Patent Application
20250114194
Certain embodiments disclosed herein relate generally to delivery systems for a prosthesis, and in some embodiments relate to a stabilizer and control systems for use with a delivery system for delivering a replacement heart valve, such as through a transseptal approach.
Human heart valves, which include the aortic, pulmonary, mitral and tricuspid valves, function essentially as one-way valves operating in synchronization with the pumping heart. The valves allow blood to flow downstream, but block blood from flowing upstream. Diseased heart valves exhibit impairments such as narrowing of the valve or regurgitation, which inhibit the valves' ability to control blood flow. Such impairments reduce the heart's blood-pumping efficiency and can be a debilitating and life-threatening condition. For example, valve insufficiency can lead to conditions such as heart hypertrophy and dilation of the ventricle. Thus, extensive efforts have been made to develop methods and apparatuses to repair or replace impaired heart valves.
Prostheses exist to correct problems associated with impaired heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace impaired native heart valves. More recently, substantial effort has been dedicated to developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient than through open heart surgery. Replacement valves are being designed to be delivered through minimally invasive procedures and even percutaneous procedures. Such replacement valves often include a tissue-based valve body that is connected to an expandable frame that is then delivered to the native valve's annulus.
Development of prostheses including but not limited to replacement heart valves that can be compacted for delivery and then controllably expanded for controlled placement has proven to be particularly challenging. An additional challenge relates to the ability of such prostheses to be secured relative to intralumenal tissue, e.g., tissue within any body lumen or cavity, in an atraumatic manner.
Delivering a prosthesis to a desired location in the human body, for example delivering a replacement heart valve to the mitral valve, can also be challenging. Obtaining access to perform procedures in the heart or in other anatomical locations may require delivery of devices percutaneously through tortuous vasculature or through open or semi-open surgical procedures. The ability to control the location of a delivery system and the deployment of the prosthesis at the desired location can also be challenging.
According to a first universal stabilizer (which may be adapted for use 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 system) of the disclosure, a rail extends along a longitudinal direction and includes a first end, a second end, an upper facing surface, a lower facing surface, and first and second sides extend between the first and second ends. A rail dock mounts on the upper facing surface of the rail. The rail dock includes first and second channel members spaced apart to receive the first and second sides of the rail therebetween. The first and second channel members include distal ends that overhang the lower facing surface of the rail and prevent removal of the rail dock from the rail in a vertical direction. 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 the rail dock is prevented from translating along the rail.
According to another aspect of the first universal stabilizer, the rail dock includes a first support for a handle of a delivery system. According to another aspect of the first universal stabilizer, the rail dock includes a carriage oriented along the longitudinal direction, the first support mounted on the carriage and movable along the longitudinal direction relative to the rail dock. According to another aspect of the first universal stabilizer, the carriage is threadingly or threadedly mounted on a travel screw, travel screw connected with a twist knob for moving the carriage. According to another aspect of the first universal stabilizer, the first support includes a fixed member (e.g., clamp portion) and a movable member (e.g., clamp portion) pivotably coupled with the fixed member. The first support is actuatable between an open configuration and closed configuration. According to another aspect of the first universal stabilizer, a screw extends through an aperture in the movable member with a threaded end received within a threaded aperture in the fixed member. A knob is disposed outside of the movable member. According to another aspect of the first universal stabilizer, the first support is actuatable between the open configuration and the closed configuration by a rotation of the knob attached with the first support. The rotation of the knob can be less than 180°, or can be about 90° (e.g., between 80° and 100°). In some implementations, the knob can be rotated 1.5 turns to transition between the open configuration and the closed configuration.
According to another aspect of the first universal stabilizer, the brake assembly includes a toggle member with 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 shifts the brake assembly from the first configuration to the second configuration; pressing the second button shifts the brake assembly from the second configuration to the first configuration. According to another aspect of the first universal stabilizer, the brake assembly includes a brake member that engages and disengages from the upper facing surface of the rail. According to another aspect of the first universal stabilizer, the brake assembly includes a ramp connected with the toggle member. The ramp actuates the brake member to engage and disengage from the upper facing surface of the rail. In some configurations, disengagement of the brake member from the upper facing surface of the rail is accomplished by a spring force built in the brake member when the ramp is toggled to disengage the brake member. The brake member may be a springless brake without springs but having a spring force as a result of a design and materials of the brake member (e.g., a molded part with flexible extensions that can deform and return to an original state, thereby acting as springs without including springs). According to another aspect of the first universal stabilizer, the distal ends of the channel members are closer together than a width of the rail and fixed in position, such that the rail dock is loaded onto the rail by alignment of the first and second channels with the first and second sides at the first end of the rail and cannot be removed in a vertical direction. According to another aspect of the first universal stabilizer, a second support is coupled with the rail. According to another aspect of the first universal stabilizer, the second support is a hub nest configured to receive an introducer hub or sheath hub associated with a delivery system, the hub nest including a locking post that inserts within a receiving aperture in the upper facing surface of the rail and rotates to removably lock into place on the rail. According to another aspect of the first universal stabilizer, second support is a hub nest configured to receive an introducer hub or sheath hub associated with a delivery system, the hub nest including a locking post that inserts within a receiving aperture in the upper facing surface of the rail and slides in the longitudinal direction to removably lock into place on the rail. The hub nest may include a first embracing member (e.g., engagement or receiving member) and a second embracing member (e.g., engagement or receiving member) spaced apart to receive the first and second sides of the rail therebetween, each of the first and second channel members including a distal end that overhangs the lower facing surface of the rail and prevents removal of the hub nest from the rail in the vertical direction. According to another aspect of the first universal stabilizer, a second rail dock is mounted on the upper facing surface of the rail. The second rail dock actuates 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.
