Release mechanism for a delivery apparatus for an implantable medical device - Patents.com

Abstract

A release mechanism for a delivery device and an associated method for operating the release mechanism are disclosed. In one example, a handle portion of the delivery device may include a release mechanism configured to adjust the linear position of a component of the delivery device. The release mechanism includes a threaded drive screw coupled to the component, the threaded drive screw including one or more retaining elements disposed at a proximal end of the drive screw and one or more grooves each forming a helically threaded portion of the drive screw extending from a corresponding star element to a distal end of the drive screw. The release mechanism also includes a rotatable knob surrounding and coaxial with the drive screw. The knob includes one or more teeth disposed at a proximal end of the knob, each tooth configured to engage with a corresponding retaining element and groove of the drive screw.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 037,501, filed June 10, 2020, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to embodiments of a release mechanism for the handle of a delivery apparatus for an implantable medical device, such as a prosthetic heart valve. [Background technology]

[0003] Delivery devices, such as intravascular delivery devices, are utilized in various procedures to deliver prosthetic medical devices to internal locations not readily accessible by surgery or where non-surgical access is desirable. Access to the target internal location is achieved by a medical professional inserting and guiding the delivery device through a passageway or cavity within the body, including, but not limited to, blood vessels, the esophagus, the trachea, any portion of the digestive tract, lymphatic vessels, etc., to name a few. The prosthetic medical device may include an expandable valve or an expandable device (e.g., a stent). In one specific example, an expandable prosthetic heart valve is mounted in a radially compressed (or crimped) state on the distal end of the 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, the delivery device can include an articulating portion having one or more steering mechanisms that can articulate (e.g., curve or flex) the distal end portion of the delivery device when navigated through a patient's vasculature. For example, at least the distal end portion of the delivery device may be required to articulate across the aortic arch to deliver a prosthetic aortic valve disposed on the distal end of the delivery device to its target implantation site. The delivery device can include multiple shafts with concentric lumens that can extend and retract relative to one another when the distal end portion of the delivery device articulates / flexes.

[0005] In some embodiments, after deflecting the distal end portion of the delivery device to reach the target implantation site, and while the distal end portion remains deflected, the valve can be released from the delivery device by rotating the knob of the delivery device's release mechanism. This causes linear (axial, proximal) translation of the inner shaft coupled to a release member releasably coupled to the valve. However, this linear translation of these concentric lumens when deflected can cause the inner shaft to shorten, thereby creating tension in the distal end portion of the delivery device when released. If the release mechanism is not unlocked (via the locking mechanism) to relieve this tension during release, the distal end portion can remain in tension, thereby preventing removal of the delivery device from the implantation site.

[0006] Such locking mechanisms can increase the complexity of the implantation procedure and can introduce tension problems that can increase the difficulty of removing the delivery device from the implantation site after the valve is implanted. Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, there is a need for an improved delivery device that can relieve the tension generated during release of the valve from the delivery device before unbending the catheter. [Means for solving the problem]

[0008] Disclosed herein are embodiments of improved delivery apparatus for implantable medical devices (e.g., prosthetic heart valves) and associated methods for using such apparatus when implanting an implantable medical device within a patient. In some embodiments, the delivery apparatus can include a handle portion that can be held and used by a user (e.g., a physician or clinician) to manipulate the delivery apparatus. In some embodiments, the handle portion can include a release mechanism configured to adjust the linear position of a component of the delivery apparatus, the handle portion including a rotatable knob and a drive screw disposed within the knob. The knob and drive screw can be mated such that rotation of the knob results in linear translational movement of the drive screw and a component of the delivery apparatus. In some embodiments, the knob and drive screw can be configured to automatically relieve tension on a distal end portion of the delivery apparatus during an implantation procedure.

[0009] In one exemplary embodiment, a delivery apparatus for an expandable implantable medical device includes a handle portion including a release mechanism configured to adjust the linear position of a component of the delivery apparatus relative to a central longitudinal axis of the delivery apparatus, the release mechanism including: a threaded drive screw including a helically threaded portion having a lead of at least 1 inch, the helically threaded portion including one or more grooves extending around the drive screw, the drive screw being coupled to the component; and a rotatable knob surrounding the drive screw and coaxial with the drive screw, the knob including one or more teeth disposed at a proximal end of the knob, each tooth of the one or more teeth configured to interface with a corresponding one of the one or more grooves of the drive screw, each tooth of the one or more teeth extending from the proximal end toward the distal end of the knob over only a portion of the total distance between the proximal and distal ends, the portion being less than one-quarter of the total distance.

[0010] In one exemplary embodiment, a method for implanting an implantable medical device using a delivery apparatus includes the steps of advancing a distal end portion of the delivery apparatus using a handle portion of the delivery apparatus to a target implantation site, wherein the implantable medical device is disposed on the distal end portion in a radially compressed configuration, and, after reaching the target implantation site, exposing the radially compressed implantable medical device and releasing the implantable medical device from the delivery apparatus. The releasing step includes the steps of: rotating, from a starting position, a knob of a release mechanism on a handle portion of the delivery device to move one or more teeth of the knob along one or more corresponding grooves of the drive screw of the release mechanism, thereby linearly translating the drive screw proximally along an axis parallel to the central longitudinal axis of the delivery device until the drive screw reaches a released position; linearly translating an inner shaft fixedly coupled to the drive screw and one or more release members fixedly coupled to a distal end portion of the inner shaft during and as a result of the proximal translation of the drive screw to release the implantable medical device from the delivery device; and actuating a steering mechanism of the delivery device to release the distal end portion of the delivery device, and passively retracting the drive screw distally and partially into the knob to automatically release tension during the release, the distal direction being opposite to the proximal direction.

[0011] In an alternative exemplary embodiment, a method for operating a release mechanism of a handle portion of a delivery apparatus configured to deliver an implantable medical device to a target implantation site includes the steps of linearly translating a drive screw of the release mechanism from an initial locked position in a proximal direction along an axis parallel to a central longitudinal axis of the delivery apparatus in response to rotation of a knob of the release mechanism by moving one or more teeth of the knob along one or more corresponding grooves of the drive screw until the drive screw reaches a released position, wherein in the initial locked position a main body of the drive screw having one or more grooves is disposed within the knob and in the released position a majority of the main body extends outside the knob. and, while the drive screw is translating in a proximal direction, linearly translating an inner shaft fixedly coupled to the drive screw and one or more release members fixedly coupled to a distal end portion of the inner shaft to release an implantable medical device mounted on the distal end portion of the delivery device from the delivery device; and, in response to actuation of a steering mechanism of the delivery device, releasing the distal end portion of the delivery device, and during the releasing, passively retracting the drive screw distally partially into the knob to automatically release tension in the distal end portion of the delivery device and enable releasing, wherein the distal direction is opposite to the proximal direction.

[0012] In an alternative exemplary embodiment, a delivery apparatus for an expandable implantable medical device comprises an inner shaft, one or more release members, each release member having a proximal end coupled to an outer surface of the distal end portion of the inner shaft and a distal end configured to be releasably coupled to the implantable medical device disposed about the distal end portion of the inner shaft distal to where the proximal end couples to the inner shaft, and a handle portion, the handle portion comprising a steering mechanism configured to adjust the curvature of the one or more shafts of a delivery apparatus comprising the inner shaft at the distal end portion of the delivery apparatus to flex the one or more shafts, and a release mechanism configured to adjust the linear position of the inner shaft and the one or more release members along a central longitudinal axis of the delivery apparatus relative to the outer housing of the handle portion. The release mechanism includes a threaded drive screw coupled to the proximal end of the inner shaft and including a helically threaded portion disposed within the main body of the drive screw, with one or more grooves forming the helically threaded portion extending from the proximal end to the distal end of the main body of the drive screw, and a rotatable release knob coupled to the housing of the handle portion and surrounding and coaxial with the drive screw, the release knob including one or more teeth disposed at the proximal end of the knob and configured to engage with the one or more grooves of the drive screw. The drive screw is configured for linear movement along a central longitudinal axis relative to the release knob in response to rotation of the release knob and sliding of the one or more teeth along the one or more grooves, and actuation of a steering mechanism to flex and release one or more shafts of the delivery device can release tension generated in the distal end portion of the delivery device by moving the drive screw distally along the central longitudinal axis.

[0013] The foregoing and other objects, features, and advantages of the present invention will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is a side elevational view of one exemplary embodiment of an implantable prosthetic heart valve that may be implanted using any of the delivery devices disclosed herein. [Figure 2] 2 is a side elevational view of an exemplary embodiment of a delivery device for delivering the prosthetic heart valve of FIG. 1. [Figure 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. [Figure 5] FIG. 3 is a side elevational view of a handle portion of the delivery device of FIG. 2. [Figure 6] 6 is a side view of the handle portion of FIG. 5 with half of the handle portion housing removed to show the internal components of the handle portion. [Figure 7] 3 is a side cross-sectional view of the handle portion of the delivery device of FIG. 2, showing some of the internal components of the handle portion. [Figure 8] 12 is a side cross-sectional view of a portion of a handle portion of a delivery device according to one embodiment, including a locking mechanism for a valve release mechanism of the handle portion. FIG. [Figure 9] 3 is a side view of a distal end portion of a delivery device, such as the delivery device of FIG. 2, in a starting configuration prior to release of the prosthetic heart valve from the delivery device. [Figure 10] 10 is a side view of the distal end portion of the delivery device of FIG. 9 in a released configuration after release of the prosthetic heart valve from the delivery device. [Figure 11] FIG. 1 is a schematic diagram of an example distal end portion of a delivery device articulating around a simulated aortic arch en route to a target implantation site for an artificial medical device disposed on the distal end portion. [Figure 12] FIG. 10 is a side elevational view of one embodiment of a handle portion of a delivery device, the handle portion comprising a release mechanism configured to automatically relieve tension on a distal end portion of the delivery device. [Figure 13] 13 is a side cross-sectional view of the handle portion of FIG. 12 with the release mechanism in a starting locked configuration. [Figure 14] 13 is a side cross-sectional view of the handle portion of FIG. 12 with the steering mechanism knob and release mechanism cap removed. FIG. [Figure 15] FIG. 15 is a cross-sectional male side view of the handle portion of FIG. 14 showing the release mechanism in a starting locked configuration. [Figure 16] 13 is a side elevational view of the handle portion of FIG. 12 with the steering mechanism knob removed and showing the release mechanism in the released configuration. FIG. [Figure 17] 17 is a side cross-sectional view of the handle portion of FIG. 16 showing the release mechanism in a release configuration. [Figure 18] 17 is another cross-sectional side view of the handle portion of FIG. 16, showing the release mechanism in the release configuration. [Figure 19] 13 is a perspective cross-sectional view of a portion of the release mechanism of the handle portion of FIG. 12 showing an end-of-travel feature of the release mechanism. [Figure 20] 17 is a side elevational view of the handle portion of FIG. 16 showing the release mechanism in a partially retracted configuration during automatic tension relief during an implantation procedure using the delivery device. FIG. [Figure 21] FIG. 13 is a perspective view from the distal end of the rotatable knob of the release mechanism of FIG. 12. [Figure 22] FIG. 22 is a side cross-sectional view of the knob of FIG. 21. [Figure 23] FIG. 22 is a proximal end view of the knob of FIG. 21. [Figure 24] FIG. 22 is a top perspective view of the knob of FIG. 21. [Figure 25] FIG. 22 is a perspective view from the proximal end of the knob of FIG. 21. [Figure 26] FIG. 13 is a perspective view of the drive screw of the release mechanism of FIG. 12. [Figure 27] FIG. 27 is a top view of the drive screw of FIG. 26. [Figure 28] FIG. 27 is a proximal end view of the drive screw of FIG. 26. [Figure 29] FIG. 29 is a side cross-sectional view of the drive screw taken along section AA of FIG. 28. [Figure 30] FIG. 27 is a side elevational view of the drive screw of FIG. 26. [Figure 31] FIG. 31 is a cross-sectional view of a first end of the drive screw taken along section line BB of FIG. 30; [Figure 32] FIG. 31 is a second end cross-sectional view of the drive screw taken along section CC of FIG. 30. [Figure 33] FIG. 27 is a distal end view of the drive screw of FIG. 26. [Figure 34] 13 is a flow diagram of a method for manipulating a handle portion of a delivery apparatus, such as the handle portion of FIG. 12, to deliver an artificial medical device to a target implantation site. DETAILED DESCRIPTION OF THE INVENTION

[0015] General matters For purposes of description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. These described methods, systems, and devices should not be construed as limiting in any respect. Rather, the present disclosure is directed to all novel and unobvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations. The methods, systems, and devices of the present disclosure are not limited to any particular aspect or feature thereof or combination thereof, nor do the methods, systems, and devices of the present disclosure require that any one or more particular advantages be present or problems be solved.

[0016] 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 to be applicable to any other aspect, embodiment, or example described herein, unless a contradiction arises. Any feature disclosed herein (including the accompanying claims, abstract, and drawings), and / or any step of any similarly disclosed method or process, may be combined in any combination, except for 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 features disclosed herein (including the accompanying claims, abstract, and drawings), or to any novel one or any novel combination of steps of any similarly disclosed method or process.

