Universal Stabilization Device for a Delivery System

Abstract

A stabilization device for use in a delivery system is provided. The stabilization device receives a delivery system, such as a handle portion, and prevents unwanted movement of the delivery system during a medical procedure. The stabilization device preferably includes an elongate rail adapted to be fixed to a base or table. A rail dock is adapted to removably couple to the delivery system. The rail dock is slidably mounted along the upper surface of the rail and includes a brake assembly. The brake assembly preferably includes a toggle member having at least one push button, and actuation of the push button can release or lock the brake assembly. The components of the stabilization device are provided to enable the stabilization device to be used with different delivery systems, and the stabilization device can be fixed to tables of different sizes.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 352,527, filed on June 15, 2022, the entire content of which is incorporated herein by reference.

Background Art

[0002] Certain embodiments disclosed herein generally relate to delivery systems for prostheses, and in some embodiments, to stabilization devices and control systems for use with delivery systems for delivering replacement heart valves, such as via a trans - septal approach.

[0003] (Related Art) Human heart valves include the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, and essentially function as one - way valves that operate in synchronization with the beating of the heart. The valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves exhibit disorders such as stenosis or regurgitation of the valve, which inhibit the valve's ability to control blood flow. Such disorders can reduce the heart's blood - pumping efficiency and can result in debilitating and life - threatening symptoms. For example, valve insufficiency can lead to symptoms such as cardiac hypertrophy and ventricular dilation. Therefore, extensive efforts have been made to develop methods and devices for repairing or replacing diseased heart valves.

[0004] Prostheses exist to correct problems associated with diseased heart valves. For example, mechanical and tissue - based heart valve prostheses can be used to replace diseased native heart valves. Recently, significant efforts have been devoted to the development of replacement heart valves, particularly tissue - based replacement heart valves that can be delivered to patients with less trauma compared to open - heart surgery. Replacement valves are designed to be delivered by minimally invasive procedures and even percutaneous procedures in many cases. Such replacement valves often include a tissue - based valve body connected to an expandable frame that is subsequently delivered to the valve annulus of the native valve.

[0005] Although not limited thereto, the development of prostheses including replacement heart valves that are compacted for delivery and then controllably expandable for controlled placement has proven particularly difficult. Additional challenges relate to the ability to secure such prostheses to intravascular tissue, such as any body lumen or tissue within a body cavity, for example, by non-invasive techniques.

[0006] Also, it can be difficult to deliver a prosthesis to a desired location within the human body, such as delivering a replacement heart valve to the mitral valve. Gaining access to perform procedures at the heart or other anatomical locations may require delivering the device percutaneously through tortuous vasculature or through open-chest or mini-thoracotomy surgical procedures. The ability to control the position of the delivery system and the deployment of the prosthesis at the desired location can also be difficult. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEMS

[0007] According to a first general stabilization device of the present disclosure (e.g., adapted to be used in conjunction with a plurality of different types of delivery systems such as a transcatheter mitral valve replacement delivery system, a transcatheter tricuspid valve replacement delivery system, a transcatheter aortic valve replacement system, or other delivery systems), a rail extends longitudinally and includes a first end, a second end, an upward-facing surface, and a downward-facing surface, and first and second side surfaces extending between the first and second ends. A rail dock is attached to the upward-facing surface of the rail. The rail dock includes first and second channel members spaced apart to receive the first and second side surfaces of the rail therebetween. The first and second channel members project from the downward-facing surface of the rail and include distal ends that prevent the rail dock from being removed vertically from the rail. A brake assembly can be actuated between a first configuration in which the rail dock translates along the rail and a second configuration in which translation of the rail dock along the rail is prevented.

[0008] According to another aspect of the first general-purpose stabilization device, the rail dock includes a first support for the handle of the delivery system. According to another aspect of the first general-purpose stabilization device, the rail dock includes a carriage oriented along the longitudinal direction, and the first support is attached onto the carriage and is movable along the longitudinal direction with respect to the rail dock. According to another aspect of the first general-purpose stabilization device, the carriage is attached to a threaded or screw-in travel screw, and the travel screw is connected to a twist knob for moving the carriage. According to another aspect of the first general-purpose stabilization device, the first support includes a fixed member (e.g., a clamp portion) and a movable member (e.g., a clamp portion) pivotally connected to the fixed member. The first support is operable between an open configuration and a closed configuration. According to another aspect of the first general-purpose stabilization device, the screw extends through an opening of the movable member having a threaded end received within a threaded opening of the fixed member. The knob is disposed outside the movable member. According to another aspect of the first general-purpose stabilization device, the first support is operable between an open configuration and a closed configuration by rotation of the knob attached to the first support. The rotation of the knob may be less than 180°, or may be about 90° (e.g., 80° to 100°). In some implementations, the knob can rotate 1.5 turns to transition between the open configuration and the closed configuration.

[0009] According to another aspect of the first general-purpose stabilization device, the brake assembly includes a toggle member having a first button on a first side of the brake assembly and a second button on a second side of the brake assembly. Pressing the first button causes the brake assembly to shift from a first configuration to a second configuration, and pressing the second button causes the brake assembly to shift from the second configuration to the first configuration. According to another aspect of the first general-purpose stabilization device, the brake assembly includes a brake member that engages and disengages with the upward-facing surface of the rail. According to another aspect of the first general-purpose stabilization device, the brake assembly includes a lamp connected to the toggle member. The lamp actuates the brake member to engage and disengage with the upward-facing surface of the rail. In some configurations, the disengagement of the brake member from the upward-facing surface of the rail is achieved by a spring force built into the brake member when the lamp is toggled to disengage the brake member. The brake member may be a springless brake that does not have a spring but has a spring force as a result of the design and material of the brake member (e.g., a molded part having a flexible extension that can deform and return to its original state, thereby acting as a spring without a spring). According to another aspect of the first general-purpose stabilization device, the distal ends of the channel members are closer to each other than the width of the rail, and the rail dock is loaded onto the rail by aligning the first and second channels with the first and second sides at the first end of the rail, and is fixed in place so that it cannot be removed vertically. According to another aspect of the first general-purpose stabilization device, the second support is connected to the rail. According to another aspect of the first general-purpose stabilization device, the second support is a hub nest configured to receive an introducer hub or a sheath hub associated with the delivery system, the hub nest is inserted into a receiving opening on the upward-facing surface of the rail, and includes a locking post that rotates to removably lock in place on the rail. According to another aspect of the first general-purpose stabilization device, the second support is a hub nest configured to receive an introducer hub or a sheath hub associated with the delivery system, the hub nest is inserted into a receiving opening on the upward-facing surface of the rail, and includes a locking post that slides longitudinally to removably latch in place on the rail.The hub nest may include a first surrounding member (e.g., an engaging or receiving member) and a second surrounding member (e.g., an engaging or receiving member) spaced apart to receive the first and second side surfaces of the rail therebetween, and each of the first and second channel members projects onto the downward-facing surface of the rail and includes a distal end that prevents the hub nest from deviating vertically from the rail. According to another aspect of the first general-purpose stabilization device, the second rail dock is attached to the upward-facing surface of the rail. The second rail dock operates between a first configuration in which the second rail dock translates along the rail and a second configuration in which the second rail dock is prevented from translating along the rail.

[0010] According to another aspect of the first general-purpose stabilization device, the first support includes a lock switch. The lock switch is rotatable between a locked position that holds the first support in a closed configuration and an unlocked position in which the first support can move between an open configuration and a closed configuration. According to another aspect of the first general-purpose stabilization device, the support includes an elastic strap fixed to the first side surface of the support at a first end, a central section extending over the handle, and a second side surface fixable to the second side surface of the first support. According to another aspect of the first general-purpose stabilization device, the support has a worm gear connected to a knob and a worm wheel connected to the handle, and rotation of the knob controls rotation of the handle about the longitudinal axis. According to another aspect of the first general-purpose stabilization device, the rail dock includes a lockable support and the second rail dock includes a passive support.

[0011] According to a second general stabilization device of the present disclosure (e.g., a transcatheter mitral valve replacement delivery system, a transcatheter tricuspid valve replacement delivery system, a transcatheter aortic valve replacement system, or other delivery systems that can be adapted to be used in combination with a plurality of different types of delivery systems), a rail extends along a longitudinal direction and has a first end, a second end, an upward-facing surface, and a downward-facing surface, and first and second side surfaces extending between the first and second ends. A rail dock is attached to the upward-facing surface of the rail. The rail dock has a first channel member on a first side surface of the rail dock aligned with the first side surface of the rail. A second channel member is on a second side surface of the rail dock. The second channel member is on a plate biased inwardly toward the second side surface of the rail. A button is coupled to the plate, and pressing the button causes the plate and the second channel member to shift away from the rail, enabling the rail dock to translate along the rail. Releasing the button causes the plate and the second channel member to shift to the second side surface of the rail, preventing the rail dock from translating along the rail.

[0012] According to another aspect of the second general-purpose stabilization device, the first and second channel members each include a protrusion having a distal end that projects to the downward-facing surface of the rail. According to another aspect of the second general-purpose stabilization device, the rail dock includes a lockable support or a passive handle support. According to another aspect of the second general-purpose stabilization device, the third channel member is biased to engage either the first or second side surface of the rail. According to another aspect of the second general-purpose stabilization device, the first side surface of the rail includes a textured surface. According to another aspect of the second general-purpose stabilization device, the second channel member is biased by a first spring force to engage the second side surface of the rail, and the third channel member is biased by a second spring force that is less than the first spring force to engage either the first or second side surface of the rail. According to another aspect of the second general-purpose stabilization device, the blocking member operates between a fixed position where the rail dock is prevented from being removed from the rail in the vertical direction and an unfixed position where the rail dock is allowed to be removed from the rail in the vertical direction. According to another aspect of the second general-purpose stabilization device, the blocking member is a locking pin that is in the fixed position and projects to the downward-facing surface of the rail.