According to another aspect of the first universal stabilizer, the first support includes a lock switch. The lock switch is rotatable between a locked position that holds the first support in the closed configuration, and an unlocked position in which the first support is allowed to move between the open and closed configurations. According to another aspect of the first universal stabilizer, the support includes an elastic strap with at first end secured to a first side of the support, a middle section extending over the handle, and a second side securable to a second side of the first support. According to another aspect of the first universal stabilizer, the support has a worm gear connected with a knob and a worm wheel connected with the handle, and rotation of the knob controls rotation of the handle about a longitudinal axis. According to another aspect of the first universal stabilizer, the rail dock includes a lockable support and the second rail dock includes a passive support.
According to a second universal stabilizer (which may be adapted for use 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 system) of the disclosure, a rail extends along a longitudinal direction with a first end, a second end, an upper facing surface, a lower facing surface, and first and second sides extending between the first and second ends. A rail dock mounted on the upper facing surface of the rail. The rail dock has a first channel member on a first side of the rail dock aligned with the first side of the rail. A second channel member is on a second side of the rail dock. The second channel member is on a plate biased inwardly towards the second side of the rail. A button couples with the plate and pressing the button shifts the plate and second channel member away from the rail to permit the rail dock to translate along the rail. Releasing the button shifts the plate and the second channel member into the second side of the rail to prevent the rail dock from translating along the rail.
According to another aspect of the second universal stabilizer, the first and second channel members each include a projection with a distal end that overhangs the lower facing surface of the rail. According to another aspect of the second universal stabilizer, the rail dock includes a lockable support or a passive handle support. According to another aspect of the second universal stabilizer, a third channel member is biased into engagement with the either the first or second sides of the rail. According to another aspect of the second universal stabilizer, the first side of the rail includes a textured surface. According to another aspect of the second universal stabilizer, the second channel member is biased into engagement with the second side of the rail by a first spring force and the third channel member is biased into engagement with the first or second side of the rail by a second spring force, less than the first spring force. According to another aspect of the second universal stabilizer, a blocking member actuates between a secured position in which the rail dock is prevented from being removed from the rail in a vertical direction and an unsecured position in which the rail dock is permitted to be removed from the rail in the vertical direction. According to another aspect of the second universal stabilizer, the blocking member is a locking pin that, in the secure position and overhangs the lower facing surface of the rail.
According to a third universal stabilizer (which may be adapted for use 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 system) of the disclosure, a rail has a first end, a second end, an upper facing surface, a lower facing surface, and first and second sides that extend between the first and second ends. A rail dock mounts on the upper facing surface of the rail. The rail dock has a first channel member along a first side of the rail dock. The first channel members includes a distal end that overhangs the lower facing surface on the first side of the rail. A second channel member is on a second side of the rail dock on a movable plate. A lever handle couples with 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 is translating along the rail and not removable therefrom in a vertical direction, and a fully unlocked configuration in which the rail dock is removable from the rail in a vertical direction.
According to another aspect of the third universal stabilizer, the lever handle includes a base having a first side with a first extension width, a second side with a second extension width, and a third side with a third extension width. In the fully locked configuration, the first side of the base positions the plate and engages the second channel member with the rail. In the semi-locked configuration, the second side of the base positions the plate with the second channel member overhanging the lower facing surface of the rail. In the fully unlocked configuration, the third side of the base positions the plate with the second channel member disengaged from the rail.
According to a fourth universal stabilizer (which may be adapted for use 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 system) of the disclosure, a rail extends along a longitudinal direction. The rail has a first end, a second end, an upper facing surface, a lower facing surface, first and second sides extending between the first and second ends. A rack on the rail extends in the longitudinal direction. A rail dock mounts on the upper facing surface of the rail. The rail dock has a pinion gear. The pinion gear is movable between a first position in which the pinion gear is engaged with the rack and a second position in which the pinion gear is not engaged with the rack. In the first position, the pinion gear is rotatable to adjust a position of the rail dock along the rail.
According to another aspect of the fourth universal stabilizer, the pinion gear is mounted on a spring loaded shaft attached with a rotation knob and depression of the knob moves the pinion gear between the first and second positions. According to another aspect of the fourth universal stabilizer, the pinion gear provides a torsional resistance to movement of the rail dock along the rail in the first position. According to another aspect of the fourth universal stabilizer, the rail dock includes first and second channel members spaced apart to receive the first and second sides of the rail therebetween. The first and second channel members include distal ends that overhang the lower facing surface of the rail and prevent removal of the rail dock from the rail in a vertical direction.
According to a surgical catheter system of the disclosure, a 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 system. A handle assembly attaches with the proximal end of the shaft assembly. A lumen extends from the distal end of the shaft assembly to a proximal end of the handle. A stabilizer system for the delivery system, has a base and a handle support mounted on the base. The handle assembly is received within the handle support. A guidewire is disposed within the lumen. A proximal section of the guidewire extending proximally from the handle assembly. A guidewire management system for controlling movement of the guidewire relative to the handle assembly has an actuator to advance and retract along an axis aligned with the lumen. An engagement clamp releasably secures the guidewire relative to the actuator. The proximal section of the guidewire is received within the engagement clamp. A support for the actuator couples with the base. A user interface receives a user input. A controller moves the actuator to selectably advance and retract the guidewire along the axis based on the user input.
