Release mechanism for a delivery device for an implantable medical device

Abstract

The present invention relates to a release mechanism for a delivery device for an implantable medical device, and discloses a release mechanism for a delivery device and a related method for operating the release mechanism. As an example, a handle portion of a delivery device may include a release mechanism configured to adjust the linear orientation of a component of the delivery device. The release mechanism may include a threaded drive screw, the drive screw including one or more retaining elements arranged at the proximal end of the drive screw and one or more grooves forming a helical threaded portion of the drive screw, each groove extending from a corresponding retaining element to a distal end of 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 arranged at the proximal end of the knob, each tooth being configured to engage with a corresponding retaining element and groove of the drive screw.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] 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. Technical Field

[0003] The present disclosure relates to embodiments of a release mechanism for a handle of a delivery apparatus for an implantable medical device, such as a prosthetic heart valve. Background Art

[0004] Delivery devices, such as intravascular delivery devices, are used in various surgeries to deliver prosthetic medical devices to locations inside the body that are not easily accessible by surgical operation or to locations that are desired to be accessible without surgical operation. Access to the target location in the body is achieved by inserting and guiding the delivery device through a pathway or lumen in the body, including but not limited to blood vessels, esophagus, trachea, any part of the gastrointestinal tract, lymphatic vessels (to name a few). The prosthetic medical device may include an expandable valve or instrument (e.g., a stent). In one specific example, an expandable artificial heart valve can be mounted in a radially compressed (or curled) state at the distal end of the delivery device and then deployed from the capsule of the delivery device at the implantation site so that the artificial valve can self-expand to its functional size.

[0005] In some embodiments, the delivery device may include an articulating portion having one or more steering mechanisms that allow a distal portion of the delivery device to articulate (e.g., bend or flex) when guided through the patient's vasculature. For example, it may be desirable for at least the distal portion of the delivery device to articulate on the aortic arch in order to deliver a prosthetic aortic valve disposed on the distal end of the delivery device to its intended implantation site. The delivery device may include multiple shafts having concentric lumens that can shorten or lengthen relative to each other when the distal portion of the delivery device articulates / flexes.

[0006] In some embodiments, after the distal portion of the delivery device is flexed to reach the target implant site, and while the distal portion remains flexed, the valve can be released from the delivery device by rotating the knob of the release mechanism of the delivery device. This results in linear motion (proximal, axial) of the inner shaft coupled to the release member that is releasably coupled to the valve. However, this linear translation of the concentric lumen causes the inner shaft to shorten upon flexion, thereby generating tension in the distal portion of the delivery device upon release. If the release mechanism is not unlocked (by a locking mechanism) to release this tension during release, the distal portion may be held under tension, thereby preventing the delivery device from being removed from the implant site.

[0007] Such locking mechanisms can complicate the implantation process and create tension issues that can make it difficult to remove the delivery device from the implantation site after the valve has been implanted.

[0008] Therefore, there is a need for an improved delivery device that can relieve the tension created during release of the valve from the delivery device before releasing the catheter. Summary of the Invention

[0009] Disclosed herein are embodiments of improved delivery devices for implantable medical devices (e.g., artificial heart valves), and related methods for implanting implantable medical devices into a patient's body using such devices. In some embodiments, the delivery device may include a handle portion that a user (e.g., a doctor, medical technician, etc.) can hold and use to operate the delivery device. In some embodiments, the handle portion may include a release mechanism configured to adjust the linear orientation of components of the delivery device, the handle portion including a rotatable knob and a drive screw disposed within the knob. The knob and drive screw may cooperate so that rotation of the knob results in linear translation of the drive screw and components of the delivery device. In some embodiments, the knob and drive screw may be configured to automatically release tension in the distal portion of the delivery device during the implantation process.

[0010] In one representative embodiment, a delivery device for an expandable, implantable medical device includes a handle portion including a release mechanism configured to adjust a linear orientation 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 including a helical threaded portion having a lead of at least one inch, wherein the helical threaded portion includes one or more grooves extending around the drive screw, the drive screw being coupled to the component; and a rotatable knob surrounding and coaxial with the drive screw, the knob including one or more teeth disposed at a proximal end of the knob, each of the one or more teeth being configured to engage a corresponding groove in the one or more grooves of the drive screw, wherein each of the one or more teeth extends from the proximal end to the distal end of the knob for only a portion of a total distance between the proximal and distal ends, wherein the portion is less than ¼ of the total distance.

[0011] In a representative embodiment, a method of implanting an implantable medical device using a delivery device includes: advancing a distal portion of the delivery device to a target implantation site using a handle portion of the delivery device, the implantable medical device being arranged to have a radially compressed configuration on the distal portion; and upon reaching the target implantation site, exposing the radially compressed implantable medical device and releasing the implantable medical device from the delivery device, the releasing comprising: from a starting position, rotating a knob of a release mechanism of the handle portion of the delivery device and moving one or more teeth of the knob along one or more corresponding grooves of a drive screw of the release mechanism to move the implantable medical device along the distal portion of the delivery device. The invention further comprises the steps of: linearly translating the drive screw in a proximal direction along an axis parallel to a central longitudinal axis of the delivery device until the drive screw reaches a release position; linearly translating an inner shaft fixedly coupled to the drive screw and one or more release members fixedly coupled to a distal portion of the inner shaft as and due to the drive screw translating in the proximal direction to release the implantable medical device from the delivery device; and actuating a steering mechanism of the delivery device to loosen the distal portion of the delivery device and passively retracting the drive screw in a distal direction, partially into a knob, to automatically release tension during loosening, the distal direction being opposite to the proximal direction.

[0012] In another representative embodiment, a method for operating a release mechanism of a handle portion of a delivery device configured to deliver an implantable medical device to a target implantation site includes: starting from a locked orientation of the release mechanism, in response to rotation of the knob, moving one or more teeth of a knob of the release mechanism along one or more corresponding grooves of a drive screw of the release mechanism to linearly translate the drive screw in a proximal direction along an axis parallel to a central longitudinal axis of the delivery device until the drive screw reaches the released orientation, wherein in the initial locked orientation, a body of the drive screw including the one or more grooves is disposed within an interior of the knob. and in a released position, a majority of the body extends outside the knob; when the drive screw translates in a proximal direction, linearly translates an inner shaft fixedly coupled to the drive screw and one or more release members fixedly coupled to the distal portion of the inner shaft to release the implantable medical device mounted on the distal portion of the delivery device from the delivery device; and in response to actuation of a steering mechanism of the delivery device, loosens the distal portion of the delivery device, and during the loosening, passively retracts the drive screw partially into the knob in a distal direction, thereby automatically releasing the tension in the distal portion of the delivery device and enabling the loosening to be achieved, wherein the distal direction is opposite to the proximal direction.

[0013] In another representative embodiment, a delivery device for an expandable, implantable medical device includes: an inner shaft; one or more release members, each release member including a proximal end coupled to an outer surface of a distal portion of the inner shaft and a distal end configured to releasably couple to an implantable medical device disposed about the distal portion of the inner shaft, the distal end being distal to where the proximal end is coupled to the inner shaft; and a handle portion including: a steering mechanism configured to adjust the curvature of one or more shafts of the delivery device at the distal portion of the delivery device and to flex the one or more shafts of the delivery device, the one or more shafts including the inner shaft; and a release mechanism, The invention relates to a device for adjusting the linear orientation of an inner shaft and one or more release members relative to a housing of a handle portion along a central longitudinal axis of a delivery device, the release mechanism comprising: a threaded drive screw coupled to a proximal end of the inner shaft and comprising a helical threaded portion disposed in a body of the drive screw, wherein one or more grooves forming the helical threaded portion extend from a proximal end to a distal end of the 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 comprising one or more teeth disposed at a proximal end of the knob and configured to engage with the one or more grooves of the drive screw. The drive screw is adapted to linearly move relative to the release knob along the central longitudinal axis in response to rotation of the release knob and sliding of the one or more teeth along the one or more grooves, and to actuate a steering mechanism to loosen the one or more shafts of the delivery device, allowing the drive screw to move distally along the central longitudinal axis to release tension generated in the distal portion of the delivery device.

[0014] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a side view of an exemplary embodiment of an implantable prosthetic heart valve that can be implanted using any of the delivery devices disclosed herein.

[0016] Figure 2 Is used for delivery Figure 1 Side view of an exemplary embodiment of a delivery device for a prosthetic heart valve.

[0017] Figure 3 yes Figure 2 A side cross-sectional view of a distal portion of a delivery device showing a prosthetic valve contained in a compressed state within a delivery capsule.

[0018] Figure 4 yes Figure 2 1. Side view of a distal portion of a delivery device showing a capsule of the delivery device being advanced over a portion of a prosthetic heart valve frame.

[0019] Figure 5 yes Figure 2 Side view of the handle portion of the delivery device.

[0020] Figure 6 yes Figure 5 A side view of the handle portion of FIG. 1 with half of the housing of the handle portion removed to reveal the internal components of the handle portion.

[0021] Figure 7 yes Figure 2 A side cross-sectional view of a handle portion of a delivery device showing a portion of the internal components of the handle portion.

[0022] Figure 8 is a side cross-sectional view of a portion of a handle portion of a delivery device including a locking mechanism for a valve release mechanism of the handle portion, according to an embodiment.

[0023] Figure 9 Such as Figure 2 A side view of a distal portion of a delivery device of a delivery device in a starting configuration prior to release of a prosthetic heart valve from the delivery device.

[0024] Figure 10 yes Figure 9 Side view of a distal portion of a delivery device in a released configuration after the prosthetic heart valve is released from the delivery device.