[0013] According to a third general stabilization device of the present disclosure (e.g., adapted to be used in combination with a plurality of different types of delivery systems such as a transcatheter mitral valve replacement delivery system, a transcatheter tricuspid valve replacement delivery system, a transcatheter aortic valve replacement system, or other delivery systems), the rail has a first end, a second end, an upward-facing surface, and a downward-facing surface, and first and second side surfaces extending between the first and second ends. The rail dock is attached to the upward-facing surface of the rail. The rail dock has a first channel member along a first side surface of the rail dock. The first channel member includes a distal end that projects onto the downward-facing surface on the first side of the rail. A second channel member is on a second side surface of the rail dock on a movable plate. The lever handle is coupled to the movable plate. The lever handle is movable between a fully locked configuration in which the rail dock is prevented from translating along the rail, a semi-locked configuration in which the rail dock can translate along the rail but is not removable vertically therefrom, and a fully unlocked configuration in which the rail dock is removable vertically from the rail.

[0014] According to another aspect of the third general stabilization device, the lever handle includes a base having a first side surface with a first extension width, a second side surface with a second extension width, and a third side surface with a third extension width. In the fully locked configuration, the first side surface of the base positions the plate and engages the second channel member with the rail. In the semi-locked configuration, the second side surface of the base positions the plate with the second channel member projecting onto the downward-facing surface of the rail. In the fully unlocked configuration, the third side surface of the base positions the plate with the second channel member disengaged from the rail.

[0015] According to a fourth general purpose stabilization device of the present disclosure (e.g., adapted to be used in combination with multiple different types of delivery systems such as a transcatheter mitral valve replacement delivery system, a transcatheter tricuspid valve replacement delivery system, a transcatheter aortic valve replacement system, or other delivery systems), rails extend along the longitudinal direction. The rail has a first end, a second end, an upward-facing surface, a downward-facing surface, and first and second side surfaces extending between the first end and the second end. The rack on the rail extends longitudinally. The rail dock is attached to the upward-facing surface of the rail. The rail dock has a pinion gear. The pinion gear is movable between a first position where the pinion gear engages the rack and a second position where the pinion gear does not engage the rack. In the first position, the pinion gear is rotatable to adjust the position of the rail dock along the rail.

[0016] According to another aspect of the fourth general purpose stabilization device, the pinion gear is attached onto a spring shaft attached to a rotary knob, and pushing down the knob moves the pinion gear between the first and second positions. According to another aspect of the fourth general purpose stabilization device, the pinion gear provides torsional stiffness against the movement of the rail dock along the rail in the first position. According to another aspect of the fourth general purpose stabilization device, the rail dock includes first and second channel members spaced apart to receive the first and second side surfaces of the rail therebetween. The first and second channel members project onto the downward-facing surface of the rail and include distal ends that prevent the rail dock from being removed vertically from the rail.

[0017] According to the surgical catheter system of the present disclosure, the delivery system has a shaft assembly including a proximal end and a distal end. The delivery system may be, for example, a transcatheter mitral valve replacement delivery system, a transcatheter tricuspid valve replacement delivery system, a transcatheter aortic valve replacement system, or other delivery systems. The handle assembly is attached to the proximal end of the shaft assembly. The lumen extends from the distal end of the shaft assembly to the proximal end of the handle. The stabilization device system for the delivery system has a base and a handle support attached to the base. The handle assembly is received within the handle support. The guide wire is disposed within the lumen. The proximal section of the guide wire extends proximally from the handle assembly. The guide wire management system for controlling the movement of the guide wire relative to the handle assembly has an actuator for advancing and retracting along an axis aligned with the lumen. The engagement clamp removably secures the guide wire to the actuator. The proximal section of the guide wire is received within the engagement clamp. The support of the actuator is connected to the base. The user interface receives user input. The controller moves the actuator to selectively advance and retract the guide wire along the axis based on the user input.

[0018] The guide wire management system of the present disclosure includes a guide wire. The engagement clamp is removably fixed around the guide wire. The actuator advances and retracts the engagement clamp along the axis. The support is attached to the actuator. The user interface generates a user input signal. The controller moves the actuator to selectively advance and retract the guide wire along the axis based on the user input signal.

[0019] According to another aspect of the present disclosure, a guidewire management system includes a stabilization device system for supporting a handle assembly of a delivery system on a base. The support is connected to the base and extends proximally relative to the distal end of the stabilization device system. According to another aspect of the guidewire management system, the shaft is aligned with the lumen of the handle assembly of the delivery system, and the guidewire is disposed within the lumen. According to another aspect of the guidewire management system, the engagement clamp is operable between a locked configuration and an unlocked configuration. According to another aspect of the guidewire management system, the user interface includes a lock button and an unlock button, and the controller operates the engagement clamp between the locked configuration and the unlocked configuration based on a user input signal. According to another aspect of the guidewire management system, the engagement clamp is manually operable. According to another aspect of the guidewire management system, the engagement clamp includes a passive fixing groove for fixing the guidewire. According to another aspect of the guidewire management system, the user interface includes a forward button and a reverse button. According to another aspect of the guidewire management system, the user interface includes a coarse forward button, a coarse reverse button, a fine forward button, and a fine reverse button. According to another aspect of the guidewire management system, the actuator includes a servo controller that measures the position of the guidewire along the shaft relative to an initial position, and the servo controller provides position feedback to the controller. According to another aspect of the guidewire management system, a load sensor that measures the force applied to the guidewire by the actuator provides force feedback to the controller. According to another aspect of the guidewire management system, the wireless interface transmits a user input signal from the user interface to a controller mounted on the support. According to another aspect of the guidewire management system, the controller generates a motor control signal based on a user input signal, and the actuator receives the motor control signal and advances or retracts the guidewire along the shaft based on the motor control signal.According to another aspect of the guidewire management system, the motor control signal is further based on the position of the guidewire or the force applied to the guidewire by the actuator.

[0020] According to a delivery system for delivering an expandable implant to a body position of the present disclosure, the outer sheath assembly has an outer lumen and an outer shaft having a proximal end and a distal end. The outer sheath assembly has an implant holding region for holding the expandable implant in a compressed configuration. The rail assembly is positioned within the outer lumen, and the rail assembly has a rail lumen and a rail shaft having a proximal end and a distal end. The rail assembly has one or more tension wires attached to an inner surface of the rail shaft that provide an axial force to the rail shaft to orient the rail assembly. The inner assembly positioned within the outer lumen has an inner shaft having an inner lumen and a proximal end and a distal end. The inner assembly has an inner holding member removably attached to the expandable implant. The outer sheath assembly and the inner assembly move together distally relative to the rail assembly while the expandable implant remains in a compressed configuration. The outer sheath assembly retracts proximally relative to the inner assembly to at least partially expand the expandable implant from the compressed configuration. The intermediate shaft assembly within the outer lumen has an intermediate shaft having an intermediate lumen and a proximal end and a distal end. The intermediate shaft assembly has an outer holding member for radially restricting at least a portion of the expandable implant. The nose cone assembly is positioned within the inner lumen, and the nose cone assembly has a nose cone shaft having a guide wire lumen, a proximal end, a distal end, and a nose cone on the distal end. The intermediate shaft assembly and the nose cone assembly move distally relative to the rail assembly together with the outer sheath assembly and the inner assembly while the expandable implant remains in a compressed configuration. The intermediate shaft assembly retracts proximally relative to the inner assembly to at least partially expand the expandable implant from the compressed configuration. The nose cone assembly includes a force sensor. The handle has a tactile feedback system coupled to the force sensor and warns the user if a force exceeding a predetermined threshold is detected.

[0021] According to the handle for the delivery system of the present disclosure, the rail housing has a first rotatable actuator connected to the first tension wire and provides an axial force to the first tension wire. The first encoder measures the position of the first rotatable actuator. The second rotatable actuator has a second tension wire and provides an axial force to the second tension wire. The second encoder measures the position of the second rotatable actuator. The delivery housing has a third rotatable actuator connected to an outer sheath assembly that moves the outer sheath assembly distally relative to the delivery housing. The third encoder measures the position of the third rotatable actuator. The fourth rotatable actuator is connected to an intermediate shaft assembly and retracts the intermediate shaft assembly proximally relative to the delivery housing. The fourth encoder measures the position of the fourth rotatable actuator. The fifth rotatable actuator moves the delivery housing relative to the rail housing. The fifth encoder measures the position of the fifth rotatable actuator. The delivery system may include, for example, a transcatheter mitral valve replacement delivery system, a transcatheter tricuspid valve replacement delivery system, a transcatheter aortic valve replacement system, or other delivery systems.

[0022] According to another aspect, the handle includes a processor that receives signals from each of the first, second, third, fourth, and fifth encoders and outputs the position states of each of the first, second, third, fourth, and fifth rotatable actuators. According to another aspect, the handle has or is connected to a user interface to display the position states of each of the first, second, third, fourth, and fifth rotatable actuators. One or more of the encoders may be mechanical encoders that measure a rotational position and have detents or other click features to provide tactile and / or audible feedback.

[0023] According to another aspect, the general-purpose stabilization device includes an electric rail system. The support is mounted on the electric rail system. The support receives the handle of the delivery system. The control system moves the support between the first and second ends of the electric rail system. According to another aspect, the user interface receives a user input signal and generates a motor control signal for the control system based on the user input signal. According to another aspect, the electric rail system includes a threaded shaft coupled to a motor, and the support is mounted on a threaded carriage engaged with the threaded shaft.

[0024] According to one aspect, a general-purpose stabilization device adapted or configured for use with a plurality of different delivery systems (e.g., may include one or more transcatheter mitral valve replacement delivery systems, one or more transcatheter tricuspid valve replacement delivery systems, one or more transcatheter aortic valve replacement systems, or one or more other delivery systems) is disclosed. The stabilization device includes a rail having a first end, a second end, an upward-facing surface, a downward-facing surface, and first and second side surfaces extending between the first and second ends, and a rail dock mounted on the upward-facing surface of the rail. The rail dock includes first and second channel members spaced apart to receive the first and second side surfaces of the rail therebetween, and the first and second channel members project beyond the downward-facing surface of the rail and include distal ends that prevent the rail dock from being removed vertically from the rail. The rail dock further includes a brake assembly configured to operate between a first configuration in which the rail dock is configured to translate along the rail and a second configuration in which the rail dock is prevented from translating along the rail. The brake assembly includes a toggle member having at least one push button configured to move the brake assembly between the first and second configurations.

[0025] The toggle member may include a first button on a first side of the brake assembly and a second button on a second side of the brake assembly. Pressing the first button actuates (e.g., shifts, transitions) the brake assembly from a first configuration to a second configuration, and pressing the second button actuates the brake assembly from the second configuration to the first configuration.

