Control handle for controlling function of delivery system of implanted medical device

Abstract

A control handle (1) for controlling the function of a delivery system (3) for implanting a medical device is described. The delivery system comprises an elongate delivery catheter (5) and a mandrel (7) longitudinally displaceable relative to the delivery catheter. The control handle (1) comprises a locking mechanism (19) and a handle housing (9). The locking mechanism is configured to be switchable between a locked configuration in which the mandrel is fixed relative to the locking mechanism such that the mandrel cannot be displaced beyond a predetermined abutment position relative to the locking mechanism due to abutment of the mechanical mandrel, and an unlocked configuration in which the mandrel cannot be displaced beyond a predetermined abutment position relative to the locking mechanism due to abutment of the mechanical mandrel. The mandrel moves in the longitudinal direction beyond a predetermined abutment position relative to the locking mechanism as the mandrel abutment barrier is released.

Description

Technical Field

[0001] The present invention relates to a control handle for controlling the functions of a delivery system for an implantable medical device. Furthermore, the present invention relates to a delivery system comprising such a control handle. Background Art

[0002] There are various medical devices (also referred to as implantable medical devices - IMDs) that must be implanted at a location within a patient's body. For example, a leadless pacemaker (ILP, sometimes also referred to as an intravascular pacemaker) will be directly implanted into a patient's heart.

[0003] Typically, IMDs and ILPs are particularly introduced into a patient's body, forwarded to a desired implantation location and fixed at such a desired location using a specific delivery system. Such a delivery system typically comprises an elongate delivery catheter and a mandrel. Therein, the catheter can be maneuverable and / or steerable such that the distal end of the catheter can be displaced throughout the patient's body (i.e., for example along the patient's blood vessels) until reaching the desired implantation location (i.e., for example the patient's heart). The mandrel is typically longitudinally displaceable relative to the delivery catheter in order to induce or control the functions of the delivery system. For example, the mandrel can be displaced in order to expose the IMD from a protector sheath, perform a pull test and / or finally release the IMD from the delivery catheter (as will be further explained in detail below).

[0004] The functions of the delivery system are typically controlled using a control handle. Such a control handle is typically arranged at the proximal end of the delivery system such that, for example, a surgeon can use the control handle to advance and / or maneuver the delivery catheter and / or appropriately displace the mandrel.

[0005] Examples of delivery systems and catheter devices for implantable medical devices are described, for example, in the applicant's prior applications WO 2020 / 043481 A1 and WO 2020 / 187663 A1. It should be noted that the control handle described herein can be used for or is adapted to control the functions of such prior art delivery systems and catheter devices, and the features and / or functionality described in the prior applications can be implemented in the delivery system and its control handle as described in the present application. Accordingly, the content of the cited prior applications is hereby incorporated by reference in its entirety.

[0006] There may be a need for a control handle for controlling the functions of a delivery system for an implantable medical device, which provides improved ergonomics and / or enables simplified or more precise manipulation of the delivery system. Furthermore, there may be a need for a delivery system comprising such a control handle.

[0007] These needs can be met by the subject matter of the independent claims. Advantageous embodiments are defined in the dependent claims and the corresponding description and drawings. Summary of the Invention

[0008] According to a first aspect of the present invention, there is provided a control handle for controlling the functions of a delivery system for an implantable medical device. The delivery system includes an elongate delivery catheter and a mandrel that is longitudinally displaceable relative to the delivery catheter. The control handle includes a locking mechanism and a handle housing. The locking mechanism is configured to be switchable between a locked configuration and an unlocked configuration such that, in the locked configuration, the mandrel is fixed relative to the locking mechanism such that the mandrel cannot be displaced relative to the locking mechanism beyond a predetermined abutment position due to mechanical mandrel abutment blocking, and in the unlocked configuration, the mandrel is movable relative to the locking mechanism in the longitudinal direction beyond the predetermined abutment position due to the release of the mandrel abutment blocking.

[0009] According to a second aspect of the present invention, there is provided a delivery system that includes a control handle according to an embodiment of the first aspect of the present invention, an elongate delivery catheter mechanically connected to the control handle, and a mandrel controlled by the control handle to be longitudinally displaceable relative to the delivery catheter.

[0010] The basic idea of the embodiments of the present invention can be explained as being particularly based on the following observations and understandings.

[0011] Briefly and non - restrictively summarized, embodiments of the present invention relate to a control handle that can be used in conjunction with other components of a delivery system to control the functions of the delivery system during the implantation of an IMD (such as a leadless pacemaker). The control handle includes a locking mechanism disposed at or within the handle housing. During a surgical procedure, the locking mechanism can be actuated, for example, by a user (such as a surgeon) of the delivery system. Specifically, the locking mechanism can be actuated to switch between a first configuration referred to herein as the locked configuration and a second configuration referred to herein as the unlocked configuration. In the locked configuration, the locking mechanism is configured to block any displacement of the mandrel relative to the locking mechanism that exceeds a predetermined abutment position due to mechanical blocking (referred to herein as mandrel abutment blocking). In the unlocked configuration, the mechanical mandrel abutment blocking is released, thereby allowing the mandrel to be displaced beyond the abutment position.

[0012] The adjacent position can be determined by the lengths of the respective parts of the mandrel, which have different diameters, as described in further detail below. In particular, the adjacent position can be set such that unless the mandrel is displaced beyond the adjacent position, a locking element provided at the distal end of the mandrel and configured to releasably fix the IMD to the mandrel may not be in a position where the locking element is open, thereby enabling irreversible release of the IMD. Thus, as long as the locking mechanism at the control handle is in its locked configuration, the locking element at the distal end of the mandrel may not be released. Therefore, accidental release of the IMD from the distal end of the mandrel does not occur unless the locking mechanism is intentionally actuated by switching it to its unlocked configuration.

[0013] Within the framework of the present application, the mandrel is understood to be a wire inserted into a delivery catheter or the sheath of a delivery catheter. The mandrel is stiffer than the delivery catheter or the sheath into which the mandrel is inserted. The mandrel can be made of metal. The mandrel can be a solid body.

[0014] The locking mechanism can be incorporated into the control handle together with other features or elements for controlling other functions of the delivery system (such as for controlling the deployment and / or tethering mode of the IMD). For example, the locking mechanism can be configured to be actuated by a rotational movement of one of its components.

[0015] All these features support improving the ergonomics of the control handle. In particular, accidental release of the IMD by displacing the mandrel beyond a predetermined adjacent position can be reliably prevented until the locking mechanism is switched to the unlocked configuration, and such switching can be achieved by a simple actuation of the locking mechanism at the control handle by the surgeon.

[0016] Hereinafter, the features of embodiments of the present invention will be described in more detail.

[0017] The control handle is generally configured to control two or more functions of the delivery system when implanting an IMD (in particular an ILP).

[0018] The delivery system includes a delivery catheter and a mandrel. The catheter is elongate, i.e., having dimensions that are much larger in the longitudinal direction than in the transverse direction. For example, the catheter can have a length greater than 10 cm, typically between 50 cm and 200 cm, while having a diameter less than 5 cm, typically between 0.5 cm and 2 cm. The catheter is bendable in its transverse direction such that it can be maneuvered and / or guided along a curved path (e.g., through a patient's blood vessel). Generally, the catheter has an internal lumen through which the mandrel extends. The mandrel is typically a wire or cord. Among them, the mandrel is generally bendable in the transverse direction but substantially inelastic in the longitudinal direction.

[0019] The locking mechanism and the handle housing are components of the control handle. The control handle may include other components, such as a manipulation mechanism for manipulating a delivery catheter or a slider mechanism for shifting a mandrel between an undeployed configuration and a deployed configuration and optionally for implementing a tethered mode of the delivery system. All these components can be made of materials suitable for medical applications, such as materials that can be suitably sterilized. For example, some or all of the components can be made of a plastic material and, optionally, can be injection-molded components. Alternatively or additionally, at least some of the components can be made of a metal such as stainless steel or nitinol.

[0020] The locking mechanism can be displaced relative to the handle housing. In particular, for example at the start of a surgical procedure, the locking mechanism can be arranged in a locked configuration. In this locked configuration, the locking mechanism prevents movement of the mandrel, thereby causing the IMD (in particular the ILP) to be released from the delivery system. Later during the surgical procedure, for example after the IMD has been positioned at the correct implantation site and, optionally, after a successful test (such as a tug test and / or a functional test of the IMD) has been performed, the surgeon can decide that the IMD has been correctly implanted and anchored and can therefore switch the locking mechanism to its unlocked configuration, thereby intentionally enabling the mandrel to be displaced to a position where it can release the IMD from the delivery system.

[0021] According to an embodiment, the locking mechanism is configured to switch between the locked configuration and the unlocked configuration by rotating an unlocking actuating member relative to the handle housing.

[0022] In other words, the locking mechanism particularly includes an unlocking actuating member that can be rotated between different states, thereby causing the locking mechanism to switch between the locked configuration and the unlocked configuration. On the one hand, this rotational actuation of the switching process can be easily performed by the surgeon and can be ergonomically beneficial, while on the other hand, any accidental actuation of the switching process is reliably prevented.

[0023] According to another particular embodiment, the rotational axis of the unlocking actuating member is aligned with the longitudinal axis of the control handle.

[0024] In other words, the unlocking actuating member of the locking mechanism can be actuated by rotating about the longitudinal axis of the control handle. Again, this rotational actuation of the switching process can be ergonomically beneficial and can be easily implemented technically.

[0025] Furthermore, according to one implementation, the locking mechanism can be configured to switch between the locked configuration and the unlocked configuration by screwing the unlocking actuating member in a clockwise direction.

[0026] Although in principle the locking mechanism can be technically implemented to actuate in both the counterclockwise and clockwise directions, it has been found that by configuring the locking mechanism to be actuated into the unlocked configuration by screwing the unlocking actuating member in the clockwise direction, accidental actuation of the locking mechanism can be more reliably prevented.

[0027] According to an embodiment, the locking mechanism includes a through-channel for receiving a mandrel, wherein lateral restraint elements of the locking element surround the through-channel from opposite sides. Wherein, the locking mechanism is configured such that in the locked configuration, the lateral restraint elements are pushed more towards each other than in the unlocked configuration, such that in the locked configuration, the lateral dimension of the through-channel is smaller than in the unlocked configuration.

[0028] In other words, the locking mechanism may include a through-channel such as a through-hole or a groove through which the mandrel can extend. Such a through-channel may be formed by a part or component of the locking element herein referred to as a lateral restraint element. The lateral restraint elements surround the through-channel from opposite sides such that the actual cross-sectional dimension of the through-channel is determined by the actual position of the lateral restraint elements. The lateral restraint elements may be configured to be elastically biased towards a first configuration, also referred to herein as the unloaded configuration. In such an unloaded configuration, no or only a weak lateral compressive force acts on the lateral restraint elements such that the through-channel may have a relatively large cross-sectional dimension or diameter. Such an unloaded configuration corresponds to the unlocked configuration of the locking mechanism. However, when a stronger lateral compressive force is induced on the lateral restraint elements, the lateral restraint elements are pushed towards each other into a second configuration, also referred to herein as the loaded configuration. In response to this increased lateral compressive force, the cross-sectional dimension or diameter of the through-channel decreases. This loaded configuration of the lateral restraint elements corresponds to the locked configuration of the locking mechanism.

[0029] According to another specific embodiment, the locking mechanism includes a compression element that releases a compressive force acting radially on the lateral restraint elements when the unlocking actuating member is rotated from the locked configuration to the unlocked configuration.

[0030] In other words, by rotating the unlocking actuating member from the locked configuration to the unlocked configuration, the lateral compressive force that initially reduces the cross-sectional dimension of the through-channel restricted by the lateral restraint elements can be reduced to such an extent that the cross-sectional dimension of the through-channel can increase towards the unloaded configuration. The compression element may be the unlocking actuating member itself or may be a separate component that cooperates with the unlocking actuating member.

