This is a conceptual diagram illustrating an example medical device delivery system for delivering an IMD to a location within the heart.

[0012] Figure 3A This is an example Figure 2 A conceptual diagram of an example tether head assembly for an example medical device delivery system.

[0013] Figure 3B This is an example Figure 3A A cross-sectional view of an example tether head assembly, the cross-section being along... Figure 3A The line AA was intercepted.

[0014] Figure 4 This is an example Figure 3A A cross-sectional view of an example tether head assembly, with the inner retainer of the tether head assembly in the retracted position, the cross-section being along... Figure 3A The line AA was intercepted.

[0015] Figure 5 This is an example Figure 3A A cross-sectional view of an example tether head assembly, wherein the inner retainer of the tether head assembly is in the extended position, the cross-section being along... Figure 3A The line AA was intercepted.

[0016] Figure 6A This illustrates a locked orientation. Figure 2 A conceptual diagram of an example tethered handle assembly for an example medical device delivery system.

[0017] Figure 6B This is an example Figure 6A A conceptual diagram of the first component of the tethered handle assembly.

[0018] Figure 7A This is an example Figure 6A A cross-sectional view of the tether handle assembly, the cross-section being along... Figure 6A The line BB was cut off.

[0019] Figure 7B This is an example Figure 6A A cross-sectional view of another example of a tethered handle assembly, the cross-section being along... Figure 6A The line BB was cut off.

[0020] Figure 8A This illustrates the unlocking orientation. Figure 6A Conceptual diagram of the tether handle assembly.

[0021] Figure 8B This is an example Figure 8A A conceptual drawing of the front view of the tether handle assembly.

[0022] Figure 9A This illustrates the unlocked orientation and the distal position. Figure 6A A cross-sectional view of the tether handle assembly, the cross-section being along... Figure 6A The line BB was cut off.

[0023] Figure 9B This illustrates the unlocked orientation and the proximal position. Figure 6A A cross-sectional view of the tether handle assembly, the cross-section being along... Figure 6A The line BB was cut off.

[0024] Figure 9C This illustrates a locked orientation and a proximal position. Figure 6A A cross-sectional view of the tether handle assembly, the cross-section being along... Figure 6A The line BB was cut off.

[0025] Figure 10 This is an example of the process. Figure 2 The flowchart illustrates an example process of a medical device delivery system implanting a medical device into a patient.

[0026] Figure 11 This illustrates the operation of a tethered handle assembly via a medical device delivery system. Figure 2 A flowchart illustrating an example process for the tethered head assembly of a medical device delivery system. Detailed Implementation

[0027] Generally, this disclosure describes an example medical device delivery system. Such a medical device delivery system may include a tether assembly comprising a tether head assembly, a tether handle assembly, and a pull shaft (e.g., a pull cable). The tether head assembly is attached to the pull shaft and configured to releasably retain an attachment member of a medical device (e.g., an intracardiac device). In some examples, the tether handle assembly is configured to retain the pull shaft attached to the tether head assembly. The tether handle assembly may include an actuator configured to transmit force through the pull shaft to the tether head assembly and to remove the attachment member of the medical device from the tether head assembly at a treatment site within the patient's body. Although the example tether assemblies are generally described herein as being configured for delivery of implantable medical devices (IMDs), it should be understood that any of the example tether assemblies described herein may alternatively be configured for delivery of other types of medical devices.

[0028] Figure 1This is a conceptual diagram illustrating a portion of the patient's anatomy, showing potential implantation sites for an IMD. For example, the IMD could be implanted on or within the patient's heart 100, such as within an appendage 102 in the right atrium (RA), within the coronary vein (CV) via the coronary sinus ostium (CSOS), or near the apex 104 of the right ventricle (RV). In other examples, the IMD could be implanted in other locations within the heart 100 or in locations other than the heart 100, such as any suitable implantation site within the patient's body.

[0029] Figure 2 This example illustrates how to use IMD ( Figure 1 A plan view of an example medical device delivery system 202 (not shown) for delivery to a location within the heart 100. Although described herein in the context of delivering an IMD to a vascular system such as the heart 100, the devices, systems, and techniques disclosed herein can be used to deliver an IMD to any anatomical location.

[0030] System 202 includes a guide 204, a delivery catheter 206, and a tether assembly 216. The guide 204 is an elongated member defining an internal lumen. The guide 204 is configured, as if inserted by a physician into a patient's vascular system, to provide a rigid passage through the internal lumen through which a medical device, apparatus, or other therapy is inserted.

[0031] The delivery catheter 206 is configured to be inserted through the lumen of the guide 204 to deliver IMD within a vascular system. The delivery catheter 206 includes an elongated shaft 212, a handle 208, and a device cup 210. As an example, the handle 208 is located at the proximal end of the shaft 212 and may include one or more elements (such as a button, switch, etc.) configured to control movement of the distal end of the shaft 212 and release of the IMD from the device cup 210.

[0032] Device cup 210 is positioned at the distal end of shaft 212. Device cup 210 includes a hollow cylindrical body configured to receive and support the IMD when it is implanted into a patient's vascular system. For example, a physician may insert the distal end of a delivery catheter 206, including device cup 210, through the lumen of a guide 204 placed within the patient's vascular system. Once device cup 210 has extended through the distal end of guide 204 and reached the implantation site in the patient, the physician may release the IMD from the distal opening 214 of device cup 210 and withdraw the delivery catheter 206 proximally through guide 204.

[0033] A tether assembly 216 extends through a delivery conduit defined by an inner lumen, which includes, for example, a handle 208 and a shaft 212. The tether assembly 216 includes an elongated body 220, a tether handle assembly 218 at a proximal end of the elongated body 220, and a tether head assembly at a distal end of the elongated body 220. Figure 2 (Not shown in the image). Pull shaft ( Figure 2 (Not shown) can extend from the tether handle assembly 218 to the tether head assembly through an inner cavity defined by the elongated body 220.

[0034] The tether assembly 216 may be long enough for a clinician to manipulate the tether handle assembly 218 to advance the tether head assembly beyond the distal opening 214 of the cup 210. As described herein, in some examples, with the tether head assembly outside the cup 210, the clinician may attach the IMD to the tether head assembly. The clinician can then load the IMD into the cup 210 through the distal opening 214 and advance the delivery catheter 206 through the guide 204 and into the vascular system using the tether assembly 216 and the IMD therein.

[0035] Figure 3A This is an example Figure 2 A conceptual diagram of the example tether head assembly 302 of system 202. Figure 3A The distal portion 216A of the tether assembly 216 is illustrated, wherein the components of the tether assembly 216 are in an assembled configuration, including a tether head assembly 302 at the distal end of the tether assembly 216 along the longitudinal axis 301. An elongated body 220 may include a shaft defining an inner cavity (not shown) in which a portion of a pull shaft 310 is received. The tether head assembly 302 may include an inner retainer 318, an outer retainer 320, and a sheath 302. The components of the tether assembly 216 may be individually formed from any suitable material. In some examples, one or more of the pull shaft 310, inner retainer 318, outer retainer 320, sheath 312, and / or one or more layers of the elongated body 220 may be formed from a conductive material, which can facilitate testing of the placement of the IMD during procedures used to deliver the IMD. One or more components of the tether assembly 216 may be manufactured using techniques such as metal injection molding or any other suitable technique.

