Delivery device for implantable medical devices

Abstract

To provide a delivery apparatus for a novel implantable medical device.SOLUTION: A delivery apparatus for an expandable, implantable medical device comprises a handle portion, a shaft extending from the handle portion, a delivery capsule configured to house the medical device in a radially compressed state, and a rotatable component disposed in the handle portion and operatively coupled to the delivery capsule to produce axial movement of the delivery capsule upon rotation of the rotatable component. The delivery apparatus further comprises a motor disposed in the handle portion that is operatively coupled to the rotatable component so as to produce rotation of the rotatable component and corresponding axial movement of the delivery capsule. Further, the delivery apparatus comprises a manual deployment tool that is also configured to produce rotation of the rotatable component and corresponding axial movement of the delivery capsule when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component.SELECTED DRAWING: Figure 7

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 000,225, filed Mar. 26, 2020. This provisional patent application is incorporated herein by reference in its entirety.

[0002] Field of the Invention The present disclosure relates to embodiments of delivery devices for implantable medical devices such as artificial valves.

Background Art

[0003] Delivery devices, such as intravascular delivery devices, for example, are utilized in various procedures to deliver an artificial medical device to a body location where surgical access is not readily possible or where access without surgery is desirable. Access to a target location within the body is achieved by a medical professional inserting and guiding a delivery device through a body passage or body cavity, including, but not limited to, for example, blood vessels, the esophagus, the trachea, any part of the gastrointestinal tract, lymphatic vessels, etc. The artificial medical device can include an expandable valve or an expandable device (such as a stent). In one specific example, an expandable artificial heart valve can be attached in a crimped state on the distal end of a delivery device and then deployed from a capsule of the delivery device at the implantation site, whereby the artificial valve can self - expand to its functional size.

[0004] In some embodiments, for ease of use, the delivery device can be motorized by including a motor within the handle portion of the device. During the delivery of an artificial valve, a medical professional operates the motor to retract the capsule and deploy the valve. Rarely, but potentially, electronic components can malfunction. If the motor fails to operate during valve deployment, it can disrupt the valve delivery process.

Prior Art Documents

Patent Documents

[0005] [Patent Document 1] U.S. Patent Application Publication No. 2014 / 0343670 [Patent Document 2] U.S. Patent Application Publication No. 2012 / 0123529 [Patent Document 3] U.S. Patent Application Publication No. 2010 / 0036484 [Patent Document 4] U.S. Patent Application Publication No. 2010 / 0049313 [Patent Document 5] U.S. Patent Application Publication No. 2009 / 0281619 [Patent Document 6] U.S. Provisional Patent Application No. 62 / 945,039 [Patent Document 7] U.S. Patent Application Publication No. 2012 / 0239142 [Patent Document 8] U.S. Provisional Patent Application No. 62 / 824,710 [Patent Document 9] U.S. Patent Application Publication No. 2007 / 0005131 [Patent Document 10] U.S. Patent Application Publication No. 2013 / 0030519 [Overview of the project] [Problems that the invention aims to solve]

[0006] This specification discloses embodiments of an improved delivery device for implantable medical devices (e.g., artificial heart valves) and related methods for using such a device when implanting an implantable medical device in a subject. The delivery device is motor-driven and includes a manual deployment tool that can serve as a backup, or "rescue," means in case the motor malfunctions. [Means for solving the problem]

[0007] In a typical embodiment, the delivery device may include a handle portion used by a medical professional to operate the device. The delivery device may have a shaft extending from the handle portion, a delivery capsule configured to house a medical device in a radially compressed state for delivery into a subject, and a rotatable component disposed within the handle portion, which is operationally coupled to the delivery capsule so as the rotatable component rotates, it causes the delivery capsule to move axially relative to the shaft. The delivery device may have a motor disposed within the handle portion and operationally coupled to the rotatable component so as to cause the rotation of the rotatable component and the corresponding axial movement of the delivery capsule.

[0008] The delivery device may further include a manual deployment tool, such as a pull cord. This manual deployment tool is configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled against the rotatable component, rotation of the rotatable component and corresponding axial movement of the delivery capsule occur.

[0009] For example, if a motor malfunction occurs during the valve deployment process, the user can operate a manual deployment tool to manually complete the deployment process.

[0010] In another representative embodiment, a delivery device for delivering an expandable implantable medical device comprises a handle portion, a shaft extending from the handle portion, a delivery capsule configured to house the medical device in a radially compressed state for delivery into a subject, a rotatable component disposed within the handle portion, which is operationally coupled to the delivery capsule so as to cause the delivery capsule to move axially relative to the shaft when the rotatable component rotates, and which has a plurality of circumferentially arranged gear teeth, a motor disposed within the handle portion and operationally coupled to the rotatable component so as to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule, and a manual deployment tool having a plurality of drive teeth configured to engage with the gear teeth of the rotatable component, which is manually movable along an axis extending through the handle portion so as to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule.

[0011] In another representative embodiment, a method for implanting a medical device in a subject includes the step of inserting the medical device into a blood vessel (or equivalent thereof) of the subject using a delivery device, the medical device being held in a radially compressed state within a delivery capsule of the delivery device. The delivery device comprises a handle portion and a rotatable component housed within the handle portion. Furthermore, the method may include the step of rotating the rotatable component by pulling a pull cord passing through the handle portion, thereby causing axial movement of the delivery capsule relative to the medical device, deploying the medical device from the delivery capsule, and radially expanding the medical device from a radially compressed state to a radially expanded state.

[0012] In another representative embodiment, a method for implanting a medical device in a subject includes the step of inserting the medical device into a blood vessel (or equivalent thereof) of the subject using a delivery device, the medical device being held in a radially compressed state within a delivery capsule of the delivery device, the delivery device comprising a handle portion and a rotatable component housed within the handle portion. Furthermore, the method includes the step of operating an electrical switch to activate a motor operationally coupled to the rotatable component. If the motor is unable to cause movement of the delivery capsule, a pull cord is pulled through the handle portion to rotate the rotatable component, further causing axial movement of the delivery capsule in a first direction relative to the medical device, thereby unfolding the medical device from the delivery capsule and radially expanding the medical device from a radially compressed state to a radially expanded state. Alternatively, if the motor malfunctions when the medical device is partially unfolded from the delivery capsule, the cord is pulled through the handle portion to rotate the rotatable component, further causing axial movement of the delivery capsule in a second direction relative to the medical device, thereby retrieving the partially unfolded medical device.

[0013] In another representative embodiment, a delivery device for an expandable implantable medical device comprises a handle portion, a delivery capsule configured to house the medical device in a radially compressed state for delivery into a subject, a rotatable component disposed within the handle portion and operationally coupled to the delivery capsule such that when the rotatable component rotates, it causes the delivery capsule to move axially relative to the handle portion, and a pull cord configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled relative to the rotatable component, the rotatable component rotates and the delivery capsule moves axially accordingly.

[0014] In other representative embodiments, a medical device for insertion into a subject includes a handle portion, a movable component configured to be inserted into the subject, and a rotatable component disposed within the handle portion. The rotatable component is operatively coupled to the movable component such that when the rotatable component rotates, the movable component is axially displaced relative to the handle portion. The medical device also includes a pull cord configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled relative to the rotatable component, rotation of the rotatable component and corresponding axial displacement of the movable component occur.

[0015] In other representative embodiments, a method of using a medical device includes inserting a movable component of the medical device into a subject, the medical device including a handle portion and a rotatable component within the handle portion, and pulling a pull cord that passes through the handle portion to cause rotation of the rotatable component and corresponding axial displacement of the movable component.

[0016] The foregoing and other objects, features, and advantages of the technology of the present disclosure will become more apparent from the following detailed description taken in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0017] [Figure 1] FIG. 16 is a side elevational view of an exemplary embodiment of an implantable artificial heart valve that can be implanted using any of the delivery devices disclosed herein. [Figure 2] FIG. 19 is a side elevational view of an exemplary embodiment of a delivery device for delivering the artificial heart valve of FIG. 1. [Figure 3] FIG. 22 is a side cross-sectional view of a distal end portion of the delivery device of FIG. 2 showing an artificial valve housed in a compressed state within a delivery capsule. [Figure 4] FIG. 25 is a side elevational view of a distal end portion of the delivery device of FIG. 2 showing the delivery device capsule advanced beyond a portion of the artificial heart valve frame. [Figure 5]Figure 2 is a side elevation view of the handle portion of the delivery device, showing an opening for receiving a manual deployment tool for manually operating the delivery device. [Figure 6] Figure 5 is a side view of the handle portion, showing the housing of the handle portion in cross-section. [Figure 7] Figure 2 is an exploded top-perspective view of the handle portion of the delivery device and an embodiment of a manual deployment tool configured to allow manual deployment or retrieval of the artificial valve from the delivery device. [Figure 8] This is a side cross-sectional view of the handle portion of the delivery device shown in Figure 2. [Figure 9A] Figure 2 is a cross-sectional view of the handle portion of the delivery device, showing the engagement of the manual deployment tool, configured as a pull cord, with the drive gear of the handle portion. [Figure 9B] Figure 2 is a cross-sectional view of the handle portion of the delivery device, showing the engagement of the manual deployment tool, configured as a pull cord, with the drive gear of the handle portion. [Figure 10] This is a side elevation view of a delivery device according to another embodiment. [Figure 11] This is a side view of another embodiment of a manual deployment tool, configured to work in conjunction with a rotatable component of the handle portion of the delivery device, enabling manual deployment or retrieval of the artificial valve from the delivery device. [Figure 12] This is a side view of another embodiment of a manual deployment tool having a coil configuration, which is configured to work in conjunction with a rotatable component of the handle portion of the delivery device to enable manual deployment or retrieval of an artificial valve from the delivery device. [Modes for carrying out the invention]

[0018] General matters For the purposes of this description, several aspects, advantages, and novel features of embodiments of the present disclosure are described herein. These methods, systems, and apparatus described herein should not be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects of the various embodiments disclosed herein, individually and in various combinations and subcombinations. The methods, systems, and apparatus of the present disclosure are not limited to any particular aspect or feature or combination thereof, nor is it essential that any one or more particular advantages or problems are solved by the methods, systems, and apparatus of the present disclosure.

[0019] Any features, wholes, properties, compounds, chemical parts, or groups described in any particular aspect, embodiment, or combination with any example of this disclosure should be understood to be applicable to any other aspect, embodiment, or example described herein, insofar as this does not conflict with the description. Any feature disclosed herein (including the appended claims, abstract, and drawings) and / or any step of any method or process similarly disclosed may be combined in any combination, except for any combination in which at least some of such features and / or steps are mutually exclusive. This disclosure is not limited to any of the details of any of the aforementioned embodiments. The scope of this disclosure extends to any novel one or any novel combination of features disclosed herein (including the appended claims, abstract, and drawings) and any novel one or any novel combination of any step of any method or process similarly disclosed.