[0031] According to another specific embodiment, the transverse limiting element is formed by an inner member surrounding the through-channel and having a longitudinal slit extending between the elongated portions of the inner member and also having a tapered outer shape at its cantilevered end. Furthermore, the compression element is formed by an outer member surrounding the inner member and having a tapered inner shape at an inner surface opposite to the cantilevered end of the inner member.

[0032] In other words, the locking mechanism may include an internal member and an external member. The internal member may include a plurality of elongated portions extending in the longitudinal direction and parallel to each other so as to enclose the through-channel between the elongated portions relative to each other in the longitudinal middle axis of the through-channel. The elongated portion may be retained at one end and may be elastically deflected at the opposite cantilever end. The elongated portion may have a shape such as a conical shape at its outer surface at the cantilever end. The external member is configured to cooperate with the internal member so as to apply a variable compressive force to the elongated portion of the internal member at or near the cantilever end of the elongated portion of the internal member, and the compressive force varies according to the actuation state of the locking mechanism. In particular, the external member surrounds the internal member and has a shape such that the inner surface of the external member is conical at least in the region relative to the cantilever end of the internal member.

[0033] The outer member and the inner member can be configured so that when the locking mechanism is actuated between the locked configuration and the unlocked configuration, they are displaced relative to each other in the longitudinal direction. For example, when actuated from the locked configuration to the unlocked configuration, the outer member and the inner member can be displaced so that the tapered outer surface of the inner member moves away from the opposite tapered inner surface of the outer member. As a result of this movement, the compressive force applied by the outer member to the cantilever end of the inner member can be reduced, so that the cross-sectional size of the through-channel surrounded by the inner member is enlarged due to the elongated portion of the inner member being resiliently biased in the radially outward direction.

[0034] According to another specific embodiment, the mandrel includes a tether hypotube portion and a release hypotube portion disposed more proximal to the tether hypotube portion. The tether hypotube portion has a first cross-sectional dimension, and the release hypotube portion has a second cross-sectional dimension greater than the first cross-sectional dimension. Wherein, when the locking mechanism is in a locked configuration, the cross-sectional dimension of the through-channel of the locking mechanism is smaller than the second cross-sectional dimension of the release hypotube portion, and when the locking mechanism is in an unlocked configuration, the cross-sectional dimension of the through-channel of the locking mechanism is greater than the second cross-sectional dimension of the release hypotube portion.

[0035] In such an embodiment, the mandrel generally includes at least two portions referred to herein as a tether hypotube portion and a release hypotube portion. Since these portions have different cross-sectional dimensions, the smaller tether hypotube portion can extend through the through-channel of the locking mechanism when the locking mechanism is in its locked configuration and thus has a smaller cross-sectional dimension, while the larger release hypotube portion can extend through the through-channel of the locking mechanism only when the locking mechanism is in its unlocked configuration and thus has a larger cross-sectional dimension.

[0036] Thus, as long as the locking mechanism is in its locked configuration, the mandrel can only be displaced longitudinally so long as its tether hypotube portion extends through the through-channel, and any further longitudinal displacement is blocked when the mandrel abuts the through-channel with its large diameter release hypotube portion. Such mandrel abutment blockage can be released only by actuating the locking mechanism to its unlocked configuration, thereby expanding the cross-sectional size of the through-channel and thus allowing the release hypotube portion to be inserted into the through-channel, thereby enabling further longitudinal distal displacement of the mandrel to a position where it can release the IMD retained at its distal end.

[0037] According to an embodiment, the control handle further comprises a tactile locker feedback mechanism configured to generate tactile locker feedback to a user of the handle when the locking mechanism is displaced relative to the handle housing beyond at least one locker feedback position when switching from the locked configuration to the unlocked configuration.

[0038] Due to the tactile locker feedback generated by such a tactile locker feedback mechanism, a user of the control handle can be informed of a particular configuration that occurs when operating the control handle. For example, locker feedback can be given when a particular configuration is reached during switching of the locker mechanism from a locked configuration to an unlocked configuration. Since such locker feedback is given in a tactile manner, the user does not need to, for example, visually observe the control handle. Giving such tactile locker feedback can ergonomically improve the user's handling of the delivery system and reliably improve the user's handling of the delivery system.

[0039] According to another specific embodiment, the tactile locker feedback mechanism includes at least one groove and at least one spring plunger, the groove being arranged at one of the handle housing and the locking mechanism, and the spring plunger being arranged at the other of the handle housing and the locking mechanism, wherein the groove and the spring plunger can be configured to induce a retraction force on the locking mechanism when the user rotates the locking mechanism beyond the at least one locker feedback position.

[0040] The recess and the spring plunger can be configured to cooperate with each other when aligned with each other so as to generate a retraction force. For example, the spring plunger can be elastically biased towards the recess such that when the spring plunger and the recess are aligned, the spring plunger can "snap" into the recess. For example, the spring plunger can project from the surface of the locking mechanism towards the opposite surface of the handle housing, and the recess can form a depression extending along the opposite surface of the handle housing, and vice versa.

[0041] By causing a retraction force on the locking mechanism when passing through the locker feedback position, the arrangement including the recess and the spring plunger can generate a haptic locker feedback to the user, which is related to a specific configuration of the delivery system to be indicated to the user. The retraction force can decelerate the rotational displacement of the locking mechanism and / or may require the user to temporarily increase the force acting on the locking mechanism in order to rotate the locking mechanism beyond the locker feedback position. Thus, the surgeon can tactilely sense, for example, when he activates the locking mechanism from its locked configuration to its unlocked configuration, thereby, for example, achieving a release mode of the delivery system, in which the IMD can be released from the delivery system.

[0042] The delivery system according to the second aspect of the present invention includes a control handle according to an embodiment of the first aspect of the present invention. In addition, the delivery system includes an elongate delivery catheter mechanically connected to the control handle and a mandrel controlled by the control handle to be longitudinally displaceable relative to the delivery catheter. Wherein, the control handle can be configured to and can cooperate with the delivery catheter and the mandrel, as further described above and below. In addition, the delivery catheter and the mandrel can be configured to perform various functions.

[0043] In particular, according to an embodiment, the delivery system can be configured such that when the mandrel is displaced a deployment distance relative to the delivery catheter, a medical device, particularly an ILP, held at the distal end of the delivery catheter is deployed from the sheath of the delivery catheter. In addition, the delivery system can further include a tether member connected to the distal end of the mandrel and connected to the medical device. Then, the delivery system can be configured such that when the mandrel is displaced a tether distance relative to the delivery catheter in addition to the deployment distance, the tether member is displaced between a retracted position and a popped-out position. Wherein, in the retracted position, the tether member pulls the medical device into a fixed state with the end cup at the distal end of the delivery catheter, while in the popped-out position, the tether member releases the medical device from the fixation with the end cup. In addition, the delivery system is further configured such that when the mandrel is displaced a release distance relative to the delivery catheter in addition to the tether distance and the deployment distance, the tether member is displaced between the popped-out position and a release position, wherein, in the release position, the tether member releases the medical device from any connection with the delivery system.

[0044] According to another specific embodiment, the mandrel includes a bare mandrel portion, a tether hypotube portion disposed further proximate to the bare mandrel portion, and a release hypotube portion disposed further proximate to the tether hypotube portion. The bare mandrel portion has a first cross-sectional dimension, the tether hypotube portion has a second cross-sectional dimension greater than the first cross-sectional dimension, and the release hypotube portion has a third cross-sectional dimension greater than the second cross-sectional dimension. Wherein the length of the bare mandrel portion corresponds to or is longer than the deployment distance, the length of the tether hypotube portion corresponds to or is longer than the tether distance, and the length of the release hypotube portion corresponds to or is longer than the release distance.

[0045] Except the feature described herein with reference to various embodiments of the present invention, control handle and delivery system can be configured according to various additional aspects and embodiments.For example, in another patent application submitted by the applicant and the present application simultaneously, such additional aspects and embodiments are described, and the title of this patent application is " Control handle with a slide mechanism for controlling functions of a delivery system for implanting a medical device ", and its content is incorporated herein by reference in its entirety.In the following paragraphs, the example of such additional aspects and embodiments is described.

[0046] According to a first additional aspect, a control handle for controlling the functions of a delivery system for an implantable medical device is provided. The delivery system includes an elongated delivery catheter and a mandrel that can be longitudinally displaced relative to the delivery catheter. The control handle includes a slider mechanism and a handle housing. The slider mechanism is configured to be able to shift between a fully undeployed position and a fully deployed position relative to the handle housing in a longitudinal direction, thereby shifting the mandrel a deployment distance relative to the delivery catheter. The slider mechanism is also configured so that, in the fully undeployed position, the mandrel is fixed relative to the slider mechanism, so that the mandrel cannot move relative to the slider mechanism beyond a predetermined stop position due to a mechanical mandrel movement block, and when the tether position exceeds the fully deployed position, the mandrel can move relative to the slider mechanism in the longitudinal direction beyond a predetermined stop position due to the release of the mandrel movement block.

[0047] According to a second additional aspect, a delivery system is proposed, which includes a control handle according to an embodiment of the first additional aspect, an elongated delivery catheter mechanically connected to the control handle, and a core shaft controlled by the control handle so as to be longitudinally displaceable relative to the delivery catheter.

[0048] The basic idea of ​​the implementation of these additional aspects can be explained as being based on, among other things, the following observations and insights.

[0049] Briefly summarized in a non-limiting manner, the implementation of these additional aspects involves a control handle that can be used in conjunction with other components of a delivery system to control the functions of the delivery system during the implantation of an IMD (such as a leadless pacemaker). Herein, the control handle includes a slider mechanism disposed at or within the handle housing. The slider mechanism can be actuated, for example, by a user (such as a surgeon) of the delivery system. In particular, the slider mechanism can be displaced in the longitudinal direction of the control handle between a first position (referred to herein as the fully undeployed position) and a second position (referred to herein as the fully deployed position). When displacing the slider mechanism between such longitudinally opposite extreme positions, the slider mechanism cooperates with a mandrel and causes the mandrel to displace a predetermined distance relative to the delivery catheter, which predetermined distance is referred to herein as the deployment distance. Due to this displacement of the mandrel, the IMD connected to the distal end of the mandrel can be displaced relative to a protective cup disposed at the distal end of the delivery catheter in order to deploy the IMD from such protective cup.

[0050] In addition to achieving such deployment movement by displacing the mandrel, the slider mechanism is further configured to automatically disable or enable additional movement of the mandrel relative to the slider mechanism based on the current position of the slider mechanism relative to the handle housing. In particular, the slider mechanism is configured to establish a mechanical mandrel movement block when positioned in the fully undeployed position and to release such mechanical mandrel movement block when slid to the fully deployed position and then reaching a so-called tethered position beyond the fully deployed position. When the mandrel movement block is established, the slider mechanism cooperates with the mandrel such that the mandrel does not displace relative to the slider mechanism beyond a predetermined stop position. In the delivery system, displacing the mandrel beyond the deployment position but not beyond the predetermined stop position can allow for the establishment of a so-called tethered configuration, where the IMD is released from fixation with the catheter but remains connected to the catheter via a tether. The predetermined stop position can be set such that the mandrel movement block prevents the mandrel from displacing beyond such tethered configuration, i.e., for example, displacing to a release configuration where the mandrel pops out of the catheter to such a distance that the tethered configuration is released and the mechanical connection between the IMD and the catheter is opened.

[0051] Thus, the slider mechanism in the control handle can be actuated ergonomically and precisely. In particular, the slider mechanism can simplify the deployment procedure established with the delivery system and can then automatically switch from a deployment mode to a tethered mode, in which the IMD is fully deployed and popped out of the delivery catheter but remains tethered to the delivery system, and thus enables tests such as a pull test, and if needed, for example, due to a negative pull test, recapture of the IMD.