[0036] The inner retainer 218 can be coupled to the pull shaft 310 and extends distally from the distal end of the pull shaft 310. The distal portion of the outer retainer 320 defines an orifice including a container and a passage, the container being sized to receive the attachment member of the IMD. The passage can extend proximally from the distal end defined by the outer retainer 320 to the container and can be narrower than the container.

[0037] The proximal portion of the outer retainer 320 may define a channel configured to receive the inner retainer 318. The inner retainer 318 may be received within the outer retainer 320 in a first position, in which the distal portion of the inner retainer 318 extends into the channel, such as... Figure 3A As shown. When the internal retainer 318 is in the first position (which may be referred to herein as the “extended position”), the size of the passage can be set to prevent the attachment member of the IMD from passing through the passage (e.g., the passage is too narrow to allow the attachment member to pass through).

[0038] Proximal movement of the pull shaft 310 can move the inner retainer 36 from a first position to a second position (which may alternatively be referred to herein as the "retracted position"), in which the inner retainer 318 does not extend into the passage. Alternatively, applying force to the inner retainer 318 (e.g., the distal end of the inner retainer 318) via an attachment member can move the inner retainer 318 from the first position to the second position. When the inner retainer 318 is in the second position, the passage can be sized to receive the attachment member. The inner retainer 318 and the outer retainer 320 can be received within a sheath 312, and more specifically, within a cavity defined by the sheath 312, which helps to retain the inner retainer 318 within the outer retainer 320 and to attach the outer retainer 320 to the elongated body 312.

[0039] In some examples, the configuration of the inner retainer 318 and the outer retainer 320 can substantially isolate the function of retaining the attachment member of the IMD to the tether head assembly 302 instead of the pull shaft 310 or another element extending to the tether handle assembly 218. For example, the path length of the pull shaft 310 and / or the elongated body 220 can be changed when the tether assembly 216 is guided through a curved portion of the patient's vascular system.

[0040] In examples of tether assembly 216 and other tether assemblies described herein, variations in the path length of the pull shaft 310 and / or elongated body 220 of tether assembly 216 may not cause significant proximal or distal movement of the inner retainer 318. For example, the sheath 312 and / or resiliently compressible member may help reduce or prevent proximal movement of the inner retainer 318 when the path length of the pull shaft 310 and / or elongated body 220 changes during guidance through a curved vascular system. In this way, the essential isolation of the IMD retention function within the tether head assembly 302 may help maintain retention of the attachment member as the tether assembly 216 is guided through a curved vascular system.

[0041] Figure 3B This is an example Figure 3A A conceptual drawing of a cross-sectional view of the tether head assembly 302, the cross-section being along... Figure 3A The line AA was intercepted. Figure 3B An example is shown of a tether head assembly 302 with the inner retainer 318 in an extended position 300A. The tether head assembly 302 may be disposed at the distal end 216A of the tether assembly 216, for example, at the distal end of the elongated body 220 of the tether assembly 216. A pull shaft 310 extends through an inner cavity 308 defined by the elongated body 220 and into a cavity 313 defined by a sheath 312. An elastically compressible member 322, a proximal portion 328 of the inner retainer 318, and a proximal portion 330 of the outer retainer 320 are disposed within the cavity 313, wherein the distal portion 332 of the elastically compressible member 322 and the proximal portion 328 of the inner retainer 318 are received within a channel defined by the proximal portion 330 of the outer retainer 320. The pull shaft 310 extends through the cavity 324 defined by the resiliently compressible member 322 and connects to the internal retainer 318, for example, being fixedly received within the proximal portion 328 of the internal retainer 318. The various components of the delivery system 202 and the tether assembly 216 can be connected using any of a variety of techniques such as welding, crimping, threading, reflowing, bonding, adhesive, or friction fitting.

[0042] The distal portion 319 of the inner retainer 318 extends into the distal portion 321 of the outer retainer 320 to help define the container 314. In the illustrated extension position 300A of the inner retainer 318, the distal portion 319 of the inner retainer 318 also extends into the passage 316 to reduce the size of the passage 316 such that the thickness or depth of the passage 316 is less than the thickness of the attachment member 304 of the IMD 305. In the illustrated extension position 300A of the inner retainer 318, the distal portion 319 of the inner retainer 318 may be disposed within the recess defined by the distal portion 321 of the outer retainer 320 as described herein. In the illustrated extension position 300A of the inner retainer 318, the resiliently compressible member 322 may be in a relaxed state or a lower kinetic energy state.

[0043] like Figure 3B As illustrated, the attachment member 304 of the IMD 305 can be included as part of a structure of various features providing support for various functions related to the delivery and retrieval of the IMD 10. In the illustrated example, the attachment member 304 is formed within the housing of the IMD 305 and connected to the housing via a protective structure 303. In the illustrated example, the attachment member 304 includes a pin (also referred to as a post) that is welded or otherwise securely attached to the protective structure 303. The attachment member 304 provides an elongated retaining surface spaced from the proximal end of the housing of the IMD 305 and extending along a length substantially orthogonal to the longitudinal axis of the IMD 305.

[0044] The shield structure 303 may define a cavity with an opening, and the attachment member 304 may span the opening and be exposed at the opening. The attachment member 304 may be welded to the opposite side of the shield structure 303 at either end. The distal portion 321 of the outer retainer 320 may be configured to enter the shield structure 303 or otherwise interact with the shield structure when the attachment member 304 is received within the passage 316 and the container 314. The configuration of the shield structure 303 and the distal portion 321 of the outer retainer 320 may selectively prevent or allow relative movement of the IMD 305 and the tether assembly 216 in multiple directions. It should be understood that the shield structure 303 and the attachment member 304 are provided for illustrative purposes only, and various other attachment members may be configured to attach to the tether assembly 216 as described herein.

[0045] Figure 4 This is an example Figure 3A A cross-sectional view of the tether head assembly 302, wherein the inner retainer 318 of the tether head assembly 302 is in the retracted position 300B, the cross-section being along... Figure 3A The line AA was intercepted. Figure 4 An inner retainer 318 in a retracted position 300B and an attachment member 304 within a container 314 defined by an outer retainer 320 are illustrated. The inner retainer 318 is movable between an extended position 300A and a retracted position 300B within a channel 408 defined by a proximal portion 330 of the outer retainer 320. The inner retainer 318 can be moved to the retracted position 300B by a proximal pointing force 402 along the longitudinal axis 301 of the tether head assembly 302. The proximal force can be provided by a pull from a pull shaft 310 or a thrust on the distal end 326 of the inner retainer 318 as the attachment member 304 is pushed through the passage 316 and into the container 314. When the inner retainer 318 is movable between the extended position 300A and the retracted position 300B, the inner retainer 318 can travel within a recess 406 defined by the outer retainer 320. Figure 4 As illustrated, the movement of the internal retainer 318 to the retracted position 300B via a compressible elastic compressible member 322, for example, causes the distal portion 332 to no longer be positioned within the channel 408. In the compressed state, the elastic compressible member 322 can possess high kinetic energy to release by expanding in the direction of the longitudinal axis 301, thereby moving the internal retainer 318 from the retracted position 300B. Figure 3B Illustrated extended position 300A.