[0026] In some configurations, the stabilization device is configured to operate in conjunction with a guide wire management system. The stabilization device may be operably coupled to a rail or a base to which the rail is attached, and the guide wire management system is configured to support a guide wire configured to be advanced by the delivery system. The guide wire management system may be configured to cause movement (e.g., advancement, retraction, and / or rotation) of the guide wire relative to the delivery system.

[0027] The surgical system may include any one or more of the delivery systems disclosed herein and / or in combination with any of the guide wire management systems disclosed herein, any of the stabilization devices disclosed herein. For example, the surgical system may include a base or platform configured to have a rail of the stabilization device attached thereto. The delivery system may include a handle configured to engage a support of the stabilization device. The delivery system may be configured to deliver an artificial heart valve to replace a native heart valve (e.g., aortic valve, mitral valve, pulmonary valve, and / or tricuspid valve).

[0028] The foregoing summary is illustrative only and is not intended to be limiting. The systems, devices, and methods and / or other aspects, features, and advantages of the other subject matter described in this application will become apparent in the teachings below. The summary of the invention is provided to introduce some of the selected concepts of the present disclosure. The summary of the invention is not intended to identify the key or essential features of any subject matter described herein.

[0029] Various examples are shown in the accompanying drawings for illustrative purposes and should in no way be construed as limiting the scope of the embodiments. The various features of the different disclosed embodiments may be combined to form additional embodiments that are part of this disclosure.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0031] The various features and advantages of the systems, devices, and methods of the technology described herein will become more fully apparent from the following description of the embodiments illustrated in the figures. These embodiments are intended to illustrate the principles of the present disclosure, and the present disclosure should not be limited to the merely illustrated embodiments. The features of the illustrated embodiments can be modified, combined, deleted, and / or substituted so as to be apparent to those skilled in the art in view of the principles disclosed herein.

[0032] This specification and the drawings provide aspects and features of the present disclosure in the context of some embodiments of prosthetic heart valves, delivery systems, and methods. The disclosed delivery systems are configured for use in a patient's vasculature, such as for replacement of the patient's native heart valve. These embodiments may be discussed in relation to replacement of a particular valve, such as the patient's aortic valve, tricuspid valve, pulmonary valve, or mitral valve. However, it should be understood that the features and concepts discussed herein are applicable to products other than heart valve implants. For example, the controlled positioning, deployment, and anchoring features described herein are applicable to medical implants for use in other locations within the body, such as within arteries, veins, or other body cavities or locations, for example, other types of expandable prostheses. Further, specific features such as valves, delivery systems, etc. should not be taken as limiting, and the features of any one embodiment discussed herein can be combined with the features of other embodiments, as desired and when appropriate. Some of the embodiments described herein are described in relation to a transfemoral (or transseptal) delivery approach, but it should be understood that these embodiments can be used with other delivery approaches, such as a transapical or transjugular approach. Further, it should be understood that some of the features described in relation to some embodiments can be incorporated with other embodiments that include features described in relation to different delivery approaches.

[0033] The embodiment of the stabilization device 1000 shown in FIGS. 1A - E can hold an embodiment of the delivery system 2 having a handle 1 in place during use. FIG. 1A illustrates an embodiment of the stabilization device 1000, such as a general - purpose stabilization device, engaged with a delivery system 2 for delivering a prosthesis to a body location. FIG. 1B shows an alternative embodiment of the stabilization device 1000 of FIG. 1A that holds the delivery system 2. FIGS. 1C and 1D are views of the stabilization device 1000 of FIG. 1A without the delivery system 2. FIG. 1E is a perspective view of the stabilization device 1000 of FIG. 1B without the delivery system 2.

[0034] Generally, the stabilization device 1000 can be used to hold the delivery system 2, for example, above a patient's leg or in a fixed position on an operating table, although the specific location is not limited. The stabilization device 1000 enables the delivery system 2 to remain stable during the procedure. In some embodiments, the stabilization device 1000 can be used to torque (rotate), advance, and / or retract the components of the delivery system 2 in a controlled manner (either independently or simultaneously). Examples of delivery systems that can be held with the stabilization device 1 are described in U.S. Patent Publication No. 2019 / 0008640, which is incorporated herein by reference in its entirety. Examples of other stabilization devices are described in U.S. Patent Publication No. 2020 / 0108225, which is incorporated herein by reference in its entirety. The disclosed stabilization device 1000 can be advantageous for a transseptal (e.g., transfemoral) approach for delivering a replacement heart valve by enabling fine motor control of the delivery system within the stabilization device. However, the embodiments of the stabilization device disclosed herein can also be used for other approaches, such as a transapical approach, and other procedures and are not limited to replacement heart valves. The stabilization device 1000 can be universal in that it can be coupled to or used with a variety of different delivery systems (e.g., a delivery system for delivering a replacement aortic valve, a system for delivering a replacement mitral valve, a system for delivering a replacement tricuspid valve, a system for delivering a replacement pulmonary valve, or any other delivery system).

[0035] As shown in FIGS. 1A - E, the stabilization device 1000 may include a base or platform 1006. The base 1006 can be a stand, table, or other flat surface. In some embodiments, the base 1006 may not be used. In some embodiments, the base 1006 can be placed on a patient's leg, for example, to help support the stabilization device 1000. The base 1006 can be sized to interact properly with the stabilization device 1000. In some embodiments, the base can include a generally flat upper surface having several legs 1007 extending downwardly from its surface. Thus, the patient can extend their leg through the gap between adjacent legs as needed. In some embodiments, the legs 1007 can be adjustable to vary the height of the upper surface. In some embodiments, the stabilization device can further include a plate or other rigid surface that can be placed under the patient to provide a stable surface for the base 1006 to be disposed on. Each of the legs 1007 can be extended or retracted (operable by the knob 1008) independently or semi - independently to adjust the angle of the upper surfaces of the base 1006 and the rail 1002.

[0036] In some embodiments, the stabilization device 1000 can be a general-purpose stabilization device system. This system can be easily adaptable to bases and delivery systems of different sizes. The stabilization device can utilize a generally attachable rail 1002, which can enable more flexibility and adaptability. The rail 1002 can include a proximal end and a distal end. Generally, the proximal end faces the user of the stabilization device 1000 (e.g., a clinician or healthcare provider) and / or the delivery system 2 connected to the stabilization device 1000, and the distal end is away from the user. The rail 1002 can extend along a longitudinal direction. The rail 1002 can include one or more clamps. The rail 1002 may be directly attached to the base 1006, such as on an upper surface. The rail 1002 can be attached by a clamp to the base 1006. The rail 1002 can include a movable clamp 1003b (operable by a knob 1004) and a longitudinally spaced fixed clamp 1003a. In some embodiments, both clamps may be movable. As discussed in detail below, the movable clamp can lock at a desired position on the rail, thus enabling the rail to be attached to surfaces of different sizes. The rail and the clamps can be both reusable and sterilizable, and can be used with a plurality of different types of delivery or repair systems (e.g., a replacement heart valve delivery system or a heart valve repair system). According to some implementations, a single knob 1004 (e.g., only the sole knob) can be used to tighten and loosen the rail 1002 to the base 1006.

[0037] The stabilization device 1000 may further include a rail dock 1100 and a hub nest 1020, both of which are connected to the rail 1002. The rail dock 1100 may include a support 1150, a carriage assembly 1170, and / or a brake system 1160. In some embodiments, multiple rail docks may be used along the rail 1002. In some embodiments, the rail dock 1100 may have an adjustable upper surface for adjusting the angle. The rail dock 1100 may be attachable on the upper surface of the rail 1002 and may be movable along the longitudinal direction. The rail dock 1100 may be locked in place along the rail 1002 by the brake system 1160. As shown in FIGS. 7-10, the rail dock 1100 may have a bottom plate 1108 having a channel member or protrusion 1109 (and distal end 1109a) that at least partially wraps around the upper surface of the rail 1002 to enable fixing the rail dock 1100 to the rail 1002 while preventing vertical removal. The protrusions 1109 can be spaced apart to receive the width of the rail therebetween. The rail dock 1100 may be attached on the rail 1002 at one or both of the proximal and distal ends.

[0038] The rail dock 1100 may further include a braking system 1160. As shown in FIGS. 7-10, the braking system 1160 may include a toggle member 1161. The toggle 1161 can include two push buttons 1162. The push buttons 1162 may be on either end of the toggle 1161. The toggle 1161 can be actuated by pressing the appropriate button 1162 in the horizontal direction indicated by the horizontal arrow 1157 in FIG. 9. In some configurations, there is only one push button for switching the braking system between a locked configuration and an unlocked configuration. The horizontal movement of the toggle 1161 can be induced by the interaction of the spline 1166 and the slotted member 1167. The toggle 1161 can be temporarily held in place by one or more spring-loaded detent members 1168 in any position. In some embodiments, the detent member 1168a can be formed integrally with the bottom plate 1108, for example, by injection molding of a plastic material. An example of the molded detent member 1168a is shown in FIG. 8B. The detent member 1168a extends from the surrounding structure of the bottom plate 1108 like a cantilever beam, bends under force when the force is released, and can recover its original position. In some implementations, the button 1162 may be replaced with an alternative input or toggle member (e.g., slide, knob, switch, and / or the like). In some configurations, the button controls the gross movement of the rail dock 1100 along the rail 1002.

[0039] Toggle 1161 may include lamp 1163. Lamp 1163 may be engaged or disengaged with brake member 1164. Brake member 1164 can be actuated downward by lamp 1163 and engage with the upper surface of rail 1002 as shown by the vertical arrow 1158 in FIG. 9. Brake member 1164 may include an elastic material or other high-friction material. Brake member 1164 that engages with the upper surface of rail 1002 (such as on its upper surface) can lock the position of rail dock 1100 along rail 1002 or at least prevent translation along the rail during use (such as in use with a delivery system) due to the friction between brake member 1164 and the upper surface of rail 1002. Brake member 1164 can be mounted on a guide column or post 1165 that guides movement along the vertical direction (for example, the opening of brake member 1164 mounted on vertical guide column or post 1165 as shown in FIG. 8). Brake member 1164 can be biased from engagement with rail 1002 (for example, by a spring). For example, four springs, such as compression or leaf springs, may be disposed between brake member 1164 and the upper surface of bottom plate 1108, with one surrounding each guide post 1165. In some embodiments, brake member 1164 can be biased into rail 1002.