A guidewire management system of the disclosure includes a guidewire. An engagement clamp releasably secures about the guidewire. An actuator advances and retracts the engagement clamp along an axis. A support attached with the actuator. A user interface generates a user input signal. A controller moves the actuator to selectably advance and retract the guidewire along the axis based on the user input signal.
According to another aspect of the disclosure, the guidewire management system includes a stabilizer system for supporting a handle assembly of the delivery system on a base. The support couples with the base and extends proximally relative to a distal end of the stabilizer system. According to another aspect of the guidewire management system, the axis is aligned with a lumen of the handle assembly of the delivery system, the guidewire disposed within the lumen. According to another aspect of the guidewire management system, the engagement clamp is actuatable 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 actuates the engagement clamp between the locked and unlocked configurations based on the user input signal. According to another aspect of the guidewire management system, the engagement clamp is manually actuatable. According to another aspect of the guidewire management system, the engagement clamp includes a passive fixing groove for securing the guidewire. According to another aspect of the guidewire management system, the user interface includes an advance button and a retract button. According to another aspect of the guidewire management system, the user interface includes a coarse advance button, coarse retract button, a fine advance button, and a fine retract button. According to another aspect of the guidewire management system, the actuator includes a servo controller that measures a position of the guidewire along the axis relative to an initial position, the servo controller provides positional feedback to the controller. According to another aspect of the guidewire management system, a load sensor that measures a force applied to the guidewire by the actuator, the load sensor provides force feedback to the controller. According to another aspect of the guidewire management system, a wireless interface transmits the user input signal from the user interface to the controller mounted on the support. According to another aspect of the guidewire management system, the controller generates a motor control signal based on the user input signal, and the actuator receives the motor control signal and to advance or retract the guidewire along the axis based on the motor control signal. According to another aspect of the guidewire management system, the motor control signal is further based on a position of the guidewire or a force exerted on the guidewire by the actuator.
According to a delivery system for delivering an expandable implant to a body location of the disclosure, an outer sheath assembly has an outer shaft with an outer lumen and a proximal end and a distal end. The outer sheath assembly has an implant retention area to retain the expandable implant in a compressed configuration. A rail assembly is located within the outer lumen, the rail assembly has a rail shaft having a rail lumen and a proximal end and a distal end. The rail assembly has one or more pull wires attached on an inner surface of the rail shaft that provide an axial force on the rail shaft to steer the rail assembly. An inner assembly located 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 retention member that is releasably 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 the compressed configuration. The outer sheath assembly retracts proximally relative to the inner assembly in order to at least partially expand the expandable implant from the compressed configuration. A mid shaft assembly within the outer lumen has a mid shaft having a middle lumen and a proximal end and a distal end. The mid shaft assembly has an outer retention member to radially restrain at least a portion of the expandable implant. A nose cone assembly located within the inner lumen, 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 mid shaft assembly and the nose cone assembly move together distally with the outer sheath assembly and the inner assembly relative to the rail assembly while the expandable implant remains in the compressed configuration. The mid shaft assembly retracts proximally relative to the inner assembly in order to at least partially expand the expandable implant from the compressed configuration. The nose cone assembly includes a force sensor. A handle has a haptic feedback system coupled with the force sensor and alerts a user if forces in excess of a predetermined threshold are detected.
According to a handle for a delivery system of the disclosure, a rail housing has a first rotatable actuator coupled with a first pull wire and provides an axial force on the first pull wire. A first encoder measures a position of the first rotatable actuator. A second rotatable actuator has a second pull wire and to provide an axial force on the second pull wire. A second encoder measures a position of the second rotatable actuator. A delivery housing has a third rotatably actuator coupled with an outer sheath assembly that move the outer sheath assembly distally relative to the delivery housing. A third encoder measures a position of the third rotatable actuator. A fourth rotatable actuator couples with a mid shaft assembly and retracts proximally the mid shaft assembly relative to the delivery housing. A fourth encoder measures a position of the fourth rotatable actuator. A fifth rotatable actuator moves the delivery housing relative to the rail housing. A fifth encoder measures a 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 system.
According to another aspect, the handle includes a processor to receive a signal from each of the first, second, third, fourth, and fifth encoders and output a positional status of each of the first, second, third, fourth, and fifth rotatable actuators. According to another aspect, the handle has or is connected with a user interface to display the positional status of each of the first, second, third, fourth, and fifth rotatable actuators. One or more of the encoders may be mechanical encoders with detents or other clicking features to measure rotational position and provide haptic and/or audible feedback.
According to another aspect, a universal stabilizer includes a motorized rail system. A support is mounted on the motorized rail system. The support receives a handle of a delivery system. A control system moves the support between first and second ends of the motorized rail system. According to another aspect, a 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 motorized rail system includes a threaded shaft coupled with a motor and the support is mounted on a threaded carriage engaged with the threaded shaft.
In accordance with one aspect, a universal stabilizer adapted or configured for use with multiple different delivery systems (which may include, for example, 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 stabilizer includes a rail extending along a longitudinal direction and having a first end, a second end, an upper facing surface, a lower facing surface, and first and second sides extending between the first and second ends; and a rail dock mounted on the upper facing surface of the rail. The rail dock includes first and second channel members spaced apart to receive the first and second sides of the rail therebetween, the first and second channel members including distal ends that overhang the lower facing surface of the rail and prevent removal of the rail dock from the rail in a vertical direction. The rail dock further includes a brake assembly configured to be actuated 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 with at least one push button configured to cause the brake assembly to transition between the first configuration and the second configuration.