[0046] Figure 5 This is an example Figure 3AA cross-sectional view of the tether head assembly 302, wherein the inner retainer 318 of the tether head assembly 302 is in the extended position 300A, the cross-section being along... Figure 3A The line AA was intercepted. Figure 5 An example is illustrated where the attachment member 304 is held in an extended position 300A by an inner retainer 318 within a container 314 defined by an outer retainer 320. The inner retainer 318 can be transitioned from a retracted position 300B to an extended position 300A in response to a distal force 502 along a longitudinal axis 301 (e.g., along the push wire 310). The container 314 is configured, for example, in a size and shape set to retain the attachment member 304 while allowing the distal portion 319 of the inner retainer 318 to move through the attachment member 304, for example, through the passage 314. Figure 5 As illustrated herein, when the attachment member 304 is positioned within the container 314, for example when the inner retainer 318 is in the extended position 300A, at least a portion 504 of the distal portion 319 of the inner retainer 318 can contact the attachment member 304. As described herein, portion 504 can secure the attachment member 304 within the container 314 and help ensure a substantially constant physical contact between the attachment member 304 and at least a portion 504 of the inner retainer 318. The physical contact between the attachment member 304 and the inner retainer 318 ensured by portion 504 can provide a substantially constant electrical contact for the conduction of electrical signals from the IMD 305 to the proximal portion of the tether assembly 216, for example, for impedance detection.

[0047] Figure 6A This is an example of a locked orientation 600A. Figure 2 A conceptual diagram of an example of a tether handle assembly 218 of system 202. The tether handle assembly 218 may define a proximal portion of a tether assembly 216. The tether handle assembly 218 may include a first element 602 and a second element 604. The first element 602 may be at least partially disposed within a recess defined by the second element 604. The second element 604 may be distal to the first element 602 along a longitudinal axis 601. The second element 604 may contact the first element 602 at a first end and contact an elongated body 220 at an opposite end. A pull shaft 310 may extend through the elongated body 220 and the second element 604 into the first element 602. The first element 602 may include one or more first features disposed on the first element 602. The second element 604 may include one or more second features disposed within a recess defined by the second element 604. The one or more first features and the one or more second features may abut to hold the tether handle assembly 218 in a locking orientation 600A.

[0048] Figure 6B This is an example Figure 6A A conceptual diagram of the first element 602 of the tethered handle assembly 218. The first element 602 may include a handle 606 and a movable body 608 extending from the handle 606. The movable body 608 may be an elongated body. The movable body 608 may be disposed within a recess defined by a second element 604. In some examples, such as Figure 6B As shown, the one or more first features may include one or more channels disposed within the movable body 608. These one or more channels may include one or more first channels 610A, 610B (which may be alternatively referred to herein as "first channel 610") and one or more second channels 612. Longitudinalally adjacent first channels 610 may be connected via second channels 612. Channels 610, 612 may extend radially inward from the outer surface of the movable body 608 and may define a region of decreasing width along the movable body 608.

[0049] Figure 7A This is an example Figure 6A A cross-sectional view of the tether handle assembly 218, the cross-section being along... Figure 6A The line BB was cut off. Figure 7B This is an example Figure 6A A cross-sectional view of another example of the tether handle assembly 218, the cross-section being along... Figure 6A The line BB was cut off. Figure 7A and Figure 7B An example is shown of a tether handle assembly 218 in the locking orientation 600A.

[0050] The second element 604 may define a recess 702. For example, the housing defining the second element 604 may include an inner surface defining the recess 702. The recess 702 may be sized to receive a movable body 608 of the first element 602. The first element 602 (e.g., the movable body 608 of the first element 602) may be partially disposed within the recess 702. A pull shaft 310 may extend from the first element 602 and enter into an elongated body 220 of the tether assembly 216. The pull shaft 310 may be attached to one or more of the movable body 608 or the handle 606 of the tether assembly 216.

[0051] In some examples, such as Figure 7A As illustrated, the proximal end 708 of the pull shaft 310 can be attached to the handle 606 via a fixing feature 706. The fixing feature 706 may include, but is not limited to, fixing screws, bolts, clamps, etc. In some examples, such as... Figure 7BAs illustrated, one or more of the movable body 608 or the handle 606 may be formed from two or more components 707A, 707B (collectively referred to herein as “components 707”). Components 707 may be attached to each other to form one or more of the handle 606 or the movable body 608. When attached, components 707 may, for example, attach the proximal end 708 of the pull shaft 310 within the first element 602 by applying a compressive force to the proximal end 708 of the pull shaft 310.

[0052] Compared to attaching the pull shaft 310 to the first element 602 using the fixing feature 706, securing the pull shaft 310 to the first element 602 via the split piece 707 can suppress or reduce unintended tension applied to the pull shaft 310 along the longitudinal axis 601. The fixing feature 706, inserted into the handle 606, may unintendedly apply tension to the pull shaft 310, thereby keeping the pull shaft 310 taut when the tether assembly 216 is in its default state. When the pull shaft 310 is in its default state, the reduction or elimination of unintended tension on the pull shaft 310 can reduce the force acting on the pull shaft 310 along the longitudinal axis 601, and / or increase the responsiveness of the tether head assembly 302 to forces applied to the tether handle assembly 218 by the clinician.

[0053] The first element 602 may include one or more first features disposed on a movable body 608 of the first element 602. In some examples, the movable body 608 is partially disposed within a recess 702, and the one or more first features may be disposed on a portion of the movable body 608 configured to be disposed within the recess 702. In some examples, such as Figure 7A As illustrated, the one or more first features may include channels 610, 612 disposed on the outer surface of the movable body 608. In some examples, such as Figure 7B As shown, the one or more first features include one or more protrusions 712 extending radially away from the outer surface of the movable body 608.

[0054] The second element 604 may include one or more second features disposed within the recess 702. In some examples, such as Figure 7A As illustrated, the one or more second features include one or more protrusions 704 extending into the recess 702. The protrusions 704 may be removably or permanently disposed within the recess 702. For example, the protrusions 704 may include bolts or screws configured to be removably inserted into the recess 702 to define the one or more second features. In some examples, such as... Figure 7BAs illustrated, the one or more second features include one or more channels disposed along the inner surface of the second element 604 defining the recess 702. The one or more channels may include one or more first channels 710A, 710B (which may be alternatively referred to herein as "first channel 710") and one or more second channels connecting longitudinally adjacent first channels.