[0020] Some operations within the methods of this disclosure are described in a specific sequence for the sake of presentation; however, this description is subject to change in order unless the specific order is required by the specific wording described herein. For example, a series of operations described sequentially may be performed in a different order or simultaneously in some cases. Furthermore, for the sake of simplification, the accompanying drawings may not show various ways in which the methods, systems, and apparatus of this disclosure can be used in combination with other systems, methods, and apparatus.

[0021] In this specification, the phrases “one” and “at least one” include one or more of the elements specifically mentioned. That is, if there are two of a particular element, then one of these elements also exists, and therefore there is “one” element. The phrase “multiple” means two or more of the elements specifically mentioned.

[0022] In this specification, the phrase "and / or" used between the last two elements in an enumerated list means any one or more of the enumerated elements. For example, the expression "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0023] In this specification, the term “combined” generally means physically joined or linked, and does not exclude the existence of intermediate elements between combined items unless there is a specificly contradictory expression.

[0024] Directions and other relative designations (e.g., internal, external, upper, lower, etc.) may be used to facilitate the illustrations and explanations of principles herein, but are not intended to be restrictive. For example, terms such as “internal,” “external,” “top,” “bottom,” “interior,” and “external” may be used. Such terms are used to clarify the explanation to some extent, particularly with respect to the illustrated embodiments, where applicable. However, such terms are not intended to represent absolute relationships, absolute positions, and / or absolute orientations. For example, with respect to an object, the “upper” portion may become the “lower” portion simply by inverting the object. However, the portion remains the same, and the object remains the same object. In this specification, “and / or” means “and” or “or,” and “and” and “or.”

[0025] In the context of this application, the terms “lower” and “upper” are interchangeable with the terms “inflow” and “outflow,” respectively. Therefore, for example, the lower end of a valve is the inflow end of the valve, and the upper end of a valve is the outflow end of the valve.

[0026] In this specification, with respect to artificial heart valves and delivery devices, “proximal” refers to the location, orientation, or portion of a component located closer to the handle of the delivery device, which is located outside the user and / or the subject; “distal” refers to the location, orientation, or portion of a component located further away from the user and / or the handle of the delivery device, and closer to the implantation site. The terms “longitudinal” and “axial” refer to axes extending in the proximal and distal directions, respectively, unless otherwise clearly defined. Furthermore, the term “radial” refers to directions oriented perpendicular to an axis and to each point along the radius from the center of an object (for example, an object whose axis is centrally located, such as the longitudinal axis of an artificial valve).

[0027] Examples of the technology disclosed herein This specification describes examples of motorized delivery devices that may be used to deliver implantable expandable medical devices, such as artificial heart valves. The delivery devices of this disclosure include a manual deployment tool that can be used to operate the device in the event of motor failure, thereby improving the physician's ability to complete the deployment and implantation of the medical device during the procedure. In some representative embodiments, the manual deployment tool is configured as a pull cord that is pulled through an opening in the handle portion of the delivery device to manually operate the device.

[0028] In some embodiments, the delivery device is configured to deliver and implant an artificial heart valve, such as the artificial heart valve illustrated in Figure 1, to a selected implantation site in a subject (e.g., within the natural aortic, mitral, tricuspid, or pulmonary valve). In addition to artificial heart valves, the delivery device of the Disclosure can be adapted to deliver and implant other types of artificial valves (e.g., venous valves) as well as various other types of artificial devices such as stents, grafts, docking devices for artificial heart valves, heart valve repair devices (e.g., leaflet clips), and embolic coils; to position imaging devices and / or their components, including ultrasonic transducers; and to position energy sources such as devices for performing lithotomy, RF sources, ultrasonic emitters, electromagnetic wave sources, laser sources, and heat sources.

[0029] In the various embodiments described herein, delivery devices and delivery methods may be deployed or performed within a subject. Subjects include (but are not limited to) medical patients, diseased animals, animal models, cadavers, and cardiovascular simulators (e.g., human phantoms and explanted tissues). Thus, various embodiments relate to methods for medical procedures, the performance of medical procedures, and / or training for medical procedures. Simulators may include simulations of the whole or part of the vascular system, the whole or part of the heart, and / or whole or partial components of the vascular system (e.g., the whole or part of the ascending aorta). References to natural tissue (e.g., natural heart valves) refer to existing structures within the subject, such as, for example, the natural tissue of a patient or components of a simulator.

[0030] Figure 1 shows an artificial heart valve 10 according to one embodiment, which can be implanted using the delivery device 100 shown in Figure 2. In some embodiments, this artificial heart valve is a self-expanding valve and is delivered to the deployment site in a radially compressed state by the delivery device 100. Once advanced from the delivery capsule (Figure 2) located at the distal end of the delivery device, the artificial valve can self-expand radially to its functional size.

[0031] The artificial heart valve 10 comprises a stent or frame 12 and a valve structure 14 (e.g., a valve leaflet or flap valve) supported by the frame. The frame 12 may have a plurality of interconnected struts 16, which are arranged in a grid pattern and form a plurality of tip portions 18 at each of the inlet end 20 and outlet end 22 of the frame 12.

[0032] The frame 12 may comprise a plurality of angle-separated posts 24 extending from each tip 18 at the outflow end of the frame 12. In the illustrated embodiment, the frame 12 comprises three such posts 24, but more or fewer posts may be used. In one implementation configuration, the frame 12 may have posts extending from all tip 18 at the outflow end of the frame. Each post 24 may have an aperture 26, which may be used to form a releasable connection with the delivery device 100, for example by using one or more cords or tethers 118 (see Figure 3), as will be described further below.

[0033] In some embodiments, the frame 12 may be without a post 24, and the aperture 26 may be formed in the tip 18 at the outflow end of the frame. In the embodiment shown in Figure 3, these apertures are formed at the outflow end of the frame such that, when loaded into the delivery device 100 as will be described further below, a releaseable coupling can be formed between the code manifold 120 and the outflow end of the frame 12 by a code 118. This configuration facilitates the delivery of the prosthetic valve 10 to the natural aortic valve using a retrograde delivery approach, thereby allowing the delivery device 100 to advance through the femoral artery and aorta to access the natural aortic valve.

[0034] In other embodiments, the aperture 26 may be formed at the inlet (or inflow) end 20 of the frame 12 (whether formed in the post 24 or the tip 18) where other delivery device configurations or other delivery techniques, such as a transapical delivery approach, require an aperture located at the inlet end of the frame. In yet another embodiment, the delivery device 100 may include a code manifold 120 positioned distal to the prosthetic valve when the prosthetic valve is loaded into the delivery device, and this code manifold 120 is coupled to the inlet (or inflow) end 20 of the frame.

[0035] In certain embodiments, the artificial heart valve 10 is a self-expanding heart valve, and the frame 12 is made from a superelastic self-expanding material (e.g., a nickel-titanium alloy such as Nitinol) as is known in the art. When used with a delivery device 100 (Figure 2), the artificial valve 10 is capable of self-expanding from a radially compressed state to a radially expanded state once advanced from the delivery capsule (e.g., delivery sheath) of the delivery device.

[0036] In other embodiments, the frame 12 can be made from any of a variety of suitable plastically expandable materials (e.g., stainless steel, cobalt-chromium alloy, etc.), and the artificial heart valve can be expanded from a radially compressed state to a radially expanded state by inflating a balloon of the delivery device or by activating other expansion means of the delivery device to cause radial expansion of the artificial valve.

[0037] The valve structure 14 may comprise multiple leaflets 28. Typically, the valve structure comprises three leaflets 28 arranged in a tricuspid configuration, but it is also possible to use more or fewer leaflets 28. The leaflets 28 can be fabricated from any of a variety of suitable materials, including natural tissues (e.g., bovine pericardium or pericardium from other sources) or synthetic materials (e.g., polyurethane). Adjacent lateral portions located at the outflow edge (upper edge in the figure) of adjacent leaflets are fixed to each other to form a commissure 30 of the valve structure, which may be fixed to the frame by sutures 32.

[0038] The artificial valve 10 may further comprise an internal skirt 34 attached to the inner surface of the frame 12. The skirt 34 helps establish a seal between the valve and surrounding tissue after implantation. The skirt 34 may also be used to attach a portion of the valve leaflet 28 to the frame 12. For example, in the illustrated embodiment, the inflow edge (lower edge in the figure) of the valve leaflet may be sutured to the skirt 34 along the suture line 36. The skirt 34 may be directly connected to the frame 12 using, for example, sutures. Although not shown, the artificial valve 10 may also comprise an external skirt attached to the outer surface of the frame instead of or in addition to the internal skirt 34, thereby further sealing the artificial valve in contact with the surrounding tissue. The internal and / or external skirts can be made from any of a variety of suitable materials, including natural tissue (e.g., pericardial tissue) or various synthetic materials which may be woven, nonwoven, braided, knitted, and / or combinations thereof. In a particular implementation, the inner skirt 34 is made from polyethylene terephthalate (PET) fibers.

[0039] Exemplary configurations of artificial heart valves are further disclosed in U.S. Patent Publication No. 2014 / 0343670, U.S. Patent Publication No. 2012 / 0123529, U.S. Patent Publication No. 2010 / 0036484, and U.S. Patent Publication No. 2010 / 0049313. These publications are incorporated herein by reference.

[0040] An artificial heart valve 10, or other types of implantable expandable medical devices such as expandable stents, can be delivered to the implantation site by a delivery device. Figures 2 to 9B show an exemplary embodiment of such a delivery device 100.

[0041] As shown in Figures 2 and 3, the delivery device 100 may comprise a handle portion 132 and a first shaft 134 extending distally from the handle portion 132. A user, such as a physician or clinician, can operate the delivery device 100 by activating a number of knobs 136, dials, and / or buttons 138 located on the handle portion 132. The first shaft 134 has a proximal end portion 140 and a distal end portion 142. The proximal end portion 140 of the first shaft 134 may be coupled to the handle portion 132. The handle portion 132 may comprise a housing 133 which may comprise two housing portions 133a, 133b (best shown in Figure 7).