[0040] Another embodiment of the brake member 1164a is shown in FIG. 8A, and the brake member 1164a includes, for example, two flexible vanes 1169 that are normally angled from the horizontal plane, parallel to the bottom surface of the brake member 1164a. According to some embodiments, the installation of the brake member 1164a in the configuration shown in FIG. 8A does not require the guide post 1165 shown in FIG. 8. When the brake member 1164a is pushed downward by the lamp 1163 and engages with the upper surface of the bottom plate 1108 to stop the carriage assembly 1170, the flexible vanes 1169 are biased to flatten to a position more parallel to the horizontal plane. The brake member 1164a may be made of an elastic material, such as injection-molded plastic, and as a result, when biased, the flexible vanes 1169 tend to recover their natural shape. Thus, when the lamp 1163 is disengaged from the brake member 1164a, the brake member 1164a returns to its un-biased configuration and position. Since the position recovery of the brake member 1164a results from the structure and the elastic material employed, a spring may not be required. Thus, the brake member 1164a can be a springless brake. This can advantageously provide the advantages of ease of manufacture and cost reduction.

[0041] Referring again to FIGS. 2 and 4, the rail dock 1100 can include a support 1150 that can be used to attach a delivery system holder to the rail 1002. For example, as shown in FIGS. 3, 5A - B, and 6, the support 1150 can include a fixed member 1151 and a movable member 1152. The movable member 1152 can be pivotally connected to the fixed member 1151 by a pin 1153. The lower end of the fixed member 1151 can be attached onto the carriage member 1171 of the carriage assembly 1170. The lower end of the fixed member 1151 includes a protrusion 1151a that fits into a stabilizing slot of the housing 1172 of the carriage assembly 1170. The upper end of the fixed member can include a concave gripping member on the opposite side of a corresponding concave gripping member on the upper end of the movable member 1152. The concave shape can be sized to receive a portion of the handle of the delivery system 2.

[0042] The support body 1150 may include a nut 1154 and a shaft 1155 connected to the knob 1156. The nut 1154 may be disposed within the fixed member 1151. The shaft 1155 may be disposed within the movable member 1152. The threaded end of the shaft 1155 may be engaged with the thread of the nut 1154 such that rotation of the knob 1156 can actuate the movable member 1152 between an open configuration and a closed configuration. The threads on the shaft 1155 can be provided to rapidly actuate the movable member 1152 between the open configuration and the closed configuration. For example, the threads can facilitate opening and closing with a rotation of the knob 1156 of 180° (half rotation) or less, or 90° (quarter rotation) or less. In some implementations, the knob 1156 can be tightened beyond a locking point. Tightening the knob 1156 beyond the locking point can fix the members 1151, 1152 together in the closed configuration with a greater force against inadvertent opening. In another example, the knob 1156 can be rotated completely (360°) to reach the closed configuration.

[0043] The carriage assembly 1170 may include a housing 1172. The housing 1172 can enclose a traveling screw or a carriage shaft 1173. The carriage shaft 1173 can be mounted horizontally or at an angle and rotatably mounted about its axis by a knob 1174. The carriage 1171 (and the fixed member 1151) can be mounted on the carriage shaft 1173 in a threaded or screwed manner and can be translatable along the length of the carriage shaft by rotation of the knob 1174. Optionally, the carriage shaft 1173 can be lockable by one of a pair of opposing spring return stop mechanisms 1175 that can engage corresponding surfaces or recesses on the carriage shaft 1173, or at a pair of intervals. In some implementations, rotation of the knob 1174, and thus rotation of the traveling screw or the carriage shaft 1173, controls fine movement of the rail dock 1100.

[0044] As shown in FIGS. 1A - 1E, the stabilization device 1000 may include a hub support or hub nest 1020. The hub nest 1020 may be located distal to the rail dock 1100. As further shown in FIGS. 11 - 12F, the hub nest 1020 may include a support 1021 (such as a fork - shaped support) for engaging or supporting a portion of an introducer hub or sheath hub 1a, or a handle or catheter of a delivery system 2 such as a shaft hub. The support 1021 can be located on a vertical portion 1022 of the hub nest 1020. The support 1021 may include one or more detents for fixing the introducer hub or sheath hub 1a within the support 1021. The first detent may be located on the first fork of the support 1021, and the second detent may be located on the second fork of the support 1021. The detent 1025 can be spring - type. The detent 1025 can extend inwardly to engage respective receiving portions (e.g., concave) of the introducer hub or sheath hub 1a. In some embodiments, the detent 1025 may be formed as part of the hub nest 1020, as shown in FIGS. 11A and 11B, for example, when the hub nest 1020 having the detent 1025 is made of plastic, it may be integrally injection - molded.

[0045] The horizontal portion 1023 of the hub nest 1020 can be attached to the upward-facing surface of the rail 1002. The horizontal portion 1023 may include a lock projection 1024 (FIG. 12A). The lock projection 1024 may include a lateral flange portion spaced apart from the horizontal portion 1023. The lock projection 1024 may be shaped to lock into a corresponding lock opening 1002a of the rail 1002 (FIG. 12B). The lock opening 1002a may be keyhole-shaped to accommodate the lateral flange of the projection 1024. The hub nest 1020 can be locked in place by inserting the lock projection 1024 into the opening 1002a (FIG. 12C), aligning and rotating the horizontal portion 1023 along the rail 1002, and engaging the lateral flange with the rail 1002 (FIG. 12D). The hub nest 1020 can be removed by rotating in the opposite direction and pulling the lock projection 1024 out of the opening 1002a. Optionally, the rail 1002 may include a plurality of openings 1002a for selectively attaching the hub nest 1020. The horizontal portion 1023 may include a detent 1026 (FIG. 12A). The detent 1026 can engage a groove 1027 or an opening in the rail 1002 to fix the hub nest 1020 in a locked configuration (FIG. 12E). The detent 1026 may be spring-loaded.

[0046] Another embodiment of the hub nest 1020 is shown in FIGS. 11A and 11B, which is the hub nest 1020 assembled to the stabilization device 1000 of FIGS. 1A, 1C, and 1D. The hub nest 1020 of FIGS. 11A and 11B includes a first side surrounding member 1028 extending from one side of the horizontal portion 1023 of the hub nest 1020 and a second surrounding member 1028 extending from the other side of the horizontal portion 1023. Each of the surrounding members 1028 has a distal end that projects onto the downward-facing surface of the rail 1002. In this way, vertical removal of the hub nest 1020 from the rail 1002 is prevented. The hub nest 1020 can, for example, slide longitudinally onto the rail 1002 from the distal end along the longitudinal direction of the rail 1002, allowing the surrounding member 1028 to engage and wrap around the side edge of the rail 1002. In this way, it is not necessary to rotate (e.g., rotate a quarter turn) when assembling the hub nest 1020 onto the rail 1002, which can result in a simpler operation and reduced manufacturing costs according to some implementations.

[0047] The hub nest 1020 further includes a locking mechanism 1029 (e.g., a slide-to-lock mechanism). When the locking mechanism 1029 is pushed downward, the protrusion 1031 can lift the lever. This leverage effect is provided because the locking mechanism 1029 is pivotally connected to the surrounding structure of the horizontal portion 1023. Due to the leverage action, the hub nest 1020 can slide further longitudinally toward the proximal end of the rail 1002 until the protrusion 1031 drops into the locking opening 1002a of the rail 1002. In this way, the hub nest 1020 is locked in place.

[0048] When made of an elastic plastic material, the locking mechanism 1029 may be injection molded integrally with the hub nest 1020. The connection of the locking mechanism to the hub nest 1020 can result from a thin connection between the locking mechanism 1029 and the surrounding structure of the horizontal portion 1023 formed around the locking mechanism 1029. The opening 1002a may have a shape formed to fit the protrusion 1031. There may be two or more locking openings 1002a in the rail 1002 to position the hub nest 1020 at different positions.

[0049] Figures 13 - 14 show another embodiment of the stabilization device 1300 for supporting the handle 1 of the delivery system 2. The stabilization device 1300 can be similar to the stabilization device 1000 having the differences described below. The stabilization device 1300 can include a base 1306 for attaching the rail 1302 (e.g., by one or more clamps). The stabilization device 1300 can include one or more supports 1320, 1340, 1360 for the handle 1. The number and type of supports can vary based on the dimensions and functions of the handle 1.

[0050] As shown in Figures 15A - B, the support 1320 can include a clamp 1321, a carriage 1322, and / or a rail dock 1323. The clamp 1321 includes a movable member and a fixed member and can be actuated by a threaded rod and a knob 1326. By rotating the knob 1326, the clamp can be opened and closed to release or grip the handle 1. The rail dock 1323 can include protrusions on a first side and a second side for engaging the rail. The protrusion on the second side can be on a movable plate 1324. The plate 1324 can be biased into the rail. The rail dock 1323 can operate between a locked configuration and an unlocked configuration using a button 1325 connected to the movable plate 1324. In the locked configuration, the rail dock 1323 can be fixed along the rail. In the unlocked configuration, the rail dock 1323 can be movable along the rail 1302 and / or removable vertically from the rail 1302.

[0051] As shown in FIGS. 16A - B, the support 1340 may include a passive support 1341. The passive support 1341 may include two upwardly extending flexible members that bend outwardly to receive the handle 1 therebetween in a semi - fixed manner. The support 1340 may further include a rail dock 1342 such as the rail dock 1323. Optionally, the rail dock 1342 may be fixedly positioned by mechanical attachment (e.g., screws) of two opposing plates each having a rail - engaging protrusion.

[0052] As shown in FIGS. 17A - B, the support 1360 may include a hub nest 1361 and a rail dock 1362 such as the rail dock 1323.