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, wherein pressing the first button actuates (e.g., shifts, transitions) the brake assembly from the first configuration to the second configuration and pressing the second button actuates the brake assembly from the second configuration to the first configuration.
In some configurations, the stabilizer is configured to operate in conjunction with a guidewire management system. The stabilizer may be operably coupled to the rail or a base to which the rail is attached, wherein the guidewire management system is configured to support a guidewire over which a delivery system is configured to be advanced. The guidewire management system may be configured to cause movement of the guidewire (e.g., advancement, retraction, and or rotation) with respect to the delivery system.
A surgical system may include any of the stabilizers disclosed herein in combination with any one or more of the delivery systems disclosed herein and/or any of the guidewire management systems disclosed herein. For example, the surgical system may include a base or platform to which the rail of the stabilizer is configured to be attached. The delivery system may include a handle with which a support of the stabilizer is configured to be engaged. The delivery system may be configured to deliver a prosthetic heart valve to replace a native heart valve (e.g., a mitral valve, aortic valve, pulmonary valve or tricuspid valve).
The foregoing summary is illustrative only and is not intended to be limiting. Other aspects, features, and advantages of the systems, devices, and methods and/or other subject matter described in this application will become apparent in the teachings set forth below. The summary is provided to introduce a selection of some of the concepts of this disclosure. The summary is not intended to identify key or essential features of any subject matter described herein.
Various examples are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the examples. Various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure.
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 examples illustrated in the figures. These examples are intended to illustrate the principles of this disclosure, and this disclosure should not be limited to merely the illustrated examples. The features of the illustrated examples can be modified, combined, removed, and/or substituted as will be apparent to those of ordinary skill in the art upon consideration of the principles disclosed herein.
The present specification and drawings provide aspects and features of the disclosure in the context of several embodiments of replacement heart valves, delivery systems and methods. The disclosed delivery systems are configured for use in the vasculature of a patient, such as for replacement of natural heart valves in a patient. These embodiments may be discussed in connection with replacing specific valves such as the patient's aortic, tricuspid, pulmonary, or mitral valve. However, it is to be understood that the features and concepts discussed herein can be applied to products other than heart valve implants. For example, the controlled positioning, deployment, and securing features described herein can be applied to medical implants, for example other types of expandable prostheses, for use elsewhere in the body, such as within an artery, a vein, or other body cavities or locations. In addition, particular features of a valve, delivery system, etc. should not be taken as limiting, and features of any one embodiment discussed herein can be combined with features of other embodiments as desired and when appropriate. While certain of the embodiments described herein are described in connection with a transfemoral (or transseptal) delivery approach, it should be understood that these embodiments can be used for other delivery approaches, such as, for example, transapical or transjugular approaches. Moreover, it should be understood that certain of the features described in connection with some embodiments can be incorporated with other embodiments, including those which are described in connection with different delivery approaches.
Embodiments of stabilizers 1000, shown in
Generally, the stabilizer 1000 can be used to hold a delivery system 2 in place, for example, above a patient's leg or on an operating table, though the particular position is not limiting. The stabilizer 1000 enables the delivery system 2 to remain stable during the procedure. In some embodiments, the stabilizer 1000 can be used to torque (rotate), advance, and/or retract components (independently or simultaneously) of the delivery system 2 in a controlled manner. Examples of delivery systems 2 that may be held with the stabilizer 1 are described in detail in U.S. Pat. Pub. No. 2019/0008640, the entirety of which is hereby incorporated by reference. Examples of other stabilizers are disclosed in U.S. Pat. Pub. No. 2020/0108225, the entirety of which is hereby incorporated by reference. The disclosed stabilizer 1000 can be advantageous for a transseptal (e.g., transfemoral) approach for delivering a replacement heart valve by allowing for fine motor control of a delivery system within the stabilizer. However, the embodiments of the stabilizers disclosed herein can be used for other approaches and other procedures as well, such as transapical approaches, and are not limited to replacement heart valves. The stabilizers 1000 may be universal in that they can be coupled to, or used with, any of a variety of different delivery systems (e.g., delivery systems for delivering replacement aortic valves, systems for delivering replacement mitral valves, systems for delivering replacement tricuspid valves, systems for delivering replacement pulmonary valves, or other delivery systems.
As shown in
In some embodiments, the stabilizer 1000 can be a universal stabilizer system. This system can be easily adaptable for different sized bases and delivery systems. The stabilizer can utilize the universally attachable rail 1002, which may allow more flexibility and adaptability. The rail 1002 can include a distal end and a proximal end. In general, the proximal end is toward the user of the stabilizer 1000 (e.g., a clinician or healthcare professional) and/or the delivery system 2 that is coupled to the stabilizer 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 attached directly to the base 1006, such as at the upper surface. The rail 1002 can be attached by clamps with the base 1006. The rail 1002 can include a moveable clamp 1003b (operable by a knob 1004) and a stationary clamp 1003a spaced longitudinally apart. In some embodiments, both clamps may be moveable. As discussed in detail below, the moveable clamp can be locked at a desired position on the rail, thus allowing the rail to be attached to different sized surfaces. The rail and the clamps can both be reusable and sterilizable and can be used for multiple different types of delivery or repair systems (e.g., replacement heart valve delivery systems or heart valve repair systems). In accordance with several implementations, a single knob 1004 (e.g., one and only one knob) may be used for clamping and unclamping the rail 1002 to the base 1006.