[0042] As shown in Figure 3, the delivery device 100 may include a second shaft 150 and a third shaft 152. The second shaft 150 extends distally from the handle portion 132 and coaxially through the first shaft 134. The third shaft 152 extends distally from the handle portion 132 and coaxially through the second shaft 150. In the figure, the first shaft 134 is the outermost shaft of the delivery device and may therefore be called the outer shaft 134 of the delivery device. In the illustrated embodiment, the third shaft 152 is the innermost shaft of the delivery device and may therefore be called the inner shaft 152 of the delivery device. In the illustrated embodiment, the second shaft 150 is located midway between the innermost shaft and the outermost shaft and may therefore be called the intermediate shaft.

[0043] The nose cone 144 can be connected to or mounted on the distal end portion 152d of the inner shaft 152. The nose cone 144 may have a tapered outer surface, as shown, for intact tracking of the delivery device 100 through the subject's blood vessels. The inner shaft 152 extends distally beyond the intermediate shaft 150, passing through the lumen of the cord manifold 120 and the artificial valve 10.

[0044] In some embodiments, the first shaft 134, the second shaft 150, and the third shaft 152 may each be configured to be movable relative to one another, including relative axial movement (proximal and distal) and / or relative rotational movement (clockwise and counterclockwise). A guidewire 154 (Figure 4) extends through the central lumen of the inner shaft 152 and the inner lumen of the nose cone 144, thereby allowing the delivery device 100 to advance along the guidewire 154 within the vascular tissue of the subject during delivery of the artificial valve 10. The guidewire 154 may be inserted into the inner shaft 152 via the proximal port 155 of the handle portion 132 (Figure 5).

[0045] The delivery capsule 146 is coupled to the distal end portion 142 of the first shaft 134 at the proximal side of the nose cone 144. As shown in Figures 3 and 4, the delivery capsule 146 houses the artificial valve 10 in a radially compressed state. In one embodiment, the delivery capsule 146 covers and holds the compressed artificial valve located at the bottom of Figure 1. The delivery device 100 is particularly suitable for delivering and implanting a self-expanding artificial valve 10 that expands radially to its functional size by its inherent elasticity when unfolded from the delivery capsule 146.

[0046] However, the artificial heart valve 10 may alternatively be a plastically expandable or mechanically expandable heart valve. When the delivery device is used to implant a plastically expandable valve, the delivery device may include a balloon catheter known in the art for expanding the artificial valve, such as the one disclosed in U.S. Patent Application Publication 2009 / 0281619, which is incorporated herein by reference. When the delivery device is used to implant a mechanically expandable valve, the delivery device may include one or more actuators for expanding the artificial valve, such as the one disclosed in U.S. Provisional Patent Application 62 / 945,039, filed December 6, 2019, which is incorporated herein by reference.

[0047] As shown in Figure 3, the delivery capsule 146 is configured to house the artificial heart valve 10 or other type of implantable medical device in a radially compressed state for delivery into the subject. The cord manifold 120 is configured to form a releasable coupling with the artificial heart valve 10 by a plurality of cords or tethers 118. The cord manifold 120 is coupled to the distal end of the first shaft 134 proximal to the nose cone 144 and the crimped artificial valve 10, respectively.

[0048] The cord manifold 120 may comprise a proximal portion 122 and a distal portion 124 axially spaced from the proximal portion 122. The proximal portion 122 of the cord manifold 120 may be fixed immovably to the distal end portion 142 of the first shaft 134 using appropriate techniques or mechanisms, such as via mechanical connectors, welding, press-fitting, and / or adhesives. For example, in some embodiments, the distal end portion 142 of the shaft 134 extends into the lumen of the proximal portion, and this proximal portion may be fixed to the shaft 134 using any of the coupling techniques described above.

[0049] Code 118 can be made from any of a variety of biocompatible materials suitable for use in a subject. In some embodiments, Code 118 may consist of a single-filament cord, or a multi-filament or multi-strand cord formed by braiding, weaving, knitting, twisting, and wrapping multiple filaments or strands together. These filaments or strands may consist of polymer fibers such as ultra-high molecular weight polyethylene, nylon, polyester, and / or aramid, or flexible wires (e.g., metal wires).

[0050] Each cord 118 may have a first end 118a attached to the cord manifold 120, for example, to the proximal portion 122. Each cord 118 may have a second end 118b in the form of a loop extending through an opening in the artificial valve frame 12 (for example, through opening 26) and held on a release member 156. The release member 156 is configured to hold the cord 118 connected to the frame 12 of the artificial valve 10 until it is activated by the user to release the cord 118. For illustrative purposes, two release members 156 are shown. It should be understood that any number of release members 156 can be used.

[0051] Similarly, although two cords 118 are illustrated for illustrative purposes, it should be understood that any number of cords can be used. Furthermore, the number of cords and release members 156 do not need to be the same. For example, the ends 118b of multiple cords 118 may be held on a single release member. Preferably, at least three cords 118 are used to balance the attachment of the frame 12 to the cord manifold 120. In certain embodiments, the number of cords 118 is equivalent to the number of tip portions 18 (Figure 1) of the frame 12 of the artificial valve 10. Furthermore, in other embodiments, a single cord may be used to connect the frame 12 to the cord manifold 120 at multiple positions along the outflow end of the frame by forming multiple passages that extend through the opening of the frame.

[0052] Each release member 156 may extend in a manner that allows it to slide through the respective openings in the proximal portion 122 and distal portion 124 of the code manifold 120. Each release member 156 may extend along its entire length through the first shaft 134 and may have a proximal end portion that is operably coupled to a knob 136 on a handle to control the movement of the release member. Each release member 156 is movable in the proximal and distal directions relative to the proximal portion 122 and distal portion 124 of the code manifold between a distal position in which each release member 156 holds its respective code 118 and a proximal position in which each release member 156 is released from its respective code 118.

[0053] Further details relating to the attachment of the artificial valve 10 to the delivery device 100 by one or more cords or sutures are disclosed in U.S. Patent Application Publication 2014 / 0343670, U.S. Patent Application Publication 2012 / 0239142, and U.S. Patent Application Publication 2010 / 0049313, and U.S. Provisional Patent Application 62 / 824,710, filed on 27 March 2019, all of which are incorporated herein by reference.

[0054] Furthermore, in alternative embodiments, various valve retention mechanisms may be used to form a releasable coupling between the artificial valve 10 and the delivery device 100. For example, in some embodiments, the posts 24 of the frame 12 are held in corresponding recesses of the shaft or retaining member of the delivery device, which allow the posts of the frame to expand out of these corresponding recesses when the capsule 146 is retracted to deploy the artificial valve. In other embodiments, the retention mechanism may comprise an inner metal fork member and an outer metal fork member that form a releasable coupling between the delivery device and the artificial valve. Further details regarding alternative valve retention mechanisms are disclosed in U.S. Patent Application Publication 2012 / 0239142 and U.S. Patent Application Publication 2010 / 0049313.

[0055] Furthermore, as shown in Figure 3, the second shaft 150 may have a male threaded portion 162 along its distal end. This threaded portion 162 may have threads formed on the outer surface of the shaft, or it may be a separate thread connected to the distal end of the proximal shaft section. The capsule 146 is operationally connected to the second shaft 150 by a female threaded nut 164 disposed on the threaded portion 162. The nut 164 may have a radially extending projection 166 extending into a corresponding opening in the capsule 146 (see Figure 2). The rotation of the nut 164 is restricted by one or more rails 165 extending from or formed along the distal end of the first shaft 134.

[0056] Therefore, the rotation of the second shaft 150 relative to the first shaft 134 causes axial movement of the nut 164 (distal and proximal), which in turn causes corresponding axial movement of the capsule 146 in the same direction during loading, deployment, and / or retrieval of the artificial valve. For example, when the nut 164 is in the distal position, the delivery capsule 146 extends over and around the artificial valve 10, holding the artificial valve 10 in a compressed state for delivery. As the nut 164 moves proximal, the delivery capsule 146 moves proximal, thereby deploying the artificial valve. The rotation of the second shaft 150 can be achieved by a motor operationally coupled to the second shaft and / or the manual control feature, as will be further described below.

[0057] In some embodiments, the delivery device 100 may include one or more steering mechanisms configured to assist in steering the delivery device through the vessel by controlling one or more curves in the shafts 134, 150, 152. For example, the steering mechanism may include one or more eccentrically positioned pull wires extending through the shafts and operationally connected to an adjustment mechanism located on or adjacent to the handle portion 132. Adjusting the adjustment mechanism changes the tension of the pull wires, which has the effect of curving or straightening the shaft in a given direction. In one implementation, one or more pull wires extend through the outer shaft 134, and adjusting the adjustment mechanism has the effect of adjusting the curvature of the distal end portion of the outer shaft 134 and the delivery device 100. Further details relating to this steering mechanism are disclosed in U.S. Patent Application Publication 2007 / 0005131 and U.S. Patent Application Publication 2013 / 0030519, which are incorporated herein by reference.

[0058] In some embodiments, as shown in Figures 6 to 11, the delivery device 100 is an electrically operated device comprising a motor 168 housed inside the handle portion 132. This electrically operated embodiment automates the deployment of the artificial valve 10. Specifically, the motor 168 is operationally coupled to the second shaft 150 to cause rotation of the second shaft 150 relative to the first shaft 134 and corresponding axial movement of the capsule 146, as will be further described below.

[0059] The proximal end portion 140 of the first shaft 134 may be coupled to the distal end of the handle portion 132. As shown in Figure 6, the proximal end portion 151 of the second shaft 150 may extend into the handle portion 132 through the distal opening 170 of the handle portion 132. A rotatable component 172 (which may be called a drive cylinder in some embodiments) is disposed inside the handle portion 132 and is operationally coupled to the second shaft 150.

[0060] In one embodiment, as best shown in Figures 7 to 9, the proximal end portion of the rotatable component comprises a gear 174 having a plurality of gear teeth 176 arranged circumferentially relative to each other. The rotatable component 172 further comprises a main body 178 configured as an extending shaft having a lumen 173 (Figure 8). In the illustrated embodiment, the main body 178 and the gear 174 are integrally formed, but may be individually formed components connected to each other using any of various mounting means. The main body 178 of the rotatable component 172 is coaxial with respect to the central longitudinal axis L-L' (shown in Figure 5) of the handle portion 132, and can also be coaxial with respect to the first shaft 134. The lumen 173 of the main body 178 can be sized to receive and hold within it the proximal end portion 151 of the second shaft 150.

[0061] In some implementations, the inner surface of the lumen 173 may have a non-circular cross-section in a plane perpendicular to the longitudinal axis L-L', and the proximal end portion 151 of the second shaft 150 may have a similar cross-sectional profile corresponding to the shape of the lumen, thereby transmitting the rotational motion of the rotatable component 172 to the second shaft 150. For example, the lumen 173 and the proximal end portion 151 may be substantially cylindrical and have a series of circumferentially spaced flat sections. Instead of giving the lumen 173 and the proximal end portion 151 a non-circular cross-section, or in addition to that, the proximal end portion 151 may be fixed to the rotatable component using fixing means such as mechanical fasteners (e.g., screws), adhesives, press-fits, snap-fit ​​connections, etc.

