Control handle equipped with slider mechanism for controlling functions of delivery system foe implanting medical device

Abstract

To provide a control handle for controlling functions of a delivery system for implanting a medical device.SOLUTION: A delivery system includes an elongate delivery catheter (5) and a mandrel (7) being displaceable longitudinally relative to the delivery catheter. A control handle (1) includes a slider mechanism (11) and a handle housing (9). The slider mechanism is configured for being displaceable in a longitudinal direction (13) between a fully undeployed position and a fully deployed position such as to thereby displace the mandrel relative to the delivery catheter by a deployment distance. The slider mechanism is further configured such that, in the fully undeployed position, the mandrel is fixed relative to the slider mechanism such that the mandrel is not displaceable relative to the slider mechanism beyond a stop position due to a mechanical mandrel motion blockage, whereas, in a tether position being beyond the fully deployed position, the mandrel is movable in the longitudinal direction relative to the slider mechanism beyond the stop position due to the mandrel motion blockage being released.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a control handle for controlling the functions of a delivery system for implanting a medical device. Further, the present invention relates to a delivery system including such a control handle.

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

[0003] Generally, IMDs and ILPs are introduced into a patient's body, particularly, transferred to an intended implantation position, and secured at such an intended position using a specific delivery system. Such a delivery system typically includes an elongate delivery catheter and a mandrel. Among them, the catheter can be maneuverable and / or guidable such that the distal end of the catheter can be displaced throughout the patient's body, i.e., along the patient's blood vessels, for example, until it reaches the intended implantation position, i.e., the patient's heart, for example. The mandrel is generally displaceable longitudinally relative to the delivery catheter to induce or control the functions of the delivery system. For example, the mandrel can be displaced (described in more detail below) to expose the IMD from a protector sheath, perform a tag test, and / or ultimately release the IMD from the delivery catheter.

[0004] The functions of the delivery system are generally controlled using a control handle. Such a control handle is typically disposed 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 implanting medical devices are described, for example, in International Publication Nos. WO 2020 / 043481 and WO 2020 / 187663, which are prior applications of the present applicant. The control handle described herein may be used or adapted to control the functions of such prior art delivery systems and catheter devices, and it should be noted that the characteristics and / or functions described in the prior applications may be implemented in the delivery system described in the present application and its control handle. Accordingly, the entire contents of the cited prior applications are hereby incorporated by reference.

[0006] There may be a need for a control handle that controls the functions of a delivery system for implanting a medical device, and the control handle provides improved ergonomics and / or enables simplified or more accurate handling of the delivery system. Further, there may be a need for a delivery system that includes such a control handle.

[0007] Such a need can be met by the subject matter of the independent claims. Advantageous embodiments are defined in the dependent claims as well as in the corresponding description and drawings.

[0008] According to a first aspect of the present invention, there is proposed a control handle for controlling the functions of a delivery system for implanting a medical device. Among them, the delivery system includes an elongated delivery catheter and a mandrel displaceable longitudinally with respect to the delivery catheter. The control handle includes a slider mechanism and a handle housing. The slider mechanism is displaceable longitudinally with respect to the handle housing between a fully undeployed position and a fully deployed position, and is configured to displace the mandrel by a deployment distance with respect to the delivery catheter thereby. The slider mechanism is such that, in the fully undeployed position, the mandrel is fixed to the slider mechanism so that the mandrel is not displaceable with respect to the slider mechanism beyond a predetermined stop position due to interference with mechanical mandrel movement, while, at a tether position beyond the fully deployed position, the mandrel is further configured to be longitudinally movable with respect to the slider mechanism beyond the predetermined stop position as the interference with mandrel movement is released.

[0009] According to a second aspect of the present invention, there is proposed a delivery system, the delivery system including a control handle according to an embodiment of the first aspect of the present invention, an elongated delivery catheter mechanically connected to the control handle, and a mandrel controlled by the control handle to be displaceable longitudinally with respect to the delivery catheter.

[0010] The idea of the underlying embodiment of the present invention can be interpreted as being based, inter alia, on the following observations and recognitions.

[0011] Briefly and without limitation, embodiments of the present invention relate to a control handle that can be used with other components of a delivery system to control the function of the delivery system during procedures for implanting an IMD, such as a leadless pacemaker. Among them, the control handle includes a slider mechanism disposed on or within a handle housing. The slider mechanism can be actuated by a user of the delivery system, such as a surgeon. In particular, the slider mechanism can be displaced longitudinally of the control handle between a first position, herein called the fully undeployed position, and a second position, herein called the fully deployed position. Displacing the slider mechanism between such longitudinally opposed extreme positions causes the slider mechanism to cooperate with a mandrel to displace the mandrel relative to the delivery catheter by a predetermined distance, herein called the deployment distance. Due to such displacement of the mandrel, an IMD connected to the distal end of the mandrel can be displaced relative to a protector cup provided at the distal end of the delivery catheter, such as for deploying the IMD from such a protector cup.

[0012] In addition to performing 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, depending on the current position of the slider mechanism relative to the handle housing. In particular, the slider mechanism is configured to establish an interference with mechanical mandrel movement when disposed in the fully undeployed position, slide to the fully deployed position, and then, when reaching a so-called tether position beyond the fully deployed position, release such interference with mechanical mandrel movement. When the interference with mandrel movement is established, the slider mechanism cooperates with the mandrel to prevent the mandrel from displacing relative to the slider mechanism beyond a predetermined stop position. In the delivery system, by displacing the mandrel beyond the deployed position without exceeding a predetermined stop position, it may be possible to establish a so-called tether configuration in which the IMD is released from fixation with the catheter but remains connected to the catheter via the tether. The predetermined stop position may be set to prevent interference with mandrel movement from displacing the mandrel beyond such a tether configuration, i.e., for example, to a release configuration in which the mandrel is ejected from the catheter to such a distance that the tether configuration is released and the mechanical connection between the IMD and the catheter is opened.

[0013] Accordingly, the slider mechanism within the control handle can be ergonomically and accurately actuated. In particular, the slider mechanism can simplify the deployment procedure established by the delivery system and then automatically switch from a deployment mode in which the IMD is fully deployed and ejected from the delivery catheter but still connected by the delivery system to a tether mode, thus enabling, for example, performing tests such as a tag test to recapture the IMD, since such a tag test is negative.

[0014] Within the scope of this application, the mandrel is understood as a wire inserted into a delivery catheter or the sheath of a delivery catheter. The mandrel is more rigid than the delivery catheter or sheath into which it is inserted. The mandrel may be made of metal. The mandrel may be solid.

[0015] Hereinafter, the features of embodiments of the present invention will be described in more detail.

[0016] The control handle is generally configured to control two or more functions of the delivery system when implanting an IMD, particularly an ILP.

[0017] The delivery system includes a delivery catheter and a mandrel. The catheter is elongated, i.e., has dimensions that are substantially greater in the longitudinal direction than in the transverse direction. For example, the catheter may have a length exceeding 10 cm, typically 50 cm to 200 cm, while having a diameter of less than 5 cm, typically 0.5 cm to 2 cm. The catheter can be bent in its transverse direction so that it can be maneuvered and / or guided along a curved path, e.g., throughout a patient's blood vessel. Generally, the catheter has a lumen through which the mandrel extends. The mandrel is typically a wire or a rope. Here, the mandrel can generally be bent in the transverse direction but is substantially inelastic in the longitudinal direction.

[0018] The slider mechanism and the handle housing are components of the control handle. The control handle may further include additional components such as, for example, a steering mechanism for maneuvering the delivery catheter or a locking mechanism for blocking any unintended movement of the mandrel that would result in the final release of the IMD from the delivery system. All such components may be made of materials suitable for medical use, e.g., appropriately sterilizable. For example, some or all of the components may be made of a plastic material and, optionally, be injection-molded components. Alternatively or additionally, at least some of the components may be made of a metal such as stainless steel or nitinol.

[0019] The slider mechanism may be displaced longitudinally relative to the handle housing. In particular, for example at the start of a surgical procedure, the slider mechanism may be arranged in a fully undeployed position. Such a fully undeployed position may be a position where the slider mechanism is arranged at a maximum proximal position relative to the handle housing. When arranged in such a fully undeployed position, the mandrel cooperating with the slider mechanism is arranged such that the IMD held at the distal end of the mandrel is arranged in an undeployed configuration housed within the delivery catheter, preferably within the protector cup of the delivery catheter. During the surgical procedure, the slider mechanism may be displaced, for example, by the surgeon pushing the slider mechanism from the fully undeployed position towards the fully deployed position relative to the handle housing. Upon reaching such a fully deployed position, the mandrel is arranged in a deployed configuration in which the IMD is deployed, i.e., released from being housed and / or secured by the delivery catheter and can be secured, for example, within the tissue of the patient which is the implantation site.

[0020] In addition to the movement between the fully undeployed position and the fully deployed position, the slider mechanism allows for further movement towards the tether position. Such a tether position can be reached when the slider mechanism is displaced longitudinally up to the fully deployed position and can then be moved actively or passively beyond such a position. When arranged in such a tether position, the mandrel not only moves to a fully deployed configuration, but the IMD at its distal end can further move into a tether mode, i.e., into a loose tether configuration relative to the catheter. Preferably, the tether position is arranged at a position laterally displaced relative to the fully deployed position. In other words, the slider mechanism can move longitudinally between the fully undeployed position and the fully deployed position, but to reach the tether position, it can further move in a lateral direction that intersects, or preferably is orthogonal to, such a longitudinal direction.

[0021] 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 the forces applied by the user are released, the slider mechanism automatically displaces to the tether position, thereby relieving the interference with the mandrel movement.

[0022] In other words, the slider mechanism may be configured to further automatically move towards the tether position when the slider mechanism reaches the fully deployed position, for example, without the need for further force applied by a surgeon.

[0023] Thus, when the delivery system reaches the deployed configuration and the surgeon releases the actuation of the slider mechanism, for example, the control handle automatically switches to the tether mode, where the mandrel can be further displaced relative to the delivery catheter beyond a predetermined stop position. Thus, the interference with the mandrel movement that is active during the first part of the surgical sequence where the IMD must first be deployed is automatically relieved when the slider mechanism reaches the fully deployed position and then further moves to the tether position. Such automatic movement of the mandrel and relief of the interference with the mandrel movement can significantly simplify the handling of the delivery system.

[0024] According to one embodiment, the slider mechanism includes a slider body and a slider housing. Here, the slider body is disposed in the slider housing so as to be elastically biased laterally away from the slider housing. Further, the slider body and the slider housing are configured such that as long as the slider mechanism is disposed anywhere between the fully undeployed position or the fully undeployed position and the fully deployed position, the slider body remains fixed to the slider housing in the pulled-down configuration, while when reaching the fully deployed position, the fixation is released and the slider body automatically displaces laterally away from the slider housing to the pulled-up configuration by elastic biasing, thereby relieving the interference with the mandrel movement.

[0025] Put another way, 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. At this time, the slider body may be elastically biased, that is, an elastic force may act on the slider body such that the slider body is elastically pre-tensioned in the lateral direction away from the slider housing. The elastic bias can be implemented using, for example, one or more springs or other elastic elements. Such elastic elements may be interposed between the slider housing and the slider body.