The stabilizer 1000 can further include a rail dock 1100 and a hub nest 1020, both coupled with the rail 1002. The rail dock 1100 can include a support 1150, a carriage assembly 1170, and/or a braking system 1160. In some embodiments, multiple rail docks may be used along the rail 1002. In some embodiments, the rail dock 1100 can have an adjustable upper surface for adjusting angles. The rail dock 1100 can be mountable on an upper surface of the rail 1002 and moveable along the longitudinal direction. The rail dock 1100 can be locked in place along the rail 1002 by the braking system 1160. As shown in
The rail dock 1100 can further include the brake system 1160. The brake system 1160 can include a toggle member 1161, as shown in
The toggle 1161 can include a ramp 1163. The ramp 1163 can be engaged or disengaged with a brake member 1164. The brake member 1164 can be actuated downwardly by the ramp 1163 and engage with the upper surface of the rail 1002, as indicated by the vertical arrow 1158 in
Another embodiment of a brake member 1164a is shown in
With reference back to
The support 1150 can include a nut 1154 and a shaft 1155 connected with a knob 1156. The nut 1154 can be disposed within the fixed member 1151. The shaft 1155 can be disposed within the movable member 1152. A threaded end of the shaft 1155 can be engaged with threads of the nut 1154 such that rotation of the knob 1156 can actuate the movable member 1152 between open and closed configurations. The threads on the shaft 1155 can provide for quickly actuating the movable member 1152 between the open and closed configurations. For example, the threads can facilitate opening/closing with rotation of the knob 1156 that is 180° (half turn) or less, or 90° (quarter turn) or less. In some implementations, the knob 1156 can be tightened past a locking point. Tightening the knob 1156 past the locking point can secure the members 1151, 1152 together in the closed configuration with greater force against inadvertent opening. In another example, the knob 1156 can be completely turned (360°) to arrive in the closed configuration.
The carriage assembly 1170 can include the housing 1172. The housing 1172 can enclose a travel screw or carriage shaft 1173. The carriage shaft 1173 can be mounted horizontally or at an angle and be rotatably about its axis by a knob 1174. The carriage 1171 (and the fixed member 1151) can be threadingly or threadedly mounted on the carriage shaft 1173 and translatable along the length of the carriage shaft by rotation of the knob 1174. Optionally, the carriage shaft 1173 can be lockable at intervals with one or a pair of opposing spring detent mechanism 1175 that can engage corresponding faces or concavities on the carriage shaft 1173. In some implementations, rotation of the knob 1174, and thus travel screw or carriage shaft 1173 controls fine movement of the rail dock 1100.
As shown in
A horizontal portion 1023 of the hub nest 1020 can attach to an upward facing surface of the rail 1002. The horizontal portion 1023 can include a locking protrusion 1024 (
Another embodiment of the hub nest 1020 is shown in
The hub nest 1020 further comprises a locking mechanism 1029 (e.g., a slide-to-lock mechanism). When the locking mechanism 1029 is pressed downward, the protrusion 1031 can be levered up. This leverage effect is provided because the locking mechanism 1029 is pivotally coupled to the surrounding structure of the horizontal portion 1023. The leverage action allows the hub nest 1020 to further slide longitudinally toward the proximal end of the rail 1002, until the protrusion 1031 drops into the locking aperture 1002a in the rail 1002. As such, the hub nest 1020 is locked in place.
The locking mechanism 1029 may be injection molded in one piece with the hub nest 1020 when they are made of resilient plastic material. The coupling of the locking mechanism to the hub nest 1020 may result from thin connections between the locking mechanism 1029 and the surrounding structure of the horizontal portion 1023 formed about the locking mechanism 1029. The aperture 1002a may have a shape formed to fit the protrusion 1031. There may be more than one locking aperture 1002a in the rail 1002 to position the hub nest 1020 in different locations.
As shown in
As shown in
As shown in
The support 1900 can include a rotatable lock 1903 that is rotatable about an axis. The axis can be transverse to a pivot axis of the movable member 1902. The rotatable lock 1903 can include an extension portion 1904. The rotatable lock 1903 can be actuatable between an unlocked position (
The various embodiments of the supports of the various stabilizers disclosed above are configured to hold the delivery system 2 stably during a medical procedure. For example, in
As shown in the figures, the lever lock 2304 can include a handle rotatably connected to one side of the rail dock 2300 and attached, such as by a spring or pair of springs and/or a shaft 2318 or other attachment member to the movable plate 2310 on an opposite side of the rail dock 2300. The handle can fit within a cutout on a side of the rail dock 2300 in some embodiments. The lever lock 2304 can be rotated between a locked configuration (
As shown in the figures, the lever lock 2404 can include a handle rotatably connected to one side of the rail dock 2400 and attached, such as by a spring or pair of springs and/or a shaft 2418 or other attachment member to the movable plate 2410 on an opposite side of the rail dock 2400. The handle can fit within a cutout on a side of the rail dock 2400 in some embodiments. The lever lock 2404 can be rotated and flipped between a locked configuration (
A rack 2608 comprising gear teeth can extend along a longitudinal direction between first and second ends of the rail 2602. The rack 2608 can be centered and/or on an upper surface of the rail 2602. The stabilizer 2600 can include a rail dock 2650. The rail dock 2650 can provide a base for a support for a delivery system. The rail dock 2650 can include opposing projections 2658 that overhang opposite sides of the rail 2602. The rail dock 2650 can be mountable on the rail 2602 at the first or second ends thereof. The rail dock 2650 can include a knob 2651 attached with a shaft 2652 and biased by a spring 2653. A pinion gear 2654 can be mounted on the shaft 2652. The pinion gear 2654 can be movable into and out of engagement with the rack 2608 based on a position of the shaft 2652 and knob 2651. As shown in
When the pinion gear 2654 is engaged with the rack 2608, rotation of the knob 2651 can cause translation of the rail dock 2650 along the longitudinal direction relative to the rail 2602 (e.g., fine position adjustment). Torsional resistance in the rotation of the knob 2651 and/or shaft 2652 can prevent unintended back driving of the rail dock 2650. When the pinion gear 2654 is disengaged with 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 relative to the rail 2602 (e.g., gross position adjustment).