[0062] As best shown in Figure 6, the motor 168 may be housed inside a retaining case or cradle 190. The motor may be an electric motor, and the handle portion may include a battery compartment for housing one or more batteries (not shown) for supplying power to the motor 168. One or more operator buttons 138a, 138b on the handle portion allow the user to operate the motor, for example, by electrically coupling current from a battery power source to the motor. The motor may be rotatable in both directions, as described below, thereby moving the capsule 146 either proximal or distal. One of the buttons (e.g., button 138a) may be operable to rotate the motor in a first rotational direction to move the capsule 146 distally, for example to load an artificial valve into the capsule, and the other button (e.g., button 138b) may be operable to rotate the motor in a second rotational direction to move the capsule proximal, for example to deploy an artificial valve. In place of or in addition to one or more batteries, the motor 168 can be configured to receive a power cord that supplies current to the motor from an external power source (e.g., a wall outlet) in the handle section.

[0063] As best shown in Figure 8, the motor 168 can be coupled to the rotatable component 172 by a drive shaft 184 connected to the motor shaft 188 and an intermediate drive gear 182 connected to the drive shaft 184. As shown in Figures 9A to 9B, the drive gear 182 may have circumferentially arranged gear teeth 192, which may engage with circumferentially arranged gear teeth 176 of the gear 174 of the rotatable component 172. When driven by the motor, the motor 168 rotates the motor shaft 188, which in turn rotates the drive shaft 184 and the drive gear 182. The drive gear 182 engages with and rotates the gear 174 of the rotatable component 172, thereby rotating the rotatable component 172 and the second shaft 150. As shown in Figures 9A and 9B, the drive gear 182 can be positioned radially offset from the central axis of the rotatable component 172 and the central longitudinal axis L-L' of the handle portion 132 so that the gears are aligned vertically when the gears mesh with each other. In other embodiments, one or more additional gears may be provided between the drive gear and the rotatable component to transmit rotation from the motor to the rotatable component.

[0064] In alternative embodiments, the motor shaft 188 or the drive shaft 184 may be connected to the rotatable component 172 without any intermediate gears. For example, the motor shaft 188 may be positioned proximal to the rotatable component along axis L-L' and connected to the rotatable component 172 in a direct drive configuration (see, for example, the embodiment of Figure 10 described later).

[0065] Figures 9A and 9B show cross-sectional views of the handle portion 132, illustrating the meshing of the gear teeth 192 of the drive gear 182 with the gear teeth 176 of the rotatable component 172. Furthermore, these figures show the vertical alignment of the gears relative to each other. In other embodiments, this positioning may be reversed. This vertical alignment of the gears allows these components to be operably coupled while being housed within the limited space obtained within the handle portion.

[0066] In the illustrated embodiment, the cradle 190 housing the motor 168 and drive shaft 184 may be configured to support the rotatable component 172 so that it rotates within the handle portion. As best shown in Figures 6 and 7, the cradle 190 may have a first distal portion 194, which comprises a distal sleeve 195 that circumferentially surrounds the distal end portion of the main body 178 of the rotatable component 172. Furthermore, the cradle 190 may have a proximal portion 196, which comprises a proximal sleeve 197 that circumferentially surrounds the proximal end portion of the main body 178 of the rotatable component 172.

[0067] Referring to Figures 3, 8, 9A, and 9B, rotation of the motor 168 in a first direction (e.g., clockwise or counterclockwise) causes rotation of the rotatable component 172. Furthermore, this causes rotation of the second shaft 150 coupled to the rotatable component 172. The rotation of the second shaft 150 causes the screw 162 on the second shaft 150 to rotate. As described above, the rotation of the screw 162 causes axial movement of the drive nut 164 and the capsule 146 (Figure 3). For example, rotation of the rotatable component in the first direction may cause the delivery capsule 146 to retract proximal, exposing the artificial valve at the distal end of the delivery device. In contrast, rotation of the motor in a second direction opposite to the first direction rotates the second shaft 150 in the opposite direction, causing the nut to move axially in the opposite direction, thereby moving the delivery capsule distally and returning it to the artificial valve. The operator can activate the motor by pressing buttons 138a and 138b on the handle (Figure 6), thereby electrically moving the delivery capsule axially. This allows for rapid deployment or retrieval of the artificial valve.

[0068] As described below, when in use, the artificial valve 10 can be connected to the delivery device 100 and loaded into the capsule. A detachable connection is formed using a separate cord 118 between each end 18 where one end of the frame 12 is located and the cord manifold 120. Optionally, the length of the cord 118 is selected such that the fixed end of the frame is held at least partially in a radially compressed state by the cord. After the end of the frame 12 is secured with the cord 118, the delivery capsule 146 can be advanced distally beyond the cord manifold 120, the cord 118, and the frame 12 (for example, by pressing button 138a), thereby causing the frame to contract into a radially compressed state under the force of the capsule 146 (as shown in Figure 4). As shown in Figure 3, the delivery capsule 146 is advanced distally until the distal end of the delivery capsule 146 abuts against the nose cone 144 and completely encloses the artificial valve 10.

[0069] As described above, after the artificial heart valve 10 is loaded into the delivery device 100, the delivery device can be inserted into a blood vessel and advanced or guided through the blood vessel to the desired implantation site (for example, through the femoral artery and aorta when delivering the artificial valve 10 to the natural aortic valve in a retrograde delivery approach).

[0070] Once the prosthetic valve 10 is delivered to a selected implantation site in the subject (e.g., the natural aortic valve), the nose cone 144 may optionally be advanced so as to move distally away from the adjacent end of the capsule 146 by pushing the inner shaft 152 distally, thereby avoiding contact between the prosthetic valve and the nose cone during valve deployment. The delivery capsule 146 may be retracted to deploy the prosthetic valve 10 (e.g., by pressing button 138b). With the delivery capsule 146 retracted (Figure 4), the prosthetic valve can self-expand radially under the elasticity of the frame 12. Even after the delivery capsule 146 has been completely retracted from the prosthetic valve 10, the prosthetic valve remains attached to the delivery device 100 by code 118. While still attached to the delivery device, the user can adjust the position of the prosthetic valve relative to the desired implantation site by maneuvering the delivery device (e.g., by moving the delivery device proximal and distally, and / or rotating the delivery device).

[0071] If desired, the delivery capsule can be advanced and returned to the prosthetic valve 10 to fully or partially retrieve the prosthetic valve (return the prosthetic valve to the capsule) to facilitate repositioning of the prosthetic valve. For example, after deploying the prosthetic valve by passing over the leaflets of the natural aortic valve in a retrograde delivery approach, it may be desirable to return and retrieve the prosthetic valve to the capsule, retract the delivery device to return the prosthetic valve to the aorta, and then advance the prosthetic valve back over the leaflets of the natural aortic valve to deploy the prosthetic valve from the capsule.

[0072] Once the artificial valve has unfolded from the capsule 146 and is positioned in the desired implantation location, the release member 156 can be retracted, for example, by rotating the knob 136 on the handle portion 132. In some examples, the cord 118 slides outward from the aperture 26 and moves away from the frame 12 as the self-expanding frame 12 expands further when the release member 156 is retracted. In other examples, the user can slightly retract the delivery device 100, which further pulls the cord 118 proximal to the frame 12, pulling the cord 118 out of the aperture 26.

[0073] Optionally, the orientation of the prosthetic valve can be reversed so that, when coupled to a delivery device, the inlet end of the prosthetic valve becomes the proximal end and the outlet end becomes the distal end. This can facilitate delivery of the prosthetic valve to various implantation sites (e.g., natural aorta, pulmonary artery, mitral valve, and tricuspid valve annulus) and / or various delivery approaches (e.g., antegrade, transseptal, transventricular, transatrial).

[0074] As discussed above, the rotational movement of the rotatable component 172 results in axial movement of the second shaft 150 and the delivery capsule 146. While the rotation of the rotatable component 172 can be driven by the motor 168, this rotation can also be achieved manually.

[0075] For these purposes, the delivery device 100 may be equipped with a manual deployment tool, which, in the event of motor or battery failure, allows for the manual operation of the rotatable components to deploy or retrieve the artificial valve. For example, if the motor fails or the battery runs out while the user is operating the motor to rotate the rotatable components, the user has only a very limited amount of time to complete the retraction of the delivery capsule or retrieve the artificial valve. Figures 7, 9A, and 9B show an exemplary embodiment of such a manual deployment tool 200.

[0076] As best shown in Figures 5–9, the handle portion 132 may have one or more openings 202 in the housing 133, and a manual deployment tool 200 may be inserted into these openings 202 to manually rotate the rotatable component 172. In the illustrated embodiment, the manual deployment tool 200 is in the form of a pull cord (which may also be called a pull belt or toothed member). To manually operate the rotatable component 172, the pull cord 200 is inserted into the opening 202 and pulled through the handle portion 132 along an axis M–M' which may be offset from the longitudinal axis L–L' of the handle portion (Figures 7 and 9A). As shown in Figures 7 and 9A–9B, the pull cord 200 may be inserted into the opening 202 in a direction substantially perpendicular to the longitudinal axis of the handle portion 132 (e.g., the longitudinal axis L–L'). In the illustrated embodiment, the manual deployment tool 200 is a pull cord that is detachable (e.g., insertable and removable) from the handle portion 132 of the delivery device.

[0077] In some embodiments, the handle portion 132 may be provided with a removable cover or plug that extends over and covers the opening 202 in the housing 133. This cover can remain in place during normal use until the pull cord 200 is needed, at which point it can be removed to provide access to the opening 202.

[0078] As shown in Figures 9A and 9B, at least a portion 205 of the pull cord 200 is provided with a plurality of teeth 204 configured to drive-engage with a plurality of gear teeth 176 of the rotatable component 172 when the pull cord 200 is pulled through the opening 202 in the handle portion 132. In this way, the pull cord 200 functions as a linear rack that causes rotation of the rotatable component 172 when it moves linearly along the axis M-M'. As shown in Figure 7, the pull cord 200 may have teeth 204 along most of its length.

[0079] The pull cord 200 may have a length in the range of approximately 12 inches to approximately 36 inches, approximately 16 inches to approximately 30 inches, or approximately 17 inches to approximately 20 inches. In some embodiments, the total length of the pull cord 200 can be 18 inches.

