Delivery apparatus for implantable medical device

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 March 26, 2020, which is incorporated herein by reference in its entirety.

[0002] FIELD OF THEINVENTION The present disclosure relates to embodiments of a delivery apparatus for implantable medical devices, such as prosthetic valves. [Background technology]

[0003] Delivery devices, such as intravascular delivery devices, are utilized in various procedures to deliver prosthetic medical devices to internal locations that are not readily accessible by surgery or where non-surgical access is desirable. Access to the internal target location is achieved by a medical professional inserting and guiding the delivery device through an internal passageway or cavity, including, but not limited to, blood vessels, the esophagus, the trachea, any portion of the digestive tract, lymphatic vessels, etc., to name a few. Prosthetic medical devices may include expandable valves or expandable devices (e.g., stents). In one specific example, an expandable prosthetic heart valve may be crimped onto the distal end of a delivery device and then deployed from the capsule of the delivery device at the implantation site, allowing the prosthetic valve to self-expand to its functional size.

[0004] In some embodiments, for ease of use, the delivery device can be motorized by including a motor in the handle portion of the device. During delivery of the prosthetic valve, a medical professional operates the motor to retract the capsule and deploy the valve. Although rare, electronic components can malfunction. If the motor stops working during valve deployment, this can disrupt the valve delivery process. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] US Patent Application Publication No. 2014 / 0343670 [Patent Document 2] US Patent Application Publication No. 2012 / 0123529 [Patent Document 3] US Patent Application Publication No. 2010 / 0036484 [Patent Document 4] US Patent Application Publication No. 2010 / 0049313 [Patent Document 5] US Patent Application Publication No. 2009 / 0281619 [Patent Document 6] U.S. Provisional Patent Application No. 62 / 945,039 [Patent Document 7] US Patent Application Publication No. 2012 / 0239142 [Patent Document 8] U.S. Provisional Patent Application No. 62 / 824,710 [Patent Document 9] US Patent Application Publication No. 2007 / 0005131 [Patent Document 10] US Patent Application Publication No. 2013 / 0030519 Summary of the Invention [Problem to be solved by the invention]

[0006] Disclosed herein are embodiments of an improved delivery apparatus for implantable medical devices (e.g., prosthetic heart valves) and associated methods for using such an apparatus in implanting an implantable medical device in a subject, the delivery apparatus including a manual deployment tool that is operated by a motor and can serve as a back-up or "rescue" means in the event of motor malfunction. [Means for solving the problem]

[0007] In an exemplary 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 the medical device in a radially compressed state for delivery into a subject, and a rotatable component disposed within the handle portion and operatively coupled to the delivery capsule to axially move the delivery capsule relative to the shaft upon rotation of the rotatable component. The delivery device may have a motor disposed within the handle portion and operatively coupled to the rotatable component to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule.

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

[0009] For example, in the event of a motor malfunction during the valve deployment process, a user may operate a manual deployment tool to manually complete the deployment process.

[0010] In another representative embodiment, a delivery apparatus 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, the rotatable component operatively coupled to the delivery capsule to cause axial movement of the delivery capsule relative to the shaft upon rotation of the rotatable component, the rotatable component comprising a plurality of circumferentially arranged gear teeth, a motor disposed within the handle portion, operatively coupled to the rotatable component to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule, and a manual deployment tool comprising a plurality of drive teeth configured to engage the gear teeth of the rotatable component, the manual deployment tool being manually movable along an axis extending through the handle portion to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule.

[0011] In another exemplary embodiment, a method of implanting a medical device in a subject includes inserting the medical device into a vasculature (or equivalent) of the subject with a delivery apparatus, the medical device being held in a radially compressed state within a delivery capsule of the delivery apparatus. The delivery apparatus includes a handle portion and a rotatable component housed within the handle portion. The method further includes pulling a pull cord passing through the handle portion to rotate the rotatable component, which may further cause axial movement of the delivery capsule relative to the medical device to deploy the medical device from the delivery capsule and radially expand the medical device from the radially compressed state to a radially expanded state.

[0012] In another representative embodiment, a method of implanting a medical device in a subject includes inserting the medical device into a vasculature (or equivalent) of the subject with a delivery apparatus, the medical device being held in a radially compressed state within a delivery capsule of the delivery apparatus, the delivery apparatus including a handle portion and a rotatable component housed within the handle portion. The method further includes operating an electrical switch to activate a motor operatively coupled to the rotatable component. If the motor fails to effect movement of the delivery capsule, a pull cord may be pulled through the handle portion to rotate the rotatable component, which in turn causes axial movement of the delivery capsule in a first direction relative to the medical device to deploy the medical device from the delivery capsule and radially expand the medical device from the radially compressed state to a radially expanded state. Alternatively, if the motor malfunctions when the medical device is partially deployed from the delivery capsule, the cord may be pulled through the handle portion to rotate the rotatable component, which in turn causes axial movement of the delivery capsule in a second direction relative to the medical device to retrieve the partially deployed medical device.

[0013] In another representative embodiment, a delivery apparatus 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 operatively coupled to the delivery capsule such that rotation of the rotatable component causes axial movement of the delivery capsule relative to the handle portion, and a pull cord configured such that when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the delivery capsule occurs.

[0014] In another representative embodiment, a medical device for insertion into a subject includes a handle portion, a movable component configured to be inserted into the subject, a rotatable component disposed within the handle portion and operatively coupled to the movable component such that rotation of the rotatable component causes axial movement of the movable component relative to the handle portion, and a pull cord configured such that when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the movable component occurs.

[0015] In another representative embodiment, a method of using a medical device includes inserting a movable component of the medical device into a subject, the medical device comprising 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 movement of the movable component.

[0016] The foregoing and other objects, features, and advantages of the techniques of the present disclosure will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 is a side elevational view of an exemplary embodiment of an implantable prosthetic heart valve that may be implanted using any of the delivery devices disclosed herein. [Diagram 2] 2 is a side elevational view of an exemplary embodiment of a delivery device for delivering the prosthetic heart valve of FIG. 1. [Diagram 3] 3 is a side cross-sectional view of the distal end portion of the delivery device of FIG. 2 showing the prosthetic valve contained in a compressed state within a delivery capsule. [Figure 4] 3 is a side elevational view of the distal end portion of the delivery device of FIG. 2, showing the capsule of the delivery device advanced beyond a portion of the prosthetic heart valve frame. FIG. [Diagram 5]3 is a side elevational view of a handle portion of the delivery device of FIG. 2 showing an opening for receiving a manual deployment tool for manually operating the delivery device. FIG. [Figure 6] 6 is a side view of the handle portion of FIG. 5, with the housing of the handle portion shown in cross-section. [Figure 7] 3 is a top perspective exploded view of a handle portion of the delivery device of FIG. 2 and one embodiment of a manual deployment tool configured to allow manual deployment or retrieval of the prosthetic valve from the delivery device. [Figure 8] 3 is a side cross-sectional view of a handle portion of the delivery device of FIG. 2. [Figure 9A] 3 is a cross-sectional view of the handle portion of the delivery device of FIG. 2 showing engagement of a manual deployment tool configured as a pull cord with a drive gear of the handle portion. [Figure 9B] 3 is a cross-sectional view of the handle portion of the delivery device of FIG. 2 showing engagement of a manual deployment tool configured as a pull cord with a drive gear of the handle portion. [Figure 10] FIG. 13 is a side elevational view of a delivery device according to another embodiment. [Figure 11] 13 is a side view of another embodiment of a manual deployment tool configured to interface with a rotatable component of a handle portion of the delivery device to allow manual deployment or retrieval of a prosthetic valve from the delivery device. [Figure 12] FIG. 13 is a side view of another embodiment of a manual deployment tool having a coil configuration configured to interface with a rotatable component in a handle portion of a delivery device to allow manual deployment or retrieval of a prosthetic valve from the delivery device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] General matters For the purposes of this description, some aspects, advantages, and novel features of the disclosed embodiments are described herein. These described methods, systems, and devices should not be construed as limiting in any respect. Rather, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations. The disclosed methods, systems, and devices are not limited to any particular aspect or feature thereof or combination thereof, and the disclosed methods, systems, and devices are not required for any one or more particular advantages to exist or problems to be solved.