[0017] Although some operations of the methods of the present disclosure are described in a particular sequential order for convenience of presentation, it should be understood that this 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 figures may not show the various ways in which the methods, systems, and devices of the present disclosure can be utilized in combination with other systems, methods, and devices.

[0018] As used herein, the phrases "one" and "at least one" include one or more of the specifically stated 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 "plurality" means two or more of the specifically stated element.

[0019] 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."

[0020] As used herein, the term "coupled" generally means physically joined or linked and does not exclude the presence of intermediate elements between the coupled items unless specifically stated to the contrary.

[0021] 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, terms such as "inner," "outer," "top," "bottom," "internal," and "external" may be used. Where applicable, such terms are used to provide some clarity of explanation, particularly when addressing relative relationships with respect to the illustrated embodiments. However, such terms are not intended to represent absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" portion can become a "lower" portion simply by flipping the object. However, the portions are still the same portion, and the object remains the same object. As used herein, "and / or" means "and" or "or" and "and" and "or."

[0022] As used herein, with respect to prosthetic heart valves and delivery devices, "proximal" refers to a location, orientation, or portion of a component that is closer to a handle of the delivery device, which is located external to the user and / or patient, and "distal" refers to a location, orientation, 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," unless expressly defined otherwise, refer to axes extending proximally and distally. Additionally, the term "radial" refers to directions oriented perpendicular to an axis and points along a radius from the center of an object (e.g., an object with a centrally located axis, such as the longitudinal axis of a prosthetic valve).

[0023] Examples of the techniques of the present disclosure Described herein are examples of delivery devices that can be used to deliver an implantable, expandable medical device, such as a prosthetic heart valve, to a target implantation site within a patient. The delivery device can include a handle portion and one or more concentric shafts extending distally away from the handle portion. The implantable medical device can be mounted on the distal end portion of the delivery device in a radially compressed configuration. For example, a delivery capsule is coupled to the outer shaft of the delivery device at the distal end portion to encase and retain the implantable medical device on the outer shaft in a radially compressed state. The handle portion can include a housing and one or more buttons and / or knobs actuable by a user and configured to adjust operation of the delivery device during an implantation procedure. In some embodiments, the handle portion can include a steering knob configured to adjust the amount of curvature of one or more shafts of the delivery device at the distal end portion of the delivery device, thereby enabling delivery of the implantable medical device through a curved cavity in a patient.

[0024] In some embodiments, the handle portion includes a valve release mechanism configured to adjust the linear position of one or more components of the delivery device (along a central longitudinal axis of the delivery device) and automatically relieve tension generated in the distal end portion of the delivery device while bending the distal end portion and linearly adjusting the position of one or more components located in the distal end portion. For example, in some embodiments, the steering mechanism is configured to adjust the linear position of one or more release members coupled to the implantable medical device to release the implantable medical device from the delivery device. In some embodiments, the release mechanism includes a rotatable knob coupled to a housing of the handle portion and a threaded drive screw disposed within the knob. Rotation of the knob can cause the drive screw to translate axially via a mating connection between one or more grooves on the drive screw and one or more teeth on the knob. The drive screw can be coupled to an inner shaft coupled to one or more release members. Thus, linear movement of the drive screw can result in simultaneous linear movement of the inner shaft and one or more release members. The pitch and lead of the drive screw's threads (formed by one or more grooves) can be relatively long, while the length of the knob's teeth is relatively short. As a result, after manually rotating the release mechanism knob to decouple the release member from the implantable medical device, and during release of the distal end portion of the delivery device (e.g., via the steering mechanism), the drive screw can passively translate distally and retract back into the knob, thereby relieving tension on the distal end portion of the delivery device and facilitating release. As a result, the delivery device can be more easily removed from the implantation site, and the implantation procedure using the delivery device can be generally simplified.

[0025] 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 patient (e.g., into 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 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 devices for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, and heat sources.

[0026] Figure 1 illustrates a prosthetic heart valve 10 according to one embodiment that may be implanted using a delivery device, such as the delivery device 100 of Figure 2. In some embodiments, the prosthetic heart valve is a self-expanding valve that is delivered to the deployment site by the delivery device in a radially compressed state. Once advanced from a delivery capsule located at the distal end of the delivery device (e.g., the distal end of the delivery device of Figure 2), the prosthetic valve may self-expand radially to its functional size.

[0027] The prosthetic heart valve 10 includes a stent or frame 12 and a valve structure 14 (e.g., a valve leaflet or flap valve) supported by the frame 12. The frame 12 may have a plurality of interconnected struts 16 arranged in a grid pattern to form a plurality of apices 18 at each of the inflow end 20 and outflow end 22 of the frame 12.

[0028] 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 posts 24 extending from all tips 18 at the outflow end 22 of the frame 12. Each post 24 may have an eyelet or aperture 26 that may be used to form a releasable connection with a delivery device (e.g., delivery device 100), such as by use of one or more cords or tethers 118 (see, e.g., FIG. 3), as described further below.

[0029] In some embodiments, frame 12 can lack posts 24, and apertures 26 can be formed in tip 18 at outflow end 22 of frame 12. In the embodiment shown in FIG. 3, these apertures are formed at the outflow end of the frame such that, when loaded into delivery device 100, as described further below, a releasable connection can be formed by cord 118 between cord manifold 120 and outflow end 22 of frame 12. This configuration facilitates delivery of prosthetic valve 10 to the native aortic valve using a retrograde delivery approach, whereby delivery device 100 is advanced through the femoral artery and aorta to access the native aortic valve.

[0030] In other embodiments, apertures 26 (whether formed in posts 24 or tips 18) may be formed in the inlet (or inflow) end 20 of frame 12 if other delivery device configurations or other delivery techniques, such as transapical delivery approaches, require apertures located at the inlet end of the frame. In yet other embodiments, 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.

[0031] In certain embodiments, prosthetic heart valve 10 is a self-expanding heart valve, and 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 delivery device 100 (FIG. 2), 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.

[0032] 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 on the delivery device to cause radial expansion of the prosthetic valve.

[0033] 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 native tissue (such as bovine pericardium or pericardium from other sources) or synthetic materials (such as polyurethane). Adjacent side portions located at the outflow edges (upper edges in the illustration) 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.

[0034] 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 surrounding tissue after implantation. The skirt 34 may also be used to attach portions of the valve 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 suture lines 36. The skirt 34 may be directly connected to the frame 12, for example, using sutures. Although not shown, 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 and / or outer skirt may be made from any of a variety of suitable materials, including native tissue (e.g., 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.

[0035] Exemplary configurations of prosthetic heart valves are further disclosed in U.S. Patent Application Publication Nos. 2014 / 0343670, 2012 / 0123529, 2010 / 0036484, and 2010 / 0049313, which are incorporated herein by reference.

[0036] The prosthetic heart valve 10, or other type of implantable, expandable medical device, such as an expandable stent, can be delivered to the implantation site by a delivery apparatus, one embodiment of which is shown in FIG.

[0037] Figures 2-7 illustrate an example embodiment of a delivery apparatus 100 that may be used to deliver a prosthetic medical device, such as the prosthetic heart valve 10 shown in Figure 1, to a target implantation site within a patient. In some embodiments, as shown in Figure 8, a handle portion 132 of the delivery apparatus 100 may include a locking mechanism for a release mechanism of a release assembly of the delivery apparatus 100. Figures 9 and 10 illustrate a distal portion of an example release assembly that may be used in the delivery apparatus 100.

[0038] As shown in FIG. 2 , delivery device 100 may include a handle portion 132 and a first shaft 134 extending distally from handle portion 132. A user, such as a physician or clinician, may operate delivery device 100 by actuating a number of knobs 136, dials, and / or buttons 138 a, 138 b located on handle portion 132. First shaft 134 has a proximal end portion 140 and a distal end portion 142. Proximal end portion 140 of first shaft 134 may be coupled to handle portion 132. Handle portion 132 may include a housing 133. In some embodiments, housing 133 may include two housing portions.

[0039] 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 illustration, the first shaft 134 is the outermost shaft of the delivery device 100 and may therefore be referred to as the outer shaft 134 of the delivery device 100. In the illustrated embodiment, the third shaft 152 is the innermost shaft of the delivery device and may therefore be referred to as the inner shaft 152 of the delivery device 100. In the illustrated embodiment, the second shaft 150 is located intermediate or between the innermost and outermost shafts and may therefore be referred to as the middle shaft.

[0040] A nosecone 144 may be coupled to or mounted on the 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 device 100 through the patient's vasculature. The inner shaft 152 extends distally beyond the midshaft 150 through the lumen of the cord manifold 120, through the prosthetic valve 10.

[0041] In some embodiments, each of the first shaft 134, second shaft 150, and third shaft 152 can be configured to be movable relative to one another, including relative axial movement (proximally and distally) and / or relative rotational movement (clockwise and counterclockwise). A guidewire 154 ( FIG. 4 ) extends through the central lumen of the inner shaft 152 and the inner lumen of the nosecone 144, allowing the delivery device 100 to be advanced over the guidewire 154 within the patient's vasculature during delivery of the prosthetic valve 10 to the target implantation site. The guidewire 154 can exit the inner shaft 152 via a proximal port 155 in a cap 157 of the handle portion 132 ( FIG. 5 ). As shown in FIGS. 5 and 8 , the cap 157 can be coupled to the end of a drive screw 161 of a release mechanism 200 of the delivery device 100 (as further described below with reference to FIGS. 8-10 ).

[0042] A delivery capsule 146 is coupled to the distal end portion 142 of the first shaft 134 proximal to the nosecone 144. As shown in FIGS. 3-4 , the delivery capsule 146 houses the prosthetic valve 10 therein in a radially compressed state. In one embodiment, the delivery capsule 146 covers and retains the prosthetic valve in its 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 its functional size due to its inherent resiliency when deployed from the delivery capsule 146.

[0043] However, the prosthetic heart valve 10 can alternatively be a plastically expandable prosthetic valve or a mechanically expandable heart valve. If 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. If 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 International Patent Application No. PCT / US2020 / 063104 (WO2021 / 113507), which is incorporated herein by reference.

[0044] As shown in Figure 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 patient's vasculature. 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 (Figure 3). The cord manifold 120 is coupled to the distal end of the first shaft 134 proximal to each of the nosecone 144 and the crimped prosthetic valve 10.

[0045] 3, 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 using a suitable technique or mechanism, such as, for example, via a mechanical connector, welding, a press fit, and / or adhesive. For example, in some embodiments, the distal end portion 142 of the shaft 134 extends within the lumen of the proximal portion 122, which may be secured to the shaft 134 using any of the connection techniques described above.

[0046] Cord 118 can be made from any of a variety of biocompatible materials suitable for use within a patient's body. In some embodiments, cord 118 can comprise 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 from polymer fibers, such as, for example, ultra-high molecular weight polyethylene, nylon, polyester, and / or aramid, or flexible wire (e.g., metal wire).

[0047] 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 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.

[0048] 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 the same in number. For example, ends 118b of multiple cords 118 may be carried on a single release member 156. Desirably, at least three cords 118 are used to balance the attachment of frame 12 to cord manifold 120. In certain embodiments, the number of cords 118 is equal to the number of tips 18 (FIG. 1) of frame 12 of prosthetic valve 10. Furthermore, in other embodiments, a single cord may be used to connect frame 12 to cord manifold 120 at multiple locations along the outflow end of the frame by forming multiple passageways extending through openings in the frame.

[0049] Each release member 156 may slidably extend through respective openings in the proximal and distal portions 122, 124 of the cord manifold 120 (FIG. 3). In some embodiments, each release member 156 may extend through the first shaft 134 along its entire length and have a proximal end portion operatively coupled to the knob 136 of the handle portion 132 to control movement of the release member 156. In alternative embodiments, each release member 156 may have a proximal end coupled to an outer surface of the third shaft 152 of the delivery device 100.

[0050] Each release member 156 is movable proximally and distally 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. As will be further described below with reference to FIG. 8 , the knob 136, release member 156, and cord manifold 120 together can form a release assembly of the delivery device 100 (e.g., FIG. 8 shows a release mechanism 200 of the release assembly disposed within the handle portion 132).

[0051] 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 International Patent Application No. PCT / US2020 / 024130 (WO 2020 / 198101), all of which are incorporated herein by reference.

[0052] 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, which 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 Nos. 2012 / 0239142 and 2010 / 0049313.

[0053] As further shown in FIG. 3 , second shaft 150 may include an externally threaded portion 162 along its distal end portion. This threaded portion 162 may comprise threads formed on the exterior surface of the shaft or may be a separate screw coupled to the distal end of the proximal shaft section. Capsule 146 is operatively coupled to second shaft 150 by an internally threaded nut 164 disposed on threaded portion 162. Nut 164 may have a radially extending protrusion 166 that extends into a corresponding opening in capsule 146 (see FIG. 2 ). Rotation of nut 164 is limited by one or more rails 165 extending from or formed along the distal end portion of first shaft 134.

[0054] 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 the distal position, the delivery capsule 146 extends over the prosthetic valve 10, holding 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.