[0080] The pull cord 200 can be made from any of a variety of suitable materials, including metals, polymers, etc. In some embodiments, the pull cord 200 can be made from molded plastic and may have a curved portion 210 connecting two straight portions 212, as shown in Figure 7. The pull cord 200 may have sufficient flexibility so that the curved portion 210 can become straight when pulled through the opening 202 in the handle portion 132. In some embodiments, the pull cord 200 may be straight along its length from one end to the other. In other embodiments, the pull cord 200 may be molded into a coil or helical shape that can be unwound or straightened when pulled through the opening 202 in the handle portion 132. Furthermore, in some embodiments, the pull cord 200 may have sufficient rigidity so that, during use, it can be pushed through the handle portion 132 instead of or in addition to being pulled through the handle portion 132. As will be further explained below, the rotatable component 172 is operated by the manual movement of the pull cord through the handle portion, whether the pull cord is pushed or pulled through the handle portion.

[0081] In some embodiments (see Figure 9A), at least one end portion 206 of the pull cord may not have teeth 204 and may have a flat surface facing the gear teeth 176 as shown. Preferably, the end portion 206 may be sized to be inserted into the opening 202 without contact with the gear teeth 176, or at least easily inserted with minimal resistance from the gear teeth 176. This allows the end portion 206 to be inserted more easily into the opening 202 from one side of the handle portion (left side in Figures 9A-9B) to the other side of the handle portion (right side in Figures 9A-9B) before any of the teeth 204 of the pull cord 200 engage with the gear teeth 176. When the end portion 206 emerges from the other side of the handle portion 132 (the right side in Figures 9A and 9B), the end portion 206 can then be grasped by the user to pull the pull cord 200 through the opening 202 and pull it further (to the right in Figures 9A and 9B) until the teeth 204 engage with the gear teeth 176.

[0082] As the pull cord 200 moves through the opening 202 in a first direction (e.g., a first direction along M-M'), the rotatable component 172 is rotated in a first rotational direction (e.g., clockwise or counterclockwise), while as the pull cord moves through the opening in a second rotational direction opposite to the first direction (e.g., opposite to the direction along M-M'), the rotatable component 172 is rotated in a second direction opposite to the first direction. As a result of the rotation of the rotatable component, axial movement of the delivery capsule occurs, so that the movement of the pull cord in the first direction along axis M-M' can be used to retract the delivery capsule 146 and deploy the artificial valve 10, while the movement of the pull cord in the second direction along axis M-M' can be used to advance the delivery capsule 146 distally and retrieve the artificial valve 10.

[0083] During the delivery process of the artificial valve, the user can insert the artificial valve 10 into the subject using the delivery device 100, and as described above, the artificial valve 10 is held in a radially compressed state within the delivery capsule 146. The user can then operate the motor 168 housed in the handle portion 132 of the delivery device by operating an electric switch (e.g., button 138b). If the motor cannot rotate and the delivery capsule 146 cannot be moved axially, the user can then insert the pull cord 200 through the opening 202 of the handle portion 132 and pull it (e.g., from left to right in Figures 9A to 9B) to rotate the rotatable component 172 inside the handle portion 132. Furthermore, this rotates the second shaft 150, causing the delivery capsule 146 to move axially proximal to the artificial valve, deploying the artificial valve from the delivery capsule and radially expanding the artificial valve from a radially compressed state to a radially expanded state. In some embodiments, once the artificial valve is radially expanded and unfurled from the delivery device 100, the pull cord 200 can be removed from the handle portion 132.

[0084] During the implantation procedure, if the motor cannot fully retract and the artificial valve cannot be deployed, and it is desirable to return the artificial valve to the delivery capsule for retrieval, the pull cord 200 can be inserted into the opening 202 in the reverse direction (for example, from right to left in Figures 9A to 9B) and pulled through this opening, thereby rotating the rotatable component in the reverse direction and moving the delivery capsule 146 distally in the axial direction, allowing the delivery capsule to move and return to the artificial valve. Once the artificial valve is positioned within the delivery capsule, the delivery device 100 can be used to reposition the artificial valve for deployment or can be completely withdrawn from the body.

[0085] In this way, a manual deployment tool is realized for manually operating the rotatable component of the delivery device that enables the axial movement of the delivery capsule. As a result, if the motor driving the rotatable component malfunctions during the valve deployment process, the user can drive the rotatable component by operating the manual deployment tool and complete the process. In this way, the manual deployment tool functions as a simple backup or rescue tool that ensures greater efficiency in completing the implantation procedure.

[0086] In an alternative embodiment, the pull cord 200 may extend through the housing 133 of the handle portion 132 in a position to engage with the drive gear 182 instead of the gear 174. In such an embodiment, the pull cord 200 is used in a similar manner to that described above, but differs in that it is pulled through the housing to rotate the gear 182, and this further rotates the gear 174 and the rotatable component 172.

[0087] Figure 10 shows an electrically operated delivery device 300 that can be operated by a pull cord 200 according to another embodiment. The delivery device 300 in the illustrated embodiment comprises a handle portion 302, a first outer shaft 304 extending distally from the handle portion 302, a second intermediate shaft 306 extending distally from the handle portion 302 through the first shaft 304, and a third inner shaft 308 extending distally from the handle portion 302 through the second shaft 306. A nose cone 310 may be mounted on the distal end portion of the inner shaft 308.

[0088] In the embodiment shown in Figure 10, the distal end portion 312 of the first shaft 304 serves as a delivery capsule. The artificial valve 10 can be releasably connected to the distal end portion of the second shaft 306 using one of the retention mechanisms described above. The artificial valve 10 can be deployed from the delivery capsule 312 by retracting the first shaft 304 relative to the artificial valve and the second shaft 306.

[0089] The handle portion 302 may house a motor 314 having a shaft 316 connected to a lead screw 318. The lead screw 318 may have a male threaded portion 320, which extends through a threaded opening in an extended portion 322 of the first shaft 304 and screws into this threaded opening. The extended portion 322 acts as a nut that can move proximal and distal as the lead screw rotates. The handle portion 302 may have other features for operating the motor 314 as described in relation to the delivery device 100. For example, the handle portion 302 may house one or more batteries and may have one or more buttons or switches (e.g., buttons 138a, 138b) for operating the motor 314.

[0090] During the implantation procedure, the user may advance the nose cone 310 distally away from the delivery capsule 312 by pushing the inner shaft 308 distally after the artificial valve has been positioned at the implantation site. The user can activate the motor 314 (e.g., by pressing button 138b), which rotates the lead screw 318, retracting the first shaft 304 proximal (to the right in Figure 10) and exposing the artificial valve. If retrieval and / or repositioning is required, the motor 314 is operated in the reverse direction (e.g., by pressing button 138a), which rotates the lead screw in the reverse direction, moving the first shaft 304 back onto the artificial valve.

[0091] To manually operate the lead screw 318, a gear 324 having multiple gear teeth may be mounted on the lead screw 318. The handle portion 302 may have an opening for receiving the pull cord 200 in a position where the teeth 204 of the pull cord 200 can engage with the teeth of the gear 324. Pulling the pull cord 200 through the handle portion 302 in a first direction has the effect of rotating the gear 324 and the lead screw 318 in a first rotational direction, thereby retracting the first shaft 304. Pulling the pull cord 200 through the handle portion 302 in a second direction opposite to the first direction has the effect of rotating the lead screw 318 in a second rotational direction, thereby moving the first shaft 304 distally.

[0092] In an alternative embodiment, instead of the gear 324, gear teeth may be provided directly on the outer surface of the lead screw to engage with the teeth 204 of the pull cord.

[0093] Furthermore, it should be noted that any movable component of the delivery devices 100, 300 may be configured to be operated by the pull cord 200. For example, in one implementation, the lead screw 318 can engage with the extended portion of the second shaft 306, in which case the artificial valve 10 can be deployed by moving the second shaft 306 and the artificial valve 10 distally relative to the first shaft 304. The motor 314 and the pull cord 200 may be used to move the second shaft 306 distally and proximally, depending on whether the artificial valve is to be deployed or to be returned and retrieved into the capsule 312.

[0094] In alternative embodiments, the pull cord 200 may have other configurations. For example, in one implementation, the pull cord 200 may have teeth 204 along both sides of the pull cord. In another implementation, instead of teeth 204, the pull cord 200 may have a male thread (similar to a screw) extending helically along the length of the pull cord. A gear (e.g., gear 174), or other delivery device component designed to engage with the pull cord, may have a corresponding feature that meshes with the helical threads of the pull cord and rotates the delivery device component when the pull cord is pulled against the delivery device component.

[0095] Figure 11 shows another exemplary embodiment of the manual deployment tool configured as a pull code 400. The pull code 400 can be configured and function similarly to the pull code 200 to manually deploy an artificial valve from a delivery device (e.g., delivery device 100 or 300, etc.) (as described above with reference to Figures 7, 9A, and 9B).

[0096] As shown in Figure 11, the pull cord 400 is linear along its length from one end to the other (for example, it has no curves, bends, or coils). For example, the pull cord 400 has a linear body 402 having an intermediate portion 404 disposed between two end portions 406. The intermediate portion 404 has a plurality of teeth 408 (for example, similar to the teeth 204 of the pull cord 200 shown in Figures 7, 9A, and 9B). The end portions 406 have no teeth and have a relatively smooth (for example, toothless) surface 410.

[0097] In an alternative embodiment, the pull cord 400 may have only a toothless end portion 406, while the rest of the pull cord 400 may have teeth 408.

[0098] The pull cord 400 may have a length in the range of approximately 12 inches to approximately 36 inches, approximately 16 inches to approximately 30 inches, or approximately 17 inches to approximately 20 inches. In some embodiments, the total length of the pull cord 400 can be 18 inches.

[0099] Figure 12 shows another exemplary embodiment of a manual deployment tool configured as a pull code 500. The pull code 500 can be configured and function similarly to the pull code 200 to manually deploy an artificial valve from a delivery device (e.g., delivery device 100 or 300, etc.) (as described above with reference to Figures 7, 9A, and 9B).

[0100] As shown in Figure 12, the pull cord 500 is shaped as a coil or a helix. In other words, the pull cord 500 can be coiled along at least a portion of its length. For example, the pull cord 500 can be formed into a coiled or helical object that can be unwound or straightened by being pulled through an opening in the handle portion of a delivery device (e.g., an opening 202 in the handle portion 132 of the delivery device 100). The pull cord 500 comprises a body 502, which comprises a coiled toothed portion 504 and an end portion 506. The toothed portion 504 is coiled and has a plurality of teeth 508 along its length. The end portion 506 has no teeth and has a relatively smooth (e.g., toothless) surface 510. In some embodiments, as shown in Figure 12, the end portion 506 is straight (not coiled).