[0055] The first feature of the first element 602 may engage with the second feature of the second element 604 to suppress movement of the first element 602 relative to the second element 604 along the longitudinal axis 601 when the tether handle assembly 218 is in the locked orientation 600A. Suppressing movement of the first element 602 in the locked orientation 600A suppresses the unintended application of forces (e.g., forces 402, 502) along the pull axis 310. This suppresses the unintended release of the IMD 303 from the tether head assembly 302 via an unintended transition from the extended position 300A to the retracted position 300B via the internal retainer 318. Instead, a clinician may need to first change the tether handle assembly from the locked orientation 300A to the unlocked orientation 300B before moving the first element 602 relative to the second element 604 along the longitudinal axis 601, for example, to release the IMD 305 from the tether head assembly 302.

[0056] In some examples, such as Figure 7A As illustrated, the protrusion 704 abuts against the channel 610 to inhibit movement of the first element 602 when the tether handle assembly 218 is in the locking orientation 600A. For example, the protrusion 704 may abut against the sidewall of the channel 610 to inhibit movement of the first element 602. In some examples, such as Figure 7B As illustrated, the protrusion 712 abuts against the channel 710 to suppress movement of the first element 602 when the tether handle assembly 218 is in the locking orientation 600A. For example, when the tether handle assembly 218 is in the locking orientation 600A, the protrusion 712 may abut against the sidewall of the channel 710 to suppress movement of the first element 602. Although Figure 7A and Figure 7B The first and second features are shown as a protrusion and a channel, but other example tether handle assemblies may include any other features that can be mated together when circumferentially aligned to inhibit longitudinal movement of one or more of the first element 602 or the second element 604.

[0057] Figure 8A This example illustrates the 600B in the unlocked orientation. Figure 6A Conceptual drawing of the tether handle assembly 218. Figure 8B This is an example Figure 8AA conceptual front view of the tether handle assembly 218. A clinician can rotate the first element 602 about a longitudinal axis 601 and relative to the second element 604 to orient the tether handle assembly 218 in an unlocking orientation 600B. The clinician can apply a rotational force 802 to the first element 602 (e.g., to the handle 606 of the first element 602) to rotate the first element 602 relative to the second element 604 to the unlocking orientation 600B. First and second features on the first element 602 and the second element 604 can be respectively shaped to facilitate rotation of the first element 602 in a single direction (e.g., clockwise or counterclockwise) or in either direction.

[0058] In some examples, excessive rotation of the first element 602 relative to the second element 604 (e.g., the first element 602 rotates more than 90 degrees about the longitudinal axis 601) causes the first element 602 to apply torque on the pull shaft 310, and thus on the tether head member 302. The first and second features of the tether handle assembly 218 may be shaped to limit the rotation of the first element 602 (e.g., in a single direction, in either direction) to less than or equal to a threshold angle, for example, to reduce the amount of torque applied to the pull shaft 310 by the first element 604 during transition to the unlocking orientation 600B. The threshold angle may be 90 degrees, such as... Figure 8B As illustrated, it could also be another angle between 0 and 180 degrees (e.g., 30 degrees, 45 degrees, 120 degrees, 135 degrees).

[0059] When the tether handle assembly 218 is in the unlocked orientation 600B, a clinician may apply a rotational force 802 to the first element 602 (e.g., on the handle 606 of the first element 602) to rotate the first element 602 back to the locking orientation 600A. The rotational force 802 required to turn the first element 602 back to the locking orientation 600A may have the same magnitude and / or direction of rotation as the rotational force 802 required to turn the first element 602 from the locking orientation 600A to the unlocked orientation 600B. For example, a clinician may rotate the first element 602 about the longitudinal axis 601 in a first direction to orient the tether handle assembly 218 in the unlocked orientation 600B, and may rotate the first element 602 about the longitudinal axis 601 in the same or different directions to return the tether handle assembly to the locking orientation 600B.

[0060] Figure 9A This example illustrates the situation where the device is in the unlocked orientation 600B and the first element 602 is in the distal position. Figure 6A A cross-sectional view of the tether handle assembly 218, the cross-section being along... Figure 6AThe line BB is cut off. In the distal position, the movable body 608 can be in the distal position within the recess 702. The protrusion 704 can be connected to the nearest side channel of the first channel 610 (e.g., as...). Figure 9A The illustrated first channel 610B engages to inhibit further distal movement of the movable body 608 within the recess 702. When the first element 602 is in the distal position, it allows the tether head assembly 302 to hold the internal retainer 318 in the extended position 300A. In some examples, clinicians hold the first element 602 in the distal position to inhibit unintended movement of the internal retainer 318 from the extended position 300A to the retracted position 300B, thereby releasing the attachment member 304 from within the container 314.

[0061] When the first element 602 is in the distal position, the tether handle assembly 218 can be in either a locking orientation 600A or an unlocking orientation 600B. When the tether handle assembly 218 is in the locking orientation 600A, the protrusion 704 can engage with the first channel 610B to inhibit movement of the first element 602 from the distal position to the proximal position. For example, the protrusion 704 can be circumferentially offset from the second channel 612 to inhibit movement of the protrusion 704 between the first channels 610 connected by the second channel 612. When the tether handle assembly 218 is in the locking orientation 600A, the protrusion 704 can engage with the sidewall of the first channel 610B in response to a force along the longitudinal axis 601 to inhibit movement (e.g., proximal movement) of the movable body 608 along the longitudinal axis 601.

[0062] A clinician can rotate the first element 602 about the longitudinal axis 601 to position the tether handle assembly 218 in the unlocking orientation 600B. As previously described above, the clinician can rotate the first element 602 by applying a rotational force 802 on the first element 602 (e.g., on the handle 606 of the first element 602).

[0063] When the tether handle assembly 218 is in the unlocking orientation 600B, the first feature on the first element 602 may not mate with the second element on the second element 604, thereby facilitating longitudinal movement of the first element 602 relative to the second element 604. For example, as Figure 9A As illustrated, when the tether handle assembly 218 is in the unlock orientation 600B, the second channel 612 is circumferentially aligned with the protrusion 704. The size of the second channel 612 can be set to receive the protrusion 704 and allow the protrusion 704 to move between one of the first channels 610 (e.g., the first channel 610B) and the other of the first channels 610 (e.g., the first channel 610A) via the second channel 612.

[0064] Figure 9BThis example illustrates the 600B in the unlocked orientation. Figure 6A A cross-sectional view of the tether handle assembly 218, wherein the first element 602 is located proximally, the cross-section being along... Figure 6A The line BB is cut. When the tether handle assembly 218 is in the unlocked orientation 600B, the clinician can withdraw the first element 602 within the recess 702 from the distal position to the proximal position by applying a force 804 to the first element 602 (e.g., to the handle 606 of the first element 602). The force 804 can be along the longitudinal axis 601 (e.g., proximal along the longitudinal axis 601).

[0065] In response to force 804, the movable body 608 can travel proximally along the longitudinal axis 601 to a proximal position. Since the tether handle assembly 218 is in the unlocking orientation 600B, the first and second features on the first element 602 and the second element 604 may not be mated to inhibit movement of the movable body 608. For example, as... Figure 9B As illustrated, the protrusion 704 can travel between the first channel 610 via the second channel 612, thereby facilitating the movement of the movable body 608 to a proximal position.