[0055] In some embodiments, the delivery device 100 may include one or more steering mechanisms configured to assist in steering the delivery device through the patient's vasculature by controlling the curvature of one or more of the shafts 134, 150, 152. For example, the steering mechanism can include one or more eccentrically positioned pull wires that extend through the shaft and are operatively coupled to an adjustment mechanism, such as a steering knob 418, located on or adjacent the handle portion 132 ( FIG. 2 ). Adjusting the adjustment mechanism changes the tension in the pull wires, which has the effect of curving or straightening the shaft in a given direction. In one implementation, one or more pull wires extend through the outer shaft 134, and adjusting the adjustment mechanism has the effect of adjusting the curvature of the distal end portion of the outer shaft 134 and the delivery device 100. Further details regarding this steering mechanism are disclosed in US Patent Application Publication Nos. 2007 / 0005131 and 2013 / 0030519, which are incorporated herein by reference.

[0056] 6-8, 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. Specifically, 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.

[0057] 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 in the handle portion 132. A rotatable component 172 (which may be referred to in some embodiments as a drive cylinder) is disposed within the handle portion 132 and is operatively coupled to the second shaft 150.

[0058] In one embodiment, as best shown in FIG. 7 , the proximal end portion of the rotatable component 172 includes a gear 174 having a plurality of gear teeth 176 circumferentially arranged relative to one another. The rotatable component 172 further includes a main body 178 configured as an elongated shaft having a lumen 173. In the illustrated embodiment, the main body 178 and gear 174 are integrally formed, but may also be separately formed components coupled to one another 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.

[0059] 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, thereby transmitting rotational motion of the rotatable component 172 relative 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 flattened 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 secured to the rotatable component using a securing means, such as a mechanical fastener (e.g., a screw), an adhesive, a press fit, a snap-fit ​​connection, or the like.

[0060] 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 138 a, 138 b on the handle portion 132 allow a user to activate the motor 168, such as by electrically coupling current from a battery power source to the motor. The motor may be rotatable in both directions, as described below, to move the capsule 146 either proximally or distally. One of the buttons (e.g., button 138 a) may be operable to rotate the motor in a first rotational direction to move the capsule 146 distally, e.g., to load a prosthetic valve into the capsule 146, and the other button (e.g., button 138 b) may be operable to rotate the motor 168 in a second rotational direction to move the capsule 146 proximally, e.g., to deploy a prosthetic valve. Instead of or in addition to one or more batteries, motor 168 may be configured to receive a power cord that provides current to the motor from a power source external to handle portion 132 (eg, a wall outlet).

[0061] As best shown in FIG. 7 , 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. The drive gear 182 may have circumferentially disposed gear teeth 192 that may engage with the circumferentially disposed gear teeth 176 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. The drive gear 182 may be positioned radially offset from the central axis of the rotatable component 172 and the central longitudinal axis L-L′ of the handle portion 132 so that the gears are vertically aligned when meshed. In other embodiments, one or more additional gears may be provided between drive gear 182 and rotatable component 172 to transfer rotation from the motor to the rotatable component.

[0062] In alternative embodiments, motor shaft 188 or drive shaft 184 may be coupled to rotatable component 172 without any intermediate gearing. For example, motor shaft 188 may be positioned proximal to the rotatable component along axis L-L′ and coupled to rotatable component 172 in a direct drive configuration.

[0063] In the illustrated embodiment, a cradle 190 housing the motor 168 and drive shaft 184 may also be configured to support the rotatable component 172 for rotational movement within the handle portion. As best shown in FIG. 6 , the cradle 190 may have a first distal portion 194 comprising 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 also have a proximal portion 196 comprising a proximal sleeve 197 that circumferentially surrounds a proximal end portion of the main body 178 of the rotatable component 172.

[0064] 3 and 7 , 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, which is coupled to the rotatable component 172. Rotation of the second shaft 150 rotates the threaded portion (screw) 162 of the second shaft 150. As described above, rotation of the threaded portion 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 can cause the delivery capsule 146 to retract proximally, exposing the prosthetic valve at the distal end of the delivery device 100. 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 moves the delivery capsule 146 distally back onto the prosthetic valve. An operator can activate buttons 138 a, 138 b ( FIGS. 2 and 6 ) on handle portion 132 to activate motor 168 and power axial movement of delivery capsule 146, thereby allowing for rapid deployment or retrieval of prosthetic valve 10.

[0065] In use, the prosthetic valve 10 can be coupled to the delivery device 100 and loaded into the capsule 146 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 so that the secured end of the frame is held in at least partial radial compression by the cord. After securing the end of the frame 12 with the cord 118, the delivery capsule 146 can be advanced distally (e.g., by pressing button 138a) over the cord manifold 120, cord 118, and frame 12, 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, completely enclosing the prosthetic valve 10.

[0066] After loading the prosthetic heart valve 10 into the delivery device 100 as described above, the delivery device 100 may be inserted into the patient's vasculature and advanced or guided through the patient's vasculature to the desired implantation site (e.g., through the femoral artery and aorta if delivering the prosthetic valve 10 to the native aortic valve in a retrograde delivery approach).

[0067] Once the prosthetic valve 10 has been delivered to a selected implantation site (e.g., the native aortic valve) within the patient, the delivery capsule 146 can be retracted (e.g., by pressing button 138b) to deploy the prosthetic valve 10. Retracting the delivery capsule 146 ( FIG. 4 ) allows the prosthetic valve 10 to radially self-expand under the resilience of the frame 12. After the delivery capsule 146 is 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 100, the user can 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 10 relative to the desired implantation location.

[0068] If desired, the delivery capsule 146 can be advanced back over the prosthetic valve 10 to fully or partially retrieve the prosthetic valve (returning the prosthetic valve within the capsule) to facilitate repositioning of the prosthetic valve. For example, after deploying the prosthetic valve over the leaflets of the native aortic valve in a retrograde delivery approach, it may be desirable to retrieve the prosthetic valve back within the capsule 146, retract the delivery device 100 to return the prosthetic valve to the aorta, and then advance the prosthetic valve back over the leaflets of the native aortic valve to deploy the prosthetic valve from the capsule.

[0069] Once the prosthetic valve has been deployed from capsule 146 and positioned at the desired implantation location, release member 156 can be retracted, such as by rotating knob 136 of handle portion 132. In some instances, cord 118 slides outward from aperture 26 and clears frame 12 due to the self-expanding frame 12 further expanding when release member 156 is retracted. In other instances, the user can slightly retract delivery device 100, which further pulls cord 118 proximally relative to frame 12, withdrawing cord 118 out of aperture 26.

[0070] Optionally, the orientation of the prosthetic valve can be reversed when coupled to a delivery device, so that the inflow end of the prosthetic valve becomes the proximal end and the outflow end of the prosthetic valve becomes the distal end. This can facilitate delivery of the prosthetic valve to various implantation locations (e.g., the annulus of the native aorta, pulmonary artery, mitral valve, and tricuspid valve) and / or for various delivery approaches (e.g., antegrade, transseptal, transventricular, transatrial). Further details regarding the components and operation of delivery devices used to deliver prosthetic medical devices, such as prosthetic heart valves, to target locations are disclosed in International Patent Application PCT / US2021 / 023696, which is incorporated herein by reference.

[0071] FIG. 8 shows a portion of one embodiment of the handle portion 132 of the delivery device 100, including a release mechanism 200. The release mechanism 200 includes a knob 136, a drive screw 161, and a locking mechanism 202. The release mechanism 200 is configured to facilitate release of the prosthetic heart valve from the delivery device through control of a release member 208, which in some embodiments may be the same as or similar to the release member 156 described above with reference to FIG. 3. The release mechanism 200 and the release member 208 may together form a release assembly of the delivery device 100. FIGS. 9 and 10 show one embodiment of a distal portion of the release assembly of the delivery device 100, including the release member 208.

[0072] As introduced above, delivery device 100 may include inner shaft 152 having an inner guidewire lumen configured to receive a guidewire (e.g., guidewire 154). This inner shaft 152 may be releasably coupled at its proximal end to drive screw 161 (FIG. 8) and coupled at its distal end to valve release member 208 (FIGS. 9 and 10). Thus, as described further below, axial movement of inner shaft 152 may result in axial movement of release member 208 (FIGS. 9 and 10).

[0073] As shown in FIG. 8 , the release mechanism 200 may include a drive screw 161 disposed within and interfacing with a knob (release knob) 136. A cap 157 is coupled to the proximal end of the drive screw 161. A locking mechanism 202 may be coupled to the proximal end of the drive screw 161 and disposed within a portion of the cap 157. The locking mechanism 202 may be rotatable via a knob 204 (which may be manually actuated by a user). For example, rotation of the knob 204, and thus the locking mechanism 202, may clamp a washer 206 onto and unclamp from the outer surface of the inner shaft 152 (locked position). The washer 206 may be fixedly coupled to the drive screw 161 and, as a result, may move axially with the axial translation of the drive screw 161. Thus, when the release mechanism 200 is locked to the inner shaft 152, rotation of the knob 136 causes axial translation of the drive screw 161, which in turn causes axial translation of the inner shaft 152.

[0074] 9 and 10, the inner shaft 152 can extend to and / or into the nosecone 144. A spool 212 can be coupled (e.g., fixedly coupled) to a portion of the outer surface of the inner shaft 152, and a proximal end of the release member 208 can be coupled to the spool 212. As described above with reference to FIG. 3, a distal end of the release member 208 can be removably coupled to a coupling element (e.g., a cord, tether, suture, or the like) coupled to the prosthetic heart valve.

[0075] Figure 9 shows the distal portion of the release assembly in a starting configuration prior to release of the prosthetic heart valve from the delivery device 100. For illustrative purposes, the prosthetic heart valve is not shown in Figures 9 and 10. However, in Figure 9, the distal end of the release member 208 can be in a position that couples the valve to the delivery device 100 (e.g., prevents axial movement of the valve relative to the delivery device 100). In this configuration, the locking mechanism 202 can be in a locked state.

[0076] After the distal end portion of the delivery device 100 containing the prosthetic heart valve reaches the target implantation site, the prosthetic heart valve may be deployed by moving the capsule 146 away from the valve to expose the valve. The knob 136 is then rotated to axially move the inner shaft 152 in the proximal direction 214 (toward the handle portion 132), allowing the release member 208 to be retracted away from the prosthetic heart valve.

[0077] As used herein, "proximal direction" refers to a direction of movement or translation along an axial direction parallel to the central longitudinal axis of the delivery device toward the handle portion or user of the delivery device, and "distal direction" can refer to a direction of movement or translation along an axial direction opposite the proximal direction, away from the handle portion and closer to the target implantation site.

[0078] 10 shows the distal portion of the release assembly in a retracted (e.g., released) configuration after release of the prosthetic heart valve from the delivery device 100. In this configuration, the inner shaft 152 translates proximally, thereby translating the spool 212 proximally. In some embodiments, as shown in FIG. 10 , the spool 212 comes into contact with a spool stop 216, which prevents further axial movement of the spool 212 and release member 208 in the proximal direction 214.

[0079] The spool stopper 216 may be axially fixed relative to the inner shaft 152 and the spool 212. In some embodiments, the spool stopper 216 may be fixed relative to another shaft component of the delivery device, such as the second shaft 150 and the first shaft 134.

[0080] Additionally, by moving the release member 208 proximally along with the spool 212, the prosthetic heart valve can be released from the delivery device 100, allowing the delivery device 100 to be removed from the implantation site.

[0081] In some embodiments, when a delivery device (e.g., delivery device 100) is used to deliver a prosthetic aortic valve to a target implantation site, at least a distal end portion of the delivery device may need to pass through a curved portion of a patient's vasculature, such as the patient's aortic arch. An exemplary simulated aortic arch 300 is illustrated in FIG. 11 . Thus, as introduced above, in some embodiments, the delivery device may include one or more steering mechanisms configured to assist in steering the delivery device through the patient's vasculature by controlling the curvature of one or more of the shafts of delivery device 100 (e.g., shafts 134, 150, and / or 152).

[0082] For example, as shown in FIG. 11 , one or more steering mechanisms may be capable of flexing and articulating (e.g., curving) at least a distal end portion 302 of a delivery device 304 (which may be the same as or similar to delivery device 100) around the aortic arch 300. As the distal end portion 302 of delivery device 304 articulates around the aortic arch, the distal end portions of the concentric shafts (e.g., shafts 134, 150, and / or 152) of delivery device 304 can telescope relative to one another. In some embodiments, after flexing the distal end portion 302 of delivery device 304 to reach the target implantation site, and while the distal end portion 302 remains in the flexed state (as shown in FIG. 11 ), the valve can be released from delivery device 304 by rotating knob 136 of release mechanism 200. This causes linear (axial, proximal) movement of drive screw 161, inner shaft 152, and release member 208. However, this linear translation of the concentric lumens when flexed can cause the inner shaft 152 to shorten, which can create tension in the distal end portion 302 when released. In this condition, the inner shaft 152 can become a tensioned pullwire. If the release mechanism 200 is not unlocked during release (to relieve this tension), the distal end portion 302 will be held in tension, thereby preventing removal of the delivery device from the implantation site.

[0083] In this manner, the locking mechanism of the release mechanism 200 may increase the complexity of the implantation procedure and may create tension problems that may increase the difficulty of removing the delivery device from the implantation site after implantation of the prosthetic heart valve. Therefore, it may be desirable to have a delivery device that does not include a locking mechanism for the release mechanism.