[0025] Figure 11 is an exemplary schematic illustration of a distal portion of a delivery apparatus articulated about a simulated aortic arch en route to a target implantation site for a prosthetic medical device disposed on the distal portion.

[0026] Figure 12 is a side view of an embodiment of a handle portion of a delivery device, the handle portion including a release mechanism configured to automatically release tension in a distal portion of the delivery device.

[0027] Figure 13 yes Figure 12 A side cross-sectional view of the handle portion of FIG. 1 with the release mechanism in an initial, locked configuration.

[0028] Figure 14 yes Figure 12 Side view of the handle section with the steering mechanism knob and release mechanism cover removed.

[0029] Figure 15 yes Figure 14 A side cross-sectional view of the handle portion of FIG. 1 , showing the release mechanism in an initial, locked configuration.

[0030] Figure 16 yes Figure 12Side view of the handle portion of a 2011 Ford F-150 with the steering mechanism knob removed and showing the release mechanism in the released configuration.

[0031] Figure 17 yes Figure 16 A side cross-sectional view of the handle portion of FIG. 1 , showing the release mechanism in the released configuration.

[0032] Figure 18 yes Figure 16 Another side cross-sectional view of the handle portion of the device, showing the release mechanism in the released configuration.

[0033] Figure 19 yes Figure 12 A perspective cutaway view of a portion of the release mechanism of the handle portion showing the end-of-travel feature of the release mechanism.

[0034] Figure 20 yes Figure 16 Side view of the handle portion of the delivery device showing the release mechanism in a partially retracted configuration while automatically releasing tension during an implantation procedure using the delivery device.

[0035] Figure 21 It's viewed from a distance Figure 12 A perspective view of the rotatable knob of the release mechanism.

[0036] Figure 22 yes Figure 21 A side sectional view of the knob.

[0037] Figure 23 yes Figure 21 Close-up view of the knob.

[0038] Figure 24 yes Figure 21 A top perspective view of the knob.

[0039] Figure 25 It's from the near side Figure 21 Perspective view of the knob.

[0040] Figure 26 yes Figure 12 A perspective view of the drive screw of the release mechanism.

[0041] Figure 27 yes Figure 26 Top view of the drive screw.

[0042] Figure 28 yes Figure 26 Proximal view of the drive screw.

[0043] Figure 29 It is along Figure 28 A side cross-sectional view of the drive screw taken at section AA.

[0044] Figure 30 yes Figure 26 Side view of the drive screw.

[0045] Figure 31 It is along Figure 30 Section BB is a cross-sectional view of the first end of the drive screw.

[0046] Figure 32 It is along Figure 30 A cross-sectional view of the second end of the drive screw taken at section CC.

[0047] Figure 33 yes Figure 26 Distal view of the drive screw.

[0048] Figure 34 The handle portion used to operate the delivery device (e.g. Figure 12 Flowchart of a method for delivering a prosthetic medical device to a target implantation site (with a handle portion). DETAILED DESCRIPTION

[0049] General Considerations

[0050] For the purposes of this specification, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The described methods, systems, and devices should not be construed as limiting in any way. On the contrary, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, individually and in various combinations and subcombinations with each other. The disclosed methods, systems, and devices are not limited to any particular aspect, feature, or combination thereof, nor are the disclosed methods, systems, and devices required to have any one or more specific advantages or to solve any one or more specific problems.

[0051] Features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the disclosure are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings) and / or all steps of any method or process so disclosed may be combined in any combination unless at least some of such features and / or steps in a combination are mutually exclusive. The disclosure is not limited to the details of any foregoing embodiments. The disclosure extends to any novel feature or any novel combination of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel step or any novel combination of the steps of any method or process so disclosed.

[0052] Although the operations of some disclosed methods are described in a specific, sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a specific ordering. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not illustrate the various ways in which the disclosed methods, systems, and devices can be used in conjunction with other systems, methods, and devices.

[0053] As used herein, the terms "a," "an," and "at least one" include one or more of the specified elements. That is, if two of a particular element are present, then one of those elements is also present, therefore, there is "one" element. The terms "plurality" and "plurality" refer to two or more of the specified elements.

[0054] As used herein, the term "and / or" used between the last two of a list of elements refers to 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."

[0055] As used herein, the term "coupled" generally means a physical connection or link and does not exclude the presence of intervening elements between the coupled items absent specific language to the contrary.

[0056] Directional and other relative references (e.g., inside, outside, up, down, etc.) may be used to facilitate the discussion of the figures and principles herein but are not intended to be limiting. For example, certain terms such as "inside," "outside," "top," "downward," "inside," "outside," etc. may be used. Where applicable, such terms are used to provide some clarity when dealing with relative relationships, particularly with respect to the illustrated embodiments. However, these terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the "upper" portion can become the "lower" portion simply by turning the object over. Nevertheless, it is still the same part and the object remains unchanged. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0057] As used herein, with respect to artificial heart valves and delivery devices, "proximal" refers to the orientation, direction, or portion of a component outside the patient's body that is closer to the user and / or the handle of the delivery device, while "distal" refers to the orientation, direction, or portion of a component that is farther away from the user and / or the handle of the delivery device and closer to the implantation site. Unless expressly defined otherwise, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions. Additionally, the term "radial" refers to directions arranged perpendicular to an axis and pointing along a radius toward the center of an object (where the axis is at the center, such as the longitudinal axis of an artificial valve).

[0058] Examples of Disclosed Technologies

[0059] This article describes examples of delivery devices that can be used to deliver implantable, expandable medical devices such as artificial heart valves to target implant sites in a patient's body. 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 portion of the delivery device in a radially compressed configuration. For example, a delivery capsule can be coupled to the outer shaft of the delivery device at the distal portion and cover and maintain the implantable medical device in a radially compressed state thereon. The handle portion can include a housing and one or more buttons and / or knobs that can be actuated by a user and configured to adjust the operation of the delivery device during the implantation process. In some embodiments, the handle portion can include a manipulation knob that is configured to adjust the curvature of one or more shafts of the delivery device at the distal portion of the delivery device, thereby allowing the implantable medical device to be delivered by bending the patient's body cavity.

[0060] In some embodiments, the handle portion may include a valve release mechanism configured to adjust the linear orientation of one or more components of the delivery device (along the central longitudinal axis of the delivery device) and automatically relieve tension generated at the distal portion of the delivery device during bending of the distal portion and linear adjustment of the orientation of one or more components at the distal portion. For example, in some embodiments, the control mechanism is configured to adjust the linear orientation 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 the 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 through a mating connection between one or more grooves in the drive screw and one or more teeth in the knob. The drive screw can be coupled to an inner shaft, which is coupled to one or more release members. Thus, linear movement of the drive screw can cause simultaneous linear movement of the inner shaft and one or more release members. The pitch and lead of the threads of the drive screw (formed by the one or more grooves) can be relatively long, while the length of the teeth of the knob can be relatively short. As a result, after the release member is separated from the implantable medical device, by manually rotating the release mechanism knob, and when the distal portion of the delivery device is loosened (e.g., by a steering mechanism), the drive screw can be passively translated in the distal axial direction and retracted into the knob, thereby relieving tension at the distal portion of the delivery device and facilitating loosening. As a result, the delivery device can be more easily removed from the implant site and the entire implantation process using the delivery device can be simplified.

[0061] In some embodiments, the delivery device is configured to deliver and implant a prosthetic heart valve at a selected implantation site within a patient's body (e.g., within a native aortic valve, mitral valve, tricuspid valve, or pulmonary valve), e.g. Figure 1 In addition to prosthetic heart valves, the disclosed delivery apparatus may 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), embolization coils, and the like; to position imaging devices and / or components thereof, including ultrasound transducers; and to position energy sources, such as devices for performing lithotripsy, RF sources, ultrasound transmitters, electromagnetic sources, laser sources, heat sources, and the like.

[0062] Figure 1 A prosthetic heart valve 10 according to one embodiment is shown, which may be implanted via a delivery device, such as Figure 2 In some embodiments, the prosthetic heart valve is a self-expanding valve that is delivered to the deployment site via a delivery device in a radially compressed state. Figure 2 When a delivery capsule at the distal end of a delivery device (e.g., a delivery device) is advanced, the prosthetic valve can radially self-expand to its functional size.

[0063] The prosthetic heart valve 10 includes a stent or frame 12 and a valve-shaped structure 14 (e.g., leaflets or a flap valve) supported by the frame 12. The frame 12 may have a plurality of interconnected struts 16 arranged in a lattice-like pattern and forming a plurality of vertices 18 at an inflow end 20 and an outflow end 22 of the frame 12, respectively.

[0064] The frame 12 may include a plurality of angularly spaced apart posts 24 extending from respective vertices 18 at the outflow end of the frame 12. The frame 12 in the illustrated embodiment includes three such posts 24, although a greater or lesser number of posts may be used. In one embodiment, the frame 12 may have posts 24 extending from all of the vertices 18 at the outflow end 22 of the frame 12. Each post 24 may have an eyelet or orifice 26 that may be used to form a releasable connection with a delivery device (e.g., delivery device 100), such as by using one or more ropes or tethers 118 (e.g., see Figure 3 ) to form a releasable connection, as further described below.

[0065] In some embodiments, the frame 12 may not have the post 24 and the orifice 26 may be formed in the apex 18 at the outflow end 22 of the frame 12. Figure 3In the embodiment shown in FIG, an orifice is formed at the outflow end of the frame so that when loaded within the delivery device 100, a releasable connection can be formed between the tether manifold 120 and the outflow end 22 of the frame 12 via the tether 118, as further described below. This arrangement facilitates delivery of the prosthetic valve 10 to the native aortic valve using a retrograde delivery approach, whereby the delivery device 100 is advanced through the femoral artery and aorta to access the native aortic valve.