[0019] A feature, integer, property, compound, chemical moiety, or group described in combination with a particular aspect, embodiment, or example of the present disclosure should be understood as applicable to any other aspect, embodiment, or example described herein, unless a contradiction occurs. Any feature disclosed in this specification (including the accompanying claims, abstract, and drawings), and / or any step of any method or process similarly disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. The present disclosure is not limited to the details of any of the foregoing embodiments. The scope of the present disclosure extends to any novel one or any novel combination of the features disclosed in this specification (including the accompanying claims, abstract, and drawings), or to any novel one or any novel combination of the steps of any method or process similarly disclosed.

[0020] Although some operations in the methods of the present disclosure are described in a particular sequential order for convenience of presentation, it should be understood that the method of description encompasses reordering unless a particular order is required by specific language set forth below. For example, a series of operations described sequentially may in some cases be reordered or performed simultaneously. Moreover, for reasons of simplicity, the accompanying drawings may not show the various ways in which the methods, systems, and devices of the present disclosure may be utilized in combination with other systems, methods, and devices.

[0021] As used herein, the phrases "a" and "at least one" include one or more of the specifically mentioned elements. That is, if there are two of a particular element, then one of those elements is also present, and thus there is "one" element. The phrase "multiple" means two or more of the specifically mentioned element.

[0022] As used herein, the term "and / or" used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0023] As used herein, the term "coupled" generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items, unless specifically stated to the contrary.

[0024] Directions and other relative designations (e.g., inner, outer, upper, lower, etc.) may be used to facilitate explanation of the figures and principles herein, but are not intended as limiting. For example, phrases such as "inner", "outer", "top", "bottom", "internal", and "external" may be used. Such phrases are used, where applicable, to provide some clarity of explanation, particularly when addressing relative relationships with respect to the illustrated embodiments. However, such phrases are not intended to represent absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" portion may become a "lower" portion by simply flipping the object. However, the portion is still the same portion, 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 used interchangeably with the terms "inflow" and "outflow," respectively. Thus, 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] As used herein, with respect to prosthetic heart valves and delivery devices, "proximal" refers to a location, direction, or portion of a component that is closer to a handle of the delivery device that is external to the user and / or subject, and "distal" refers to a location, direction, or portion of a component that is farther from the user and / or handle of the delivery device and closer to the implantation site. The terms "longitudinal" and "axial" refer to an axis that extends in the proximal and distal directions, unless expressly defined otherwise. Additionally, the term "radial" refers to a direction oriented perpendicular to an axis and points along a radius from the center of an object (e.g., an object with an axis centrally located, such as the longitudinal axis of a prosthetic valve).

[0027] Examples of the techniques disclosed herein Described herein are examples of powered delivery devices that may be used to deliver an implantable expandable medical device, such as a prosthetic heart valve. The delivery device of the present disclosure includes a manual deployment tool that can be used to operate the device in the event of a motor malfunction, thereby improving the physician's ability to complete the deployment and implantation of the medical device during a procedure. In some representative embodiments, the manual deployment tool is configured as a pull cord that is pulled through an opening in a handle portion of the delivery device to manually operate the device.

[0028] In some embodiments, the delivery device is configured to deliver and implant a prosthetic heart valve, such as the exemplary prosthetic heart valve of Figure 1, at a selected implantation site within a subject (e.g., in a native aortic, mitral, tricuspid, or pulmonary valve). In addition to prosthetic heart valves, the delivery device of the present disclosure can be adapted to deliver and implant other types of prosthetic valves (e.g., venous valves) and various other types of prosthetic devices, such as, for example, stents, grafts, docking devices for prosthetic heart valves, heart valve repair devices (e.g., leaflet clips), and embolic coils; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, such as, for example, devices for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, and heat sources.

[0029] In various embodiments described herein, the delivery device and delivery method may be deployed or performed in a subject. Subjects include (but are not limited to) medical patients, veterinary patients, animal models, cadavers, and cardiovascular simulators (e.g., human body phantoms and explanted tissues). Thus, various embodiments relate to methods for performing medical procedures, performing medical procedures, and / or training medical procedures. Simulators may include simulations of all or part of the vascular system, all or part of the heart, and / or all or part of the vascular system (e.g., all or part of the ascending aorta). References to native tissue (e.g., native heart valves) refer to existing structures in the subject, such as (e.g.,) the patient's (e.g.) native tissue or simulator components.

[0030] Figure 1 illustrates a prosthetic heart valve 10 according to one embodiment that can be implanted using the delivery device 100 of Figure 2. In some embodiments, the prosthetic 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 a delivery capsule (Figure 2) located at the distal end of the delivery device, the prosthetic valve can self-expand radially to its functional size.

[0031] The prosthetic heart valve 10 includes a stent or frame 12 and a valve structure 14 (e.g., a leaflet or flap valve) supported by the frame. The frame 12 can have a plurality of interconnected struts 16 arranged in a grid pattern to form a plurality of apices 18 at each of the inflow and outflow ends 20 and 22 of the frame 12.

[0032] The frame 12 may include a plurality of angularly separated posts 24 extending from respective tips 18 at the outflow end of the frame 12. In the illustrated embodiment, the frame 12 includes three such posts 24, although more or fewer posts may be used. In one implementation, the frame 12 may have a post extending from every tip 18 at the outflow end of the frame. Each post 24 may have an eyelet or aperture 26 that may be used to form a releasable connection with the delivery device 100, such as by use of one or more cords or tethers 118 (see FIG. 3), as described further below.

[0033] In some embodiments, the frame 12 can have no posts 24, and apertures 26 can be formed in the tip 18 at the outflow end of the frame. In the embodiment shown in Figure 3, the apertures are formed at the outflow end of the frame such that when loaded into a delivery device 100, as described further below, a releasable connection can be formed by the cord 118 between the cord manifold 120 and the outflow end of the frame 12. This configuration facilitates delivery of the prosthetic valve 10 to the native aortic valve using a retrograde delivery approach, whereby the delivery device 100 is advanced through the femoral artery and aorta to access the native aortic valve.

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

[0035] In certain embodiments, the prosthetic 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 known in the art. When used with the delivery device 100 (FIG. 2), the prosthetic valve 10 is capable of self-expanding from a radially compressed state to a radially expanded state upon advancement from a delivery capsule (e.g., a 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 prosthetic heart valve can be expanded from a radially compressed state to a radially expanded state by inflating a balloon on the delivery device or activating other expansion means of the delivery device to cause radial expansion of the prosthetic valve.

[0037] The valve structure 14 may include multiple leaflets 28. The valve structure typically includes three leaflets 28 arranged in a tricuspid configuration, although more or fewer leaflets 28 may be used. The leaflets 28 may be made from any of a variety of suitable materials, including natural tissue (such as bovine pericardium or pericardium from other sources) or synthetic materials (such as polyurethane). Adjacent side portions at the outflow edges (upper edges as shown) of adjacent leaflets are secured to one another to form commissures 30 of the valve structure, which may be secured to the frame by sutures 32.