[0066] The proximal position of the first element 602 may correspond to the inner retainer 318 of the tether head assembly 302 in the retracted position 300B. For example, moving the first element 602 proximal to the proximal position may cause the first element 602 to apply a force 402 to the inner retainer 318, thereby causing the inner retainer 318 to retract from the extended position 300A to the retracted position 300B. The distance between the distal and proximal positions of the first element 602 may be less than, equal to, or greater than the travel length of the inner retainer 318 from the extended position 300A to the retracted position 300B.

[0067] The first and second feature portions of the first element 602 and the second element 604 can be mated to suppress the first element 602 from traveling proximally past the proximal position. Figure 9B In the illustrated example, the protrusion 704 abuts against the sidewall of the first channel 610A to prevent further proximal movement of the first element 602 past the proximal position. Restricting the movement of the first element 602 between the distal and proximal positions increases the controllability of the tether head assembly 302 via the tether handle assembly 218 and simplifies the control of the tether head assembly 302 via the tether handle assembly 218. For example, restricting the movement of the first element 602 by the protrusion 704, the first channel 610, and the second channel 612 facilitates repeatable and uniform movement of the internal retainer 381 within the tether head assembly 302.

[0068] Figure 9CThis example illustrates a locked orientation 600C and a proximal position. Figure 6A A cross-sectional view of the tether handle assembly 218, the cross-section being along... Figure 6A The line BB is cut. Once the first element 602 is in the proximal position within the recess 702, the clinician can apply a rotational force 802 to the first element 602 to change the tether handle assembly 218 from the unlocking orientation 600B to the locking orientation 600C. The clinician can change the tether handle assembly 218 to the locking orientation 600C to prevent the first element 602 from unintentionally moving out of the proximal position (e.g., toward or to the distal position), thereby preventing unintentional movement of the inner retainer 318 from the retracted position 600B within the tether head assembly 302.

[0069] When the clinician rotates the first element 602 to the locking orientation 600B, the first and second features are oriented to mate with each other and inhibit longitudinal movement of the first element 602. For example, as Figure 9C As illustrated, when the clinician rotates the first element 602 to the locking orientation 600B, the protrusion 702 exits from the second channel 612 ( Figure 9C (not shown) circumferential offset, thereby suppressing the movement of the protrusion 702 between the first channels 610 (e.g., between the first channel 610A and the first channel 610B).

[0070] Figures 9A to 9C An example procedure is illustrated for manipulating the first element 602 to change from a distal position to a proximal position, for example, to release the IMD 305 from the tether head assembly 302 or to allow access to the container 314. Clinicians can perform the procedure in reverse order. Figures 9A to 9C The example procedures illustrated herein are for changing the first element 602 from a proximal position to a distal position, for example, to secure the IMD 305 to the tether head assembly 302 or to restrict access to the container 314. Some example procedures for operating the example medical device system described herein are discussed in more detail below.

[0071] Figure 10 This is an example of the process. Figure 2 The flowchart illustrates an example process by which system 202 implants a medical device (e.g., IMD 305) into a patient. Although Figure 10 The exemplary procedures illustrated are described primarily with reference to intracardiac medical devices, but the exemplary procedures, devices, and systems described herein can be used with other medical devices and / or for implanting medical devices in other locations within a patient's body.

[0072] Clinicians can navigate the tether head assembly 302 and the IMD 305 to a target location (902) within the patient's body. The IMD 305 and tether assembly 216 can be carried within the delivery catheter 206 as it is advanced to the treatment site. Clinicians can advance the distal end of the delivery catheter 206 to the treatment site via a handle 208 connected to the shaft 212 of the delivery catheter 206. Clinicians can determine whether the IMD 305 is correctly positioned relative to the target location based on impedance signals sensed through the electrical path of one or more components including the IMD 305, attachment member 304, and tether assembly 216 (e.g., the internal retainer 318 of the tether head assembly 302 and / or one or more other components). In some examples, clinicians determine whether the IMD 305 is correctly positioned at the target location via one or more imaging techniques, including but not limited to fluoroscopy.

[0073] Clinicians can implant the IMD 305 into the tissue at the target location (904). During navigation of the delivery catheter 206 to the target location, the IMD 305 can be held within the device cup 210 of the delivery catheter 206. Once the clinician confirms that the IMD 305 is correctly positioned at the target location, the clinician can push the IMD 305 distally out of the device cup 210 via the tether assembly 216. For example, the clinician can apply a distal force along the tether assembly 216 via the tether handle assembly 218 to at least partially push the tether head assembly 302 and the IMD 305 out of the distal opening 214 of the device cup 210.

[0074] A clinician can cause one or more fixation features IMD 305 to pierce tissue at a target location and attach IMD 305 to the tissue at the target location. Fixation features may include, but are not limited to, sharp teeth, coiled elongated bodies (e.g., helical coils), etc. In some examples, the clinician expands the one or more fixation features and secures the IMD 305 to the tissue. In some examples, the clinician advances the one or more fixation features into the tissue to secure the IMD 305 to the tissue. In such examples, the clinician can rotate the tether handle assembly 218 to rotate the IMD 305 and advance the one or more features into the tissue. The clinician can rotate the tether handle assembly 218 (e.g., about longitudinal axis 601) while maintaining the first element 602 and the second element 604 in locking orientation 600A.

[0075] Clinicians can rotate the first element 602 of the tether handle assembly 218 from a locking orientation 600A to an unlocking orientation 600B (906) relative to the second element 604. In some examples, once the clinician has determined that the IMD 305 is secured to the tissue at the target location, the clinician rotates the tether handle assembly 218 to the unlocking orientation 600B. When the tether handle assembly 218 is in the locking orientation 600A, a first feature on the first element 602 (e.g., channels 610, 612, protrusion 712) engages with a second feature on the second element 604 (e.g., protrusion 702, channel 710) to inhibit longitudinal movement of the first element 602 relative to the second element 604. Clinicians can rotate the first element 602 to the unlocking orientation 600B to facilitate longitudinal movement of the first element 602 relative to the second element 604, for example, to detach the IMD 305 from the tether assembly 216.

[0076] A clinician may apply a rotational force 802 to the handle 606, causing the first element 602 to rotate to the unlocking orientation 600B. The clinician may apply the rotational force 802 to the handle 606 in a clockwise or counterclockwise direction. In some examples, the clinician applies the rotational force 802 to the first element 602 in a single specific direction to rotate the first element 602. The clinician may rotate the first element 602 until the clinician determines (e.g., visually, tactilely) that the tether handle assembly 218 is in the unlocking orientation 600B. In some examples, one or more of the first or second features may be shaped to inhibit rotation of the first element 602 relative to the second element 604 beyond the unlocking orientation 600B, for example, to inhibit excessive rotation of the first element 602 and unintended application of torque on the pull shaft 310 of the tether assembly 216. For example, one or more of the first channel 610 or channel 710 may extend only partially around the inner surface of the movable body 608 or the second element 604, respectively, to limit the maximum rotation angle of the first element 602. When the clinician rotates the first element 602 to the unlocking orientation 600B, the first and second features may no longer engage to inhibit longitudinal movement of the first element 602 relative to the second element 605.