[0084] 12-33 illustrate one embodiment of a release mechanism 402 for a handle portion 400 of a delivery device. In some embodiments, the handle portion 400 can replace the handle portion 132 of the delivery device 100 shown in FIG. 8. In some embodiments, the handle portion 400 can control the movement of a distal end portion of the delivery device, such as the distal end portion shown in FIGS. 9 and 10. Additionally, the delivery device can be configured to deliver a radially compressed prosthetic medical device, such as the prosthetic heart valve 10 of FIG. 1, disposed on the distal end of the distal end portion of the delivery device to a target implantation site.

[0085] The release mechanism 402 of Figures 12-33 is configured to automatically provide strain relief for tension generated by flexing the distal end portion of the delivery apparatus and releasing a radially compressed medical device mounted thereon, as described above. As such, the release mechanism 402 does not include a locking mechanism (e.g., locking mechanism 202 of Figure 8). Figures 12-20 show the assembled handle portion 400 with the release mechanism 402 in different positions or configurations during a prosthetic medical device implantation procedure using the delivery apparatus. Figures 21-25 show various views of the release knob 404 of the release mechanism 402 (disassembled from the rest of the handle portion), and Figures 26-33 show various views of the drive screw 406 of the release mechanism 402 (disassembled from the rest of the handle portion).

[0086] As shown in FIGS. 12-18 and 20 , the handle portion 400 can include a housing 410 (e.g., an outer housing). The housing 410 can house the internal components of the handle portion 400, such as those described above with reference to FIGS. 2-8 and further below with reference to FIGS. 13 , 15 , 17 , and 18 . In some embodiments, the handle portion 400 can include a number of knobs and buttons actuatable by a user (e.g., a physician or clinician) to control operation of the delivery device. For example, in some embodiments, the handle portion 400 can include buttons 412 a and 412 b, which can be similar to buttons 138 a and 138 b described above with reference to FIGS. 2 , 5 , and 6 .

[0087] 12 and 13, a steering knob 418 of a steering mechanism of the delivery device can be coupled to the distal end 416 of the housing 410. The steering mechanism can be configured to adjust (e.g., rotate) the steering knob 418 to adjust the amount of curvature or flexion of one or more shafts of the delivery device at the distal end portion of the delivery device, as previously described herein.

[0088] The release knob 404 of the release mechanism 402 is coupled to the proximal end 414 of the housing 410 and may be configured to rotate about a central longitudinal axis 420 of the release mechanism (which may also be the central longitudinal axis of the knob 404, drive screw 406, and delivery device). However, the movement of the release knob 404 may be fixed in the axial direction (along the central longitudinal axis 420). In this manner, the release knob 404 may rotate but be fixed for linear translational movement in the axial direction.

[0089] As shown in FIGS. 21, 22, and 24, for example, the release knob 404 may include a main body 428 having a distal end 424 and a proximal end 426. The body 428 may be a portion of the release knob 404 configured to be held and rotated by a user. The release knob 404 may further include a collar 422 extending axially outward from the distal end 424 of the release knob 404. As shown in FIG. 22, the outer diameter 430 of the collar 422 can be smaller than the outer diameter 432 of the body 428 (e.g., the maximum outer diameter at its widest portion). The collar 422 may include one or more grooves 434 (or channels) extending around (e.g., around the entire circumference) and recessed into the outer surface of the collar 422. As shown in FIGS. 21, 22, and 24, the collar 422 includes two grooves 434 spaced axially apart on the collar 422. However, in alternative embodiments, collar 422 may include more or fewer than two (e.g., one or three) grooves 434. Each groove 434 is configured (e.g., shaped) to mate with a corresponding annular protrusion 436 on housing 410.

[0090] For example, as shown in FIGS. 13 , 15 , 17 , and 18 , the inner surface 438 of the housing 410 includes one or more annular protrusions 436 at its proximal end 414, with each annular protrusion 436 extending radially inward from the inner surface 438 of the housing 410 toward the central longitudinal axis 420. The collar 422 may extend into the proximal end 414 of the housing 410. Each of the annular protrusions 436 of the collar 422 may extend along the entire circumference of the inner surface 438. The number of annular protrusions 436 may be the same as the number of grooves 434. In this manner, each annular protrusion 436 may extend into and mate with a corresponding groove 434. There may be sufficient clearance between the mating annular projection 436 and groove 434 to allow the release knob 404 to rotate while the housing 410 remains rotationally fixed, and also sufficient clearance to prevent the release knob 404 from moving axially relative to the housing 410. In this manner, the release knob 404 is configured to rotate but fixed for linear translational movement (axially and radially) relative to the housing 410 due to the mating connection between the groove 434 and the annular projection 436 of the housing 410.

[0091] 21-25, the release knob 404 may include an internal cylindrical bore (or cavity) 440 defined by an inner surface 442 of the release knob 404 that extends from the proximal end 426 of the body 428 to the distal end of the collar 422. The inner surface 442 may define an inner diameter 444 of the release knob 404 (FIG. 22). As shown in FIGS. 13, 15, 17, and 18, the bore 440 is configured to receive the drive screw 406. The drive screw 406 and the release knob 404 may be coaxial with each other (e.g., the central longitudinal axis 420 may be common).

[0092] As shown in FIGS. 22-25 , the release knob 404 can include one or more teeth 446 extending radially from the inner surface 442 toward the central longitudinal axis 420. Each tooth 446 is disposed on the proximal end 426 of the release knob 404. For example, each tooth 446 can extend along the inner surface 442 from the proximal end 426 toward the distal end 424 of the release knob 404, spanning only a portion of the total distance 448 between the proximal end 426 and the distal end 424. In some embodiments, this portion can be less than one-quarter of the total distance 448. In other embodiments, this portion can be less than one-tenth of the total distance 448. As such, the length of each tooth 446 can be relatively short compared to the length of the helical groove 452 of the thread of the drive screw 406 with which the tooth 446 is configured to mate and slide, as described further below.

[0093] As shown in FIGS. 23-25 ​​, each tooth 446 extends in a curved manner along the inner surface 442 to match the helical profile of the groove 452 with which it is configured to cooperate. For example, each tooth 446 may have a pitch and lead that match the pitch and lead of the drive screw 406, as described further below. However, rather than being fully threaded, each tooth 446 can extend in a curved manner less than 90 degrees around the circumference of the proximal end 426 of the knob 404 (as shown in FIGS. 23-25 ​​). In some embodiments, each tooth 446 extends in a curved manner approximately 45 degrees or less around the circumference of the proximal end 426. In some embodiments, each tooth 446 extends in a curved manner between 30 degrees and 80 degrees around the circumference of the proximal end 426.

[0094] The release knob 404 is shown having two teeth 446 spaced apart from one another along the periphery of the inner surface 442. In some embodiments, the two teeth 446 can be spaced apart from one another approximately 180 degrees along the periphery of the inner surface 442. For example, as shown in the distal end view of FIG. 23, the two teeth 446 can consist of a first tooth 446a and a second tooth 446b. In alternative embodiments, such as when the drive screw is a single-start thread or another multiple-start thread, the release knob 404 can include only one tooth or more than two (e.g., three) teeth.

[0095] 21, 22, 24, and 25, the outer surface of the main body 428 of the release knob 404 may have a curved profile (e.g., a smaller diameter at the middle portion of the body 428 than at the end portions) with one or more protruding elements 450. The one or more protruding elements 450 may be configured to provide an ergonomic knob surface for a user to grasp and turn. However, in alternative embodiments, the body 428 may not include protruding elements 450 and / or may have a different shape profile.

[0096] The drive screw 406 can be disposed within the interior (e.g., bore 440) of the release knob 404 (FIGS. 12-20). In some embodiments, as shown in FIGS. 26-33, the drive screw 406 can have threads defined by one or more grooves 452 recessed into an outer surface 454 of a main body 456 of the drive screw 406. Each groove 452 can form a helical path along the helically threaded portion of the main body 456 of the drive screw 406, and the corresponding tooth 446 of the release knob 404 can move along this helical path as the release knob 404 rotates (e.g., changes orientation). The main body 456 further includes one or more retaining elements 458 (FIGS. 26-32). Each groove 452 can be coupled to a corresponding retaining element 458 of the drive screw 406. Furthermore, each retaining element can be disposed at a proximal end 476 of the drive screw 406 (e.g., the proximal end of the main body 456).

[0097] In some embodiments, each retaining element 458 includes a protruding member (also referred to as a pawl) 460, a first linear thread portion 462 disposed on a first side of the protruding member 460, and a second linear thread portion 464 disposed on a second side of the protruding member 460 ( FIGS. 26 and 27 ). In some embodiments, as shown in FIGS. 26 , 27 , and 30 , the second linear thread portion 464 is coupled to and continuous with a corresponding groove 452. Thus, the first linear thread portion 462 and the second linear thread portion 464 can be grooves recessed into the outer surface 454 on each side of the protruding member 460 and extending circumferentially along the main body of the drive screw. In some embodiments, the first linear thread portion 462 and the second linear thread portion 464 need not be helical (e.g., relatively straight or linear). As will be explained in more detail below, when a corresponding tooth 446 of the release knob 404 is disposed in the first linear thread portion 462, the tooth 446 is captured behind the protruding member 460, thereby maintaining the release knob 404 in the locked configuration.

[0098] In some embodiments, each retaining element 458 can include a tab 485 disposed inward (distal axially) of the protruding member 460 ( FIGS. 26, 27, 30, and 32 ). The tab 485 can set the length, width, and height of the tab 485 and the cantilever of the protruding member 460, which sets the force required to depress the protruding member 460 and initiate movement of the tooth 446 along the second linear thread portion 464 and groove 453. As a result, the release knob 404 can be rotated to allow linear movement of the drive screw 406.

[0099] Each groove 452 may extend from the second linear thread portion 464 of the corresponding retaining element 458 and extend in a spiral curve around the outer surface 454 of the main body 456 of the drive screw 406 from the corresponding retaining element 458 to the distal end 474 of the main body 456.

[0100] In some embodiments, as shown in Figures 26-33, the helically threaded portion has a double thread formed by two helical grooves 452, a first groove 452a and a second groove 452b (as shown, for example, in Figures 16 and 30). The proximal end of the first groove 452a can originate at the first retaining member, and the proximal end of the second groove 452b can originate at the second retaining member spaced apart from the first retaining member. In some embodiments, as shown in Figures 26 and 28-33, these two retaining elements 458 can be positioned 180 degrees apart from each other around the circumference of the main body 456 of the drive screw 406.

[0101] In some embodiments, the helically threaded portion can have a lead 466 of greater than 1 inch and a pitch 468 of greater than 0.5 inches. As used herein and shown in FIG. 30 , pitch 468 is the distance between the root of one thread (groove) and the root of the next adjacent thread (groove), and lead 466 is the distance along the axis of the drive screw covered by one full revolution of the knob (e.g., the knob teeth along the drive screw groove). In the case of a double-start thread, lead 466 is twice the pitch 468. In some embodiments, the helically threaded portion can have a lead 466 of approximately 1.5 inches and a pitch 468 of approximately 0.75 inches. In some embodiments, lead 466 can be in the range of 1 inch to 1.75 inches, and pitch 468 can be in the range of 0.5 inch to 0.875 inches.

[0102] In alternative embodiments, the helically threaded portion may instead have a single thread formed by a single groove 452. In these embodiments, the release knob 404 may include only one tooth 446 configured to mate with the single groove 452. In single-thread embodiments, the helically threaded portion may have a 1.5 inch lead and a 1.5 inch pitch, or a lead of at least 1 inch and a pitch of at least 1 inch.

[0103] 18, each tooth 446 of the release knob 404 is configured to engage with and slide along a corresponding one of the grooves 452. For example, in the case of a two-beam release mechanism, as described above, when the release knob is turned to change orientation, a first tooth 446a of the release knob 404 engages with and slides (moves) along the first groove 452a, and a second tooth 446b of the release knob 404 engages with and slides along the second groove 452b (FIG. 18).

[0104] Thus, each tooth 446 can be shaped to fit within a corresponding groove 452. For example, as shown in FIG. 29, each groove 452 can have a profile 470. In some embodiments, profile 470 can have a trapezoidal shape, such as a triangular shape with a flat top. As shown in FIGS. 22-25, each tooth 446 can have a profile 472 that corresponds to (e.g., matches) profile 470 of groove 452 such that tooth 446 and groove 452 can fit together, while still providing sufficient clearance between tooth 446 and groove 452 to allow sliding of tooth 446 along groove 452. For example, in some embodiments, profile 472 can also have a trapezoidal shape, such as a triangular shape with a flat top. However, as explained above, each tooth 446 can be a protrusion (protruding radially outward from the inner surface 442 of the release knob 404), while each groove 452 can be a recess (e.g., recessed into the outer surface 454 of the drive screw 406), thereby allowing each tooth 446 to extend into and mate with the corresponding groove 452.

[0105] Each groove 452 extends curvilinearly around the outer surface 454, extending from a proximal end 476 to a distal end 474 of the main body 456 of the drive screw 406, while each tooth 446 extends only a portion of the total distance (e.g., overall length) 448 between the proximal and distal ends 426, 424 of the release knob 404. Thus, the path length 478 of each tooth 446 (e.g., from the proximal end to the distal end of each tooth 446) (as shown in FIG. 25 ) is relatively short compared to the path length of the corresponding groove 452.