[0066] In other embodiments, the orifice 26 (whether formed in the post 24 or the apex 18) can be formed at the inlet (or inflow) end 20 of the frame 12, where other delivery device configurations or other delivery techniques require an orifice at the inlet end of the frame, such as a transapical delivery approach. In further embodiments, the delivery device 100 can include a tether manifold 120 positioned distal to the prosthetic valve when loaded within the delivery device, wherein the tether manifold is coupled to the inlet (or inflow) end 20 of the frame.

[0067] In certain embodiments, the prosthetic heart valve 10 is a self-expanding heart valve in which the frame 12 is made of a superelastic, self-expanding material known in the art (e.g., a nickel-titanium alloy such as Nitinol). Figure 2 ), the prosthetic valve 10 can self-expand from a radially compressed state to a radially expanded state when advanced from a delivery capsule (e.g., a delivery sheath) of a delivery device.

[0068] In other embodiments, the frame 12 can be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, cobalt-chromium alloy, etc.), and the artificial heart valve can be expanded from a radially compressed state to a radially expanded state by inflating a balloon of the delivery device or by actuating other expansion devices of the delivery device and producing radial expansion of the artificial valve.

[0069] The petal-shaped structure 14 may include a plurality of leaflets 28. The petal-shaped structure typically includes three leaflets 28 arranged in a tricuspid arrangement, but a greater or lesser number of leaflets 28 may be used. The leaflets 28 may be made of any of a variety of suitable materials, including natural tissue (e.g., bovine pericardium or pericardium from other sources) or synthetic materials (e.g., polyurethane). Adjacent side portions at the outflow edges (upper edges in the figure) of adjacent leaflets may be secured to each other to form commissures 30 of the petal-shaped structure, which may be secured to the frame with sutures 32.

[0070] The artificial valve 10 may also include an inner skirt 34 mounted on the inside of the frame 12. The skirt 34 helps to establish a seal with the surrounding tissue after implantation. The skirt 34 can also be used to mount portions of the leaflet 28 to the frame 12. For example, in the illustrated embodiment, the inflow edge of the leaflet (the lower edge in the figure) can be sutured to the skirt 34 along sutures 36. The skirt 34 can be directly connected to the frame 12, for example with sutures. Although not shown, the artificial valve 10 may include an outer skirt mounted on the outside of the frame to replace the inner skirt 34 or to be installed together with the inner skirt 34 to further seal the artificial valve relative to / against the surrounding tissue. The inner skirt and / or outer skirt can be made of any of a variety of suitable materials, including any of natural tissue (e.g., pericardial tissue) or various synthetic materials, which can be woven, non-woven, braided, knitted and / or a combination thereof. In a specific embodiment, the inner skirt 34 is made of polyethylene terephthalate (PET) fabric.

[0071] 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, the disclosures of which are incorporated herein by reference.

[0072] The artificial heart valve 10, or another type of implantable, expandable medical device, such as an expandable stent, can be delivered to the implantation site by a delivery device, an example of which is shown in FIG. Figure 2 middle.

[0073] Figure 2-7 An exemplary embodiment of a delivery apparatus 100 is shown that can be used to deliver a prosthetic medical device, (e.g., Figure 1 In some embodiments, the handle portion 132 of the delivery device 100 may include a locking mechanism for a release mechanism of a release assembly of the delivery device 100, such as Figure 8 An exemplary distal portion of a release assembly that may be used with the delivery device 100 is shown in FIG. Figure 9 and Figure 10 middle.

[0074] like Figure 2As shown, the delivery device 100 may include a handle portion 132 and a first shaft 134 extending distally from the handle portion. A user, such as a physician or clinician, may operate the delivery device 100 by actuating a plurality of knobs 136, dials, and / or buttons 138a, 138b located on the handle portion 132. The first shaft 134 has a proximal portion 140 and a distal portion 142. The proximal portion 140 of the first shaft 134 may be coupled to the handle portion 132. The handle portion 132 may include a housing 133. In some embodiments, the housing 133 may include two housing portions.

[0075] like Figure 3 As shown, 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 passes through the first shaft 134. The third shaft 152 extends distally from the handle portion 132 and coaxially with the second shaft 150. In the illustration, the first shaft 134 is the outermost shaft of the delivery device 100 and, therefore, may be referred to as the outer shaft 134 of the delivery device 100. In the illustrated embodiment, the first shaft 134 is the outermost shaft of the delivery device 100 and, therefore, may 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, therefore, may be referred to as the inner shaft 152 of the delivery device 100. In the illustrated embodiment, the second shaft 150 is located between or intermediate the innermost and outermost shafts and, therefore, may be referred to as an intermediate shaft.

[0076] The nose cone 144 can be connected to or mounted on the distal end portion 152d of the inner shaft 152. The nose cone 144 can have a tapered outer surface as shown to facilitate atraumatic tracking of the delivery device 100 through the patient's vasculature. The inner shaft 152 extends distally beyond the intermediate shaft 150, through the lumen of the tether manifold 120, and through the prosthetic valve 10.

[0077] In certain embodiments, the first shaft 134, the second shaft 150, and the third shaft 152 can each be configured to be movable relative to one another, including relative axial movement (in proximal and distal directions) and / or relative rotational movement (in clockwise and counterclockwise directions). Figure 4 ) can extend through the central lumen of the inner shaft 152 and the lumen of the nose cone 144 so that the delivery device 100 can be advanced over a guidewire 154 within the patient's vasculature during delivery of the prosthetic valve 10 to the target implantation site. The guidewire 154 can be passed through a proximal port 155 ( Figure 5 ) leaves the inner shaft 152. Figure 5 and Figure 8 As shown, the cap 157 can be coupled to the end of the drive screw 161 of the release mechanism 200 of the delivery device 100 (as described below with reference to FIG. Figure 8-10 further described).

[0078] The delivery capsule 146 is coupled to the distal portion 142 of the first shaft 134 proximate the nose cone 144. The delivery capsule 146 holds the prosthetic valve 10 therein in a radially compressed state, such as Figure 3-4 In one embodiment, the delivery capsule 146 covers and holds Figure 1 The delivery device 100 is particularly suitable for delivering and implanting a self-expanding prosthetic valve 10 that, when deployed from the delivery capsule 146, radially expands to its functional size under its own elasticity.

[0079] Alternatively, however, the artificial heart valve 10 can be a plastically expandable artificial valve or a mechanically expandable heart valve. If the delivery device is for implanting a plastically expandable valve, the delivery device may include a balloon catheter known in the art for expanding an artificial valve, such as disclosed in U.S. Publication No. 2009 / 0281619, which is incorporated herein by reference. If the delivery device is for implanting a mechanically expandable valve, the delivery device may include one or more actuators for expanding the artificial valve, such as disclosed in International Application No. PCT / US2020 / 063104, which is incorporated herein by reference.

[0080] like Figure 3 As shown, the delivery capsule 146 is configured to contain the prosthetic heart valve 10 or another type of implantable medical device in a radially compressed state for delivery to the patient's vasculature. The tether manifold 120 is configured to be connected to the patient's vasculature by a plurality of tethers or ropes 118 ( Figure 3 ) forms a releasable connection with the prosthetic heart valve 10. The tether manifold 120 is coupled to the distal end of the first shaft 134, which is proximate to each of the nose cone 144 and the crimped prosthetic valve 10.

[0081] like Figure 3 As shown, the tether manifold 120 can include a proximal portion 122 and a distal portion 124, with the distal portion 124 being axially spaced apart from the proximal portion 122. The proximal portion 122 of the tether manifold 120 can be fixedly coupled to the distal portion 142 of the first shaft 134 using a suitable technique or mechanism, such as a mechanical connector, welding, press fit, and / or adhesive. For example, in some embodiments, the distal portion 142 of the shaft 134 can extend into the lumen of the proximal portion 122, and the proximal portion 122 can be coupled to the shaft 134 using any of the connection techniques described above.

[0082] The tether 118 can be made of any of a variety of suitable biocompatible materials for use within a patient. In certain embodiments, the tether 118 can include a monofilament tether or a multifilament or multi-strand tether formed by weaving, braiding, knitting, twisting, or twisting together multiple filaments or strands. The filaments or strands can include polymer fibers such as ultra-high molecular weight polyethylene, nylon, polyester, and / or aramid, or flexible wires (e.g., metal wires).

[0083] Each tether 118 can have a first end 118a that is attached to the tether manifold 120 (e.g., to the proximal portion 122). Each tether 118 extends through an opening in the frame 12 of the prosthetic valve (e.g., through the opening 26) and can have a second end 118b that is in the form of a loop that is retained on a release member 156. The release member 156 is configured to maintain the tethers 118 in a state connected to the frame 12 of the prosthetic valve 10 until they are actuated by the user to release the tethers 118. Two release members 156 are shown for illustrative purposes. It should be understood that any number of release members 156 can be used.

[0084] Similarly, two tethers 118 are shown for illustrative purposes, but it should be understood that any number of tethers may be used. Likewise, the same number of tethers and release members 156 is not required. For example, the ends 118b of multiple tethers 118 may be retained on a single release member 156. Ideally, at least three tethers 118 are used to balance the attachment of the frame 12 to the tether manifold 120. In certain embodiments, the number of tethers 118 is equal to the number of tethers 118 in the prosthetic valve 10 ( Figure 1 ) of the frame 12. Additionally, in other embodiments, a single tether can be used to connect the frame 12 to the tether manifold 120 at multiple locations along the outflow end of the frame by forming multiple passageways extending through the frame opening.