[0101] The pull cord 500 may have a length ranging from approximately 12 inches to approximately 36 inches, from approximately 16 inches to approximately 30 inches, or from approximately 17 inches to approximately 20 inches.

[0102] In alternative embodiments, pull cords, such as pull cords 200, 400, or 500, can be used to operate delivery device components that do not have motors. For example, delivery devices 100 and 300 may not have motors 168 and 314, and alternatively, the artificial valve 10 may be deployed from delivery capsules 146 and 312 solely by the use of pull cords.

[0103] Finally, it should be noted that the general use concept of pull cords, such as the Pull Cord 200, 400, or 500, can be used to move a movable component of a medical device having a handle and a rotatable component inside the handle, with or without a motor inside the handle. The pull cord is configured to rotate the rotatable component, and this rotation can further cause the movable component of the medical device to move axially. This movable component can be a delivery capsule as described above, or it can be another component of the medical device, such as a shaft, a guide wire, or an instrument that moves or deploys inside the main body after the pull cord is activated.

[0104] Further Examples of the Technology Disclosed In view of the above-mentioned implementation forms of the subject matter of this disclosure, the Application discloses the following further embodiments. Note that a single feature of an embodiment or a combination of two or more features of an embodiment also constitutes a further embodiment that is still included within the scope of this disclosure, in combination with one or more features of one or more other embodiments, which may be any other.

[0105] [Example 1] A delivery device for an expandable implantable medical device, comprising: a handle portion; a shaft extending from the handle portion; a delivery capsule configured to house the medical device in a radially compressed state for delivery into a subject; a rotatable component disposed within the handle portion, which is operationally coupled to the delivery capsule such that when the rotatable component rotates, it causes the delivery capsule to move axially relative to the shaft; a motor disposed within the handle portion, which is operationally coupled to the rotatable component such that it causes the rotation of the rotatable component and the corresponding axial movement of the delivery capsule; and a pull cord configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled relative to the rotatable component, it causes the rotation of the rotatable component and the corresponding axial movement of the delivery capsule.

[0106] [Example 2] A delivery device of any embodiment of this chapter, particularly Embodiment 1, wherein the shaft is a first shaft, and the delivery device further comprises a second shaft extending through the first shaft, the second shaft having a proximal end portion operably coupled to a rotatable component and a distal end portion operably coupled to the delivery capsule, such that the rotation of the rotatable component causes the second shaft to rotate relative to the first shaft, resulting in axial movement of the delivery capsule.

[0107] [Example 3] A delivery device according to any embodiment of this chapter, particularly Embodiment 1, wherein the delivery capsule is connected to the distal end portion of the shaft and the rotatable component is operationally coupled to the proximal end portion of the shaft, such that axial movement of the shaft and the delivery capsule occurs by the rotation of the rotatable component.

[0108] [Example 4] A delivery device relating to any embodiment of this chapter, particularly any one of embodiments 1 to 3, wherein the handle portion is provided with an opening for inserting a pull cord into the handle portion.

[0109] [Example 5] A delivery device according to any embodiment of this chapter, particularly Embodiment 4, wherein a pull cord is configured to cause rotation of a rotatable component by being pulled through an opening in a direction substantially perpendicular to the longitudinal axis of the handle portion.

[0110] [Example 6] A delivery device of any embodiment of this chapter, particularly embodiment 4 or 5, wherein a pull cord moves through an opening in a first direction, causing a rotatable component to rotate in a second direction, moving the delivery capsule in a third proximal direction; and a pull cord moves through an opening in a fourth direction opposite to the first direction, causing the rotatable component to rotate in a fifth direction opposite to the second direction, moving the delivery capsule in a sixth distal direction.

[0111] [Example 7] A delivery device according to any embodiment of this chapter, particularly one of Embodiments 1 to 6, wherein the motor is an electric motor powered by at least one battery, and the battery is housed in the handle portion.

[0112] [Example 8] A delivery device relating to any embodiment of this chapter, particularly any one of embodiments 1 to 7, wherein the pull cord is removable from the handle portion.

[0113] [Example 9] A delivery device of any embodiment of this chapter, in particular one of embodiments 1 to 8, wherein a rotatable component comprises a plurality of gear teeth, and a pull cord comprises a plurality of teeth configured to drive-engage with the gear teeth of the rotatable component.

[0114] [Example 10] A delivery device according to any embodiment of this chapter, particularly embodiment 9, further comprising a drive gear coupled to a motor and having a plurality of teeth that engage with the teeth of a gear of a rotatable component.

[0115] [Example 11] A delivery device of any embodiment of this chapter, particularly of embodiment 9 or 10, wherein the pull cord comprises at least one end portion that does not have teeth.

[0116] [Example 12] A delivery device according to any embodiment of this chapter, particularly one of embodiments 1 to 11, wherein the pull cord comprises an intermediate portion having a plurality of teeth and two end portions without teeth, the intermediate portion being disposed between the two end portions.

[0117] [Example 13] A delivery device relating to any embodiment of this chapter, particularly one of Examples 1 to 12, wherein the pull cord is linear along its longitudinal direction.

[0118] [Example 14] A delivery device of any embodiment of this chapter, particularly one of embodiments 1 to 12, wherein the pull cord is coiled along at least a portion of its length, and the coiled portion of the pull cord has a plurality of teeth.

[0119] [Example 15] A delivery device according to any embodiment of this chapter, particularly one of embodiments 1 to 12, wherein the pull cord comprises a curved portion disposed between two straight portions.

[0120] [Example 16] A delivery device of any embodiment of this chapter, particularly any one of Examples 1 to 15, wherein the pull cord is in the range of 16 inches to 30 inches in length.

[0121] [Example 17] A delivery device for an expandable implantable medical device, comprising: a handle portion; a shaft extending from the handle portion; a delivery capsule configured to house the medical device in a radially compressed state for delivery into a subject; a rotatable component disposed within the handle portion, which is operationally coupled to the delivery capsule so as to cause the delivery capsule to move axially relative to the shaft when the rotatable component rotates, and which has a plurality of circumferentially arranged gear teeth; a motor disposed within the handle portion and operationally coupled to the rotatable component so as to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule; and a manual deployment tool having a plurality of drive teeth configured to engage with the gear teeth of the rotatable component, which is manually movable along an axis extending through the handle portion so as to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule.

[0122] [Example 18] A delivery device of any embodiment in this chapter, particularly of Embodiment 17, wherein the axis of the unfolding tool is offset from the axis of rotation of the rotatable component.

[0123] [Example 19] A delivery device according to any embodiment of this chapter, particularly the delivery device of Embodiment 18, wherein the axis of the unfolding tool is perpendicular to the longitudinal axis of the handle portion.

[0124] [Example 20] A delivery device according to any embodiment of this chapter, particularly one of embodiments 17 to 19, further comprising a drive gear coupled to a motor, wherein the drive gear engages with the teeth of a rotatable component.

[0125] [Example 21] A delivery device according to any embodiment of this chapter, particularly one of embodiments 17 to 20, wherein a rotatable component comprises a drive cylinder having a main body, and the aforementioned gear teeth are arranged on the outer surface of the main body.

[0126] [Example 22] A delivery device of any embodiment of this chapter, particularly Embodiment 21, wherein a shaft is a first shaft, and the delivery device further comprises a second shaft extending through the first shaft, the second shaft having a proximal end portion coupled to the main body of a rotatable component and a distal end portion operably coupled to the delivery capsule, such that the rotation of a rotatable component causes the second shaft to rotate relative to the first shaft, resulting in axial movement of the delivery capsule.

[0127] [Example 23] A delivery device of any embodiment of this chapter, particularly embodiment 22, further comprising a drive nut disposed on a threaded portion of the distal end of a second shaft, wherein the drive nut is connected to a delivery capsule such that the rotation of the second shaft relative to the first shaft causes axial movement of the drive nut and the delivery capsule.

[0128] [Example 24] A delivery device of any embodiment in this chapter, particularly any one of embodiments 17 to 23, wherein the manual deployment tool is a pull code.

[0129] [Example 25] A method for implanting a medical device in a subject, comprising the steps of: inserting the medical device into the subject using a delivery device, wherein the medical device is held in a radially compressed state within a delivery capsule of the delivery device, and the delivery device comprises a handle portion and a rotatable component housed within the handle portion; and rotating the rotatable component by pulling a pull cord passing through the handle portion, thereby causing axial movement of the delivery capsule relative to the medical device, thereby unfolding the medical device from the delivery capsule and radially expanding the medical device from a radially compressed state to a radially expanded state.

[0130] [Example 26] A method of any embodiment of this chapter, particularly of Embodiment 25, wherein the delivery device comprises a motor operationally coupled to a rotatable component to cause rotation of the rotatable component and corresponding axial movement of a delivery capsule, the method further comprising the steps of operating an electrical switch to activate the motor before the aforementioned step of pulling a pull cord, and, if the motor is unable to cause movement of the delivery capsule, pulling a pull cord passing through a handle portion.

[0131] [Example 27] A method of any embodiment of this chapter, particularly of embodiment 25 or 26, wherein the medical device is an artificial heart valve, and the aforementioned step of inserting the medical device into a subject includes advancing the artificial heart valve, which is held in a delivery capsule, through the blood vessels of the subject until the artificial heart valve is positioned at or near the position of the natural annulus of the heart.

[0132] [Example 28] A method of any embodiment of this chapter, particularly one of embodiments 25 to 27, wherein the pull cord is pulled along an axis perpendicular to the longitudinal axis of the handle portion.

[0133] [Example 29] A method of any embodiment of this chapter, particularly one of embodiments 25 to 27, wherein the pull cord is pulled along an axis offset from the axis of rotation of the rotatable component.

[0134] [Example 30] A method relating to any embodiment of this chapter, particularly one of embodiments 25 to 29, wherein the pull cord comprises a plurality of teeth that engage with a plurality of teeth of a rotatable component when pulled through the handle portion.

[0135] [Example 31] A method relating to any embodiment of this chapter, particularly the method of Embodiment 26, wherein the delivery device comprises a drive gear coupled to a motor, the drive gear engaging with the teeth of a rotatable component.