[0053] FIGS. 18A - C illustrate another rail dock 1800. Similar to the rail dock 1100, the rail dock 1800 may include a support or clamp for a delivery system, carriage, and / or brake assembly 1811 that attaches to the rail 1802. The brake assembly may include a first side having a first protrusion 1809 that can project onto a first side surface 1801 of the rail 1802. The second side of the brake assembly may include a second protrusion 1810. The second protrusion 1810 can project onto a second side surface 1803 of the rail 1802 on the opposite side of the first side. The second protrusion 1810 may be biased (e.g., via a spring) into the second side surface 1803 of the rail 1802 by a force and be operable (e.g., via a button 1821) between a locked configuration and an unlocked configuration. The second protrusion 1810 can prevent the vertical removal of the rail dock 1800 from the rail 1802, but in the unlocked configuration, still allow translation along the rail. The first and / or second side surfaces of the rail 1802 may be textured (e.g., grooved) to increase friction with the protrusions 1809, 1810 and enhance the braking force.

[0054] Figures 19A - C illustrate a support 1900. The support 1900 can be used as a support for a delivery system and can be used in conjunction with a rail dock, for example, one of the rail docks described above. The support 1900 can include a fixed member 1901 connected to a movable member 1902. The upper ends of the fixed member 1901 and the movable member 1902 can be concave to receive the delivery system. The support 1900 can be operable between an open configuration (Figure 19B) and a closed configuration (Figures 19A, 19C) based on the position of the movable member 1902. A handle (e.g., handle 1) of the delivery system (e.g., delivery system 2) can be clamped within a space defined by the fixed member 1901 and the movable member 1902 when the support 1900 is locked in the closed configuration. The handle can be loaded into or removed from the space between the fixed member 1901 and the movable member 1902 when the support 1900 is in the open configuration.

[0055] The support 1900 can include a rotatable lock 1903 that is rotatable about an axis. The axis can be transverse to the pivot axis of the movable member 1902. The rotatable lock 1903 can include an extension portion 1904. The rotatable lock 1903 can be operable between an unlocked position (Figures 19A - B) that allows the opening of the movable member 1902 and a locked position (Figure 19C) that blocks the opening of the movable member 1902. The extension portion 1904 in the locked position can fix the movable member 1902 in the closed configuration.

[0056] Figures 20A - B illustrate a support 2000. The support 2000 can be used as a support for a delivery system and can be used in conjunction with, for example, a rail dock. The support 2000 can include a fixed member 2001 connected to a movable member 2002. The upper ends of the fixed member 2001 and the movable member 2002 can be concave to receive the delivery system. The support 2000 can be operable between an open configuration (Figure 20B) and a closed configuration (Figure 20A) based on the position of the movable member 2002. The support 2000 can include a rotatable lock 2003 that is rotatable about an axis. The axis can be transverse to the pivot axis of the movable member 2002. The rotatable lock 2003 can be operable between an unlocked position (Figure 20B) that allows the opening of the movable member 2002 and a locked position (Figure 20A) that blocks the opening of the movable member 2002.

[0057] Figure 21 shows a support 2100 for holding a handle 1 of a delivery system 2. The support 2100 can be mounted on a rail dock. The support 2100 can include a lower portion 2101 and a strap 2102. The handle 1 of the delivery system 2 can be supported on the lower portion 2101 that can include a concave region. The strap 2102 can be fixed at a first end (not shown), and a second end 2103 can be wrapped around the handle 1 and fixed at the lower portion 2101. The strap 2102 can include an elastic or conforming material. The second end 2103 can include an opening that is received over a protrusion 2104 on the lower portion 2101. The second end 2103 can include a plurality of openings or positions for adjusting the tension of the strap 2102. For example, one position can prevent the removal of the handle 1 and allow rotation, and a second position can prevent rotation. Alternatively, the position of the protrusion 2104 can be adjustable. For example, by adjusting the position of the protrusion 2104, the tension on the strap 2102 can be selected or adjusted to allow rotation of the handle 1 about the longitudinal axis within the support 2100. Alternatively, the second end 2103 can be T - shaped and can be locked under a shelf or can protrude over the support 2100.

[0058] Figure 22 shows a support 2200 for the handle 1 of the delivery system 2. The support 2200 can be mounted on the rail dock. The support 2200 can include a clamp that at least partially engages around the periphery 2204 of the handle 1. The clamp can have a fixed member 2201 and a movable member 2202. The clamp can be locked in a fixed position around the handle 1. The support 2200 can further include a knob 2203 connected to a worm gear (not shown). The worm gear can engage a thread extending around the periphery 2204 of the handle 1. Thus, rotation of the knob 2203 can cause rotation of the handle 1 around its longitudinal axis while being held within the clamp. The thread of the handle 1 can be integral with its housing or, alternatively, the clamp can include a separate worm wheel member that can be attached around the handle 1. The support 2200 or the handle 1 can include a position indicator for indicating the adjustment angle.

[0059] The various embodiments of the support of the various stabilization devices disclosed above are configured to stably hold the delivery system 2 during a medical procedure. For example, in FIG. 1A, the handle 1 of the delivery system 2 is held within the support 1150, and the introducer hub or sheath hub 1a attached to the guide wire of the delivery system 2 is held by the hub nest 1020 (another support). As shown in FIG. 14, the handle 1 of the delivery system 2 is held by two supports 1350 and 1340. The introducer hub or sheath hub 1a is held by the support 1360. The position of each support on the rails 1002, 1302 of the stabilization device 1000 can be adjusted to fit the handle and then locked in place. The grip airtightness can be adjusted to ensure that the handle 1 and the delivery system 2 are stably held in place. The introducer hub or sheath hub 1a may be a shaft hub into which one or more shafts of the delivery system 2 are inserted. The introducer hub may be connected to an introducer sheath inserted into the patient's vasculature to facilitate introduction of the delivery system into the vasculature.

[0060] Figures 23A - D illustrate a rail dock 2300 that can be used with a support, such as one of the supports disclosed above, for a delivery system. The rail dock 2300 may have a bottom surface with a first side having a protrusion 2308 that at least partially wraps around the bottom of the rail to allow the rail dock 2300 to slide along the rail while preventing removal. The rail dock 2300 may include a movable plate 2310 on a second side of the bottom surface having a protrusion 2309. The movable plate 2310 can be connected to a lever lock 2304 for attachment and detachment to and from the rail and for maintaining the position of the rail dock 2300 on the rail.

[0061] As shown in the figure, the lever lock 2304 is rotatably connected to one side of the rail dock 2300 and may include a spring or a pair of springs and / or a handle attached to the movable plate 2310 on the opposite side of the rail dock 2300 by a shaft 2318 or other attachment member. The handle may fit within a notch on the side surface of the rail dock 2300 in some embodiments. The lever lock 2304 has a locked configuration (FIG. 23A) where the protrusions 2308, 2309 engage the side surface of the rail to lock the rail dock 2300 in place, a semi-locked configuration (FIG. 23B) where the protrusions prevent vertical removal of the rail dock 2300 from the rail and allow it to slide along the rail, and an unlocked configuration (FIG. 23C) where the protrusions allow the rail dock to be removed vertically from the rail, and can rotate between these configurations. The base 2321 of the lever lock 2304 can include different widths a, b, c, each positioning the movable plate 2310 (connected through the shaft 2318) corresponding to one of the locked, semi-locked, and unlocked configurations respectively.

[0062] Figures 24A - E illustrate a rail dock 2400 that can be used with a support for a delivery system. The rail dock 2400 may have a bottom surface with a first side having a protrusion 2408 that at least partially wraps around the bottom surface of the rail to allow the rail dock 2400 to slide along the rail while preventing removal. The rail dock 2400 may include a movable plate 2410 on a second side of the bottom surface having a protrusion 2409. The movable plate 2410 may be connected to a lever lock 2404 for attachment and removal to and from the rail and for maintaining the position of the rail dock 2400 on the rail.

[0063] As shown in the figure, the lever lock 2404 may be rotatably connected to one side of the rail dock 2400 and include a handle attached to a movable plate 2410 on the opposite side of the rail dock 2400 by a spring or a pair of springs and / or a shaft 2418 or other attachment members. The handle may fit within a notch on the side surface of the rail dock 2400 in some embodiments. The lever lock 2404 has a locked configuration (Figure 24A) where the protrusions 2408, 2409 engage the side surface of the rail to lock the rail dock 2400 in place, a semi-locked configuration (Figures 24B - C) where the protrusions prevent vertical removal of the rail dock from the rail and allow it to slide along the rail, and an unlocked configuration (Figure 24D) where the protrusions allow the rail dock to be removed vertically from the rail, and can rotate between these configurations. The base 2421 of the lever lock 2404 can include different widths a, b, c, each positioning a movable plate 2410 (connected through the shaft 2418) corresponding to one of the locked, semi-locked, and unlocked configurations respectively. The rail dock 2400 shown in Figures 24A - E is similar to the rail dock 2300 shown in Figures 23A - D. The difference is that the rail dock 2400 has a notch for exposing the base 2421 of the rail lock 2404, which the rail dock 2300 does not have.

[0064] Figure 25A illustrates another rail dock 2500a for attachment on a rail 2502. The rail dock 2500 may include a lever 2508 that protrudes to one side of the rail. The lever 2508 can swing inwardly and outwardly to actuate a protrusion (e.g., a button or bump 2509) between a locked configuration that prevents and allows movement of the rail dock 2500 along the rail 2502, similar to the disclosed rail docks of the stabilization device, and an unlocked configuration.

[0065] Figures 25B - C illustrate another rail dock 2500b for attachment onto rail 2502. The rail dock 2500b may include a separate lock actuator 2505 to prevent vertical removal of the rail dock 2500 from the rail 2502. The lock actuator 2505 may be a pin that can be inserted into the side of the rail dock 2500 in the direction of arrow 2506 or rotated in the direction of arrow 2507. When inserted and / or rotated, the lock actuator 2505 projects directly onto one side of the rail 2502 (e.g., the side opposite the protrusion 2509), thereby preventing vertical removal. As another method, the lock actuator 2505 can operate a mechanism that projects directly onto the rail 2502.

[0066] Figures 26 - 28 show another stabilization device assembly 2600. The stabilization device assembly 2600 may include a rail 2602. The rail 2602 may include a fixed clamp 2603 and a movable clamp 2604. One or both of the clamps 2603, 2604 may be integrated with the rail 2602. The rail 2602 may be attachable to a base by the clamps 2603, 2604. The movable clamp 2604 may include an adjustment wheel 2605 that operates the movable clamp 2604 movable along the longitudinal direction of the rail 2602. The adjustment wheel 2605 may include a gear that engages a rack along the side of the movable clamp 2604.