[0077] Clinicians can retract the first element 602 proximally relative to the second element 604 (908). In some examples, such as Figures 3A to 5As illustrated, when the attachment member 304 of the IMD 305 is disposed within the container 314 of the tether head assembly 302, the internal retainer 318 of the tether head assembly 302 can restrict the passage 316 to the container 314 when the internal retainer 318 is in the extended position 300A, for example, to prevent the attachment member 304 from protruding from the container 314. By preventing the attachment member 304 from protruding from the container 314, the internal retainer 318 secures the IMD 305 to the tether head assembly 302.

[0078] Once the IMD 305 is attached to the target location within the patient's body, the clinician can detach the tether assembly 216 from the IMD 305 and remove it from the patient's body. The clinician can then deflect the first element 602 from a distal position to a proximal position within the recess 702 of the second element 604. The retraction of the first element 602 to the distal position transmits a proximal force 402 along the pull shaft 310 to the internal retainer 318, thereby retracting the internal retainer 318 from the extended position 300A to the retracted position 300B. When the internal retainer 318 is in the retracted position 300B, the passage 316 is unobstructed by the internal retainer 318 and can be sized to facilitate the removal of the attachment member 304 from the container 314 through the passage 316.

[0079] The clinician can release the tether head assembly 302 (910) from the IMD 305. The clinician can retract the tether head assembly 302 proximally to release the IMD 305. In some examples, the clinician retracts the tether assembly 216 proximally to withdraw the attachment member 304 from the container 314 via passage 316. Once the attachment member 304 withdraws from passage 316 of the tether head assembly 302, the IMD 305 disengages from the tether head assembly 302. In some examples, the clinician can rotate the first element 602 to a locking orientation 600A in the proximal position before retracting the tether assembly 302, for example, to suppress unintended longitudinal movement of the internal retainer 318 within the tether head assembly 302 when the tether head assembly 216 disengages from the IMD 305.

[0080] Figure 11 This illustrates operation via the tether handle assembly 218 of system 202. Figure 2 A flowchart illustrating an example process for the tether head assembly 302 of system 202. Although Figure 11 The exemplary procedures illustrated are described primarily with reference to intracardiac medical devices, but the exemplary procedures, devices, and systems described herein can be used with other medical devices and / or for implanting medical devices in other locations within a patient's body.

[0081] A clinician can rotate the first element 602 of the tether handle assembly 218 relative to the second element 604 from a locking orientation 600A to an unlocking orientation 600B (1002). The clinician can retract the first element 602 proximally relative to the second element 604 to retract the internal retainer 318 within the tether head assembly 302 from a first position (e.g., extended position 300A) to a second position (e.g., retracted position 300B) (1004). The clinician can rotate and retract the first element 602 according to other example procedures discussed earlier herein.

[0082] Clinicians can position the attachment member 304 of the IMD 305 within the container 314 of the tether head assembly (1006). When the inner retainer 318 is in the retracted position 300B, the size of the passage 316 can be configured to facilitate insertion of the attachment member 304 of the IMD 305 into the container 314. Clinicians can insert the attachment member 304 through the passage 316 until it is positioned within the container 314. In some examples, the attachment member 304 moves into the container 304, causing the inner retainer 38 to retract from the extended position 300A to the retracted position 300B, for example, in response to contact between the attachment member 304 and the distal end 326 of the inner retainer 318. For example, a clinician can hold the tether head assembly 302 with one hand and press the attachment member 304 against, for example, the distal end 326 of the inner retainer 318 into the passage 316 defined by the outer retainer 308, thereby causing the inner retainer 318 to move to the retracted position 300B when the attachment member 304 moves through the passage 316 to the container 314 and when the resiliently compressible member 322 is compressed.

[0083] A clinician may advance the first element 602 distally relative to the second element 604 to advance the inner retainer 318 to a first position (1008). In some examples, the inner retainer 318 may be returned from a retracted position 300B to an extended position 300A under spring pressure via a bias provided by the resiliently compressible member 322. Distal movement of the inner retainer 318 to the extended position 300A advances the first element 602 from a proximal position to a distal position. In some examples, the clinician manually advances the movable body 608 of the first element 602 into the recess 702 of the second element 604 until the first element 602 is in the distal position. One or more of the first or second features may prevent the first element 602 from moving further into the recess 702 beyond the distal position. When the first element 602 is in the distal position, the internal retainer 318 is in the extended position 300A within the tether head assembly 302 and narrows the passage 316 to restrict the attachment member 304 from exiting the container 314, thereby securing the IMD 305 to the tether head assembly 302.

[0084] Clinicians can rotate the first element 602 relative to the second element 604 from the unlocking orientation 600B to the locking orientation 600C (1010). Once the tether handle assembly 218 is in the locking orientation 600C, two separate actions are required to release the IMD 305 from the tether head assembly 302. The clinician may need to rotate the first element 602 to the unlocking orientation 600B and then retract the first element 602 from the recess 702 of the second element 604 to allow the attachment member 204 to exit the container 314 of the tether head assembly 302. The requirement for two separate actions can prevent unintended detachment of the IMD 305 from the tether assembly 216 during the implantation procedure.

[0085] The following examples illustrate the techniques described herein.

[0086] Example 1: A tether assembly for a medical device delivery system, the tether assembly comprising: a tether head assembly; and a tether handle assembly, the tether handle assembly being coupled to the tether head assembly via a pull shaft, the tether handle assembly comprising: a first element coupled to a proximal end of the pull shaft, the first element comprising: a movable body; one or more first features disposed on the movable body of the first element; and a second element configured to retain at least a portion of the movable body of the first element, the second element comprising: a housing defining a recess sized to receive the at least a portion of an elongated body; and one or more second features. The first element is configured to rotate about the longitudinal axis of the tether handle assembly to switch between a locking orientation and an unlocking orientation, wherein when the first element is in the locking orientation relative to the second element, the one or more first features are configured to abut with the one or more second features to inhibit movement of the first element relative to the second element along the longitudinal axis, wherein when the first element is in the unlocking orientation relative to the second element, the first element is configured to move relative to the second element along the longitudinal axis and apply force along the pull axis, and wherein the tether head assembly is configured to release the medical device in response to the force along the pull axis.

[0087] Example 2: According to the tether assembly of Example 1, wherein the one or more first features include two or more channels that extend at least partially around the circumference of the elongated body, and wherein the one or more second features include one or more protrusions that extend into the recess.

[0088] Example 3: The tether assembly according to Example 1, wherein the one or more first features include one or more protrusions extending radially away from the outer surface of the elongated body, and wherein the one or more second features include two or more channels extending along the inner surface of the housing, wherein the inner surface defines the recess.

[0089] Example 4: A tether assembly according to any one of Examples 2 and 3, wherein the two or more channels are longitudinally offset along the longitudinal axis.

[0090] Example 5: A tether assembly according to any one of Examples 2 to 4, wherein one or more protrusions are configured to be disposed within at least one of the two or more channels when the first element is in the locking orientation, and wherein the one or more protrusions are configured to travel between the channels of the two or more channels when the first element is in the unlocking orientation.