The delivery system 2 can include a shaft assembly with a proximal end and a distal end. As with the stabilizer 1000, the proximal end of the shaft assembly is toward the operator (e.g., clinician or healthcare professional), and the distal end is away from the operator. The proximal end of the shaft assembly attached with the handle 1. A distal portion of the shaft assembly can be inserted within a patient's body over the guidewire 5. A lumen can extend from the distal end of the shaft assembly to a proximal end of the handle. The guidewire 5 can be received within the lumen. A proximal section of the guidewire 5 can extend proximally from the handle 1. The guidewire can comprise a metal material or other suitable material. In one example, the guidewire 5 can include a solid core with a braided metal sheath.
In a conventional delivery system, one physician or other healthcare professional generally controls the delivery system 2 and a second physician or other healthcare professional controls the position of the guidewire 5 (e.g., by grasping 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 an operation. For example, the guidewire 5 can be retracted to aid in crossover of a septum or turning 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 advancing, retracting or holding a static position of the guidewire 5 is done manually using current systems by the second physician or healthcare professional. Aspects of the present disclosure relate to an improved system that can function as a “third hand” to advantageously allow a single physician to position the guidewire 5 during an operation.
As shown in
The guidewire management system 3020 can include a support 3026. The support 3026 can be coupled with the base 3006 or rail 3002. The support 3026 can be adjustable to align the guidewire 5 with the lumen of the handle 1. The support 3026 can include an actuatable joint 3027 for positioning the actuator 3022 and/or the guidewire 5.
In another embodiment, the actuator 3022 can include a linear actuator, electric motor, servo motor, or other mechanism for advancing and retracting. The actuator 3022 can include a servo controller that measures a position of the guidewire 5 along the axis relative to an initial position. The servo controller can provide positional feedback to a controller. The actuator 3022 can include a force sensor that measures a force applied to the guidewire 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.
The actuator 3022 can include an engagement clamp 3024 or otherwise function to clamp onto the guidewire 5. The engagement clamp 3024 can releasably secure with the guidewire 5. The engagement clamp 3024 can be actuatable between a locked configuration and an unlocked configuration. The engagement clamp 3024 can be manually or automatically actuatable. The engagement clamp 3024 can include a passive fixing groove, pinching members or wheels, or other mechanism for securing the guidewire 5 thereto.
The guidewire management system 3020 can include a user interface 3030 (
The user interface 3030 can include fine and/or coarse controls for movement of the guidewire 5. The user interface can include a fine advance button V (ventricular direction), a fine retract button A (atrial direction), a coarse advance button a, and/or a coarse retract button v. The user interface can include a lock button 3031 and/or an unlock button 3032 for actuating the engagement clamp 3024 between the locked and unlocked configurations based on the user input signal. The guidewire management system 3020 can include a wireless (e.g., BLUETOOTH) communication system configured to transmit the user input signal from the user interface 3030 to the controller mounted on the support. The buttons may be substituted with other actuators (e.g., switches, levers, toggles, slides, etc.).
In some configurations, the guidewire management system 3020 can 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 grip interface that could provide a force feedback to the controller (e.g., one or more microprocessors). A force threshold may be programmed (in a manufacturing assembly stage and/or by an operator before or during a procedure) as a safeguard to ensure that forces are not generated that exceed a determined perforation force threshold. The programmed force threshold may advantageously be lower than the determined perforation force threshold.
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).
The guidewire management system 3020 may also be capable of rotating or twisting the guidewire 5 or delivery system component. For example, the user interface 3030 may include one or more rotation buttons or inputs (e.g., clockwise input and counter-clockwise input). The guidewire management system 3020 may include one or more torque-limiting sensors that provide force feedback to the controller.
In some configurations, voltage or other input may be applied to the guidewire 5 to cause the guidewire to energize the guidewire to facilitate tissue ablation, cutting or other tissue modification and/or to change stiffness of at least a portion of the guidewire, as desired and/or required. For example, a coating or other portion of the guidewire at a proximal end of the guidewire outside the body may be energized (e.g., via a radiofrequency generator) so as to allow cutting of native valve leaflet tissue or to facilitate ablation of tissue to treat atrial fibrillation or other heart rhythm abnormalities. In some implementations, voltage may be applied to cause a phase change of at least a portion of the guidewire 5 (e.g., a guidewire formed at least partially of phase change nitinol or other material capable of changing shape due to phase changes) so as to generate heat to cause a change in a phase from shape memory phase to a superelastic phase or between other types of phases or configurations.