[0085] Each release member 156 can slidably extend through the tether manifold 120 ( Figure 3 ) in the proximal and distal portions 122, 124 of the delivery device 100. In some embodiments, each release member 156 can extend through the first shaft 134 along its entire length and can have a proximal end portion operably coupled to the knob 136 on the handle portion 132 to control the movement of the release member 156. In alternative embodiments, each release member 156 can have a proximal end coupled to an outer surface of the third shaft 152 of the delivery device 100.

[0086] Each release member 156 is movable in proximal and distal directions relative to the proximal and distal portions 122, 124 of the tether manifold between a distal position in which each release member 156 retains a corresponding tether 118 and a proximal position in which each release member 156 is released from the corresponding tether 118. The knob 136, release members 156, and tether manifold 120 may together form a release assembly of the delivery device 100, as described below with reference to Figure 8 Further described (e.g., the release mechanism 200 of the release assembly disposed within the handle portion 132) Figure 8 shown in ).

[0087] Further details regarding the attachment of the prosthetic valve 10 to the delivery device 100 via one or more tethers or sutures are disclosed in U.S. Publication Nos. 2014 / 0343670, 2012 / 0239142, and 2010 / 0049313, and International Application No. PCT / US2020 / 024130, all of which are incorporated herein by reference.

[0088] Furthermore, in alternative embodiments, different valve retention mechanisms can 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 can be retained in corresponding recesses of a shaft or retention member of the delivery device, which allows the posts of the frame to expand out of their corresponding recesses when the capsule 146 is retracted to deploy the prosthetic valve. In other embodiments, the retention mechanism can include an inner metal fork member and an outer metal fork member that form a releasable connection between the delivery device and the prosthetic valve. Further details regarding alternative valve retention mechanisms are disclosed in U.S. Publication Nos. 2012 / 0239142 and 2010 / 0049313.

[0089] like Figure 3 As further shown, the second shaft 150 may include an externally threaded portion 162 along its distal end. The threaded portion 162 may include threads formed on the outer surface of the shaft or may be a separate screw connected to the distal end of the proximal shaft section. The capsule 146 is operably connected to the second shaft 150 by an internally threaded nut 164 disposed on the threaded portion 162. The nut 164 may have radially extending protrusions 166 (see FIG. 1 ) that extend into corresponding openings in the capsule 146. Figure 2 The rotation of the nut 164 is limited by one or more tracks 165 extending from or formed along the distal portion of the first shaft 134 .

[0090] Thus, the rotation of the second shaft 150 relative to the first shaft 134 produces axial movement (in the distal and proximal directions) of the nut 164, which in turn produces corresponding axial movement of the capsule 146 in the same direction during loading, deployment and / or recapture of the artificial valve. For example, when the nut 164 is in the distal position, the delivery capsule 146 extends over the artificial valve 10 and holds the artificial valve 10 in a compressed state for delivery. The movement of the nut 164 in the proximal direction causes the delivery capsule 146 to move in the proximal direction, thereby deploying the artificial valve. The rotation of the second shaft 150 can be achieved by a motor and / or manual control feature operably coupled to the second shaft, as described further below.

[0091] In certain embodiments, the delivery device 100 may include one or more steering mechanisms configured to control the curvature of one or more of the shafts 134, 150, 152 to assist in steering the delivery device through the patient's vasculature. For example, the steering mechanism may include one or more eccentrically positioned pull wires extending through the shaft and operably connected to an adjustment mechanism, such as one located at a position adjacent to the delivery device. Figure 2 The outer shaft 134 is provided with a steering knob 418 on or near the handle portion 132. Adjustment of the adjustment mechanism is effective to change the tension of the pull wires, thereby bending or straightening the shaft in a given direction. In one embodiment, one or more pull wires extend through the outer shaft 134, and adjustment of the adjustment mechanism is effective to adjust the curvature of the distal portion of the outer shaft 134 and the delivery device 100. Further details regarding the steering mechanism are disclosed in U.S. Publication Nos. 2007 / 0005131 and 2013 / 0030519, which are incorporated herein by reference.

[0092] In certain embodiments, as Figure 6-8 As shown, the delivery device 100 is a motorized device that includes a motor 168 housed within the handle portion 132. The motorized embodiment automates the deployment of the prosthetic valve 10. In particular, the motor 168 is operably coupled to the second shaft 150 to produce rotation of the second shaft 150 relative to the first shaft 134 and corresponding axial movement of the capsule 146, as further described below.

[0093] The proximal portion 140 of the first shaft 134 can be coupled to the distal end of the handle portion 132. Figure 6 As shown, the proximal end portion 151 of the second shaft 150 can extend into the handle portion 132 through the distal opening 170 of the handle portion 132. A rotatable member 172 (which may be referred to as a drive cylinder in some embodiments) is disposed within the handle portion 132 and operably coupled to the second shaft 150.

[0094] In one embodiment, Figure 7As best shown, the proximal portion of the rotatable component 172 includes a gear 174 having a plurality of gear teeth 176 arranged circumferentially relative to each other. The rotatable component 172 also includes a body 178 configured as an extended shaft having an inner cavity 173. In the illustrated embodiment, the body 178 and the gear 174 are integrally formed, but they can be separately formed components that are connected to each other by any of a variety of attachment means. The body 178 of the rotatable component 172 can be aligned with the central longitudinal axis LL' (e.g., Figure 5 150 and 151. As shown in FIG, the proximal end portion 151 of the second shaft 150 is coaxial with the first shaft 134. The lumen 173 of the body 178 can be sized to receive and retain the proximal end portion 151 of the second shaft 150 therein.

[0095] In some embodiments, the inner surface of lumen 173 can have a non-circular cross-section in a plane perpendicular to longitudinal axis LL', and the proximal portion 151 of second shaft 150 can have a similar cross-sectional profile that corresponds to the shape of the lumen, such that rotational motion of rotatable member 172 is transmitted to second shaft 150. For example, lumen 173 and proximal portion 151 can be generally cylindrical with a series of circumferentially spaced flat sections. Instead of or in addition to providing lumen 173 and proximal portion 151 with non-circular cross-sections, proximal portion 151 can be coupled to the rotatable member using a fastening device, such as a mechanical fastener (e.g., a screw), an adhesive, a press fit, a snap-fit ​​connection, etc.

[0096] like Figure 6 As best shown, the motor 168 can be retained within a retaining box or bracket 190. The motor can be an electric motor and the handle portion can include a battery compartment containing one or more batteries (not shown) for powering the motor 168. One or more operating buttons 138a, 138b on the handle portion 132 allow the user to activate the motor 168, for example by electrically coupling current from a battery power source to the motor. As described below, the motor can be rotated in either direction, thereby moving the capsule 146 in a proximal or distal direction. One button (e.g., button 138a) can be operable to rotate the motor in a first rotational direction to move the capsule 146 in a distal direction, for example, for loading an artificial valve into the capsule 146, while another button (e.g., button 138b) can be operable to rotate the motor 168 in a second rotational direction to move the capsule 146 in a proximal direction, for example, for deploying an artificial valve. Instead of or in addition to one or more batteries, the motor 168 can be configured to receive a power tether that provides current to the motor from a power source external to the handle portion 132 (eg, a wall outlet).

[0097] like Figure 7As best shown, the motor 168 can be coupled to the rotatable member 172 via a drive shaft 184 connected to a motor shaft 188 and an intermediate drive gear 182 connected to the drive shaft 184. The drive gear 182 can have circumferentially arranged gear teeth 192 that can mesh with the circumferentially arranged gear teeth 176 of the rotatable member 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 meshes with and rotates the gear 174 of the rotatable member 172, thereby rotating the rotatable member 172 and the second shaft 150. The drive gear 182 can be positioned radially offset from the central axis of the rotatable member 172 and the central longitudinal axis LL' of the handle portion 132 so that when engaged, the gears are vertically aligned. In further embodiments, one or more additional gears can be provided between the drive gear 182 and the rotatable member 172 to transfer rotation from the motor to the rotatable member.

[0098] In an alternative embodiment, the motor shaft 188 or the drive shaft 184 can be connected to the rotatable member 172 without any intermediate gears. For example, the motor shaft 188 can be positioned proximal to the rotatable member along the axis LL' and the motor shaft 188 can be connected to the rotatable member 172 in a direct drive arrangement.

[0099] In the illustrated embodiment, the bracket 190 housing the motor 168 and the drive shaft 184 may also be configured to support the rotatable member 172 for rotational movement within the handle portion. Figure 6 As best shown, bracket 190 can have a first distal portion 194 including a distal sleeve 195 that surrounds a distal portion of body 178 of rotatable member 172. Bracket 190 can also have a proximal portion 196 including a proximal sleeve 197 that surrounds a proximal portion of body 178 of rotatable member 172.

[0100] refer to Figure 3 and Figure 7 , rotation of the motor 168 in a first direction (e.g., clockwise or counterclockwise) causes rotation of the rotatable member 172. This, in turn, causes rotation of the second shaft 150 coupled to the rotatable member 172. The rotation of the second shaft 150 causes rotation of the threaded portion (screw) 162 of the second shaft 150. As described above, the rotation of the threaded portion 162 produces a rotation of the drive nut 164 and the capsule 146 ( Figure 3) axial movement. For example, rotation of the rotatable member in a first direction can cause the delivery capsule 146 to retract in a proximal direction and expose the prosthetic valve at the distal end of the delivery device 100. Conversely, rotation of the motor in a second direction opposite to 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, causing the delivery capsule 146 to move in a distal direction back over the prosthetic valve. The operator can actuate buttons 138a, 138b ( Figure 2 and Figure 6 ) to actuate the motor 168 and axially move the delivery capsule 146 in a motorized manner. This allows for rapid deployment or retrieval of the prosthetic valve 10.