[0038] The prosthetic valve 10 may further include an inner skirt 34 attached to the inner surface of the frame 12. The skirt 34 helps establish a seal with the surrounding tissue after implantation. The skirt 34 may also be used to attach portions of the leaflets 28 to the frame 12. For example, in the illustrated embodiment, the inflow edges (lower edges as shown) of the leaflets may be sewn to the skirt 34 along a suture line 36. The skirt 34 may be directly connected to the frame 12, such as with sutures. Although not illustrated, the prosthetic valve 10 may include an outer skirt attached to the outer surface of the frame instead of or in addition to the inner skirt 34, which may further seal the prosthetic valve against the surrounding tissue. The inner skirt and / or the outer skirt may be made from any of a variety of suitable materials, including natural tissue (such as pericardial tissue) or any of a variety of synthetic materials that may be woven, nonwoven, braided, knitted, and / or combinations thereof. In one particular implementation, the inner skirt 34 is made from polyethylene terephthalate (PET) fibers.

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

[0040] The prosthetic heart valve 10, or other types of implantable, expandable medical devices, such as, for example, an expandable stent, can be delivered to an implantation site by a delivery device, one exemplary embodiment of which is shown in Figures 2-9B.

[0041] As shown in Figures 2 and 3, the delivery device 100 may include a handle portion 132 and a first shaft 134 extending distally from the handle portion 132. A user, such as a physician or clinician, may operate the delivery device 100 by actuating 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 include a housing 133, which may include two housing portions 133a, 133b (best shown in Figure 7).

[0042] As shown in FIG. 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 figures, the first shaft 134 is the outermost shaft of the delivery device and therefore may be referred to as 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 therefore may be referred to as the inner shaft 152 of the delivery device. In the illustrated embodiment, the second shaft 150 is located intermediate or between the innermost and outermost shafts and therefore may be referred to as the middle shaft.

[0043] A nosecone 144 may be coupled to or mounted on a distal end portion 152d of the inner shaft 152. The nosecone 144 may have a tapered outer surface as shown for atraumatic tracking of the delivery apparatus 100 through the subject's vasculature. The inner shaft 152 extends distally past the midshaft 150 through the lumen of the cord manifold 120, through the prosthetic valve 10.

[0044] In some embodiments, each of the first shaft 134, second shaft 150, and third shaft 152 may 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 (FIG. 4) extends through a central lumen of the inner shaft 152 and an inner lumen of the nosecone 144, allowing the delivery device 100 to be advanced over the guidewire 154 within the subject's vasculature during delivery of the prosthetic valve 10. The guidewire 154 may be inserted into the inner shaft 152 via a proximal port 155 in the handle portion 132 (FIG. 5).

[0045] A delivery capsule 146 is coupled to the distal end portion 142 of the first shaft 134 proximal to the nose cone 144. As shown in FIGS. 3-4, the delivery capsule 146 contains the prosthetic valve 10 therein in a radially compressed state. In one embodiment, the delivery capsule 146 covers and retains the prosthetic valve in a compressed state, which is located at the bottom of FIG. 1. The delivery device 100 is particularly suited for delivering and implanting a self-expanding prosthetic valve 10, which radially expands to a functional size due to its inherent resiliency when deployed from the delivery capsule 146.

[0046] However, the prosthetic heart valve 10 can alternatively be a plastically expandable prosthetic valve or a mechanically expandable heart valve. When the delivery device is used to implant a plastically expandable valve, the delivery device can include a balloon catheter as known in the art for expanding the prosthetic valve, such as that disclosed in U.S. Patent Application Publication No. 2009 / 0281619, which is incorporated herein by reference. When the delivery device is used to implant a mechanically expandable valve, the delivery device can include one or more actuators for expanding the prosthetic valve, such as that disclosed in U.S. Provisional Patent Application No. 62 / 945,039, filed December 6, 2019, which is incorporated herein by reference.

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

[0048] The cord manifold 120 may include 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 fixedly secured to the distal end portion 142 of the first shaft 134 utilizing any suitable technique or mechanism, such as, for example, via a mechanical connector, welding, press fit, and / or adhesive. For example, in some embodiments, the distal end portion 142 of the shaft 134 extends within a lumen of the proximal portion, which may be secured to the shaft 134 utilizing any of the connection techniques described above.

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

[0050] Each cord 118 may have a first end 118a attached to the cord manifold 120, such as to the proximal portion 122. Each cord 118 may have a second end 118b in the form of a loop that extends through an opening in the prosthetic valve frame 12 (e.g., through opening 26) and is retained on a release member 156. The release member 156 is configured to hold the cord 118 coupled to the prosthetic valve 10 frame 12 until actuated by a 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 may be used.

[0051] Similarly, while two cords 118 are shown for illustrative purposes, it should be understood that any number of cords may be used. Furthermore, the cords and release members 156 need not be of the same number. For example, ends 118b of multiple cords 118 may be carried on a single release member. Desirably, 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 equal to the number of tips 18 (FIG. 1) of the frame 12 of the prosthetic valve 10. Furthermore, in other embodiments, a single cord may be used to couple the frame 12 to the cord manifold 120 at multiple locations along the outflow end of the frame by forming multiple passages extending through openings in the frame.

[0052] Each release member 156 may slidably extend through respective openings in the proximal and distal portions 122, 124 of the cord manifold 120. Each release member 156 may extend through the first shaft 134 along its entire length and may have a proximal end portion operatively coupled to the knob 136 on the handle to control movement of the release member. Each release member 156 is proximally and distally movable relative to the proximal and distal portions 122, 124 of the cord manifold between a distal position in which each release member 156 retains a respective cord 118 and a proximal position in which each release member 156 is released from a respective cord 118.

[0053] Further details regarding attachment of the prosthetic valve 10 to the delivery device 100 with one or more cords or sutures are disclosed in U.S. Patent Application Publication Nos. 2014 / 0343670, 2012 / 0239142, and 2010 / 0049313, as well as U.S. Provisional Patent Application No. 62 / 824,710, filed March 27, 2019, all of which are incorporated by reference herein.

[0054] Additionally, in alternative embodiments, various valve retention mechanisms may be used to form a releasable connection between the prosthetic valve 10 and the delivery device 100. For example, in some embodiments, the posts 24 of the frame 12 are retained within corresponding recesses in the shaft or retention member of the delivery device that allow the frame posts to expand out of the corresponding recesses when the capsule 146 is retracted to deploy the prosthetic valve. In other embodiments, the retention mechanism may include inner and outer metal fork members that form a release connection between the delivery device and the prosthetic valve. Further details regarding alternative valve retention mechanisms are disclosed in U.S. Patent Application Publication No. 2012 / 0239142 and U.S. Patent Application Publication No. 2010 / 0049313.

[0055] As further shown in FIG. 3, the second shaft 150 may include an externally threaded portion 162 along its distal end portion. The threaded portion 162 may include threads formed on an exterior surface of the shaft or may be a separate screw coupled to the distal end of the proximal shaft section. The capsule 146 is operatively coupled to the second shaft 150 by an internally threaded nut 164 disposed on the threaded portion 162. The nut 164 may have a radially extending protrusion 166 that extends into a corresponding opening in the capsule 146 (see FIG. 2). Rotation of the nut 164 is limited by one or more rails 165 extending from or formed along the distal end portion of the first shaft 134.