[0067] The rack 2608 including gear teeth may extend longitudinally between the first and second ends of the rail 2602. The rack 2608 can be placed at the center of the rail 2602 and / or on the upper surface. The stabilization device 2600 may include a rail dock 2650. The rail dock 2650 can provide a base for a support for the delivery system. The rail dock 2650 may include opposing protrusions 2658 that project beyond both sides of the rail 2602. The rail dock 2650 may be attachable onto the rail 2602 at its first or second end. The rail dock 2650 may include a knob 2651 attached to a shaft 2652 and biased by a spring 2653. A pinion gear 2654 may be attached onto the shaft 2652. The pinion gear 2654 may be movable to engage or disengage from the rack 2608 based on the positions of the shaft 2652 and the knob 2651. As shown in FIG. 27A, when the knob 2651 is pushed toward the left side, the spring 2653 is compressed and the pinion gear 2654 is disengaged from the rack 2608. Next, in FIG. 27B, the pushing force on the knob 2651 is released. The pinion gear 2654 is pushed to the right side by the spring 2653 and returns to the position where it engages with the rack 2608.

[0068] When the pinion gear 2654 engages with the rack 2608, the rotation of the knob 2651 may cause a translation (e.g., fine position adjustment) of the rail dock 2650 along the longitudinal direction with respect to the rail 2602. The torsional rigidity in the rotation of the knob 2651 and / or the shaft 2652 may prevent an unintentional backward drive of the rail dock 2650. When the pinion gear 2654 is disengaged from the rack 2608 (and received within a well 2609 adjacent to the rack 2608), the rail dock 2650 can move freely along the longitudinal direction with respect to the rail 2602 (e.g., coarse position adjustment).

[0069] Figures 29 - 31 show a surgical catheter system 3000 including a handle 1 of a delivery system 2 attached to a stabilization device assembly 3001. The stabilization device 3001 may include any features of the stabilization devices disclosed herein. The stabilization device 3001 may include a support 3003, a base 3006, and a rail 3002 for the handle 1.

[0070] The delivery system 2 may include a shaft assembly having a proximal end and a distal end. Similar to the stabilization device 1000, the proximal end of the shaft assembly faces the operator (e.g., clinician or medical practitioner), and the distal end is away from the operator. The proximal end of the shaft assembly is attached to the handle 1. The distal portion of the shaft assembly may be inserted into the patient's body over a guidewire 5. A lumen may extend from the distal end of the shaft assembly to the proximal end of the handle. The guidewire 5 may be received within the lumen. The proximal section of the guidewire 5 may extend proximally from the handle 1. The guidewire may include a metallic material or other suitable material. In one embodiment, the guidewire 5 may include a solid core having a braided metal sheath.

[0071] In conventional delivery systems, one physician or other medical practitioner generally controls the delivery system 2, and a second physician or other medical practitioner controls the position of the guidewire 5 (e.g., by gripping the proximal portion of the guidewire 5). The position of the guidewire 5 may need to be manipulated based on the surgical steps required for the procedure. For example, the guidewire 5 may be retracted to assist with a septal crossover or rotation of a stiff section of the delivery system 2. The guidewire 5 can be advanced to add height to the position of the delivery system 2. All of advancing, retracting, or holding the guidewire 5 in a stationary position is manually performed by a second physician or medical practitioner using the current system. Aspects of the present disclosure advantageously relate to an improved system that can function as a “third hand” to enable a single physician to position the guidewire 5 during operation.

[0072] As shown in FIG. 31, the surgical catheter system 3000 may include a guide wire management system 3020. The guide wire management system 3020 supports the movement of the guide wire 5 relative to the handle 1 (e.g., forward and backward along the lumen), and can optionally control and stop it. The guide wire management system 3020 may include an actuator 3022. The actuator 3022 may include a wheel or a pair of wheels (e.g., on both sides) that can engage the guide wire 5. The actuator 3022 can move the guide wire 5 forward and backward along the lumen by rotation while engaged with the guide wire 5. The actuator 3022 can move the guide wire 5 forward and backward along an axis aligned with the lumen and / or the handle 1. The actuator 3022 can also lock the guide wire against movement relative to the lumen of the handle 1.

[0073] The guide wire management system 3020 may include a support 3026. The support 3026 can be connected to the base 3006 or the rail 3002. The support 3026 can be adjustable to align the guide wire 5 with the lumen of the handle 1. The support 3026 may include an operable joint 3027 for positioning the actuator 3022 and / or the guide wire 5.

[0074] In another embodiment, the actuator 3022 may include a linear actuator, an electric motor, a servo motor, or other mechanism for forward and backward movement. The actuator 3022 may include a servo controller that measures the position of the guide wire 5 along an axis relative to an initial position. The servo controller can provide position feedback to the controller. The actuator 3022 may include a force sensor that measures the force applied to the guide wire 5 by the actuator 3022. The load sensor can provide force feedback to the controller. Optionally, the actuator 3022 can be integrated with the support 3026.

[0075] The actuator 3022 may include an engagement clamp 3024 or may otherwise function to clamp onto the guide wire 5. The engagement clamp 3024 may be removably fixed to the guide wire 5. The engagement clamp 3024 may be operable between a locked configuration and an unlocked configuration. The engagement clamp 3024 may be operable manually or automatically. The engagement clamp 3024 may include a passive fixing groove, a clamping member or wheel, or other mechanism for fixing the guide wire 5 thereto.

[0076] The guide wire management system 3020 may include a user interface 3030 (FIG. 30). The user interface may include one or more inputs such as buttons, dials for receiving user input. The controller may be programmed to move the guide wire 5 based on user input to selectively advance and retract along the lumen. The controller can generate a motor control signal based on the user input signal, and the actuator 3022 can receive the motor control signal and advance or retract the guide wire 5 along the axis based on the motor control signal. The motor control signal may further be based on the position of the guide wire 5 or the force applied to the guide wire 5 by the actuator 3022. The force may be detected by a sensor on the guide wire management system 3020, such as on the support 3026, the actuator 3022, or the clamp 3024.

[0077] The user interface 3030 may include fine and / or gross control for the movement of the guidewire 5. The user interface may include a fine forward button V (ventricular direction), a fine reverse button A (atrial direction), a gross forward button a, and / or a gross reverse button v. The user interface may include a lock button 3031 and / or an unlock button 3032 for actuating the engagement clamp 3024 between a locked configuration and an unlocked configuration based on a user input signal. The guidewire management system 3020 may include a wireless (e.g., BLUETOOTH®) communication system configured to transmit the user input signal from the user interface 3030 to a controller mounted on a support. The buttons may be replaced with other actuators (e.g., switches, levers, toggles, slides, etc.).

[0078] In some configurations, the guidewire management system 3020 may be configured to prevent or reduce the likelihood of tissue perforation by the guidewire. For example, the guidewire management system 3020 may include a strain gauge or force gauge incorporated into a slide assembly or gripping interface that may provide force feedback to a controller (e.g., one or more microprocessors). The force threshold may be programmed (at the manufacturing assembly stage and / or by the operator before or during the procedure) as a protective means to ensure that a force exceeding the determined perforation force threshold is not generated. The programmed force threshold may advantageously be lower than the determined perforation force threshold.

[0079] The guidewire management system 3020 can be used with any delivery system and is not limited to use with the delivery systems or guidewires disclosed herein. The guidewire management system 3020 can be used to hold and / or control other guidewires or delivery system components (e.g., elongate tubes or elongate solid members).

[0080] The guidewire management system 3020 can also rotate or twist the guidewire 5 or the delivery system components. For example, the user interface 3030 can include one or more rotation buttons or inputs (e.g., clockwise input and counterclockwise input). The guidewire management system 3020 can include one or more torque limit sensors that provide force feedback to the controller.

[0081] In some configurations, a voltage or other input is applied to the guidewire 5 to energize the guidewire to facilitate tissue resection, cutting, or other tissue modification and / or, optionally and / or as desired, to change the stiffness of at least a portion of the guidewire. For example, the coating or other portion of the guidewire at the proximal end of the guidewire outside the body can be energized (e.g., via a high-frequency generator) to enable cutting of the leaf tissue of the native valve cusp or to facilitate resection of tissue for treating atrial fibrillation or other cardiac arrhythmias. In some implementations, the voltage is applied to cause a phase change in at least a portion of the guidewire 5 (e.g., a guidewire at least partially formed from a material that can change shape by a phase change such as shape memory alloy or other material that can change shape by a phase change) to generate heat and cause a change in phase from a shape memory phase to a superelastic phase or other type of phase change between phases or configurations.

[0082] Figures 32-33 illustrate a delivery system 3200 for delivering an expandable implant to a body location. Examples of delivery systems are described in U.S. Patent Publication No. 2019 / 0008640, which is incorporated herein by reference. One aspect of delivery system 3200 is reduction of trauma to the heart. Trauma can occur due to excessive force on body tissue by insertion and advancement of the distal end 3212 of delivery system 3200 by nose cone assembly 3231. Thus, nose cone assembly 3231 can include a force sensor 3290. Force sensor 3290 can be a strain gauge. Force sensor 3290 can be positioned between the proximal and distal ends of the nose cone. Force sensor 3290 may be embedded within the material of the nose cone or can be attached to the inside or outside thereof.

[0083] Handle 3214 can include a tactile feedback device 3280 or other means for alerting the user of excessive force detected by force sensor 3290. Feedback device 3280 can include a vibration motor, piezoelectric, or other device. For example, handle 3214 of delivery system 3200 can vibrate when nose cone assembly 3231 detects high force (e.g., above a threshold force) or ventricular interaction when traversing the septum (mitral valve approach) in both tricuspid and mitral valve applications. Adding a strain gauge to nose cone assembly 3231 can further detect forces on the heart's anatomical structure, particularly the interaction between nose cone 3231 and the ventricles. If the force is considered to exceed a predetermined threshold (e.g., potentially causing damage to the heart or other tissue), feedback device 3280 vibrates to warn the user of the strong force (e.g., above the threshold force).