[0052] Hereinafter, the characteristics of embodiments of such additional aspects will be described in more detail.

[0053] The control handle is typically configured to control two or more functions of the delivery system during implantation of the IMD (especially an ILP).

[0054] The delivery system includes a delivery catheter and a mandrel. The catheter is elongate, i.e., having dimensions much larger in the longitudinal direction than in the transverse direction. For example, the catheter can have a length greater than 10 cm, typically between 50 cm and 200 cm, while having a diameter less than 5 cm, typically between 0.5 cm and 2 cm. The catheter is bendable in its transverse direction such that it can be maneuvered and / or guided along a curved path (e.g., through a patient's blood vessel). Typically, the catheter has an internal lumen through which the mandrel extends. The mandrel is typically a wire or cord. Therein, the mandrel is typically bendable in the transverse direction but substantially inelastic in the longitudinal direction.

[0055] The slider mechanism and the handle housing are components of the control handle. The control handle can include additional components, such as a manipulation mechanism for maneuvering the delivery catheter or a locking mechanism for blocking any unintended mandrel movement that causes the IMD to be finally released from the delivery system. All of these components can be made of materials suitable for medical applications, such as materials that can be suitably sterilized. For example, some or all of the components can be made of plastic materials and optionally can be injection-molded components. Alternatively or additionally, at least some of the components can be made of metals such as stainless steel or nitinol.

[0056] The slider mechanism can be displaced in the longitudinal direction relative to the handle housing. In particular, for example at the start of a surgical procedure, the slider mechanism can be arranged in a fully undeployed position. Such a fully undeployed position can be a position where the slider mechanism is arranged at the most proximal position relative to the handle housing. When arranged in such a fully undeployed position, the IMD held at the distal end at the mandrel can be arranged in an undeployed configuration, where the IMD is housed within the delivery catheter, preferably within a protective cup of the delivery catheter. During the surgical procedure, the slider mechanism can then be displaced, for example, by the surgeon pushing the slider mechanism relative to the handle housing away from the fully undeployed position towards the fully deployed position. Upon reaching such a fully deployed position, the mandrel is arranged in a deployed configuration, where the IMD is deployed, i.e., released from the accommodation and / or fixation with the delivery catheter, and can be anchored, for example, in the tissue of the patient at the implantation site.

[0057] In addition to movement between a fully undeployed position and a fully deployed position, the slider mechanism allows further movement towards a tether position. Such a tether position can be reached when the slider mechanism is longitudinally displaced to the fully deployed position and can then be moved further, either actively or passively, beyond such a position. When arranged at such a tether position, the mandrel can be moved not only to the fully deployed configuration but also further to a tether configuration in which the IMD is in a tethered mode at its distal end, i.e., loose relative to the catheter. Preferably, the tether position is arranged at a location laterally remote from the fully deployed position. In other words, while the slider mechanism can move in the longitudinal direction between the fully undeployed position and the fully deployed position, it can move further in a lateral direction that intersects or is preferably orthogonal to such a longitudinal direction in order to reach the tether position.

[0058] According to one embodiment, the slider mechanism is configured such that when the slider mechanism is displaced to the fully deployed position and then all forces applied by the user are released, the slider mechanism automatically displaces to the tether position, thereby releasing the mandrel movement block.

[0059] In other words, the slider mechanism can be configured such that when the slider mechanism reaches the fully deployed position, it automatically moves further towards the tether position without any further force being applied, for example, by a surgeon.

[0060] Thus, when the delivery system reaches the deployed configuration and the surgeon, for example, releases their actuation of the slider mechanism, the control handle automatically switches to the tether mode, in which the mandrel can be further displaced relative to the delivery catheter beyond a predetermined stop position. Thus, the mandrel movement block activated during the initial part of the surgical sequence for initially deploying the IMD is automatically released when the slider mechanism reaches the fully deployed position and then moves further to the tether position. This automatic movement and release of the mandrel movement block can significantly simplify the handling of the delivery system.

[0061] According to one embodiment, the slider mechanism includes a slider body and a slider housing. The slider body is arranged at the slider housing in a manner that is elastically biased in a lateral direction away from the slider housing. In addition, the slider body and the slider housing are configured such that as long as the slider mechanism is positioned at the fully undeployed position or somewhere between the fully undeployed position and the fully deployed position, the slider body remains fixed to the slider housing in a pulled-down configuration, while at the fully deployed position, this fixation is released such that the slider body automatically displaces in the lateral direction away from the slider housing to a pulled-up configuration due to the elastic biasing, thereby releasing the mandrel movement block.

[0062] In other words, the slider mechanism can include at least two sub-components that can move relative to each other. In particular, the slider body and the slider housing can move relative to each other in a lateral direction that intersects the longitudinal direction of the control handle. Among them, the slider body can be elastically biased, that is, there can be an elastic force acting on the slider body such that the slider body is elastically pre-tensioned in the lateral direction away from the slider housing. The elastic biasing can be achieved using, for example, one or more springs or other elastic elements. Such elastic elements can be interposed between the slider housing and the slider body.

[0063] To achieve a beneficial and preferably automatic function of the slider mechanism, the slider mechanism together with its slider body and slider housing is configured such that as long as the slider mechanism is somewhere between the fully undeployed position and the fully deployed position, the slider body remains in the pulled-down configuration, but once the fully deployed position is reached, and furthermore, the slider body is not actively pressed down by, for example, a surgeon to its pulled-down configuration, the slider body automatically switches to the pulled-up configuration. Among them, in the pulled-down configuration, the slider body is closer to the central axis of the control handle, while in the pulled-up configuration, the slider body is laterally displaced and thus farther from the central axis.

[0064] Therefore, between the fully undeployed position and the fully deployed position, the slider mechanism has only a single degree of freedom of movement and can only slide in the longitudinal direction, while when the fully deployed position has been reached, the slider mechanism and its slider body acquire a further degree of freedom of movement, where the slider body can be laterally displaced from the pulled-down configuration to the pulled-up configuration.

[0065] Therefore, a surgeon can easily push the slider mechanism from the initial fully undeployed position to the fully deployed position, and then, when the surgeon releases the lateral pressure on the slider mechanism, for example, by removing his thumb, the slider body can "pop up" into the pulled-up configuration and can thereby release the core shaft movement block.

[0066] After reaching the pulled-up configuration, the core shaft can thus move longitudinally relative to the slider mechanism beyond a predetermined stop position, thereby activating the tethering mode of the delivery system. In other words, if the slider body is in the pulled-down configuration, any movement of the slider is converted into a corresponding movement of the core shaft. If the slider body is in the pulled-up configuration, the core shaft can move independently of the slider.

[0067] According to one embodiment, the slider body and the slider housing each include through-holes extending in the longitudinal direction such that the core shaft extends longitudinally through the two through-holes. Among them, the through-hole of the slider body includes two parts, where the first section has a smaller cross-sectional dimension than the second section, such that when the slider body is in the pulled-down configuration, the core shaft extends through the first section, and when the slider body is in the pulled-up configuration, the core shaft extends through the second section.

[0068] In other words, the mandrel may extend along a straight line that passes through a through hole that extends through both the slider body and the slider housing. While the through hole in the slider housing may have, for example, a circular cross section having a single diameter that is larger than the mandrel, the through hole in the slider body comprises two sections, each of which may have a circular cross section, but the two sections have different diameters. The two sections overlap laterally so that they form a single through hole having a profile with a smaller first section and a larger second section, similar to the profile of a keyhole. Therein, the first section of the through hole of the slider body generally has a smaller transverse dimension than the through hole of the slider housing, while the second section of the through hole of the slider body generally has the same or larger transverse dimension as the through hole of the slider housing.

[0069] As long as the slider body is in its pulled-down configuration, the first section of its through hole with the smaller dimension is aligned with the through hole of the slider housing. Therefore, a portion of the spindle extending through the through holes in the slider body and the slider housing must have a smaller diameter than the smaller dimension of the first section of the through hole in the slider body in order to be able to be displaced laterally along the slider mechanism.

[0070] However, when the slider body is in its pull-up configuration, the second section of its through hole having a larger size is aligned with the through hole in the slider housing. Therefore, the portion of the spindle extending through the slider body and the slider housing can have a larger size than in the first case, that is, its diameter can be as large as the diameter of the through hole through the slider housing and the second section of the through hole through the slider body.

[0071] According to one embodiment, the mandrel includes a bare mandrel portion and a tether hypotube portion disposed more proximal to the bare mandrel portion. The bare mandrel portion has a first cross-sectional dimension, and the tether hypotube portion has a second cross-sectional dimension greater than the first cross-sectional dimension. The cross-sectional dimension of a first section of the through hole of the slider body is smaller than the second cross-sectional dimension of the tether hypotube portion, and the cross-sectional dimension of a second section of the through hole of the slider body is larger than the second cross-sectional dimension of the tether hypotube portion.

[0072] In such an embodiment, the mandrel generally comprises at least two distinct portions, referred to herein as a bare mandrel portion and a tether hypotube portion. Since these portions have different cross-sectional dimensions, the smaller bare mandrel portion can extend through the through hole having the smaller cross-sectional dimension, while the larger tether hypotube portion can extend only through the through hole having the larger cross-sectional dimension. Wherein the cross-sectional dimensions of the mandrel are set such that the tether hypotube portion can extend through the slider mechanism, and thus the tether hypotube portion can only be displaced in the longitudinal direction when the slider body is in its pull-up configuration and thus the mandrel extends along the larger second section of its through hole.

[0073] According to one embodiment, the control handle further includes a haptic deployment feedback mechanism. The haptic deployment feedback mechanism is configured to generate haptic deployment feedback to a user of the handle when the slider mechanism is displaced beyond at least one predetermined deployment feedback position longitudinally located between the fully undeployed position and the fully deployed position.

[0074] Due to the haptic deployment feedback generated by such a haptic deployment feedback mechanism, a user of the control handle can be notified of a particular configuration that occurs when operating the control handle. For example, a deployment feedback can be given when a particular configuration is reached during displacement of the slider mechanism from the fully undeployed position to the fully deployed position. Since such deployment feedback is given haptically, the user does not need to visually observe the handle, for example. Giving such haptic deployment feedback can ergonomically improve the user's handling of the delivery system and reliably improve the user's handling of the delivery system.

[0075] According to an embodiment, the predetermined first deployment feedback position corresponds to a position such that when the slider mechanism is between the fully undeployed position and the first deployment feedback position, the slider mechanism positions the mandrel in a protected configuration in which the mandrel and the delivery catheter are positioned relative to each other such that a protector sheath held at the distal end of the delivery catheter completely covers a medical device held at the distal end of the mandrel, while when the slider mechanism is longitudinally displaced beyond the first deployment feedback position, the slider mechanism positions the mandrel in at least a partially unprotected configuration in which the mandrel and the delivery catheter are positioned relative to each other such that the protector sheath no longer completely covers the medical device.

[0076] Thus, when the slider mechanism is displaced beyond the position where the IMD transitions from the configuration where the IMD is completely covered by the protector sheath to the configuration where the IMD is no longer completely covered by the protector sheath, the user of the control handle can receive haptic deployment feedback that the IMD has at least partially or completely popped out of the protector sheath and can thus be anchored, for example, in patient tissue at the intended implantation location.

[0077] According to a further embodiment, the predetermined second deployment feedback position corresponds to a position such that when the slider mechanism slides longitudinally from the first deployment feedback position to the second deployment feedback position, the slider mechanism continuously positions the mandrel relative to the delivery catheter in an anchoring configuration such that an anchoring mechanism at the distal end of the medical device pops out of the sheath in order to anchor the medical device in cardiac tissue, while when the slider mechanism is displaced beyond the second deployment feedback position towards the fully undeployed position, the slider mechanism continuously positions the mandrel in an unprotected configuration in which the mandrel and the delivery catheter are positioned relative to each other such that the sheath no longer covers the medical device.