[0056] Thus, rotation of the second shaft 150 relative to the first shaft 134 causes axial movement (distal and proximal) of the nut 164, which in turn causes corresponding axial movement of the capsule 146 in the same direction during loading, deployment, and / or retrieval of the prosthetic valve. For example, when the nut 164 is in a distal position, the delivery capsule 146 extends over the prosthetic valve 10 and holds it in a compressed state for delivery. Proximal movement of the nut 164 causes the delivery capsule 146 to move proximally, thereby deploying the prosthetic valve. Rotation of the second shaft 150 may be accomplished by a motor operatively coupled to the second shaft and / or manual control features, as described further 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 a vessel by controlling one or more curvatures in the shafts 134, 150, 152. For example, the steering mechanism may include one or more eccentrically positioned pull wires that extend through the shaft and are operatively coupled to an adjustment mechanism located on or adjacent the handle portion 132. Adjusting the adjustment mechanism changes the tension in the pull wires to effect curvature or straightening of 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 regarding this steering mechanism are disclosed in U.S. Patent Application Publication No. 2007 / 0005131 and U.S. Patent Application Publication No. 2013 / 0030519, which are incorporated herein by reference.

[0058] 6-11, the delivery device 100 is a powered device that includes a motor 168 housed within the handle portion 132. This powered embodiment automates the deployment of the prosthetic valve 10. In particular, the motor 168 is operatively 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 described further below.

[0059] A proximal end portion 140 of the first shaft 134 may be coupled to a distal end of the handle portion 132. As shown in FIG. 6 , a proximal end portion 151 of the second shaft 150 may extend into the handle portion 132 via a distal opening 170 of the handle portion 132. A rotatable component 172 (which in some embodiments may be referred to as a drive cylinder) is disposed within the handle portion 132 and is operatively coupled to the second shaft 150.

[0060] In one embodiment, as best shown in FIGS. 7-9, the proximal end portion of the rotatable component comprises a gear 174 having a plurality of gear teeth 176 circumferentially disposed relative to one another. The rotatable component 172 further comprises a main body 178 configured as an elongated shaft (FIG. 8) having a lumen 173. In the illustrated embodiment, the main body 178 and the gear 174 are integrally formed, but may also be separately formed components that are interconnected using any of a variety of attachment means. The main body 178 of the rotatable component 172 is coaxial with the central longitudinal axis L-L′ (shown in FIG. 5) of the handle portion 132 and can also be coaxial with the first shaft 134. The lumen 173 of the main body 178 can be sized to receive and retain the proximal end portion 151 of the second shaft 150 therein.

[0061] In some implementations, the inner surface of the lumen 173 can 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 can have a similar cross-sectional profile corresponding to the shape of the lumen, whereby rotational motion of the rotatable component 172 is transmitted to the second shaft 150. For example, the lumen 173 and the proximal end portion 151 can be generally cylindrical and have a series of circumferentially spaced flat sections. Instead of or in addition to imparting the lumen 173 and the proximal end portion 151 with a non-circular cross-section, the proximal end portion 151 can be fixed to the rotatable component using a fastening means, such as, for example, a mechanical fastener (e.g., a screw), an adhesive, a press fit, a snap-fit ​​connection, or the like.

[0062] As best shown in FIG. 6, the motor 168 may be held within a holding case or cradle 190. The motor may be an electric motor, and the handle portion may include a battery compartment housing one or more batteries (not shown) for powering the motor 168. One or more operator buttons 138a, 138b on the handle portion allow a user to activate the motor, such as by electrically coupling current from a battery power source to the motor. The motor may be rotatable in both directions, as described hereinafter, to move the capsule 146 either proximally or distally. 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 in a distal direction, such as for loading a prosthetic 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 in a proximal direction, such as for deploying a prosthetic valve. Alternatively or in addition to one or more batteries, the motor 168 can be configured to receive a power cord that provides current to the motor from a power source external to the handle portion (eg, a wall outlet).

[0063] As best shown in FIG. 8 , the motor 168 may be coupled to the rotatable component 172 by a drive shaft 184 coupled to the motor shaft 188 and an intermediate drive gear 182 coupled to the drive shaft 184. As shown in FIGS. 9A-9B , the drive gear 182 may have circumferentially disposed gear teeth 192 that may engage circumferentially disposed 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 and rotates the gear 174 of the rotatable component 172, which in turn rotates the rotatable component 172 and the second shaft 150. 9A-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 such that the gears are vertically aligned when meshed. In other embodiments, one or more additional gears can be provided between the drive gear and the rotatable component to transfer rotation from the motor to the rotatable component.

[0064] In alternative embodiments, the motor shaft 188 or drive shaft 184 may be coupled 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 coupled to the rotatable component 172 in a direct drive configuration (see, for example, the embodiment of FIG. 10 described below).

[0065] 9A-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. Additionally, these views show the vertical alignment of the gears with respect to one another. In other embodiments, this positioning may be reversed. The vertical alignment of the gears allows these components to be operably coupled while being contained within the limited space available within the handle portion.

[0066] In the illustrated embodiment, a cradle 190 housing the motor 168 and drive shaft 184 may further be configured to support the rotatable component 172 for rotational movement within the handle portion. As best shown in FIGS. 6-7 , the cradle 190 may have a first distal portion 194 including a distal sleeve 195 that circumferentially surrounds a distal end portion of the main body 178 of the rotatable component 172. The cradle 190 may further have a proximal portion 196 including a proximal sleeve 197 that circumferentially surrounds a proximal end portion of the main body 178 of the rotatable component 172.

[0067] 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. This, in turn, causes rotation of the second shaft 150 coupled to the rotatable component 172. Rotation of the second shaft 150 rotates the thread 162 of the second shaft 150. As described above, rotation of the thread 162 causes axial movement of the drive nut 164 and capsule 146 (FIG. 3). For example, rotation of the rotatable component in a first direction may cause the delivery capsule 146 to retract proximally, exposing the prosthetic valve at the distal end of the delivery device. In contrast, rotation of the motor in a second direction opposite the first direction causes the second shaft 150 to rotate in the opposite direction, which causes the nut to move axially in the opposite direction, which causes the delivery capsule to move distally back onto the prosthetic valve. An operator can activate buttons 138a, 138b (FIG. 6) on the handle portion to activate a motor to power the delivery capsule axially, allowing for rapid deployment or retrieval of the prosthetic valve.

[0068] In use, the prosthetic valve 10 can be coupled to the delivery device 100 and loaded into the capsule as follows. A releasable connection is formed between each tip 18 at one end of the frame 12 and the cord manifold 120 using a separate cord 118. Optionally, the length of the cord 118 is selected such that the fixed end of the frame is held in at least partial radial compression by the cord. After fixing the end of the frame 12 with the cord 118, the delivery capsule 146 can be advanced distally over the cord manifold 120, the cord 118, and the frame 12 (e.g., by pressing the button 138a), causing the frame to contract into a radially compressed state under the force of the capsule 146 (as shown in FIG. 4). As shown in FIG. 3, the delivery capsule 146 is advanced distally until the distal end of the delivery capsule 146 abuts the nosecone 144 to completely surround the prosthetic valve 10.

[0069] After loading the prosthetic heart valve 10 into the delivery device 100 as described above, the delivery device may be inserted into the vasculature and advanced or guided through the vasculature to the desired implantation site (e.g., through the femoral artery and aorta in the case of a retrograde delivery approach to deliver the prosthetic valve 10 to the native aortic valve).