[0136] [Example 32] A method for implanting a medical device in a subject, comprising the steps of: inserting the medical device into the subject using a delivery device, wherein the medical device is held in a radially compressed state within a delivery capsule of the delivery device, and the delivery device comprises a handle portion and a rotatable component housed within the handle portion; operating an electrical switch to activate a motor operationally coupled to the rotatable component; and, if the motor is unable to cause movement of the delivery capsule, rotating the rotatable component by pulling a pull cord passing through the handle portion, thereby causing axial movement of the delivery capsule in a first direction relative to the medical device, thereby unfolding the medical device from the delivery capsule and radially expanding the medical device from a radially compressed state to a radially expanded state; or, if the motor malfunctions when the medical device is partially unfolded from the delivery capsule, rotating the rotatable component by pulling a cord passing through the handle portion, thereby causing axial movement of the delivery capsule in a second direction relative to the medical device, thereby recovering the partially unfolded medical device.

[0137] [Example 33] A method of any embodiment of this chapter, particularly of Embodiment 32, wherein the medical device is an artificial heart valve, and the aforementioned step of inserting the medical device into a subject includes advancing the artificial heart valve, which is held in a delivery capsule, through the blood vessels of the subject until the artificial heart valve is positioned at or near the position of the natural annulus of the heart.

[0138] [Example 34] A method of any embodiment of this chapter, particularly of embodiment 32 or 33, in which the pull cord is pulled along an axis perpendicular to the longitudinal axis of the handle portion.

[0139] [Example 35] A method of any embodiment of this chapter, particularly of embodiment 32 or 33, wherein the pull cord is pulled along an axis offset from the axis of rotation of the rotatable component.

[0140] [Example 36] A method relating to any embodiment of this chapter, particularly one of embodiments 32 to 35, wherein the pull cord has multiple teeth that engage with multiple teeth of a rotatable component when pulled through the handle portion.

[0141] [Example 37] A method relating to any embodiment of this chapter, particularly one of embodiments 32 to 36, wherein the pull cord is removable from the handle portion.

[0142] [Example 38] A delivery device for an expandable implantable medical device, comprising: a handle portion; a delivery capsule configured to house the medical device in a radially compressed state for delivery into a subject; a rotatable component disposed within the handle portion, which is operationally coupled to the delivery capsule such that when the rotatable component rotates, it causes the delivery capsule to move axially relative to the handle portion; and a pull cord configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled relative to the rotatable component, the rotatable component rotates and the delivery capsule moves axially accordingly.

[0143] [Example 39] A delivery device of any embodiment of this chapter, particularly of Embodiment 38, further comprising a motor disposed within a handle portion and operationally coupled to the rotatable component to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule.

[0144] [Example 40] A delivery device according to any embodiment of this chapter, particularly embodiment 38 or 39, wherein the handle portion is provided with an opening for inserting a pull cord into the handle portion.

[0145] [Example 41] A delivery device of any embodiment of this chapter, particularly of Embodiment 40, wherein a pull cord is pulled through an opening in a direction substantially perpendicular to the longitudinal axis of the handle portion, thereby causing rotation of a rotatable component.

[0146] [Example 42] A delivery device according to any embodiment of this chapter, particularly one of embodiments 39 to 41, wherein the motor is an electric motor powered by at least one battery, the battery being housed in the handle portion.

[0147] [Example 43] A delivery device relating to any embodiment of this chapter, particularly any one of embodiments 38 to 42, wherein the pull cord is removable from the handle portion.

[0148] [Example 44] A delivery device of any embodiment of this chapter, particularly one of embodiments 38 to 43, wherein a rotatable component comprises a plurality of gear teeth, and a pull cord comprises a plurality of teeth configured to drive-engage with the gear teeth of the rotatable component.

[0149] [Example 45] A delivery device of any embodiment of this chapter, particularly of Embodiment 44, wherein the pull cord comprises at least one end portion that does not have teeth.

[0150] [Example 46] A delivery device of any embodiment of this chapter, particularly embodiment 44, wherein the pull cord comprises an intermediate portion having a plurality of teeth and two end portions without teeth, the intermediate portion being disposed between the two end portions.

[0151] [Example 47] A delivery device relating to any embodiment of this chapter, particularly one of embodiments 44 to 46, wherein the pull cord is linear along its longitudinal direction.

[0152] [Example 47] A delivery device of any embodiment of this chapter, particularly one of embodiments 44 to 46, wherein the pull cord is coiled along at least a portion of its longitudinal direction, and the coiled portion of the pull cord comprises a plurality of teeth.

[0153] [Example 48] A delivery device according to any embodiment of this chapter, particularly one of embodiments 44 to 46, wherein the pull cord comprises a curved portion disposed between two straight portions.

[0154] [Example 49] A delivery device of any embodiment of this chapter, particularly any one of embodiments 38 to 48, wherein the pull cord is in the range of 16 inches to 30 inches in length.

[0155] [Example 50] A delivery device according to any embodiment of this chapter, particularly one of embodiments 38 to 49, further comprising a shaft extending from a handle portion, wherein the shaft has a proximal end portion connected to the handle portion and a distal end portion connected to a delivery capsule.

[0156] [Example 51] A medical device for insertion into a subject, comprising: a handle portion; a movable component configured to be inserted into a subject; a rotatable component disposed within the handle portion, which is operationally coupled to the movable component such that when the rotatable component rotates, it causes the movable component to move axially relative to the handle portion; and a pull cord, which is configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the movable component occur.

[0157] [Example 52] A medical device relating to any embodiment of this chapter, particularly the medical device of Embodiment 51, comprising a delivery capsule in which a movable component is configured to hold an implantable medical device in a radially compressed state for delivery into a subject.

[0158] [Example 53] A medical device of any embodiment of this chapter, particularly embodiment 51 or 52, further comprising a motor disposed within a handle portion and operationally coupled to a rotatable component to cause rotation of the rotatable component and axial movement of a corresponding movable component.

[0159] [Example 54] A medical device of any embodiment of this chapter, particularly embodiment 53, wherein the motor is an electric motor powered by at least one battery, and the battery is housed in the handle portion.

[0160] [Example 55] A medical device according to any embodiment of this chapter, particularly any one of embodiments 51 to 54, wherein the handle portion is provided with an opening for inserting a pull cord into the handle portion.

[0161] [Example 56] A medical device of any embodiment of this chapter, particularly of Embodiment 55, wherein a pull cord is configured to cause rotation of a rotatable component by being pulled through an opening in a direction substantially perpendicular to the longitudinal axis of the handle portion.

[0162] [Example 57] A medical device according to any embodiment of this chapter, particularly any one of embodiments 51 to 56, wherein the pull cord is removable from the handle portion.

[0163] [Example 58] A medical device according to any embodiment of this chapter, particularly one of embodiments 51 to 57, wherein a rotatable component comprises a plurality of gear teeth, and a pull cord comprises a plurality of teeth configured to drive-engage with the gear teeth of the rotatable component.

[0164] [Example 59] A medical device of any embodiment of this chapter, particularly of Embodiment 58, wherein the pull cord comprises at least one end portion that does not have teeth.

[0165] [Example 60] A medical device of any embodiment of this chapter, particularly embodiment 58, wherein the pull cord comprises an intermediate portion having a plurality of teeth and two end portions without teeth, the intermediate portion being disposed between the two end portions.

[0166] [Example 61] A medical device according to any embodiment of this chapter, particularly one of embodiments 58 to 60, wherein the pull cord is linear along its longitudinal direction.

[0167] [Example 62] A medical device according to any embodiment of this chapter, particularly one of embodiments 58 to 60, wherein the pull cord is coiled along at least a portion of its length, and the coiled portion of the pull cord comprises a plurality of teeth.

[0168] [Example 63] A medical device according to any embodiment of this chapter, particularly any one of embodiments 58 to 60, wherein the pull cord comprises a curved portion disposed between two straight portions.

[0169] [Example 64] A medical device according to any embodiment of this chapter, particularly any one of embodiments 51 to 63, wherein the pull cord is in the range of 16 inches to 30 inches in length.

[0170] [Example 65] A method for using a medical device, comprising the steps of: inserting a movable component of the medical device into a subject, wherein the medical device comprises a handle portion and a rotatable component within the handle portion; and pulling a pull cord passing through the handle portion to cause rotation of the rotatable component and corresponding axial movement of the movable component.

[0171] [Example 66] A method relating to any embodiment of this chapter, particularly the method of Embodiment 65, wherein a movable component comprises a delivery capsule that holds an implantable medical device in a radially compressed state, and the delivery capsule is moved relative to the implantable medical device by the aforementioned step of pulling a pull cord that passes through a handle portion, thereby unpacking the implantable medical device from the delivery capsule.

[0172] [Example 67] A method of any embodiment of this chapter, particularly of Embodiment 66, wherein the implantable medical device is an artificial heart valve, and the aforementioned step of inserting a movable component of the medical device into a subject includes advancing the artificial heart valve, which is held within a delivery capsule, through the blood vessels of the subject until the artificial heart valve is positioned at or near the position of the natural annulus of the heart.

[0173] [Example 68] A method of any embodiment of this chapter, particularly one of embodiments 65 to 67, wherein the medical device comprises a motor operationally coupled to a rotatable component to cause rotation of the rotatable component and axial movement of a corresponding movable component, the method further comprising the steps of operating an electrical switch to activate the motor before the aforementioned step of pulling a pull cord, and, if the motor is unable to cause movement of the movable component, pulling a pull cord passing through a handle portion.

[0174] [Example 69] A method relating to any embodiment of this chapter, particularly any one of Examples 25 to 37 and 65 to 68, wherein the subject is a medical patient, an animal model, a cadaver, and / or a cardiovascular simulator.

[0175] [Example 70] A method of any embodiment of this chapter, particularly any one of Examples 25 to 37 and 65 to 69, which is performed as a training or practice technique in a cadaver or cardiovascular simulator.