[0078] Thus, when the slider mechanism is displaced beyond a position where the IMD transitions from a configuration in which its anchoring mechanism has not yet been activated, e.g., by popping out of a protector sheath, to a configuration in which the anchoring mechanism is activated to anchor the IMD at the intended implantation location, the user of the control handle can receive haptic deployment feedback.

[0079] According to one implementation, the haptic deployment feedback mechanism includes at least one ridge and at least one buffer. The ridge is disposed at one of the handle housing and the slider mechanism, and the buffer is disposed at the other of the handle housing and the slider mechanism. The ridge and the buffer are configured to cause a retracting force on the slider mechanism when the user longitudinally pushes the slider mechanism beyond at least one deployment feedback position.

[0080] By causing a retracting force on the slider mechanism as it passes through the deployment feedback position, the arrangement including the ridge and the buffer can generate haptic deployment feedback to the user that is related to a particular configuration of the delivery system to be indicated to the user. The retracting force can decelerate the longitudinal displacement of the slider mechanism and / or may require the user to temporarily increase the force he exerts on the slider mechanism in order to translate the slider mechanism beyond the deployment feedback position.

[0081] According to another particular embodiment, the slider mechanism is guided in the handle housing during longitudinal displacement, and the deployment feedback mechanism is configured such that the ridge and the buffer are elastically biased towards each other in a lateral direction that intersects the longitudinal direction.

[0082] For example, the ridge can be a protrusion that projects from the handle housing in a direction towards the slider mechanism. The buffer can be an element that projects from the slider mechanism in a direction towards the handle housing. Thus, the ridge and the buffer can project in opposite directions. The projecting direction of the ridge as well as the projecting direction of the buffer can be orthogonal to the longitudinal direction of the handle. At least one of the ridge and the buffer can be implemented to be elastically displaceable in a direction opposite to the projecting direction. Thus, when a force acts on the ridge and / or the buffer in such a direction, the corresponding element can be pulled aside, i.e., can move or deflect away from the other element. Due to such an action, the buffer and the ridge temporarily cause a higher retracting force that resists the displacement of the slider mechanism relative to the handle housing and can thus generate haptic deployment feedback.

[0083] According to one embodiment, the control handle further includes a valve disposed in the slider mechanism to prevent backflow through the lumen of the delivery catheter.

[0084] Such a valve may be disposed within the slider mechanism at or adjacent to the lumen of the delivery catheter and may block blood from such a lumen from otherwise flowing through the through passage of the control handle. Thus, the valve may prevent blood that enters the delivery catheter at the distal end within the patient from exiting at the proximal end of the delivery catheter, thereby potentially contaminating components of the control handle or even exiting the control handle.

[0085] According to a further particular embodiment, the valve is formed by a membrane which is held in a slide mechanism in a cross-sectional direction and has a through hole which is configured to closely surround a mandrel extending through the slide mechanism and through the through hole of the membrane.

[0086] Thus, the valve can seal a through passage through the control handle, wherein the mandrel generally extends from a location proximal to the control handle to an extended portion of the delivery catheter extending through the distal side of the control handle. Due to the diaphragm valve, no blood can flow from the interior of the delivery catheter toward a location proximal to the control handle in a direction parallel to the mandrel.

[0087] The delivery system according to the second additional aspect comprises a control handle according to an embodiment of the first additional aspect. In addition, the delivery system comprises an elongated delivery catheter mechanically connected to the control handle and a mandrel controlled by the control handle so as to be longitudinally displaceable relative to the delivery catheter. Wherein, the control handle can be configured as and can cooperate with the delivery catheter and the mandrel, as further described above and below. In addition, the delivery catheter and the mandrel can be configured to achieve various functions.

[0088] In particular, according to one embodiment, the delivery system may be configured such that when the mandrel is displaced relative to the delivery catheter by a deployment distance, the medical device held at the distal end of the delivery catheter is deployed from the sheath of the delivery catheter. In addition, the delivery system may include a tether member connected to the distal end of the mandrel and to the medical device, and the delivery system may be configured such that when the mandrel is displaced relative to the delivery catheter by a tether distance other than the deployment distance, the tether member is displaced between a retracted position and an ejected position. In the retracted position, the tether member pulls the medical device into fixation with the end cup at the distal end of the delivery catheter, and in the ejected position, the tether member releases the medical device from fixation with the end cup.

[0089] According to a further specific embodiment, the mandrel comprises at least a bare mandrel portion and a tether hypotube portion disposed more proximal to the bare mandrel portion. The bare mandrel portion has a first cross-sectional dimension, and the tether hypotube portion has a second cross-sectional dimension greater than the first cross-sectional dimension. The length of the bare mandrel portion corresponds to or is longer than the deployment distance, and the length of the tether hypotube portion corresponds to or is longer than the tether distance.

[0090] It should be noted that the various embodiments of the control handle described herein, as well as various additional aspects and embodiments of such a control handle, describe possible features and advantages of embodiments of the present invention. Those skilled in the art will recognize that features can be appropriately transferred from one embodiment or implementation to another, and features can be modified, adapted, combined, and / or replaced, etc., in order to arrive at additional embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0091] Hereinafter, advantageous embodiments of the present invention will be described with reference to the drawings. However, neither the drawings nor the description should be construed as limiting the present invention.

[0092] Figure 1 A partial exploded longitudinal cross-sectional view of a control handle in a deployment system according to an embodiment of the present invention is shown.

[0093] Figure 2 Shows Figure 1 a perspective view of a part of the control handle.

[0094] Figure 3 Visualizes various operating stages when actuating the slider mechanism in the control handle in longitudinal cross-sectional views and associated cross-sectional views.

[0095] Figure 4 Details of the control handle are shown in perspective views and associated cross-sectional views.

[0096] Figure 5 A cross-sectional view showing internal details of a haptic deployment feedback mechanism within the control handle is shown.

[0097] Figure 6 A perspective view of a locking mechanism in the control handle is shown.

[0098] Figure 7 Visualizes Figure 6 the internal details of the locking mechanism.

[0099] Figure 8 Visualizes various operating stages when actuating the locking mechanism and the mandrel in the control handle in side views.

[0100] Figure 9 A longitudinal cross-sectional view showing internal details of the locking mechanism is shown.

[0101] Figure 10 Cross-sectional views and longitudinal cross-sectional views showing internal details of a haptic locker feedback mechanism within the control handle are shown. DETAILED DESCRIPTION

[0102] The drawings are only schematic and not to scale. The same reference numerals denote the same or similar features.

[0103] Figure 1 Shown is a control handle 1 according to an embodiment of the present invention and according to other embodiments for controlling the functionality of a delivery system 3 for an implantable medical device (not shown).

[0104] The delivery system 3 includes an elongate delivery catheter 5 and a mandrel 7 that is longitudinally displaceable relative to the delivery catheter 5 and also extends through the control handle 1. Herein, the longitudinal positioning of the mandrel 7 controls or affects the operation of the delivery system 5, for example, during a surgical procedure, an IMD (particularly an ILP) held at the distal end of the delivery system 5 is successively deployed, anchored, tested, and ultimately released. Although Figure 1 focusing mainly on the visualization details of the control handle 1 and showing only the proximal portion of the delivery system 3, details of a possible delivery system 3 controlled by the control handle 1, particularly details of the operating principle of such a delivery system 3, have been described in the applicant's prior applications (such as WO 2020 / 043481 A1 and WO 2020 / 187663 A1).

[0105] The control handle 1 includes a handle housing 9 and a slider mechanism 11. The handle housing 9 is composed of a half shell 8. The slider mechanism 11 can be used to specifically control the deployment procedure and / or the recapture procedure at the delivery system, and to selectively activate or deactivate a so-called tether mode at the delivery system 3.

[0106] The slider mechanism 11 can be displaced relative to the handle housing 9 in a longitudinal direction 13. In particular, the slider mechanism 11 can be longitudinally displaced between a fully undeployed position and a fully deployed position. In the fully undeployed position, the slider mechanism 11 is arranged at the most proximal position, i.e., slid along the proximal direction 15 to the proximal end of the displacement range, while in the fully deployed position, the slider mechanism is arranged at the most distal position, i.e., slid along the distal direction 17 to the distal end of the displacement range.

[0107] The slider mechanism 11 interacts with the mandrel 7 such that when the slider mechanism 11 is displaced between the fully undeployed position and the fully deployed position, the mandrel 7 is displaced a predetermined deployment distance relative to the delivery catheter 5. In addition, the slider mechanism 11 is configured such that when arranged in the fully undeployed position, the mandrel 7 is fixed relative to the slider mechanism 11 such that the mandrel 7 does not displace relative to the slider mechanism 11 beyond a predetermined stop position due to the establishment of a mechanical mandrel movement block. However, when set to a so-called tether position, which can be reached when the slider mechanism 11 is displaced beyond the fully deployed position, the mandrel 7 can move relative to the slider mechanism 11 in the longitudinal direction beyond the predetermined stop position due to the release of the mandrel movement block.

[0108] In addition, the control handle 1 includes a locking mechanism 19. The locking mechanism 19 can specifically be used to control whether the mandrel 7 can be shifted to a position where the delivery system 3 finally releases the medical device at its distal end without being mechanically connected to the delivery system 3.

[0109] The locking mechanism 19 can be switched between a locked configuration and an unlocked configuration. In the locked configuration, the mandrel 7 is fixed relative to the locking mechanism 19 such that the mandrel 7 does not shift relative to the locking mechanism 19 beyond a predetermined abutment position due to activation of the mechanical mandrel abutment block. However, when switching to the unlocked configuration, the mandrel abutment block is released, and the mandrel 7 can move longitudinally relative to the locking mechanism 19 beyond the abutment position.

[0110] In addition, Figure 1 A manipulation mechanism 10 for manipulating the delivery catheter 5 and an insertion tube 12 that can be used to insert a contrast agent through the delivery catheter 5 are shown.

[0111] First, reference will be made to Figures 1 to 5 describe the details, features, and possible advantages of the slider mechanism 11 in the control handle 1, which is used to control the deployment or retraction of the IMD and further control the activation or deactivation of the tethering mode in the delivery system 3. Among them, the details, characteristics, and possible advantages are described with reference to exemplary embodiments or implementations related to the implantation process of a leadless pacemaker.

[0112] The implantation process of a leadless pacemaker generally requires an implantation catheter capable of manipulating, positioning, and delivering the implant to a specific location in the heart. The normal implantation procedure for implanting a leadless pacemaker into the right ventricle or atrial appendage of the heart utilizes access through the femoral vein of the patient. A guidewire is installed, which traverses upward from the incision site into the atrium of the heart. Once the guidewire is in place, a catheter is required that can safely accommodate the implant and its fixation mechanism and safely protect it from harmful interactions with the patient's anatomy or the guidewire. The catheter is then inserted through the guidewire until its distal end exits the guidewire in the atrium. Once the distal end of the catheter is no longer contained within the guidewire, it must pass through the tricuspid valve and enter the right ventricle, or directly from the atrium upward and over the atrium to reach the atrial appendage. Once the distal end of the catheter is at the selected deployment position, the implant is deployed into the heart wall tissue.

[0113] Once the implant is deployed, the user performs tests including electrical measurements and fixation measurements to confirm that the implantation site is suitable before releasing the implant. If any electrical or fixation test results are shown to be unacceptable, the implant is recaptured, repositioned, and implanted at a new location. Once the electrical and fixation test measurement results are found to be acceptable, the user releases the implant from the tether connecting it to the implantation catheter. After successfully releasing the implant, the tool is then safely removed from the patient's anatomy.