[0070] Once the prosthetic valve 10 has been delivered to a selected implantation site (e.g., the native aortic valve) within the subject, the nosecone 144 may optionally be advanced distally away from the adjacent end of the capsule 146 by pushing the inner shaft 152 distally to avoid contact between the prosthetic valve and the nosecone during valve deployment. The delivery capsule 146 may be retracted (e.g., by pressing button 138b) to deploy the prosthetic valve 10. The delivery capsule 146 may be retracted ( FIG. 4 ) to allow the prosthetic valve to self-expand radially under the resilience of the frame 12. After the delivery capsule 146 has been fully retracted from the prosthetic valve 10, the prosthetic valve remains attached to the delivery device 100 by the cord 118. While still attached to the delivery device, the user may manipulate the delivery device (e.g., by moving the delivery device proximally and distally and / or rotating the delivery device) to adjust the position of the prosthetic valve relative to the desired implantation location.

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

[0072] Once the prosthetic valve has been deployed from capsule 146 and positioned at the desired implantation location, release member 156 may be retracted, such as by rotating knob 136 on handle portion 132. In some instances, cord 118 slides outward from aperture 26 and clears frame 12 due to the self-expanding frame 12 expanding further when release member 156 is retracted. In other instances, the user may retract delivery device 100 slightly, which in turn pulls cord 118 proximally relative to frame 12, pulling cord 118 out of aperture 26.

[0073] Optionally, the orientation of the prosthetic valve can be reversed when coupled to a delivery device, such that the inflow end of the prosthetic valve becomes the proximal end and the outflow end of the prosthetic valve becomes the distal end, which can facilitate delivery of the prosthetic valve to various implantation locations (e.g., the native aortic, pulmonary, mitral, and tricuspid annulus) and / or for various delivery approaches (e.g., antegrade, transseptal, transventricular, transatrial).

[0074] As discussed above, rotational movement of the rotatable component 172 results in axial movement of the second shaft 150 and the delivery capsule 146. While rotation of the rotatable component 172 may be acted upon by the motor 168, it may also be accomplished manually.

[0075] To these ends, the delivery device 100 can include a manual deployment tool that allows the rotatable components to be manually operated to deploy or retrieve the prosthetic valve in the event of motor or battery malfunction. For example, if the motor stops working or the battery dies while the user is operating the motor to rotate the rotatable components, the user has only a limited amount of time to complete retraction of the delivery capsule or retrieve the prosthetic valve. An exemplary embodiment of such a manual deployment tool 200 is shown in Figures 7, 9A, and 9B.

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

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

[0078] 9A-9B, at least a portion 205 of pull cord 200 includes a plurality of teeth 204 configured to drivingly engage a plurality of gear teeth 176 of rotatable component 172 when pull cord 200 is pulled through opening 202 in handle portion 132. In this manner, pull cord 200 functions as a linear rack that, upon linear translation along axis M-M', causes rotation of rotatable component 172. As shown in FIG. 7, pull cord 200 may have teeth 204 along a majority of the length of pull cord 200.

[0079] Pull cord 200 can have a length in the range of about 12 inches to about 36 inches, in the range of about 16 inches to about 30 inches, or in the range of about 17 inches to about 20 inches. In some embodiments, the overall length of 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, and the like. In some embodiments, the pull cord 200 can be made from molded plastic and can have a curved portion 210 connecting two straight portions 212 as shown in FIG. 7. The pull cord 200 can be sufficiently flexible such that the curved portion 210 can be straightened by being pulled through an opening 202 in the handle portion 132. In some embodiments, the pull cord 200 can be straight along its length from one end of the pull cord to the other. In other embodiments, the pull cord 200 can be shaped into a coil or helix shape that can be unwound or straightened by being pulled through an opening 202 in the handle portion 132. Additionally, in some embodiments, the pull cord 200 can be sufficiently stiff so that it can be pushed through the handle portion 132 instead of or in addition to being pulled through the handle portion 132 during use. As will be further explained below, manual movement of the pull cord through the handle portion operates the rotatable component 172, whether the pull cord is pushed or pulled through the handle portion.

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

[0082] Movement of the pull cord 200 in a first direction (e.g., a first direction along M-M') through the opening 202 rotates the rotatable component 172 in a first rotational direction (e.g., a clockwise or counterclockwise direction), while movement of the pull cord through the opening in a second rotational direction opposite the first direction (e.g., opposite the direction along M-M') rotates the rotatable component 172 in the second direction opposite the first direction. Because rotation of the rotatable component results in axial movement of the delivery capsule, movement of the pull cord in a first direction along axis M-M' can be utilized to retract the delivery capsule 146 and deploy the prosthetic valve 10, while movement of the pull cord in a second direction along axis M-M' can be utilized to distally advance the delivery capsule 146 and retrieve the prosthetic valve 10.

[0083] During the prosthetic valve delivery process, a user can insert the prosthetic valve 10 into a subject using the delivery device 100, with the prosthetic valve 10 held in a radially compressed state within the delivery capsule 146 as described above. The user can then operate an electrical switch (e.g., button 138b) to activate a motor 168 housed within the handle portion 132 of the delivery device. If the motor cannot rotate to cause axial movement of the delivery capsule 146, the user can then rotate a rotatable component 172 within the handle portion 132 by inserting a pull cord 200 through an opening 202 in the handle portion 132 and pulling (e.g., from left to right in FIGS. 9A-9B ). This, in turn, can rotate the second shaft 150 and axially move the delivery capsule 146 proximally relative to the prosthetic valve, deploying the prosthetic valve from the delivery capsule and radially expanding the prosthetic valve from the radially compressed state to the radially expanded state. In some embodiments, once the prosthetic valve has been radially expanded and deployed 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 is not able to fully retract and deploy the prosthetic valve and it is desired to retrieve the prosthetic valve back into the delivery capsule, the pull cord 200 can be inserted in a reverse direction (e.g., from right to left in FIGS. 9A-9B ) into and pulled through the opening 202 to rotate the rotatable component in the reverse direction and axially move the delivery capsule 146 distally, moving the delivery capsule back over the prosthetic valve. Once the prosthetic valve is in the delivery capsule, the delivery device 100 can be used to reposition the prosthetic valve for deployment or can be completely withdrawn from the body.

[0085] In this way, a manual deployment tool is provided for manually operating the rotatable component of the delivery device that allows for 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 operate the manual deployment tool to drive the rotatable component and complete the process. In this way, the manual deployment tool serves as a simple back-up or rescue tool to ensure greater efficiency in completing the implantation procedure.

[0086] In an alternative embodiment, pull cord 200 may extend through housing 133 of handle portion 132 at a location where it engages drive gear 182 instead of gear 174. In such an embodiment, pull cord 200 is used in a similar manner as described above, except that pull cord 200 is pulled through the housing to rotate gear 182, which in turn rotates gear 174 and rotatable component 172.

[0087] 10 illustrates a powered delivery device 300 that can be operated by a pull cord 200, according to another embodiment. The delivery device 300 in the illustrated embodiment includes 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 can be attached on a distal end portion of the inner shaft 308.

[0088] 10 , the distal end portion 312 of the first shaft 304 serves as a delivery capsule. The prosthetic valve 10 may be releasably coupled to the distal end portion of the second shaft 306 using any of the retention mechanisms described above. The prosthetic valve 10 may be deployed from the delivery capsule 312 by retracting the first shaft 304 relative to the prosthetic valve and the second shaft 306.

[0089] The handle portion 302 may house a motor 314 having a shaft 316 coupled to a lead screw 318. The lead screw 318 may have an externally threaded portion 320 that extends through and threadably engages a threaded opening in an extension portion 322 of the first shaft 304. The extension portion 322 acts as a nut that may move proximally and distally as the lead screw rotates. The handle portion 302 may have other features for operating the motor 314 described in connection with 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 activating the motor 314.