[0026] To implement a beneficial, preferably automatic function of the slider mechanism, the slider mechanism is configured with the slider body and the slider housing such that the slider body remains in the lowered configuration as long as the slider mechanism is anywhere between the fully non-deployed position and the fully deployed position. However, when the slider body reaches the fully deployed position, it is not further actively pushed down into its lowered configuration, for example, by a surgeon, and the slider body automatically transitions to the raised configuration. Here, in the lowered configuration, the slider body is close to the central axis of the control handle, while in the raised configuration, the slider body is displaced laterally and thus further away from the central axis.

[0027] Thus, between the fully non-deployed 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. On the other hand, when the fully deployed position is reached, the slider mechanism, together with its slider body, gains an additional degree of freedom of movement in which the slider body can be displaced laterally from the lowered configuration to the raised configuration.

[0028] Thus, the surgeon can easily push the slider mechanism from its initial fully non-deployed position to the fully deployed position. Then, when the surgeon releases the lateral pressure on the slider mechanism, for example, by removing a thumb, the slider body can "pop up" into the raised configuration, thereby releasing the interference of the mandrel movement.

[0029] Thus, upon reaching the lifting configuration, the mandrel can move longitudinally relative to the slider mechanism beyond a predetermined stop position, thereby activating the tether mode of the delivery system. In other words, when the slider body is in the lowering configuration, any movement of the slider is transmitted to the corresponding movement of the mandrel. When the slider body is in the lifting configuration, the mandrel can move independently of the slider.

[0030] According to one embodiment, the slider body and the slider housing each include a longitudinally extending through-hole such that the mandrel extends longitudinally through both through-holes. Therein, the through-hole of the slider body includes two sections having a first section with a cross-sectional dimension smaller than that of a second section such that the mandrel extends through the first section when the slider body is in the lowering configuration and the mandrel extends through the second section when the slider body is in the lifting configuration.

[0031] In other words, the mandrel may extend along a straight line through a through-hole that penetrates both the slider body and the slider housing. The through-hole of the slider housing can have, for example, a circular cross-section with a single diameter larger than that of the mandrel, while the through-hole of the slider body can have a circular cross-section but includes two sections with different diameters. The two sections overlap laterally to form a single through-hole having a contour with one smaller first section and one larger second section, similar to the contour of a keyhole. Here, the first section of the through-hole of the slider body generally has a smaller lateral 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 a larger lateral dimension as the through-hole of the slider housing.

[0032] As long as the slider body is in its lowered configuration, the first section of its through-hole, which has a smaller dimension, is aligned with the through-hole of the slider housing. Thus, a portion of the mandrel extending through the through-holes of both the slider body and the slider housing must have a diameter smaller than the smaller dimension of the first section of the through-hole of the slider body so that it can be displaced laterally along the slider mechanism.

[0033] However, when the slider body is in its raised configuration, the second section of its through-hole, which has a larger dimension, is aligned with the through-hole of the slider housing. Thus, the portion of the mandrel extending through the slider body and the slider housing can have a dimension larger than in the first case, i.e., its diameter can be the same size as the diameter of the through-hole passing through the slider housing and the second section of the through-hole passing through the slider body.

[0034] According to one embodiment, the mandrel includes an exposed mandrel portion and a tether hypo tube portion disposed more proximally to the exposed mandrel portion. The exposed mandrel portion has a first cross-sectional dimension, and the tether hypo tube portion has a second cross-sectional dimension larger than the first cross-sectional dimension. The first section of the through-hole of the slider body has a cross-sectional dimension smaller than the second cross-sectional dimension of the tether hypo tube portion, while the second section of the through-hole of the slider body has a cross-sectional dimension larger than the second cross-sectional dimension of the tether hypo tube portion.

[0035] In such an embodiment, the mandrel typically includes at least two different portions herein referred to as the exposed mandrel portion and the tether hypo tube portion. Since these portions have different cross-sectional dimensions, the smaller exposed mandrel portion can extend through a through-hole having a smaller cross-sectional dimension, while the larger tether hypo tube portion can only extend through a through-hole having a larger cross-sectional dimension. Here, the cross-sectional dimension of the mandrel is set such that the tether hypo tube portion can extend through the slider mechanism, so that the slider body is in the lifted configuration, and thus the mandrel can be displaced longitudinally only when it extends along the larger second section of its through-hole.

[0036] 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 the user of the handle when the slider mechanism is displaced beyond at least one predetermined deployment feedback position longitudinally positioned between the fully non-deployed position and the fully deployed position.

[0037] With the haptic deployment feedback generated by such a haptic deployment feedback mechanism, the user of the control handle can be notified of a specific configuration that occurs during the operation of the control handle. For example, when a specific configuration is reached while displacing the slider mechanism from the fully non-deployed position to the fully deployed position, deployment feedback can be provided. Since such deployment feedback is provided haptically, the user does not need to visually observe the handle, for example. By providing such deployment haptic feedback, the ergonomic and reliable handling of the delivery system by the user can be improved.

[0038] According to one embodiment, a predetermined first deployment feedback position corresponds to a position where the slider mechanism positions the mandrel in a sheath configuration when the slider mechanism is between the fully undeployed position and the first deployment feedback position, and 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. On the other hand, when the slider mechanism is longitudinally displaced beyond the first deployment feedback position, the slider mechanism positions the mandrel in a configuration where at least part of it is not covered, and the mandrel and the delivery catheter are positioned relative to each other such that the protector sheath does not completely cover the medical device any more.

[0039] Accordingly, a user of the control handle can receive tactile deployment feedback when displacing the slider mechanism beyond a position where the IMD transitions from a configuration completely covered by the protector sheath to a configuration not completely covered by the protector sheath, i.e., at least partially or completely discharged from the protector sheath and thus, for example, can be fixed within the patient's tissue at the intended implantation site.

[0040] According to a further embodiment, a predetermined second deployment feedback position corresponds to a position where when the slider mechanism is longitudinally slid from the first deployment feedback position to the second deployment feedback position, the slider mechanism continuously positions the mandrel in a fixed configuration relative to the delivery catheter such that a fixing mechanism at the distal end of the medical device is discharged from the protector sheath to fix the medical device to the heart 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 uncovered configuration and the mandrel and the delivery catheter are positioned relative to each other such that the protector sheath does not cover the medical device any more.

[0041] Accordingly, when the user of the control handle displaces the slider mechanism beyond the position where the IMD moves, for example, from a configuration where the fixing mechanism is not yet activated by being discharged from the protector sheath, to a configuration where the fixing mechanism is activated to fix the IMD at the intended implantation position, the user can receive tactile deployment feedback.

[0042] According to one embodiment, the tactile deployment feedback mechanism includes at least one protrusion and at least one bumper. The protrusion is disposed on one of the handle housing and the slider mechanism, and the bumper is disposed on the other of the handle housing and the slider mechanism. The protrusion and the bumper are configured to induce a retracting force on the slider mechanism when the user longitudinally presses the slider mechanism beyond at least one deployment feedback position.

[0043] By inducing a pulling force on the slider mechanism when passing through the deployment feedback position, the configuration including the protrusion and the bumper can generate tactile deployment feedback to the user regarding a specific configuration of the delivery system. The pulling force can decelerate the longitudinal displacement of the slider mechanism and / or can require the user to temporarily increase the force acting on the slider mechanism to translate the slider mechanism beyond the deployment feedback position.

[0044] According to a further specific embodiment, the slider mechanism is guided within the handle housing when displaced longitudinally, and the deployment feedback mechanism is configured such that the protrusion and the bumper are elastically biased towards each other in a lateral direction intersecting the longitudinal direction.

[0045] For example, the raised portion may be a protrusion protruding in a direction from the handle housing toward the slider mechanism. The bumper may be an element protruding from the slider mechanism in a direction toward the handle housing. Therefore, the raised portion and the bumper can protrude in opposite directions. Both the protruding direction of the raised portion and the protruding direction of the bumper may be orthogonal to the longitudinal direction of the handle. At least one of the raised portion and the bumper may be configured to be elastically displaceable in a direction opposite to the protruding direction. Therefore, when a force is applied to the raised portion and / or the bumper in such a direction, each element can be pulled aside, that is, can move or deflect away from the other element. By such an action, the bumper and the raised portion can temporarily induce a higher pulling force acting on the displacement of the slider mechanism with respect to the handle housing, and thus can generate tactile deployment feedback.

[0046] According to one embodiment, the control handle further includes a valve disposed in the slider mechanism to prevent back bleeding through the lumen of the delivery catheter.

[0047] Such a valve may be disposed within the slider mechanism at or adjacent to the lumen of the delivery catheter and may block a passage through which blood coming from such a lumen can flow through the control handle. Therefore, the valve can prevent blood entering the delivery catheter at the distal end within the patient from being discharged at the proximal end of the delivery catheter, which may contaminate the components of the control handle or even be discharged from the control handle.

[0048] According to a further specific embodiment, the valve is formed by a membrane having a through-hole configured to closely surround a mandrel held in the cross-sectional direction within the slider mechanism and extending through the through-hole of the membrane through the slider mechanism.

[0049] Thus, the valve can seal a passage through the control handle that extends to an extension portion where the mandrel generally extends from a proximal position of the control handle through a distal delivery catheter of the control handle. With such a membrane valve, blood cannot flow from the inside of the delivery catheter in a direction parallel to the mandrel toward a position proximal to the control handle.

[0050] A delivery system according to a second aspect of the present invention includes a control handle according to an embodiment of the first aspect of the present invention. Further, 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. Among them, the control handle is configured as further described above and below and can cooperate with the delivery catheter and the mandrel. Further, the delivery catheter and the mandrel may be configured to perform various functions.

[0051] In particular, according to one embodiment, the delivery system can be configured such that when the mandrel is displaced by a deployment distance relative to the delivery catheter, a medical device held at the distal end of the delivery catheter is deployed from a protector sheath of the delivery catheter. Further, the delivery system can include a tethering member connected to the distal end of the mandrel and connected to the medical device, and the delivery system can be configured such that when the mandrel is displaced relative to the delivery catheter by a tethering distance in addition to the deployment distance, the tethering member is displaced between a retracted position and an ejection position. In the retracted position, the tethering member pulls the medical device to be fixed to the end cup at the distal end of the delivery catheter, while in the ejection position, the tethering member releases the medical device from the fixation to the end cup.

[0052] According to a further specific embodiment, the mandrel includes at least an exposed mandrel portion and a tether hypo tube portion disposed more proximally to the exposed mandrel portion. The exposed mandrel portion has a first cross-sectional dimension, and the tether hypo tube portion has a second cross-sectional dimension greater than the first cross-sectional dimension. The length of the exposed mandrel portion corresponds to or is longer than the deployment distance, and the length of the tether hypo tube portion corresponds to or is longer than the tethering distance.

[0053] In addition to the features described herein with reference to various embodiments of the present invention, the control handle and delivery system can be configured according to various additional aspects and embodiments. For example, such additional aspects and embodiments are described in another patent application entitled "Control Handle with Locking Mechanism for Controlling the Function of a Delivery System for Implanting a Medical Device" filed by the applicant simultaneously with the present application, the content of which is hereby incorporated by reference in its entirety. Examples of such additional aspects and embodiments are described in the following paragraphs.