[0101] In use, the prosthetic valve 10 can be connected to the delivery device 100 and loaded into the capsule 146 as described below. A releasable connection can be formed between each vertex 18 at one end of the frame 12 and a tether manifold 120 having a separate tether 118. Optionally, the length of the tether 118 is selected so that the fixed end of the frame is maintained in a state of at least partial radial compression by the tether. After the end of the frame 12 is secured with the tether 118, the delivery capsule 146 can be advanced distally over the tether manifold 120, the tether 118, and the frame 12 (e.g., by pressing the button 138a), thereby causing the frame to fold into a state of radial compression under the force of the capsule 146 (e.g., Figure 4 ). The delivery capsule 146 is advanced distally until the distal end of the delivery capsule 146 abuts the nose cone 144 to completely surround the prosthetic valve 10, as shown. Figure 3 shown.

[0102] As described above, after the prosthetic heart valve 10 is loaded into the delivery device 100, the delivery device 100 can be inserted into the patient's vasculature and advanced or navigated through the patient's vasculature to the desired implantation site (e.g., through the femoral artery and aorta when delivering the prosthetic valve 10 to the native aortic valve in a retrograde delivery method).

[0103] Once the prosthetic valve 10 is delivered to the selected implantation site (e.g., the native aortic valve) in the patient, the delivery capsule 146 can be retracted (e.g., by pressing the button 138b) to deploy the prosthetic valve 10. Figure 4 ), the prosthetic valve 10 can radially self-expand under the elasticity 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 12 by the tether 118. While still attached to the delivery device 100, the user can manipulate the delivery device (e.g., by moving it in the proximal and distal directions and / or rotating it) to adjust the orientation of the prosthetic valve 10 relative to the desired implantation location.

[0104] If desired, the delivery capsule 146 can be advanced backward over the prosthetic valve 10 to fully or partially recapture the prosthetic valve (bring the prosthetic valve back into the capsule) to facilitate repositioning of the prosthetic valve. For example, after passing through the native aortic valve leaflets and deploying the prosthetic valve in a retrograde delivery approach, it may be necessary to recapture the prosthetic valve back into the capsule 146, retract the delivery device 100 to bring the prosthetic valve back into the aorta, and then advance the prosthetic valve through the native aortic valve leaflets and deploy the prosthetic valve from the capsule.

[0105] Once the prosthetic valve is deployed from capsule 146 and positioned at the desired implantation location, release member 156 can be retracted, for example, by rotating knob 136 on handle portion 132. In some cases, tether 118 slides outward from orifice 26 and releases itself from frame 12 due to further expansion of self-expanding frame 12 as release member 156 is retracted. In other cases, the user can slightly retract delivery device 100, which in turn pulls tether 118 proximally relative to frame 12 to pull the tether out of orifice 26.

[0106] Optionally, the orientation of the artificial valve can be reversed so that the inflow end of the artificial valve is the proximal end and the outflow end of the artificial valve is the distal end when coupled to the delivery device. This can facilitate the delivery of the artificial valve to different implantation locations (e.g., native aortic, pulmonary, mitral and tricuspid annuli) and / or for various delivery methods (e.g., antegrade, transseptal, transventricular, transatrial). Further details of the components and operation of a delivery device for delivering a prosthetic medical device (e.g., a prosthetic heart valve) to a target location are disclosed in International Patent Application No. PCT / US2021 / 023696, which is incorporated herein by reference.

[0107] Figure 8 A portion of an embodiment of a handle portion 132 of a delivery device 100 is shown, which includes a release mechanism 200 comprising 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 via control of a release member 208, which in some embodiments can be the same as or similar to release member 156, as described above with reference to FIG. Figure 3 The release mechanism 200 and the release member 208 can together form a release assembly of the delivery device 100 . Figure 9 and Figure 10 An embodiment of a distal portion of a release assembly of the delivery device 100 is shown, the release assembly including a release member 208 .

[0108] As described above, the delivery device 100 may include an inner shaft 152 having an inner guidewire lumen configured to receive a guidewire (e.g., guidewire 154) therein. The inner shaft 152 may be releasably connected at its proximal end to a drive screw 161 ( Figure 8 ) and connected at its distal end to the valve release member 208 ( Figure 9 and Figure 10 ). Thus, as further described below, axial movement of the inner shaft 152 can cause the release member 208 ( Figure 9 and Figure 10 ) axial movement.

[0109] like Figure 8 As shown, release mechanism 200 may include a drive screw 161 disposed within and engaged with a knob (release knob) 136. Cap 157 is coupled to the proximal end of drive screw 161. Locking mechanism 202 may be coupled to the proximal end of drive screw 161 and disposed within a portion of cap 157. Locking mechanism 202 may be rotated by knob 204 (which may be manually actuated by a user). For example, rotation of knob 204, and therefore rotation of locking mechanism 202, may cause washer 206 to clamp onto (in a locked position) and disengage (in an unlocked position) the outer surface of inner shaft 152. Washer 206 may be fixedly coupled to drive screw 161 and, therefore, may move axially with axial translation of drive screw 161. Thus, when release mechanism 200 is locked to inner shaft 152, rotation of knob 136, which causes axial translation of drive screw 161, causes axial translation of inner shaft 152.

[0110] like Figure 9 and Figure 10 As shown, the inner shaft 152 can extend to and / or into the nose cone 144. The spool 212 can be coupled (e.g., fixedly coupled) to a portion of the outer surface of the inner shaft 152, and the proximal end of the release member 208 can be coupled to the spool 212. Figure 3 As described, the distal end of release member 208 can be removably coupled to a coupling element (eg, a tether, rope, suture, etc.) that is coupled to the prosthetic heart valve.

[0111] Figure 9 The distal portion of the release assembly is shown in a starting configuration prior to releasing the prosthetic heart valve from the delivery device 100. For illustrative purposes, the prosthetic heart valve is not shown in FIG. Figure 9 and Figure 10 However, as Figure 9 As shown, the distal end of release member 208 can be in a position that couples the valve to delivery device 100 (eg, prevents axial movement of the valve relative to delivery device 100). In this configuration, locking mechanism 202 can be in a locked state.

[0112] After the distal portion of the delivery device 100 containing the prosthetic heart valve reaches the target implantation site, the prosthetic heart valve can be deployed by moving the capsule 146 away from the valve to expose the valve. The knob 136 can then be rotated to axially move the inner shaft 152 in the proximal direction 214 (toward the handle portion 132), thereby retracting the release member 208 away from the prosthetic heart valve.

[0113] As used herein, "proximal direction" may refer to a direction of movement or travel along an axial direction parallel to the central longitudinal axis of the delivery device toward the handle portion of the delivery device or the user, while "distal direction" may refer to a direction of movement or travel along the axial direction opposite to the proximal direction, i.e., away from the handle portion and closer to the target implantation site.

[0114] Figure 10 The distal portion of the release assembly is shown in a retracted (e.g., released) configuration after the prosthetic heart valve is released from the delivery device 100. In this configuration, the inner shaft 152 has been translated proximally, thereby translating the spool 212 proximally. In some embodiments, as Figure 10 As shown, spool 212 may come into contact with spool stop 216 , which prevents further axial movement of spool 212 and release member 208 in proximal direction 214 .

[0115] The spool stop 216 can be axially fixed relative to the inner shaft 152 and the spool 212. In some embodiments, the spool stop 216 can be fixed to a component of another shaft of the delivery device, such as the second shaft 150 or the first shaft 134.

[0116] Because release member 208 has also moved proximally with spool 212, the prosthetic heart valve can now be released from delivery device 100 and delivery device 100 can be removed from the implantation site.

[0117] In some embodiments, when a delivery device (e.g., delivery device 100) is used to deliver a prosthetic aortic valve to its intended implantation site, at least a distal portion of the delivery device must traverse a curved portion of the patient's vasculature, such as the patient's aortic arch. An exemplary simulated aortic arch 300 is shown in FIG. Figure 11 Thus, as described above, in some embodiments, the delivery device can include one or more steering mechanisms configured to control the curvature of one or more axes (e.g., axes 134, 150, 152, and / or 152) of the delivery device 100 to assist in steering the delivery device through the patient's vasculature.

[0118] For example, Figure 11As shown, one or more steering mechanisms can allow at least a distal portion 302 of a delivery device 304 (which can be the same as or similar to the delivery device 100) to flex and articulate (e.g., bend) about the aortic arch 300. As the distal portion 302 of the delivery device 304 articulates about the aortic arch, the distal portions of the concentric axes (e.g., axes 134, 150, 152, and / or 152) of the delivery device 304 can shorten or lengthen relative to each other. In some embodiments, after flexing the distal portion 302 of the delivery device 304 to reach the target implantation site, and while the distal portion 302 remains flexed (e.g., Figure 11 ), the valve can be released from the delivery device 304 by rotating the knob 136 of the release mechanism 200. This results in linear movement (axial, in the proximal direction) of the drive screw 161, the inner shaft 152, and the release member 208. However, this linear translation of the concentric lumen causes the inner shaft 152 to shorten when flexed, thereby generating tension in the distal portion 302 when released. In this state, the inner shaft 152 can become a tensioned pull wire. If the release mechanism 200 is not unlocked during release (e.g., to release this tension), the distal portion 302 is held under tension, thereby preventing the delivery device from being removed from the implant site.

[0119] In this manner, the locking mechanism of the release mechanism 200 can increase the complexity of the implantation process and introduce tension issues that can 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.