[0090] During the implantation procedure, the user may advance the nosecone 310 distally away from the delivery capsule 312 by pushing the inner shaft 308 distally after the prosthetic valve is positioned at the implantation site. The user can actuate the motor 314 (e.g., by pressing button 138b), which rotates the lead screw 318 and retracts the first shaft 304 proximally (to the right in FIG. 10 ) to expose the prosthetic valve. If retrieval and / or repositioning is required, operating the motor 314 in the opposite direction (e.g., by pressing button 138a) rotates the lead screw in the opposite direction and moves the first shaft 304 back over the prosthetic valve.

[0091] A gear 324 having a plurality of gear teeth may be mounted on the lead screw 318 to manually operate the lead screw 318. The handle portion 302 may include an opening for receiving the pull cord 200 at a location where the teeth 204 of the pull cord 200 may engage 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 to retract the first shaft 304. Pulling the pull cord 200 through the handle portion 302 in a second direction opposite the first direction has the effect of rotating the lead screw 318 in a second rotational direction to move the first shaft 304 distally.

[0092] In an alternative embodiment, instead of gear 324, gear teeth may be provided directly on the exterior surface of the lead screw for engaging the teeth 204 of the pull cord.

[0093] Additionally, it should be noted that any movable component of the delivery device 100, 300 may be configured to be operated by the pull cord 200. For example, in one implementation, the lead screw 318 may engage an extension of the second shaft 306, whereupon the prosthetic valve 10 may be deployed by moving the second shaft 306 and the prosthetic valve 10 distally relative to the first shaft 304. The motor 314 and pull cord 200 may be used to move the second shaft 306 distally and proximally depending on whether the prosthetic valve is to be deployed or retrieved back 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 external threads (similar to a screw) that run helically along the length of the pull cord. A gear (e.g., gear 174) or other delivery device component designed to engage the pull cord can have corresponding features that mesh with the helical threads of the pull cord and rotate the delivery device component when the pull cord is pulled relative to the delivery device component.

[0095] 11, another exemplary embodiment of a manual deployment tool configured as a pull cord 400 is shown. Pull cord 400 can be configured and function similarly to pull cord 200 (as described above with reference to FIGS. 7, 9A, and 9B) to manually deploy a prosthetic valve from a delivery device (such as delivery device 100 or 300).

[0096] As shown in Figure 11, pull cord 400 is straight (e.g., has no curves, bends, or coils) along its length from one end of pull cord 400 to the other end. For example, pull cord 400 has a straight body 402 with an intermediate portion 404 disposed between two end portions 406. Intermediate portion 404 has a number of teeth 408 (e.g., similar to teeth 204 of pull cord 200 shown in Figures 7, 9A, and 9B). End portion 406 does not have teeth and has a relatively smooth (e.g., toothless) surface 410.

[0097] In an alternative embodiment, the pull cord 400 may include only a toothless end portion 406 , and other portions of the pull cord 400 may include teeth 408 .

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

[0099] 12 illustrates another exemplary embodiment of a manual deployment tool configured as a pull cord 500. Pull cord 500 can be configured and function similarly to pull cord 200 (as described above with reference to FIGS. 7, 9A, and 9B) to manually deploy a prosthetic valve from a delivery device (such as delivery device 100 or 300).

[0100] As shown in FIG. 12, the pull cord 500 is configured as a coil or 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 coil or helix shape that can be unwound or straightened by being pulled through an opening in a handle portion of a delivery device (such as opening 202 in handle portion 132 of delivery device 100). The pull cord 500 includes a body 502 that includes a coiled toothed portion 504 and an end portion 506. The toothed portion 504 is coiled and includes a plurality of teeth 508 along its length. The end portion 506 does not include teeth and has a relatively smooth (e.g., toothless) surface 510. In some embodiments, the end portion 506 is straight (not coiled), as shown in FIG. 12.

[0101] The pull cord 500 can have a length in the range of about 12 inches to about 36 inches, in the range of about 16 inches to about 30 inches, or in the range of about 17 inches to about 20 inches.

[0102] In alternative embodiments, a pull cord, such as pull cord 200, 400, or 500, can be used to operate delivery device components that do not include a motor. For example, delivery device 100, 300 can lack motor 168, 314, and instead prosthetic valve 10 can be deployed from delivery capsule 146, 312 solely through use of a pull cord.

[0103] Finally, it should be noted that the general concept of use of a pull cord, such as pull cord 200, 400, or 500, may be used to move a movable component of a medical device having a handle and a rotatable component within the handle, with or without a motor within the handle. The pull cord is configured to rotate the rotatable component, which in turn may cause axial movement of the movable component of the medical device. The movable component may be a delivery capsule as described above, or may be another component of the medical device, such as a shaft, guidewire, or instrument that is moved or deployed within the body upon actuation of the pull cord.

[0104] Further examples of the techniques disclosed herein In view of the above implementations of the subject matter of the present disclosure, the present application discloses further embodiments as listed below. It should be noted that a feature of an embodiment alone or a combination of two or more features of an embodiment, optionally in combination with one or more features of one or more other embodiments, constitutes a further embodiment that is also within the scope of the present disclosure of the present application.

[0105] [Example 1] 1. A delivery apparatus 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, the rotatable component operatively coupled to the delivery capsule to cause axial movement of the delivery capsule relative to the shaft upon rotation of the rotatable component; a motor disposed within the handle portion, the motor operatively coupled to the rotatable component to cause rotation of the rotatable component and 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 to pull the pull cord relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the delivery capsule occur.

[0106] [Example 2] A delivery device of any embodiment of this section, 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 operatively coupled to the rotatable component and a distal end portion operatively coupled to the delivery capsule, such that rotation of the rotatable component rotates the second shaft relative to the first shaft, resulting in axial movement of the delivery capsule.

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

[0108] [Example 4] The delivery device of any one of the embodiments of this section, particularly any one of embodiments 1 to 3, wherein the handle portion comprises an opening for inserting a pull cord through the handle portion.

[0109] [Example 5] A delivery device of any embodiment of this chapter, particularly embodiment 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.

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

[0111] [Example 7] A delivery device of any of the embodiments of this section, particularly any one of embodiments 1 to 6, wherein the motor is an electric motor powered by at least one battery, the battery being housed within the handle portion.

[0112] [Example 8] The delivery device of any of the embodiments of this section, 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 of the embodiments of this chapter, particularly any one of embodiments 1 to 8, wherein the rotatable component comprises a plurality of gear teeth, and the pull cord comprises a plurality of teeth configured to drivingly engage the gear teeth of the rotatable component.

[0114] [Example 10] A delivery device of any of the embodiments of this chapter, particularly embodiment 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.

[0115] [Example 11] A delivery device of any embodiment of this chapter, particularly 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 of any of the embodiments of this chapter, particularly any one of embodiments 1 to 11, wherein the pull cord comprises an intermediate portion having a plurality of teeth and two end portions having no teeth, the intermediate portion being disposed between the two end portions.

[0117] [Example 13] A delivery device of any of the embodiments of this section, particularly any one of embodiments 1 to 12, wherein the pull cord is straight along its length.

[0118] [Example 14] A delivery device of any embodiment of this chapter, particularly any 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 comprises a plurality of teeth.

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

[0120] [Example 16] The delivery device of any of the embodiments of this section, particularly any one of embodiments 1 to 15, wherein the pull cord has a length in the range of 16 inches to 30 inches.

[0121] [Example 17] 1. A delivery apparatus 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, the rotatable component operatively coupled to the delivery capsule to cause axial movement of the delivery capsule relative to the shaft upon rotation of the rotatable component, the rotatable component comprising a plurality of circumferentially arranged gear teeth; a motor disposed within the handle portion, operatively coupled to the rotatable component to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule; and a manual deployment tool comprising a plurality of drive teeth configured to engage the gear teeth of the rotatable component, the manual deployment tool being manually movable along an axis extending through the handle portion to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule.