The handle 3214 can include a haptic feedback device 3280 or other means for alarming a user of excessive forces detected by the force sensor 3290. The feedback device 3280 can include a vibrating motor, piezoelectric or other device. For example, the handle 3214 of the delivery system 3200 can vibrate if the nose cone assembly 3231 detects high forces (e.g., above a threshold force) when crossing the septum (mitral valve approach) or ventricular interactions in both tricuspid and mitral applications. Adding a strain gauge to the nose cone assembly 3231 can further detect forces on heart anatomy, especially interactions between the nose cone 3231 and ventricle. If forces are considered in excess of a predetermined threshold (e.g., may cause damage to heart or other tissue) the feedback device 3280 will vibrate a warning of the high forces (e.g., above a threshold force) to the user.
The delivery system 3200 can include an outer sheath assembly 3222 including an outer shaft having an outer lumen and a proximal end 3211 attached with the handle 3214 and a distal end 3212. As shown in
The positional control knobs can include rotatable actuators. The position or status of each the rotatable actuators can be measured with one or more encoders. The encoders can allow for accurate measurement of travel for the lumens, flex members, and/or depth adjusters. The encoders can include any encoder type including magnetic, optical, inductive, capacitive, resistive, or mechanical. The handle 3400 can include or be electronically connected with a processor (not shown) configured to receive a signal from each of the encoders and output a positional status of each of the actuators. In some embodiments, the one or more encoders are adapted or configured for measuring the travel (axial or rotational) of lumens, flex members, and/or depth adjusters and can be mechanical encoders. Such mechanical encoders can have detents that can indicate rotational positions corresponding to different translational or depth positions of the above-mentioned mechanisms of the handle 3400. The detents may provide tactile and/or audible clicks when engaged at specific rotational positions. For example, the detents (or other physical components) can reduce in spacing as a function of an amount of rotation (e.g., progressing from 2 mm to 0.5 mm spacings) so as to create a sensation of reaching a point of furthest flex for each control (e.g., control knob). A user interface 3430 can display the positional status of each of the rotatable actuators. The user interface 3430 can include a digital screen used during surgery. The positional status can be displayed in relation to a model of a patient's body. The user interface 3430 can provide the limits of the movements of each of the control knobs. This can assist in planning of a procedure based on the available movement of the delivery system. A warning can also be displayed based on nearing control knob/movement limits.
The rotatable actuators can include a sheath knob 3410, a mid shaft knob 3414, a distal rail flex knob 3406, a proximal rail flex knob 3408, and/or a depth knob 3412. The rail housing 3404 can include the distal rail flex knob 3406. The rotation of the distal rail flex knob 3406 can provide an axial force on a first pull wire connected with a rail through an adapter connected thereto. The distal rail flex knob 3406 can be mounted about a circumference of the rail housing 3404. The distal rail flex knob 3406 can rotate about a longitudinal axis of the rail housing 3404. A first encoder 3426 can be mounted on the rail housing 3404 to measure a position of the knob 3406. A code track can be printed on the knob 3406, such as along a side thereof.
The rail housing 3404 can include the proximal rail flex knob 3408. The rotation of the knob 3408 can provide an axial force on a second pull wire connected with a rail through an adapter connected thereto. The proximal rail flex knob 3408 can be mounted about a circumference of the rail housing 3404. The proximal rail flex knob 3408 can rotate about a longitudinal axis of the rail housing 3404. A second encoder 3428 can be mounted on the rail housing 3404 to measure a position of the knob 3408. A code track can be printed on the knob 3408.
The delivery housing 3402 can include the sheath knob 3410 and the mid shaft knob 3414. The sheath knob 3410 can have an outer sheath assembly distally relative to the delivery housing 3402. The mid shaft knob 3414 can retract proximally a mid shaft assembly relative to the delivery housing 3402. The sheath knob 3410 and the mid shaft knob 3414 can be mounted about a circumference of the delivery housing 3402 and rotate about a longitudinal axis of the delivery housing 3402. A third encoder 3420 can be mounted on the delivery housing 3402 to measure a position of the knob 3410. A code track can be printed on the knob 3410. A fourth encoder 3424 can be mounted on the delivery housing 3402 to measure a position of the knob 3414. A code track can be printed on the knob 3414.
The depth knob 3412 can move the delivery housing 3402a relative to the rail housing 3404. An internal thread of the depth knob 3412 can engage with external threads of the delivery housing 3402a to adjust a position thereof along the longitudinal axis relative to the rail housing 3404. A fifth encoder 3422 can be mounted on the rail housing 3404 and measure a position of the depth knob 3412, which corresponds to a position of the delivery housing 3402 relative to the rail housing 3404.
The motorized rail system 3602 can include a support 3650. The support 3650 can receive and/or clamp about a portion of a handle of a delivery system. The support 3650 can 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 can be operable between an open configuration and a closed configuration (e.g., locked) position for receiving the handle therein. The support 3650 can be mounted on one or both of the rail members and slidable between the first and second end plates 3603 and 3604 (e.g., along a longitudinal axis of the rail system). The support 3650 can include a threaded carriage 3655. The threaded carriage 3655 can be configurable between an engaged position that is engaged with the threaded shaft 3606 and a disengaged position away from the threaded shaft 3606. In the disengaged position, the support 3650 can be freely slid along the rail members in first and second directions along the longitudinal axis.