[0054] According to a first additional aspect, a control handle for controlling the function of a delivery system for implanting a medical device is proposed. Among them, the delivery system includes an elongated delivery catheter and a mandrel displaceable longitudinally relative to the delivery catheter. The control handle includes a locking mechanism and a handle housing. Among them, the locking mechanism is configured to be switchable between a locked configuration and an unlocked configuration, whereby, in the locked configuration, due to interference of mechanical mandrel abutment, the mandrel is fixed relative to the locking mechanism so that the mandrel cannot be displaced beyond a predetermined abutment position relative to the locking mechanism, while in the unlocked configuration, the mandrel is movable longitudinally relative to the locking mechanism beyond the predetermined abutment position because the interference of mandrel abutment is released.

[0055] According to a second additional aspect, a delivery system is proposed, the delivery system including a control handle according to the implementation of the first additional aspect, 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.

[0056] The concept underlying the implementation of such additional aspects can be interpreted as being based, inter alia, on the following observations and recognitions.

[0057] Briefly and non - limitingly, embodiments of such additional aspects relate to a control handle that can be used with other components of the delivery system to control the function of the delivery system during a procedure for implanting an IMD such as a leadless pacemaker. Among them, the control handle includes a locking mechanism disposed on or within a handle housing. During a surgical procedure, the locking mechanism can be actuated by a user of the delivery system, such as a surgeon. In particular, the locking mechanism may be actuated to switch between a first configuration herein called a locked configuration and a second configuration herein called an unlocked configuration. In the locked configuration, the locking mechanism is configured to prevent any displacement of the mandrel relative to the locking mechanism beyond a predetermined abutment position by a mechanical interference herein called interference of mandrel abutment. In the unlocked configuration, the mechanical interference of mandrel abutment is released, thereby allowing the mandrel to be displaced beyond the abutment position.

[0058] The abutment position can be determined by the lengths of the various parts of the mandrel, which parts have different diameters, as will be described in more detail below. In particular, the abutment position is provided at the distal end of the mandrel and is configured such that a locking element configured to releasably secure the IMD to the mandrel does not lie in a position that would allow the locking element to open and thereby irreversibly release the IMD, as long as the mandrel does not displace beyond the abutment position. Thus, as long as the locking mechanism of the control handle is in its locked configuration, the locking element at the distal end of the mandrel may not need to be released. Thus, the IMD cannot be inadvertently released from the distal end of the mandrel unless the locking mechanism is intentionally actuated by switching the locking mechanism to its unlocked configuration.

[0059] The locking mechanism may be incorporated into the control handle along with other features or elements that control other functions of the delivery system, such as, for example, controlling the deployment of the IMD and / or tether mode. For example, the locking mechanism may be configured to be actuated by a rotational movement of one of its components.

[0060] All of these features assist in improving the ergonomics of the control handle. In particular, until the locking mechanism is switched to its unlocked configuration, inadvertent release of the IMD by displacing the mandrel beyond a predetermined abutment position can be reliably prevented, and such a switch can be accomplished by the surgeon simply actuating the locking mechanism with the control handle.

[0061] The implementation features of such additional aspects will be described in more detail below.

[0062] The control handle is generally configured to control two or more functions of the delivery system when implanting the IMD.

[0063] The delivery system includes a delivery catheter and a mandrel. The catheter is elongate, i.e., has a dimension in the longitudinal direction that is substantially greater than the dimension in the transverse direction. For example, the catheter may have a length exceeding 10 cm, typically 50 cm to 200 cm, while having a diameter of less than 5 cm, typically 0.5 cm to 2 cm. The catheter can be bent in its transverse direction so as to be maneuvered and / or guided along a curved path, e.g., throughout a patient's blood vessel. Generally, the catheter has a lumen through which the mandrel extends. The mandrel is typically a wire or a rope. Here, the mandrel can generally be bent in the transverse direction but is substantially inelastic in the longitudinal direction.

[0064] The lock mechanism and the handle housing are components of the control handle. The control handle can further include, for example, an operating mechanism for operating the delivery catheter, or a slider mechanism for displacing the mandrel between a non-deployed configuration and a deployed configuration and, optionally, enabling a tether mode of the delivery system. All such components may be made of materials suitable for medical use, e.g., so as to be appropriately sterilizable. For example, some or all of the components may be made of a plastic material and, optionally, be injection-molded components. Alternatively or additionally, at least some of the components may be made of a metal such as stainless steel or nitinol.

[0065] The locking mechanism may be displaced relative to the handle housing. In particular, for example, at the start of a surgical procedure, the locking mechanism may be placed in a locked configuration. In such a locked configuration, the locking mechanism prevents movement of the mandrel and releases the IMD, particularly the ILP, from the delivery system. Later, during the surgical procedure, for example, after positioning the IMD at the correct implantation site and optionally after successful testing such as a tag test and / or a functionality test of the IMD, the surgeon can determine that the IMD is correctly implanted and fixed, and thus can switch the locking mechanism to its unlocked configuration, thereby intentionally enabling displacement of the mandrel to a position that allows the IMD to be released from the delivery system.

[0066] According to one embodiment, the locking mechanism is configured to be switched between a locked configuration and an unlocked configuration by rotating an unlocking actuating member relative to the handle housing.

[0067] In other words, the locking mechanism includes, among other things, an unlocking actuating member that can be rotated between different states, thereby switching the locking mechanism between the locked configuration and the unlocked configuration. On the one hand, the rotational actuation of such a switching procedure can be easily performed by the surgeon and can be ergonomically beneficial, while on the other hand, it reliably prevents unintentional actuation of the switching procedure.

[0068] According to a further particular embodiment, the axis of rotation of the unlocking actuating member is aligned with the longitudinal axis of the control handle.

[0069] In other words, the unlocking actuating member of the locking mechanism may be actuated by rotating it around the longitudinal axis of the control handle. Again, such rotational actuation of the switching procedure can be ergonomically beneficial and can be technically easily implemented.

[0070] Furthermore, according to one embodiment, the locking mechanism may be configured to be switched between a locked configuration and an unlocked configuration by removing the unlocking actuating member in a clockwise direction along the CCW / left-handed thread.

[0071] In principle, the locking mechanism can be technically implemented to operate in both the clockwise and counterclockwise directions. However, it has been found that by configuring the locking mechanism to be actuated to the unlocked configuration by removing the unlocking actuating member in the clockwise direction, unintentional operation of the locking mechanism can be more reliably prevented.

[0072] According to one embodiment, the locking mechanism includes a through passage for accommodating the mandrel, and the lateral limiting element of the locking element surrounds the through passage from the opposite side. Among them, in the locked configuration, the locking mechanism is configured such that the lateral limiting elements are pushed towards each other more than in the unlocked configuration, and in the locked configuration, the lateral dimension of the through passage is smaller than in the unlocked configuration.

[0073] In other words, the locking mechanism can include a through-passage such as a through-hole or a groove through which the mandrel can extend. Such a through-passage may be formed by a part or component of a locking element, which is referred to herein as a lateral restriction element. The lateral restriction element surrounds the through-passage from both sides such that the actual cross-sectional dimension of the through-passage is determined by the actual position of the lateral restriction element. The lateral restriction element can be configured to be elastically biased towards a first configuration, which is also referred to herein as an unloaded configuration. In such an unloaded configuration, no lateral compressive force acts on the lateral restriction element, or only a weak lateral compressive force acts, and the through-passage can have a relatively large cross-sectional dimension or diameter. Such an unloaded configuration corresponds to the unlocking configuration of the locking mechanism. However, when a stronger lateral compressive force is applied to the lateral restriction element, the lateral restriction elements are pushed towards each other into a second configuration, which is also referred to herein as a loaded configuration. In response to such an increase in the lateral compressive force, the cross-sectional dimension or diameter of the through-passage decreases. Such a loaded configuration of the lateral restriction element corresponds to the locking configuration of the locking mechanism.

[0074] According to a further specific embodiment, the locking mechanism includes a compression element that releases a compressive force acting radially on the lateral restriction element when the unlocking actuating member is rotated from the locking configuration to the unlocking configuration.

[0075] In other words, by rotating the unlocking actuating member from the locking configuration to the unlocking configuration, the lateral compressive force that initially reduces the cross-sectional dimension of the through-passage restricted by the lateral restriction element can be reduced until the cross-sectional dimension of the through-passage extends such that it can increase towards the unloaded configuration. The compression element can be the unlocking actuating member itself or a separate component that cooperates with the unlocking actuating member.

[0076] According to a further specific embodiment, the lateral restriction element is formed by an inner member that surrounds the through passage, extends between the elongated portions of the inner member, and further has a longitudinal slit with a conical outer shape at its cantilever end. Further, the compression element is formed by an outer member that surrounds the inner member and has a conical inner shape on the inner surface facing the cantilever end of the inner member.

[0077] In other words, the locking mechanism may include an inner member and an outer member. The inner member may extend longitudinally so as to surround the through passage between elongated portions that face each other with respect to the longitudinal central axis of the through passage, and may include several elongated portions that are parallel to each other. The elongated portions may be held at one end and may be elastically deflectable at the opposite cantilever end. The elongated portions may have a shape such that they are conical on their outer surface at the cantilever end. The outer member is configured to cooperate with the inner member so as to apply various compression forces to the elongated portions of the inner member at or near its cantilever end, and the compression force varies according to the operating state of the locking mechanism. Specifically, the outer member surrounds the inner member and has a shape such that the inner surface of the outer member is conical at least in the region facing the cantilever end of the inner member.

[0078] The outer member and the inner member may be configured such that they are displaced relative to each other longitudinally when the locking mechanism is operated between the locked configuration and the unlocked configuration. For example, when operating from the locked configuration to the unlocked configuration, the outer member and the inner member may be displaced such that the conical outer surface of the inner member moves away from the opposing conical inner surface of the outer member. As a result of such movement, the compression force exerted by the outer member on the cantilever end of the inner member can be reduced such that the cross-sectional dimensions of the through passage surrounded by the inner member are enlarged as the elongated portions of the inner member are elastically biased radially outward.

[0079] According to a further specific embodiment, the mandrel includes a tether hypo-tube portion and a release hypo-tube portion disposed further proximally to the tether hypo-tube portion. The tether hypo-tube portion has a first cross-sectional dimension, and the release hypo-tube portion has a second cross-sectional dimension that is larger than the first cross-sectional dimension. Here, when the locking mechanism is in the locked configuration, the through-passage of the locking mechanism has a cross-sectional dimension smaller than the second cross-sectional dimension of the release hypo-tube portion, while when the locking mechanism is in the unlocked configuration, the through-passage of the locking mechanism has a cross-sectional dimension larger than the second cross-sectional dimension of the release hypo-tube portion.

[0080] In such an embodiment, the mandrel typically includes at least two portions, herein referred to as the tether hypo-tube portion and the release hypo-tube portion. Since these portions have different cross-sectional dimensions, the smaller tether hypo-tube portion can extend through the through-passage 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 hypo-tube portion can extend through the through-passage of the locking mechanism only when the locking mechanism is in its unlocked configuration and thus has a larger cross-sectional dimension.