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

[0123] [Example 19] The delivery device of any of the embodiments herein, particularly embodiment 18, wherein the axis of the deployment tool is perpendicular to the longitudinal axis of the handle portion.

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

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

[0126] [Example 22] A delivery device of any embodiment of this chapter, particularly embodiment 21, 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 coupled to the main body of the rotatable component and a distal end portion operatively coupled to the delivery capsule, such that rotation of the rotatable component rotates the second shaft 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 the threaded portion of the distal end portion of the second shaft, the drive nut being coupled to the delivery capsule such that rotation of the second shaft relative to the first shaft causes axial movement of the drive nut and the delivery capsule.

[0128] [Example 24] The delivery device of any one of the embodiments of this section, particularly any one of embodiments 17 to 23, wherein the manual deployment tool is a pull cord.

[0129] [Example 25] A method for implanting a medical device in a subject, the method comprising the steps of inserting the medical device into 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 having a handle portion and a rotatable component housed within the handle portion, and rotating the rotatable component by pulling a pull cord that passes through the handle portion, thereby causing axial movement of the delivery capsule relative to the medical device to deploy the medical device from the delivery capsule and radially expand the medical device from the radially compressed state to a radially expanded state.

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

[0131] [Example 27] The method of any embodiment of this chapter, particularly embodiment 25 or 26, wherein the medical device is a prosthetic heart valve, and the step of inserting the medical device into the subject includes the step of advancing the prosthetic heart valve, held within a delivery capsule, through the subject's vasculature until the prosthetic heart valve is located at or near the native annulus of the heart.

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

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

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

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

[0136] [Example 32] 11. A method of implanting a medical device in a subject, comprising: inserting the medical device into the subject using a delivery apparatus, the medical device being held in a radially compressed state within a delivery capsule of the delivery apparatus, the delivery apparatus comprising a handle portion and a rotatable component housed within the handle portion; operating an electrical switch to activate a motor operatively coupled to the rotatable component; and if the motor is unable to effect 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 to deploy the medical device from the delivery capsule and radially expanding the medical device from the radially compressed state to a radially expanded state; or if the motor fails when the medical device is partially deployed 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 to retrieve the partially deployed medical device.

[0137] [Example 33] The method of any embodiment of this chapter, particularly embodiment 32, wherein the medical device is a prosthetic heart valve, and the step of inserting the medical device into the subject includes the step of advancing the prosthetic heart valve, held within a delivery capsule, through the subject's vasculature until the prosthetic heart valve is located at or near the native annulus of the heart.

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

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

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

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

[0142] [Example 38] 1. A delivery apparatus 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, the rotatable component operatively coupled to the delivery capsule such that rotation of the rotatable component causes axial movement of the delivery capsule relative to the handle portion; and a pull cord configured such that when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the delivery capsule occurs.

[0143] [Example 39] A delivery device of any embodiment of this chapter, particularly embodiment 38, further comprising a motor disposed within the handle portion and operatively 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 of any embodiment of this chapter, particularly embodiment 38 or 39, wherein the handle portion comprises an opening for inserting a pull cord through the handle portion.

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

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

[0147] [Example 43] The delivery device of any one of the embodiments of this section, 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 any one of embodiments 38 to 43, wherein the rotatable component has a plurality of gear teeth and the pull cord has a plurality of teeth configured to drivingly engage the gear teeth of the rotatable component.

[0149] [Example 45] A delivery device of any embodiment of this chapter, particularly 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 has an intermediate portion having a plurality of teeth and two end portions having no teeth, and the intermediate portion is disposed between these two end portions.

[0151] [Example 47] A delivery device of any one of the embodiments of this chapter, particularly any one of embodiments 44 to 46, wherein the pull cord is straight along its length.

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

[0153] [Example 48] A delivery device of any one of the embodiments of this chapter, particularly any 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 one of the embodiments of this section, particularly any one of embodiments 38 to 48, wherein the pull cord has a length in the range of 16 inches to 30 inches.

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

[0156] [Example 51] 1. A medical device for insertion into a subject, the medical device comprising: a handle portion; a movable component configured to be inserted into the subject; a rotatable component disposed within the handle portion, the rotatable component operatively coupled to the movable component such that rotation of the rotatable component causes axial movement of the movable component relative to the handle portion; and a pull cord configured such that when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the movable component occurs.

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

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

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

[0161] [Example 56] A medical device of any embodiment of this chapter, particularly embodiment 55, 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.

[0162] [Example 57] The medical device of any of the embodiments 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 of any embodiment of this chapter, particularly any one of embodiments 51 to 57, wherein the rotatable component has a plurality of gear teeth and the pull cord has a plurality of teeth configured to drivingly engage the gear teeth of the rotatable component.

[0164] [Example 59] A medical device of any embodiment of this chapter, particularly embodiment 58, wherein the pull cord has 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 has an intermediate portion having a plurality of teeth and two end portions having no teeth, and the intermediate portion is disposed between the two end portions.

[0166] [Example 61] The medical device of any of the embodiments in this section, particularly any one of embodiments 58 to 60, wherein the pull cord is straight along its length.

[0167] [Example 62] A medical device of any embodiment of this chapter, particularly any 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 has a plurality of teeth.

[0168] [Example 63] The medical device of any of the embodiments 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] The medical device of any embodiment of this chapter, particularly any one of embodiments 51 to 63, wherein the pull cord has a length within the range of 16 inches to 30 inches.

[0170] [Example 65] A method of using a medical device, the method comprising the steps of inserting a movable component of the medical device into a subject, the medical device having 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 movement of the movable component.

[0171] [Example 66] A method of any embodiment of this chapter, particularly embodiment 65, wherein the movable component includes a delivery capsule that holds the implantable medical device in a radially compressed state, and the aforementioned step of pulling a pull cord passing through the handle portion moves the delivery capsule relative to the implantable medical device to deploy the implantable medical device from the delivery capsule.

[0172] [Example 67] A method of any embodiment of this chapter, particularly embodiment 66, wherein the implantable medical device is a prosthetic heart valve, and the step of inserting a movable component of the medical apparatus into the subject includes a step of advancing the prosthetic heart valve, held within a delivery capsule, through the subject's vasculature until the prosthetic heart valve is located at or near the native annulus of the heart.

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

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

[0175] [Example 70] The method of any one of the embodiments in this chapter, particularly any one of embodiments 25 to 37 and embodiments 65 to 69, wherein the method is performed as a training or practice procedure in a cadaver or cardiovascular simulator.