[0120] Figure 12-33 An embodiment of a release mechanism 402 for a handle portion 400 of a delivery device is shown. In some embodiments, the handle portion 400 may replace Figure 8 The handle portion 132 of the delivery device 100 is shown. In some embodiments, the handle portion 400 can control the operation of the distal portion of the delivery device, such as Figure 9 and Figure 10 Further, the delivery device can be configured to deliver a radially compressed prosthetic medical device (e.g., disposed on a distal end of the distal portion of the delivery device). Figure 1 The prosthetic heart valve 10) reaches the target implantation site.

[0121] As mentioned above, Figure 12-33 The release mechanism 402 is configured to automatically provide tension release by flexing the distal portion of the delivery device and releasing the tension generated by the radial compression of the medical device mounted on the distal portion of the delivery device. Thus, the release mechanism 402 does not include a locking mechanism (e.g., Figure 8 Locking mechanism 202). Figure 12-20An assembled handle portion 400 is shown including a release mechanism 402 in different orientations or configurations during a prosthetic medical device implantation procedure with a delivery apparatus. Figure 21-25 A different view of the release knob 404 of the release mechanism 402 is shown (disassembled from the rest of the handle portion), and Figure 26-33 A different view of the drive screw 406 of the release mechanism 402 is shown (disassembled from the rest of the handle portion).

[0122] like Figure 12-18 and Figure 20 As shown, the handle portion 400 may include a housing 410 (eg, an outer housing). The housing 410 may house the internal components of the handle portion 400, such as those described above with reference to FIG. Figure 2-8 And further reference below Figure 13 、 Figure 15 、 Figure 17 and Figure 18 In some embodiments, the handle portion 400 may include a plurality of knobs and buttons that may be actuated by a user (e.g., a physician or clinician) to control the operation of the delivery device. For example, in some embodiments, the handle portion 400 may include buttons 412a and 412b, which may be similar to buttons 138a and 138b, as described above with reference to FIG. Figure 2 、 Figure 5 and Figure 6 described.

[0123] In some embodiments, as Figure 12 and Figure 13 As shown, a steering knob 418 of a steering mechanism of the delivery device can be coupled to the distal end 416 of the housing 410. By adjusting (e.g., rotating) the steering knob 418, the steering mechanism can be configured to adjust the curvature or amount of flexion of one or more shafts of the delivery device at the distal portion of the delivery device, as previously described.

[0124] The release knob 404 of the release mechanism 402 can be coupled to the proximal end 414 of the housing 410 and configured to rotate about a central longitudinal axis 420 of the release mechanism (which can also be the central longitudinal axis of the knob 404, the drive screw 406, and the delivery device). However, the movement of the release knob 404 can be fixed in the axial direction (along the central longitudinal axis 420). In this way, the release knob 404 can rotate but can be fixed so as not to linearly translate in the axial direction.

[0125] For example, Figure 21 、 Figure 22 and Figure 24As shown, the release knob 404 may include a body 428 having a distal end 424 and a proximal end 426. The body 428 may be a portion of the release knob 404 that is configured to be held and rotated by a user. The release knob 404 may also include a collar 422 extending axially outward from the distal end 424 of the release knob 404. The outer diameter 430 of the collar 422 may be smaller than the outer diameter 432 of the body 428 (e.g., the outermost diameter of the widest portion), as shown in FIG. Figure 22 As shown. The collar 422 may include one or more grooves (or channels) 434 that extend around the circumference (eg, the entire circumference) and are recessed into the outer surface of the collar 422. Figure 21 、 Figure 22 and Figure 24 As shown, the collar 422 includes two grooves 434 spaced apart from each other in the axial direction on the collar 422. However, in alternative embodiments, the collar 422 may include more or less than two grooves 434 (e.g., one, three, etc.). Each groove 434 is configured (e.g., shaped) to mate with a corresponding annular protrusion 436 of the housing 410.

[0126] For example, Figure 13 、 Figure 15 、 Figure 17 and Figure 18 As shown, the inner surface 438 of the housing 410 includes one or more annular protrusions 436 at its proximal end 414. Each annular protrusion 436 extends radially inward from the inner surface 438 of the housing 410 toward the central longitudinal axis 420. A collar 422 can extend into the interior of the proximal end 414 of the housing 410. Each annular protrusion 436 of the collar 422 can extend around the entire circumference of the inner surface 438. The number of annular protrusions 436 can match the number of grooves 434. In this way, each annular protrusion 436 can extend into and mate with a corresponding groove 434. There can be sufficient clearance between the mating annular protrusions 436 and grooves 434 to allow the release knob 404 to rotate while the housing 410 remains fixed and cannot rotate, and also to prevent the release knob 404 from moving axially relative to the housing 410. In this manner, release knob 404 is configured to rotate but is fixed against linear translation (axially and radially) relative to housing 410 due to the mating connection between groove 434 and annular protrusion 436 of housing 410 .

[0127] Return to Figure 21-25 , the release knob 404 may include an inner cylindrical bore (or cavity) 440 defined by an inner surface 442 of the release knob 404, which extends from the proximal end 426 of the body 428 to the distal end of the collar 422. The inner surface 442 may define the release knob 404 ( Figure 22) has an inner diameter 444. The hole 440 is configured to receive the drive screw 406 therein, as Figure 13 、 Figure 15 、 Figure 17 and Figure 18 The drive screw 406 and the release knob 404 can be coaxial with each other (eg, the central longitudinal axis 420 can be a common axis).

[0128] like Figure 22-25 As shown, 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 at 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 to the distal end 424 of the release knob 404 for only a portion of the total distance (length) 448 between the proximal end 426 and the distal end 426. In some embodiments, this portion can be less than 1 / 4 of the total distance 448. In other embodiments, this portion can be less than 1 / 10 of the total distance 448. Thus, the length of each tooth 446 can be relatively short compared to the length of the helical groove 452 of the threads of the drive screw 406, and the teeth 446 are configured to mate (engage) with and travel (slide) along the helical groove 452, as further described below.

[0129] like Figure 23-25 As shown, each tooth 446 is curved along the inner surface 442 to match the helical profile of the groove 452 with which the tooth 446 is configured to engage. For example, each tooth 446 can have a pitch and lead that matches the pitch and lead of the drive screw 406, as described further below. However, each tooth 446 is less than a full thread and can bend less than 90 degrees around the circumference of the proximal end 426 of the knob 404 (e.g., Figure 23-25 In some embodiments, each tooth 446 is curved about or less than 45 degrees around the circumference of the proximal end 426. In some embodiments, each tooth 446 is curved between 30 and 80 degrees around the circumference of the proximal end 426.

[0130] The release knob 404 is shown with two teeth 446 spaced apart from each other around the circumference of the inner surface 442. In some embodiments, the two teeth 446 may be spaced apart from each other by approximately 180 degrees around the circumference of the inner surface 442. For example, Figure 23 As shown in the distal end view of , the two teeth 446 may include a first tooth 446a and a second tooth 446b. In alternative embodiments, such as when the drive screw is a single start screw or a different multi start screw, the release knob 404 may include only one tooth or more than two teeth (e.g., three).

[0131] In some embodiments, as Figure 21 、 Figure 22 、 Figure 24 and Figure 25 As shown, the outer surface of the body 428 of the release knob 404 can have a curved profile (e.g., a diameter in the middle portion is smaller than a diameter at the ends of the body 428) with one or more protruding elements 450. The one or more protruding elements 450 can be configured to provide an ergonomic knob surface for the user to grasp and turn. However, in alternative embodiments, the body 428 can include no protruding elements 450 and / or can have a profile of a different shape.

[0132] The drive screw 406 may be disposed on the release knob 404 ( Figure 12-20 ) inside (e.g., hole 440). In some embodiments, as Figure 26-33 As shown, the drive screw 406 can have threads defined by one or more grooves 452 that are recessed into an outer surface 454 of a body 456 of the drive screw 406. Each groove 452 can form a helical track along the helical threaded portion of the body 456 of the drive screw 406, along which a corresponding tooth 446 of the release knob 404 can travel when the release knob 404 is rotated (e.g., turned). The body 456 also includes one or more retaining elements 458 ( Figure 26-32 ). Each groove 452 can be connected to a corresponding retaining element 458 of the drive screw 406. In addition, each retaining element can be disposed at a proximal end 476 of the drive screw 406 (eg, a proximal end of the body 456).

[0133] In some embodiments, each retaining element 458 includes a protruding member (also referred to as a pawl) 460, a first linear threaded portion 462 disposed on a first side of the protruding member 460, and a second linear threaded portion 464 disposed on a second side of the protruding member 460. Figure 26 and Figure 27 ). In some embodiments, as Figure 26 、 Figure 27 and Figure 30 As shown, the second linear threaded portion 464 is connected to and continuous with the corresponding groove 452. Thus, the first linear threaded portion 462 and the second linear threaded portion 464 can be grooves that are recessed into the outer surface 454 and extend circumferentially along the body of the drive screw on either side of the protruding member 460. In some embodiments, the first linear threaded portion 462 and the second linear threaded portion 464 can be non-helical (e.g., they are relatively straight or linear). As described in further detail below, when the corresponding teeth 446 of the release knob 404 are disposed in the first linear threaded portion 462, the teeth 446 are trapped behind the protruding member 460, thereby maintaining the release knob 404 in a locked configuration.

[0134] In some embodiments, each retaining element 458 may include a protruding member 460 ( Figure 26 、 Figure 27 、 Figure 30 and Figure 32 ). The tongue 485 can set the length, width, and height of the tongue 485 and the cantilever of the protruding member 460, which sets the force required to depress the protruding member 460 and allow the teeth 446 to begin traveling along the second linear threaded portion 464 and the groove 453. As a result, the release knob 404 can be rotated and cause the linear travel of the drive screw 406.