[0081] Thus, as long as the locking mechanism is in its locked configuration, the mandrel can be displaced only longitudinally as long as its tether hypo-tube portion extends through the through-passage, while when the mandrel abuts against the through-passage with its large-diameter release hypo-tube portion, further longitudinal displacement is blocked. Such interference of the mandrel's abutment can be released only by actuating the locking mechanism to its unlocked configuration, thereby enlarging the cross-sectional dimension of the through-passage and thus enabling the release hypo-tube portion to be inserted into the through-passage, thereby allowing further longitudinal distal displacement of the mandrel to a position where the IMD held at its distal end can be released.

[0082] According to one embodiment, the control handle further includes a haptic rocker feedback mechanism. The haptic rocker feedback mechanism is configured to generate haptic rocker feedback to the user of the handle when the locking mechanism is displaced beyond at least one rocker feedback position relative to the handle housing during a switch from a locked configuration to an unlocked configuration.

[0083] The haptic rocker feedback generated by such a haptic rocker feedback mechanism can notify the user of the control handle of a particular configuration that occurs when the control handle is operated. For example, haptic rocker feedback may be provided when a particular configuration is reached while switching the rocker mechanism from the locked configuration to the unlocked configuration. Since such rocker feedback is provided haptically, the user need not visually observe the control handle, for example. By providing such haptic rocker feedback, the ergonomic and reliable handling of the delivery system by the user can be improved.

[0084] According to a further particular embodiment, the haptic rocker feedback mechanism includes at least one groove and at least one spring plunger, the groove is disposed on one of the handle housing and the locking mechanism, and the spring plunger is disposed on the other of the handle housing and the locking mechanism. Therein, the groove and the spring plunger can be configured to induce a backward force on the locking mechanism when the user rotates the locking mechanism beyond at least one rocker feedback position.

[0085] The groove and the spring plunger may be configured to cooperate with each other when aligned with each other to generate a pulling force. For example, the spring plunger may be elastically biased toward the groove so that the spring plunger can be "fitted" into the groove when the spring plunger and the groove are aligned. For example, the spring plunger may protrude from the surface of the locking mechanism toward the opposing surface of the handle housing, and the groove may form a recess extending along the opposing surface of the handle housing, or vice versa.

[0086] By inducing a pulling force on the locking mechanism when passing through the rocker feedback position, the configuration including the groove and the spring plunger can generate haptic rocker feedback to the user regarding a particular configuration of the delivery system shown to the user. The pulling force can decelerate the rotational displacement of the locking mechanism and / or can require the user to temporarily increase the force acting on the locking mechanism to rotate the locking mechanism beyond the rocker feedback position. Thus, a surgeon can tactilely feel, for example, when actuating the locking mechanism from its locked configuration to its unlocked configuration, thereby enabling, for example, a release mode of the delivery system in which the IMD can be released from the delivery system.

[0087] The delivery system according to a second additional aspect includes a control handle according to an embodiment of the first additional aspect. Further, 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. Among them, the control handle is configured as further described above and below and can cooperate with the delivery catheter and the mandrel. Further, the delivery catheter and the mandrel may be configured to perform various functions.

[0088] In particular, according to one embodiment, the delivery system may be configured such that when the mandrel is displaced by 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 protector sheath of the delivery catheter. Further, the delivery system may further include a tethering member connected to the distal end of the mandrel and connected to the medical device. Then, when the mandrel is displaced relative to the delivery catheter by a tethering distance in addition to the deployment distance, the delivery system can be configured such that the tethering member is displaced between a retracted position and an ejection position. In this case, in the retracted position, the tethering member draws the medical device into fixation with the end cup at the distal end of the delivery catheter, while in the ejection position, the tethering member releases the medical device from fixation with the end cup. Further, the delivery system is further configured such that when the mandrel is displaced relative to the delivery catheter by a release distance in addition to the tethering distance and the deployment distance, the tethering member is displaced between the ejection position and a release position, and in the release position, the tethering member releases the medical device from any connection with the delivery system.

[0089] According to a further particular embodiment, the mandrel includes an exposed mandrel portion, a tether hypo tube portion disposed more proximally to the exposed mandrel portion, and a release hypo tube portion disposed more proximally to the tether hypo tube portion. The exposed mandrel portion has a first cross-sectional dimension, the tether hypo tube portion has a second cross-sectional dimension larger than the first cross-sectional dimension, and the release hypo tube portion has a third cross-sectional dimension larger than the second cross-sectional dimension. Among them, the length of the exposed mandrel portion corresponds to or is longer than the deployment distance, the length of the tether hypo tube portion corresponds to or is longer than the tethering distance, and the length of the release hypo tube portion corresponds to or is longer than the release distance.

[0090] Note that the possible features and advantages of the embodiments of the present invention are described herein with respect to various embodiments of the control handle and with respect to various additional aspects and embodiments of such control handles. Those skilled in the art will recognize that features can be appropriately transferred from one embodiment or aspect to another in order to arrive at further embodiments of the present invention, and that features can be modified, adapted, combined, and / or exchanged.

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

Brief Description of the Drawings

[0092]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

[0093] The drawings are only schematic and not to scale. The same reference signs refer to the same or similar features.

[0094] FIG. 1 shows a control handle 1 according to an embodiment of the present invention and according to a further embodiment for controlling the function of a delivery system 3 for implanting a medical device (not shown).

[0095] 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 extends through the control handle 1. There, the longitudinal positioning of the mandrel 7 controls or influences the operation of the delivery system 3, for example, during a surgical procedure in which an IMD, particularly an ILP, held at the distal end of the delivery system 3 is continuously deployed, fixed, tested, and finally released. FIG. 1 mainly focuses on visualizing the details of the control handle 1 and shows only the proximal end portion of the delivery system 3, but details of the possible delivery system 3 controlled by the control handle 1, particularly details of the operating principle of such a delivery system 3, are described in the applicant's prior applications such as International Publication No. 2020 / 043481 and International Publication No. 2020 / 187663.

[0096] 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 in the delivery system and to selectively activate or deactivate the so-called tether mode in the delivery system 3.

[0097] The slider mechanism 11 may be displaced in the longitudinal direction 13 with respect to the handle housing 9. In particular, the slider mechanism 11 can be displaced longitudinally between a fully non-deployed position and a fully deployed position. In the fully non-deployed position, the slider mechanism 11 is disposed at the most proximal position, i.e., slid proximally in the proximal direction 15 to the proximal end of the displacement range. On the other hand, in the fully deployed position, the slider mechanism is disposed at the most distal position, i.e., slid distally in the distal direction 17 to the distal end of the displacement range.

[0098] The slider mechanism 11 interacts with the mandrel 7 such that when the slider mechanism 11 is displaced between the fully non-deployed position and the fully deployed position, the mandrel 7 is displaced by a predetermined deployment distance with respect to the delivery catheter 5. Further, the slider mechanism 11 is configured such that when disposed in the fully non-deployed position, the mandrel 7 is fixed with respect to the slider mechanism 11 so that the mandrel 7 cannot be displaced with respect to the slider mechanism 11 beyond a predetermined stop position because interference of the mechanical mandrel movement is established. However, if the slider mechanism 11 is set to a so-called tether position that can be reached when displaced beyond the fully deployed position, the mandrel 7 can move longitudinally with respect to the slider mechanism 11 beyond the predetermined stop position because the interference of the mandrel movement is released.

[0099] Furthermore, the control handle 1 includes a locking mechanism 19. The locking mechanism 19 can be particularly used to control whether the delivery system 3 can displace the mandrel 7 to a position where the delivery system 3 is finally released from the state where the medical device is mechanically connected to the delivery system 3 at its distal end.

[0100] The locking mechanism 19 can be switched between a locked configuration and an unlocked configuration. In the locked configuration, the mandrel 7 is fixed to the locking mechanism 19 such that, as a result of the mechanical mandrel abutment interference being actuated, the mandrel 7 cannot be displaced relative to the locking mechanism 19 beyond a predetermined abutment position. However, when switched to the unlocked configuration, the mandrel abutment interference is released and the mandrel 7 can move longitudinally relative to the locking mechanism 19 beyond the abutment position.

[0101] Furthermore, FIG. 1 shows an operating mechanism 10 for operating the delivery catheter 5 and an insertion tube 12 that can be used to insert a contrast agent into the delivery catheter 5.

[0102] First, with reference to FIGS. 1-5, the details, characteristics, and possible advantages of the slider mechanism 11 within the control handle 1 that controls the deployment or retraction of the IMD and further controls the activation or deactivation of the tether mode in the delivery system 3 will be described. Among them, the details, characteristics, and possible advantages are described with reference to exemplary embodiments or modes of implementation related to the implant procedures of leadless pacemakers.

[0103] Leadless pacemaker implant procedures generally require an implant catheter that can manipulate, position, and deliver the implant to a specific location in the heart. Conventional implant procedures for implanting a leadless pacemaker into either the right ventricle or the atrial appendage of the heart utilize access to the patient's femoral vein. An introducer is placed that traverses from the incision site to the atrium of the heart. Once the introducer is in place, a catheter is required that can safely house the implant and its fixation mechanism and protect the implant from the patient's anatomy or harmful interactions with the introducer. The catheter is then inserted through the introducer until it exits the introducer within the atrium. Once the distal end of the catheter is no longer contained within the introducer, it is necessary to proceed into the right ventricle across the tricuspid valve or straight up from the atrium to the atrial appendage. When the distal end of the catheter reaches the selected deployment location, the implant is deployed into the heart wall tissue.

[0104] Once the implant is deployed, tests, including electrical measurements and fixation measurements, are performed by the user to confirm that the implant site is appropriate prior to releasing the implant. If the results of the electrical or fixation tests indicate unacceptable results, the implant is recaptured, repositioned, and implanted in a new location. Once the measurements of the electrical and fixation tests are determined to be acceptable, the user then releases the implant from its tether connected to the delivery catheter. After the implant is successfully released, the delivery is safely removed from the patient's anatomy.

[0105] The control handle 1 described herein can function as a deployment actuator mechanism for a transcatheter that enables both the user to deploy the implant and to seamlessly and controllably enter a tether mode used to evaluate the fixation of the implant to the heart wall. If the user determines through measurement that the implantation site is unacceptable, the novel mechanism detailed by this disclosure enables the user to safely and surely exit the tether mode and recapture and return the implant to the protector cup of the catheter, as a result of which the implant can be repositioned, redeployed, and ultimately released at a newly selected location.