[0106] 34 , having relatively short teeth 446 with a relatively long lead 466 and pitch 468 on the release knob 404 and threaded drive screw 406 may reduce engagement between the teeth 446 of the release knob 404 and the grooves 452 of the drive screw 406 (as opposed to teeth 446 that extend curvilinearly along a relatively wide portion of the inner surface of the release knob 404). This reduced level of engagement may be sufficient to allow the release knob to be rotated and reoriented (as shown in FIGS. 16-19 ) to move the teeth 446 along the grooves 452 until the release mechanism achieves a release configuration in which the drive screw 406 extends axially proximally outward from the proximal end of the release knob 404. At the same time, this reduced level of engagement may be small enough to allow the drive screw 406 to automatically (e.g., by manual actuation of the release knob 404) slide distally back into the release knob 404 for tension relief in the delivery device during the implantation procedure (e.g., after retraction of the capsule and during release of the distal end portion of the delivery device, as described further below and shown in FIG. 20).

[0107] Additionally, in some embodiments, the materials of the drive screw 406 and the release knob 404 can be selected to achieve a desired amount of engagement between the teeth 446 of the release knob 404 and the grooves 452 of the drive screw 406. For example, in some embodiments, the materials of at least the teeth 446 of the drive screw 406 and the release knob 404 can be selected to allow the teeth 446 to easily slide along the grooves 452. In some embodiments, the drive screw 406 and / or the release knob 404 can include a material that provides the components with relatively low-friction contact surfaces, such as a thermoplastic polymer. In some embodiments, the drive screw 406 and the release knob 404 can include different polymeric materials (e.g., different thermoplastic polymers) configured to promote sliding between the surfaces of the drive screw 406 and the release knob 404. Possible polymeric materials can include polycarbonate, acrylonitrile butadiene styrene (ABS), polytetrafluoroethylene (PTFE), ABS impregnated with PTFE or another lubricious additive, nylon, and / or polyethylene. For example, in some embodiments, the drive screw 406 can comprise polycarbonate and the release knob can comprise ABS (or vice versa). Additionally, in some embodiments, the material of the drive screw 406 and / or release knob 404, along with the lead of the grooves 452 and teeth 446, can be selected to achieve a desired level of engagement, as described above.

[0108] As shown in FIGS. 26-33, the drive screw 406 may include a collar 480 (or collar portion) extending axially proximally outward from the proximal end 476 of the main body 456. The collar 480 may be an annular collar 480 that extends around the circumference of the drive screw 406. The collar 480 may have an outer diameter 482 that is larger than an outer diameter 484 of the main body 456 (FIG. 29). The collar 480 may also have an inner surface that defines an inner diameter 486 of the collar 480. The inner diameter 486 may be shaped to receive a portion of the cap 408 of the release mechanism 402. For example, as shown in FIGS. 12, 13, and 16-20, the cap 408 is coupled to the proximal end 476 of the main body 456 of the drive screw 406 by the collar 480. In some embodiments, the collar 480 may include one or more apertures 481 each configured to receive a fastener to couple the cap 408 to the collar 480 .

[0109] In some embodiments, as shown in FIG. 13 , the inner shaft 488 (e.g., inner shaft 152 of FIG. 8 ) can be fixedly coupled (e.g., bonded, adhesively secured, or pressure-fitted, etc.) to the interior of the cap 408. For example, similar to those shown in FIGS. 8-10 , the inner shaft 488 is fixed to the cap 408 and then extends through the delivery device from the cap 408 to a distal end portion or end of the delivery device (e.g., to the nosecone 144). The inner shaft 488 can be configured to receive a guidewire and, therefore, in some embodiments, can be referred to as a guidewire lumen. The inner shaft 488 is fixedly coupled to the cap 408, and the cap 408 is coupled to the drive screw 406, such that axial linear translation of the drive screw 406 causes linear translation of the inner shaft 488 (e.g., the drive screw 406 and inner shaft 488 translate together).

[0110] 26-33 , the drive screw 406 may further include an extension portion 490 extending axially distally outward from the distal end 474 of the main body 456. The extension portion 490 may include a central bore 492 (channel) and one or more side bores 494 that are offset from the central bore 492 (as shown in the distal end view of FIG. 33 ). The central bore 492 may be configured to receive the inner shaft 488. In some embodiments, as shown in FIG. 29 , the central bore 492 of the extension portion 490 may be continuous with and connect to a central bore portion 496 that extends entirely through the interior of the main body 456. The central bore portion 496 may provide additional support for the inner shaft 488 and prevent tangling. However, in alternative embodiments, the drive screw 406 may not include the central bore portion 496.

[0111] As shown in FIGS. 15 and 17-19, each side bore 494 may be configured to receive a corresponding rod 499 (of two rods) (only one of two pairs of side bores 494 and rods 499 is shown). The rods 499 may be fixed to an internal coupling element 417 disposed within the housing 410 of the handle portion 400 ( FIG. 17 ). The drive screw 406 may be configured to move linearly axially along the rod 499. In this manner, the rod 499 may guide the linear movement of the drive screw 406 within the release knob 404.

[0112] In some embodiments, as shown in FIGS. 15 and 17-19, the proximal end of each rod 499 includes a stop (or travel end) element 497 having at least one dimension greater than the diameter of the rod 499. The stop element 497 can also be greater than the maximum width of the inner side bore 494 of the drive screw 406. As shown in FIGS. 15 and 17-19, the stop element 497 is disposed within an open cavity 495 within the main body 456 of the drive screw 406, which is disposed between the proximal end 476 and the distal end 474 of the main body 456 of the drive screw 406. The distal end 474 of the main body 456 can include an inner surface 493 configured normal to the central longitudinal axis 420 (FIG. 19). The inner surface 493 and the stop element 497 can together form an end stop that stops further proximal axial movement of the drive screw 406. As such, the drive screw 406 may be prevented from moving too far out of the release knob 404. In some embodiments, the linear movement of the release mechanism 402 may be stopped (at or beyond the release configuration, as described further herein) by the spool 212 coming into contact with the spool stopper 216 at the distal end portion of the delivery device (as shown in FIG. 10 ) before the stop element 497 comes into contact with the inner surface 493 (at the proximal end of the delivery device).

[0113] In some embodiments, as shown in Figure 33, the extension portion 490 can have a major axis (e.g., along the major dimension) with a major diameter 491 and a minor axis (e.g., along the minor dimension) with a minor diameter 489. The central bore 492 and two side bores 494 can be spaced apart from one another along this major axis. The major diameter 491 can be smaller than the outer diameter 484 of the main body 456 (Figure 33).

[0114] In some embodiments, as shown in FIG. 33, the extension portion 490 can include a raised (e.g., protruding) area around the central bore 492, which creates a wider portion having a diameter 487 larger than the minor diameter 489.

[0115] 34 is a flow diagram of a method 500 for manipulating the handle portion 400 to deliver a prosthetic medical device (e.g., a prosthetic heart valve) to a target implantation site. As described above, the handle portion 400 with the release mechanism 402 can be part of a delivery device, such as the delivery device 100 of FIGS. 1-10. The method 500 can also provide a method for manipulating the release mechanism 402. The method 500 will now be described with reference to FIGS. 9-20.

[0116] Method 500 begins at step 502 and includes advancing a distal end portion of a delivery device (e.g., the distal end portion shown in FIGS. 9 and 10, which may be included in delivery device 100 of FIGS. 1-8) toward a target implantation site within a patient and adjusting a steering mechanism of the delivery device to flex and articulate the distal end portion along a curved portion of the patient's vasculature. In some embodiments, an implantable medical device, such as a prosthetic heart valve (e.g., valve 10 of FIG. 1), is disposed on the distal end portion of the delivery device in a radially compressed configuration. For example, the prosthetic heart valve may be contained within a capsule (e.g., capsule 146 shown in FIGS. 2-4) of the delivery device in the radially compressed configuration.

[0117] In some embodiments, the curved portion of the patient's vasculature may include the aortic arch. Figure 11 shows an example in which the distal end portion of the delivery device is articulated around a simulated aortic arch.

[0118] At step 504, the method includes translating a capsule covering the radially compressed prosthetic heart valve (or alternative implantable medical device) away from the valve after reaching the target implantation site to expose the prosthetic heart valve. In some embodiments, after retracting the capsule from the radially compressed valve, the valve may self-expand to a radially expanded configuration. In some embodiments, translating the capsule may be in response to actuating one or more buttons on a handle portion of the delivery device. For example, as described above with reference to FIGS. 2 and 5-7, a user actuating one or more buttons may activate a motor, thereby axially moving the capsule to expose the valve.

[0119] After exposing the prosthetic heart valve or other medical device in step 504, method 500 proceeds to step 506. In step 506, the method includes rotating a knob of a release mechanism (e.g., release knob 404 of release mechanism 402 as shown in FIGS. 12-25) to linearly translate a drive screw of the release mechanism (e.g., drive screw 406 as shown in FIGS. 12-20 and 26-33) in a proximal direction (e.g., proximally or axially proximally) and linearly translate an inner shaft fixedly coupled to the drive screw and one or more release members fixedly coupled to a distal end of the inner shaft, thereby releasing the valve from the delivery device. For example, linearly translating the drive screw by rotating the knob in step 506 may include rotating the knob 404 of the valve release mechanism from an initial locked position (as shown in FIGS. 12-15) and moving one or more teeth 446 of the knob 404 along corresponding grooves 452 of the drive screw 406 to linearly translate the drive screw 406 axially and proximally until the drive screw 406 reaches a released position (as shown in FIGS. 16-19).

[0120] In some embodiments, as described herein with reference to Figures 26-33, the drive screw 406 can have a double-start thread with a relatively long lead and pitch, and the knob 404 can have two teeth positioned opposite each other (e.g., spaced approximately 180 degrees apart) around the circumference of the inner surface of the knob 404. The threads of the drive screw 406 can be defined by two helical grooves 452. Each tooth 446 mates with a corresponding groove 452 and is configured to translate (e.g., move or slide) along the groove 452.

[0121] 12-15 , in a starting locked position or configuration, the drive screw 406 is retracted within the handle portion 400, with a majority of the main body 456 of the drive screw 406 disposed within the knob 404. For example, only the collar 480 of the drive screw 406 may extend axially outwardly proximally of the knob 404 in the starting locked position.

[0122] Furthermore, in the initial locked position or configuration, each tooth 446 may be disposed within a first linear thread portion 462 of a corresponding retention element 458 (as shown in FIG. 15 ). Each tooth 446 may be retained within the retention element 458 by a protruding member 460 of the retention element 458 that protrudes radially outward relative to the first linear thread portion 462. The protruding member 460 prevents rotation of the knob 404 in response to forces generated by articulating (e.g., flexing) the distal end portion of the delivery device in step 502 during the method. In this manner, accidental premature release of the prosthetic heart valve from the delivery device (due to unintentional actuation of the knob 404) may be prevented.

[0123] Upon initial rotation of the knob 404 (e.g., by a user), each tooth 446 may overcome the protruding member 460 of the retaining element 458 by moving over the protruding member 460 and up to the second linear thread portion 464 aligned with the corresponding groove 452. In this manner, rotating the knob in step 506 may first include initially rotating the knob to decouple (or release) the tooth 446 from the corresponding retaining element 458. The user may feel initial resistance in the protruding member 460 overcoming the retaining element 458. However, after passing the protruding member 460, the user may feel little resistance in rotating and reorienting the knob 404. The tooth 446 may then slide and move along the path of the groove as the knob 404 is rotated and reoriented. In response to the knob 404 being turned and reoriented, the teeth 446 move along the grooves 452, causing the drive screw 406 to translate axially proximally, while the axial position of the knob 404 remains fixed. For example, the proximal end 476 of the drive screw 406 extends further out of the knob 404 as each tooth 446 continues to move along its corresponding groove 452.

[0124] The method may further include, at step 506, linearly translating an inner shaft 488 ( FIG. 13 ) fixedly coupled to the drive screw 406 and one or more release members fixedly coupled to a distal end of the inner shaft (e.g., release member 208 coupled to shaft 152 in FIGS. 9 and 10 ) to release the valve from the delivery device while the drive screw 406 is translating in the proximal axial direction. For example, as described above with reference to FIG. 13 , the proximal end of the inner shaft 488 may be fixedly coupled to a cap 408 coupled to the proximal end of the drive screw 406, and a release member, such as release member 208, may be fixedly coupled to a distal end portion of the inner shaft 488. Thus, linearly translating the drive screw 406 in the proximal axial direction results in linear translation of the release member in the proximal axial direction (e.g., these components move together). As explained above, by moving the release member proximally axially away from the prosthetic heart valve (or other implantable medical device), the release member becomes uncoupled from the prosthetic heart valve, thereby decoupling and releasing the prosthetic heart valve from the delivery apparatus.