[0091] Example 6: The tether assembly according to Example 5, wherein the two or more channels include two or more first channels, wherein the longitudinally adjacent first channels of the two or more first channels are connected via a second channel, and wherein when the first element is in the unlocking orientation, the one or more protrusions are configured to travel via the second channel between the longitudinally adjacent first channels of the two or more first channels.

[0092] Example 7: A tether assembly according to any one of Examples 2 to 6, wherein the tether head assembly comprises: an outer retainer defining a passage configured to receive an attachment member of the medical device; and an inner retainer at least partially disposed within the passage, wherein the inner retainer is coupled to a distal end of the traction shaft, and wherein the inner retainer is configured to change between a first position and a second position in response to a force along the traction shaft.

[0093] Example 8: The tether assembly according to Example 7, wherein when the inner retainer is in the first position, the inner retainer narrows the width of the passage and inhibits the attachment member from moving into or out of the passage, wherein when the inner retainer is in the second position, the inner retainer increases the width of the passage to facilitate the attachment member moving into the passage.

[0094] Example 9: A tether assembly according to any one of Examples 7 and 8, wherein a first channel of the two or more channels corresponds to a first position of the inner retainer, and wherein a second channel of the two or more channels corresponds to a second position of the retainer, wherein the second channel is proximal to the first channel.

[0095] Example 10: The tether assembly according to Example 9, wherein the internal retainer travels a specific distance between the first position and the second position, and wherein the first channel and the second channel are separated by at least the specific distance.

[0096] Example 11: A tether assembly according to any one of Examples 2 to 10, wherein when the one or more protrusions are disposed in at least one of the two or more channels, the one or more protrusions abut against one or more sidewalls of the at least one channel to suppress longitudinal movement of the first element relative to the second element.

[0097] Example 12: A tether assembly according to any one of Examples 1 to 9, wherein the second element extends distally to the elongated body, wherein the first element further includes a handle attached to and disposed proximal to the elongated body, and wherein the first element is configured to switch between the locking orientation and the unlocking orientation in response to rotation of the handle about the longitudinal axis.

[0098] Example 13: The tether assembly according to Example 12, wherein the proximal end of the pull shaft is connected to the handle.

[0099] Example 14: According to the tether assembly of Example 13, the handle includes a first component and a second component, wherein the proximal end of the pull shaft is disposed between the first component and the second component, and wherein the pull shaft is attached to the handle via a compressive force between the first component and the second component.

[0100] Example 15: A tether assembly according to any one of Examples 1 to 14, wherein one or more first features are configured to dock with one or more second features to limit the rotation of the first element relative to the second element to less than or equal to a rotation angle.

[0101] Example 16: The rope assembly according to Example 15, wherein the rotation angle is 90 degrees.

[0102] Example 17: A rope assembly according to any one of Examples 1 to 16, wherein the pull shaft includes a pull line.

[0103] Example 18: A tether assembly according to any one of Examples 1 to 17, wherein the movable body comprises an elongated body.

[0104] Example 19: A method comprising: advancing a tether head assembly of a tether assembly and a medical device to a target location within a patient's body lumen, wherein an attachment member of the medical device is held between an external retainer and an internal retainer of the tether head assembly; implanting the medical device into tissue at the target location in the patient; rotating a first element of a tether handle assembly relative to a second element of the tether handle assembly from a locked orientation to an unlocked orientation, wherein the tether handle assembly is coupled to the tether head assembly via a pull shaft, wherein at least a portion of a movable body of the first element is disposed within a recess defined by a housing of the second element, and wherein one or more first features disposed on the movable body abut against one or more second features within the recess to inhibit movement of the first element relative to the second element along a longitudinal axis of the tether handle assembly when the first element is in the locked orientation; and retracting the first element proximally relative to the second element along the longitudinal axis when the first element is in the unlocked orientation, such that the pull shaft retracts the internal retainer proximally and releases the attachment member from the tether head assembly.

[0105] Example 20: The method according to Example 19, wherein retracting the first element proximally to retract the inner retainer proximally by the pull shaft comprises: retracting the first element proximally to retract the inner retainer from a first position to a second position by the pull shaft, wherein in the first position, the inner retainer is configured to prevent the attachment member from moving out of the passage defined by the outer retainer and the inner retainer, and wherein in the second position, the inner retainer is configured to allow the attachment member to move out of the passage.

[0106] Example 21: The method of Example 20, the method further comprising: rotating the first element from the locking orientation to the unlocking orientation; retracting the first element proximally relative to the second element to retract the internal retainer proximally from the first position to the second position; inserting the attachment member of the medical device into the passage when the internal retainer is in the second position; advancing the first element distally relative to the second element along the longitudinal axis to advance the internal retainer distally from the second position to the first position; and rotating the first element from the unlocking orientation to the locking orientation.

[0107] Example 22: The method according to any one of Examples 19 to 21, wherein the one or more first features include two or more channels that extend at least partially around the circumference of the elongated body, and wherein the one or more second features include one or more protrusions that extend into the recess.

[0108] Example 23: The method according to any one of Examples 19 to 21, wherein the one or more first features include one or more protrusions extending radially away from the outer surface of the elongated body, and wherein the one or more second features include two or more channels extending along the inner surface of the housing, wherein the inner surface defines the recess.

[0109] Example 24: The method according to any one of Examples 22 and 23, wherein the two or more channels include two or more first channels, wherein the longitudinally adjacent first channels of the two or more first channels are connected by a second channel, wherein rotating the first element from the locking orientation to the unlocking orientation circumferentially aligns the one or more protrusions with the second channel, and wherein retracting the first element proximally relative to the second element causes the one or more protrusions to travel between the longitudinally adjacent first channels via the second channel.

[0110] Example 25: The method according to any one of Examples 22 to 24, wherein the first channel of the two or more channels corresponds to the first position, wherein the second channel of the two or more channels corresponds to the second position, and wherein the second channel is proximal to the first channel.

[0111] Example 26: According to the method of Example 25, wherein retracting the first element proximally to retract the inner retainer from the first position to the second position comprises: retracting the first element proximally to retract the inner retainer proximally by a specific distance, and wherein the first channel and the second channel are separated by at least the specific distance.

[0112] Example 27: According to any one of Examples 19 to 26, wherein one or more first features are configured to dock with one or more second features to limit the rotation of the first element relative to the second element to less than or equal to a rotation angle.

[0113] Example 28: The method described in Example 27, wherein the rotation angle is 90 degrees.

[0114] Example 29: The method according to any one of Examples 19 to 28, wherein the pull shaft includes a pull wire.

[0115] Example 30: A tether handle assembly comprising: a first element coupled to a proximal end of a pull shaft, the first element comprising: a movable body; one or more first features disposed on the movable body; and a second element configured to retain at least a portion of the movable body of the first element, the second element comprising: a housing defining a recess sized to receive the at least a portion of the movable body; and one or more second features disposed within the recess, wherein the first element is configured to rotate about a longitudinal axis to switch between a locking orientation and an unlocking orientation, wherein when the first element is in the locking orientation relative to the second element, the one or more first features are configured to abut against the one or more second features to inhibit movement of the first element relative to the second element along the longitudinal axis of the tether handle assembly, wherein when the first element is in the unlocking orientation relative to the second element, the first element is configured to move relative to the second element along the longitudinal axis and apply a proximal force along the pull shaft.