[0114] The control handle 1 described herein can be used as a deployment actuator mechanism for an implant catheter, which allows a user to deploy an implant and seamlessly and controllably enter a tethering mode for evaluating the fixation of the implant to the heart wall. If the user has determined through measurement that the implantation site is unacceptable, the novel mechanism detailed in this disclosure will allow the user to safely and reliably exit the tethering mode and recapture the implant back into the protective cup of the catheter so that the implant can be repositioned, deployed, and ultimately released at a newly selected location.

[0115] Previous solutions in the art have included using an actuator to retract the outer catheter and the protective cup proximally away from the implant in order to deploy the implant into the heart wall. The actuator thus retracts proximally to deploy the implant and advances distally to recapture the implant. The deployment actuator only controls the deployment process of the implant and is completely separate from switching the tethering mode to active or inactive. This solution uses a separate actuator to control the tethering mode, which is used to lock and unlock the tether from moving (i.e., making the tethering mode inactive for locking and active for unlocking). Additionally, this solution utilizes a long flexible suture as a means for tethering to the implant catheter.

[0116] Furthermore, the tether locking / unlocking mechanism is essentially just a stopcock through which the suture extends internally. When the stopcock is locked via the handle actuator, it clamps / tightens the suture within it and prevents the suture from moving distally or proximally. When it is actuated to the unlocked position, the stopcock releases its tightening on the suture. Additionally, the stopcock has no valve or device to prevent back bleeding within it when it is in the open / unlocked position. Thus, once the mechanism becomes unlocked and the tethering mode becomes engaged, it is essentially an open tube connected to the wet path of the catheter, where blood can slowly drip backward from the proximal end of the catheter and around the tether itself. This means that it is not advisable to perform any flushing of the catheter when the catheter is in the tethering mode, as the flushing fluid medium will only exit from the proximal end of the catheter and reach the patient or the user.

[0117] Another currently commercially available solution has a different approach, which consists of two flexible release pins to maintain the tether and the handle, and the handle deploys the implant by screwing the implant into the heart wall.

[0118] Another method uses a separate actuator to deploy the implant and switch between the active / inactive tethering mode. Multiple actuators result in reduced usability for the user as they have more controls to actuate and steps to perform and remember throughout the implantation process. Additionally, since the actuators are separated, there is a chance that the user may accidentally start the recapture process without deactivating the tethering mode by locking the tether actuator. This can lead to complications during recapture and may damage the implant catheter during the recapture process (e.g., if the user fails to lock the tether before attempting the recapture process).

[0119] Furthermore, there is no valve or device to prevent back bleeding inside the stopcock valve. Thus, once the mechanism becomes unlocked and the tethering mode becomes engaged, it is essentially an open tube connected to the wet path of the catheter, where blood can slowly drip back from the proximal end of the catheter. This means that it is not recommended to perform any flushing on the catheter when it is in the tethering mode, as the flushing fluid medium will only exit the proximal end of the catheter and reach the patient / user.

[0120] It is also known that sutures exert excessive friction on both the user and the implant during removal, which may potentially cause the user to accidentally dislodge the fixation mechanism of the implant from the heart wall if the user accidentally applies excessive force during the release and removal of the suture. Sutures also increase the risk of clotting or tangling during use. Finally, sutures do not have fluoroscopic visibility.

[0121] In view of such conventional methods, the aim is to design the control handle 1 as a single actuator and handle mechanism, which allows the user to provide superior means to safely and reliably deploy the leadless pacemaker implant and automatically switch to the tethering mode, and also exit the tethering mode and recapture the leadless pacemaker implant so that it can be repositioned to a new location, redeployed and finally fully released from the catheter.

[0122] The control handle 1 includes a slider mechanism 11. The slider mechanism 11 is configured to automatically switch from the deployment mode to the tethering mode. Specifically, the slider mechanism 11 is configured such that when the slider mechanism is displaced from the fully undeployed position to the fully deployed position and then all forces applied by the user on the slider mechanism are released, the slider mechanism automatically moves to the tethering position, in which the core shaft movement block is released.

[0123] For this configuration and as Figure 1 shown and in Figures 2 to 5As shown in more detail in FIG. 1 , the slider mechanism 11 comprises a slider body 21 and a slider housing 23. The slider body 21 is arranged at or in the slider housing 23 so as to be elastically biased away from the slider housing 23 in the lateral direction 25. To this end, some slider springs 27 are arranged between the slider body 21 and the slider housing 23. In addition, at the side opposite to the side of the slider housing 23, the slider body 21 comprises a textured actuation structure 29, via which the user can displace the slider mechanism 11 in the longitudinal direction 13, i.e., in the proximal direction 15 for the deployment process, or in the distal direction 17 for the recapture process, and via which the user can additionally apply pressure to the slider body 21 to resist the elastic bias in the lateral direction 25 or to release such pressure.

[0124] Therein, the slider body 21 and the slider housing 23 are configured such that, as long as the slider mechanism 11 is positioned in the fully undeployed position or somewhere between the fully undeployed position and the fully deployed position, the slider body 21 remains fixed to the slider housing 23 in the pull-down configuration. However, upon reaching the fully deployed position, this fixation is automatically released, so that the slider body 21 automatically shifts away from the slider housing 23 in the lateral direction 25 into the pull-up configuration due to the elastic biasing force. Due to this lateral displacement of the slider body 21, the spindle movement block is automatically released, so that the spindle 7 can be longitudinally displaced beyond the predetermined stop position.

[0125] The predetermined stop position is determined by the fact that the mandrel 7 has different sections which differ from one another in their cross-sectional dimensions, ie in their diameters. Figure 1 In the example shown, the mandrel 7 comprises a bare mandrel portion 31. More proximal to this bare mandrel portion 31, the mandrel 7 comprises a tether hypotube portion 33, which has a larger diameter than the bare mandrel portion 31. More proximal to this tether hypotube portion 33, the mandrel 7 also comprises a release hypotube portion 35, which has an even larger diameter than the tether hypotube portion 33. At the most proximal end, the mandrel 7 comprises a tether actuator 37, which has a larger diameter than the release hypotube portion 35.

[0126] The individual lengths of each of the portions 31, 33, 35 of the mandrel 7 are set so that when the mandrel 7 is longitudinally displaced relative to the delivery catheter 5, various procedures or modes, such as a deployment / recapture procedure / mode, a tether procedure / mode, and a release procedure / mode, can be induced at the distal end of the delivery system 3. Among other things, the different diameters of the mandrel portions 31, 33, 35 can be used to achieve a stop to prevent the user from inadvertently displacing the mandrel 7 beyond a predetermined stop position, thereby inadvertently switching from one of such procedures / modes to another.

[0127] refer to Figures 1 to 3 Describing in more detail, the design of the control handle 1 includes a deployment slider mechanism 11 having a slider body 21 having a tactile surface intended for a user to advance or retract the slider using their thumb or finger. The slider body 21 has a keyed cutout extending completely through its interior, which is referred to as a tether control groove 38. This keyed cutout is formed by a through hole 39 extending in the longitudinal direction so that the spindle 7 can extend longitudinally through this through hole 39. The through hole 39 includes a keyed profile having a first section 41 having a smaller cross-sectional dimension than a second section 43. The slider housing 23 serves as another through hole 45. The through hole 45 in the slider housing 23 and the through hole 39 in the slider body 21 are aligned with each other so that the spindle 7 can extend longitudinally through both through holes 39, 45. In which, depending on the lateral positioning of the slider body 21 relative to the slider housing 23, the smaller first section 41 or the larger second section 43 of the through hole 39 in the slider body 21 is aligned with the through hole 45 in the slider housing 23, the latter having the same or larger diameter as the larger second section 43 in the through hole 39 of the slider body 21.

[0128] Thus, when the slider body 21 is in its pull-down configuration, the mandrel 7 extends through the smaller first section 41 so that only its bare mandrel portion 31 with its small diameter can extend through the through-holes 39, 45. Thus, in this pull-down configuration, the mandrel 7 may not be displaced beyond a predetermined stop position at which the tether hypotube portion 33 with its larger diameter would have to be inserted into the through-holes 39, 45. However, when the slider body 21 is arranged in its pull-up configuration, the mandrel 7 extends through the larger second section 43 of the through-hole 39 so that the larger tether hypotube portion 33 may also extend and may be displaced through the through-holes 39, 45.

[0129] In other words, the slider body 21 can be placed inside the slider housing 23. The spring 29 located between the slider body 21 and the slider housing 23 forces the slider body 21 to pop out from the inside of the slider housing 23 unless the slider body 21 is depressed. In addition, the geometry inside the left and right halves 8, 8 of the handle housing 9 prevents the slider housing 23 from rotating or moving in any direction other than axially in the distal or proximal directions 15, 17. The left handle housing geometry and the right handle housing geometry also control the position (height) of the slider body 21 from inside the slider housing 23. The slider body 21 will always be in the depressed position unless the slider mechanism 11 (i.e., the slider body 21 and the slider housing 23) has been advanced to its fully deployed position, i.e., its most forward (distal) position. Once the slider body 21 has been advanced to the distal position, the slider body 21 can pop up, which allows the larger second section 43 in the through hole 39 of the tether control groove 38 to align with the proximal through hole 45 on the slider housing 23.

[0130] Therefore, if Figure 3 As can be seen in FIG. 1 , when the slider body 21 is in the depressed, pulled-down configuration (in the fully undeployed to fully deployed position, i.e., the proximal to distal position), the tether hypotube portion 33 cannot be advanced into the tether control groove 38 in the slider mechanism 11 (see in particular FIG. 1 ). Figure 3 ). However, when the slider body 21 is in the undepressed pull-up configuration (which only occurs when the slider mechanism 11 slides to or beyond its distal fully deployed position), the tether hypotube portion 33 can advance into the tether control groove 38 in the slider mechanism 11, and thus the tether mode can be achieved.

[0131] Thus, once the larger second section 43 of the through hole 39 of the slider body 21 of the tether control groove 38 has been aligned with the through hole 45 of the slider housing 23, the tether hypotube portion 33 fixedly attached to the mandrel 7 can now be advanced forward through the slider mechanism 11. This is because the tether hypotube portion 33 has a larger geometry than the bare mandrel portion 31. When the slider body 21 is in the pressed-down, pulled-down configuration, the keyed internal geometry of the tether control groove 38 thus prevents the tether hypotube portion 33 from being able to advance through it. Once the proximal tether assembly (i.e., tether hypotube portion 33 / bare mandrel portion 31) has been advanced distally through the slider mechanism 11, the tether cable assembly at the distal end of the delivery catheter 5 will have been deployed by the same amount, and thus the tether mode will be in an activated state.

[0132] Figure 4 It is further illustrated how the keying geometry of the deployment slider prevents or allows movement of the proximal tether assembly, depending on whether the slider body 21 has been ejected (slider not depressed) or is in a depressed position.

[0133] Figure 3 Also shown are different stages that the control handle 1 can assume. In the first stage, Figure 3 As shown in (a) of FIG. 1 , the slider mechanism 11 is in its retracted state, i.e., in its fully undeployed position. The slider body 21 is depressed so that the tether may not advance, i.e., the tether hypotube portion 33 of the mandrel 7 may not advance beyond a predetermined stop position, and the mandrel motion blocking is effective. In the second stage, as shown in FIG. Figure 3 As shown in (b) of FIG. 1 , the slider mechanism 11 slides to its advanced state, i.e., is in its fully deployed position. The slider body 21 is still pressed down by the user. Therefore, the tether may still not advance. In the third stage, as shown in FIG. Figure 3 As shown in (c) of FIG. 1 , the slider mechanism 11 is still in the advanced state, i.e. in a position corresponding longitudinally to the fully deployed position, but the user has removed their hand from the slider body 21, i.e. has released lateral pressure on the slider body 21. As a result, the slider body 21 is allowed to pop out into its pull-up configuration. Thus, the tether mode is engaged, and the tether can be advanced further, i.e., the tether hypotube portion 33 of the mandrel 7 can be advanced beyond the predetermined stop position, and the mandrel motion blocking is deactivated. In the fourth stage, as shown in FIG. 1 , the tether mode is engaged, and the tether can be advanced further, i.e., the tether hypotube portion 33 of the mandrel 7 can be advanced beyond the predetermined stop position, and the mandrel motion blocking is deactivated. Figure 3 As shown in (d) in the figure, the slider mechanism is still in the advanced state, and the slider body 21 is in its pull-up configuration, and the tether has been advanced to the maximum extent. In this maximum advancement configuration, the further advancement of the spindle 7 is blocked by the locking mechanism 19, as will be further described below.