The motor 3605 can be coupled with a controller for actuating 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. Actuating the motor 3605 can spin the threaded shaft 3606. In the engaged position of the threaded carriage, the spinning of the threaded shaft 3606 can move the support 3650 along the rail members in the first or second directions along the longitudinal axis. The support 3650 can be moved in discrete increments. A precise location of the support 3650 can be measured by the rail system 3602. The rail system 3602 can include one or more encoders that track a position of the support 3650 based on a position of the threaded shaft 3606 and a starting position of the support 3650. The controller can be remotely controlled and/or automatically controlled.
Optionally, the motorized rail system 3602 can include a second support (not shown). The second support can be a hub nest or passive support, such as the hub nests and passive support disclosed above herein. The second support can be mounted on the rail members. The second support can be coupled with the support 3650 and move therewith. Alternatively, the second support can be movable independently from the support 3650. In one example, the second support can be engaged with a second threaded actuator. In another alternative, the second support can be configured to move independently from the support 3650 or moved therewith, such as through a threaded carriage that is configurable between an engaged position and a disengaged position relative to the threaded shaft.
Terms of orientation used herein, such as “upper,” “lower,” “top,” “bottom,” “proximal,” “distal,” “longitudinal,” “lateral,” and “end,” are used in the context of the illustrated example. However, the present disclosure should not be limited to the illustrated orientation. Indeed, other orientations are possible and are within the scope of this disclosure. Terms relating to circular shapes as used herein, such as diameter or radius, should be understood not to require perfect circular structures, but rather should be applied to any suitable structure with a cross-sectional region that can be measured from side-to-side. Terms relating to shapes generally, such as “circular,” “cylindrical,” “semi-circular,” or “semi-cylindrical” or any related or similar terms, are not required to conform strictly to the mathematical definitions of circles or cylinders or other structures, but can encompass structures that are reasonably close approximations.
Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain examples include or do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more examples.
Conjunctive language, such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require the presence of at least one of X, at least one of Y, and at least one of Z.
The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, in some examples, as the context may dictate, the terms “approximately,” “about,” and “substantially,” may refer to an amount that is within less than or equal to 10% of the stated amount. The term “generally” as used herein represents a value, amount, or characteristic that predominantly includes or tends toward a particular value, amount, or characteristic. As an example, in certain examples, as the context may dictate, the term “generally parallel” can refer to something that departs from exactly parallel by less than or equal to 20 degrees. All ranges are inclusive of endpoints.
Several illustrative examples of stabilizer systems and related delivery system improvements have been disclosed. Although this disclosure has been described in terms of certain illustrative examples and uses, other examples and other uses, including examples and uses which do not provide all of the features and advantages set forth herein, are also within the scope of this disclosure. Components, elements, features, acts, or steps can be arranged or performed differently than described and components, elements, features, acts, or steps can be combined, merged, added, or left out in various examples. All possible combinations and sub-combinations of elements and components described herein are intended to be included in this disclosure. No single feature or group of features is necessary or indispensable.
Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation also can be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can in some cases be excised from the combination, and the combination may be claimed as a subcombination or variation of a subcombination.
Any portion of any of the steps, processes, structures, and/or devices disclosed or illustrated in one example in this disclosure can be combined or used with (or instead of) any other portion of any of the steps, processes, structures, and/or devices disclosed or illustrated in a different example or flowchart. The examples described herein are not intended to be discrete and separate from each other. Combinations, variations, and some implementations of the disclosed features are within the scope of this disclosure.
While operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Additionally, the operations may be rearranged or reordered in some implementations. Also, the separation of various components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. Additionally, some implementations are within the scope of this disclosure.
Further, while illustrative examples have been described, any examples having equivalent elements, modifications, omissions, and/or combinations are also within the scope of this disclosure. Moreover, although certain aspects, advantages, and novel features are described herein, not necessarily all such advantages may be achieved in accordance with any particular example. For example, some examples within the scope of this disclosure achieve one advantage, or a group of advantages, as taught herein without necessarily achieving other advantages taught or suggested herein. Further, some examples may achieve different advantages than those taught or suggested herein.
Some examples have been described in connection with the accompanying drawings. The figures are drawn and/or shown to scale, but such scale should not be limiting, since dimensions and proportions other than what are shown are contemplated and are within the scope of the disclosed invention. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various examples can be used in all other examples set forth herein. Additionally, any methods described herein may be practiced using any device suitable for performing the recited steps.
For purposes of summarizing the disclosure, certain aspects, advantages and features of the inventions have been described herein. Not all, or any such advantages are necessarily achieved in accordance with any particular example of the inventions disclosed herein. No aspects of this disclosure are essential or indispensable. In many examples, the devices, systems, and methods may be configured differently than illustrated in the figures or description herein. For example, various functionalities 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 functionalities described with reference to the examples described and illustrated in the figures. Many implementation variations are possible. Any of the features, structures, steps, or processes disclosed in this specification can be included in any example.
In summary, various examples of stabilizer systems and related delivery system improvements and related methods have been disclosed. This disclosure extends beyond the specifically disclosed examples to other alternative examples and/or other uses of the examples, as well as to certain modifications and equivalents thereof. Moreover, this disclosure expressly contemplates that various features and aspects of the disclosed examples can be combined with, or substituted for, one another. Accordingly, the scope of this disclosure should not be limited by the particular disclosed examples described above, but should be determined only by a fair reading of the claims.
This application is a continuation of International Application No. PCT/US2023/024350 filed Jun. 2, 2023, which claims the benefit of U.S. Provisional Application No. 63/352,527 filed Jun. 15, 2022, the entire content of which is hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63352527 | Jun 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/024350 | Jun 2023 | WO |
| Child | 18981330 | US |