[0116] Example 31: The tethered handle assembly according to Example 30, wherein the proximal force is configured to release the medical device from the tethered head assembly connected to the distal end of the pull shaft.

[0117] Example 32: A tethered handle assembly according to any one of Examples 30 and 31, wherein the one or more first features include two or more channels that extend at least partially around the circumference of the movable body, and wherein the one or more second features include one or more protrusions that extend into the recess.

[0118] Example 33: A tethered handle assembly according to any one of Examples 30 and 31, wherein the one or more first features include one or more protrusions extending radially away from the outer surface of the movable body, and wherein the one or more second features include two or more channels extending along the inner surface of the housing, wherein the inner surface defines the recess.

[0119] Example 34: A tether handle assembly according to any one of Examples 32 and 33, wherein one or more protrusions are configured to be disposed within at least one of the two or more channels when the first element is in the locking orientation, and wherein the one or more protrusions are configured to travel between the channels of the two or more channels when the first element is in the unlocking orientation.

[0120] Example 35: The tether handle assembly according to Example 34, wherein the two or more channels include two or more first channels, wherein the longitudinally adjacent first channels of the two or more first channels are connected via a second channel, and wherein when the first element is in the unlocking orientation, the one or more protrusions are configured to travel via the second channel between the longitudinally adjacent first channels of the two or more first channels.

[0121] Example 36: A tether assembly according to any one of Examples 30 to 35, wherein the second element is distal to the movable body, wherein the first element further includes a handle attached to the movable body and disposed proximal to the movable body, and wherein the first element is configured to switch between the locking orientation and the unlocking orientation in response to rotation of the handle about the longitudinal axis.

[0122] Example 37: The tether assembly according to Example 36, wherein the proximal end of the pull shaft is connected to the handle.

[0123] Example 38: According to the tether assembly of Example 37, the handle includes a first part and a second part, wherein the proximal end of the pull shaft is disposed between the first part and the second part, and wherein the pull shaft is attached to the handle via a compressive force between the first part and the second part.

[0124] Example 39: A tether assembly according to any one of Examples 30 to 38, wherein one or more first features are configured to dock with one or more second features to limit the rotation of the first element relative to the second element to less than or equal to a rotation angle.

[0125] Example 40: The tether assembly according to Example 39, wherein the rotation angle is 90 degrees.

[0126] Example 41: A rope assembly according to any one of Examples 30 to 40, wherein the pull shaft includes a pull line.

[0127] Example 42: A tether assembly according to any one of Examples 30 to 41, wherein the movable body comprises an elongated body.

[0128] Various aspects of this disclosure have been described. These and other aspects are within the scope of the following claims.

Claims

1. A tether assembly for a medical device delivery system, the tether assembly comprising: Rope end assembly; and A tether handle assembly, the tether handle assembly being connected to the tether head assembly via a pull shaft, the tether handle assembly comprising: - A first element, coupled to the proximal end of the pull shaft, the first element comprising: - - Movable main body; - One or more first features, said one or more first features being disposed on the movable body of the first element; and - A second element, configured to retain at least a portion of the movable body of the first element, the second element comprising: - A housing defining a recess sized to receive at least a portion of the elongated body; and - One or more second feature portions, said one or more second feature portions being disposed within the recess. - wherein the first element is configured to rotate about the longitudinal axis of the tether handle assembly to switch between a locking orientation and an unlocking orientation. When the first element is in the locking orientation relative to the second element, the one or more first features are configured to abut with the one or more second features to suppress movement of the first element relative to the second element along the longitudinal axis. - Wherein, when the first element is in the unlocking orientation relative to the second element, the first element is configured to move relative to the second element along the longitudinal axis and apply force along the pull axis, and - The tether head assembly is configured to release the medical device in response to the force along the pull axis.

2. The rope assembly according to claim 1, The one or more first features include two or more channels that extend at least partially around the circumference of the elongated body. The one or more second features include one or more protrusions that extend into the recess.

3. The rope assembly according to claim 1, The one or more first feature portions include one or more protrusions that extend radially away from the outer surface of the elongated body, and The one or more second features include two or more channels that extend along the inner surface of the housing, wherein the inner surface defines the recess.

4. The tethering assembly according to any one of claims 2 and 3, wherein the two or more channels are longitudinally offset along the longitudinal axis.

5. The tether assembly according to any one of claims 2 to 4, wherein the one or more protrusions are configured to be disposed within at least one of the two or more channels when the first element is in the locking orientation, and wherein the one or more protrusions are configured to travel between the channels of the two or more channels when the first element is in the unlocking orientation.

6. The tether assembly of claim 5, wherein the two or more channels comprise two or more first channels, wherein longitudinally adjacent first channels of the two or more first channels are connected via a second channel, and wherein when the first element is in the unlocking orientation, the one or more protrusions are configured to travel via the second channel between longitudinally adjacent first channels of the two or more first channels.

7. The tether assembly according to any one of claims 2 to 6, wherein the tether head assembly comprises: An external retainer that defines a passage configured to receive an attachment member of the medical device; and An internal retainer, the internal retainer being at least partially disposed within the passage, The internal retainer is coupled to the distal end of the pull shaft, and The internal retainer is configured to change between a first position and a second position in response to the force along the pull shaft.

8. The tethering assembly according to claim 7, When the internal retainer is in the first position, the internal retainer narrows the width of the passage and inhibits the attachment member from moving in and out of the passage. When the internal retainer is in the second position, the internal retainer increases the width of the passage to facilitate the movement of the attachment member into the passage.

9. The tethering assembly according to any one of claims 7 and 8, The first of the two or more channels corresponds to the first position of the internal retainer, and The second channel of the two or more channels corresponds to the second position of the retainer, wherein the second channel is proximal to the first channel.

10. The tethering assembly according to any one of claims 2 to 9, When the one or more protrusions are disposed within at least one of the two or more channels, the one or more protrusions abut against one or more sidewalls of the at least one channel to suppress longitudinal movement of the first element relative to the second element.

11. The tether assembly according to any one of claims 1 to 9, wherein the second element extends distally to the elongated body, wherein the first element further includes a handle attached to and disposed proximal to the elongated body, and wherein the first element is configured to switch between the locking orientation and the unlocking orientation in response to rotation of the handle about the longitudinal axis.

12. The tether assembly of claim 11, wherein the proximal end of the pull shaft is coupled to the handle.

13. The tether assembly of claim 12, wherein the handle comprises a first component and a second component, wherein the proximal end of the pull shaft is disposed between the first component and the second component, and wherein the pull shaft is attached to the handle via a compressive force between the first component and the second component.

14. The tether assembly according to any one of claims 1 to 13, wherein the one or more first features are configured to engage with the one or more second features to limit the rotation of the first element relative to the second element to less than or equal to a rotation angle.

15. The tether assembly according to claim 14, wherein the rotation angle is 90 degrees.

Images