Stabilizing clamp device for use with implant delivery devices

Abstract

Devices, systems, and methods are disclosed for stabilizing a delivery device and / or a guide catheter device during the delivery and implantation of an artificial implant. Each of the delivery device and the guide catheter device may include a handle and a shaft (delivery shaft or guide catheter shaft) extending distally from the handle. The distal cap portion of each handle may be coupled to a stabilization clamp of a stabilization system to maintain the axial position of the handle relative to each other. The stabilization clamp is configured to allow rotation of the distal cap within it so that torque applied to the handle is transmitted to each shaft. The jaw portions of the stabilization clamp may be configured to balance or equalize the torque resistance to the rotation of the handle in a first (e.g., clockwise) direction with respect to a second opposite (e.g., counterclockwise) direction.

Description

Technical Field

[0004] ,

[0003] , , ,

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 490,143, filed on March 14, 2023, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure relates to a delivery device for artificial medical devices and a stabilization device for use with the delivery device.

Background Art

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can cause serious heart dysfunction and may ultimately require repair of the original valve or replacement of the original valve with an artificial valve. Many repair devices (e.g., stents) and artificial valves are known, and many methods for implanting those devices and valves into the human body are also known. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver artificial medical devices to locations inside the human body that are not easily accessible surgically or where access without surgery is desirable. In one particular example, an artificial heart valve can be attached in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery or femoral vein) until the artificial valve reaches the implantation site within the heart. The artificial valve is then expanded to its functional size, for example, by inflating a balloon to which the artificial valve is attached, or by actuating a mechanical actuator that applies an expanding force to the artificial valve, or by deploying the artificial valve from the sheath of the delivery device such that the artificial valve can self - expand to its functional size.

[0004] A guide catheter (also called a guide sheath) may be used to introduce a delivery device, such as the artificial heart valve delivery device described above, into the patient's vascular structure. The guide catheter may include an extended shaft inserted into the vascular structure and a handle that remains outside the patient and can be used to manipulate the shaft. The delivery device may be pushed through the main lumen of the guide catheter to help navigate the delivery device to the target implantation site within the patient. The delivery device may also include a handle that remains outside the patient and can be used to manipulate the delivery device. The guide catheter and delivery device may be controlled via the rotation of their respective handles and / or the operation of one or more actuators or knobs on each handle. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] International Publication No. 2020 / 247907 [Patent Document 2] U.S. Patent No. 9339384 [Patent Document 3] U.S. Provisional Patent Application No. 63 / 268322 [Patent Document 4] International application PCT / US2020 / 036577 [Patent Document 5] U.S. Patent Publication No. 2018 / 0318079 [Patent Document 6] U.S. Patent Publication No. 2018 / 0263764 [Patent Document 7] U.S. Provisional Patent Application No. 63 / 363162 [Patent Document 8] International application No. PCT / US2021 / 056150 [Patent Document 9] U.S. Patent Application Publication No. 2017 / 0231756 [Patent Document 10] U.S. Patent Application Publication No. 2019 / 0000615 [Patent Document 11] U.S. Patent No. 11185406 [Overview of the project]

[0006] Described herein are artificial heart valves, docking devices, delivery devices, guide catheter devices, implant delivery systems, and methods for utilizing such devices and systems for implanting artificial heart valves. Each delivery device and guide catheter device may comprise a handle and one or more shafts coupled to each handle. The disclosed systems and methods may provide stable positioning and control of one or more delivery device or guide catheter device handles during an implantation procedure, for example, so that the positioning of the artificial implant(s) can be adjusted and / or maintained during the implantation procedure via the control of each handle. Thus, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies of various known delivery devices and systems for implanting implantable devices.

[0007] The delivery device system may include a delivery device and a stabilizing clamp.

[0008] In some embodiments, the stabilizing clamp is configured to receive a portion of the handle of the delivery device.

[0009] In some embodiments, the stabilizing clamp includes a base portion configured to be coupled to or integrated with a stabilizing rail or table.

[0010] In some embodiments, the stabilizing clamp includes a jaw portion that extends from a base portion and is configured to receive a portion of the handle.

[0011] In some embodiments, the jaw portion includes a first jaw member and a second jaw member, each having an internally curved wall, and together the first jaw member and the second jaw member define an opening for receiving a portion of the handle.

[0012] In some embodiments, the first jaw member is a movable jaw member, the second jaw member is a fixed jaw member, and the stabilizing clamp includes a spring member between the movable jaw member and the fixed jaw member, biasing the movable jaw member to the closed position of the mouth.

[0013] In some embodiments, the curved inner wall of the movable jaw member has a reduced surface area relative to the curved inner wall of the fixed jaw member.

[0014] In some embodiments, the curved inner wall of the movable jaw member has a reduced or recessed lip at the opening of the mouth relative to the lip of the fixed jaw member.

[0015] In some embodiments, the curved inner wall of the movable jaw member has a surface gradient that includes a lower friction surface in the region of the upper lip at the opening of the mouth and a higher friction region in the region of the lower lip at the opposing end of the curved inner wall of the movable jaw member.

[0016] In some embodiments, the stabilizing clamp includes a locking mechanism or locking portion for locking or restricting the movement of the movable member.

[0017] In some embodiments, the stabilizing clamp is a dual lever stabilizing clamp.

[0018] In some embodiments, each of the first jaw member and the second jaw member is a lever or a movable jaw member (i.e., the first lever and the second lever).

[0019] In some embodiments, the stabilizing clamp includes a mechanism coupled to or between the first jaw member and the second jaw member to apply a rotational force toward the open position of the mouth of one of the first lever or the second lever to effect the opening of the other of the first lever or the second lever.

[0020] In some embodiments, the minimum torque applied or required to overcome the clamping force of the stabilizing clamp is at least 21 N-cm.

[0021] In some embodiments, the minimum torque required for rotation of the handle in one or more of the first direction or the second opposite direction is within the range of 15 N-cm to 30 N-cm.

[0022] In some embodiments, at least one spring member may have a spring constant sufficient to resist axial rotation of the handle when a rotational force (such as the application of torque to the handle by an operator) does not act on the handle.

[0023] In some embodiments, at least one spring member may have a spring constant within the range of 5 pounds per inch to 50 pounds per inch, such as 30 pounds per inch.

[0024] In some embodiments, the ratio of the torque resistance to rotation of the handle in the first direction to the torque resistance to rotation of the handle in the second opposite direction is within the range of 0.8 to 1.2.

[0025] In some embodiments, the ratio of the torque resistance to rotation of the handle in the first direction to the torque resistance to rotation of the handle in the second opposite direction is within the range of 0.9 to 1.1.

[0026] In some embodiments, the ratio of the torque resistance to rotation of the handle in the first direction to the torque resistance to rotation of the handle in the second opposite direction is approximately 1.0.

[0027] In some embodiments, the stabilization system includes a stabilization table or rail and two or more stabilizing clamps. <00,00114>

[0028] In some embodiments, the stabilization system is configured to connect the handles of the delivery device and the guide catheter device in series via two or more stabilization clamps.

[0029] In some embodiments, the stabilizing clamp is configured to resist or limit the movement of the handle when no rotational force is applied to it.

[0030] In some embodiments, the stabilizing clamp is configured to resist or limit the movement of the handle when a knob or other actuator on the handle is activated.

[0031] In some embodiments, the stabilizing clamp is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2.

[0032] In some embodiments, the stabilizing clamp is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.9 to 1.1.

[0033] In some embodiments, the stabilizing clamp is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is approximately 1.0.

[0034] In some embodiments, the delivery device stabilization system or stabilization clamp or method of using it includes one or more of the components listed in Examples 1 to 33 below.

[0035] A typical example is a delivery device system comprising: a delivery device comprising: a handle; a shaft extending distally from the handle and configured for the delivery of an implantable device; a stabilizing clamp comprising: a base portion; and a jaw portion extending from the base portion, wherein the jaw portion comprises: a first jaw member having a first curved inner wall; a second jaw member having a second curved inner wall, wherein the first and second curved inner walls form a mouth configured to receive a portion of the handle; and at least one of the first or second jaw member is a lever rotatable around a pivot point for opening and closing the mouth; and at least one spring member configured to bias the lever toward the closed position of the mouth, wherein when a portion of the handle is received in the mouth, the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2.

[0036] In another representative embodiment, a stabilization clamp configured for use with an implant delivery device, the stabilization clamp comprises a base portion and a jaw portion extending from the base portion, the jaw portion comprising: a first jaw member having a first curved inner wall; a second jaw member having a second curved inner wall, wherein the first and second curved inner walls form a mouth configured to receive a portion of the handle of the implant delivery device, and at least one of the first or second jaw member is a lever rotatable around a pivot point for opening and closing the mouth; and at least one spring member configured to bias the lever toward the closed position of the mouth, the stabilization clamp configured such that when the portion of the handle is received in the mouth, the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2.

[0037] In another representative embodiment, a method for operating a delivery device system, the method comprising the steps of inserting a portion of a first handle of a first delivery device into the opening of a first stabilizing clamp, the first stabilizing clamp comprising a base portion attached to a stabilizing rail or table, a first jaw member extending from the base portion, and a second jaw member, the opening being defined by a first curved inner wall of the first jaw member and a second curved inner wall of the second jaw member, and at least one of the first jaw member or the second jaw member being a lever rotatable around a pivot point for opening and closing the opening, the first stabilizing clamp moving the lever to the closed position of the opening A method comprising the steps of inserting, further comprising at least one spring member configured to bias toward, rotating a first handle in a first direction to transmit torque to a first shaft coupled to the first handle, and rotating the first handle in a second opposite direction to transmit torque to a first shaft coupled to the first handle, wherein the first stabilizing clamp is configured such that, when the portion of the first handle is received in its opening, the ratio of the torque resistance to rotation of the first handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2.

[0038] In some embodiments, the above method(s) may be performed on living animals or in connection with transplant procedures performed on simulations such as corpses, corpse hearts, anthropomorphic ghosts, or simulators (in which body parts, hearts, tissues, etc., are simulated).

[0039] The various innovations in this disclosure can be used in combination or separately. This summary is provided to introduce in a simplified form a selection of concepts that will be further described in the following detailed description. This summary of the invention is not intended to identify any major or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other purposes, features, and advantages of this disclosure will become clearer from the following detailed description, the claims, and the accompanying drawings. [Brief explanation of the drawing]

[0040] [Figure 1] Figure 1 schematically illustrates the steps in an exemplary mitral valve replacement procedure, in which a guide catheter and guidewire are inserted into the patient's blood vessels and navigated through the vessels into the patient's heart toward the heart's original mitral valve. [Figure 2A] Figure 2A schematically illustrates another step in an exemplary mitral valve replacement procedure, in which a docking device delivery device extending through a guide catheter implants a docking device for an artificial heart valve into the original mitral valve. [Figure 2B] Figure 2B schematically illustrates another stage in an exemplary mitral valve replacement procedure, where the docking device from Figure 2A has been fully implanted in the patient's original mitral valve and the docking device delivery device has been removed from the patient. [Figure 3A] Figure 3A schematically illustrates another stage in an exemplary mitral valve replacement procedure, in which an artificial heart valve delivery device extending through a guide catheter implants the artificial heart valve into an implanted docking device at the site of the original mitral valve. [Figure 3B] Figure 3B schematically shows another stage in an exemplary mitral valve replacement procedure, where the artificial heart valve has been fully implanted within the docking device at the site of the original mitral valve and the artificial heart valve delivery device has been removed from the patient. [Figure 4] Figure 4 schematically shows another stage in an exemplary mitral valve replacement procedure, where the guide catheter and guidewire have been removed from the patient. [Figure 5] Figure 5 is a side view of a guide catheter according to one embodiment, configured to receive a delivery device and / or tool and to guide the delivery device and / or tool through a portion of the patient's vascular structure. [Figure 6] Figure 6 is a side view of a delivery device for a docking device according to one embodiment. [Figure 7] Figure 7 is a perspective view of a docking device for use in the delivery device shown in Figure 6, according to one embodiment. [Figure 8] Figure 8 is a perspective view of a delivery device for an artificial heart valve according to one embodiment. [Figure 9] Figure 9 is a perspective view of an artificial heart valve for use in the delivery device shown in Figure 11, according to one embodiment. [Figure 10A] Figure 10A is a perspective view of an exemplary stabilization rail system for use in a delivery device disclosed herein, according to one embodiment. [Figure 10B] Figure 10B is a top view of an exemplary stabilization rail system for use in a delivery device disclosed herein, according to one embodiment. [Figure 11] Figure 11 is a cross-sectional view of an exemplary single-lever stabilization clamp for use in the stabilization rail system of Figures 10A and 10B, according to one embodiment. [Figure 12] Figure 12 is a cross-sectional view of an exemplary opening portion of a stabilizing clamp according to one embodiment. [Figure 13] Figure 13 is a cross-sectional view of an exemplary opening portion of a stabilizing clamp according to another embodiment. [Figure 14] Figure 14 is a cross-sectional view of an exemplary single-lever stabilization clamp, including a locking mechanism for use in the stabilization rail system of Figures 10 and 10B, according to one embodiment. [Figure 15] Figure 15 is a cross-sectional view of an exemplary dual-lever stabilization clamp for use in the stabilization rail system of Figures 10A and 10B, according to one embodiment. [Modes for carrying out the invention]

[0041] General Considerations For the purposes of this description, specific aspects, advantages, and novel features of the examples of this disclosure are described herein. The methods, apparatus, and systems of this disclosure should not be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects relating to the various examples disclosed, individually, in various combinations of each other, and in various subcombinations of each other. The methods, apparatus, and systems are not limited to any specific aspects, features, or combinations thereof, and the examples disclosed do not require the existence of any one or more specific advantages or the resolution of any problem.

[0042] While some operations in the disclosed examples are described in a specific sequential order for the sake of presentation, it should be understood that this style of description is inclusive of reordering unless a specific order is required by the specific wording described below. For example, operations described sequentially may be reordered and performed simultaneously in some cases. Furthermore, for the sake of simplification, the accompanying drawings may not show various ways in which the methods of this disclosure may be used in combination with other methods. In addition, the description sometimes uses terms such as “provides” or “achieves” to describe the methods of this disclosure. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may differ depending on the specific implementation and will be readily apparent to those skilled in the art.

[0043] As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural form unless the context clearly specifies otherwise. Furthermore, the term “includes” means “comprises.” Furthermore, the term “coupled” generally means to be joined or linked physically, mechanically, chemically, magnetically, and / or electrically, and does not preclude the presence of intermediate elements between the joined or associated items unless otherwise specified.

[0044] As used herein, the term “proximal” refers to a location, orientation, or part of the device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a location, orientation, or part of the device that is further away from the user and closer to the implantation site. For example, proximal movement of the device is movement of the device away from the implantation site toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user toward the implantation site (e.g., inward). The terms “longitudinal” and “axial” refer to axes extending in the proximal and distal directions, respectively, unless otherwise explicitly defined.

[0045] As used herein, the term “approximately” means within a specified range relative to a given value and / or the value described. For example, “approximately” could mean within + / - 10% of a given value, within + / - 8% of a given value, within + / - 5% of a given value, within + / - 1% of a given value, and so on.

[0046] Implementation of the disclosed technologies This specification describes examples of steerable guide catheter devices and steerable delivery devices (sometimes referred to as steerable catheters) that can be used to navigate a target vascular structure to deliver implantable medical devices (e.g., artificial heart valves, docking devices), tools, drugs, or other therapies to a location within the target body. Examples of procedures in which guide catheters and steerable catheters are useful include transcatheter arterial procedures, neurological, urological, reproductive, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvascular, transrectal, and any access to body tubules or cavities. As described above, examples include placing implants, including, for example, artificial valves, docking devices, stents, grafts, and embolic coils; positioning imaging devices and / or their components, including ultrasound transducers; and positioning energy sources for performing, for example, lysotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, and heat sources.

[0047] In connection therewith, various systems, devices, and methods are described herein that, in some embodiments, may be used to stabilize and / or enable control of one or more guide catheter devices or delivery devices, for example, during the exemplary implantation procedures described above or other implantation procedures. For example, a guide catheter device may include a first handle located at its proximal end. A delivery device may include a second handle located at its proximal end. An extended shaft of the delivery device may extend through the lumen of the guide catheter and the first handle such that the second handle (of the delivery device) is located proximal to the first handle. In some embodiments, the guide catheter may be inserted into a target and steered to the implantation site via the first handle. In some embodiments, a delivery device including a docking device held therein may be navigated through the main lumen of the guide catheter toward the target location of the docking device via the second handle. In some embodiments, a delivery device including an artificial heart valve held therein may be navigated through the main lumen of the guide catheter toward the target location of the artificial heart valve via the second handle.

[0048] In some embodiments, the guide catheter device and delivery device are used in combination with a stabilization rail or table system to enable positioning and stabilization of the delivery device handle during implantation. For example, portions of the first and second handles of the guide catheter device and delivery device may be fitted with a stabilization system or device to enable positioning and stabilization of the handle during implantation. In some embodiments, the stabilization system or device may include a rail and one or more stabilization clamps (e.g., slidably mounted on the rail) that can be mounted on the rail in a manner that enables the positioning of the clamps. In some embodiments, only one handle of the guide catheter device or delivery device may be fitted with the stabilization system. In some embodiments, both handles of the guide catheter device and delivery device may be fitted with the stabilization system. In some embodiments, both handles of the guide catheter device and delivery device may be fitted in series with the stabilization system in a linear arrangement. For example, the first handle of the guide catheter device may be fitted to the rail by a first stabilization clamp distal to the body of the first handle, and the second handle of the delivery device may be fitted to the rail by a second stabilization clamp proximal to the first handle and distal to the body of the second handle. The linear or axial arrangement of the handles may allow the extended shaft of the delivery device to extend through the lumen of the guide catheter and the first handle, and mounting to a rail or table may allow the handles to maintain their respective positions and / or be stably positioned relative to each other and to the stabilizing device.