[0084] Delivery system 3200 may include an outer sheath assembly 3222 that includes an outer lumen, an outer shaft having a proximal end 3211 attached to a handle 3214, and a distal end 3212. As shown in FIG. 33, the outer sheath assembly 3222 may include an implant holding region 3216 that holds an expandable implant 3270 in a compressed configuration. A rail assembly 3220 may be positioned within the outer lumen. The rail assembly 3220 may include a rail lumen and a rail shaft having a proximal end and a distal end. The rail assembly 3220 may include one or more tension wires attached to the inner surface of the rail shaft and capable of providing an axial force on the rail shaft to orient the rail assembly 3220. An inner assembly 3218 may be positioned within the outer lumen. The inner assembly 3218 may include an inner shaft having an inner lumen, a proximal end, and a distal end. The inner assembly 3218 may include an inner holding member configured to removably attach to an expandable implant 3270. The outer sheath assembly 3222 and the inner assembly 3218 may move distally together relative to the rail assembly 3220 while the expandable implant 3270 remains in a compressed configuration. The outer sheath assembly 3222 may retract proximally relative to the inner assembly 3218 to at least partially expand the expandable implant 3270 from a compressed configuration. An intermediate shaft assembly 3221 may be within the outer lumen. The intermediate shaft assembly 3221 may include an intermediate shaft having an intermediate lumen, a proximal end, and a distal end. The intermediate shaft assembly 3221 may include an outer holding member 3242 configured to radially limit at least a portion of the expandable implant 3270. The proximal end of the nose cone assembly 3231 may be positioned within the inner lumen. The nose cone assembly 3231 may include a nose cone shaft having a guide wire lumen 3232, a proximal end and a distal end, and a nose cone on the distal end. The intermediate shaft assembly 3221 and the nose cone assembly 3231 may move distally relative to the rail assembly 3220 together with the outer sheath assembly and the inner assembly while the expandable implant 3270 remains in a compressed configuration.The intermediate shaft assembly 3221 can be retracted proximally relative to the inner assembly 3218 to at least partially expand the expandable implant from its compressed configuration.

[0085] Figures 34 - 35 show a handle 3400 for a delivery system having an electronic position control knob. The handle 3400 can be used as part of a delivery system such as the delivery system 3200 disclosed herein. The handle 3400 can include a delivery housing 3402 and a rail housing 3404. The delivery housing 3402 can be movable relative to the rail housing 3404.

[0086] The position control knob may include a rotatable actuator. The position or state of each rotatable actuator may be measured by one or more encoders. The encoder can enable accurate measurement of the movement of the lumen, the bending member, and / or the depth adjuster. The encoder may include any encoder type including magnetic, optical, inductive, capacitive, resistive, or mechanical. The handle 3400 may include or be electronically connected to a processor (not shown) configured to receive signals from each of the encoders and output the position state of each of the actuators. In some embodiments, one or more encoders may be adapted or configured to measure the movement (axial or rotational direction) of the lumen, the bending member, and / or the depth adjuster and may be mechanical encoders. Such mechanical encoders may have a detent that can indicate the rotational position corresponding to different translational or depth positions of the above-described mechanism of the handle 3400. The detent can provide a tactile and / or audible click when engaged at a particular rotational position. For example, the detent (or other physical component) can reduce the spacing as a function of the amount of rotation (e.g., progressing from an interval of 2 mm to 0.5 mm) to create the sensation of reaching the most distal bending point for each control (e.g., control knob). The user interface 3430 can display the position state of each of the rotatable actuators. The user interface 3430 may include a digital screen used during the surgery. The position state may be displayed in relation to a model of the patient's body. The user interface 3430 can provide limits on the movement of each of the control knobs. This can assist in the treatment planning based on the available movement of the delivery system. A warning can be displayed based on approaching the control knob / movement limit.

[0087] The rotatable actuator may include a sheath knob 3410, an intermediate shaft knob 3414, a distal rail flexion knob 3406, a proximal rail flexion knob 3408, and / or a depth knob 3412. The rail housing 3404 may include a distal rail flexion knob 3406. Rotation of the distal rail flexion knob 3406 can provide an axial force to a first tension wire connected to the rail through an adapter connected thereto. The distal rail flexion knob 3406 may be attached around the rail housing 3404. The distal rail flexion knob 3406 may rotate about the longitudinal axis of the rail housing 3404. A first encoder 3426 may be attached on the rail housing 3404 to measure the position of the knob 3406. The code track may be printed on the knob 3406, such as along its side surface.

[0088] The rail housing 3404 may include a proximal rail flexion knob 3408. Rotation of the knob 3408 can provide an axial force to a second tension wire connected to the rail through an adapter connected thereto. The proximal rail flexion knob 3408 may be attached around the rail housing 3404. The proximal rail flexion knob 3408 may rotate about the longitudinal axis of the rail housing 3404. A second encoder 3428 may be attached on the rail housing 3404 to measure the position of the knob 3408. The code track may be printed on the knob 3408.

[0089] The delivery housing 3402 may include a sheath knob 3410 and an intermediate shaft knob 3414. The sheath knob 3410 may have an outer sheath assembly distal to the delivery housing 3402. The intermediate shaft knob 3414 may retract proximally an intermediate shaft assembly relative to the delivery housing 3402. The sheath knob 3410 and the intermediate shaft knob 3414 may be attached around the perimeter of the delivery housing 3402 and may rotate about the longitudinal axis of the delivery housing 3402. A third encoder 3420 may be attached on the delivery housing 3402 to measure the position of the knob 3410. A code track may be printed on the knob 3410. A fourth encoder 3424 may be attached on the delivery housing 3402 to measure the position of the knob 3414. A code track may be printed on the knob 3414.

[0090] The depth knob 3412 may move the delivery housing 3402a relative to the rail housing 3404. The female threads of the depth knob 3412 may engage the male threads of the delivery housing 3402a to adjust its position along the longitudinal axis relative to the rail housing 3404. A fifth encoder 3422 may be attached on the rail housing 3404 to measure the position of the depth knob 3412 corresponding to the position of the delivery housing 3402 relative to the rail housing 3404.

[0091] FIG. 36 illustrates another embodiment of the stabilization device 3600. The stabilization device 3600 may include an electric rail system 3602. The electric rail system 3602 may be attachable on a base such as the base 1006 of the stabilization device 1000 shown in FIGS. 1A - B. The electric rail system 3602 may include a pair of rail members 3612. The rail members 3612 may extend between a first end plate 3603 and a second end plate 3604. The electric rail system 3602 may include a motor 3605. The motor 3605 may be mounted on the second end plate. The motor 3605 may include an electric motor, a servo motor, a stepper motor, or another type of motor. A threaded shaft 3606 may be coupled to the motor 3605. The threaded shaft 3606 may extend between the first and second rail members and may be supported by the first and second end plates (e.g., stored on bearings).

[0092] The electric rail system 3602 may include a support 3650. The support 3650 may be capable of receiving and / or clamping around a portion of the handle of the delivery system. The support 3650 may include any of the features and structures of the supports disclosed herein (e.g., supports 1150, 1320, 1340, 1350, 1900, 2000, 2100, 2200). The support 3650 may be operable between an open configuration and a closed configuration (e.g., locked) position to receive the handle therein. The support 3650 may be mounted on one or both of the rail members and may be slidable between the first end plate 3603 and the second end plate 3604 (e.g., along the longitudinal axis of the rail system). The support 3650 may include a threaded carriage 3655. The threaded carriage 3655 may be configurable between an engaged position engaging the threaded shaft 3606 and a disengaged position away from the threaded shaft 3606. In the disengaged position, the support 3650 may be free to slide in the first and second directions along the longitudinal axis along the rail member.

[0093] The motor 3605 can be coupled to a controller for operating the motor based on a motor control signal. The motor control signal can be generated based on an input from a user through a user interface. Operating the motor 3605 can spin the threaded shaft 3606. At the engagement position of the threaded carriage, the spin of the threaded shaft 3606 can move the support 3650 in a first or second direction along the longitudinal axis along the rail member. The support 3650 can move in individual increments. The exact position of the support 3650 can be measured by the rail system 3602. The rail system 3602 can include one or more encoders that track the position of the support 3650 based on the position of the threaded shaft 3606 and the starting position of the support 3650. The controller can be remotely controlled and / or automated.

[0094] Optionally, the electric rail system 3602 can include a second support (not shown). The second support can be a hub nest or a passive support such as the hub nests and passive supports disclosed herein. The second support can be mounted on the rail member. The second support can be coupled to and move with the support 3650. Alternatively, the second support can be movable independently of the support 3650. In one embodiment, the second support can engage a second threaded actuator. In another alternative, the second support can be configured to move independently of the support 3650 or to move with it, such as through a threaded carriage that can be configured between an engaged position and a disengaged position with respect to the threaded shaft.

[0095] Specific terms Oriental terms used in this specification such as "upper", "lower", "top", "bottom", "proximal", "distal", "longitudinal direction", "lateral direction", and "end" are used in the context of the example illustration. However, the present disclosure should not be limited to the illustrated orientation. In fact, other orientations are possible and within the scope of the present disclosure. It should be understood that terms related to circular shapes used in this specification, such as diameter or radius, do not require a complete circular structure, but rather apply to any suitable structure having a cross-sectional area that can be measured horizontally. Generally, terms related to shapes such as circular, cylindrical, semi-circular, or semi-cylindrical, or any related or similar terms, do not need to strictly conform to the mathematical definitions of circles or cylinders or other structures, but can include structures that are reasonably close approximations.

[0096] Conditional language such as "can", "would be able to", "may be", "could be", etc., generally conveys, unless specifically stated otherwise or understood otherwise within the context in which it is used, whether a particular instance includes or does not include a particular feature, member, and / or step. Thus, such conditional language is not generally intended to mean that a feature, member, and / or step is necessary in any way with respect to one or more instances.

[0097] Conjunctive language such as the expression "at least one of X, Y, and Z" is understood in context as generally used to convey that an item, term, etc. can be any of X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive language is not generally intended to mean the necessity of the presence of at least one X, at least one Y, and at least one Z in a particular instance.

[0098] As used herein, the terms "about," "approximately," and "substantially" represent an amount close to the recited amount that still performs the desired function or achieves the desired result. For example, in some embodiments, as the context indicates, the terms "about," "approximately," and "substantially" may refer to an amount that is within 10% of the recited amount. As used herein, the term "generally" represents a value, amount, or characteristic that mainly includes a particular value, amount, or characteristic or tends towards a particular value, amount, or characteristic. As an example, in a particular embodiment, as the context may indicate, the term "generally parallel" may refer to something that deviates from being strictly parallel by 20 degrees or less. All ranges include the evaluation items.