[0106] Previous solutions in this field consist of using an actuator to pull the outer catheter and protector cup proximally away from the implant in order to deploy the implant into the heart wall. Thus, the actuator 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 decoupled from switching the tether mode to active or non-active. This solution uses a separate actuator to control the tether mode, and the tether mode is used to lock and unlock so that the tether is not movable (i.e., make the tether mode non-active when locked and active when unlocked). Further, this solution utilizes a long flexible suture as a means for tethering to the embedded catheter. Further, this tether lock / unlock mechanism is essentially just a stopcock through which the suture passes inside. When the stopcock is locked via a handle actuator, the stopcock clamps / constricts on the suture inside it, preventing movement of the suture either distally or proximally. When actuated to the unlock position, the stopcock releases the constriction of the suture. Further, the stopcock does not have a valve inside and has no means to prevent back bleeding when in the open / unlock position. Thus, when this mechanism is unlocked and the tether mode is engaged, it is essentially an open tube connected to a wet path of the catheter where blood can slowly drip backward around the tether itself from the proximal end of the catheter. This means that no washing of the catheter is recommended while the catheter is in the tether mode, and the washed fluid medium just comes out onto the patient or user from the proximal end of the catheter.

[0107] Another currently commercially available solution has a different approach consisting of two flexible release pins for maintaining the tether and a handle for deploying the implant by screwing the implant into the heart wall.

[0108] Another approach uses a separate actuator to deploy the implant and switch the tether mode between active / inactive. Multiple actuators reduce the user's ease of use because they have more steps for the user to operate, execute, and remember throughout the implantation procedure. Further, because the actuators are separate, there is a chance of accidentally initiating the recapture process without the user stopping the tether mode by locking the tether actuator. This can result in complications during recapture and damage to the implantation catheter during the recapture process (e.g., if the user fails to lock the tether before attempting the recapture process).

[0109] Furthermore, the stopcock does not have a valve or means to prevent back bleeding inside. Thus, when this mechanism is unlocked and the tether mode is engaged, it is essentially an open tube connected to a wet path of the catheter where blood can slowly drip backward from the proximal end of the catheter. This means that no washing of the catheter is recommended while the catheter is in tether mode, and the washed fluid medium just exits onto the patient / user from the proximal end of the catheter.

[0110] Sutures are also known to impart excessive frictional forces on both the user and the implant during removal, and if the user accidentally applies excessive force during suture release and removal, the user may accidentally dislodge the implant's fixation mechanism from the heart wall. Sutures can also increase the risk of clotting or entanglement during use. Finally, sutures do not have fluoroscopic visibility.

[0111] In view of such conventional approaches, it was an object to design the control handle 1 with a single actuator and handle mechanism that enables a user to safely and surely perform excellent means of deploying a leadless pacemaker implant, automatically transitioning to the tether mode, exiting the tether mode, recapturing the leadless pacemaker implant, repositioning it to a new position, redeploying it, and finally completely releasing it from the catheter.

[0112] The control handle 1 includes a slider mechanism 11. The slider mechanism 11 is configured to automatically transition from the deployment mode to the tether mode. Specifically, after the slider mechanism is displaced from the fully undeployed position to the fully deployed position, when all the forces applied by the user acting on the slider mechanism are released, the slider mechanism automatically moves to the tether position, where the interference of the mandrel movement is released.

[0113] For such a configuration, as shown in more detail in FIG. 1 and specifically in FIGS. 2 to 5, the slider mechanism 11 includes a slider body 21 and a slider housing 23. The slider body 21 is disposed in or within the slider housing 23 so as to be elastically biased in the lateral direction 25 away from the slider housing 23. For such a purpose, several slider springs 27 are disposed between the slider body 21 and the slider housing 23. Further, on the side opposite to the side surface of the slider housing 23, the slider body 21 includes a textured actuation structure 29 through which the user can displace the slider mechanism 11 in the longitudinal direction 13, i.e., in the proximal direction 15 for the deployment procedure or in the distal direction 17 for the recapture procedure, and through which the user can further apply pressure to the slider body 21 against the elastic bias in the lateral direction 25 or release such pressure.

[0114] Among them, the slider body 21 and the slider housing 23 are configured such that the slider body 21 remains fixed to the slider housing 23 in a pulled-down configuration as long as the slider mechanism 11 is disposed anywhere between the fully non-deployed position or the fully non-deployed position and the fully deployed position. However, upon reaching the fully deployed position, such fixation is automatically released, whereby the slider body 21 is automatically displaced laterally 25 away from the slider housing 23 in a pulled-up configuration by the elastic biasing force. As a result of such lateral displacement of the slider body 21, interference with the mandrel movement is automatically released, and thus the mandrel 7 can be displaced longitudinally beyond a predetermined stop position.

[0115] Here, the predetermined stop position is determined because the mandrel 7 has different portions, and the portions are different from each other with respect to their cross-sectional dimensions, i.e., their diameters. In the example shown in FIG. 1, the mandrel 7 includes an exposed mandrel portion 31. Further proximal to such an exposed mandrel portion 31, the mandrel 7 includes a tether hypo tube portion 33 having a diameter larger than that of the exposed mandrel portion 31. Further proximal to such a tether hypo tube portion 33, the mandrel 7 further includes a release hypo tube portion 35 having a diameter even larger than that of the tether hypo tube portion 33. At the most proximal end, the mandrel 7 includes a tether actuator 37 having a diameter larger than that of the release hypo tube portion 35.

[0116] The individual lengths of each of the portions 31, 33, 35 of the mandrel 7 are set such that when the mandrel 7 is displaced longitudinally with respect to the delivery catheter 5, various procedures or modes such as the deployment / recapture procedure / mode, the tether procedure / mode, and the release procedure / mode can be induced at the distal end of the delivery system 3. Therein, the different diameters of the mandrel portions 31, 33, 35 are used to implement an interference to prevent the user from inadvertently displacing the mandrel 7 beyond a predetermined stop position, thereby inadvertently switching from one such treatment / mode to another.

[0117] As will be described in more detail with reference to FIGS. 1-3, the design solution of the control handle 1 includes a deployable slider mechanism 11 having a slider body 21 with a tactile surface intended for the user to advance or retract the slider using either the thumb or a finger. The slider body 21 has a keyed notch extending through its entire interior, called a tether control groove 38. Such a keyed notch is formed by a longitudinally extending through-hole 39 such that the mandrel 7 can extend longitudinally through such a through-hole 39. The through-hole 39 includes a keyed profile having a first section 41 with a cross-sectional dimension smaller than a second section 43. The slider housing 23 functions as another through-hole 45. The through-hole 45 of the slider housing 23 and the through-hole 39 of the slider body 21 are aligned with each other such that the mandrel 7 can extend longitudinally through both through-holes 39, 45. Here, 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 of the slider body 21 is aligned with the through-hole 45 of the slider housing 23, which has a diameter equal to or larger than the larger second section 43 of the through-hole 39 of the slider body 21.

[0118] Thus, when the slider body 21 is in its lowered configuration, the mandrel 7 extends through the smaller first section 41 such that only its exposed mandrel portion 31 having its smaller diameter can extend through the through-holes 39, 45. Thus, in such a lowered configuration, the mandrel 7 cannot be displaced beyond a predetermined stop position where it must insert its larger diameter tether hypotenuse portion 33 into the through-holes 39, 45. However, when the slider body 21 is arranged in the raised configuration, the mandrel 7 extends through the larger second section 43 of the through-hole 39 such that the larger tether hypotenuse portion 33 can also extend through the through-holes 39, 45 and be displaced.

[0119] In other words, the slider body 21 may be disposed inside the slider housing 23. The spring 29 positioned between the slider body 21 and the slider housing 23 projects the slider body 21 out of the inside of the slider housing 23 unless the slider body 21 is depressed. Further, the geometric shapes inside the left half of the handle housing 9 and the right half 8 prevent the slider housing 23 from rotating or moving in any direction except the axial directions of the proximal direction or the distal direction 15, 17. The left and right handle housing shapes also control the position (height) of the slider body 21 from within the slider housing 23. The slider body 21 is always in the depressed position unless the slider mechanism 11 (i.e., the slider body 21 and the slider housing 23) has advanced to its fully deployed position, i.e., its most forward (distal) position. When advancing to the distal position, the slider body 21 can pop up upward, thereby aligning the larger second compartment 43 within the through hole 39 of the tether control groove 38 with the proximal through hole 45 of the slider housing 23.

[0120] Accordingly, as seen in FIG. 3, while the slider body 21 is in the depressed retracted configuration (both from the fully non-deployed position to the fully deployed position, i.e., from the proximal to the distal position), the tether hypo tube portion 33 cannot advance within the tether control groove 38 of the slider mechanism 11 (see in particular the cross-sectional views of FIGS. 3(a) / (b)). However, when the slider body 21 is in the non-depressed retracted configuration (which only occurs when the slider mechanism 11 slides to or beyond its distal fully deployed position), the tether hypo tube portion 33 can advance within the tether control groove 38 within the slider mechanism 11, and thus the tether mode can be enabled.

[0121] Accordingly, when the larger second section 43 of the through-hole 39 of the slider body 21 of the tether control groove 38 is aligned with the through-hole 45 of the slider housing 23, the tether hypo-tube portion 33 fixedly attached to the mandrel 7 can here advance forward through the slider mechanism 11. This is because the tether hypo-tube portion 33 has a larger geometric shape than the exposed mandrel portion 31. When the slider body 21 is in the depressed retracted configuration, the keyed inner shape of the tether control groove 38 thus prevents the tether hypo-tube portion 33 from being able to advance through the tether hypo-tube portion. When the proximal tether assembly (i.e., the tether hypo-tube portion 33 / exposed mandrel portion 31) advances distally through the slider mechanism 11, the tether cable assembly at the distal end of the delivery catheter 5 is deployed by the same amount, and thus the tether mode is activated.

[0122] Figure 4 further shows how the keyed geometry of the placement slider prevents or enables the movement of the proximal tether assembly depending on whether the slider body 21 is popped up (slider not depressed) or in the depressed position.

[0123] Figure 3 also shows the different stages that the control handle 1 can assume. In the first stage, as shown in Figure 3(a), the slider mechanism 11 is in its retracted state, i.e., the fully non-deployed position. The slider body 21 is pushed down so that the tether cannot advance, i.e., the tether hypo tube portion 33 of the mandrel 7 cannot advance beyond a predetermined stop position and the mandrel movement interference is effective. In the second stage, as shown in Figure 3(b), the slider mechanism 11 is slid to its advanced state, i.e., its fully deployed position. The slider body 21 is still being pushed down by the user. Thus, the tether may still not advance. In the third stage, as shown in Figure 3(c), 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 released their hand from the slider body 21, i.e., the lateral pressure on the slider body 21 is released. Thus, the slider body 21 can pop up into its raised configuration. Thus, the tether mode is engaged and the tether can be advanced further, i.e., the tether hypo tube portion 33 of the mandrel 7 can be advanced beyond a predetermined stop position and the mandrel movement interference is stopped. In the fourth stage, as shown in Figure 3(d), the slider mechanism is still in the advanced state and the slider body 21 is in the raised configuration while the tether is advanced to the maximum. In such a maximally advanced configuration, further advancement of the mandrel 7 is blocked by the locking mechanism 19, as will be further explained below.