[0134] The slider mechanism 11 is also designed to facilitate safe recapture of the medical device forming the implant. In order to safely recapture the implant, the tether must be pulled completely proximally (backward) so that the tether cable slack has been removed and pulled up, and the implant's hook has been pulled back into the alignment cup of the catheter. If this is not done, and there is still tether cable slack at the distal end of the catheter, the implant's hook may get stuck on the catheter's protective cup and damage / kink the protective cup or prevent the catheter from being fully re-inserted into the implant. To prevent this from happening, the user is required to pull the tether back proximally until the tether hypotube is located at the proximal end of the deployment slider. This results in the hook being safely positioned inside the alignment cup of the catheter. If the tether hypotube is fully forward inside the deployment slider (causing tether cable slack at the distal end of the catheter), the user cannot press down on the deployment slider and retract the deployment slider assembly proximally. This is because the deployment slider has been designed to not be fully depressed if the tether hypotube portion is still inside the deployment slider. If the deployment slider is not fully depressed, it cannot be retracted and therefore the implant cannot be re-tethered. Therefore, the mechanism has a built-in safety feature to prevent the user from inadvertently deactivating the tether mode and unsafely recapturing the implant if they have not placed the implant in a safe position for recapture.

[0135] As a result of all these design features and considerations, this novel mechanism can automatically transition between deployed and tethered states and then return to the untethered mode / re-insertable state of the implant, all by using a single actuator to control these modes.

[0136] Next, we will refer to Figure 2 and Figure 5 Another possible feature of the control handle 1 is described in relation to a tactile deployment feedback mechanism 51. Such a deployment feedback mechanism 51 is configured to generate tactile deployment feedback that can be sensed by a user of the control handle 1 when the slider mechanism 11 is displaced beyond one or more predetermined deployment feedback positions along its path of travel between the fully undeployed position and the fully deployed position.

[0137] Among them, the first deployment feedback position can be located at the position where the indicating slider mechanism 11 starts to push the mandrel 7, so that the medical device fixed to the mandrel 7 at its distal end pops out of the sheath. This first deployment feedback position can also be referred to as the proximal deployment control position. Therefore, until the haptic feedback is sensed at the first deployment feedback position, the user knows that the slider mechanism 11 positions the mandrel 7 into the sheathed configuration, in which the mandrel 7 and the delivery catheter 5 are positioned relative to each other such that the sheath held at the distal end of the delivery catheter completely covers the medical device held at the distal end of the mandrel 7. When the slider mechanism 11 longitudinally displaces beyond this first deployment feedback position, the slider mechanism 11 positions the mandrel 7 into at least a partially unsheathed configuration, in which the mandrel 7 and the delivery catheter 5 are positioned relative to each other such that the sheath no longer completely covers the medical device. For example, in such an unsheathed configuration, the anchoring spikes of the medical device can be deployed.

[0138] The second deployment feedback position can be at a position such as indicating to the user the start of the anchoring procedure when further sliding the slider mechanism 11 towards the fully undeployed position. Such a second deployment feedback position can also be referred to as the distal deployment control position or indicating the haptic pause for implant fixation deployment. Therefore, when the haptic feedback is sensed at the second deployment feedback position, the user knows that the slider mechanism 11 continuously positions the mandrel 7 relative to the delivery catheter 5 into the anchoring configuration, so that the anchoring mechanism at the distal end of the medical device pops out of the sheath to anchor the medical device in the heart tissue. When the slider mechanism 11 displaces beyond the second deployment feedback position towards the fully undeployed position, the slider mechanism 11 continuously positions the mandrel 7 into the unprotected configuration, in which the mandrel 7 and the delivery catheter 5 are positioned relative to each other such that the sheath no longer covers the medical device.

[0139] Among them, the haptic deployment feedback mechanism 51 includes at least one ridge 53, 55 and at least one buffer 57. For example, the first ridge 53 can project inwardly from the handle housing 9 towards the slider housing 23 at a longitudinal position corresponding to the first haptic feedback position, and thus serves as the proximal deployment control ridge. The second ridge 55 can project inwardly at a longitudinal position corresponding to the second haptic feedback position, and thus serves as the distal deployment control ridge. The buffer 57 can be provided at the slider housing 23 and can project outwardly towards the handle housing 9.

[0140] As Figure 5As shown, the deployment feedback mechanism 51 may include two first ridges 53 and two second ridges 55 that are respectively opposite to each other and project inwardly at the handle housing 9, and may also include two buffers 57 that project outwardly at the slider housing 23. Thus, the ridges 53, 55 and the buffers 57 may slide along each other when the slider mechanism 11 is longitudinally displaced, and cause a retracting force on the slider mechanism 11 when the user longitudinally pushes the slider mechanism 11 beyond one of the deployment feedback positions. Among them, the ridges 53, 55 and the buffers 57 are elastically biased towards each other in the transverse direction 25.

[0141] In other words, the control handle 1 preferably includes features for controlling the position of the deployment slider assembly and providing haptic feedback to the user when various states are activated or deactivated. The proximal deployment control ridges (located on the left and right handle housings and visible in Figure 5 are used to lock the deployment slider assembly in the proximal covering position unless the user applies sufficient force to advance the deployment slider assembly past the proximal control ridges. The deployment slider housing has flexible buffers that provide a friction-based interaction with the deployment control ridges, which results in a haptic response to the user when the buffers of the deployment slider housing advance against the ridges. These buffers can also be seen in Figure 5 The user must apply a certain amount of forward force to move the deployment slider assembly and thus move the buffers of the deployment slider housing past each deployment control ridge. Once the deployment slider assembly has advanced past the proximal deployment control ridges, it is important that the user does not quickly continue to push the implant forward - otherwise, if the fixation mechanism of the implant and the implant itself advance too quickly, they may cause perforation. Therefore, the second distal deployment control ridge is located at a position corresponding to the fixation of the implant deployed from the protective cup of the catheter. This distal control ridge provides a haptic pause for the user to let them know that the tines have been deployed and also to proceed carefully from this point forward when they continue the deployment process. The control ridges can be seen in Figure 2 and Figure 5

[0142] In addition, as shown in Figure 5 , the control handle 1 further includes a valve 59 in the slider mechanism 11 to prevent backflow through the lumen of the delivery catheter 5. The valve 59 is formed by a membrane 60 that is held in the slider mechanism 11 in the cross-sectional direction and has a through-hole 58 that is configured to closely surround a mandrel 7 that extends through the slider mechanism 11 and through the through-hole 58 of the membrane 60. The valve 59 is assembled into the slider housing 23 and is used to prevent backflow through the inner diameter of the tether catheter and around the tether, and potentially into both the slider mechanism 11 and the control handle 1.

[0143] Design solutions including the slider mechanism 11 described herein particularly include the following key features:​

[0144] 1) A single actuator for implant deployment and automatically converting the tether mode to an active state.

[0145] 2) A single actuator for implant recapture and automatically converting the tether mode to an inactive state.

[0146] 3) A deployment slider with a bonded internal geometry that controls the position of the proximal tether assembly (tether hypotube and tether mandrel) and prevents the tether from advancing and activating the tether mode if the implant is not fully deployed.

[0147] 4) If the tether is not fully retracted first, the mechanism also prevents the user from fully depressing the deployment slider and simultaneously retracting it and the tether to re-sheath the implant.

[0148] 5) A handle housing geometry that controls the position (height) and orientation of the deployment slider (and the bonded internal geometry) relative to the deployment slider housing.

[0149] 6) A tether having multiple different outer diameters, where the smaller diameter fits within the smaller bonded geometry of the deployment slider, and the larger outer hypotube can only advance through the largest hole in the deployment slider bonded internal geometry.

[0150] 7) A tactile buffer on the deployment slider housing that provides a tactile sensation to the user as they transition through the various stages of the implant deployment process.

[0151] 8) Ridges on the left and right handle housings that interact with the buffer on the deployment slider housing, which locks the deployment slider assembly in a proximal overwrap position and also provides a tactile pause to the user once the fixation mechanism of the implant has been deployed.

[0152] 9) A valve located at the center within the deployment slider housing to prevent backflow or air from always returning through the tether catheter lumen.

[0153] The core concept associated with the control handle 1 including the slider mechanism 11 is centered around a single actuator that is used to deploy the implant in a safe and controlled manner and then, once the implant is deployed, automatically unlocks the tether so that the tether mode is active and the tether can become advanceable. Additionally, once the tether has been fully retracted, the core concept works in the same way to automatically lock the tether so that the implant can be safely recaptured using the same actuator. If for any reason the tether has not been fully retracted before starting the implant recapture process, the deployment slider mechanism will not allow the user to recapture the implant until the catheter is in a safe and reliable state for implant re-sheathing.

[0154] This method is different from other market designs, which use two independent actuators to 1) deploy the implant, and 2) lock and unlock the tether so that the tether mode can become activated or inactivated, rather than using a single actuator as described in the present method described in the present disclosure. It is also different from another current market design due to the inclusion of tactile feedback during the deployment process. In addition, currently commercially available products do not include any tactile feedback features or technologies in the implanted catheter. It is also different from other market designs again, which do not have an internal valve to prevent the return of blood from always returning around the tether and passing through the tether catheter ID / lumen during use. When the current commercially available product enters the tether mode and unlocks the tether, back infiltration through the tether catheter cavity may occur. In the method proposed in this article, a valve (which is always activated and sealed) is included to always prevent reverse bleeding through the tether catheter inner diameter (ID). This also means that even when the catheter is in tether mode, the fluid medium can be flushed through the tether catheter at any point.

[0155] The proposed control handle is specifically designed to incorporate and utilize the novel tether mechanism as described in applicant's previously filed applications to maintain connection to the implant until the user determines that the implant site position is acceptable, at which time they can safely release the tether and remove the catheter tool.

[0156] Lastly and briefly summarized in alternative wording, a control handle including the slider mechanism described herein for a leadless pacemaker implant catheter includes a new mechanism that allows a user to control the deployment of the implant with a single actuator and also when a secondary implant state called the tethered mode becomes active or inactive. This novel design provides a superior means of controlling the deployment process of a leadless pacemaker while also allowing the user to seamlessly transition to a state called the tethered mode, all with a single actuator and internal mechanism within the implant catheter. This novel design provides the user with a superior means to safely and reliably switch between controlled deployment of the implant and then seamlessly transition to the tethered mode (which is used to evaluate fixation of the implant without any bias from the catheter), and then recapture the implant if needed or release the implant from its tether connection if it is determined that the position and fixation are appropriate. To achieve this, the novel mechanism uses an advanceable and retractable slider that has an internal mechanism that controls what size geometry can pass through it based on what position the slider is in. This mechanism, in combination with a tether that incorporates different size outer diameter geometries along its proximal length in the handle, is able to determine whether the tether mode of the handle is active or inactive based on the position of the deployment slider actuator relative to the implant catheter handle. This novel leadless pacemaker deployment and tether control mechanism utilizes a novel tether mechanism as detailed in an earlier invention disclosure as a means of establishing a tether connection between the implant and the catheter. However, the scope of the present disclosure presented herein is specific to the deployment actuator and tether control mechanism located in the handle of the implant catheter.