[0049] In some embodiments, a stabilization clamp may include a base portion configured to connect to a stabilization rail or table, and a mouth or jaw portion configured to receive and tighten a portion of a handle. For example, the mouth or jaw portion of the stabilization clamp may be configured to receive a distal cap attached to or integrated with the body housing of the handle. In some embodiments, the distal end cap and / or other portion of a first handle may be fixed to the guide catheter such that the application of a rotational force to the first handle may result in the application of torque to the guide catheter. In some embodiments, the distal end cap and / or other portion of a second handle may be fixed to an extended shaft such that the application of a rotational force to the second handle may result in the application of torque to the extended shaft. In some embodiments, the mouth or jaw portion of the stabilization clamp may be configured to allow rotation of a portion of the handle (e.g., the distal cap) when torque or rotational force is applied to the handle by an operator, and may be further configured to resist or limit the rotation of a portion of the handle (e.g., the distal cap) when torque or rotational force is not applied to the handle by an operator. In some embodiments, the stabilizing clamp is configured to balance or equalize the amount of force required for rotation and torque application, and / or the degree of rotational resistance, experienced by the user operating the handle when rotating in a first direction (e.g., clockwise) and a second direction (e.g., counterclockwise). In some embodiments, the stabilizing clamp is configured such that the ratio of torque resistance to rotation of the handle in the first direction to torque resistance to rotation of the handle in the second opposite direction is in the range of 0.8 to 1.2. In some embodiments, the stabilizing clamp is configured such that the ratio of torque resistance to rotation of the handle in the first direction to torque resistance to rotation of the handle in the second opposite direction is approximately 1.0.

[0050] In some embodiments, the stabilizing clamp may include a fixed jaw member and a movable jaw member. The movable jaw member may be a lever that rotates on or around a pivot point on the fixed jaw member or on the base of the stabilizing clamp. The base portion may form one end (e.g., the lower end) of the stabilizing clamp, and the fixed jaw member and the movable jaw member may extend from the base portion. The mouth portion may have an opening relative to the base portion at the opposing end (e.g., the upper end) of the stabilizing clamp. The fixed jaw member and the movable jaw member may each include a curved inner wall, which may cooperatively define the mouth portion. In some embodiments, the mouth portion may form a substantially cylindrical space or gap configured to receive the distal cap of a delivery device handle. The movable jaw member may be configured to move between an open position and a closed position for opening and closing the mouth. One or more spring members may be positioned between the fixed jaw member or base portion and the movable jaw member or lever to bias the movable jaw member toward the closed position. The opening to the mouth portion can be wider in the open position of the movable jaw member to allow insertion (or removal) of the distal cap of the handle, and narrower in the closed position of the movable jaw member to allow tightening to the outer surface of the distal cap. In some embodiments, the spring member may be positioned at an angle to the longitudinal axis of the stabilizing clamp. In some embodiments, the spring member is parallel to the longitudinal axis of the stabilizing clamp. In some embodiments, the minimum torque applied or required to overcome the tightening force of the stabilizing clamp is at least 21 N-cm. In some embodiments, the minimum torque required to rotate the handle in one or more of the first or second opposite directions is in the range of 15 N-cm to 30 N-cm. In some embodiments, the spring member may have a spring constant in the range of 5 lbs / inch to 50 lbs / inch, for example, 30 lbs / inch, which is sufficient to resist axial rotation of the handle when no rotational force (such as torque applied to the handle by an operator) is acting on the handle.

[0051] In some embodiments, such as those illustrated in Figure 11, the surface area of ​​the curved inner wall of the movable jaw member may be smaller than the surface area of ​​the curved inner wall of the fixed jaw member. In some embodiments, the curved inner wall of the movable jaw member includes a reduced or recessed (upper) lip at the opening of the mouth portion. In some embodiments, when the movable jaw member is in the closed position, the reduced lip is at a greater distance from the vertical axis of the mouth portion than the upper lip of the fixed jaw member. In such embodiments, the reduction in the surface area of ​​the curved inner wall of the movable jaw member at the opening of the mouth can reduce the torque resistance in the (first) rotational direction away from the movable jaw member (lever), and as a result, the ratio of the torque resistance for rotation of the handle in the first direction to the torque resistance for rotation of the handle in the second opposite direction is in the range of 0.8 to 1.2.

[0052] In some embodiments, the stabilizing clamp may include additional or other features for controlling and / or balancing torque resistance. In some embodiments, one or more of the curved inner walls of the mouth portion may include high friction against a textured surface or a low-friction gradient surface (Figures 12 and 13). In some embodiments, the stabilizing clamp may include a locking mechanism (Figure 14). In some embodiments, the stabilizing clamp may include a dual-lever mechanism (Figure 15).

[0053] In some embodiments, the delivery devices disclosed herein may be used to introduce one or more delivery shafts, guide catheters and / or implant catheters into the patient's vascular structure and guide one or more delivery devices at least partially through the vascular structure toward the target implantation site. For example, Figures 1–4 schematically illustrate an exemplary transcatheter heart valve replacement procedure in which a guide catheter is used to guide a docking device delivery device toward the annulus of the original valve, and then an artificial heart valve delivery device toward the annulus of the original valve. The docking device delivery device is used to deliver the docking device to the annulus of the original valve, and then the artificial heart valve delivery device is used to deliver the transcatheter artificial heart valve inside the docking device. An exemplary guide catheter is shown in more detail in Figure 5. An exemplary delivery device for delivering a docking device at the original heart valve is shown in Figure 6, and an exemplary docking device is shown in Figure 7. An exemplary delivery device for delivering an artificial heart valve at the original heart valve is shown in Figure 8, and an exemplary artificial heart valve is shown in Figure 9.

[0054] Examples of the disclosed technology Figures 1 to 4 show an example of a transcatheter heart valve replacement procedure (e.g., mitral valve replacement) using a docking device 52 and an artificial heart valve 62 according to one embodiment. During the procedure, the user first uses a guide catheter 30 to create a pathway to the patient's original heart valve (Figure 1). Next, the user uses a docking device delivery device 50 to deliver and implant the docking device 52 to the patient's original heart valve (Figure 2A), and then removes the docking device delivery device 50 from the patient 10 after implanting the docking device 52 (Figure 2B). Next, the user uses an artificial valve delivery device 60 to implant the artificial heart valve 62 inside the implanted docking device 52 (Figure 3A). After that, the user removes the artificial valve delivery device 60 from the patient 10 (Figure 3B), and then removes the guide catheter 30 (Figure 4).

[0055] Figure 1 shows a step in a mitral valve replacement procedure according to one embodiment, in which a guide catheter 30 and a guide wire 40 are inserted into a blood vessel 12 of patient 10 and navigated through the blood vessel 12 into patient 10's heart 14 and further toward the original mitral valve 16. Together, the guide catheter 30 and guide wire 40 may provide a pathway through and along which a docking device delivery device 50 and an artificial valve delivery device 60 should be navigated toward the implantation site (original mitral valve 16, or original mitral annulus). As shown, the heart 14 is shown schematicly. For example, the anterior leaflet and chordae tendineae of the original mitral valve 16 are omitted for illustrative purposes so that only a portion of the posterior leaflet of the original mitral valve 16 is shown.

[0056] Initially, the user may first make an incision in the patient's body to access the blood vessel 12. For example, in the example shown in Figure 1, the user may make an incision in the patient's groin to access the femoral vein. Thus, in such embodiments, the blood vessel 12 may be the femoral vein.

[0057] After creating an incision in the blood vessel 12, the user may insert a guide catheter 30, a guide wire 40, and / or additional devices (such as an introducer device or a transseptal puncture device) into the blood vessel 12 through the incision. The guide catheter 30 (which may also be referred to as the “introducer device,” “introducer,” or “guide sheath”) is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., docking device delivery device 50 and prosthetic valve delivery device 60) into and through the blood vessel 12, and may extend through the blood vessel 12 into the heart 14, but may stop before reaching the original mitral valve 16. The guide catheter 30 may comprise a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend into the heart 14 through the blood vessel 12, while the handle 32 remains outside the patient's body and can be operated by the user for the purpose of manipulating the shaft 34 (Figure 1).

[0058] The guidewire 40 is configured to guide the delivery device (e.g., guide catheter 30, docking device delivery device 50, prosthetic valve delivery device 60, additional catheter or similar) and their associated devices (e.g., docking device, prosthetic heart valve or similar) to the implantation site within the heart 14, and thus may extend throughout into the left atrium 18 of the heart 14 through the blood vessels 12 (Figure 1), and, in some embodiments, into the left ventricle of the heart 14 through the original mitral valve 16.

[0059] In some cases, a transseptal puncture device or transseptal puncture catheter may be used to first access the left atrium 18 before inserting the guidewire 40 and the guide catheter 30. For example, after creating an incision in a blood vessel 12, the user may insert the transseptal puncture device into the blood vessel 12 through the incision. The user may guide the transseptal puncture device through the blood vessel 12 into the heart 14 (for example, through the femoral vein into the right atrium 20). The user may then create a small incision in the atrial septum 22 of the heart 14 to allow access from the right atrium 20 to the left atrium 18. The user may then insert and advance the guidewire 40 into the left atrium 18 through the transseptal puncture device in the blood vessel 12 and further through the incision in the atrial septum 22. After positioning the guidewire 40 in the left atrium 18 and / or left ventricle 26, the transseptal puncture device may be removed from the patient 10. Next, the user can insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 into the left atrium 18 along the guide wire 40 (Figure 1).

[0060] In some cases, an introducer device may be inserted through the lumen of the guide catheter 30 before inserting the guide catheter 30 into the blood vessel 12. In some cases, the introducer device may include a tapered end that extends outward from the distal end of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 along the guidewire 40. Furthermore, in some cases, the introducer device may include a proximal end portion that extends outward from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user may remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then positioned to receive the implant delivery device and assist in guiding it into the left atrium 18, as further described below.

[0061] Figure 2A shows another stage in an exemplary mitral valve replacement procedure, in which a docking device 52 is implanted into the original mitral valve 16 of the patient's heart 14 using a docking device delivery device 50 (which may also be referred to as “implant catheter” and / or “docking device delivery device”).

[0062] Generally, the docking device delivery device 50 comprises a delivery shaft 54, a handle 56, and a pusher assembly 58. The delivery shaft 54 ​​is configured to be advanced by the user through the patient's vascular structure (blood vessel 12) to the implantation site (e.g., the original mitral valve 16), and may be configured to hold the docking device 52 within the distal end portion 53 of the delivery shaft 54. In some embodiments, the distal end portion 53 of the delivery shaft 54 ​​holds the docking device 52 therein in a linear delivery configuration.

[0063] The handle 56 of the docking device delivery device 50 is configured to be grasped and / or otherwise held by the user outside the patient 10's body in order to advance the delivery shaft 54 ​​through the patient's vascular structure (e.g., blood vessel 12).

[0064] In some embodiments, the handle 56 may include one or more articulated members 57 (or rotatable knobs) configured to assist in navigating the delivery shaft 54 ​​through the blood vessels 12. For example, one or more articulated members 57 may include one or more knobs, buttons, wheels and / or other types of physically adjustable control members, which are configured to be adjusted by the user to bend, curve, twist, rotate and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 ​​in order to assist in navigating the delivery shaft 54 ​​through the blood vessels 12 and within the heart 14.

[0065] The pusher assembly 58 may be configured to deploy and / or implant the docking device 52 at the implantation site (e.g., the original mitral valve 16). For example, the pusher assembly 58 may be configured to be adjusted by the user to push the docking device 52 out from the distal end portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 may extend through the delivery shaft 54 ​​and may be positioned adjacent to the docking device 52 within the delivery shaft 54. In some embodiments, the docking device 52 may be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery device 50 so that the docking device 52 can be released after it has been deployed at the original mitral valve 16.

[0066] Further details of docking device delivery apparatus and variations thereof are described in Patent Document 1, which is incorporated herein by reference in its entirety.

[0067] Referring again to Figure 2A, after the guide catheter 30 is positioned inside the left atrium 18, the user may insert the docking device delivery device 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the docking device delivery device 50 along the guide wire 40 through the guide catheter 30. In some embodiments, the guide wire 40 may be moved away from the left atrium 18 and at least partially retracted into the guide catheter 30. The user may then continue to advance the delivery shaft 54 ​​of the docking device delivery device 50 along the guide wire 40 through the blood vessel 12 until the delivery shaft 54 ​​reaches the left atrium 18, as shown in Figure 2A. Specifically, the user may advance the delivery shaft 54 ​​of the docking device delivery device 50 toward the patient 10 by grasping the handle 56 of the docking device delivery device 50 and applying force (e.g., pushing). While advancing the delivery shaft 54 ​​through the blood vessels 12 and the heart 14, the user can adjust one or more joint members 57 of the handle 56 to navigate various bends, angles, narrowings and / or other obstacles within the blood vessels 12 and the heart 14.

[0068] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends beyond the distal end of the guide catheter 30, the user can use the handle 56 (e.g., the articulating member 57) to position the distal end portion 53 of the delivery shaft 54 ​​at and / or near the posterior commissure of the original mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 ​​in order to deploy and / or implant the docking device 52 into the annulus of the original mitral valve 16.

[0069] In some embodiments, the docking device 52 may be constructed from, formed from, and / or contain a shape memory material, so that when it exits the delivery shaft 54, it can return to its original preformed shape when it is released from its constraint by the delivery shaft 54. In one embodiment, the docking device 52 may be originally formed as a coil, so that when it exits the delivery shaft 54 ​​and returns to its original coiled configuration, it can wind around the original mitral valve leaflets 24 of the mitral valve 16.

[0070] After pushing in the ventricular portion of the docking device 52 (for example, the portion of the docking device 52 shown in Figure 2A, configured to be positioned within the left ventricle 26 and / or on the ventricular side of the original mitral valve 16), the user can then deploy the remaining portion of the docking device 52 (for example, the atrial portion of the docking device 52) from the delivery shaft 54 ​​inside the left atrium 18 by retracting the delivery shaft 54 ​​in a direction that separates it from the posterior commissure of the original mitral valve 16.

[0071] After deploying and implanting the docking device 52 on the original mitral valve 16, the user may disconnect the docking device delivery device 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery device 50, the user may retract the docking device delivery device 50 from the blood vessel 12 in a direction that moves it away from the patient 10, thereby allowing the user to deliver and implant the artificial heart valve 62 within the implanted docking device 52 to the original mitral valve 16.

[0072] Figure 2B illustrates this stage in mitral valve replacement, where the docking device 52 is fully deployed and implanted at the site of the original mitral valve 16, and the docking device delivery device 50 (including the delivery shaft 54) is removed from the patient 10, leaving only the guidewire 40 and guide catheter 30 inside the patient 10. In some embodiments, after removal of the docking device delivery device, the guidewire 40 may be advanced out of the guide catheter 30 through the docking device 52 implanted at the site of the original mitral valve 16 into the left ventricle 26 (Figure 2A). Thus, the guidewire 40 may help guide the prosthetic valve delivery device 60 through the annulus of the original mitral valve 16 into the left ventricle 26, at least partially.

[0073] As shown in Figure 2B, the docking device 52 may include multiple turns (or coils) that wrap around the leaflets 24 of the original mitral valve 16 (in the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the original mitral valve 16, thereby providing a geometric shape that more closely matches the shape or profile of the implanted prosthetic valve. As a result, the docking device 52 can be more tightly fitted between the prosthetic valve and the original mitral valve 16, as further described below, and thus can provide a better seal.

[0074] Figure 3A shows another stage in a mitral valve replacement procedure, in which the user uses an artificial valve delivery device 60 to deliver and / or implant an artificial heart valve 62 (which may also be referred to herein as a “transcatheter heart valve” or simply “THV,” “replacement heart valve,” and / or “artificial mitral valve”) into a docking device 52.

[0075] As shown in Figure 3A, the artificial valve delivery device 60 may comprise a delivery shaft 64 and a handle 66, the delivery shaft 64 may extend distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vascular structure to deliver, implant, expand and / or otherwise deploy the artificial heart valve 62 in the docking device 52 to the location of the original mitral valve 16. The handle 66 is configured to be grasped and / or otherwise held by the user to advance the delivery shaft 64 through the patient's vascular structure.

[0076] In some embodiments, the handle 66 may include one or more articulated members 68 configured to assist in navigating the delivery shaft 64 through the blood vessels 12 and the heart 14. Specifically, the articulated members 68 may include one or more knobs, buttons, wheels and / or other types of physically adjustable control members, which are configured to be adjusted by the user to articulate the distal end portion of the delivery shaft 64 by bending, curving, twisting, rotating and / or other means, in order to assist in navigating the delivery shaft 64 through the blood vessels 12 into the left atrium 18 of the heart 14 and further into the left ventricle 26.

[0077] In some embodiments, the artificial valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the artificial heart valve 62 at the implantation site. In some cases, as shown in Figure 3A, the expansion mechanism 65 may include an inflatable balloon configured to inflate in order to radially expand the artificial heart valve 62 within the docking device 52. The inflatable balloon may be coupled to the distal end portion of the delivery shaft 64.

[0078] In other embodiments, the artificial heart valve 62 may be self-expanding and may be configured to expand radially on its own at the time of removal of the sheath or capsule covering the radially compressed artificial heart valve 62 on the distal end portion of the delivery shaft 64. In yet another embodiment, the artificial heart valve 62 may be mechanically expandable and the artificial valve delivery device 60 may include one or more mechanical actuators (e.g., expansion mechanisms) configured to expand the artificial heart valve 62 radially.

[0079] As shown in Figure 3A, the artificial heart valve 62 is mounted on the distal end of the delivery shaft 64 in a radially compressed configuration around the expansion mechanism 65 (inflatable balloon).