[0124] This slider mechanism 11 is also designed to facilitate the safe recapture of the medical device forming the implant. To safely recapture the implant, the tether must be pulled fully proximally (rearward) such that slack in the tether cable is removed and it is tensioned and the implant hitch is pulled back into the catheter alignment cup. If this is not done and slack in the tether cable still exists at the distal end of the catheter, the implant hitch can catch on the catheter protector cup, damaging / kinking the protector cup or preventing the catheter from fully recoating the implant. To prevent this from occurring, the user is forced to pull the tether proximally until the tether hypo tube is proximal to the deployment slider. This places the hitch safely inside the catheter alignment cup. If the tether hypo tube is all the way forward inside the deployment slider (causing slack in the tether cable at the distal end of the catheter), the user cannot push the deployment slider down and retract the deployment slider assembly proximally. This is because the deployment slider is designed such that it cannot be fully pushed down if the tether hypo tube portion is still inside it. If the deployment slider is not fully pushed down, the deployment slider cannot retract and thus the implant cannot be recoated. Thus, this mechanism incorporates a safety feature to prevent the user from inadvertently stopping the tether mode and dangerously recapturing the implant if the user does not position the implant in a safe position for recapture.

[0125] Due to all of these design characteristics and considerations, this novel mechanism can automatically transition between the deployed state and the tethered state and then return to the untethered mode / recathetable state of the implant, all using a single actuator to control these modes.

[0126] Next, another possible feature of the control handle 1 regarding the tactile deployment feedback mechanism 51 will be described with reference to FIGS. 2 and 5. 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 a travel path between a fully non-deployed position and a fully deployed position.

[0127] Therein, the first deployment feedback position may be at a position indicating that the slider mechanism 11 begins to push the mandrel 7 and the medical device fixed to the mandrel 7 at its distal end is discharged from the protector sheath. Such a first deployment feedback position may also be referred to as a proximal deployment control position. Thus, until detecting the tactile feedback at the first deployment feedback position, the user positions the slider mechanism 11 in an outer configuration in which the mandrel 7 and the delivery catheter 5 are positioned relative to each other such that the protector sheath held at the distal end of the delivery catheter completely covers the medical device held at the distal end of the mandrel 7. On the other hand, when the slider mechanism 11 is longitudinally displaced beyond such a first deployment feedback position, the slider mechanism 11 knows to position the mandrel 7 in a configuration that is at least partially unclad in which the mandrel 7 and the delivery catheter 5 are positioned relative to each other such that the protector sheath no longer completely covers the medical device. For example, in such an unclad configuration, the fixation tine of the medical device can be deployed.

[0128] The second deployment feedback position may be in a position that indicates to the user that the fixation procedure is initiated when the slider mechanism 11 is further slid towards the fully undeployed position. Such a second deployment feedback position is also referred to as the distal deployment control position or indicates a haptic pause for implant fixation. Thus, upon sensing haptic feedback at the second deployment feedback position, the user knows that the slider mechanism 11 continuously positions the mandrel 7 in a fixed configuration relative to the delivery catheter 5 such that the fixation mechanism at the distal end of the medical device is ejected from the protector sheath to fix the medical device to the heart tissue, while when the slider mechanism 11 is displaced beyond the second deployment feedback position towards the fully undeployed position, the slider mechanism 11 continuously positions the mandrel 7 in an uncovered configuration and the mandrel 7 and the delivery catheter 5 are positioned relative to each other such that the protector sheath no longer covers the medical device.

[0129] There, the haptic deployment feedback mechanism 51 includes at least one ridge 53, 55 and at least one bumper 57. For example, the first ridge 53 projects inwardly from the handle housing 9 towards the slider housing 23 at a longitudinal position corresponding to the first haptic feedback position and thus can function as a proximal deployment control ridge. The second ridge 55 may project inwardly at a longitudinal position corresponding to the second haptic feedback position and thus may function as a distal deployment control ridge. The bumper 57 may be provided on the slider housing 23 and may project outwardly towards the handle housing 9.

[0130] As shown in FIG. 5, the deployment feedback mechanism 51 may include two first ridges 53 and two second ridges 55 that face each other and project inwardly in the handle housing 9, and may further include two bumpers 57 that project outwardly in the slider housing 23. Accordingly, the ridges 53, 55 and the bumpers 57 slide along each other when the slider mechanism 11 is displaced in the longitudinal direction, and when the user pushes the slider mechanism 11 in the longitudinal direction beyond one of the deployment feedback positions, a retracting force can be induced in the slider mechanism 11. Among them, the ridges 53, 55 and the bumpers 57 are elastically biased toward each other in the lateral direction 25.

[0131] In other words, the control handle 1 preferably includes a mechanism for controlling the position of the deployment slider assembly and providing tactile feedback to the user when various states are activated or deactivated. The proximal deployment control ridges (disposed on the left and right handle housings and visible in FIG. 5) are used to lock the deployment slider assembly in the proximal exterior position unless the user applies sufficient force to advance the deployment slider assembly beyond the proximal control ridges. The deployment slider housing has a flexible bumper that provides a friction-based interaction with the deployment control ridges that results in a tactile response to the user when the bumper of the deployment slider housing advances against the ridges. These bumpers can also be seen in FIG. 5. The user must apply a certain amount of forward force to move the deployment slider assembly, and thus the bumper of the deployment slider housing, past each deployment control ridge. It is important that the user not continue to rapidly advance the implant forward once the deployment slider assembly has advanced beyond the proximal deployment control ridges, as otherwise the fixation mechanism of the implant and the implant itself may advance too rapidly and cause perforation. Accordingly, the second distal deployment control ridge is disposed at a position corresponding to the fixation of the implant deployed from the catheter's protector cup. This distal control ridge provides a tactile interruption for the user to know that the tine has been deployed and to proceed forward with caution from that point while the deployment process continues. The control ridges can be seen in FIGS. 2 and 5.

[0132] Further, as shown in FIG. 5, the control handle 1 further includes a valve 59 within the slider mechanism 11 to prevent back bleeding through the lumen of the delivery catheter 5. The valve 59 is formed by a membrane 60 having a through hole 58 that is held in the cross-sectional direction in the slider mechanism 11 and tightly surrounds a mandrel 7 that extends through the through hole 58 of the membrane 60 through the slider mechanism 11. The valve 59 is assembled to the slider housing 23 and is used to prevent back bleeding through the inner diameter of the tether catheter and around the tether, and in some cases through both the slider mechanism 11 and the control handle 1.

[0133] The design solution including the slider mechanism 11 described in this specification incorporates, among other things, the following main features. 1.) A single actuator for automatically transitioning the implant deployment and tether modes to the active state. 2.) A single actuator for both recapturing the implant and automatically transitioning the tether mode to the inactive state. 3.) A deployment slider with a keyed internal shape that controls the position of the proximal tether assembly (tether hypo tube and tether mandrel), allows the tether to advance when the implant is not fully deployed, and prevents activation of the tether mode. 4.) This mechanism also prevents the user from fully depressing the deployment slider and simultaneously retracting both the deployment slider and the tether for re-covering the implant if the tether has not been fully retracted initially. 5.) A handle housing shape that controls the position (height) and orientation of the deployment slider (and keyed inner shape) relative to the deployment slider housing. 6.) A tether having a plurality of different outer diameters, where the smaller diameter fitting is in the smaller keyed geometry of the deployment slider and the larger outer hypo tube can only advance through the largest hole in the keyed inner geometry of the deployment slider. 7.) A haptic bumper on the deployment slider housing that provides haptic feedback to the user as the user progresses through the various stages of the implant deployment process. 8.) Raised portions on the left and right handle housings that interact with the bumpers on the placement slider housing, both of which lock the placement slider assembly in the proximal exterior position and provide a haptic interruption to the user when the implant's fixation mechanism is engaged. 9.) A valve centrally located within the deployment slider housing that always prevents back bleeding or air entry through the tether catheter lumen.

[0134] The central concept related to the control handle 1 including the slider mechanism 11 is the implementation of a single actuator used to deploy the implant in a safe and controlled manner and then, when the implant is deployed, to automatically unlock the tether to activate the tether mode and enable the tether to be advanced. Further, this core concept functions to automatically lock the tether in the same manner when the tether is fully retracted, such that the same actuator can be used to safely recapture the implant. If for some reason the tether is not fully retracted before starting the implant recapture process, the deployment slider mechanism does not allow the user to recapture the implant until the catheter is in a state for safe and reliable re-covering of the implant.

[0135] Such an approach is different from other market designs that use two independent actuators in that it does not use a single actuator that both 1.) deploys the implant and 2.) locks and unlocks the tether such that the tether mode can be active or inactive, as described by the approach described by the present disclosure. Also, because haptic feedback is included during the deployment process, it is different from current market designs. Further, currently commercially available products do not include a haptic feedback function or technology within the implant catheter. This is also different from another market design that does not feature an inner valve to always prevent back bleeding around the tether and through the tether catheter ID / lumen during use. When currently commercially available products enter the tether mode and unlock the tether, reverse bleeding through the tether catheter lumen can occur. In the approach presented herein, by including a valve (that always operates and seals), back bleeding through the tether catheter inner diameter (ID) is always prevented. This also means that a fluid medium can be flowed through the tether catheter at any point in time, even when the catheter is in the tether mode.

[0136] The presented control handle is specifically designed to incorporate and utilize a novel tether mechanism as described in the applicant's prior application filed earlier to maintain connection to the implant until the user is confident that the position of the implant site is acceptable, at which point the tether can be safely released and the catheter tool removed.

[0137] Finally, to summarize briefly in an alternative expression, a control handle including the slider mechanism described herein enables a user to control both the deployment of an implant with a single actuator and when a secondary implanted state known as the tether mode is active or inactive. This novel mechanism for a leadless pacemaker implantable catheter includes a novel design that provides an excellent means of controlling the deployment process of a leadless pacemaker, while at the same time enabling the user to seamlessly transition to a state known as the tether mode, all with a single actuator and internal mechanisms within the implantable catheter. This novel design provides an excellent means for a user to safely and reliably switch between the controlled deployment of an implant and the subsequent seamless transition to the tether mode (which is used to evaluate the fixation of the implant without any bias from the catheter), and, if the position and fixation are determined to be appropriate, to recapture the implant if necessary or proceed to the release of the implant from its tether connection. To achieve this, the novel mechanism uses a retractable slider having an internal mechanism that controls which size of geometric shape can pass through depending on the position of the slider. Thus, this mechanism, along with a tether that incorporates different sized outer diameter shapes along the proximal length of the handle, enables the tether mode of the handle to be determined as active or inactive depending on the position of the deployment slider actuator relative to the implantable catheter handle. This novel leadless pacemaker deployment and tether control mechanism utilizes a novel tether mechanism as detailed in previous invention disclosures as a means of establishing a tether connection between the implant and the catheter. However, the scope of the disclosure presented herein is specific to the deployment actuator and tether control mechanism located on the handle of the implantable catheter.

[0138] Next, with reference to FIGS. 6 to 10, the details, characteristics, and possible advantages of the locking mechanism 19 within the control handle 1 that selectively controls the activation or deactivation of the release mode in the delivery system 3 will be described. Here, with reference to exemplary embodiments or implementations regarding the embedding procedures of the wireless pacemaker, the details, characteristics, and possible advantages will be described again.