[0176] In light of the numerous possible embodiments to which the principles of the art of this disclosure may be applied, it should be understood that these exemplary embodiments are merely preferred examples of the art of this disclosure and should not be construed as limiting the scope of the claims. Furthermore, the scope of the claims is defined by the appended claims and their equivalents. Further aspects of the present invention are provided by the subject matter of the following sections. [Section 1] A delivery device for expandable implantable medical devices, The handle part, A shaft extending from the aforementioned handle portion, A delivery capsule configured to contain the medical device in a radially compressed state for delivery into the subject, A rotatable component disposed within the handle portion, wherein the rotatable component is operationally coupled to the delivery capsule such that when the rotatable component rotates, it causes the delivery capsule to move axially relative to the shaft, A motor disposed within the handle portion and operationally coupled to the rotatable component to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule, A pull cord, configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the delivery capsule occur. A delivery device equipped with the following features. [Section 2] The delivery device according to claim 1, wherein the shaft is a first shaft, and the delivery device further comprises a second shaft extending through the first shaft, the second shaft having a proximal end portion operationally coupled to the rotatable component and a distal end portion operationally coupled to the delivery capsule, such that the rotation of the rotatable component causes the second shaft to rotate relative to the first shaft, resulting in axial movement of the delivery capsule. [Section 3] The delivery device according to item 1, wherein the delivery capsule is connected to the distal end portion of the shaft, and the rotatable component is operationally coupled to the proximal end portion of the shaft, such that rotation of the rotatable component causes axial movement of the shaft and the delivery capsule. [Section 4] The delivery device according to any one of claims 1 to 3, wherein the handle portion is provided with an opening for inserting the pull cord through the handle portion. [Section 5] The delivery device according to claim 4, wherein the pull cord is configured to cause rotation of the rotatable component by being pulled through the opening in a direction substantially perpendicular to the longitudinal axis of the handle portion. [Section 6] The delivery device according to claim 4 or 5, wherein the pull cord moves through the opening in a first direction, causing the rotatable component to rotate in a second direction to move the delivery capsule in a third proximal direction, and the pull cord moves through the opening in a fourth direction opposite to the first direction, causing the rotatable component to rotate in a fifth direction opposite to the second direction to move the delivery capsule in a sixth distal direction. [Section 7] The delivery device according to any one of claims 1 to 6, wherein the motor is an electric motor powered by at least one battery, the battery being housed within the handle portion. [Section 8] The delivery device according to any one of claims 1 to 7, wherein the pull cord is removable from the handle portion. [Section 9] The delivery device according to any one of claims 1 to 8, wherein the rotatable component comprises a plurality of gear teeth, and the pull cord comprises a plurality of teeth configured to drive-engage with the gear teeth of the rotatable component. [Section 10] The delivery device according to claim 9, further comprising a drive gear coupled to the motor and having a plurality of teeth that engage with the gear teeth of the rotatable component. [Section 11] The delivery device according to claim 9 or 10, wherein the pull cord comprises at least one end portion that does not have teeth. [Section 12] The delivery device according to any one of claims 1 to 11, wherein the pull cord comprises an intermediate portion having a plurality of teeth and two end portions without teeth, the intermediate portion being disposed between the two end portions. [Section 13] The delivery device according to any one of claims 1 to 12, wherein the pull code is linear along its length. [Section 14] The delivery device according to any one of claims 1 to 12, wherein the pull cord is coiled along at least a portion of its length, and the coiled portion of the pull cord is provided with a plurality of teeth. [Section 15] A delivery device for expandable implantable medical devices, The handle part, A delivery capsule configured to contain the medical device in a radially compressed state for delivery into a subject, A rotatable component disposed within the handle portion, wherein the rotatable component is operationally coupled to the delivery capsule such that when the rotatable component rotates, it causes the delivery capsule to move axially relative to the handle portion; A pull cord, configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the delivery capsule occur. A delivery device equipped with the following features. [Section 16] The delivery device according to claim 15, further comprising a motor disposed within the handle portion and operationally coupled to the rotatable component to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule. [Section 17] The delivery device according to claim 15 or 16, wherein the handle portion is provided with an opening for inserting the pull cord through the handle portion, and the pull cord is pulled through the opening in a direction substantially perpendicular to the longitudinal axis of the handle portion, thereby causing rotation of the rotatable component. [Section 18] The delivery device according to any one of claims 15 to 17, wherein the rotatable component comprises a plurality of gear teeth, the pull cord comprises a plurality of teeth configured to engage with the gear teeth of the rotatable component, and the pull cord comprises at least one end portion that does not have teeth. [Section 19] The delivery device according to claim 18, wherein the pull cord is linear along its length and comprises an intermediate portion having a plurality of teeth and two end portions without teeth, the intermediate portion being disposed between the two end portions. [Section 20] A medical device for insertion into a subject's body, The handle part, A movable component configured to be inserted into the subject, A rotatable component disposed within the handle portion, wherein the rotatable component is operationally coupled to the movable component such that when the rotatable component rotates, it causes the movable component to move axially relative to the handle portion; A pull cord configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the movable component occur. A medical device equipped with [a specific feature / feature]. [Section 21] The medical device according to claim 20, wherein the movable component comprises a delivery capsule configured to hold an implantable medical device in a radially compressed state for delivery into the subject. [Section 22] The medical device according to claim 20 or 21, further comprising a motor disposed within the handle portion and operationally coupled to the rotatable component to cause rotation of the rotatable component and corresponding axial movement of the movable component. [Section 23] The medical device according to any one of claims 20 to 22, wherein the handle portion is provided with an opening for inserting the pull cord through the handle portion, and the pull cord is configured to cause rotation of the rotatable component by being pulled through the opening in a direction substantially perpendicular to the longitudinal axis of the handle portion. [Section 24] The medical device according to any one of claims 20 to 23, wherein the rotatable component comprises a plurality of gear teeth, the pull cord comprises a plurality of teeth configured to drive-engage with the gear teeth of the rotatable component, the pull cord comprises an intermediate portion having the plurality of teeth and two end portions without teeth, the intermediate portion being disposed between the two end portions. [Explanation of Symbols]

[0177] 10. Artificial heart valves, self-expanding artificial valves 12 Stents, frames, self-expanding frames 14 Valve structure 16 strut 18 Tip 20 Inlet end 22 Outflow end 24 posts 26. Eye holes, apertures, openings 28 Valve leaflet 30 commissures 32 Sutures 34 Skirt, Inner Skirt 36 Suture lines 100 Delivery device 118 Code, Tether 118a First end 118b Second end 120 Code Manifold 122 Proximal portion 124 Distal portion 132 Handle section 133 Housing 133a Housing section 133b Housing section 134 First shaft, outer shaft 136 Knob 138 buttons 138a Operator button 138b Operator Button 140 Proximal end portion 142 Distal end portion 144 Nose cone 146 Delivery Capsules 150 Second shaft, intermediate shaft 151 Proximal end portion 152 Third shaft, inner shaft 152d Distal end portion 154 Guidewire 155 Proximal Port 156 Release Member 162 Male threaded part, screw 164 Female threaded nuts, nuts, drive nuts 165 rails 166 Radial Extending Projection 168 Motor 170 Distal opening 172 Rotatable Components 173 lumens 174 Gears 176 gear teeth 178 Main body 182 Intermediate drive gear 184 Drive shaft 188 Motor shaft 190 Cradle 192 gear teeth 194 First distal portion 195 Distal sleeve 196 Proximal portion 197 Proximal sleeve 200 manual deployment tools, pull code 202 Aperture 204 teeth 205 Part of the pull cord 206 End section 210 Curved section 212 Straight section 300 Motorized Delivery Device 302 Handle section 304 First outside shaft 306 Second intermediate shaft 308 Third Inner Shaft 310 Nose Cone 312 Delivery capsule, distal end portion 314 Motor 316 Shaft 318 Lead screw 320 Male threaded part 322 Extended part 324 Gears 400 pull cord 402 Linear Body 404 Middle part 406 End portion, toothless end portion 408 teeth 410 Toothless surface 500 pull cord 502 Main Unit 504 Toothed part 506 End section 508 teeth 510 Toothless surface

Claims

1. A medical device (100) to be inserted into a subject, wherein the medical device is configured to deliver an implantable medical device, The handle part (132) and A movable component (146) configured to be inserted into the subject, A rotatable component (172) disposed within the handle portion, wherein the rotatable component (172) is operationally coupled to the movable component such that when the rotatable component rotates, it causes the movable component to move axially relative to the handle portion, A pull cord (200) is configured such that when a manual pulling force is applied to the pull cord and the pull cord is pulled relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the movable component occur. Equipped with, The medical device (100) has an opening (202) for inserting the pull cord through the handle portion.

2. The medical device according to claim 1, wherein the movable component comprises a delivery capsule (146) configured to hold an implantable medical device (10) in a radially compressed state for delivery into the subject.

3. The medical device according to claim 1 or 2, further comprising a motor disposed within the handle portion and operationally coupled to the rotatable component, which causes rotation of the rotatable component and corresponding axial movement of the movable component.

4. The medical device according to any one of claims 1 to 3, wherein the pull cord is configured to rotate the rotatable component by being pulled through the opening in a direction substantially perpendicular to the longitudinal axis of the handle portion.

5. The medical device according to any one of claims 1 to 4, wherein the pull cord is detachable from the handle portion.

6. The medical device according to any one of claims 1 to 5, wherein the rotatable component comprises a plurality of gear teeth (176), and the pull cord comprises a plurality of teeth (204) configured to engage kinetically with the gear teeth of the rotatable component.

7. The medical device according to claim 6, wherein the pull cord comprises an intermediate portion (404) having a plurality of teeth and two end portions (406) without teeth, and the intermediate portion is positioned between the two end portions.

8. The medical device according to claim 6, wherein the pull cord comprises at least one end portion (406) that does not have teeth.

9. The pull cord is a) It is in a straight line along that length, or b) It is coiled along at least a portion of its length, and the coiled portion of the pull cord has multiple teeth, or c) A medical device according to any one of claims 6 to 8, comprising a curved portion (210) positioned between two straight portions (212).

10. The medical device according to any one of claims 1 to 9, wherein the length of the pull cord is in the range of 16 inches (40.6 cm) to 30 inches (76.2 cm).

11. A method of using the medical device described in any one of claims 1 to 10, The aforementioned method, The step includes inserting the movable component of the medical device into the subject's body and pulling the pull cord via the handle portion to cause rotation of the rotatable component and corresponding axial movement of the movable component, The subject is a cadaver or a cardiovascular system simulator, in this method.

12. The method according to claim 11, wherein the movable component comprises a delivery capsule that holds an implantable medical device in a radially compressed state, and the delivery capsule is moved relative to the implantable medical device by pulling the pull cord via the handle portion, thereby unfolding the implantable medical device from the delivery capsule.

13. The method according to claim 12, wherein the implantable medical device includes an artificial heart valve, and the operation of inserting the movable component of the medical device into a subject includes advancing the artificial heart valve through the subject's vascular system while it is held within the delivery capsule until the artificial heart valve is positioned at or near the position of the natural annulus of the heart.

14. The method according to any one of claims 11 to 13, wherein the medical device comprises a motor which is operationally coupled to the movable component and causes rotation of the rotatable component and corresponding axial movement of the movable component, and the method further comprises operating an electric switch to activate the motor before pulling the pull cord, and if the motor does not cause movement of the movable component, pulling the pull cord via the handle portion.

15. The method according to any one of claims 11 to 14, wherein the method is performed as a training or practice technique in a cadaver or cardiovascular simulator.

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