[0135] Each groove 452 may extend from the second linear threaded portion 464 of the corresponding retaining element 458 and helically curve around the outer surface 454 of the body 456 of the drive screw 406 from the corresponding retaining element 458 to the distal end 474 of the body 456 .

[0136] In some embodiments, as Figure 26-33 As shown, the helical thread portion has a double-start thread formed by two helical grooves 452, including a first groove 452a and a second groove 452b (e.g., Figure 16 and Figure 30 ). The proximal end of the first groove 452a can start at the first retaining member and the proximal end of the second groove 452b can start at the second retaining member spaced apart from the first retaining member. In some embodiments, as Figure 26 and Figure 28-33 As shown, two retaining elements 458 may be arranged 180 degrees apart from one another around the circumference of the body 456 of the drive screw 406 .

[0137] In some embodiments, the helical threaded portion may have a lead 466 greater than 1 inch and a pitch 468 greater than 0.5 inches. As used herein and Figure 30 As shown, the pitch 468 is the distance between the notch of one thread (groove) and the next notch of the adjacent thread (groove), while the lead 466 is the distance along the axis of the drive screw that is covered by one complete rotation of the knob (e.g., knob teeth along the drive screw groove). In the case of a double-start thread, the lead 466 is twice the pitch 468. In some embodiments, the helical thread portion may have a lead 466 of approximately 1.5 inches and a pitch 468 of approximately 0.75 inches. In some embodiments, the lead 466 may be in the range of 1-1.75 inches and the pitch 468 may be in the range of 0.5-0.875 inches.

[0138] In alternative embodiments, the helical threaded portion may instead have a single starting thread formed by a single groove 452. In these embodiments, the release knob 404 may include only a single tooth 446 configured to mate with the single groove 452. In single-start thread embodiments, the helical threaded portion may have a lead of 1.5 inches and a pitch of 1.5 inches or a lead of at least 1 inch and a pitch of at least 1 inch.

[0139] like Figure 18 As shown, each tooth 446 of the release knob 404 engages with and is configured to slide along a corresponding one of the grooves 452. For example, in the case of a dual-wire release mechanism, as described above, as the release knob is rotated ( Figure 18 ), the first tooth 446a of the release knob 404 engages with the first groove 452a and slides (e.g., travels) along the first groove 452a, and the second tooth 446b of the release knob 404 engages with the second groove 452b and slides along the second groove 452b.

[0140] Thus, each tooth 446 can be shaped to fit within a corresponding groove 452. Figure 29 As shown, each groove 452 may have a profile 470. In some embodiments, the profile 470 may have a trapezoidal shape, such as a triangular shape with a flat peak. Figure 22-25 As shown, each tooth 446 can have a profile 472 that corresponds to (e.g., matches) the profile 470 of the groove 452, so that they can fit together while still having sufficient clearance between them to allow the tooth 446 to slide along the groove 452. For example, in some embodiments, the profile 472 can also have a trapezoidal shape, such as a triangular shape with a flat peak. However, as described above, each tooth 446 can be a protrusion (e.g., protruding radially outward from the inner surface 442 of the release knob 404), while each groove 452 can be a recess (e.g., pressed 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.

[0141] Although each groove 452 curves around the outer surface 454 and extends from a proximal end 476 to the distal end 474 of the body 456 of the drive screw 406, each tooth 446 extends only a portion of the total distance (e.g., length) 448 between the proximal end 426 and the distal end 424 of the release knob 404. Thus, the path length 478 (e.g., from its proximal end to its distal end) of each tooth 446 is smaller than the path length of the corresponding groove 452. Figure 25 shown) is relatively short.

[0142] As the following reference Figure 34As further explained, by having relatively short teeth 446 on the release knob 404 and a threaded drive screw 406 having a relatively long lead 466 and pitch 468, the engagement between the teeth 446 of the release knob 404 and the grooves 452 of the drive screw 406 can be reduced (as opposed to the teeth 446 being curved around and extending through a larger portion of the inner surface of the release knob 404). This reduced level of engagement can be great enough to allow the teeth 446 to travel along the grooves 452 as the release knob is rotated until the release mechanism reaches a point where the drive screw 406 is proximal to the release knob 404 in the axial direction (e.g., Figure 16-19 At the same time, this reduced level of engagement can 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 to release tension on the delivery device during implantation (e.g., after retracting the capsule and upon loosening the distal portion of the delivery device, as further described below, and as Figure 20 shown).

[0143] In some embodiments, the materials of the drive screw 406 and the release knob 404 can also be selected to provide 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 the drive screw 406 and at least the teeth 446 of the release knob 404 can be selected to allow the teeth 446 to slide more easily along the grooves 452. In some embodiments, the drive screw 406 and / or the release knob 404 can comprise a material that provides a relatively low-friction contact surface for each of these components, such as a thermoplastic polymer. In some embodiments, the drive screw 406 and the release knob 404 can comprise different polymeric materials (e.g., different thermoplastic polymers) that are configured to facilitate sliding between the surfaces of the drive screw 406 and the release knob 404. Possible polymeric materials may include polycarbonate, acrylonitrile butadiene styrene (ABS), polytetrafluoroethylene (PTFE), ABS impregnated with PTFE or other lubricating additives, nylon, and / or polyethylene. For example, in some embodiments, the drive screw 406 may comprise polycarbonate and the release knob may comprise ABS (or vice versa). Furthermore, in some embodiments, the drive screw 406 and / or release knob 404, as well as the lead of the groove 452 and the material of the teeth 446, may be selected together to provide a desired level of engagement, as described above.

[0144] like Figure 26-33As shown, the drive screw 406 may include a collar (or collar portion) 480 that extends proximally and outwardly in an axial direction from the proximal end 476 of the body 456. The collar 480 may be an annular collar 480 that extends around the circumference of the drive screw 406. The outer diameter 482 of the collar 480 may be greater than the outer diameter 484 of the body 456 ( Figure 29 ). The collar 480 may also have an inner surface defining 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 therein. For example, Figure 12 、 Figure 13 、 Figure 16-20 As shown, cap 408 is coupled to proximal end 476 of body 456 of drive screw 406 via collar 480. In some embodiments, collar 480 may include one or more apertures 481, each configured to receive a fastener therein to couple cap 408 to collar 480.

[0145] In some embodiments, as Figure 13 As shown, the inner shaft 488 (e.g., Figure 8 The inner shaft 152 of the cap 408 can be fixedly coupled (e.g., bonded, glued, press-fitted, etc.) to the interior of the cap 408. For example, similar to Figure 8-10 As shown, the inner shaft 488 can be coupled to the cap 408 and then extend from the cap 408 through the delivery device to the distal portion or end of the delivery device (e.g., to the nose cone 144). The inner shaft 488 can be configured to receive a guidewire therein, and thus, in some embodiments, the inner shaft 488 can be referred to as a guidewire lumen. Because the inner shaft 488 is fixedly coupled to the cap 408, which is coupled to the drive screw 406, linear translation of the drive screw 406 in the axial direction causes linear translation of the inner shaft 488 (e.g., they translate together).

[0146] Return to Figure 26-33 The drive screw 406 may further include an extension portion 490 extending axially outward and distally from the distal end 474 of the body 456. The extension portion 490 may include a central hole (channel) 492 and one or more side holes 494 (e.g., Figure 33 492 can be configured to receive the inner shaft 488 therein. In some embodiments, the central bore 492 of the extension portion 490 can be continuous with and connected to a central bore portion 496 extending through the interior of the body 456, as shown in FIG. Figure 29 As shown. The central hole portion 496 can provide additional support for the inner shaft 488 and prevent kinking. However, in alternative embodiments, the drive screw 406 may not include the central hole portion 496.

[0147] like Figure 15 and Figure 17-19As shown, each of the side holes 494 can be configured to receive a corresponding rod 499 (of the two rods) therein (only one side hole 494 and rod 499 pair is shown). The rod 499 can be coupled to an interior of the housing 410 disposed within the handle portion 400 ( Figure 17 ) in the internal connecting element 417. The drive screw 406 can be configured to travel linearly in the axial direction along the rod 499. In this way, the rod 499 can guide the linear travel of the drive screw 406 within the release knob 404.

[0148] In some embodiments, as Figure 15 and Figure 17-19 As shown, the proximal end of each rod 499 includes a stop (or end of travel) element 497 having at least one dimension wider than the diameter of the rod 499. The stop element 497 may also be wider than the maximum width of the internal side hole 494 of the drive screw 406. Figure 15 and Figure 17-19 As shown, the stop element 497 is disposed within an open cavity 495 within the body 456 of the drive screw 406, the open cavity 495 being disposed between the proximal end 476 and the distal end 474 of the body 456 of the drive screw 406. The distal end 474 of the body 456 may include an inner surface 493 disposed perpendicular to the central longitudinal axis 420 ( Figure 19 ). The inner surface 493 and the stop element 497 together can form an end stop that prevents the drive screw 406 from traveling further in the proximal axial direction. In this way, the drive screw 406 can be prevented from traveling too far beyond the release knob 404. In some embodiments, the linear travel of the release mechanism 402 can be stopped by the spool 212 (in or beyond the release configuration, as further described herein) at the distal portion of the delivery device (e.g., the distal end of the delivery device) before the stop element 497 contacts the inner surface 493 (at the proximal end of the delivery device). Figure 10 As shown) in contact with the spool stop 216.