[0080] To navigate the distal end of the delivery shaft 64 to the implantation site, the user may insert the prosthetic valve delivery device 60 (delivery shaft 64) into the patient 10 via the guide catheter 30 and along the guide wire 40. The user may continue to advance the prosthetic valve delivery device 60 along the guide wire 40 (through the blood vessel 12) until the distal end of the delivery shaft 64 reaches the original mitral valve 16, as shown in Figure 3A. More specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force (e.g., pushing). While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user may navigate various turns, corners, stenoses and / or other obstacles within the blood vessel 12 and the heart 14 by adjusting one or more articulated members 68 of the handle 66.

[0081] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed artificial heart valve 62, which is mounted around the distal end portion of the delivery shaft 64, is positioned within the docking device 52 and within the original mitral valve 16. In some embodiments, as shown in Figure 3A, the distal end of the delivery shaft 64 and at least a portion of the radially compressed artificial heart valve 62 can be positioned within the left ventricle 26.

[0082] Once the radially compressed artificial heart valve 62 is properly positioned within the docking device 52 (Figure 3A), the user can operate one or more operating mechanisms of the handle 66 of the artificial valve delivery device 60 to activate the expansion mechanism 65 (for example, by inflating an inflatable balloon), thereby radially expanding the artificial heart valve 62 within the docking device 52.

[0083] Figure 3B shows another stage in the mitral valve replacement procedure, in which the artificial heart valve 62, in its radially extended configuration, is implanted within the docking device 52 of the original mitral valve 16. As shown in Figure 3B, the artificial heart valve 62 is received and held inside the docking device 52. Thus, the docking device 52 assists in anchoring the artificial heart valve 62 inside the original mitral valve 16. The docking device 52 can enable a better seal between the artificial heart valve 62 and the leaflets 24 of the original mitral valve 16, thereby reducing paravalvular leakage around the artificial heart valve 62.

[0084] Furthermore, as shown in Figure 3B, once the artificial heart valve 62 has been fully deployed and implanted within the docking device 52 in the original mitral valve 16, the artificial valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10, thereby leaving only the guidewire 40 and the guide catheter 30 inside the patient 10.

[0085] Figure 4 shows another stage in the mitral valve replacement procedure, where the guidewire 40 and guide catheter 30 have been removed from patient 10.

[0086] Figures 1-4 specifically illustrate mitral valve replacement procedures, but it should be understood that the same and / or similar procedures can be used to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and / or aortic valve). Furthermore, the same and / or similar delivery devices (e.g., docking device delivery device 50, prosthetic valve delivery device 60, guide catheter 30 and / or guidewire 40), docking device (e.g., docking device 52), replacement heart valve (e.g., prosthetic heart valve 62) and / or components can be used to replace these other heart valves.

[0087] For example, when replacing the original tricuspid valve, the user may also have access to the right atrium 20 via the femoral vein, but it would not be necessary to cross the atrial septum 22 and enter the left atrium 18. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the tricuspid valve leaflets, freeing the rest of the docking device 52 from the delivery shaft 54 ​​in the right atrium 20, and then remove the delivery shaft 54 ​​of the docking device delivery device 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar artificial heart valve implantation process at the tricuspid valve within the docking device 52. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vascular structure until the prosthetic heart valve 62 is positioned / placed within the docking device 52 and the tricuspid valve. The user may then expand the prosthetic heart valve 62 inside the docking device 52, after which the prosthetic valve delivery device 60 may be removed from the patient 10. In another embodiment, the user may perform the same and / or similar process to replace the aortic valve, but access the aortic valve from the outflow side via the femoral artery.

[0088] Furthermore, while Figures 1-4 illustrate mitral valve replacement procedures that access the original mitral valve 16 from the left atrium 18 via the right atrium 20 and femoral vein, it should be understood that the original mitral valve 16 can also be accessed alternatively from the left ventricle 26. For example, a user may access the original mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery devices through the arteries to the aortic valve, and then through the aortic valve to the left ventricle 26.

[0089] Moving to Figure 5, an exemplary guide catheter is shown, hereafter referred to as guide sheath 100 (and may also be referred to herein as “delivery device,” “introducer device,” or “introducer”). In some embodiments, guide sheath 100 may be used in place of guide catheter 30 in docking device and / or artificial valve implantation procedures, as described above with reference to Figures 1–4. Guide sheath 100 may be inserted into the patient’s vascular structure to introduce the implant catheter into the patient’s vascular structure and to at least partially guide the implant catheter within it to the target implantation site, and may be configured to receive the implant catheter or delivery device therein (e.g., delivery device 200 in Figure 6 and / or delivery device 300 shown in Figure 8). Guide sheath 100 is described herein as being used in conjunction with delivery devices 200, 300, but guide sheath 100 may be configured to receive a variety of delivery devices or implant catheters, such as alternative artificial heart valve delivery devices, docking device delivery devices, and / or delivery devices for other artificial medical devices or medical therapies, such as stents.

[0090] The guide sheath 100 of the illustrated embodiment comprises a handle assembly 102 and an extended shaft 104 extending distally from the handle assembly 102 along a central longitudinal axis. The shaft 104 may have a main (or primary) lumen defined by the inner surface of the shaft 104's wall. The main lumen may be configured to receive a delivery device (an artificial device delivery device or implant catheter as described herein, e.g., one of the delivery devices 200, 300). In some embodiments, the shaft 104 may extend into the handle assembly 102. Furthermore, in some embodiments, the main lumen may extend through the handle assembly 102 to an inlet port 106 located at the proximal end of the handle assembly 102. Thus, in some embodiments, the inner surface of the wall of a portion of the handle assembly (e.g., at the proximal end) may define the proximal portion of the main lumen. Thus, the main lumen may extend from the inlet port 106 to the distal end 108 of the shaft 104.

[0091] The handle 105 of the handle assembly 102 may be coupled to the shaft 104 such that the handle 105 transmits torque applied to the handle to the shaft 104, thereby causing or resulting in axial rotation of the shaft 104 when the handle 105 rotates. The handle assembly 102 may have a housing 113 (also called the “outer housing”) comprising a nose portion 103 and a body portion 118. The body portion 118 may be configured to be gripped by a user or operator to apply force to it in order to drive the rotation of the handle. In some embodiments, the body portion 118 of the handle 105 may have a cross-sectional shape (e.g., hexagonal, octagonal, etc.) that helps facilitate gripping of the housing 113.

[0092] The nose cone portion 103 may include a frustoconical base 109 attached to the main body portion 118, and a cylindrical cap 107 extending distally from the distal end of the base 109, or positioned above or on the distal end of the base 109. The cylindrical cap 107 may include a frustoconical distal tip 111. In some embodiments, the cylindrical cap 107 may include a coupler positioned within it that connects or attaches the nose cone 103 (and handle 105) to the shaft 104. The cap 107 may be configured to prevent movement of the coupler relative to the nose cone 103 (and handle 105), such as axial movement. In some embodiments, the cap 107 may include an elastomer material or have an elastomer coating. In some embodiments, the cap 107 may include an internal shape (e.g., hexagonal) that is complementary to the external shape (e.g., hexagonal) of the coupler in order to restrict or prevent the rotation of the cap 107 relative to the coupler and nose cone 103.

[0093] A coupler positioned inside the cap 103 may be configured to cover (e.g., surround) at least a portion of the shaft 104. The coupler may support the shaft 104 when torque is applied to the handle 105. Specifically, the coupler may connect to the housing 113 (and / or a fixed component within the housing) and may transmit torque applied to the handle 105 (such as a rotational force applied by the assembly operator to the body portion 118 of the housing 113 of the handle) from the handle 105 to the shaft 104, including the distal end portion 108 of the shaft 104.

[0094] In some embodiments, the nose cone portion 103 may have a different configuration. For example, the cap 107 may include one or more protrusions or grooves, or may have a configuration similar to other caps disclosed herein (e.g., cap 232, as shown in Figure 6 and discussed below, which includes a narrower or recessed central portion having annular flanges or shoulders at each end). In some embodiments, the cap 107 may be configured to be received by or coupled to a stabilizing clamp, such as the stabilizing clamps shown in Figures 10A to 15, as discussed in detail below.

[0095] In some embodiments, the handle assembly 102 may further include a seal housing assembly 110 (which may also be called a “seal stack” and comprises one or more sealing parts housed therein) within the housing 113. One or more sealing parts of the seal housing assembly 110 may be configured to fluidly seal the main lumen of the guide sheath 100 from the external environment. For example, one or more sealing parts of the seal housing assembly 110 may be configured to prevent blood from the patient into which the guide sheath 100 is inserted from leaving the guide sheath 100 and to prevent air from the environment from entering the guide sheath 100 (e.g., through the inlet port 106). One or more sealing parts may include various types of sealing parts, such as a duckbill seal, a flapper seal, an umbrella valve, a cross-slit valve, a dome valve, or similar.

[0096] The main body portion 118 is positioned adjacent to and distal to the seal housing assembly 110. The handle 102 may include a steering mechanism configured to adjust the curvature of the distal end portion of the shaft 104 (thus the shaft 104 may be referred to as a steerable shaft). In the shown embodiment, the handle assembly 102 includes an adjustment member such as the illustrated rotatable knob 120. In some embodiments, the handle assembly 102 may include buttons, wheels, and / or other means for controlling and / or operating one or more components of the guide sheath 100. The main body portion 118 may house an internal bending mechanism of the guide sheath 100, operably coupled to the rotatable knob 120. In some embodiments, the bending mechanism and therefore the knob 120 may be operably coupled to the proximal end portion of a pull wire. The pull wire may extend distally from the handle assembly 102 through the shaft 104 and may have a distal end portion fixed to the shaft 104 at or near the distal end 108 of the shaft 104. Rotating the knob 120 increases or decreases the tension of the pull wire, thereby adjusting the curvature of the distal end portion of the shaft 104. Further details relating to steering or bending mechanisms in a delivery device can be found in Patent Document 2, which is incorporated herein by reference.

[0097] The handle 102 may include a flush port 116 located distal to the seal housing assembly 110 and connected to the housing 113. In some embodiments, the flush port 116 is connected to the main body portion 118 of the housing 113. The handle assembly 102 may further include a compressible reservoir located within the housing 113. In some embodiments, the reservoir may be filled with fluid and may have an adjustable fluid volume. The reservoir may be fluid-coupled to the flush port 116 by a channel (or flush lumen).

[0098] As described above, the guide sheath 100 may be configured to receive a delivery device, such as the delivery device 200 in Figure 6 and / or the delivery device 300 in Figure 8, into the main lumen of the guide sheath 100. Before inserting the delivery devices 200, 300 into the guide sheath (and / or before inserting the guide sheath into the patient's vascular structure), the main lumen and reservoir of the guide sheath 100 may be primed or flushed through the flush port 116. For example, fluid may flow through the flush port 116 into the reservoir cavity. In some cases, the cavity may be filled with fluid until the walls of the reservoir are expanded as much as possible and hit the walls of the housing 113 or the flexure mechanism. Once the reservoir is filled (and in its expanded configuration), fluid entering the reservoir from the flush port 116 may continue to flow into the main lumen. In some cases, this process may continue until the main lumen is filled to a desired level. In some embodiments, the fluid used to fill the reservoir and main lumen is saline or an alternative biocompatible flushing fluid.

[0099] After positioning the shaft 104 of the guide sheath 100 within the patient's vascular structure, the distal ends of the delivery devices 200, 300 can be inserted into the inlet port 106 of the handle 102 of the guide sheath 100. The distal ends of the delivery devices 200, 300 can then be navigated through the seal housing assembly 110 into the main lumen of the guide sheath 100 within the handle assembly 102. The delivery devices 200, 300 can then continue to be navigated through the main lumen of the shaft 104 toward the implantation site. An exemplary implant delivery assembly or system 400 including the guide sheath 100 and the delivery device 200 is shown in Figures 10A and 10B and will be discussed further below.

[0100] Additional examples and details relating to the guide sheath and its function and use are described in Patent Document 3, filed on February 22, 2022, which is incorporated herein by reference.

[0101] Figure 6 shows an exemplary delivery device 200 configured to deliver a docking device, such as the docking device 240 (Figure 7) described later, or another docking device, to a target implantation site in the patient. For example, the delivery device 200 may be used as a docking device delivery device 50 in an artificial valve implantation procedure, as described above with reference to Figure 2A. The delivery device 200 may also be called a “dock delivery catheter” or “dock delivery system”.

[0102] As shown, the delivery device 200 may include a handle assembly 202 and a delivery sheath 204 (also called the “delivery shaft,” “outer shaft,” or “outer sheath”) extending distally from the handle assembly 202. The handle assembly 202 may include a handle 206 coupled to the delivery sheath 204 such that the handle 206 is configured to transmit torque applied to the handle to the delivery sheath 204, thereby causing or resulting in axial rotation of the delivery sheath 204 when the handle 206 is rotated. Furthermore, the handle assembly 202 may include one or more knobs, buttons, wheels, and / or other means for controlling and / or operating one or more components of the delivery device 200. For example, in some embodiments, as shown in Figure 6, the handle assembly 202 may include knobs 208 and 210 which can be configured to steer or control the bending of the delivery device 200, such as the delivery sheath 204 and / or sleeve shaft 220, which will be described later.

[0103] In certain embodiments, the delivery device 200 may also include a pusher shaft 212 and a sleeve shaft 220, both of which may extend through the lumen of the delivery sheath 204 and each having a proximal end portion that extends into the handle assembly 202.

[0104] The distal end portion of the sleeve shaft 220 (also referred to as the “distal section”) may be configured to cover (e.g., surround) the docking device 240 (see Figure 7). For example, the docking device 240 may be held inside the sleeve shaft 220, further held by the distal end portion 205 of the delivery sheath 204 when it is navigated through the patient’s vascular structure.

[0105] As described above, the handle 206 may be coupled to the proximal region of the delivery sheath 204 and may be configured to transmit torque applied to the handle 206 to the delivery sheath 204. In some embodiments, the housing 228 of the handle 206 (in the main body portion 230 of the handle) may have a cross-sectional shape (e.g., hexagonal, octagonal, etc.) that helps to facilitate gripping the handle 206.

[0106] In some embodiments, the cap 232 may extend from or be positioned on the distal end of the nose cone portion 234 of the handle 206 and may include a coupler disposed therein that couples or attaches the nose cone 234 (and handle 206) to the delivery sheath 204. The cap 232 may be configured to prevent movement of the coupler relative to the nose cone 234 (and handle 206) (e.g., axial movement). In some embodiments, the cap 232 may include an elastomer material. In some embodiments, the cap 232 may include an internal shape (e.g., hexagonal) complementary to the external shape (e.g., hexagonal) of the coupler to restrict or prevent rotation of the cap 232 relative to the coupler and the nose cone 234. In some embodiments, the cap 232 (as shown in Figure 6) may include a narrower or recessed central portion having annular flanges or shoulders (formed by a frustoconical proximal end region and a frustoconical distal end region) at each of its ends. In some embodiments, the cap 232 may include other shapes, such as a cylindrical shape or a cylindrical shape including an annular ridge in the proximal and / or distal end regions.

[0107] A coupler positioned inside the cap 232 may be configured to cover (e.g., surround) at least a portion of the delivery shaft 204. The coupler may support the delivery shaft 204 when torque is applied to the handle 206. Specifically, the coupler may connect to the housing 228 (and / or a fixed component within the housing) and may transmit torque applied to the handle 206 (e.g., rotational force applied to the body portion 230 of the handle by the assembly operator) from the housing 228 of the handle 206 to the delivery shaft 204, including the distal end portion 205 of the delivery shaft 204.

[0108] In some embodiments, the nose cone portion 234 may have a different configuration. For example, the cap 232 may include one or more ridges or grooves, or may have a configuration similar to other caps disclosed herein (e.g., the cylindrical configuration of cap 107 shown in Figure 5 and described above). In some embodiments, the cap 232 is configured to be received by or coupled to a stabilizing clamp, such as the stabilizing clamps shown in Figures 10A to 15, which will be discussed in detail below.

[0109] In addition, the distal end portion 205 of the delivery sheath 204 may be configured to be steerable. In one embodiment, the curvature of the distal end portion 205 can be adjusted so that the distal end portion 205 of the delivery sheath 204 can be oriented at a desired angle by rotating a knob (e.g., 208 or 210) on the handle 206. For example, to implant a docking device 240 in the position of the original mitral valve, the distal end portion 205 of the delivery sheath 204 may be steered in the left atrium so that at least a portion of the sleeve shaft 220 and the docking device 240 held inside it can extend through the original mitral annulus in a position adjacent to the posterior commissure.

[0110] In some embodiments, the pusher shaft 212 and the sleeve shaft 220 may be coaxial with each other at least within the delivery sheath 204. In some embodiments, the delivery sheath 204 may be configured to be axially movable relative to the sleeve shaft 220 and the pusher shaft 212. As further described below, the distal end of the pusher shaft 212 may be inserted into the lumen of the sleeve shaft 220 and may press against the proximal end of the docking device 240 held inside the sleeve shaft 220.

[0111] After reaching the target implantation site, the docking device 240 can be deployed from the delivery sheath 204 by manipulating the pusher shaft 212 and sleeve shaft 220 using the hub assembly 218, as further described below. For example, the docking device 240 can be pushed out of the distal end 204d of the delivery sheath 204 by pushing the pusher shaft 212 distally while holding the delivery sheath 204 in place, or by retracting the delivery sheath 204 proximal while simultaneously pushing the pusher shaft 212 distally while retracting the delivery sheath 204 proximal, and thus the docking device 240 can be deployed from its delivery configuration (e.g., extended configuration) and changed to a coiled configuration (see Figure 7). In certain embodiments, the pusher shaft 212 and the sleeve shaft 220 can be operated independently of each other.