[0157] Next, details, features, and possible advantages of the locking mechanism 19 in the control handle 1 will be described with reference to Figures 6 to 10 the activation or deactivation of the release mode in the delivery system 3, which is selectively controlled thereby. In so doing, the details, characteristics, and possible advantages are described again with reference to an exemplary embodiment or implementation related to the implantation process of a leadless pacemaker.

[0158] The control handle 1 described herein may be provided with a specific design of a locking mechanism 19 of the implant catheter that serves as a release actuator mechanism, which allows a user to initiate the release process of the implant from the catheter. If the release actuator has not been actuated, the user will be prevented from releasing the implant from the catheter. Thus, during an implantation procedure, such as during deployment of the implant from the catheter, anchoring the implant, and performing various tests while the delivery system is in its tethered mode, inadvertent release of the implant from the catheter can be reliably prevented. However, after such steps, the locking mechanism may be deactivated, for example, by appropriately longitudinally displacing the mandrel 7 relative to the delivery catheter 5 to intentionally release the implant.

[0159] Previous solutions in the art include using a pair of scissors to cut the tether (which is a suture) of a leadless pacemaker catheter in order to initiate the process of releasing the implant from its tether (suture) into the catheter. Given that these scissors are separate tools, their implant catheters do not consist of dedicated actuators to initiate the release process.

[0160] In an alternative method, the tether consists of a suture that extends proximally from outside the handle, through the catheter and around the hook of the implant, then back through the catheter and terminates outside the proximal end of the handle. The two ends of the suture are fixed to each other and cannot be separated. In order to release the implant from its tether, the user must cut the suture with a pair of scissors and then fully retract the suture from the catheter in order to release the implant from the tether into the catheter.

[0161] Unless the user has a pair of scissors or a blade on hand to cut the suture, there is usually no means to initiate the release process. There are no built-in features, actuators or mechanisms to cut the suture present within the handle. Therefore, additional tools not included within the catheter system are required to complete the implantation procedure.

[0162] Given such conventional methods, the aim is to design the control handle 1 such that the user is prevented from being able to release the implant from its tether into the implant catheter unless the user actuates the mechanism. Preferably, once the user performs the action, the mechanism should provide the user with clear tactile feedback that the mechanism has been actuated. Unless actuated by the user, the mechanism must always remain in the locked state.

[0163] The control handle 1 includes a locking mechanism 19, as Figures 6 to 10 shown. Among them, the locking mechanism 19 can be switched between a locked configuration and an unlocked configuration by rotating the unlocking actuating member 6l relative to the handle housing 9. The unlocking actuating member 61 can also be referred to as a release actuator. The axis of rotation of the unlocking actuating member 61 is generally aligned with the longitudinal axis of the control handle 1. Preferably, the locking mechanism 19 is configured to be switched between a locked configuration and an unlocked configuration by screwing the unlocking actuating member 61 in a clockwise direction along a left-handed thread. The locked configuration can be indicated, for example, by the "LOCK" icon 63 shown on the handle housing 9, while the unlocked configuration can be indicated, for example, by the "UNLOCK" icon 65. The rotational state of the locking mechanism 19 can be indicated by a visual device, such as a colored protrusion 67 provided on the unlocking actuating member 61.

[0164] For this configuration, the locking mechanism 19 includes a through-channel 69 for accommodating the mandrel 7. Among them, the lateral limiting elements 71 of the locking mechanism 19 surround the through-channel 69 from opposite sides. The locking mechanism 19 is specifically configured such that in the locked configuration, the lateral limiting elements 71 are pushed towards each other to a greater extent than in the unlocked configuration, such that in the locked configuration, the lateral dimension of the through-channel 69 is smaller than in the unlocked configuration.

[0165] For this purpose, the locking mechanism 19 comprises a compression element 75. Such a compression element 75 is configured to release the compression force acting radially on the lateral restraining element 71 when the unlocking actuation member 61 is rotated from the locked configuration to the unlocked configuration. In the example presented in the figures, the compression element 75 is formed by the unlocking actuation member 61 itself. However, alternatively, the compression element 75 can be a separate element cooperating with the unlocking actuation member 61.

[0166] In the example shown in the figures, the transverse limiting element 71 is formed by an inner member 77 surrounding the through-channel 69. Therein, longitudinal slits 73 extend between and separate the elongated portions 79 of the inner member 77. The elongated portions 79 extend from a common inner member body portion 81 and have cantilevered ends 83 on their opposite sides. At the cantilevered ends 83, the elongated portions 79 of the inner member 77 have a conical outer shape with an inclined outer surface 85. The compression element 75 is formed by an outer member 87 surrounding the inner member 77. The outer member 87 has a conical inner shape at an inclined inner surface 89 opposite the cantilevered end 83 of the inner member 77.

[0167] The mandrel 7 comprises a tether hypotube portion 33 and a release hypotube portion 35 arranged more proximal to the tether hypotube portion 33. The tether hypotube portion 33 has a first cross-sectional size, ie a first diameter, while the release hypotube portion 35 has a second, larger diameter.

[0168] Thus, when the locking mechanism 19 is in the locked configuration, the cross-sectional dimension of the through passage 69 is smaller than the second cross-sectional dimension of the release hypotube portion 35. Thus, the mandrel 7 may not be introduced into the locking mechanism 19 with its release hypotube portion 35 and thus prevented from being displaced beyond a predetermined abutment position relative to the locking mechanism 19 due to activation of the mandrel abutment barrier, wherein the abutment position is determined by the position of the transition between the smaller tether hypotube portion 33 and the larger release hypotube portion 35.

[0169] However, when the locking mechanism 19 is switched to its unlocked configuration, the through passage 69 acquires a larger cross-sectional dimension that is large enough to accommodate the second cross-sectional dimension of the released hypotube portion 35. Figure 8 As shown in Figure 8 (a) to (c) in FIG. 1 show that the mandrel 7 can be continuously displaced in the distal direction 17, that is, the tether actuator 37 can be pushed toward the control handle 1. This displacement can continue beyond the tether mode (such as Figure 8 until the release mode is reached (as shown in (a) Figure 8). When the locking mechanism 19 is in its unlocked configuration, the mandrel 7 can be pushed in the distal direction 17 until its release hypotube portion 35 is completely pushed through the locking mechanism 19 and the tether actuator 37 abuts the proximal end of the locking mechanism 19, thereby stopping further displacement of the mandrel 7 (see Figure 8 Due to this continued distal displacement of the mandrel 7, the delivery system is set to a release mode in which the medical device at the distal end of the delivery catheter 5 is released, i.e., the mechanical connection between the medical device and the delivery system 3 is opened.

[0170] In other words, the locking mechanism 19 is designed to be used with tether mechanisms having multiple diameters. Figures 6 to 8 As shown, the tether assembly includes a tether hypotube having a smaller outer diameter (OD) and a release hypotube having a larger OD. In order to place the tether in a releasable state, the tether assembly must be advanced distally so that the distal side of the tether actuator abuts against the proximal side of the release actuator. The release actuator prevents the tether from being advanced distally to the maximum extent by blocking the larger OD of the release hypotube from advancing through it. Figure 8 This and a visualization of the important position of the tether relative to the tethered actuator can be seen in . Figure 8 (a) in FIG. 1 shows a case where the unlocking actuating member 61 is switched to the unlocking configuration. Figure 8 (b) in FIG. 4 shows that distal movement of the catheter from this position must be restricted unless the unlocking actuation member 61 has been rotated to the unlocked configuration. Figure 8 As shown in (c) , once the tether has been advanced to its furthest distal position, the tether has been released.

[0171] To achieve this, the locking mechanism 19 works by screwing the unlocking actuation member 61 inwardly (distally) along the threads 97 to the locked position. When the unlocking actuation member 61 is advanced in the distal direction 17 via rotation, the unlocking actuation member 61 compresses the inclined outer surface 85 at the cantilevered end 83 of the inner element 77 radially inwardly, which reduces the inner diameter of the through passage 69 in the locking mechanism 19, as shown in FIG. Figure 9 As shown. Thus, when the unlocking actuation member 61 is in the locked position, it is fully screwed inwards. This causes the inner diameter of the through passage 69 at the locking mechanism 19 to be reduced, so that it prevents the release hypotube portion 35 from being able to enter it or advance through it.

[0172] When the unlocking actuation member 61 is in the unlocking position, the unlocking actuation member 61 is unscrewed, which releases the radial compression along the locking mechanism 19, which allows the biased proximal feature in such a locking mechanism 19 to relax back to its initial geometry. Once back to its original relaxed geometry, the release hypotube portion 35 can now be advanced distally through the position, which will enable the tether to be released. In other words, when the unlocking actuation member 61 is screwed outwardly (proximally) to the unlocking position, it advances in the proximal direction 15 via rotation, thereby releasing the radial compression onto the cantilevered ends 83 of the internal element 77. Therefore, these cantilevered ends 83, which are elastically biased in the outward transverse direction 25, can relax to a configuration in which the inner diameter of the through-channel 69 is enlarged, so as to enable the mandrel 7 to pass through its release hypotube portion 35.

[0173] As an additional feature, the control handle 1 also includes a tactile detent feedback mechanism 91, such as Figure 10 The tactile locker feedback mechanism 91 is configured to generate tactile locker feedback to a user of the control handle 1 when the locking mechanism 19 is displaced relative to the handle housing 9 beyond at least one locker feedback position when switching from the locked configuration to the unlocked configuration.

[0174] To this end, the tactile locker feedback mechanism 91 includes a groove 93 in the handle housing 9 and a spring plunger 95 at the unlocking actuation member 61. The groove 93 and the spring plunger 95 are configured to cause a retraction force on the locking mechanism 19 when the user rotates the unlocking actuation member 61 beyond at least one locker feedback position. For example, the groove 93 may be present at both a rotational position corresponding to the locked configuration and a rotational position corresponding to the unlocking configuration. Therefore, when the unlocking actuation member 61 is rotated between the two configurations, its spring plunger 95 may snap into such corresponding groove 93, thereby tactilely indicating to the user that the locking mechanism 19 has been correctly switched from one configuration to another configuration.

[0175] In other words, another feature of the locking mechanism 19 is that it utilizes a spring plunger 95 to create tactile feedback when it is actuated to a locked or unlocked state. The spring plunger 95 is embedded in the release actuator component or the handle component within which the release actuator rotates. There is a small groove 93 inside the handle component to provide a spring release of the spring plunger 95 when the actuator is rotated to the locked position or the unlocked position. This release creates a tactile feeling that the actuator has been rotated to the correct state (locked or unlocked). Figure 10 An embodiment in which a spring plunger 95 is located in the release actuator and rotates about the handle housing component can be seen.

[0176] The design scheme including the locking mechanism 19 described herein incorporates, among other things, the following key features:

[0177] 1) A single actuator for controlling the release of a tether for a leadless implant catheter.

[0178] 2) An actuator and mechanism for enabling an implant to be released from a catheter tether, where the tether is already built into the implant catheter and is not a separate stand-alone tool.

[0179] 3) An actuator that, when rotated to a locked position, radially compresses an internal separate component or feature to reduce the ID of a hole or lumen so as to prevent a feature of a larger geometry from advancing through the actuator.

[0180] 4) An actuator that will remain in a locked or unlocked state unless actuated by the user.

[0181] 5) An actuator that, when rotated to an unlocked position, radially releases the compression on an internal separate component or feature, which allows the component or feature to relax back to an uncompressed state where its uncompressed state results in a larger ID of a hole or lumen inside it.

[0182] 6) Includes a spring plunger and a spring release groove to provide a tactile response when the release actuator is rotated to a locked or unlocked state.