[0125] When the release mechanism 402 (and drive screw 406) is in the release position or configuration, the drive screw 406 extends axially proximally outward from the proximal end of the release knob 404 (as shown in FIGS. 16-19). Additionally, the teeth 446 of the release knob 404 may engage corresponding grooves 452 of the drive screw 406 (as shown in FIG. 18) at or near the distal end 474 of the main body 456 of the drive screw 406. In this release position, the stop element 497 of the rod 499 may be disposed near the inner surface 493 of the distal end 474 of the main body 456 (as shown in FIGS. 18 and 19). Also, in this release configuration, the release member (e.g., release member 208) is positioned away from the prosthetic heart valve. For example, as shown in FIG. 10, in this release configuration, the spool 212 may be positioned near or in contact with the spool stopper 216, and therefore the release member 208 may be positioned closer to the spool stopper 216 (as compared to the starting configuration shown in FIG. 9).

[0126] At step 508, the method may continue by adjusting (e.g., actuating) the steering mechanism to release the distal end portion of the delivery device after release of the prosthetic heart valve (or other implantable medical device) and passively retracting the drive screw distally axially partially into the knob to release tension during release. As explained above, tension in the shaft of the delivery device may be generated while the distal end portion of the delivery device is being released during release of the valve from the delivery device. Therefore, this tension needs to be relieved to allow for complete and successful release of the distal end portion of the delivery device and removal of the delivery device from the implantation site. Allowing the drive screw 406 to be passively retracted into the knob 404, thereby linearly translating the inner shaft 488 axially distally, releases the distal end portion of the delivery device, thereby allowing the tension generated during release to be relieved (e.g., by actuating the steering mechanism, such as by rotating the steering knob 418).

[0127] For example, from the release configuration of the release mechanism 402 (shown in FIGS. 16-19 ), the distal end portion of the delivery apparatus may be released (e.g., by rotating the steering knob 418) to cause the drive screw to translate distally and at least partially back into the release knob 404, as shown in FIG. 20 . As used herein, “passively” refers to the free movement of the drive screw without manual actuation of the knob 404 (e.g., by a user turning the knob 404). During release of the distal end portion of the delivery apparatus, the attractive force at the distal end portion of the delivery apparatus may be sufficient to overcome the resistance of the mating connection between the teeth 446 of the knob 404 and the grooves 452 of the drive screw 406, thereby allowing the drive screw 406 to be retracted into the knob 404. The retraction of the drive screw 406 into the knob 404 causes the teeth 446 to move along the grooves 452, which passively turns and reorient the knob 404. In this manner, tension built up in the distal end portion of the delivery device can be automatically relieved (without user intervention) via the release mechanism 402, allowing the distal end portion of the delivery device to be released and removed from the implantation site and the patient. This may simplify the implantation process and allow the user to more easily remove the delivery device from the implantation site. As introduced above, the relatively low friction contact surfaces of the knob 404 and drive screw 406, combined with the relatively short teeth 446 of the knob 404 and the long lead / pitch of the grooves 452 of the drive screw 406, allow the drive screw 406 to passively pull back into the knob to relieve tension during release.

[0128] Thus, the method includes unflexing the distal end portion of the delivery device in step 508, followed by removing the delivery device from the implantation site (and the patient) in step 510.

[0129] Further examples of the techniques of the present disclosure In view of the above implementations of the subject matter of the present disclosure, the present application discloses the following additional embodiments: It should be noted that one 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 an additional embodiment that is also within the scope of the present disclosure of the present application.

[0130] Example 1. A delivery apparatus for an expandable implantable medical device, the delivery apparatus comprising: a handle portion comprising a release mechanism configured to adjust the linear position of a component of the delivery apparatus relative to a central longitudinal axis of the delivery apparatus, the release mechanism comprising: a threaded drive screw having a helically threaded portion having a lead of at least 1 inch, the helically threaded portion comprising one or more grooves extending around the drive screw, the drive screw being coupled to the component; and a rotatable knob surrounding the drive screw and coaxial with the drive screw, the knob comprising one or more teeth disposed at a proximal end of the knob, each tooth of the one or more teeth configured to interface with a corresponding one of the one or more grooves of the drive screw, each tooth of the one or more teeth extending from the proximal end toward the distal end of the knob for only a portion of the total distance between the proximal and distal ends, the portion being less than ¼ of the total distance.

[0131] Example 2. A delivery device of any of the examples of this chapter, particularly Example 1, wherein the threaded drive screw comprises one or more retaining elements disposed at a proximal end of the drive screw, wherein one or more grooves of the helically threaded portion are each coupled to a corresponding one of the one or more retaining elements and extend around the drive screw from the corresponding retaining element to a distal end of the drive screw, and wherein each tooth of the one or more teeth is configured to interface with a corresponding retaining element.

[0132] Example 3. A delivery device of any example of this chapter, particularly Example 2, wherein each tooth is configured to mate with and move along a corresponding groove as the knob is rotated about a central longitudinal axis; the drive screw is configured to move linearly in an axial direction relative to the knob as the knob rotates and the tooth moves along the corresponding groove; the knob is fixed for translational movement in an axial direction, the axial direction being relative to the central longitudinal axis; the knob comprises a collar extending distally from a distal end of the knob into an interior of a housing of the handle portion; the collar comprises one or more collar grooves extending along a periphery of the collar, each collar groove mates with a corresponding annular protrusion extending radially from an inner surface of the housing of the handle portion; and the knob is fixed for translational movement in an axial direction by a mating connection between each collar groove and the corresponding annular protrusion and is configured to rotate about the central longitudinal axis relative to the housing of the handle portion.

[0133] Example 4. A delivery device of any embodiment of this chapter, particularly Example 2 or 3, wherein the drive screw is linearly movable between an initial locked configuration, in which each tooth is coupled to a corresponding retaining element and the entire helically threaded portion of the drive screw is disposed within the interior of the knob and handle portion, and a released configuration, in which each tooth is mated with a distal portion of a corresponding groove and the distal portion is disposed closer to the distal end of the drive screw than the proximal end of the drive screw, and the majority of the helically threaded portion of the drive screw extends axially outward from the proximal end of the knob.

[0134] Example 5. A delivery device of any example of this chapter, particularly example 4, wherein each retention element comprises a protruding member, a first linear thread portion disposed on a first side of the protruding member, and a second linear thread portion disposed on a second side of the protruding member, the second linear thread portion coupled to and continuous with a corresponding groove of the one or more grooves of the drive screw.

[0135] Example 6. The delivery device of any of the examples of this section, particularly example 5, wherein in the initial locked configuration, each tooth is disposed within the first linear thread portion of the corresponding retaining element.

[0136] Example 7. The delivery device of any of the embodiments of this chapter, particularly any one of embodiments 2 to 6, further comprising a rod having a distal end fixedly coupled to an inner surface of the handle portion, wherein the drive screw comprises an extension portion extending axially outward from the distal end of the drive screw, the extension portion comprising an internal bore mounted around the rod and configured to slide linearly along the rod.

[0137] Example 8. The delivery device of any of the embodiments of this chapter, particularly Example 7, wherein the proximal end of the rod comprises a stop element wider than the maximum width of the internal bore of the drive screw, the stop element being disposed within an open cavity within the drive screw, and the open cavity being disposed between the proximal and distal ends of the drive screw.

[0138] Example 9. The delivery device of any embodiment of this chapter, particularly Example 7 or 8, wherein the extension portion further comprises a central bore centrally located along the central longitudinal axis, the inner bore being radially offset from the central bore, and the central bore being configured to receive the inner shaft of the delivery device therethrough.

[0139] Example 10. The delivery device of any of the embodiments of this chapter, particularly any one of Examples 1 to 9, wherein the component of the delivery device configured for adjustment of its linear position by a release mechanism comprises one or more release members removably coupled to the implantable medical device.

[0140] Example 11. A delivery device of any of the embodiments of this chapter, particularly Example 10, further comprising an inner shaft having a proximal end fixedly coupled to a cap of the release mechanism, the cap being coupled to a proximal end of the drive screw, the inner shaft extending to a distal end of the delivery device, and one or more release members being fixedly coupled to a distal end portion of the inner shaft.

[0141] Example 12. A delivery device of any embodiment of this chapter, particularly any one of Examples 1 to 11, wherein the threads formed by one or more grooves of the helically threaded portion are double-start threads formed by two grooves, the drive screw has two retaining elements, each groove extending from a respective one of the two retaining elements, and the knob has two teeth, each tooth configured to mate with a respective one of the two grooves and slide along a respective one of the two grooves.

[0142] Example 13. A delivery device of any of the embodiments of this chapter, particularly Example 12, wherein the two teeth are spaced apart from one another along the periphery of the proximal end of the knob.

[0143] Example 14. A delivery device of any of the embodiments of this chapter, particularly any one of Examples 1 to 13, wherein the handle portion further comprises a steering mechanism comprising a steering knob configured to rotate relative to the housing of the handle portion and adjust the curvature of one or more shafts of the delivery device at the distal end portion of the delivery device.

[0144] Example 15. A delivery device of any of the embodiments of this chapter, particularly Example 14, wherein the steering knob is coupled to the distal end of the housing of the handle portion, and the release mechanism knob is coupled to the proximal end of the housing of the handle portion.

[0145] Example 16. The delivery apparatus of any of the embodiments of this chapter, particularly any one of Examples 1 to 15, wherein the implantable medical device is a prosthetic heart valve configured to radially self-expand to a functional size.

[0146] Example 17. A delivery device of any embodiment of this chapter, particularly any one of Examples 1 to 16, wherein the portion of the total distance between the proximal end and the distal end is less than 1 / 10 of the total distance.

[0147] Example 18. A method for implanting an implantable medical device using a delivery apparatus, comprising: advancing a distal end portion of the delivery apparatus using a handle portion of the delivery apparatus to a target implantation site, wherein the implantable medical device is disposed on the distal end portion in a radially compressed configuration; and, after reaching the target implantation site, exposing the radially compressed implantable medical device and releasing the implantable medical device from the delivery apparatus, the releasing step comprising rotating a knob of a release mechanism on the handle portion of the delivery apparatus from a start position to move one or more teeth of the knob along one or more grooves of a drive screw of the release mechanism until the drive screw reaches a released position. and linearly translating a drive screw proximally along an axis parallel to a central longitudinal axis of the delivery device; releasing the implantable medical device from the delivery device by linearly translating an inner shaft fixedly coupled to the drive screw and one or more release members fixedly coupled to a distal end portion of the inner shaft; and actuating a steering mechanism of the delivery device to release the distal end portion of the delivery device and passively retracting the drive screw distally and partially into a knob to automatically release tension during release, the distal direction being opposite the proximal direction.

[0148] Example 19. The method of any example of this chapter, particularly example 18, wherein the step of rotating from a starting position includes initially rotating the knob to release each tooth of the one or more teeth of the knob from a corresponding retaining element located on the proximal end of the drive screw and coupled to a corresponding groove of the one or more grooves, and then continuing to rotate the knob to move the one or more teeth along the one or more grooves of the drive screw and linearly translate the drive screw in a proximal direction.

[0149] Example 20. The method of any of the examples of this chapter, particularly Example 19, wherein, in the starting position, each tooth is disposed within a first linear thread portion of a corresponding retaining element and is retained within the first linear thread portion via a protruding member of the retaining element that protrudes radially outward relative to the first linear thread portion, and the retaining element has a second linear thread portion disposed on the opposite side of the protruding member from the first linear thread portion and directly connected to the corresponding groove.

[0150] Example 21. The method of any example of this chapter, particularly example 19 or 20, further comprising, during the step of advancing the distal end portion to the target implantation site, adjusting a steering mechanism of the delivery device to flex and articulate the distal end portion of the delivery device along one or more curves in a body cavity of the patient en route to the target implantation site, and maintaining one or more teeth of the knob within a corresponding retaining element of the drive screw during the step of adjusting the steering mechanism.

[0151] Example 22. The method of any of the embodiments of this chapter, particularly any one of embodiments 18 to 21, wherein in the starting position, a release member is coupled to the implantable medical device.

[0152] Example 23. The method of any embodiment of this chapter, particularly any one of Examples 18 to 22, wherein the one or more grooves of the drive screw comprise two helical grooves extending curvilinearly along the outer surface of the main body of the drive screw from the proximal end to the distal end of the main body, the drive screw has a double thread formed by the two grooves, and the one or more teeth of the knob comprise two teeth spaced apart from each other along the periphery of the proximal end of the knob.

[0153] Example 24. The method of any embodiment of this chapter, particularly Example 23, wherein the lead of the double start thread is at least 1 inch.

[0154] Example 25. The method of any embodiment of this chapter, particularly any one of Examples 18 to 24, wherein each of the one or more teeth of the knob is located at the proximal end of the knob and extends over only a portion of the entire length of the inner surface of the knob, this length extending in an axial direction parallel to the central longitudinal axis from the proximal end to the distal end of the knob, this portion being less than 1 / 4 of the entire length, and each of the one or more grooves extends in a curved manner along the outer surface of the main body of the drive screw from the proximal end to the distal end of the main body, and the main body is longer than the inner surface of the knob.

[0155] Example 26. The method of any of the embodiments of this chapter, particularly any one of Examples 18 to 25, wherein in the released position, each tooth of the one or more teeth of the knob engages with a corresponding groove of the one or more grooves of the drive screw at the distal end portion of the main body of the drive screw, and the one or more grooves are disposed in the main body.