[0112] During delivery, the docking device 240 may be coupled to the delivery device 200 via a release suture (or other retrieval line including a string, thread or other material which may be configured to be coupled around the docking device 240 and which may be configured to be cut for removal). In a particular embodiment, the release suture may extend through the delivery device 200, for example, through the lumen of the pusher shaft 212, to the suture locking assembly 216 of the delivery device 200.

[0113] The handle assembly 202 may further include a hub assembly 218 to which a suture locking assembly 216 and a sleeve handle 224 are attached. The hub assembly 218 can be configured to independently control the pusher shaft 212 and the sleeve shaft 220, while the sleeve handle 224 can control the axial position of the sleeve shaft 220 relative to the pusher shaft 212. In this way, the operation of the various components of the handle assembly 202 can actuate and control the operation of components located within the delivery sheath 204. In some embodiments, the hub assembly 218 may be coupled to the handle 206 via a connector 226.

[0114] The handle assembly 202 may further include one or more flush ports (e.g., a flush port 232, shown in Figure 6) for supplying flushing fluid to one or more lumens located inside the delivery device 200 (e.g., annular lumens located between coaxial components of the delivery device 200).

[0115] Further details regarding delivery devices / catheters / systems (including various embodiments of handle assemblies) configured to deliver a docking device to a target implantation site can be found in Patent Documents 4, 5, and 6, as well as Patent Document 7 (filed April 18, 2022), each of which is incorporated herein by reference in its entirety.

[0116] Figure 7 shows an example of a docking device 240. The docking device 240 can be used as a docking device 52 in an artificial valve implantation procedure, for example, as described above with reference to Figures 1 to 4. As shown in Figure 7, the docking device 240 in its deployed configuration can be configured to receive and fix an artificial valve inside the docking device, thereby fixing the artificial valve to the annulus of the original valve.

[0117] The docking device 240 may include a coil member 242 and a guard member 244 covering at least a portion of the coil member 242. In some embodiments, the coil member 242 may include a shape memory material (e.g., nickel-titanium alloy or "nitinol") so that the docking device 240 (and the coil member 242) can move from a substantially linear configuration (or delivery configuration) when placed inside the delivery sheath 204 of the delivery device 200 to a coiled or helical unfolded configuration after being removed from the delivery sheath 204.

[0118] The coil member 242 has a proximal end 242p and a distal end 242d (which also define the proximal and distal ends of the docking device 240, respectively). When positioned within the delivery sheath 204 (for example, during the delivery of the docking device 240 into the patient's vascular structure), the body of the coil member 242 between the proximal end 242p and the distal end 242d may form a generally linear delivery configuration (i.e., having no coiled or looped portions, but being bent or curved) to maintain a small radial profile as it moves through the patient's vascular structure. After being removed from the delivery sheath 204 and unfolded at the implantation site, the coil member 242 may move from the delivery configuration to a helical unfolded configuration and may wrap around the original tissue adjacent to the implantation site. For example, when transplanting a docking device to the original valve location, the coil member 242 may be configured to surround the original valve leaflets of the original valve (and, if present, the chordae tendineae that connect the original valve leaflets to the adjacent papillary muscles).

[0119] The docking device 240 may be detachably coupled to the delivery device 200. For example, in certain embodiments, the docking device 240 may be coupled to the delivery device (as described above) via a release suture which may be coupled to the docking device 240 and configured to be cut for removal.

[0120] As shown in Figure 7, the coil member 242 in its deployed configuration may include a leading turn 246 (or "leading coil"), a central region 248, and a stabilizing turn 250 (or "stabilizing coil") around a central longitudinal axis. The central region 248 may have one or more helical turns having substantially equal inner diameters. In the shown embodiment, the leading turn 246 may extend from the distal end of the central region 248 and have a diameter greater than the diameter of the central region 248. In the shown embodiment, the stabilizing turn 250 may extend from the proximal end of the central region 248 and have a diameter greater than the diameter of the central region 248. In some embodiments, the stabilizing turn 250 may be omitted from the coil member 242, for example, when the retaining member is used to stabilize the position of the docking device 240 relative to the original anatomical structure during implantation. Alternatively, the stabilizing turn 250 may have a diameter equal to, approximately equal to, or smaller than (as opposed to) the diameter of the central region 248, and / or the stabilizing turn may consist of fewer turns than the complete turn, as illustrated in Figure 7.

[0121] Further details relating to exemplary docking devices and their modifications are described in Patent Document 8, which is incorporated herein by reference.

[0122] Figure 8 shows an exemplary heart valve implantation delivery device 300 (also referred to here as “implant catheter”) that may be used to implant an expandable heart valve (e.g., the expandable heart valve 350 shown in Figure 9 or other heart valves). In some embodiments, the delivery device 300 is specifically adapted for use in introducing the heart valve into the heart. For example, the delivery device 300 may be used as a heart valve delivery device 60 in a heart valve implantation procedure, as described above with reference to Figure 3A.

[0123] As shown, the delivery device 300 may include a handle assembly 302 and a steerable outer shaft 304 (also referred to as the “delivery shaft,” “outer shaft,” or “outer sheath”) extending distally from the handle assembly 302. The handle assembly 202 may include a handle 305 coupled to the outer shaft 304 such that the handle 305 is configured to transmit torque applied to the handle to the outer shaft 304, thereby causing or resulting in axial rotation of the outer shaft 304 when the handle 305 rotates. Furthermore, in some embodiments, the handle assembly 302 may include one or more knobs, buttons, wheels, and / or other means for controlling and / or operating one or more components of the delivery device 300. For example, as shown in Figure 8, the handle assembly 302 may include knobs 360, 362 which can be configured to steer or control the bending of the delivery device 300, such as the outer shaft 304 and / or intermediate shaft 306, described later.

[0124] The delivery device 300 may further include an intermediate shaft 306 (which may also be called a balloon shaft) extending proximal and distal to the handle assembly 302, the portion extending distally from the handle 302 also extending coaxially through an outer shaft 304. In some embodiments, the delivery device 300 may further include an inner shaft that extends distally from the handle assembly 302 coaxially through the intermediate shaft 306 and the outer shaft 304, and extends proximal to the handle assembly 302 coaxially through the intermediate shaft.

[0125] The outer shaft 304 and the intermediate shaft 306 may be configured to translate (e.g., move) longitudinally relative to each other along the central longitudinal axis 320 of the delivery device 300 in order to facilitate the delivery and positioning of the artificial valve to the implantation site in the patient's body.

[0126] The intermediate shaft 306 may include a proximal end portion that extends proximal from the proximal end of the handle 302 to the adapter 312. The adapter 312 may include a first port 338 configured to receive a guidewire through it, and a second port 340 configured to receive fluid (e.g., expansion fluid) from a fluid source. The second port 340 may be fluid-coupled to the inner lumen of the intermediate shaft 306.

[0127] In some embodiments, the intermediate shaft 306 may further include a distal end portion that extends distally beyond the distal end of the outer shaft 304 when the distal end of the outer shaft 304 is positioned spaced apart from the inflatable balloon 318 of the delivery device 300. In some embodiments, the distal end portion of the inner shaft may extend distally beyond the distal end portion of the intermediate shaft 306 toward or to the nose cone 322 located at the distal end of the delivery device 300.

[0128] In some embodiments, the distal end of the balloon 318 may be coupled to the distal end of the delivery device 300, for example, to the nose cone 322 (as shown in Figure 8), or to an alternative component at the distal end of the delivery device 300 (e.g., the distal shoulder). The middle portion of the balloon 318 may overlay the valve mounting portion 324 of the distal end portion of the delivery device 300, and the distal end portion of the balloon 318 may overlay the distal shoulder of the delivery device 300. As shown in Figure 8, the artificial heart valve 350 may be mounted around the balloon 318 at the valve mounting portion 324 of the delivery device 300 in a radially compressed state. The artificial heart valve 350 may be configured to expand radially by the inflation of the balloon 318 at the annulus of the original valve, as described above with reference to Figure 3A.

[0129] The balloon shoulder assembly of the delivery device 300, including the distal shoulder, may be configured to maintain the artificial heart valve 350 (or other medical device) in a fixed position on the balloon 318 during delivery through the patient's vascular structure.

[0130] The outer shaft 304 may include a distal tip portion 328 attached to its distal end. In some embodiments, the outer shaft 304 and the intermediate shaft 306 may be axially translated relative to each other to position the distal tip portion 328 adjacent to the proximal end of the valve attachment portion 324 when the prosthetic valve 350 is mounted radially compressed on the valve attachment portion 324 (for example, as shown in Figure 8) and during delivery of the prosthetic valve to the target implantation site. Thus, the distal tip portion 328 may be configured to resist the movement of the prosthetic valve 350 relative to the balloon 318 axially proximal to the balloon 318 when the distal tip portion 328 is positioned adjacent to the proximal side of the valve attachment portion 324.

[0131] An annular space can be defined between the outer surface of the inner shaft and the inner surface of the intermediate shaft 306, and this annular space may be configured to receive fluid from a fluid source via the second port 340 of the adapter 312. The annular space may be fluid-coupled to a fluid passage formed between the outer surface of the distal end portion of the inner shaft and the inner surface of the balloon 318. In this way, fluid from the fluid source can flow from the annular space to the fluid passage, thereby inflating the balloon 318 and radially expanding and deploying the artificial valve 350.

[0132] The lumen of the inner shaft may be configured to receive a guidewire through it in order to navigate the distal end of the delivery device 300 to the target implantation site.

[0133] As described above, the handle 305 may be coupled to the proximal region of the outer shaft 304 and may be configured to transmit torque applied to the handle 305 to the outer shaft 304. The handle assembly 302 may have a housing 313 (also referred to as the “outer housing”) comprising a nose portion 303 and a body portion 319. The body portion 319 may be configured to be gripped by a user or operator to apply force to it in order to drive the rotation of the handle. In some embodiments, the body portion 319 of the handle 305 may have a cross-sectional shape (e.g., hexagonal, octagonal, etc.) that helps to facilitate gripping the housing 313.

[0134] The nose cone portion 303 may include a frustoconical base 309 attached to the body portion 319, and a cylindrical cap 307 extending distally from or positioned above the distal end of the base 309. The cylindrical cap 307 may include a frustoconical distal tip 311. In some embodiments, the cylindrical cap 307 may include a coupler positioned within it that connects or attaches the nose cone 303 (and handle 305) to the shaft 304. The cap 307 may be configured to prevent movement of the coupler relative to the nose cone 303 (and handle 305), such as axial movement. In some embodiments, the cap 307 may include an elastomer material or have an elastomer coating. In some embodiments, the cap 307 may include an internal shape (e.g., hexagonal) that is complementary to the external shape of the coupler (e.g., hexagonal) in order to restrict or prevent the rotation of the cap 307 relative to the coupler and nose cone 303.

[0135] A coupler positioned inside the cap 303 may be configured to cover (e.g., surround) at least a portion of the shaft 304. The coupler may support the shaft 304 when torque is applied to the handle 305. Specifically, the coupler may connect to the housing 313 (and / or a fixed component within the housing) and may transmit torque applied to the handle 305 (e.g., rotational force applied by the assembly operator to the body portion 319 of the housing 313 of the handle) from the handle 305 to the outer shaft 304, including the distal end portion of the outer shaft 304 (e.g., including the valve mounting portion 324).

[0136] In some embodiments, the nose cone portion 303 may have a different configuration. For example, the cap 307 may include one or more ridges or grooves, or may have a configuration similar to other caps disclosed herein (e.g., the cap 232, as shown in Figure 6 and described above, which includes a narrower or recessed central portion having annular flanges or shoulders at each end). In some embodiments, the cap 307 is configured to be received or coupled to a stabilizing clamp, such as the stabilizing clamps shown in Figures 10A to 15, which are described in detail below.

[0137] The handle assembly 302 may further include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 300. In the shown embodiment, for example, the handle assembly 302 includes an adjustment member such as a rotatable knob 360, which is further operably coupled to the proximal end portion of a pull wire. The pull wire may extend distally from the handle assembly 302 through an outer shaft 304 and have a distal end portion attached to the outer shaft 304 at or near the distal end of the outer shaft 304. By rotating the knob 360, the tension of the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 300. Further details relating to a steering or bending mechanism for a delivery device can be found in Patent Document 2, which has been previously incorporated above by reference.

[0138] The handle assembly 302 may further include an adjustment mechanism 361, which includes an adjustment member such as a rotatable knob 362, and an associated locking mechanism, which includes another adjustment member configured as a rotatable knob 378, for example. The adjustment mechanism 361 may be configured to adjust the axial position of the intermediate shaft 306 relative to the outer shaft 304 (for example, for fine positioning at the implant site).

[0139] The artificial valves disclosed herein (e.g., artificial heart valve 350, artificial heart valve 62, etc.) may be radially compressible and expandable between a radially compressed state and a radially expanded state. Therefore, the artificial valve can be crimped onto or held by an implant delivery device (e.g., delivery device 300, artificial valve delivery device 60, etc.) in a radially compressed state during delivery, and then expanded to a radially expanded state after reaching the implantation site. It will be understood that the artificial valves disclosed herein can be used with various implant delivery devices and can be implanted via various delivery procedures.

[0140] Figure 9 shows an exemplary prosthetic valve 350 in a radially expanded position or state. The prosthetic valve 350 may be used as an artificial heart valve 62 in a prosthetic valve implantation procedure, as described above with reference to Figures 1 to 4. Any prosthetic valve disclosed herein is adapted to be implanted within the original aortic annulus, but in other embodiments it may be adapted to be implanted within other original annulus of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed prosthetic valve may also be implanted in a vessel communicating with the heart, including the pulmonary artery (to replace the function of an affected pulmonary valve) or the superior vena cava, or the inferior vena cava (to replace the function of an affected tricuspid valve), or various other veins, arteries, and vessels of the patient. The disclosed prosthetic valve may also be implanted in a valve-in-valve procedure inside a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve).

[0141] In some embodiments, the disclosed prosthetic valve may be implanted inside a docking or anchoring device (e.g., docking device 240 in Figure 7 or another docking / anchoring device) implanted inside the original heart valve or blood vessel. For example, the disclosed prosthetic valve may be implanted inside a docking device implanted in a pulmonary artery to replace the function of an affected pulmonary valve, as disclosed in Patent Document 9, incorporated herein by reference. In other embodiments, the disclosed prosthetic valve may be implanted inside the original mitral valve or inside a docking device implanted in the original mitral valve, as disclosed in Patent Document 1, incorporated herein by reference, etc. In other embodiments, the disclosed prosthetic valve may be implanted inside a docking device implanted inside the superior or inferior vena cava to replace the function of an affected tricuspid valve, as disclosed in Patent Document 10, incorporated herein by reference.

[0142] As shown in Figure 7, the prosthetic valve 350 may include a frame 352, and several valve leaflets 354 may be at least partially positioned within the frame 352. The prosthetic valve 350 may also include an outer cover 356 positioned around the frame 352. As shown in Figure 7, the prosthetic valve 350 includes an inlet end 357 and an outlet end 358. The terms “inlet” and “outlet” relate to the normal direction of blood flow through the prosthetic valve 350 (e.g., antegrade blood flow). For example, the valve leaflets 354 may allow blood flow through the valve 350 in the direction from the inlet end 357 to the outlet end 358 and prevent backflow (e.g., prevent flow in the direction from the outlet end 358 to the inlet end 357).

[0143] The frame 352 may be formed from any variety of suitable plastic expandable materials (e.g., stainless steel) or from a self-expanding material (e.g., nitinol), as is known in the art. If the frame 352 (and therefore the valve 350) is constructed from a plastic expandable material, it may be crumpled into a radially compressed state on the delivery catheter and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. When constructed from a self-expanding material, the frame 352 (and therefore the valve 350) may be crumpled into a radially compressed state and may be constrained in that compressed state by insertion into the sheath of the delivery catheter or into an equivalent mechanism. Inside the human body, the valve may be advanced from the delivery sheath, thereby expanding the valve to its functional size.

[0144] Suitable plastic and expandable materials that can be used to form the frames disclosed herein (e.g., frame 352) include metal alloys, polymers, or combinations thereof. Exemplary metal alloys include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, frame 352 may include stainless steel. In some embodiments, frame 352 may include cobalt-chromium. In some embodiments, frame 352 may include nickel-cobalt-chromium. In some embodiments, frame 352 includes a nickel-cobalt-chromium-molybdenum alloy such as MP35N® (trade name of SPS Technologies), which is equivalent to UNS R30035 (coated by ASTM F562-02). MP35N® / UNS R30035 contains 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0145] Further details relating to artificial heart valves and their deformations are described in Patent Document 11, which is incorporated herein by reference.

[0146] As described above, the delivery device 200 and / or delivery device 300 may be introduced into the patient's vascular structure via a guide catheter, such as the guide catheter 100 in Figure 5. For example, to introduce the delivery device 200 and / or 300 (or an alternative implant catheter or delivery device) into the patient's vascular structure, the shaft 104 of the guide catheter 100 may first be inserted into the patient's vascular structure and navigated through the vascular structure toward the target implantation site of the medical device or implant. The handle assembly 102 of the guide catheter 100 remains outside the patient and may be accessed and / or controlled by the user (e.g., a physician). The distal end portion 205 of the delivery device 200 and / or the distal end portion of the delivery device 300 may then be inserted into the main inlet port 130 of the handle assembly 102 of the guide catheter 100 and pushed toward the implantation site through the main lumen 112 of the shaft 104, for example, in the mitral valve replacement procedure described above in relation to Figures 1 to 4.