[0183] 7) Includes a spring plunger and a spring release groove to prevent accidental rotation of the actuator unless actuated by the user.

[0184] 8) A tether assembly at the proximal end, including different diameters to restrict the tether from advancing through the release actuator unless the release actuator has been rotated to an unlocked position.

[0185] 9) A release actuator mechanism having clockwise or counterclockwise threads. In our expected embodiments, CCW threads are preferably used because it is more difficult for the user to inadvertently actuate the release actuator mechanism to the unlocked position by rotating the release actuator mechanism away from their body rather than towards their body.

[0186] The core concept associated with this control handle 1 including a locking mechanism 19 is centered around a single actuator that can be used to prevent the user from inadvertently releasing an implant from its tether to the catheter unless the user is ready to do so. This single actuator is capable of controlling the inner diameter of a hole or lumen inside the implant. When the actuator is rotated to the locked position, the inner diameter of the hole / lumen decreases. When the actuator is rotated to the unlocked position, the inner diameter relaxes outwards and becomes larger. This release mechanism docks with a tether mechanism consisting of multiple outer diameters. When the release actuator is in the locked position, only the smaller diameter of the tether can advance through the release actuator. When the release actuator is in the unlocked position, the larger diameter of the tether can advance through the release actuator, and the implant can thus be released from the tether.

[0187] In particular, the control handle 1 with the locking mechanism 19 is different from another market design that uses a pair of scissors (not included within the implant catheter) to cut a suture that serves as a tether for the implant. By incorporating a release mechanism into the handle, the usability of the leadless pacemaker implant catheter is greatly enhanced.

[0188] The proposed control handle 1 is specifically designed to incorporate and utilize a novel tethering mechanism as described in the applicant's previously filed applications to maintain connection to the implant, as well as interface with a novel deployment slider tether control mechanism established by including a slider mechanism as further described above herein.

[0189] Finally and briefly summarized in alternative wording, the control handle including the locking mechanism described herein includes a new mechanism for a leadless pacemaker implant catheter that allows the user, when permitted, to utilize actuator control to release the implant from its tether to the implant catheter. This novel design utilizes a safety mechanism that prevents the user from initiating the release process of the implant from the catheter unless the actuator is actuated to an unlocked position. Once the actuator is placed in this position, the user can release the implant from the catheter. This mechanism is intended as a safety precaution to prevent the user from accidentally releasing the implant from the catheter unless they are fully certain they are ready to do so. To achieve this, the novel mechanism uses a rotation screw-based actuator that can be rotated, for example, up to 90 degrees to switch the actuator between a "locked" configuration and an "unlocked" configuration. When the actuator is placed in the "locked" configuration, it twists downward as the internal component becomes inwardly compressed. When the internal component is inwardly compressed, the inner diameter of the internal component (through which the tethering mechanism passes) becomes smaller. In the case where the inner diameter of the internal component is in a state with a smaller inner diameter, the tether (which has a plurality of outer diameters) cannot fully advance through the component because the maximum size diameter of the tether cannot pass through the mating of the handle component when the actuator is engaged in the locked position. The tethering mechanism can only be released after it has advanced all the way through the handle component. Once the release actuator is rotated to the "unlocked" position, the torque applied to the internal component is released, and the internal component can return to its natural position. The natural position of the internal member includes a larger inner diameter. Thus, once the release actuator is in the "unlocked" position, the tethering mechanism can now pass through the handle component assembly, and the implant can be released from the tether to the catheter. This novel release control mechanism utilizes a novel tethering mechanism as detailed in the earlier invention disclosure as a way to establish a tether connection between the implant and the catheter.

[0190] Finally, it should be noted that the term "comprising" does not exclude other elements or steps, and "a" or "an" does not exclude a plurality. Elements associated with different embodiments can also be combined. It should also be noted that the reference signs in the claims should not be construed as limiting the scope of the claims.

[0191] Reference numerals list

[0192] 1 Control handle

[0193] 3 Delivery system

[0194] 5 Delivery Catheter

[0195] 7 Mandrel

[0196] 8 Half Shell

[0197] 9 Handle housing

[0198] 10. Operating mechanism

[0199] 11 Slider mechanism

[0200] 12 Insertion tube

[0201] 13. Vertical direction

[0202] 15 Proximal direction

[0203] 17 Distal direction

[0204] 19 Locking mechanism

[0205] 21 Slider body

[0206] 23 Slider housing

[0207] 25 Horizontal direction

[0208] 27 Slider spring

[0209] 29 Actuation structure

[0210] 31 Bare mandrel part

[0211] 33 Tether Hypotube Section

[0212] 35 Release the hypotube section

[0213] 37 Tether Actuator

[0214] 38 Control groove

[0215] 39 Through hole through the slider body

[0216] 41 First section of through hole

[0217] 43 The second section of the through hole

[0218] 45 through the through hole of the slider housing

[0219] 51Haptic Deployment Feedback Mechanism

[0220] 53 First Ridge

[0221] 55 Second ridge

[0222] 57 Buffer

[0223] 58 Through-hole in the valve

[0224] 59 Valve

[0225] 60 Membrane

[0226] 61 Unlock actuating member

[0227] 63 Locking icon

[0228] 65 Unlock icon

[0229] 67 Protrusion

[0230] 69 Through-channel

[0231] 71 Lateral restraint element

[0232] 73 Slit

[0233] 75 Compression element

[0234] 77 Internal element

[0235] 79 Elongated portion

[0236] 81 Common internal member body portion

[0237] 83 Cantilever end

[0238] 85 Tapered outer surface

[0239] 87 External member

[0240] 89 Tapered inner surface

[0241] 91 Tactile locker feedback mechanism

[0242] 93 Groove

[0243] 95 Spring plunger

[0244] 97 Thread

Claims

1. A control handle (1) for controlling the functions of a delivery system (3) for implanting a medical device, The delivery system (3) comprises: - an elongated delivery catheter (5), and - a mandrel (7) capable of being longitudinally displaced relative to the delivery catheter (5); The control handle (1) comprises: - a locking mechanism (19), and - handle housing (9); The locking mechanism (19) is configured to be switchable between a locking configuration and an unlocking configuration, so that in the locking configuration, the spindle (7) is fixed relative to the locking mechanism (19), so that the spindle (7) cannot be shifted relative to the locking mechanism (19) beyond a predetermined adjacent position due to a mechanical spindle abutment block, and in the unlocking configuration, the spindle (7) can move relative to the locking mechanism (19) along the longitudinal direction (13) beyond the predetermined adjacent position due to the spindle abutment block being released.

2. The control handle according to claim 1, wherein the locking mechanism (19) is configured to switch between the locked configuration and the unlocked configuration by rotating an unlocking actuation member (61) relative to the handle housing (9).

3. The control handle according to claim 2, wherein the rotation axis of the unlocking actuation member (61) is aligned with the longitudinal axis of the control handle (1).

4. The control handle according to claim 2, wherein the locking mechanism (19) is configured to switch between the locked configuration and the unlocked configuration by unscrewing the unlocking actuation member (61), preferably in a clockwise direction on a CCW / left-hand thread.

5. A control handle according to claim 1, wherein the locking mechanism (19) includes a through channel (69) for accommodating the spindle (7), wherein lateral limiting elements (71) of the locking mechanism (19) surround the through channel (69) from opposite sides, and wherein the locking mechanism (19) is configured so that in the locked configuration, the lateral limiting elements (71) are pushed toward each other more than in the unlocked configuration, so that in the locked configuration, the lateral dimension of the through channel (69) is smaller than the lateral dimension in the unlocked configuration.

6. The control handle according to claim 5, wherein the locking mechanism (19) includes a compression element (75) which releases a compression force acting radially on the lateral restraining element (71) when the unlocking actuation member (61) is rotated from the locked configuration to the unlocked configuration.

7. A control handle according to claim 5, wherein the lateral limiting element (71) is formed by an inner member (77) which surrounds the through passage (69) and has a longitudinal slit (73) extending between the elongated portions (79) of the inner member (77) and also has a conical outer shape at its cantilevered end (83), and wherein the compression element (75) is formed by an outer member (87) which surrounds the inner member (77) and has a conical inner shape at an inner surface opposite the cantilevered end (83) of the inner member (77).

8. The control handle according to claim 5, wherein the core shaft (7) includes a tether hypotube portion (33) and a release hypotube portion (35) arranged more proximal to the tether hypotube portion (33), wherein the tether hypotube portion (33) has a first cross-sectional size, and the release hypotube portion (35) has a second cross-sectional size greater than the first cross-sectional size, wherein when the locking mechanism (19) is in the locked configuration, the cross-sectional size of the through-channel (69) of the locking mechanism (19) is smaller than the second cross-sectional size of the release hypotube portion (35), and when the locking mechanism (19) is in the unlocked configuration, the cross-sectional size of the through-channel (69) of the locking mechanism (19) is greater than the second cross-sectional size of the release hypotube portion (35).

9. A control handle according to claim 1, wherein the control handle (1) further comprises a tactile locker feedback mechanism (91), wherein the tactile locker feedback mechanism (91) is configured to generate tactile locker feedback to a user of the control handle (1) when the locking mechanism (19) is displaced relative to the handle housing (9) beyond at least one locker feedback position when switching from the locked configuration to the unlocked configuration.

10. The control handle of claim 9, wherein the tactile locker feedback mechanism (91) comprises at least one groove (93) disposed at one of the handle housing (9) and the locking mechanism (19) and at least one spring plunger (95), the groove (93) disposed at one of the handle housing (9) and the locking mechanism (19), and the spring plunger (95) disposed at the other of the handle housing (9) and the locking mechanism (19), and configured to induce a retraction force on the locking mechanism (19) when a user rotates the locking mechanism (19) beyond the at least one locker feedback position.

11. A delivery system (3), comprising: A control handle (1) according to claim 1, an elongated delivery catheter (5) mechanically connected to the control handle (1); and a core shaft (7) controlled by the control handle (1) so as to be longitudinally displaceable relative to the delivery catheter (5).

12. A delivery system according to claim 11, wherein the delivery system (3) is configured so that when the core shaft (7) is displaced by a deployment distance relative to the delivery catheter (5), the medical device retained at the distal end of the delivery catheter is deployed from the sheath of the delivery catheter; and wherein, The delivery system (3) also includes a tether member connected to the distal end of the core shaft (7) and to the medical device, wherein the delivery system (3) is configured so that when the core shaft (7) is displaced by a tether distance other than the deployment distance relative to the delivery catheter (5), the tether member is displaced between a retracted position and a pop-up position, wherein in the retracted position, the tether member pulls the medical device to be fixed to the end cup at the distal end of the delivery catheter, and in the pop-up position, the tether member releases the medical device from the fixation with the end cup, and wherein the delivery system (3) is also configured so that when the core shaft (7) is displaced by a release distance other than the tether distance and the deployment distance relative to the delivery catheter (5), the tether member is displaced between the pop-up position and the released position, wherein in the released position, the tether member releases the medical device from any connection with the delivery system (3).

13. A delivery system according to claim 12, wherein the core shaft (7) includes a bare core shaft portion (31), a tethered sea wave tube portion (33) arranged more proximal to the bare core shaft portion (31), and a release sea wave tube portion (35) arranged more proximal to the tethered sea wave tube portion (33), wherein the bare core shaft portion (31) has a first cross-sectional size, the tethered sea wave tube portion (33) has a second cross-sectional size larger than the first cross-sectional size, and the release sea wave tube portion (35) has a third cross-sectional size larger than the second cross-sectional size, wherein the length of the bare core shaft portion (31) corresponds to or is longer than the deployment distance, the length of the tethered sea wave tube portion (33) corresponds to or is longer than the tether distance, and the length of the release sea wave tube portion (35) corresponds to or is longer than the release distance.

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