[0139] The control handle 1 described herein may be provided with a specific design of the locking mechanism 19 of the implant catheter that functions as a release actuator mechanism that enables the user to initiate the release process of the implant from the catheter. When the release actuator is not activated, the user is prevented from releasing the implant from the catheter. Thus, in the implantation procedure, for example, while deploying the implant from the catheter, fixing the implant, and performing various tests while the delivery system is in its tether mode, it is possible to reliably prevent the implant from being inadvertently released from the catheter. On the other hand, after such steps, the locking mechanism, such as intentionally releasing the implant, can be performed by appropriately displacing the mandrel 7 longitudinally with respect to the delivery catheter 5.

[0140] Previous solutions in this field consisted of using a pair of scissors to cut the tether (suture) of the wireless pacemaker catheter to initiate the release process from the implant's tether (suture) to the catheter. Considering that the pair of scissors are separate tools, those implant catheters are not composed of a dedicated actuator for initiating the release process.

[0141] In an alternative approach, the tether consists of a suture that passes through the catheter from the proximal end outside the handle, all the way around the hitch of the implant, then back through the catheter and terminates outside the proximal end of the handle. The two ends of the suture line are fixed to each other and cannot be separated. To release the implant from its tether, the user must cut the suture line with a pair of scissors and then fully retract the suture line from the catheter to release the implant from the tether.

[0142] Unless the user has scissors or a blade in hand to cut the suture line, there is generally no means to initiate the release process. There is no built-in mechanism, actuator, or means within the handle to cut the suture line that is present within the handle. Thus, additional tooling not included within the catheter system is required to complete the implantation procedure.

[0143] In view of such conventional techniques, it was an object to design the control handle 1 such that the user cannot release the implant from its tether to the implant catheter unless the user actuates a mechanism. Preferably, the mechanism should provide the user with a distinct tactile feedback that the mechanism has been actuated when the user performs an action. The mechanism should always remain in a locked state unless actuated by the user.

[0144] The control handle 1 includes a locking mechanism 19 as shown in FIGS. 6 to 10. Here, the locking mechanism 19 can be switched between a locked configuration and an unlocked configuration by rotating an unlocking actuator member 61 with respect to the handle housing 9. The unlocking actuator member 61 may also be referred to as an unlocking actuator. The rotation axis of the unlocking actuator member 61 is substantially aligned with the longitudinal axis of the control handle 1. Preferably, the locking mechanism 19 is configured to be switched between the locked configuration and the unlocked configuration by removing the unlocking actuator member 61 in the clockwise direction along the CCW thread. The locked configuration may be indicated, for example, by a "lock" icon 63 shown on the handle housing 9, while the unlocked configuration may be indicated, for example, by an "unlock" icon 65. The rotational state of the locking mechanism 19 can be indicated by visual means such as a colored protrusion 67 provided on the unlocking actuator member 61.

[0145] Due to such a configuration, the locking mechanism 19 includes a through passage 69 for accommodating the mandrel 7. Among them, the lateral limiting element 71 of the locking mechanism 19 surrounds the through passage 69 from both sides. The locking mechanism 19 is specifically configured such that in the locked configuration, the lateral limiting elements 71 are pushed towards each other more greatly than in the unlocked configuration, whereby in the locked configuration, the lateral dimension of the through passage 69 is smaller than in the unlocked configuration.

[0146] For such a purpose, the locking mechanism 19 includes a compression element 75. Such a compression element 75 is configured to release a compressive force acting radially on the lateral limiting element 71 when the unlocking actuator member 61 is rotated from the locked configuration to the unlocked configuration. In the example shown in the figure, this compression element 75 is formed by the unlocking actuator member 61 itself. However, alternatively, the compression element 75 may be a separate element that cooperates with the unlocking actuator member 61.

[0147] In the illustrated example, the lateral restraint element 71 is formed by an inner member 77 that surrounds the through passage 69. Among them, the longitudinal slit 73 extends between the elongated portions 79 of the inner member 77 and separates these elongated portions 79 from each other. The elongated portions 79 extend from a common inner member body portion 81 and have cantilevered end portions 83 on both sides thereof. At the cantilevered end portions 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 that surrounds the inner member 77. This outer member 87 has a conical inner shape at an inclined inner surface 89 that faces the cantilevered end portions 83 of the inner member 77.

[0148] The mandrel 7 includes a tether hypo-tube portion 33 and a release hypo-tube portion 35 disposed more proximally to the tether hypo-tube portion 33. The tether hypo-tube portion 33 has a first cross-sectional dimension, i.e., a first diameter, while the release hypo-tube portion 35 has a larger second diameter.

[0149] Thus, while the locking mechanism 19 is in the locked configuration, the through passage 69 has a cross-sectional dimension smaller than the second cross-sectional dimension of the release hypo-tube portion 35. Thus, the mandrel 7 may not need to be introduced into the locking mechanism 19 together with its release hypo-tube portion 35, and thus, displacement of the mandrel abutment beyond a predetermined abutment position is prevented by the activation of the interference of the mandrel abutment with respect to the locking mechanism 19. Here, the abutment position is determined by the position of the transition portion between the smaller tether hypo-tube portion 33 and the larger release hypo-tube portion 35.

[0150] However, when the lock mechanism 19 is switched to its unlocked configuration, the through-passage 69 attains a larger cross-sectional dimension large enough to accommodate the second cross-sectional dimension of the release hypo tube portion 35. Such a situation is shown in FIG. 8, and FIGS. 8(a) - 8(c) visualize that the mandrel 7 can be continuously displaced in the distal direction 17, i.e., the tether actuator 37 can be pushed towards the control handle 1. Such displacement can continue beyond the tether mode (as shown in FIG. 8(a)) until the release mode is reached (as shown in FIGS. 8(b) and 8(c)). Here, when the lock mechanism 19 is in its unlocked configuration, the mandrel 7 may be pushed in the distal direction 17 until its release hypo tube portion 35 is fully pushed through the lock mechanism 19 and the tether actuator 37 abuts against the proximal end of the lock mechanism 19, thereby stopping further displacement of the mandrel 7 (see FIG. 8C). Such continuous distal displacement of the mandrel 7 sets the delivery system to the 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.

[0151] In other words, the lock mechanism 19 is designed to be used with a tether mechanism having multiple diameters. As seen in FIGS. 6 - 8, the tether assembly includes a tether hypo tube having a smaller outer diameter (OD) and a release hypo tube having a larger OD. To put the tether in a releasable state, the tether assembly must be advanced distally such that the distal face of the tether actuator becomes a hard stop against the proximal face of the release actuator. The release actuator prevents the tether from advancing distally to its maximum extent by preventing the larger OD of the release hypo tube from advancing therethrough. Visualization of this critical position of the tether relative to the tether actuator can be seen in FIG. 8. Here, FIG. 8(a) shows the situation where the unlock actuating member 61 is switched to the unlock configuration. FIG. 8(b) visualizes that the movement of the catheter distally from this position must be restricted unless the unlock actuating member 61 is rotated to the unlock configuration. As shown in FIG. 8(c), when the tether advances to its most distal position, the tether is released.

[0152] To achieve this, the lock mechanism 19 functions by the unlock actuating member 61 being screwed inwardly (distally) along the thread 97 to the locked position. When the unlock actuating member 61 advances in the distal direction 17 by rotation, as shown in FIG. 9, it radially compresses the inclined outer surface 85 of the cantilevered end 83 of the inner element 77, reducing the inner diameter of the through passage 69 inside the lock mechanism 19. Thus, when the unlock actuating member 61 is in the locked position, it is fully screwed inwardly. This reduces the inner diameter of the through passage 69 in the lock mechanism 19, such that either the release hypo tube portion 35 cannot enter it or advance therethrough.

[0153] When the unlocking actuating member 61 is in the unlocking position, it is unlocked, and the radial compression along the locking mechanism 19 is released. As a result, the biased proximal mechanism inside such a locking mechanism 19 can relax to its original shape. When returning to the original relaxed geometric shape, the release hypo tube portion 35 can advance distally through this position, thereby releasing the tether. In other words, when the unlocking actuating member 61 is unscrewed outward (proximally) to the unlocking position, it advances proximally 15 by rotation, thereby releasing the radial compression on the cantilever end 83 of the inner element 77. As a result, these cantilever ends 83 that are elastically biased in the outer lateral direction 25 can relax to a configuration where the inner diameter of the through passage 69 is enlarged to allow passage through the release hypo tube portion 35 of the mandrel 7.

[0154] As an additional feature, the control handle 1 further includes a tactile rocker feedback mechanism 91 as visualized in FIG. 10. The tactile rocker feedback mechanism 91 is configured to generate tactile rocker feedback to the user of the control handle 1 when the locking mechanism 19 is displaced relative to the handle housing 9 beyond at least one rocker feedback position during a switch from the locked configuration to the unlocked configuration.

[0155] For such purposes, the haptic locker feedback mechanism 91 includes a groove 93 included in the handle housing 9 and a spring plunger 95 in the unlocking actuating member 61. The groove 93 and the spring plunger 95 are configured to induce a pulling force on the locking mechanism 19 when the user rotates the unlocking actuating member 61 beyond at least one locker feedback position. For example, there may be grooves 93 at both the rotational position corresponding to the locked configuration and the rotational position corresponding to the unlocked configuration. Thus, when the unlocking actuating member 61 is rotated between both configurations, the spring plunger 95 can snap into such respective grooves 93, thereby being able to tactilely indicate to the user that the locking mechanism 19 has been correctly switched from one configuration to the other.

[0156] In other words, another feature of the locking mechanism 19 is to utilize the spring plunger 95 to generate haptic feedback when actuated to either the locked or unlocked state. The spring plunger 95 is embedded in either a release actuator component or a handle component where the release actuator rotates internally. When the actuator is rotated to either the locked position or the unlocked position, there is a small groove 93 inside the handle component to provide spring relief for the spring plunger 95. This relief creates the tactile sensation that the actuator has been rotated to the correct state (either locked or unlocked). An embodiment of the spring plunger 95 disposed within the release actuator and rotated around the handle housing component can be seen in FIG. 10.

[0157] The design solution including the locking mechanism 19 described herein incorporates, among other things, the following main features. 1.) A single actuator that controls the release of the tether for a leadless implantable catheter. 2.) An actuator and mechanism used to enable the release of an implant from the catheter's tether that is incorporated into the implantable catheter and is not a separate, independent tool. 3.) When rotated to the locked position, the actuator radially compresses a separate component or mechanism disposed therein to reduce the ID of the hole or lumen, preventing larger geometric features from advancing therethrough. 4.) An actuator that remains in either a locked or unlocked state unless actuated by the user. 5.) When rotated to the unlocked position, the actuator radially releases the compression of a separate component or mechanism disposed therein, allowing the component or mechanism to relax and return to an uncompressed state, which increases the ID of the inner hole or lumen. 6.) Including a spring plunger and a spring relief groove to provide a tactile response whenever the release actuator is rotated to either the locked or unlocked state. 7.) Including a spring plunger and a spring relief groove to prevent unintentional rotation of the actuator unless actuated by the user. 8.) A proximally disposed tether assembly incorporating different diameters to limit the advancement of the tether beyond the release actuator unless the release actuator is rotated to the unlocked position. 9.) A release actuator mechanism having either clockwise or counterclockwise threads. In the embodiments contemplated by the inventors, it is preferred to utilize CCW / left-handed threads, as 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 the body rather than towards the body.