[0147] Figures 10A and 10B show an exemplary delivery system 1000, which includes a guide catheter 1100 (which may be analogous to one or more of the guide catheters 30 or 100), a docking device delivery device 1200 (which may be analogous to one or more of the delivery devices 50 or 200), and a stabilization device 1002 (also referred herein as the “stabilization tower,” “stabilization device,” or “stabilization system”). The delivery system 1000 may be used in transcatheter heart valve replacement procedures, for example, as described above with reference to Figures 1 to 4. Specifically, the delivery system 1000 shown in Figures 10A and 10B may be used during the second stage of the procedure described above with reference to Figure 2A.

[0148] As shown in Figures 10A and 10B, the guide catheter 1100 is coupled to a stabilization device 1002 to stabilize the position of the guide catheter 1100 during and / or after insertion into the target, and can be navigated or steered to the implantation site via its handle assembly 1102. The delivery device 1200 can be inserted through the guide catheter 1100. Specifically, the delivery shaft 1204 of the delivery device 1200 can advance through the central lumen of the guide catheter 1100 (e.g., through the handle assembly 1102 and the central lumen extending through the extended shaft 1104 of the guide catheter 1100). The handle assembly 1202 of the delivery device 1200 includes a hub or pusher assembly 1218, the shaft 1212 of the hub assembly 1218 can be inserted through the central lumen of the delivery device 1200 and can extend distally into the delivery shaft 1204 through the handle assembly 1202. As described above with reference to hub assembly 218, the hub assembly 1218 may be configured to selectively allow movement of the pusher shaft relative to the handle assembly 1202 and the delivery shaft 1204 (e.g., axial and / or rotational movement).

[0149] The guide catheter 1100 and delivery device 1200 may be coupled to a stabilization device 1002 that can support and stabilize the guide catheter 1100 and delivery device 1200 (e.g., during implantation). The stabilization device 1002 may include a stabilization clamp 1004 (e.g., a clip, clamp, brace, etc.) which may be configured to hold or grasp portions of the guide catheter 1100 and delivery device 1200 and maintain the position of the guide catheter 1100 and delivery device 1200 relative to the stabilization device 1002 and / or relative to each other.

[0150] In some embodiments, each base portion 1008 of the stabilization clamp 1004 can be slidably coupled to a stabilization rail or table 1006 and can be repositioned or re-located axially on the stabilization rail 1006. In some embodiments, the stabilization rail 1006 includes a linear track 1010 having rising walls or side walls 1012 on opposing sides of the linear track 1010. In some embodiments, each rising wall or side wall 1012 includes a base, a web, and a head or overhang. In some embodiments, the base portion 1008 may include a groove on the opposing side of the base portion configured to receive the head or overhang of the rising wall or side wall 1012 and to allow slidable coupling of the stabilization clamp 1004 to the stabilization rail 1006.

[0151] In some embodiments, the base portion 1008 may further include a locking mechanism 1014 that can releasely fix the position of the base portion 1008 relative to the stabilizing rail 1006. For example, the locking mechanism 1014 may be a compression locking mechanism that can be actuated by a knob, a winding mechanism or other actuator and can be configured to close and / or grip around a portion of the stabilizing rail 1006, such as an upward wall or side wall 1012 or the bottom surface of the stabilizing rail 1006. In some embodiments, the base portion 1008 may include a silicone layer (e.g., a silicone brake) on one or more surfaces, such as the bottom surface of the base portion. The silicone brake may engage with one or more surfaces of the stabilizing rail 1006, such as the upper surface of the track portion of the stabilizing rail, via the actuation of a knob, a winding mechanism or other actuator. Friction between the silicone brake and the surface of the stabilizing rail may lock the axial position of the stabilizing clamp 1004 relative to the stabilizing rail 1006. In some embodiments, one or more surfaces of the stabilizing rail may include raised and / or protruding portions perpendicular to the directional movement of the stabilizing clamp (e.g., perpendicular to the axial movement), as well as a high-friction texture or coating to increase friction between the brake and the surface of the stabilizing rail. In some embodiments, the locking mechanism 1014 may be configured to widen its base so as to be braced between the inner surfaces of the rising wall or side wall 1012. In some embodiments, the locking mechanism may have additional and / or alternative features and configurations.

[0152] Naturally, the position of the stabilizing clamp 1004 can be adjusted to accommodate the lengths of the handle assemblies 1102 and 1202 and / or the desired relative positions of the guide catheter 1100 and the delivery device 1200, thereby allowing the delivery sheath or shaft 1204 to be fixed in series with the stabilizing device 1002 at an appropriate interval for insertion into the central lumen of the guide catheter 1100.

[0153] In some embodiments, as shown in Figures 10A and 10B, the jaw or mouth portion 1016 of each stabilizing clamp 1004 may extend upward from the base portion 1008 and may be configured to engage with a portion of the handle assembly 1102 or 1202. For example, similar to cap 107, the cap 1107 of the handle assembly 1102 may be fixed to its handle 1105 (a portion of the assembly configured to be gripped by the user) and may include a coupler for fixing the handle assembly 1102 to an extended shaft 1104. The cap 1107 may be received or clamped within one of the jaw or mouth portions 1016 of the stabilizing clamp 1004 to connect the handle assembly 1102 to the stabilizing device 1002. In another embodiment, similar to cap 232, the cap 1232 of the handle assembly 1202 may be fixed to its handle 1206 (configured to be gripped by the user) and may include a coupler for fixing the handle assembly 1202 to the delivery shaft 1104. The cap 1232 can be received or clamped into one of the jaw or mouth portions 1016 of the stabilizing clamp 1004 to connect the handle assembly 1102 to the stabilizing device 1002.

[0154] In some embodiments, while the cap 1107 is coupled to the stabilization clamp 1004, torque may be applied to the handle 1105 of the guide catheter 1100, and the torque may be transmitted to the shaft 1104. In some embodiments, while the cap 1107 is coupled to the stabilization clamp 1004 and the handle 1105 remains stationary (or its movement is restricted), one or more actuators, such as the knob 1120 of the handle assembly 1102, may be rotated. In some embodiments, while the cap 1232 is coupled to the stabilization clamp 1004, torque may be applied to the handle 1206 of the delivery device 1200, and the torque may be transmitted to the delivery sheath 1204. In some embodiments, one or more actuators, such as the knobs 1208 and / or 1210 of the handle assembly 1202, may rotate while the cap 1232 is coupled to the stabilization clamp 1004 and the handle 1206 remains stationary (or its movement is restricted).

[0155] Therefore, the stabilizing clamp may be configured to (i) hold the axial positions of the handle assemblies 1102 and 1202 relative to each other and to the track 1010 of the stabilizing device 1002, (ii) allow axial rotation of the caps 1107 and 1232, which are held within the mouth or jaw portion 1016 when torque is applied to each of the handles 1105 and 1206 of the handle assembly, (iii) resist axial rotation of each of the handles 1105 and 1206 of the handle assembly when no torque is applied to the handles (including when the actuators of the handle assembly (e.g., knobs 1120, 1208 and / or 1210) are rotating), and / or (iv) maintain the position of the caps 1107 and 1232 and resist their rotation when torque is accumulated in the distal end portion of each delivery system (i.e., the guide catheter 1100 and / or delivery device 1200).

[0156] During the operation of the guide catheter 1100 and delivery device 1200 (e.g., steering, navigating, positioning, bending, etc.), their respective handles 1105 and 1206 may be rotated by the operator in a clockwise and counterclockwise direction, respectively, to adjust the corresponding shafts (i.e., the extended shaft 1104 and the delivery sheath 1204). In some embodiments, it is desirable that the rotation of the handles in each clockwise and counterclockwise direction requires approximately the same amount of force applied to the handles. In other words, the torque resistance to the rotation of the handles in each clockwise and counterclockwise direction should be approximately equal so that the operator does not perceive any difference while operating the guide catheter 1100 and / or delivery device 1200. In some embodiments, a stabilizing clamp may be configured to balance and / or equalize the torque resistance to the rotation of the handles in a first direction and a second opposite direction. For example, a stabilizing clamp may be configured such that the ratio of the torque resistance of the handle in its first direction (e.g., clockwise) to the torque resistance of the handle in its second opposite direction (e.g., counterclockwise) is in the range of 0.8 to 1.2, such as 0.9 to 1.1 or approximately 1.0.

[0157] Furthermore, the positions of each handle 1105 and 1206 should be maintained when the operator stops applying rotational force or torque to them, or otherwise does not apply rotational force to the handles. Thus, in some embodiments, the stabilizing clamp may apply sufficient and / or minimal compressive force to the handles to limit and / or resist rotational movement of the handles when no rotational force is acting on the handles (e.g., when no torque is applied to the handles by the operator). In some embodiments, the stabilizing clamp may apply sufficient and / or minimal compressive force to the handles to limit and / or resist rotational movement of the handles when torque is applied to the distal portion of each delivery system (i.e., the guide catheter 1100 and / or delivery device 1200) by the patient's body and / or vascular structure. In some embodiments, the stabilizing clamp may restrict and / or resist rotational movement of the handle by applying sufficient and / or minimal compressive force to the handle so that the torque accumulated in the distal portion of each delivery system (i.e., the guide catheter 1100 and / or delivery device 1200) can be maintained while the distal portion is in the patient's body and / or vascular structure. For example, the stabilizing clamp may include one or more spring members configured to bias the mouth portion or jaw portion toward a closed position. In some embodiments, the spring members may have a spring constant in the range of 5 lbs / inch to 50 lbs / inch, for example, 30 lbs / inch. In some embodiments, the minimum torque required to overcome the clamping force is in the range of 15 N-cm to 30 N-cm, for example, 18 N-cm to 25 N-cm. In some embodiments, the minimum torque that can be applied to or required to overcome the clamping force of the stabilizing clamp is 21 N-cm.

[0158] In some embodiments, it will be understood that the exemplary delivery system 1000 may include a guide catheter 1100, a stabilization device 1002, and an artificial heart valve delivery device (similar to delivery devices 60 and 300) instead of the docking device delivery device 1200. Specifically, the delivery system 1000 may be used during the third stage of the implant delivery procedure, as described above with reference to Figure 3A. In such embodiments, the cap of the handle of the artificial heart valve delivery device (e.g., cap 307) may be coupled to a stabilization clamp. During the operation of the artificial heart valve delivery device (e.g., steering, navigating, positioning, bending, etc.), its handle may be rotated by the operator in both clockwise and counterclockwise directions to adjust the implant delivery shaft. Similar to the operation of the guide catheter 1100 and the delivery device 1200, it may be desirable that the rotation of the handle in both clockwise and counterclockwise directions requires approximately the same amount of force applied to the handle. Furthermore, it may be desirable that the position of the handle be maintained when no rotational force is applied to the handle by the operator.

[0159] Referring to Figures 11–15, exemplary stabilization clamps configured to balance torque resistance to rotation of the guide catheter device and delivery device handles in a first direction and a second opposite direction are shown and described. Figure 11 shows one exemplary stabilization clamp 1304 according to the present disclosure. Specifically, Figure 11 shows the jaw portion 1316 of the stabilization clamp 1304. Although the base portion of the stabilization clamp 1304 is not shown, the base portion of claim 1304 may have one or more features of a base portion 1008 configured to be slidably coupled to a rail, as shown in Figures 10A and 10B above, or having other features or configurations. For example, the base portion of the stabilization clamp 1304 may be a fixed base portion attached to or integrated with a stabilization table. In another embodiment, the base portion of the stabilization clamp 1304 may include a coupler (e.g., a snap-fit ​​coupler, a screw coupler, etc.) configured to couple to a mating partner on a stabilization table.

[0160] As shown in Figure 11, the jaw portion 1316 may include or be formed by a fixed jaw member 1318 and a movable jaw member 1320. In some embodiments, the movable jaw member 1320 may be a lever that rotates on or around a pivot point 1322 on the fixed jaw member 1318. In other embodiments, the lever may rotate on or around a pivot point on the base portion of the stabilizing clamp 1304. Although not shown, the base portion may form one end (e.g., the lower end) of the stabilizing clamp 1304, and the fixed jaw member 1318 may extend from the base portion. In some embodiments, the fixed jaw member 1318 may be mounted or attached to the base portion. In some embodiments, the fixed jaw member 1318 may be integrated with the base portion.

[0161] The fixed jaw member 1318 and the movable jaw member 1320 may each include curved inner walls 1324 and 1326 that cooperatively define the mouth portion 1328. In some embodiments, the mouth portion 1328 may form a substantially cylindrical space or void configured to receive the distal cap of a delivery device or guide catheter handle, such as one of the caps 107, 232, 307, 1107, and 1232 or other parts of the handle of a delivery device or guide catheter. The mouth portion 1328 may have an opening 1330 at the opposing end (e.g., the upper end) of the stabilizing clamp 1304 relative to the base portion (not shown).

[0162] The movable jaw member 1320 may be configured to move or rotate between an open position and a closed position for opening and closing the mouth 1328. The opening 1330 to the mouth portion can be made wider in the open position of the movable jaw member 1320 to allow insertion (or removal) of the distal cap of the handle of the delivery device or guide catheter, and can be made narrower in the closed position of the movable jaw member 1320 to allow retention of the distal cap of the handle within it.

[0163] In some embodiments, a spring member 1332 (which may be one or more spring members, as discussed below) may be positioned between a fixed jaw member 1318 (or base portion) and a movable jaw member 1320. The spring member 1332 may be configured to bias the movable jaw member 1320 toward the closed position, enabling the application of a clamping or compressive force on the outer surface of the distal cap of a handle (or other portion of the handle) positioned within the opening 1328. Furthermore, the distal cap may be sandwiched or captured between the curved inner walls 1324 and 1326 when the opening 1328 is in the closed position via the force applied by the spring member 1332 to the fixed jaw member 1318 and the movable jaw member 1320.

[0164] The movable jaw member 1320 may include an extension 1334 configured to be pressed by an operator to overcome the biasing force of the spring member 1332 and move the movable jaw member 1320 to the open position. In some embodiments, the extension 1334 may include surface features or ribs 1336 configured to facilitate gripping on the extension 1334.

[0165] As shown in the illustrated embodiment, the spring member 1332 may be a coil member having a first end held in a first spring seat 1342 within the fixed jaw member 1318 and a second end held in a second spring seat 1344 within the movable jaw member 1320. The coil may include steel, e.g., high-carbon steel, steel alloy, stainless steel, or other elastic materials. In some embodiments, the spring member may have different non-coil configurations. In some embodiments, the spring member may be a curved or angled elastic member configured to curve or bend when an extension of the movable jaw member is pressed down and the jaw is moved to the open position. In some embodiments, the spring member may be a torsion spring member. For example, a torsion spring may be mounted around or on a pivot point and engage with each portion of the jaw member.

[0166] As described above, the spring constant of the spring member 1332 is sufficient to resist axial rotation of the distal cap and / or handle when no rotational force is applied to the handle by the operator (e.g., when the handle is first coupled to the stabilization clamp or when the operator stops rotating the handle), and / or to resist axial rotation of the distal cap and / or handle from torque accumulated at the distal end portion of the delivery device while the distal end portion is in the patient's body. In some embodiments, the spring member 1332 may have a spring constant in the range of 5 lbs / inch to 50 lbs / inch. In some embodiments, the spring member 1332 has a minimum spring constant of 30 lbs / inch. In some embodiments, the minimum torque required to overcome the clamping force is in the range of 15 N-cm to 30 N-cm, for example, 18 N-cm to 25 N-cm. In some embodiments, the minimum torque that can be applied to or required to overcome the clamping force of the stabilization clamp is 21 N-cm. In some embodiments, the minimum torque that can be applied to or required to overcome the tightening force of the stabilizing clamp may represent the tightening force of the stabilizing clamp.

[0167] In some embodiments, the spring member 1332 may extend at an angle between the movable jaw member 1320 and the fixed jaw member 1318, for example, due to the relative positions of the spring seats 1342 and 1344. For example, the base of the first spring seat 1342 may be positioned at an angle in the range of 1° to 40° with respect to the longitudinal axis of the stabilizing clamp 1304, such as 1° to 25° or 1° to 10°, while the base of the second spring seat 1344 may be perpendicular to the longitudinal axis of the stabilizing clamp 1304. In some embodiments, the spring member 1332 may be parallel to the longitudinal axis of the stabilizing clamp 1304. In such embodiments, each of the bases of the first and second spring seats may be perpendicular to the longitudinal axis of the stabilizing clamp.

[0168] In some embodiments, a larger angle of the spring member can decrease the effective spring constant of the spring member (i.e., the contribution of the spring's biasing force to the overall clamping force of the stabilizing clamp), while a smaller angle or parallel position of the spring member can increase the effective spring constant of the spring member. Therefore, in some embodiments, when the spring member is positioned at an angle to the longitudinal axis of the stabilizing clamp, a spring with a larger spring constant can be utilized. In some embodiments, when the spring member is parallel to the longitudinal axis of the stabilizing clamp, a spring with a smaller spring constant can be utilized.

[0169] Although only a single spring member 1332 is shown in Figure 11, it will be understood that one or more additional spring members may be included in the stabilizing clamp. In some embodiments, the stabilizing clamp may include two (or more) spring members in a side-by-side arrangement or other arrangements, each of which may be coupled to or seated in first and second spring seats within or on the fixed jaw member and movable jaw member. For example, the stabilizing clamp 1304 may include two identical springs 1332 in a side-by-side configuration. In other words, Figure 11 may represent a diagram of one side of the stabilizing clamp 1304 including the first spring 1332, while the opposing side of the clamp may have a similar configuration including the second spring 1332.

[0170] Naturally, in embodiments including a larger number of spring members, each individual spring may have a smaller spring constant to achieve sufficient and / or minimum clamping force compared to embodiments including fewer spring members. For example, in a stabilizing clamp including two identical springs 1332, each spring may have a spring constant of 30 pounds / inch. In a stabilizing claim including one spring 1332, the spring may have a larger spring constant, such as a spring constant in the range of 40 to 60 pounds / inch.