[0156] Example 27. The method of any embodiment of this chapter, particularly any one of Examples 18 to 26, wherein the step of linearly translating the drive screw in the proximal direction includes sliding an inner bore disposed within an extension portion of the drive screw extending outward in the distal direction from the distal end of the main body of the drive screw, the main body having one or more spiral grooves therein along a rod coupled to the interior of the handle portion at the distal end of the rod, and in the released position, a blade, a stop element disposed at the proximal end of the rod, is disposed proximal to the inner surface of the distal end of the main body of the drive screw, the inner surface being disposed normal to the rod.

[0157] Example 28. The method of any of the embodiments of this chapter, particularly any one of embodiments 18 to 27, wherein in the release position, the release member is positioned away from the implantable medical device and is decoupled from the implantable medical device.

[0158] Example 29. The method of any of the embodiments of this chapter, particularly any one of Examples 18 to 28, wherein the step of linearly translating the drive screw until the drive screw reaches a release position includes translating the inner shaft and one or more release members until a spool coupled to a distal end portion of the inner shaft reaches a spool stop of a delivery device axially fixed relative to the inner shaft.

[0159] Example 30. The method of any embodiment of this chapter, particularly any one of Examples 18 to 29, wherein the step of passively retracting the drive screw includes the step of retracting the drive screw distally back into the knob in response to a force pulling the inner shaft distally during deflexion, causing one or more teeth of the knob to move along one or more corresponding grooves of the drive screw from a distal end to a proximal end of the one or more corresponding grooves.

[0160] Example 31. The method of any of the embodiments of this chapter, particularly any one of embodiments 18 to 30, further comprising, during the step of advancing the distal end portion to the target implantation site, adjusting a steering mechanism of the delivery device to flex and articulate the distal end portion of the delivery device along one or more curves in a body cavity of the patient en route to the target implantation site.

[0161] Example 32. A method of any of the embodiments of this chapter, particularly Example 31, wherein the steering mechanism includes a steering knob coupled to a distal end of the housing of the handle portion, and the knob of the release mechanism is coupled to a proximal end of the housing of the handle portion.

[0162] Example 33. The method of any of the examples of this chapter, particularly any one of Examples 18 to 32, further comprising the step of removing the delivery device from the implantation site after unflexing the distal end portion of the delivery device.

[0163] Example 34. The method of any of the embodiments of this chapter, particularly any one of Examples 18 to 33, wherein the step of exposing the radially compressed implantable medical device includes the step of retracting a capsule coupled to the outer shaft of the delivery device away from the radially compressed implantable medical device in response to actuation of one or more buttons on the handle portion.

[0164] Example 35. The method of any of the embodiments of this chapter, particularly any one of Examples 18 to 34, wherein the implantable medical device is a self-expanding prosthetic heart valve.

[0165] Example 36. A method for operating a release mechanism of a handle portion of a delivery apparatus configured to deliver an implantable medical device to a target implantation site, comprising the steps of: from an initial locked position of the release mechanism, in response to rotation of a knob of the release mechanism, linearly translating the drive screw of the release mechanism proximally along an axis parallel to a central longitudinal axis of the delivery apparatus by moving one or more teeth of the knob along one or more corresponding grooves of the drive screw until the drive screw reaches a released position, wherein in the initial locked position a main body of the drive screw having one or more grooves is disposed within the knob and in the released position a majority of the main body extends outside the knob. and, while the drive screw is translated in a proximal direction, linearly translating an inner shaft fixedly coupled to the drive screw and one or more release members fixedly coupled to a distal end portion of the inner shaft to release an implantable medical device mounted on the distal end portion of the delivery device from the delivery device; and, in response to actuation of a steering mechanism of the delivery device, releasing the distal end portion of the delivery device, and during the releasing, passively retracting the drive screw distally partially into a knob to automatically release tension in the distal end portion of the delivery device and enable the releasing, wherein the distal direction is opposite to the proximal direction.

[0166] Example 37. The method of any embodiment of this chapter, particularly Example 36, wherein the step of moving one or more teeth of the knob from an initial locked position includes initially moving each tooth of the one or more teeth from a first linear thread portion of a corresponding retaining element of one or more retaining elements disposed at a proximal end of the main body of the drive screw, over a protruding member of the corresponding retaining element, to a second linear thread portion disposed on the opposite side of the protruding member from the first linear thread portion, the second linear thread portion coupled to the proximal end of the corresponding groove of the one or more grooves, thereby releasing each tooth of the one or more teeth from the corresponding retaining element; and then continuing to move each tooth along the corresponding groove in response to rotation of the knob to linearly translate the drive screw in a proximal direction.

[0167] Example 38. The method of any of the examples herein, particularly Example 36 or 37, wherein in the initial locked position, the release member is coupled to the implantable medical device.

[0168] Example 39. The method of any embodiment of this chapter, particularly any one of Examples 36 to 38, wherein the one or more grooves of the drive screw comprise two helical grooves extending curvilinearly along the outer surface of the main body from the proximal end to the distal end of the main body of the drive screw, the drive screw has a double thread formed by the two grooves, and the one or more teeth of the knob comprise two teeth spaced apart from each other along the periphery of the proximal end of the knob.

[0169] Example 40. The method of any embodiment of this chapter, particularly Example 39, wherein the lead of the double-start thread is at least 1 inch.

[0170] Example 41. A method of any embodiment of this chapter, particularly any one of Examples 36 to 40, wherein each of the one or more teeth of the knob is located at the proximal end of the knob and extends over only a portion of the entire length of the inner surface of the knob, the entire length extending in an axial direction parallel to the central longitudinal axis from the proximal end to the distal end of the knob, the portion being less than 1 / 4 of the entire length, and each of the one or more grooves extends in a curved manner along the outer surface of the main body of the drive screw from the proximal end to the distal end of the main body, the main body being longer than the inner surface of the knob.

[0171] Example 42. The method of any of the embodiments of this chapter, particularly any one of Examples 36 to 41, wherein in the released position, each tooth of the one or more teeth of the knob engages with a corresponding groove of the one or more grooves of the drive screw at the distal end portion of the main body of the drive screw.

[0172] Example 43. A method of any embodiment of this chapter, particularly any one of Examples 36 to 42, wherein the step of linearly translating the drive screw in the proximal direction includes sliding an inner bore disposed within an extension portion of the drive screw extending outward in the distal direction from the distal end of the main body of the drive screw along a rod coupled at its distal end to the interior of the handle portion, wherein in the released position, a stop element disposed at the proximal end of the rod is positioned proximal to an inner surface of the distal end of the main body of the drive screw, the inner surface being positioned normal to the rod.

[0173] Example 44. The method of any of the embodiments of this chapter, particularly any one of Examples 36 to 43, wherein in the release position, the release member is positioned away from and decoupled from the implantable medical device.

[0174] Example 45. The method of any of the examples of this chapter, particularly any one of Examples 36 to 44, wherein the step of linearly translating the drive screw until the drive screw reaches a release position includes translating the inner shaft and one or more release members until a spool coupled to a distal end portion of the inner shaft reaches a spool stop of a delivery device axially fixed relative to the inner shaft.

[0175] Example 46. The method of any embodiment of this chapter, particularly any one of Examples 36 to 45, wherein the step of passively retracting the drive screw includes the step of retracting the drive screw distally back into the knob in response to a force pulling the inner shaft distally during deflexion, causing one or more teeth of the knob to move along one or more corresponding grooves of the drive screw from the distal end to the proximal end of the one or more corresponding grooves.

[0176] Example 47. The method of any of the embodiments of this chapter, particularly any one of embodiments 36 to 46, wherein the steering mechanism includes a steering knob coupled to a distal end of the housing of the handle portion, and the knob of the release mechanism is coupled to a proximal end of the housing of the handle portion.

[0177] Example 48. The method of any of the embodiments of this chapter, particularly any one of Examples 36 to 47, wherein the implantable medical device is a self-expanding prosthetic heart valve.

[0178] Example 49. A delivery apparatus for an expandable implantable medical device, the delivery apparatus comprising: an inner shaft; one or more release members, each release member having a proximal end coupled to an outer surface of the distal end portion of the inner shaft and a distal end configured to be releasably coupled to the implantable medical device disposed around the distal end portion of the inner shaft distal to where the proximal end couples to the inner shaft; and a handle portion, the handle portion comprising: a steering mechanism at the distal end portion of the delivery apparatus configured to adjust the curvature of the one or more shafts of the delivery apparatus comprising the inner shaft to flex the one or more shafts; and a release mechanism configured to adjust the linear position of the inner shaft and the one or more release members along a central longitudinal axis of the delivery apparatus relative to an outer housing of the handle portion, the release mechanism coupled to the proximal end of the inner shaft and disposed within a main body of a drive screw. a threaded drive screw having a helically threaded portion formed thereon, wherein one or more grooves forming the helically threaded portion extend from a proximal end to a distal end of a main body of the drive screw; and a rotatable release knob coupled to a housing of the handle portion, surrounding the drive screw and coaxial with the drive screw, the release knob comprising one or more teeth disposed at a proximal end of the knob and configured to interface with the one or more grooves of the drive screw, the drive screw configured for linear movement along a central longitudinal axis relative to the release knob in response to rotation of the release knob and sliding of the one or more teeth along the one or more grooves, wherein actuation of a steering mechanism to flex release one or more shafts of the delivery device can release tension generated in the distal end portion of the delivery device by distal movement of the drive screw along the central longitudinal axis.

[0179] Example 50. A delivery device of any of the embodiments of this chapter, particularly Example 49, wherein each of the one or more teeth of the release knob is not a full-circumferential thread but extends in a curved manner of less than 45 degrees along the periphery of the proximal end of the release knob.

[0180] Example 51. A delivery device of any embodiment of this chapter, particularly example 49 or 50, wherein the main body of the drive screw further comprises one or more retaining elements disposed at the proximal end of the main body, and each groove of the one or more grooves of the helically threaded portion is coupled to a corresponding one of the one or more retaining elements and extends curvilinearly along the outer surface of the main body, extending from the retaining element to the distal end of the main body.

[0181] Example 52. A delivery device of any embodiment of this chapter, particularly Example 51, wherein the drive screw is linearly movable between an initial locking configuration in which each tooth of the one or more teeth is engaged with a corresponding retaining element of the one or more retaining elements, and the entire helically threaded portion of the drive screw is positioned within the release knob and handle portion, and a release configuration in which each tooth is mated with a distal portion of a corresponding groove, the distal portion being positioned closer to the distal end of the main body than the proximal end, and the majority of the helically threaded portion of the drive screw extending axially outward from the proximal end of the release knob.

[0182] Example 53. A delivery device of any of the examples of this chapter, particularly example 52, wherein each retaining element comprises a protruding member, a first linear thread portion disposed on a first side of the protruding member, and a second linear thread portion disposed on a second side of the protruding member, the second linear thread portion being coupled to and continuous with a corresponding groove of one or more grooves of the drive screw.

[0183] Example 54. A delivery device of any of the embodiments of this chapter, particularly Example 53, wherein in the initial lock configuration, each tooth is disposed within the first linear thread portion of the corresponding retaining element.

[0184] Example 55. A delivery device of any embodiment of this chapter, particularly any one of embodiments 49 to 54, wherein the drive screw comprises an extension portion extending axially outward from the distal end of the main body, the extension portion comprising a central bore centered along the central longitudinal axis and two side bores radially offset from the central bore on each side of the central bore.

[0185] Example 56. A delivery device of any of the embodiments of this chapter, particularly example 55, wherein the inner shaft extends through the central bore.

[0186] Example 57. A delivery device of any embodiment of this chapter, particularly Example 55 or 56, further comprising two rods, each rod having a distal end fixedly coupled to an internal connecting element of the handle portion and a proximal end having a stop element having a dimension wider than the diameter of the rod, each rod extending through a corresponding one of two side bores of the drive screw, the stop element being positioned within an open cavity within the main body of the drive screw, the open cavity being positioned between the proximal and distal ends of the main body, and the drive screw being configured for linear movement along the two rods.

[0187] Example 58. A delivery device of any of the embodiments of this chapter, particularly Example 57, wherein the stopper element is wider than the maximum width of the side bore of the drive screw, and the open cavity is formed by an inner wall of the main body and an inner surface disposed between the extension portion and the distal end of the main body, the inner surface being disposed normal to the central longitudinal axis.

[0188] Example 59. A delivery device of any embodiment of this chapter, particularly any one of embodiments 49 to 58, wherein the threads formed by one or more grooves of the helically threaded portion are double-start threads formed by two grooves, and the release knob has two teeth, each tooth of which is configured to mate with and slide along a respective one of the two grooves.

[0189] Example 60. A delivery device of any of the embodiments of this chapter, particularly Example 59, wherein the two teeth are spaced apart from one another along the periphery of the proximal end of the release knob.

[0190] Example 61 The delivery device of any embodiment of this chapter, particularly Example 59 or 60, wherein the drive screw threads have a lead of at least 1 inch and a pitch of at least 0.5 inches.

[0191] Example 62 The delivery device of any embodiment of this chapter, particularly Example 59 or 60, wherein the drive screw thread has a lead in the range of 1 inch to 1.75 inches.

[0192] Example 63. A delivery device of any embodiment of this chapter, particularly any one of embodiments 49 to 62, wherein the steering mechanism comprises a steering knob configured to rotate relative to the housing of the handle portion, the steering knob being coupled to a distal end of the housing of the handle portion, and the release knob of the release mechanism being coupled to a proximal end of the housing of the handle portion.