[0158] The central concept related to this control handle 1 including the lock mechanism 19 is to be used to prevent the user from inadvertently releasing the implant from its tether to the catheter unless the user is ready to do so, and focuses on the realization of a single actuator that can control the inner diameter of its inner hole or lumen. When the actuator rotates to the locked position, the inner diameter of the inner hole / lumen decreases. When the actuator rotates to the unlocked position, the inner diameter relaxes outward and increases. This release mechanism engages with a tether mechanism consisting of multiple outer diameters. When the release actuator is in the locked position, only the tether with a smaller diameter can advance through the release actuator. When the release actuator is in the unlocked position, the tether with a larger diameter can be advanced through the release actuator, and as a result, the implant can be released from the tether.

[0159] In particular, the control handle 1 having the lock mechanism 19 is different from another market design that uses a pair of scissors not included in the implant catheter to cut the suture that functions as a tether to the implant. By incorporating the release mechanism into the handle, the usefulness of the leadless pacemaker implant catheter is greatly improved.

[0160] The presented control handle 1 is designed to incorporate and utilize a novel tether mechanism as described in the applicant's prior application for maintaining the connection to the implant, and to interface with a novel deployment slider tether control mechanism established by including a slider mechanism as further described herein.

[0161] Finally, to briefly summarize in an alternative expression, the control handle including the locking mechanism described herein enables a user to control, using an actuator, to release the implant from its tether to the implant catheter, if possible, for a novel mechanism for a leadless pacemaker implantable catheter. This novel design utilizes a safety mechanism that prevents the user from initiating the process of releasing the implant from the catheter unless the actuator is actuated to the unlocked position. When 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 discharging the implant from the catheter unless the user is fully confident that they are ready to do so. To achieve this, the novel mechanism uses, for example, a rotary screw actuator that can rotate 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, torque is applied to an inner component that is compressed inward. When the inner component is compressed inward, the inner diameter of the inner component (through which the tether mechanism passes) becomes smaller. When the inner component is placed in a state with a smaller inner diameter, the tether (having a plurality of outer diameters) cannot have its largest diameter fit into this handle component while the actuator is engaged in the locked position, so this component cannot be fully advanced. The tether mechanism can only be released after it has fully advanced through this handle component. When the release actuator is rotated to the "unlocked" position, the torque applied to the inner component is released, and the inner component can return to its natural position. The natural position of the inner component consists of a larger inner diameter. Thus, when the release actuator is in the "unlocked" position, the tether mechanism can fit through the handle component, and the implant can be released from the tether to the catheter. This novel release control mechanism utilizes a novel tether mechanism as detailed in the previous invention disclosure as a way to establish a tether connection between the implant and the catheter.

[0162] 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. Also, elements described in connection with different embodiments may be combined. It should also be noted that reference signs in the claims should not be construed as limiting the claims.

Description of Reference Signs

[0163] 1 Control handle 3 Delivery system 5 Delivery catheter 7 Mandrel 8 Half shell 9 Handle housing 10 Steering mechanism 11 Slider mechanism 12 Insertion tube 13 Longitudinal direction 15 Proximal direction 17 Distal direction 19 Locking mechanism 21 Slider body 23 Slider housing 25 Lateral direction 27 Slider spring 29 Actuating structure 31 Exposed mandrel portion 33 Tether hypo tube portion 35 Release hypo tube portion 37 Tether actuator 38 Control groove 39 Through hole penetrating the slider body 41 First section of the through hole 43 Second section of the through hole 45 Through hole penetrating the slider housing 51 Tactile deployment feedback mechanism 53 First raised portion 55 Second raised portion 57 Bumper 58 Through hole of the valve 59 Valve 60 film 61 unlocking actuating member 63 lock icon 65 unlocking icon 67 protrusion 69 through-passage 71 lateral limiting element 73 slit 75 compression element 77 inner element 79 elongated portion 81 common inner member body portion 83 cantilever end 85 inclined outer surface 87 outer member 89 inclined inner surface 91 tactile rocker feedback mechanism 93 groove 95 spring plunger 97 thread

Claims

1. A control handle (1) for controlling the functions of a delivery system (3) for implanting a medical device, comprising: The delivery system (3) comprises: an elongated delivery catheter (5); a mandrel (7) that is longitudinally displaceable relative to said delivery catheter (5); Including, The control handle (1) A slider mechanism (11); A handle housing (9), the slider mechanism (11) is configured to be displaceable longitudinally (13) relative to the handle housing (9) between a fully undeployed position and a fully deployed position, thereby displacing the mandrel (7) a deployed distance relative to the delivery catheter (5); The slider mechanism (11) is further configured such that in the fully undeployed position, the mandrel (7) is fixed relative to the slider mechanism (11) such that the mandrel (7) cannot be displaced relative to the slider mechanism (11) beyond a predetermined stop position due to mechanical obstruction of mandrel motion, while in a tethered position beyond the fully deployed position, the mandrel (7) is movable in the longitudinal direction relative to the slider mechanism (11) beyond the predetermined stop position due to release of obstruction of the mandrel motion.

2. 2. The control handle of claim 1, wherein the slider mechanism is configured such that when the slider mechanism is displaced to the fully deployed position and then all force applied by a user is released, the slider mechanism automatically displaces to the tethered position, thereby unblocking the mandrel motion.

3. 2. The control handle of claim 1, wherein the slider mechanism includes a slider body and a slider housing, the slider body being disposed in the slider housing such that the slider body is resiliently biased in a lateral direction away from the slider housing, the slider body and the slider housing being configured such that the slider body remains secured to the slider housing in a retracted configuration as long as the slider mechanism is disposed in the fully undeployed position or anywhere between the fully undeployed and fully deployed positions, while upon reaching the fully deployed position, the securing is released and the slider body is automatically displaced in a lateral direction away from the slider housing by a resiliently biased movement to a raised configuration, thereby unblocking the mandrel motion.

4. 4. The control handle of claim 3, wherein the slider body (21) and the slider housing (23) each include a through hole (39, 45) extending in the longitudinal direction (13) such that the mandrel (7) extends longitudinally through both through holes (39, 45), the through hole (39) of the slider body (21) includes two sections (41, 43), a first section (41) having a smaller cross-sectional dimension than a second section (43), and wherein the mandrel (7) extends through the first section (41) when the slider body (21) is in the lowered configuration and the mandrel (7) extends through the second section (43) when the slider body (21) is in the raised configuration.

5. 5. The control handle of claim 4, wherein the mandrel (7) comprises a bare mandrel portion (31) and a tether hypotube portion (33) disposed proximally of the bare mandrel portion (31), the bare mandrel portion (31) having a first cross-sectional dimension and the tether hypotube portion (33) having a second cross-sectional dimension greater than the first cross-sectional dimension, the first section (41) of the through hole (39) of the slider body (21) having a cross-sectional dimension smaller than the second cross-sectional dimension of the tether hypotube portion (33), while the second section (43) of the through hole (39) of the slider body (21) having a cross-sectional dimension greater than the second cross-sectional dimension of the tether hypotube portion (33).

6. 2. The control handle of claim 1, further comprising a tactile deployment feedback mechanism configured to generate tactile deployment feedback to a user of the control handle when the slider mechanism is displaced beyond at least one predetermined deployment feedback position located longitudinally between the fully undeployed position and the fully deployed position.

7. 7. The control handle of claim 6, wherein 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 places the mandrel in a sheathed configuration in which the mandrel and the delivery catheter are positioned relative to one another such that a protector sheath held at the distal end of the delivery catheter completely covers the medical device held at the distal end of the mandrel, whereas when the slider mechanism is displaced longitudinally beyond the first deployment feedback position, the slider mechanism positions the mandrel in an at least partially unsheathed configuration in which the mandrel and the delivery catheter are positioned relative to one another such that the protector sheath no longer completely covers the medical device.

8. 8. The control handle of claim 7, wherein the predetermined second deployment feedback position corresponds to a position such that when the slider mechanism (11) is slid longitudinally from the first deployment feedback position to the second deployment feedback position, the slider mechanism (11) successively positions the mandrel (7) relative to the delivery catheter (5) in a fixed configuration such that a fixation mechanism on a distal end of the medical device is ejected from the protector sheath to fixate the medical device within cardiac tissue, while when the slider mechanism (11) is displaced beyond the second deployment feedback position toward the fully undeployed position, the slider mechanism (11) successively positions the mandrel (7) in an unsheathed configuration in which the mandrel and the delivery catheter are positioned relative to one another such that the protector sheath no longer covers the medical device.

9. 7. The control handle of claim 6, wherein the tactile deployment feedback mechanism (51) includes at least one ridge (53, 55) and at least one bumper (57), the ridge (53, 55) disposed on one of the handle housing (9) and the slider mechanism (11) and the bumper (57) disposed on the other of the handle housing (9) and the slider mechanism (11), and configured to induce a retraction force on the slider mechanism (11) when a user pushes the slider mechanism (11) longitudinally beyond the at least one deployment feedback position.

10. 10. The control handle of claim 9, wherein the slider mechanism (11) is guided within the handle housing (9) when displaced longitudinally, and the deployment feedback mechanism (51) is configured such that the ridges (53, 55) and the bumper (57) are resiliently biased toward each other in a lateral direction (25) intersecting the longitudinal direction (13).

11. The control handle of claim 1, further comprising a valve (59) disposed on the slider mechanism (11) to prevent back bleeding through a lumen of the delivery catheter (5).

12. 12. The control handle of claim 11, wherein the valve (59) is formed by a membrane (60) having a through hole (58) configured to closely surround the mandrel (7) that is cross-sectionally held within the slider mechanism (11) and extends through the slider mechanism (11) and through the through hole (58) of the membrane (60).

13. A delivery system (3) comprising a control handle (1) according to claim 1 and an elongated delivery catheter (5) mechanically connected to the control handle (1), A delivery system (3), wherein a mandrel (7) is controlled by said control handle (1) so as to be longitudinally displaceable relative to said delivery catheter (5).

14. 14. The delivery system of claim 13, wherein the delivery system is configured such that when the mandrel is displaced a deployment distance relative to the delivery catheter, the medical device held at the distal end of the delivery catheter is deployed from the protective sheath of the delivery catheter, the delivery system further comprising a tethering member connected to the distal end of the mandrel and connected to the medical device, the delivery system is configured such that when the mandrel is displaced a tethering distance in addition to the deployment distance relative to the delivery catheter, the tethering member is displaced between a retracted position and an ejection position, wherein in the retracted position, the tethering member retracts the medical device into fixation with an end cup at the distal end of the delivery catheter, while in the ejection position, the tethering member releases the medical device from fixation with the end cup.

15. 15. The delivery system of claim 14, wherein the mandrel (7) comprises a bare mandrel portion (31) and a tether hypotube portion (33) disposed proximally of the bare mandrel portion (31), the bare mandrel portion (31) having a first cross-sectional dimension, the tether hypotube portion (33) having a second cross-sectional dimension greater than the first cross-sectional dimension, a length of the bare mandrel portion (31) corresponding to or greater than the deployed distance, and a length of the tether hypotube portion (33) corresponding to or greater than the tethering distance.

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