[0171] In some embodiments, the surface area of ​​the curved inner wall 1326 of the movable jaw member 1320 may be smaller than the surface area of ​​the curved inner wall 1324 of the fixed jaw member 1318. In some embodiments, the curved inner wall 1326 of the movable jaw member 1320 includes a retracted or recessed lip 1338 into the opening 1330 of the mouth portion 1328. In some embodiments, when the movable jaw member 1320 is in the closed position, the retracted or recessed lip 1338 is at a greater distance from the vertical axis of the mouth portion than the (non-retracted) lip 1340 of the fixed jaw member 1318.

[0172] In such embodiments, the reduced surface area of ​​the curved inner wall 1326 of the movable jaw member 1320 at the opening 1330 of the mouth 1328 can reduce the torque resistance in a first rotational direction away from the movable jaw member (lever) (for example, counterclockwise in the embodiment of Figure 11) compared to a curved inner wall having the same configuration as the curved inner wall 1324 or the same surface area as the curved inner wall 1324 of the fixed jaw member 1318. For example, when a cap or handle placed therein rotates away from the movable jaw member (for example, counterclockwise), the highest point or friction area may occur or be located on the lip of the curved inner wall of the movable jaw member. Therefore, in some embodiments, the reduced or recessed lip 1338 can reduce or eliminate high-friction points or areas on the curved inner wall 1326, thereby reducing torque resistance to the rotation of the handle attached to or coaxial with the distal cap coupled to the stabilizing clamp 1304 when the handle is rotated in a direction away from the movable jaw member (for example, counterclockwise in the example of Figure 11).

[0173] In some embodiments, reducing or eliminating high-friction points or areas on the curved inner wall 1326 of the movable jaw member 1320 via the recessed lip 1338 can balance the torque resistance and / or provide the torque resistance required to rotate the handle away from the movable jaw member (for example, counterclockwise in the embodiment of Figure 11), which is close to the torque resistance required to rotate the handle in the opposite direction toward the movable jaw member (for example, clockwise in Figure 11).

[0174] In some embodiments, the stabilizing clamp 1304 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2. In some embodiments, the stabilizing clamp 1304 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.9 to 1.1. In some embodiments, the stabilizing clamp 1304 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is approximately 1.0.

[0175] Figures 12 and 13 show exemplary stabilization clamps 1404 and 1504 according to the present disclosure. Specifically, Figures 12 and 13 show the upper sections of the jaw portions 1416 and 1516 of the stabilization clamps 1404 and 1504 (i.e., the sections including the jaw portions 1428 and 1528). The lower sections of the jaw portions 1416 and 1516 of the stabilization clamps 1404 and 1504 are not shown but may have one or more features of the lower section of the stabilization claim 1304 shown in Figure 11. For example, the lower sections of the jaw portions 1416 and 1516 of the stabilization clamps 1404 and 1504 may include a pivot point and a spring member seated in a spring seat, similar to the pivot point 1322 and spring member 1332 of the stabilization clamp 1304. In some embodiments, the lower sections of the jaw portions 1416, 1516 of the stabilizing clamps 1404, 1504 may include additional or alternative features compared to the stabilizing clamp 1304. Furthermore, the base portions of the stabilizing clamps 1404, 1504 may have one or more features of the base portion 1008, which is configured to be slidably coupled to a rail, as described above and as shown in Figures 10A and 10B, although not shown. For example, the base portion may be a fixed base portion attached to or integrated with a stabilizing table. In another embodiment, the base portion may include a coupler (e.g., a snap-fit ​​coupler, a screw coupler, etc.) configured to be coupled to a mating partner on a stabilizing table.

[0176] As seen in Figures 12 and 13, the jaw portions 1416, 1516 may include, or be formed by, fixed jaw members 1418, 1518 and movable jaw members 1420, 1520. In some embodiments, the movable jaw members 1420, 1520 may be levers that rotate on or around a pivot point on the fixed jaw members 1418, 1518. In other embodiments, the levers may rotate on or around a pivot point on the base portions of the stabilizing clamps 1404, 1504. Although not shown, the base portions may form one end (e.g., the lower end) of the stabilizing clamp, and the fixed jaw members 1418, 1518 may extend from the base portions. In some embodiments, the fixed jaw members 1418, 1508 may be mounted or attached to the base portions. In some embodiments, the fixed jaw members 1418, 1518 may be integrated with the base portions.

[0177] The fixed jaw members 1418, 1518 may include curved inner walls 1424, 1524, and the movable jaw members 1420, 1520 may include curved inner walls 1426, 1526. The curved inner walls 1424, 1524 and the curved inner walls 1426, 1526 may collaboratively define the mouth portions 1428, 1528 of the clamps 1404, 1504. In some embodiments, the mouth portions 1428, 1528 may form a substantially cylindrical space or void configured to receive a distal cap of a delivery device or guide catheter handle, such as a cap 107, 232, 307, 1107, 1232 or other caps or other parts of the handle of a delivery device or guide catheter. The mouth portions 1428 and 1528 may have openings 1430 and 1530 at the opposing ends (e.g., upper ends) of the stabilizing clamps 1404 and 1504 relative to the base portion (not shown).

[0178] The movable jaw members 1420, 1520 may be configured to move or rotate between an open position and a closed position for opening and closing the mouths 1428, 1528. The openings 1430, 1530 to the mouth portions 1428, 1528 can be made wider in the open position of the movable jaw members 1420, 1520 to allow insertion (or removal) of the distal cap of the handle, and can be made narrower in the closed position of the movable jaw members 1420, 1520 to allow retention of the distal cap of the handle within them.

[0179] As described above with reference to the stabilizing clamp 1304 in Figure 11, in some embodiments, the spring member can bias the movable jaw member to the closed position, enabling clamping or compression force to be applied to the outer surface of the distal cap or handle located within the openings 1428, 1528. Furthermore, the movable jaw members 1420, 1520 may include extensions 1434, 1534 configured to be pressed by an operator to overcome the biasing force of the spring member and move the movable jaw members 1420, 1520 to the open position. Furthermore, the spring member of the stabilizing clamps 1404, 1504 may have one or more of the features described above with reference to the spring member 1332, or additional or alternative features.

[0180] In some embodiments, such as the exemplary stabilizing clamp 1404 shown in Figure 12, the surface area of ​​the curved inner wall 1426 of the movable jaw member 1420 may be smaller than the surface area of ​​the curved inner wall 1424 of the fixed jaw member 1418. In some embodiments, the curved inner wall 1426 of the movable jaw member 1420 may include a retracted or recessed lip 1438 in the opening 1430 of the mouth portion 1428. In some embodiments, when the movable jaw member 1420 is in the closed position, the retracted or recessed lip 1438 is at a greater distance from the vertical axis of the mouth portion than the (non-retracted) lip 1440 of the fixed jaw member 1418.

[0181] In such embodiments, the reduced surface area of ​​the curved inner wall 1426 of the movable jaw member 1420 at the opening 1430 of the mouth 1428 can reduce the torque resistance in a first rotational direction away from the movable jaw member (lever) (for example, counterclockwise in the embodiment of Figure 12) compared to a curved inner wall having the same configuration as the curved inner wall 1424 or the same surface area as the curved inner wall 1424 of the fixed jaw member 1418. For example, when a cap placed therein rotates away from the movable jaw member (for example, counterclockwise), the point or area of ​​highest friction may occur or be located on the lip of the curved inner wall of the movable jaw member. Therefore, in some embodiments, a reduced or recessed lip 1438 can reduce or eliminate the high-friction point or area of ​​the curved inner wall 1426, thereby reducing the torque resistance to the rotation of a handle attached to or coaxial with the cap when the handle is rotated away from the movable jaw member (for example, counterclockwise in the example of Figure 12).

[0182] Furthermore, as schematically shown in Figure 12, the curved inner wall 1426 may include a textured or coated surface 1446. In some embodiments, the textured or coated surface 1446 is a progressive or gradient surface, including a lower friction region in the first end region 1448 of the curved inner wall 1426 (e.g., the end region of the curved inner wall 1426 adjacent to the lip 1438) and a higher friction region in the second end region 1450 of the curved inner wall 1426 (e.g., the end region of the curved inner wall 1426 facing the lip 1438). In some embodiments, the lower friction region may include a smooth surface and / or a low-friction material coating, and the higher friction region may include a rough surface and / or a high-friction material coating. For example, the surface 1446 may include a plastic substrate having silicone or rubber protrusions (e.g., bumps or beads) placed thereon. The region of higher friction in the second end region 1450 of the curved inner wall 1426 may include protrusions of higher density compared to the region of lower friction in the first end region 1448.

[0183] In such embodiments, the reduction or elimination of high friction points or areas on the curved inner wall 1426 of the movable jaw member 1420 via a recessed lip 1438, combined with a textured surface gradient 1446 on the curved inner wall, can balance the torque resistance and / or provide the torque resistance required to rotate the handle away from the movable jaw member (for example, counterclockwise in the embodiment of Figure 12), which is close to the torque resistance required to rotate the handle in the opposite direction toward the movable jaw member (for example, clockwise in Figure 12).

[0184] In some embodiments, the stabilizing clamp 1404 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2. In some embodiments, the stabilizing clamp 1404 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.9 to 1.1. In some embodiments, the stabilizing clamp 1404 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is approximately 1.0.

[0185] In some embodiments, a progressive or gradient textured surface on the curved inner wall of a movable jaw member is sufficient to balance the torque resistance, and the curved inner wall of a movable jaw member may include a non-recessed lip or have a configuration similar to that of the curved inner wall of a fixed jaw member. For example, as shown in Figure 13, the curved inner wall 1526 of a movable jaw member 1520 may have a surface area approximately equal to or similar to that of the curved inner wall 1524 of a fixed jaw member 1518. In a particular embodiment, the lip 1538 of the curved inner wall 1526 may have a configuration similar to that of the lip 1540 of the curved inner wall 1524, and / or may not be recessed relative to the lip 1540 of the curved inner wall 1524.

[0186] As schematically shown in Figure 13, the curved inner wall 1526 may include a textured surface or a coated surface 1546. In some embodiments, the textured surface or coated surface 1546 is a progressive or gradient surface that includes a lower friction region in the first end region 1548 of the curved inner wall 1526 (e.g., the end region of the curved inner wall 1526 adjacent to the lip 1538) and a higher friction region in the second end region 1550 of the curved inner wall 1526 (e.g., the end region of the curved inner wall 1526 facing the lip 1538). In some embodiments, the lower friction region may include a smooth surface and / or a low-friction material coating, and the higher friction region may include a rough surface and / or a high-friction material coating. For example, the textured surface 1546 may include a plastic substrate having silicone or rubber protrusions (e.g., bumps or beads) placed thereon. The region of higher friction in the second end region 1550 of the curved inner wall 1526 may include a higher density of protrusions compared to the region of lower friction in the first end region 1548.

[0187] In such embodiments, the textured surface gradient 1546 on the curved inner wall 1526 can balance the torque resistance and / or provide the torque resistance required to rotate the handle away from the movable jaw member (for example, counterclockwise in the example of Figure 13), which is close to the torque resistance required to rotate the handle in the opposite direction toward the movable jaw member (for example, clockwise in Figure 13).

[0188] In some embodiments, the stabilizing clamp 1504 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2. In some embodiments, the stabilizing clamp 1504 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.9 to 1.1. In some embodiments, the stabilizing clamp 1504 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is approximately 1.0.

[0189] In some embodiments, the curved inner walls 1424 (Figure 12) and / or curved inner walls 1524 (Figure 13) may include a coated or textured surface. In some embodiments, the curved inner walls 1424, 1524 may include a surface with a gradient that extends from a region of higher friction to a region of lower friction. In some embodiments, the curved inner walls 1424, 1524 may include a surface that includes a continuous surface having a desired coefficient of friction (e.g., a high-coefficient surface or a low-coefficient surface). In some embodiments, the coated or textured surface on the curved inner walls 1424, 1524 allows for balancing the torque resistance to the rotation of the handle coupled to the clamp in the first direction with the torque resistance to the rotation of the handle in the second direction. For example, a coating or textured surface on curved inner walls 1424, 1524, combined with a coating or textured surface on curved inner walls 1426, 1526, allows for a desired or specified ratio (e.g., within the exemplary range and / or corresponding ratio as described above) of torque resistance to rotation in a first direction of the handle and torque resistance to rotation in a second opposite direction of the handle.

[0190] In some embodiments, if the curved inner walls 1424, 1524 on the fixed jaw members 1418, 1518 include a coated or textured surface, the opposing curved inner walls 1426, 1526 on the movable jaw members 1420, 1520 may be a smooth or low-friction surface. In such embodiments, the fixed jaw members 1418, 1518 can provide all or most of the friction necessary to hold the distal cap (or other portion) of the handle of the delivery device or guide catheter in place within the mouth portion 1428, 1528, while the movable jaw members 1420, 1520 apply little to no friction to the distal cap. In such embodiments, the opening and closing of the movable jaw members 1420, 1520 can be reduced and / or minimized during torque application to the handle, thereby equalizing and / or balancing the torque for counterclockwise and clockwise rotation of the handle. For example, the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction can be in the range of 0.8 to 1.2, such as 0.9 to 1.1, or the ratio can be approximately 1.0.

[0191] Figure 14 shows another exemplary stabilization clamp 1604 according to the present disclosure. Specifically, Figure 14 shows the jaw portion 1616 of the stabilization clamp 1604. The base portion of the stabilization clamp 1604 is not shown but may have one or more features of the base portion 1008 configured to be slidably coupled to a rail, as described above and shown in Figures 10A and 10B, or otherwise. For example, the base portion of the stabilization clamp 1604 may be a fixed base portion attached to or integrated with a stabilization table. In another embodiment, the base portion may include a coupler (e.g., a snap-fit ​​coupler, a screw coupler, etc.) configured to couple to a mating partner on a stabilization table.

[0192] As shown in Figure 14, the jaw portion 1616 may include, or be formed by, a fixed jaw member 1618 and a movable jaw member 1620. In some embodiments, the movable jaw member 1620 may be a lever that rotates on or around a pivot point 1622 on the fixed jaw member 1618. In other embodiments, the lever may rotate on or around a pivot point on the base portion of the stabilizing clamp. Although not shown, the base portion may form one end (e.g., the lower end) of the stabilizing clamp 1604, and the fixed jaw member 1618 may extend from the base portion. In some embodiments, the fixed jaw member 1618 may be mounted or attached to the base portion. In some embodiments, the fixed jaw member 1618 may be integrated with the base portion.

[0193] The fixed jaw member 1618 and the movable jaw member 1620 may each include curved inner walls 1624, 1626 that cooperatively define the mouth portion 1628. In some embodiments, the mouth portion 1628 may form a substantially cylindrical space or void configured to receive the distal cap of the delivery device or guide catheter handle, such as the caps 107, 232, 307, 1107, 1232 or other parts of the handle of the delivery device or guide catheter. The mouth portion 1628 may have an opening 1630 at the opposing end (e.g., the upper end) of the stabilizing clamp 1604 relative to the base portion (not shown).

[0194] The movable jaw member 1620 may be configured to move or rotate between an open position and a closed position for opening and closing the mouth 1628. The opening 1630 to the mouth portion 1628 can be made wider in the open position of the movable jaw member 1620 to allow insertion (or removal) of the distal cap of the handle, and can be made narrower in the closed position of the movable jaw member 1620 to allow retention of the distal cap of the handle within it.

[0195] In some embodiments, the spring member 1632 may be positioned between the fixed jaw member 1618 (or base portion) and the movable jaw member 1620. The spring member 1632 may be configured to bias the movable jaw member 1620 toward the closed position, enabling the application of a clamping or compressive force to the outer surface of the distal cap (or other part of the handle) positioned within the mouth 1628. Furthermore, the distal cap may be sandwiched or captured between the curved inner walls 1624 and 1626 when the mouth 1628 is in the closed position via the force applied by the spring member 1632 to the fixed jaw member 1618 and the movable jaw member 1620. As shown in the illustrated embodiment, the spring member 1632 may be a coil member having a first end held in a spring seat 1642 within the fixed jaw member 1618 and a second end held in a spring seat 1644 within the movable jaw member 1320. In some embodiments, the spring member 1632 has one or more of the features and / or variations described above with reference to the spring member 1332 in Figure 11. In some embodiments, the spring member 1632 may be one or more spring members, such as two spring members 1632 in a side-by-side arrangement. In some embodiments, the spring member 1632 includes additional or alternative features.

[0196] The movable jaw member 1620 may include an extension 1634 configured to be pressed by an operator to overcome the biasing force of the spring member 1632 and move the movable jaw member 1620 to the open position. In some embodiments, the extension 1634 may include surface features or ribs 1636 configured to facilitate gripping on the extension 1634.

[0197] Unlike the stabilization clamp 1304, the stabilization clamp 1604 may further include a locking mechanism or locking portion 1652 configured to selectively hold or lock the position of the movable jaw member 1620 relative to the fixed jaw member 1618. In some embodiments, the locking mechanism 1652 includes an actuator or control 1654 (e.g., a button, switch, slider, etc.) located on an extension 1634, which can be operated by the user to engage and / or disengage the shaft 1656 of the locking mechanism 1652 from the fixed jaw member 1618 or a base portion (not shown). When the shaft 1656 of the locking mechanism is engaged (as shown in Figure 14), the movement of the movable jaw member 1620 is restricted relative to the fixed jaw member 1618, and the jaw portion 1628 can be held in a closed position. When the locking mechanism shaft 1656 is disengaged (not shown), the movable jaw member 1620 is rotatable or movable relative to the fixed jaw member 1618, and the jaw portion 1628 can be moved to the open position.