[0193] Example 64. A delivery device of any embodiment of this chapter, particularly any one of embodiments 49 to 63, wherein each tooth of the one or more teeth of the release knob extends from the proximal end of the release knob toward the distal end of the release knob over only a portion of the total distance between the proximal end and the distal end, and this portion is less than 1 / 10 of the total distance.

[0194] Example 65. A delivery device of any embodiment of this chapter, particularly any one of embodiments 49 to 64, further comprising an outer shaft having a proximal end portion and a distal end portion coupled to the handle portion, and further comprising a capsule coupled to the distal end portion of the outer shaft, wherein the inner shaft is concentric with the outer shaft and disposed within the outer shaft, and the capsule is configured to accommodate an implantable medical device in a radially compressed state on the distal end portion of the inner shaft.

[0195] Example 66. A delivery device of any of the embodiments of this chapter, particularly any one of Examples 49 to 65, wherein the implantable medical device is a prosthetic heart valve configured to radially self-expand to a functional size.

[0196] Example 67. A delivery device of any embodiment of this chapter, particularly any one of embodiments 49 to 66, wherein the release knob comprises a main body disposed outside the housing of the handle portion and a collar extending distally from a distal end of the main body of the release knob into the interior of the housing of the handle portion, the collar having one or more collar grooves extending along the periphery of the collar, each collar groove mating with a corresponding annular protrusion extending radially from the interior surface of the housing of the handle portion, and the release knob is fixed against axial translational movement by the mating connection between each collar groove and the corresponding annular protrusion, and is configured to rotate about a central longitudinal axis relative to the housing of the handle portion.

[0197] In view of the numerous 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, which is rather defined by the appended claims and their equivalents. [Explanation of symbols]

[0198] 10 Prosthetic heart valve, self-expanding prosthetic valve, 12 Stent, frame, self-expanding frame, 14 Valve structure, 16 Strut, 18 Tip, 20 Inflow end, 22 Outflow end, 24 Post, 26 Eyelet, aperture, opening, 28 Leaflet, 30 Commissure, 32 Suture, 34 Skirt, inner skirt, 36 Suture line, 100 Delivery device, 118 Cord, tether, 118a First end, 118b Second end, 120 Cord manifold, 122 Proximal portion, 124 Distal portion, 132 Handle portion, 133 Housing, 134 First shaft, outer shaft, 136 Knob, release knob, 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, 157; cap, 161; drive screw, 162; externally threaded portion, 164; internally threaded nut, 165; rail, 166; radially extending protrusion, 168; motor, 170; distal opening, 172; rotatable component, 173; lumen, 174; gear, 176; gear teeth, 178; main body, 182; intermediate drive gear, 184; drive shaft, 188; motor shaft, 190; cradle, 192; gear teeth, 194; first distal portion, 195; distal sleeve, 196; proximal portion, 197; proximal sleeve, 200 Release mechanism, 202, locking mechanism, 204, knob, 206, washer, 208, release member, valve release member, 212, spool, 214, proximal direction, 216, spool stopper, 300, simulated aortic arch, 302, distal end portion, 304, delivery device, 400, handle portion, 402, release mechanism, 404, knob, release knob, 406, drive screw, 408, cap, 410, housing, 412a, button, 412b, button, 414, proximal end, 416, distal end, 417, internal coupling element, 418, steering knob, 420, central longitudinal axis, 422, collar, 424, distal end, 426, proximal end, 428, main body, 430, outer diameter, 432, maximum outer diameter, 434, grooveChannel, 436, Annular protrusion, 438, Inner surface, 440, Internal cylindrical bore, cavity, 442, Inner surface, 444, Inner diameter, 446, Teeth, 446a, First teeth, 446b, Second teeth, 448, Total distance, 450, Protruding element, 452, Spiral groove, single groove, 452a, First groove, 452b, Second groove, 453, Groove, 454, Outer surface, 456, Main body, 458, Retaining element, 460, Protruding member, 462, First linear thread portion, 464, Second linear thread portion, 466, Lead, 468, Pitch, 469, Protruding member, 470, Profile, 472, Profile, 474, Distal end, 476, Proximal end, 478, Path length, 480 Collar, collar portion, annular collar, 481 aperture, 482 outer diameter, 484 outer diameter, 485 tab, 486 inner diameter, 487 diameter, 488 inner shaft, 489 minor diameter, 490 extension portion, 491 major diameter, 492 central bore, channel, 493 inner surface, 494 side bore, 495 open cavity portion, 496 central bore portion, 497 stop element, moving end element, 499 rod,

Claims

1. 1. A delivery apparatus for an expandable implantable medical device, comprising: a handle portion including a release mechanism configured to adjust the linear position of a component of the delivery device relative to a central longitudinal axis of the delivery device; The release mechanism includes: a threaded drive screw comprising a helically threaded portion having a lead of at least 2.54 cm, said helically threaded portion comprising one or more grooves extending around the periphery of said threaded drive screw, said threaded drive screw being coupled to said component; a rotatable knob surrounding and coaxial with the threaded drive screw, the rotatable knob including one or more teeth disposed at a proximal end of the rotatable knob; Equipped with each of the one or more teeth is configured to interface with a corresponding one of the one or more grooves of the threaded drive screw, and each of the one or more teeth extends from the proximal end toward the distal end of the rotatable knob over only a portion of the total distance between the proximal end and the distal end; The portion is less than 1 / 4 of the total distance.

2. the threaded drive screw comprising one or more retention elements disposed on a proximal end of the threaded drive screw; one or more of the grooves of the helically threaded portion are respectively coupled to a corresponding one of the one or more retaining elements and extend around the threaded drive screw from the corresponding retaining element to a distal end of the threaded drive screw; The delivery device of claim 1 , wherein each of the one or more teeth is configured to cooperate with a corresponding retaining element.

3. each of the teeth is configured to mate with and move along a corresponding groove as the rotatable knob is rotated about the central longitudinal axis; the threaded drive screw is configured to move linearly in an axial direction relative to the rotatable knob as the rotatable knob rotates and the teeth move along the corresponding grooves; the rotatable knob is fixed for translational movement in the axial direction, the axial direction being relative to the central longitudinal axis; the rotatable knob includes a collar extending distally from the distal end of the rotatable knob into an interior of the handle portion housing, the collar including one or more collar grooves extending along a periphery of the collar, each collar groove mating with a corresponding annular projection extending radially from an inner surface of the handle portion housing; 3. The delivery device of claim 2, wherein the rotatable knob is fixed against axial translational movement and configured to rotate about the central longitudinal axis relative to the housing of the handle portion by a mating connection between each of the collar grooves and the corresponding annular protrusion.

4. 4. The delivery device of claim 2 or 3, wherein the threaded drive screw is linearly movable between an initial locked configuration in which each tooth is coupled to a corresponding retaining element and the entire helically threaded portion of the threaded drive screw is disposed within the rotatable knob and the handle portion, and a released configuration in which each tooth is mated with a distal portion of a corresponding groove and the distal portion is disposed closer to the distal end of the threaded drive screw than the proximal end of the threaded drive screw, with a majority of the helically threaded portion of the threaded drive screw extending axially outward from the proximal end of the rotatable knob.

5. each of the retaining elements comprises a protruding member, a first linear thread portion disposed on a first side of the protruding member, and a second linear thread portion disposed on a second side of the protruding member, the second linear thread portion being coupled to and continuous with a corresponding one of the one or more grooves of the threaded drive screw; The delivery device of claim 4 , wherein in the initial lock configuration, each of the teeth is disposed within the first linear thread portion of the corresponding retaining element.

6. a rod having a distal end fixedly coupled to an inner surface of the handle portion; 6. The delivery device of claim 2, wherein the threaded drive screw comprises an extension portion extending axially outward from the distal end of the threaded drive screw, the extension portion comprising an internal bore mounted around the rod and configured to slide linearly along the rod.

7. a proximal end of the rod comprising a stop element wider than a maximum width of the internal bore of the threaded drive screw; 7. The delivery device of claim 6, wherein the stop element is disposed within an open cavity within the threaded drive screw, the open cavity being disposed between the proximal end and the distal end of the threaded drive screw.

8. the extension portion further comprises a central bore centrally located along the central longitudinal axis, the internal bore being radially offset from the central bore; The delivery device of claim 6 or 7, wherein the central bore is configured to receive an inner shaft of the delivery device therethrough.

9. 9. The delivery device of claim 1, wherein the component of the delivery device configured for adjustment of its linear position by the release mechanism comprises one or more release members removably coupled to the implantable medical device.

10. an inner shaft having a proximal end fixedly coupled to a release mechanism cap, the cap being coupled to the proximal end of the threaded drive screw; the inner shaft extends to a distal end of the delivery device; The delivery device of claim 9 , wherein the one or more release members are fixedly coupled to a distal end portion of the inner shaft.

11. the threads formed by the one or more grooves of the helically threaded portion are double-start threads formed by two of the grooves; the threaded drive screw has two retaining elements, each of the grooves extending from one of the two retaining elements; 11. The delivery device of claim 1, wherein the rotatable knob includes two teeth, each configured to mate with and slide along a different one of the grooves, and the two teeth are spaced apart from each other along a periphery of the proximal end of the rotatable knob.

12. 12. The delivery device of claim 1, wherein the handle portion further comprises a steering mechanism comprising a steering knob configured to rotate relative to the handle portion housing and adjust the curvature of one or more shafts of the delivery device at a distal end portion of the delivery device.

13. 13. The delivery apparatus of any one of claims 1 to 12, wherein the implantable medical device is a prosthetic heart valve configured to radially self-expand to a functional size.

14. 14. The delivery device of claim 1, wherein the portion of the total distance between the proximal end and the distal end is less than 1 / 10 of the total distance.

15. 1. A delivery apparatus for an expandable implantable medical device, comprising: An inner shaft; one or more release members, each release member having a proximal end coupled to an outer surface of the distal end portion of the inner shaft and a distal end configured to be releasably coupled to an implantable medical device disposed about the distal end portion of the inner shaft distal to where the proximal end couples to the inner shaft; The handle and Equipped with The handle portion a steering mechanism at a distal end portion of the delivery device configured to adjust the curvature of one or more shafts of the delivery device comprising the inner shaft and to flex the one or more shafts; a release mechanism configured to adjust the linear position of the inner shaft and one or more release members along a central longitudinal axis of the delivery device relative to an outer housing of the handle portion; Equipped with The release mechanism includes: a threaded drive screw coupled to a proximal end of the inner shaft, the threaded drive screw comprising a helically threaded portion disposed within a main body of the threaded drive screw, one or more grooves forming the helically threaded portion extending from the proximal end to the distal end of the main body of the threaded drive screw; a rotatable release knob coupled to the outer housing of the handle portion and surrounding and coaxial with the threaded drive screw; Equipped with the rotatable release knob includes one or more teeth disposed at a proximal end of the rotatable release knob and configured to interface with one or more of the grooves of the threaded drive screw, the threaded drive screw configured to translate linearly along the central longitudinal axis relative to the rotatable release knob in response to rotation of the rotatable release knob and sliding of the one or more teeth along the one or more grooves; A delivery device, wherein by actuating the steering mechanism to unflex one or more of the shafts of the delivery device, the threaded drive screw can be moved distally along the central longitudinal axis, thereby releasing tension generated in the distal end portion of the delivery device.

16. 16. The delivery device of claim 15, wherein each of the teeth of the one or more teeth of the rotatable release knob is not a full thread, but rather extends in a curved fashion of less than 45 degrees around the circumference of the proximal end of the rotatable release knob.

17. 17. The delivery device of claim 15, wherein the main body of the threaded drive screw further comprises one or more retaining elements disposed at the proximal end of the main body, and wherein each of the grooves of the one or more grooves of the helically threaded portion is coupled to a corresponding one of the one or more retaining elements and extends curvilinearly along an outer surface of the main body, extending from the retaining element to the distal end of the main body.

18. 18. The delivery device of claim 17, wherein the threaded drive screw is linearly movable between an initial locked configuration in which each tooth of the one or more teeth is coupled to a corresponding one of the one or more retaining elements and the entire helically threaded portion of the threaded drive screw is disposed within the rotatable release knob and the handle portion, and a released configuration in which each tooth is mated with a distal portion of a corresponding one of the one or more grooves and the distal portion is disposed closer to the distal end of the main body than the proximal end, and a majority of the helically threaded portion of the threaded drive screw extends axially outward from the proximal end of the rotatable release knob.

19. the threads formed by the one or more grooves of the helically threaded portion are double-start threads formed by two of the grooves; the rotatable release knob includes two teeth, each of which is configured to mate with and slide along a different one of the two grooves; two of the teeth are spaced apart from one another along the periphery of the proximal end of the rotatable release knob; 19. The delivery device of any one of claims 15 to 18, wherein the threads of the threaded drive screw have a lead in the range of 2.54 cm to 4.445 cm.

20. each of the one or more teeth of the rotatable release knob extends from the proximal end of the rotatable release knob toward the distal end of the rotatable release knob over only a portion of the total distance between the proximal end and the distal end; 20. The delivery device of any one of claims 15 to 19, wherein the portion is less than 1 / 10 of the total distance.

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