[0176] In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be understood that these illustrative embodiments are merely preferred examples of the disclosed technology and should not be construed as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter 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] 1. A delivery apparatus for an expandable implantable medical device, comprising: The handle part, a shaft extending from the handle portion; 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, the rotatable component operatively coupled to the delivery capsule to axially move the delivery capsule relative to the shaft upon rotation of the rotatable component; a motor disposed within the handle portion and operatively 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 application of a manual pulling force to the pull cord to pull the pull cord relative to the rotatable component results in rotation of the rotatable component and corresponding axial translation of the delivery capsule; A delivery device comprising: [Section 2] Item 2. The delivery device of item 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 operatively coupled to the rotatable component and a distal end portion operatively coupled to the delivery capsule, such that rotation of the rotatable component rotates the second shaft relative to the first shaft, resulting in axial movement of the delivery capsule. [Section 3] Item 1, a delivery device as described in item 1, wherein the delivery capsule is coupled to a distal end portion of the shaft and the rotatable component is operatively coupled to a 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] 4. The delivery device of any one of claims 1 to 3, wherein the handle portion includes an opening for inserting the pull cord through the handle portion. [Section 5] Item 5. The delivery device of item 4, wherein the pull cord is configured to be pulled through the opening in a direction substantially perpendicular to a longitudinal axis of the handle portion to cause rotation of the rotatable component. [Section 6] 6. The delivery device of claim 4 or 5, wherein moving the pull cord through the opening in a first direction rotates the rotatable component in a second direction, moving the delivery capsule in a third proximal direction, and moving the pull cord through the opening in a fourth direction opposite to the first direction, rotates the rotatable component in a fifth direction opposite to the second direction, moving the delivery capsule in a sixth distal direction. [Section 7] 7. The delivery device of 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] Item 8. The delivery device of any one of items 1 to 7, wherein the pull cord is removable from the handle portion. [Section 9] 9. The delivery device of 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 drivingly engage the gear teeth of the rotatable component. [Section 10] Item 10. The delivery device of item 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] Item 11. The delivery device of item 9 or 10, wherein the pull cord comprises at least one end portion that does not have teeth. [Section 12] Item 12. The delivery device of any one of items 1 to 11, wherein the pull cord comprises a middle portion having a plurality of teeth and two end portions having no teeth, the middle portion being disposed between the two end portions. [Section 13] Item 13. The delivery device of any one of items 1 to 12, wherein the pull cord is straight along its length. [Section 14] Item 13. The delivery device of any one of items 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 includes a plurality of teeth. [Section 15] 1. A delivery apparatus for an expandable implantable medical device, comprising: 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, the rotatable component operatively coupled to the delivery capsule to axially move the delivery capsule relative to the handle portion upon rotation of the rotatable component; a pull cord configured such that application of a manual pulling force to the pull cord to pull the pull cord relative to the rotatable component results in rotation of the rotatable component and corresponding axial translation of the delivery capsule; A delivery device comprising: [Section 16] Item 16. The delivery device of item 15, further comprising a motor disposed within the handle portion and operatively coupled to the rotatable component to cause rotation of the rotatable component and corresponding axial movement of the delivery capsule. [Section 17] Item 17. The delivery device of item 15 or 16, wherein the handle portion includes an opening for passing the pull cord through the handle portion, and the pull cord is configured to be pulled through the opening in a direction substantially perpendicular to a longitudinal axis of the handle portion to cause rotation of the rotatable component. [Section 18] 18. The delivery device of 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 drivingly engage the gear teeth of the rotatable component, and the pull cord comprises at least one end portion having no teeth. [Section 19] Item 19. The delivery device of item 18, wherein the pull cord is straight along its length and comprises a middle portion having the plurality of teeth and two end portions having no teeth, the middle portion being disposed between the two end portions. [Section 20] 1. A medical device for insertion into a subject, comprising: The handle part, a movable component configured to be inserted into the subject; and a rotatable component disposed within the handle portion, the rotatable component operatively coupled to the movable component such that rotation of the rotatable component causes axial movement of the movable component relative to the handle portion; a pull cord configured such that application of a manual pulling force to the pull cord to pull the pull cord relative to the rotatable component results in rotation of the rotatable component and corresponding axial movement of the movable component; A medical device comprising: [Section 21] 21. The medical apparatus of claim 20, wherein the movable component comprises a delivery capsule configured to hold the implantable medical device in a radially compressed state for delivery into the subject. [Section 22] 22. The medical device of claim 20 or 21, further comprising a motor disposed within the handle portion and operatively coupled to the rotatable component to cause rotation of the rotatable component and corresponding axial movement of the movable component. [Section 23] 23. The medical device of any one of claims 20 to 22, wherein the handle portion includes an opening for passing the pull cord through the handle portion, and the pull cord is configured to be pulled through the opening in a direction substantially perpendicular to a longitudinal axis of the handle portion to cause rotation of the rotatable component. [Section 24] 24. The medical device of 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 drivingly engage the gear teeth of the rotatable component, the pull cord comprises an intermediate portion comprising the plurality of teeth and two end portions having no 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 Eyelet, aperture, opening 28 Valve leaflet 30 commissures 32 Sutures 34 Skirt, inner skirt 36 Suture Line 100 Delivery device 118 Cord, Tether 118a first end 118b Second end 120 Code manifold 122 Proximal part 124 Distal part 132 Handle part 133 Housing 133a Housing part 133b Housing part 134 First shaft, outer shaft 136 Nobu 138 Buttons 138a Operator Button 138b Operator button 140 Proximal end portion 142 Distal end portion 144 Nosecone 146 Delivery Capsule 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, driving nuts 165 Rail 166 Radial Extending Projection 168 Motor 170 Distal opening 172 Rotatable Components 173 lumens 174 Gears 176 gear teeth 178 Main body 182 Intermediate driving gear 184 Drive shaft 188 Motor shaft 190 Cradle 192 gear teeth 194 First Distal Part 195 Distal Sleeve 196 Proximal part 197 Proximal Sleeve 200 Manual Deployment Tool, Pull Cord 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 part 304 First outer shaft 306 Second intermediate shaft 308 Third Inner Shaft 310 Nosecone 312 Delivery capsule, distal end portion 314 Motor 316 Shaft 318 Lead screw 320 Male threaded part 322 Extension part 324 Gears 400 pull cord 402 Straight body 404 Middle part 406 End part, toothless end part 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 apparatus (100) for insertion into a subject, the medical apparatus configured to deliver an implantable medical device; and a handle portion (132); a movable component (146) configured to be inserted into the subject; a rotatable component (172) disposed within the handle portion, the rotatable component (172) operatively coupled to the movable component such that rotation of the rotatable component causes axial movement of the movable component relative to the handle portion; a pull cord (200) configured such that when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component, rotation of the rotatable component and corresponding axial movement of the movable component occur; Equipped with The handle portion includes an opening for inserting the pull cord through the handle portion.

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

3. A medical device as described in claim 1 or 2, further comprising a motor disposed within the handle portion and operatively coupled to the rotatable component, causing rotation of the rotatable component and corresponding axial movement of the movable component.

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

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

6. A medical device as described in any one of claims 1 to 5, wherein the rotatable component has a plurality of gear teeth (176) and the pull cord has a plurality of teeth (204) configured to drivingly engage the gear teeth of the rotatable component.

7. The medical device described in claim 6, wherein the pull cord has an intermediate portion (404) having a plurality of teeth and two end portions (406) without teeth, the intermediate portion being positioned between the two end portions.

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

9. The pull cord is a) is straight along its length, or b) is coiled along at least a portion of its length, the coiled portion of the pull cord having a plurality of teeth; or The medical device according to any one of claims 6 to 8, comprising: c) a curved portion (210) disposed between two straight portions (212).

10. A medical device described in 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 according to any one of claims 1 to 10, comprising: The method comprises: inserting the movable component of the medical device into a subject and pulling the pull cord through the handle portion to cause rotation of the rotatable component and corresponding axial movement of the movable component; The method, wherein the subject is a cadaver or a cardiovascular simulator.

12. The method of claim 11, wherein the movable component comprises a delivery capsule that holds the implantable medical device in a radially compressed state, and pulling the pull cord through the handle portion moves the delivery capsule relative to the implantable medical device and deploys the implantable medical device from the delivery capsule.

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

14. A method according to any one of claims 11 to 13, wherein the medical device comprises a motor operatively coupled to the movable component and causing rotation of the rotatable component and corresponding axial movement of the movable component, the method further comprising operating an electrical 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. A method according to any one of claims 11 to 14, wherein the method is performed as a training or practice procedure in a cadaver or cardiovascular simulator.

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