[0198] In some embodiments, the surface area of ​​the curved inner wall 1626 of the movable jaw member 1620 may be smaller than the surface area of ​​the curved inner wall 1624 of the fixed jaw member 1618. In some embodiments, the curved inner wall 1626 of the movable jaw member 1620 includes a retracted or recessed lip 1638 at the opening 1630 of the mouth portion 1628. In some embodiments, when the movable jaw member 1420 is in the closed position, the retracted or recessed lip 1638 is at a greater distance from the vertical axis of the mouth portion than the (non-retracted) lip 1640 of the fixed jaw member 1618.

[0199] In such embodiments, the reduced surface area of ​​the curved inner wall 1626 of the movable jaw member 1620 at the opening 1630 of mouth 1628 can reduce the torque resistance in a first rotational direction away from the movable jaw member (lever) (for example, counterclockwise in the embodiment of Figure 14) to a curved inner wall having the same configuration as the curved inner wall 1624 or an equal surface area to the curved inner wall 1624 of the fixed jaw member 1618. For example, when a cap placed therein rotates away from the movable jaw member (for example, counterclockwise), the point or area of ​​highest friction may occur or be located on the lip of the curved inner wall of the movable jaw member. Therefore, in some embodiments, the reduced or recessed lip 1638 can reduce or eliminate high-friction points or areas on the curved inner wall 1626, thereby reducing torque resistance to the rotation of the handle attached to or coaxial with the distal cap when the handle is rotated away from the movable jaw member 1620 (for example, counterclockwise in the example of Figure 14).

[0200] Although not shown, in some embodiments the curved inner wall 1626 may further include a textured surface or coating or textured surface or coating gradient similar to the textured surface gradient 1446 described above with reference to Figure 14. In some embodiments including a textured surface gradient, the lip of the curved inner wall 1626 may be non-recessed or have a configuration similar to the lip 1640 of the curved inner wall of the fixed jaw member 1618 (similar to the stabilizing clamp 1504 shown in Figure 13). In some embodiments the curved inner wall 1624 may include a textured surface or coated surface that is a gradient from a higher friction region to a lower friction region, or a continuous surface with a specific coefficient of friction (as described above).

[0201] In some embodiments, the reduction or elimination of high friction points or areas on the curved inner wall 1626 of the movable jaw member 1620 by the inclusion of a recessed lip 1638 and / or the inclusion of a textured surface gradient to the curved inner wall 1626 can balance the torque resistance and / or provide the torque resistance required to rotate the handle away from the movable jaw member (for example, counterclockwise in the embodiment of Figure 14), and that is close to the torque resistance required to rotate the handle in the opposite direction toward the movable jaw member (for example, clockwise in the embodiment of Figure 14).

[0202] Furthermore, in embodiments where the curved inner wall of the movable member includes a recessed lip and / or textured surface gradient, when the shaft 1656 of the locking mechanism 1652 engages, the locking mechanism 1652 can further balance the torque resistance and / or provide the torque resistance required to rotate the handle away from the movable jaw member (for example, counterclockwise in the embodiment of Figure 14), which is close to the torque resistance required to rotate the handle toward the movable jaw member in the opposite direction (for example, clockwise in the embodiment of Figure 14) by resisting or limiting the movement of the movable member 1620.

[0203] Alternatively, in embodiments where a recessed lip and / or textured surface gradient is excluded from the curved inner wall of the movable member, when the shaft 1656 of the locking mechanism 1652 engages, the locking mechanism 1652 can balance the torque resistance and / or provide the torque resistance required to rotate the handle away from the movable jaw member (for example, counterclockwise in the embodiment of Figure 14), which is close to the torque resistance required to rotate the handle toward the movable jaw member in the opposite direction (for example, clockwise in the embodiment of Figure 14) by resisting or limiting the movement of the movable member 1620.

[0204] In some embodiments, the stabilizing clamp 1604 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2. In some embodiments, the stabilizing clamp 1604 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.9 to 1.1. In some embodiments, the stabilizing clamp 1604 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is approximately 1.0.

[0205] The locking mechanism 1652 shown is merely illustrative, and it will be understood that the stabilizing clamp 1604 may include locking mechanisms having different configurations. For example, the locking mechanism may include a post or threaded member that can be inserted through a portion of the movable jaw member 1620 and the fixed jaw member 1618 to hold the position of the movable jaw 1620 relative to the fixed jaw member 1618 or to restrict its movement.

[0206] Figure 15 shows another exemplary stabilization clamp 1704 according to the present disclosure. Specifically, Figure 15 shows the jaw portion 1716 of the stabilization clamp 1704. The base portion of the stabilization clamp 1704 is not shown but may have one or more features of the base portion 1008 configured to be slidably coupled to a rail, as described above and shown in Figures 10A and 10B, or other features or configurations. For example, the base portion of the stabilization clamp 1704 may be a fixed base portion attached to or integrated with a stabilization table. In another embodiment, the base portion may include a coupler (e.g., a snap-fit ​​coupler, a screw coupler, etc.) configured to couple to a mating partner on a stabilization table.

[0207] Unlike the stabilization clamps 1304, 1404, 1504, and 1604, the stabilization clamp 1704 can be a dual-lever stabilization clamp. For example, as shown in Figure 15, the jaw portion 1716 may include or be formed by a first movable jaw member 1720a and a second movable jaw member 1720b. In some embodiments, each of the movable jaw members 1720a, 1720b may be a lever that rotates on or around a pivot point 1722 on the fixed portion 1758 of the stabilization clamp 1704, either coaxial with or attached to the base portion. In other embodiments, the lever may rotate on or around a pivot point on the base portion of the stabilization clamp 1704.

[0208] The movable jaw members 1720a and 1720b may each include curved inner walls 1726a and 1726b that cooperatively define the mouth portion 1728. In some embodiments, the mouth portion 1728 may form a substantially cylindrical space or void configured to receive the distal cap of the delivery device or guide catheter handle, such as the caps 107, 232, 307, 1107, 1232 or other parts of the handle of the delivery device or guide catheter. The mouth portion 1728 may have an opening 1730 at the opposing end (e.g., the upper end) of the stabilizing clamp 1704 relative to the base portion (not shown).

[0209] The movable jaw members 1720a and 1720b may be configured to move or rotate between an open position and a closed position for opening and closing the mouth 1728. The opening 1730 to the mouth portion 1728 can be made wider in the open position of the movable jaw members 1720a and 1720b to allow insertion (or removal) of the distal cap of the handle, and can be made narrower in the closed position of the movable jaw members 1720a and 1720b to allow retention of the distal cap of the handle within it.

[0210] In some embodiments, spring members 1732a, 1732b may be positioned between the fixed portion 1758 (or base portion) and the movable jaw members 1720a, 1720b. The spring members 1732a, 1732b may be configured to bias the movable jaw members 1720a, 1720b toward the closed position, enabling clamping or compression force to be applied to the outer surface of the distal cap (or other part of the handle) positioned within the opening 1728. Furthermore, the distal cap may be sandwiched or captured between the curved inner walls 1726a and 1726b when the opening 1728 is in the closed position via the force applied to the fixed portion 1758 and the movable jaw members 1720a, 1720b by the spring members 1732a, 1732b. As shown in the illustrated embodiment, the spring members 1732a and 1732b may be coil members having a first end held within the spring seats 1742a and 1742b in the fixed portion 1758, and a second end held within the spring seats 1744a and 1744b in the movable jaw members 1720a and 1720b.

[0211] In some embodiments, spring members 1732a and 1732b have one or more of the features and / or variations described above with reference to spring member 1332 in Figure 11. In some embodiments, each of spring members 1732a and 1732b may be one or more spring members, such as two spring members 1732a and two spring members 1732b arranged side by side. In some embodiments, spring members 1732a and 1732b include additional or alternative features. In some embodiments, spring members 1732a and 1732b have the same configuration or orientation. In some embodiments, spring members 1732a and 1732b each have different configurations or orientations.

[0212] The movable jaw members 1720a and 1720b may include extensions 1734a and 1734b configured to be pressed by an operator in order to overcome the biasing force of the spring members 1732a and 1732b and move the movable jaw members 1720a and 1720b to the open position.

[0213] In some embodiments, the configurations of the curved inner walls 1726a and 1726b may be similar or identical. For example, the surface area and shape of the lips 1738a and 1738b at the opening 1730 of the mouth portion 1728 may be the same or similar to those of the curved inner walls 1726a and 1726b. In some embodiments, the curved inner walls 1726a and 1726b may have different configurations.

[0214] In some embodiments, the curved inner walls 1726a, 1726b may further include a textured surface or coating, or a textured surface or coated surface gradient, or may be a continuous surface having a specific coefficient of friction, similar to the embodiments described above with reference to Figures 14 and 15.

[0215] In some embodiments, the stabilizing clamp 1704 may further include a coupler 1760 positioned between the movable jaw members 1720a and 1720b. In some embodiments, the coupler may be configured to connect the movable jaw members 1720a and 1720b such that the opening and / or rotation of one of the movable jaw members 1720a and 1720b causes or results in the opening or rotation of the other of the movable jaw members 1720a and 1720b. For example, pressing the extension 1734b causes the movable jaw member 1720a to rotate away from the longitudinal axis of the stabilizing clamp 1704, which in turn causes the movable jaw member 1720b to rotate away from the longitudinal axis of the stabilizing clamp 1704 via the coupler 1760. In another embodiment, pressing the extension 1734b causes rotation of the movable jaw member 1720b so as to move away from the longitudinal axis of the stabilizing clamp 1704, which in turn causes rotation of the movable jaw member 1720a so as to move away from the longitudinal axis of the stabilizing clamp 1704 via the coupler 1760.

[0216] In some embodiments, a coupler 1760 positioned between dual levers (movable jaw members 1720a, 1720b) ​​can be used to balance torque resistance to rotation in a first direction of the handle (e.g., counterclockwise in the embodiment of Figure 15) and torque resistance to rotation in a second opposite direction of the handle (e.g., clockwise in the embodiment of Figure 15). For example, in the embodiment shown, counterclockwise rotation of the distal cap of the handle positioned within the mouth portion 1728 can move or rotate (at least partially) the movable jaw member 1720a so as to move away from the longitudinal axis of the stabilizing clamp 1704, which in turn results in rotation of the movable jaw member 1720b via the coupler 1760 so as to move away from the longitudinal axis of the stabilizing clamp 1704. In another embodiment, clockwise rotation of the distal cap of the handle located within the mouth portion 1728 can move or rotate (at least partially) the movable jaw member 1720b so as to move away from the longitudinal axis of the stabilizing clamp 1704, which in turn results in rotation of the movable jaw member 1720a so as to move away from the longitudinal axis of the stabilizing clamp 1704 via the coupler 1760. In some embodiments, the coupler 1760 may be omitted from the stabilizing clamp 1704. For example, the movable jaw members 1720a and 1720b may be independently movable and require similar torque to the rotation of the handle coupled thereto in a first direction for rotation of the handle in a second direction. In such embodiments, rotating the handle counterclockwise can move the movable jaw member 1720a away from the central axis while pulling the movable jaw member 1720b toward the central axis, and rotating the handle clockwise can move the movable jaw member 1720b away from the central axis while pulling the movable jaw member 1720a toward the central axis.In some embodiments, the stabilizing clamp 1704 may further include a stop structure (e.g., a stop structure on or near the pivot point 1722) for each of the movable jaw members 1720a, 1720b, so that when one of the jaw members is opened to insert or remove the other part of the cap or handle, the opposing jaw member remains in place and does not rotate beyond the central axis of the stabilizing clamp.

[0217] In some embodiments, the stabilizing clamp 1704 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2. In some embodiments, the stabilizing clamp 1704 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.9 to 1.1. In some embodiments, the stabilizing clamp 1704 is configured such that the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is approximately 1.0.

[0218] Any system, device, apparatus, etc. described herein may be sterilized (e.g., by heating / heat, pressure, steam, radiation and / or chemicals) to ensure safe use for patients, and any method described herein may include sterilization of the relevant system, device, apparatus, etc. as one of the steps of the method. Examples of sterilization by heating / heat include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet rays and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde and glutaraldehyde. Sterilization by hydrogen peroxide may be achieved, for example, by using hydrogen peroxide plasma.

[0219] The therapeutic techniques, methods, and procedures described or suggested in this disclosure or the reference materials incorporated herein may be performed on living animals or on non-living simulations such as corpses, corpse hearts, anthropomorphic ghosts, or simulators (e.g., simulations using body parts, tissues, etc.).

[0220] delivery technology To implant the prosthetic valve into the original aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned inside the original aortic valve and expanded radially (for example, by inflating a balloon, by driving one or more actuators of the delivery device, or by deploying the prosthetic valve from the sheath to make it self-expandable). Alternatively, the prosthetic valve can be implanted inside the original aortic valve via a transapical procedure, in which case the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve can be positioned inside the original aortic valve. Alternatively, in transaortic procedures, the prosthetic valve (on the distal end of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J-sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta towards the original aortic valve.

[0221] To implant the prosthetic valve into the original mitral valve via a transseptal delivery approach, the prosthetic valve is installed in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava, and through the inferior vena cava into the right atrium, across the atrial septum (through a puncture performed within the atrial septum) into the left atrium, and toward the original mitral valve. Alternatively, the prosthetic valve can be implanted into the original mitral valve via a transapical procedure, in which case the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and at the apex of the heart, and the prosthetic valve can be positioned within the original mitral valve.

[0222] To implant a prosthetic valve into the original tricuspid valve, the prosthetic valve is installed in a radially compressed state along the distal end of the delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral vein, advanced into the inferior vena cava, and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the original tricuspid valve. A similar approach can be used to implant a prosthetic valve into the original pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the original tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0223] Another delivery approach is the transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through a chest incision and an incision formed through the atrial wall (the atrial wall of the right or left atrium) to access one of the original heart valves. Atrial delivery can also be performed intravascularly, for example, through the pulmonary vein. Yet another delivery approach is the transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through a chest incision and an incision formed through the wall of the right ventricle (typically the base of the heart or nearby) to implant the prosthetic valve inside the original tricuspid valve, or inside the original pulmonary valve, or inside the pulmonary artery.

[0224] In all delivery approaches, the delivery device can be advanced along a guidewire previously inserted into the patient's vascular structure. Furthermore, the disclosed delivery approaches are not intended to be limiting. Any artificial valve disclosed herein can be implanted using any variety of delivery procedures and any variety of delivery devices known in the art.

[0225] The therapeutic techniques, methods, and procedures described or suggested in this disclosure or the reference materials incorporated herein may be performed on living animals or on non-living simulations such as corpses, corpse hearts, anthropomorphic ghosts, or simulators (e.g., simulations using body parts, tissues, etc.).

[0226] Additional examples of the disclosed technology In consideration of the implementation forms described above with respect to the subject matter to be disclosed, this application discloses the following additional embodiments. It should be noted that a distinct feature of one embodiment, or two or more features in a combination of such embodiments, and optionally a combination of one or more features in one or more further embodiments, also constitutes further embodiments within the disclosure of this application.

[0227] Example 1. A delivery device system comprising: a delivery device comprising: a handle and a shaft extending distally from the handle and configured for the delivery of an implantable device; and a stabilizing clamp comprising: a base portion and a jaw portion extending from the base portion, a first jaw member having a first curved inner wall and a second jaw member having a second curved inner wall, wherein the first and second curved inner walls form a mouth configured to receive a portion of the handle, and at least one of the first jaw member or the second jaw member is a lever rotatable around a pivot point for opening and closing the mouth, and at least one spring member configured to bias the lever toward the closed position of the mouth, wherein when the portion of the handle is received in the mouth, the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2.

[0228] Example 2. Any embodiment of the delivery device system disclosed herein, in particular the one described in Example 1, wherein the first jaw member is a first lever rotatably mounted to the base, and the second jaw member is a stationary member mounted to the base and immovable relative to the base.

[0229] Example 3. Any embodiment disclosed herein, in particular Example 1 or 2, of the delivery device system, wherein the first curved inner wall has a reduced surface area with respect to the second curved inner wall.

[0230] Example 4. Any embodiment of the delivery device system disclosed herein, in particular the one described in Examples 1 to 3, wherein the first curved inner wall comprises a first upper lip defining a first side of the opening of the mouth, and the second curved inner wall comprises a second upper lip defining a second side of the opening of the mouth.

[0231] Example 5. Any embodiment of the delivery device system disclosed herein, in particular the one described in Example 4, wherein the first upper lip is recessed relative to the second upper lip.

[0232] Example 6. A delivery device system according to any embodiment disclosed herein, particularly Example 4 or 5, wherein the first curved inner wall further comprises a first lower lip opposite the first upper lip, and the first curved inner wall has a surface gradient including a higher friction surface in the region of the first lower lip and a lower friction surface in the region of the first upper lip.

[0233] Example 7. Any embodiment of the delivery device system described herein, in particular the examples 1 to 6, wherein the stabilizing clamp further comprises a locking portion configured to hold the lever in a position such that the opening is locked in the closed position.

[0234] Example 8. Any embodiment of the delivery device system disclosed herein, in particular the one described in Example 7, wherein the lever further comprises an extension configured to be pressed to rotate the lever to the open position of the opening, and the locking portion comprises an actuator on the extension for releasing the locking portion.

[0235] Example 9. Any embodiment of the delivery device system disclosed herein, in particular the one described in Example 1, wherein the first jaw member is a first lever, the second jaw member is a second lever, and each of the first lever and the second lever is rotatably mounted on the base portion, and the at least one spring comprises a first spring configured to bias the first lever toward the closed position of the mouth, and a second spring member configured to bias the second lever toward the closed position of the mouth.

[0236] Example 10. Any embodiment of the delivery device system disclosed herein, in particular the one described in Example 9, wherein the first lever and the second lever are coupled to each other such that a rotational force is applied toward the open position of the opening on one of the first lever or the second lever, thereby causing the other of the first lever or the second lever to open.

[0237] Example 11. Any embodiment of the delivery device system according to this specification, particularly Examples 1 to 10, wherein the minimum torque required to rotate the handle in one or more of the first or second opposite directions when the portion of the handle is received in the mouth is in the range of 15 N-cm to 30 N-cm.