[0099] Conclusion Some exemplary examples of improvements to stabilization device systems and related delivery systems are disclosed. Although the present disclosure has been described from the perspective of specific exemplary embodiments and uses, other embodiments and other uses, including embodiments and uses that do not necessarily provide all of the features and advantages described herein, are within the scope of the present disclosure. Components, elements, features, operations, or steps can be arranged or implemented differently from those described, and components, elements, features, operations, or steps can be combined, merged, added, or omitted in various embodiments. All possible combinations and sub-combinations of the elements and components described herein are intended to be included in the present disclosure. A single feature or group of features is neither necessary nor indispensable.

[0100] Certain features that are described in the context of separate implementations in this disclosure can also be implemented in combination within a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented, in multiple implementations, individually or in any suitable sub-combination. Moreover, while features may be described as functioning in a particular combination, in some cases, one or more features from the claimed combination can be excluded from that combination, and that combination can be claimed as any sub-combination or as a variation of any sub-combination.

[0101] Any part of any step, process, structure, and / or apparatus disclosed or exemplified in an embodiment of this disclosure can be combined with, or used in conjunction with (or instead of), any other part of any step, process, structure, and / or apparatus disclosed or exemplified in a different embodiment or flowchart. The embodiments described herein are not intended to be discrete and separate from one another. Combinations, variations, and some implementations of the disclosed features are within the scope of this disclosure.

[0102] The operations may be illustrated in the drawings or described in the specification in a particular order, but such operations need not be performed in the particular order or in a sequential order shown to achieve the desired result, and not all of the operations need to be performed. Other operations not illustrated or described may be incorporated into the illustrated methods and processes. For example, one or more additional operations can be performed before any operation described, after any operation described, simultaneously with any operation described, or between any operations described. Further, the operations may be rearranged or reordered in some embodiments. Also, the separation of various components in the implementations described above should not be understood as required in all implementations, and it should be understood that the components and systems described can generally be integrated together within a single product or packaged into multiple products. Additionally, some implementations are within the scope of the present disclosure.

[0103] Furthermore, while exemplary embodiments are described, any embodiments having equivalent elements, modifications, omissions, and / or combinations are also within the scope of the present disclosure. Additionally, while certain aspects, advantages, and novel features are described herein, not all such advantages may necessarily be achieved according to any particular embodiment. For example, some embodiments within the scope of the present disclosure achieve one advantage or a group of advantages as taught herein without necessarily achieving other advantages taught or suggested herein. Further, some embodiments may achieve advantages different from those taught or suggested herein.

[0104] Several examples are described with reference to the accompanying drawings. The figures are depicted and / or shown to a certain scale, but such a scale is not limiting because dimensions and ratios other than those shown are envisioned and are also within the scope of the disclosed invention. Distances, angles, etc. are merely illustrative and do not necessarily have an exact relationship to the actual dimensions and layout of the illustrated device. Components can be added, removed, and / or reconfigured. Additionally, the disclosure herein regarding any particular feature, aspect, method, property, characteristic, quality, attribute, member, or the like associated with the various examples can be used in all other examples described herein. Additionally, any method described herein can be implemented using any device suitable for performing the described steps.

[0105] For the purpose of summarizing the present disclosure, certain aspects, advantages, and novel features of the invention are described herein. Not all advantages are necessarily achieved, or any such advantages are not necessarily achieved, in accordance with any particular embodiment of the invention disclosed herein. No aspect of the present disclosure is essential or indispensable. In many embodiments, the apparatus, system, and method may be configured differently from what is illustrated in the figures or described herein. For example, the various functions provided by the illustrated modules can be combined, rearranged, added, or deleted. In some implementations, additional or different processors or modules may perform some or all of the functions described with reference to the embodiments illustrated and described in the figures. Many implementations are possible. Any of the features, structures, steps, or processes disclosed herein can be included in any embodiment.

[0106] In summary, various examples of stabilization device systems and related delivery systems improvements and related methods are disclosed. The present disclosure extends beyond the specifically disclosed examples to other alternative examples and / or other uses of the examples, as well as to specific modifications and equivalents. Further, the present disclosure expressly contemplates that the various features and aspects of the disclosed examples can be combined with or substituted for one another. Accordingly, the scope of the present disclosure should not be limited by the specific disclosed examples described above, but should be determined only by a fair reading of the claims.

Claims

1. A general-purpose stabilization device adapted or configured for use with multiple different delivery systems, wherein the general-purpose stabilization device is A rail extending along its longitudinal direction, having a first end, a second end, an upward-facing surface, a downward-facing surface, and first and second sides extending between the first and second ends, A rail dock mounted on the upward surface of the rail, A rail dock comprising first and second channel members spaced apart to receive the first and second sides of the rail, the first and second channel members having distal ends that protrude from the downward surface of the rail and prevent the rail dock from being removed vertically from the rail, The brake assembly comprises a first configuration in which the rail dock is configured to move along the rail, and a second configuration that prevents the rail dock from moving along the rail, A general-purpose stabilization device wherein the brake assembly includes a toggle member having a first button on a first side surface of the brake assembly and a second button on a second side surface, wherein pressing the first button operates the brake assembly from the first configuration to the second configuration, and pressing the second button operates the brake assembly from the second configuration to the first configuration.

2. The stabilization device according to claim 1, further comprising a guide wire management system operably connected to the rail or a base to which the rail is attached, wherein the guide wire management system is configured to support a guide wire configured to be advanced by the delivery system.

3. The stabilization device according to claim 1, wherein the rail dock includes a first support for the handle of the delivery system.

4. The stabilization device according to claim 3, wherein the rail dock includes a carriage oriented along the longitudinal direction, and the first support is mounted on the carriage and movable along the longitudinal direction relative to the rail dock.

5. The stabilization device according to claim 4, wherein the carriage is attached to a drive screw in a screw-in manner, and the drive screw is connected to a twist knob for moving the carriage.

6. The stabilization device according to claim 3, wherein the first support comprises a fixed member and a movable member movably connected to the fixed member, and the first support is operable between an open configuration and a closed configuration.

7. The stabilization device according to claim 6, wherein the first support is operable between the open configuration and the closed configuration by rotation of the knob, and the rotation is less than approximately 180°.

8. The stabilization device according to claim 6, further comprising a lock switch, wherein the lock switch is rotatable between a locked position that holds the first support in the closed configuration and an unlocked position that allows the first support to move between the open configuration and the closed configuration.

9. The stabilization device according to claim 3, wherein the first support comprises a worm gear connected to a knob and a worm wheel connected to a handle, and the rotation of the knob controls the rotation of the handle around a longitudinal axis.

10. The stabilization device according to claim 3, wherein the first support comprises an elastic strap fixed at a first end to a first side surface of the first support, a central section extending over the handle, and a second side surface that can be fixed to a second side surface of the first support.

11. A surgical system comprising the stabilization device described in Claim 3, The stabilizing device further comprises a base configured to which the rail is attached, The delivery system comprises the handle configured to engage with the first support of the stabilizing device, A surgical system wherein the delivery system is configured to deliver a heart valve prosthesis for the replacement of an autologous heart valve.

12. A general-purpose stabilization device adapted or configured for use with multiple different delivery systems, wherein the general-purpose stabilization device is A rail extending along its longitudinal direction, having a first end, a second end, an upward-facing surface, a downward-facing surface, and first and second sides extending between the first and second ends, A rail dock mounted on the upward surface of the rail, A rail dock comprising first and second channel members spaced apart to receive the first and second sides of the rail, the first and second channel members having distal ends that protrude from the downward surface of the rail and prevent the rail dock from being removed vertically from the rail, The brake assembly comprises a first configuration in which the rail dock is configured to move along the rail, and a second configuration that prevents the rail dock from moving along the rail, A general-purpose stabilization device wherein the brake assembly includes a toggle member having at least one push button on a first side surface of the brake assembly, wherein pressing the at least one push button operates the brake assembly from the first configuration to the second configuration, and releasing the at least one button operates the brake assembly from the second configuration to the first configuration.

13. The brake assembly includes a brake member that engages with and disengages from the upward surface of the rail, The stabilization device according to claim 12, wherein the brake assembly includes a lamp connected to the toggle member, and the lamp is configured to actuate the brake member to engage and disengage with the upward surface of the rail.

14. The stabilization device according to claim 12, wherein the distal end of the channel member is closer than the width of the rail, and the rail dock is mounted on the rail by aligning the first and second channels with the first and second sides of the rail at the first end, and is fixed in place so as not to be removed in the vertical direction.

15. The rail is further connected to a second support, The stabilization device according to claim 12, wherein the second support is a hub nest configured to receive an introducer hub or sheath hub associated with a delivery system, the hub nest includes a locking post that is inserted into a receiving opening on the upward face of the rail and rotates to be removably locked in place on the rail.

16. A general-purpose stabilization device adapted or configured for use with multiple different delivery systems, wherein the general-purpose stabilization device is A rail extending along its longitudinal direction, having a first end, a second end, an upward-facing surface, a downward-facing surface, and first and second sides extending between the first and second ends, A rail dock mounted on the upward surface of the rail, A first channel member is placed on the first side surface of the rail dock, which is aligned with the first side surface of the rail, A second channel member on the second side surface of the rail dock, comprising a second channel member on a plate biased inward toward the second side surface of the rail, A general-purpose stabilization device comprising: a plate connected to the plate, which, when pressed, shifts the plate and the second channel member away from the rail, thereby enabling the rail dock to translate along the rail; and a button, when released, shifts the plate and the second channel member toward the second side of the rail, thereby preventing the rail dock from translating along the rail.

17. The stabilization device according to claim 16, wherein each of the first and second channel members includes a projection having a distal end that extends outward from the downward surface of the rail.

18. The stabilization device according to claim 16, wherein the rail dock includes a lockable support or a passive handle support.

19. Further comprising a third channel member biased to engage with either the first or second side surface of the rail, The stabilization device according to claim 16, wherein the first side surface of the rail includes a textured surface.

20. The stabilization device according to claim 16, further comprising a blocking member that is operable between a fixed position that prevents the rail dock from being removed vertically from the rail and an unfixed position that allows the rail dock to be removed vertically from the rail.

Images