[0238] Example 12. Any embodiment of the delivery device system described herein, particularly the examples 1 to 11, wherein the base portion is configured to be slidably coupled to a stabilizing rail.

[0239] Example 13. Any embodiment disclosed herein, in particular the delivery device system described in Example 12, wherein the base portion comprises a locking mechanism configured to fix the position of the base portion of the stabilizing clamp on the stabilizing rail.

[0240] Example 14. A stabilizing clamp configured for use with an implant delivery device, wherein the stabilizing clamp comprises a base portion and a jaw portion extending from the base portion, the jaw portion comprising a first jaw member having a first curved inner wall and a second jaw member having a second curved inner wall, wherein the first curved inner wall and the second curved inner wall form a mouth configured to receive a portion of the handle of the implant delivery device, and at least one of the first jaw member or the second jaw member is a lever rotatable around a pivot point for opening and closing the mouth, and at least one spring member configured to bias the lever toward the closed position of the mouth, wherein the stabilizing clamp is configured such that, when the portion of the handle is received in the mouth, the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.2.

[0241] Example 15. Any embodiment disclosed herein, in particular the stabilizing clamp according to Example 14, wherein the first jaw member is a first lever rotatably mounted to the base, and the second jaw member is a stationary member mounted to the base and immovable relative to the base.

[0242] Example 16. Any embodiment disclosed herein, in particular the stabilizing clamp according to Example 15, further comprising a locking portion configured to hold the position of the first lever such that the opening is locked in the closed position.

[0243] Example 17. Any embodiment of the stabilizing clamp described herein, particularly the embodiments described in Examples 14-16, wherein the first curved inner wall comprises a first upper lip defining a first side of the opening of the mouth, and the second curved inner wall comprises a second upper lip defining a second side of the opening of the mouth.

[0244] Example 18. Any embodiment disclosed herein, in particular the stabilizing clamp described in Example 17, wherein the first upper lip is recessed relative to the second upper lip, and the first curved inner wall has a reduced surface area relative to the second curved inner wall.

[0245] Example 19. A stabilizing clamp according to any embodiment disclosed herein, particularly Example 17 or 18, wherein the first curved inner wall further comprises a first lower lip opposite the first upper lip, and the first curved inner wall has a textured surface gradient including a high-friction surface in the region of the first lower lip and a low-friction surface in the region of the first upper lip.

[0246] Example 20. Any embodiment of the stabilizing clamp disclosed herein, in particular Example 14, wherein the first jaw member is a first lever, the second jaw member is a second lever, and each of the first lever and the second lever is rotatably mounted on the base portion, and the at least one spring comprises a first spring configured to bias the first lever toward the closed position of the mouth, and a second spring member configured to bias the second lever toward the closed position of the mouth.

[0247] Example 21. Any embodiment disclosed herein, in particular the stabilization clamp according to Example 20, wherein the first lever and the second lever are coupled to each other such that a rotational force is applied toward the open position of the opening on one of the first lever or the second lever, resulting in the opening of the other of the first lever or the second lever.

[0248] Example 22. Any embodiment disclosed herein, in particular the stabilizing clamp according to Examples 14-21, wherein the stabilizing clamp is configured such that the minimum torque applied to overcome the tightening force of the stabilizing clamp when the portion of the handle is received in the mouth is at least 21 N-cm.

[0249] Example 23. A method for operating a delivery device system, the method comprising the step of inserting a portion of a first handle of a first delivery device into the opening of a first stabilizing clamp, wherein the first stabilizing clamp comprises a base portion attached to a stabilizing rail or table, a first jaw member extending from the base portion, and a second jaw member, wherein the opening is defined by a first curved inner wall of the first jaw member and a second curved inner wall of the second jaw member, and at least one of the first jaw member or the second jaw member is a lever rotatable around a pivot point for opening and closing the opening, and the first stabilizing clamp attaches the lever toward the closed position of the opening. A method comprising the steps of: inserting; rotating the first handle in a first direction to transmit torque to a first shaft coupled to the first handle; and rotating the first handle in a second opposite direction to transmit torque to the first shaft coupled to the first handle, wherein the first stabilizing clamp is configured such that, when the portion of the first handle is received in its opening, the ratio of the torque resistance of the first handle to rotation in the first direction to the torque resistance of the first handle to rotation in the second opposite direction is in the range of 0.8 to 1.2.

[0250] Example 24. Any embodiment disclosed herein, in particular the method of Example 23, further comprising the step of acting on a rotatable knob on the first handle, wherein the tightening force of the stabilizing clamp resists the movement of the first handle during the acting of the rotatable knob.

[0251] Example 25. Any embodiment disclosed herein, particularly the method of Example 24, wherein the stabilizing clamp is configured such that the minimum torque required to overcome the tightening force of the stabilizing clamp is at least 21 N-cm when the portion of the handle is received in the mouth.

[0252] Example 26. Any embodiment disclosed herein, particularly the method according to Examples 23-25, wherein the first jaw member is a first lever rotatably mounted to the base, and the second jaw member is a stationary member mounted to the base and immovable relative to the base.

[0253] Example 27. Any embodiment disclosed herein, in particular the method of Example 26, wherein the stabilizing clamp further comprises a locking portion configured to hold the position of the first lever such that the opening is locked in the closed position.

[0254] Example 28. Any embodiment disclosed herein, particularly the method of Example 26 or 27, wherein the first curved inner wall comprises a first upper lip defining a first side of the opening of the mouth, and the second curved inner wall comprises a second upper lip defining a second side of the opening of the mouth.

[0255] Example 29. Any embodiment disclosed herein, particularly the method of Example 28, wherein the first upper lip is recessed relative to the second upper lip, and the first curved inner wall has a reduced surface area relative to the second curved inner wall.

[0256] Example 30. Any embodiment disclosed herein, particularly the method of Example 28 or 29, wherein the first curved inner wall further includes a first lower lip opposite the first upper lip, and the first curved inner wall has a textured surface gradient including a higher friction surface in the region of the first lower lip and a lower friction surface in the region of the first upper lip.

[0257] Example 31. Any embodiment disclosed herein, particularly the method according to Examples 23-25, wherein the first jaw member is a first lever, the second jaw member is a second lever, and each of the first lever and the second lever is rotatably mounted on the base portion, and the at least one spring comprises a first spring member configured to bias the first lever toward the closed position of the mouth, and a second spring member configured to bias the second lever toward the closed position of the mouth.

[0258] Example 32. Any embodiment disclosed herein, in particular the method according to Example 31, wherein the first lever and the second lever are coupled to each other such that a rotational force is applied toward the open position of the opening on one of the first lever or the second lever, resulting in the opening of the other of the first lever or the second lever.

[0259] Example 33. Inserting a delivery shaft of a second delivery device through the lumen of the first handle and the first shaft, wherein the first shaft is a guide catheter and the delivery shaft includes an implantable device coupled to its distal end region; and inserting a portion of the second handle of the second delivery device into the opening of a second stabilizing clamp, wherein the second stabilizing clamp comprises a base portion attached to the stabilizing rail or table, a first jaw member extending from the base portion, and a second jaw member, wherein the opening is defined by a first curved inner wall of the first jaw member and a second curved inner wall of the second jaw member, and at least one of the first jaw member or the second jaw member is a lever rotatable around a pivot point for opening and closing the opening. - The method according to any embodiment disclosed herein, in particular embodiment 23, comprising the steps of inserting, rotating the second handle in a first direction to transmit torque to the delivery shaft coupled to the second handle, and rotating the second handle in a second opposite direction to transmit torque to the delivery shaft coupled to the second handle, wherein the second stabilizing clamp is configured such that, when the portion of the second handle is received in its opening, the ratio of the torque resistance of the second handle to rotation in the first direction to the torque resistance of the second handle to rotation in the second opposite direction is in the range of 0.8 to 1.

[0260] Features described herein in relation to any embodiment can be combined with other configurations described in one or more other embodiments, unless otherwise specified. For example, any one or more features of one stabilizing clamp can be combined with any one or more features of another stabilizing clamp. As another example, any one or more features of one delivery device can be combined with any one or more features of another delivery device.

[0261] Considering the many possible ways in which the principles of this disclosure may be applied, it will be recognized that the illustrated configurations illustrate examples of the disclosed technology and should not be considered as limiting the scope of this disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A delivery device system, A delivery device, The handlebars and A delivery device comprising: a shaft extending distally from the handle, configured for the delivery of an implantable device; It comprises a base portion and a stabilizing clamp having a jaw portion extending from the base portion, The jaw portion, A first jaw member having a first curved inner wall, A second jaw member having a second curved inner wall, wherein the first curved inner wall and the second curved inner wall form an opening configured to receive a portion of the handle, and at least one of the first jaw member or the second jaw member is a lever rotatable around a pivot point for opening and closing the opening, The lever comprises at least one spring member configured to bias the opening toward the closed position, A delivery device system in which, when the portion of the handle is received in the mouth, the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.8 to 1.

2.

2. The delivery device system according to claim 1, wherein the first jaw member is a first lever rotatably attached to the base portion, and the second jaw member is a stationary member attached to the base portion and immovable relative to the base portion.

3. The delivery device system according to claim 1 or 2, wherein the first curved inner wall has a reduced surface area with respect to the second curved inner wall.

4. A delivery device system according to any one of claims 1 to 3, wherein the first curved inner wall comprises a first upper lip defining a first side of the opening of the mouth, and the second curved inner wall comprises a second upper lip defining a second side of the opening of the mouth, and the first upper lip is recessed relative to the second upper lip.

5. The delivery device system according to claim 4, wherein the first curved inner wall further comprises a first lower lip opposite the first upper lip, and the first curved inner wall has a surface gradient including a higher friction surface in the region of the first lower lip and a lower friction surface in the region of the first upper lip.

6. A delivery device system according to any one of claims 1 to 4, wherein one of the first curved inner wall or the second curved inner wall has a higher coefficient of friction than the other of the first curved inner wall or the second curved inner wall.

7. The delivery device system according to any one of claims 1 to 6, wherein the stabilizing clamp further comprises a locking portion configured to hold the position of the lever such that the opening is locked in the closed position.

8. The delivery device system according to claim 7, wherein the lever further comprises an extension configured to be pressed to rotate the lever to the open position of the opening, and the locking portion comprises an actuator on the extension for releasing the locking portion.

9. The delivery device system according to claim 1, wherein the first jaw member is a first lever, the second jaw member is a second lever, and each of the first lever and the second lever is rotatably mounted on the base portion, and the at least one spring comprises a first spring configured to bias the first lever toward the closed position of the mouth, and a second spring member configured to bias the second lever toward the closed position of the mouth.

10. The delivery device system according to claim 9, wherein the first lever and the second lever are coupled to each other such that a rotational force is applied toward the open position of the opening on one of the first lever or the second lever, causing the other of the first lever or the second lever to open.

11. The delivery device system according to any one of claims 1 to 10, wherein, when the portion of the handle is received in the mouth, the minimum torque required to rotate the handle in one or more of the first direction or the second opposite direction is in the range of 15 N-cm to 30 N-cm.

12. The delivery device system according to any one of claims 1 to 11, wherein the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is in the range of 0.9 to 1.

1.

13. The delivery device system according to claim 12, wherein the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is approximately 1.

0.

14. A stabilizing clamp configured for use with an implant delivery device, wherein the stabilizing clamp is The base part, A jaw portion extending from the base portion, A first jaw member having a first curved inner wall, A second jaw member having a second curved inner wall, wherein the first curved inner wall and the second curved inner wall form a mouth configured to receive a portion of the handle of the implant delivery device, and at least one of the first jaw member or the second jaw member is a lever rotatable around a pivot point for opening and closing the mouth, A jaw portion comprising: at least one spring member configured to bias the lever toward the closed position of the mouth, A stabilizing clamp configured such that, when the portion of the handle is received in the opening, the ratio of the torque resistance to rotation of the handle in a first direction to the torque resistance to rotation of the handle in a second opposite direction is within the range of 0.8 to 1.

2.

15. The stabilizing clamp according to claim 14, wherein the first jaw member is a first lever rotatably attached to the base portion, and the second jaw member is a stationary member attached to the base portion and immovable relative to the base portion.

16. The stabilizing clamp according to claim 15, further comprising a locking portion configured to hold the position of the first lever such that the opening is locked in the closed position.

17. A stabilizing clamp according to any one of claims 14 to 16, wherein the first curved inner wall comprises a first upper lip defining a first side of the opening of the mouth, and the second curved inner wall comprises a second upper lip defining a second side of the opening of the mouth.

18. The stabilizing clamp according to claim 17, wherein the first upper lip is recessed relative to the second upper lip, and the first curved inner wall has a reduced surface area relative to the second curved inner wall.

19. The stabilizing clamp according to claim 17 or 18, wherein the first curved inner wall further comprises a first lower lip opposite the first upper lip, and the first curved inner wall has a textured surface gradient including a high-friction surface in the region of the first lower lip and a low-friction surface in the region of the first upper lip.

20. The stabilizing clamp according to claim 14, wherein the first jaw member is a first lever, the second jaw member is a second lever, each of the first lever and the second lever is rotatably mounted on the base portion, and the at least one spring comprises a first spring configured to bias the first lever toward the closed position of the mouth, and a second spring member configured to bias the second lever toward the closed position of the mouth.

21. The stabilizing clamp according to claim 20, wherein the first lever and the second lever are coupled to each other such that a rotational force is applied toward the open position of the opening on one of the first lever or the second lever, causing the other of the first lever or the second lever to open.

22. A stabilizing clamp according to any one of claims 14 to 21, wherein the stabilizing clamp is configured such that the minimum torque applied to overcome the tightening force of the stabilizing clamp when the portion of the handle is received in the opening is at least 21 N-cm.

23. A method for operating a delivery device system, wherein the method is A step of inserting a portion of a first handle of a first delivery device into the opening of a first stabilizing clamp, wherein the first stabilizing clamp comprises a base portion attached to a stabilizing rail or table, a first jaw member extending from the base portion, and a second jaw member, the opening being defined by a first curved inner wall of the first jaw member and a second curved inner wall of the second jaw member, and at least one of the first jaw member or the second jaw member being a lever rotatable around a pivot point for opening and closing the opening, and the first stabilizing clamp further comprising at least one spring member configured to bias the lever toward the closed position of the opening, The steps include rotating the first handle in a first direction to transmit torque to the first shaft connected to the first handle, The step includes rotating the first handle in the opposite direction to the second to transmit torque to the first shaft coupled to the first handle, A method wherein, when the first stabilizing clamp is received in its opening, the ratio of the torque resistance of the first handle to rotation in the first direction to the torque resistance of the first handle to rotation in the second opposite direction is within the range of 0.8 to 1.

2.

24. The method according to claim 23, further comprising the step of operating a rotatable knob on the first handle, wherein the tightening force of the stabilizing clamp resists the movement of the first handle during the operation of the rotatable knob.

25. The method according to claim 24, wherein the stabilizing clamp is configured such that the minimum torque required to overcome the tightening force of the stabilizing clamp is at least 21 N-cm when the portion of the handle is received in the opening.

26. The method according to any one of claims 23 to 25, wherein the first jaw member is a first lever rotatably attached to the base portion, and the second jaw member is a stationary member attached to the base portion and immovable relative to the base portion.

27. The method according to claim 26, wherein the stabilizing clamp further comprises a locking portion configured to hold the position of the first lever such that the opening is locked in the closed position.

28. The method according to claim 26 or 27, wherein the first curved inner wall comprises a first upper lip defining a first side of the opening of the mouth, and the second curved inner wall comprises a second upper lip defining a second side of the opening of the mouth.

29. The method according to claim 28, wherein the first upper lip is recessed relative to the second upper lip, and the first curved inner wall has a reduced surface area relative to the second curved inner wall.

30. The method according to claim 28 or 29, wherein the first curved inner wall further comprises a first lower lip opposite the first upper lip, and the first curved inner wall has a textured surface gradient including a higher friction surface in the region of the first lower lip and a lower friction surface in the region of the first upper lip.

31. The method according to any one of claims 23 to 25, wherein the first jaw member is a first lever, the second jaw member is a second lever, and each of the first lever and the second lever is rotatably mounted on the base portion, and the at least one spring comprises a first spring member configured to bias the first lever toward the closed position of the mouth, and a second spring member configured to bias the second lever toward the closed position of the mouth.

32. The method according to claim 31, wherein the first lever and the second lever are coupled to each other such that a rotational force is applied toward the open position of the opening on one of the first lever or the second lever, causing the other of the first lever or the second lever to open.

33. A step of inserting a delivery shaft of a second delivery device through the lumen of the first handle and the first shaft, wherein the first shaft is a guide catheter and the delivery shaft includes an implantable device coupled to its distal end region, A step of inserting a portion of the second handle of the second delivery device into the opening of a second stabilizing clamp, wherein the second stabilizing clamp comprises a base portion attached to the stabilizing rail or table, a first jaw member extending from the base portion, and a second jaw member, the opening being defined by a first curved inner wall of the first jaw member and a second curved inner wall of the second jaw member, and at least one of the first jaw member or the second jaw member being a lever rotatable around a pivot point for opening and closing the opening, and the second stabilizing clamp further comprising at least one spring member configured to bias the lever toward the closed position of the opening, The steps include rotating the second handle in the first direction to transmit torque to the delivery shaft coupled to the second handle, The step includes rotating the second handle in the opposite direction to the second to transmit torque to the delivery shaft coupled to the second handle, The method according to claim 23, wherein the second stabilizing clamp is configured such that, when the portion of the second handle is received within its opening, the ratio of the torque resistance to rotation of the second handle in the first direction to the torque resistance to rotation of the second handle in the second opposite direction is in the range of 0.8 to 1.2.

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