[0149] In some embodiments, as Figure 33 As shown, the extension portion 490 may have a major axis (e.g., long dimension) with a major diameter 491 and a minor axis (e.g., short dimension) with a minor diameter 489. The central hole 492 and the two side holes 494 may be spaced apart from each other along the major axis. The major diameter 491 may be smaller than the main body 456 ( Figure 33 )’s outer diameter is 484.

[0150] In some embodiments, as Figure 33 As shown, the extension portion 490 may include a raised (eg, protruding) area surrounding the central aperture 492 , forming a wider portion having a diameter 487 that is wider than the minor diameter 489 .

[0151] Figure 34 is a flow chart of a method 500 for operating a 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, including the release mechanism 402, can be part of a delivery device, e.g., Figure 1-10 The method 500 may also provide a method for operating the release mechanism 402. The method 500 is described below with reference to Figure 9-20 Provide a description.

[0152] Method 500 begins at 502 and includes placing a distal portion of a delivery device (e.g., Figure 9 and Figure 10 The distal portion shown in Figure 1-8 The delivery device 100 of the embodiment of the present invention is advanced toward a target implantation site in a patient and a steering mechanism of the delivery device is adjusted to flex and articulate the distal portion around a curvature of the patient's vasculature. In some embodiments, a prosthetic heart valve (e.g., Figure 1 The implantable medical device of the valve 10) is arranged in a radially compressed configuration on the distal portion of the delivery device. For example, the artificial heart valve can be contained in a capsule of the delivery device (e.g., Figure 2-4 146).

[0153] In some embodiments, the curved portion of the patient's vasculature may include the aortic arch. An example of a distal portion of a delivery device articulated around a simulated aortic arch is shown in FIG. Figure 11 Shown in.

[0154] At 504, the method includes, after reaching the target implantation site, translating a capsule covering the radially compressed prosthetic heart valve (or alternative implantable medical device) away from the valve to expose the prosthetic heart valve. In some embodiments, after retracting the capsule away from the radially compressed valve, the valve can self-expand to a radially expanded configuration. In some embodiments, translating the capsule can be responsive to actuation of one or more buttons on a handle portion of the delivery device. For example, when a user actuates the one or more buttons, as described above with reference to Figure 2 and Figure 5-7 As described, the motor can be activated to move the capsule axially to expose the valve.

[0155] After exposing the prosthetic heart valve or other medical device at 504, method 500 proceeds to 506. At 506, the method includes rotating a release mechanism knob (e.g., release knob 404 of release mechanism 402, such as Figure 12-25 ) to linearly translate a drive screw (eg, Figure 12-20 and Figure 26-33 The valve can be released from the delivery device by rotating the knob at 506 to linearly translate the drive screw from an initial locked position (e.g., a locking position). Figure 12-15 4) rotates the knob 404 of the valve release mechanism and moves 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 proximally in the axial direction until the drive screw 406 reaches the release position (as shown). Figure 16-19 shown).

[0156] In some embodiments, as described herein with reference to Figure 26-33 As depicted, 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 disposed opposite each other (e.g., 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 is configured to mate with and translate (e.g., travel or slide) along a corresponding groove 452.

[0157] like Figure 12-15 As shown, in the initial locked orientation or configuration, the drive screw 406 is retracted into the handle portion 400 and a majority of the body 456 of the drive screw 406 is disposed within the interior of the rotation knob 404. For example, only the collar 480 of the drive screw 406 may extend axially in the proximal direction outside of the rotation knob 404 in the initial locked orientation.

[0158] Furthermore, in the initial locked orientation or configuration, each tooth 446 can be disposed within the first linear threaded portion 462 of the corresponding retaining element 458 (eg, Figure 15 4. As shown in FIG. 4A , each tooth 446 can be retained in the retaining element 458 by a protruding member 460 of the retaining element 458 that protrudes radially outward relative to the first linear threaded portion 462. The protruding member 460 prevents the knob 404 from rotating in response to the forces generated by articulating (e.g., flexing) the distal portion of the delivery device during step 502 of the method. In this way, accidental, premature release of the prosthetic heart valve from the delivery device (through unintentional actuation of the knob 404) can be prevented.

[0159] Upon initial rotation of knob 404 (e.g., by a user), each tooth 446 can overcome protruding member 460 of retaining element 458 by moving over and past protruding member 460 to reach second linear threaded portion 464 connected to corresponding groove 452. Thus, rotating the knob at 506 can first include initially rotating the knob to disengage (or release) tooth 446 from its corresponding retaining element 458. The user may feel an initial resistance in overcoming retaining element 458 due to protruding member 460. However, after overcoming protruding member 460, the user may feel less resistance when turning knob 404. As knob 404 is turned, teeth 446 can slide and travel along the path of the groove. As teeth 446 travel along groove 452, drive screw 406 translates proximally in the axial direction in response to rotation of knob 404, while the axial orientation of knob 404 remains fixed. For example, as each tooth 446 continues to travel along the corresponding groove 452 , the proximal end 476 of the drive screw 406 extends further outside of the knob 404 .

[0160] The method at 506 can further include linearly translating the drive screw 406 ( Figure 13 ) fixedly coupled to the inner shaft 488 and one or more release members fixedly coupled to the distal end of the inner shaft (e.g., coupled to Figure 9 and Figure 10 The release member 208 of the shaft 152 in the delivery device is used to release the valve from the delivery device. Figure 13 As explained, the proximal end of the inner shaft 488 can be fixedly coupled to the cap 408, which is coupled to the proximal end of the drive screw 406, and the release member (e.g., release member 208) can be fixedly coupled to the distal portion of the inner shaft 488. Thus, linear translation of the drive screw 406 in the proximal axial direction causes linear translation of the release member in the proximal axial direction (e.g., these components move together). As described above, by moving the release member in the proximal axial direction away from the prosthetic heart valve (or other implantable medical device), the release member becomes separated from the prosthetic heart valve, thereby disconnecting and releasing the prosthetic heart valve from the delivery device.

[0161] In the release orientation or configuration of the release mechanism 402 (and the drive screw 406), the drive screw 406 is released from the proximal end (eg, Figure 16-19 4 and 5. In addition, the teeth 446 of the release knob 404 can engage with corresponding grooves 452 of the drive screw 406 at or near the distal end 474 of the body 456 of the drive screw 406 (as shown). Figure 18In this released position, the stop element 497 of the rod 499 can be arranged adjacent to the inner surface 493 of the distal end 474 of the body 456 (as shown). Figure 18 and Figure 19 ). Moreover, in the released configuration, the release member (e.g., release member 208) is arranged away from the artificial heart valve. Figure 10 As shown, in the released configuration, the spool 212 can be arranged to be proximate to or in contact with the spool stop 216, and thus, the release member 208 can be arranged (with Figure 9 closer to the spool stop 216 compared to the starting configuration shown).

[0162] Continuing to 508, the method may include, after releasing the prosthetic heart valve (or other implantable medical device), adjusting (e.g., actuating) a steering mechanism to loosen the distal portion of the delivery device and passively retracting a drive screw 406 into the knob in a distal axial direction to release tension during the loosening process. As described above, when the distal portion of the delivery device is loosened, tension is generated in the shaft of the delivery device during the process of releasing the valve from the delivery device. Therefore, this tension needs to be reduced to enable complete and successful loosening of the distal portion of the delivery device and removal of the delivery device from the implant site. By allowing the drive screw 406 to passively retract into the knob 404, thereby linearly translating the inner shaft 488 distally in the axial direction, the tension generated during loosening can be reduced when the distal portion of the delivery device is loosened (e.g., by actuating the steering mechanism, such as by rotation of the steering knob 418).

[0163] For example, by releasing mechanism 402 (e.g. Figure 16-19 404, as shown in the release configuration, when the distal portion of the delivery device is loosened (e.g., as the steering knob 418 is rotated), the drive screw can translate in the distal direction, in the axial direction, at least partially back into the interior of the release knob 404, as shown in the release configuration. Figure 20As used herein, "passively" refers to the free movement of the drive screw without the need for manual actuation of the knob 404 (e.g., by a user turning the knob 404). During the release of the distal portion of the delivery device, the pulling force at the distal portion of the delivery device can 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 pulled back into the knob 404. As the drive screw 406 is pulled back into the knob 404, the teeth 446 move along the grooves 452, which passively rotates the knob 404. In this way, the tension accumulated in the distal portion of the delivery device can be automatically reduced by the release mechanism 402 (without the need for user intervention), and the distal portion of the delivery device can be released and removed from the implant site and the patient. This can simplify the implantation process while allowing the user to more easily remove the delivery device from the implant site. As described above, the relatively short teeth 446 of the knob 404 and the long lead / pitch of the grooves 452 of the drive screw 406, together with the low friction contact surfaces of the knob 404 and the drive screw 406, enable the drive screw 406 to be passively pulled back into the knob to relieve tension during loosening.

[0164] Thus, step 510 of the method includes, after releasing the distal portion of the delivery device at step 508, removing the delivery device from the implantation site (and the patient).

[0165] Other Examples of the Disclosed Technology

[0166] In view of the above embodiments of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or more than one feature of a combined example, as well as an example optionally combined with one or more features of one or more other examples, are further examples falling within the disclosure of the present application.

[0167] Example 1. A delivery device for an expandable, implantable medical device, the delivery device comprising: a handle portion, the handle portion including a release mechanism, the release mechanism configured to adjust the linear orientation of a component of the delivery device relative to a central longitudinal axis of the delivery device, the release mechanism comprising: a threaded drive screw comprising a helical thread portion having a lead of at least one inch, wherein the helical thread portion includes 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 arranged at a proximal end of the knob, each of the one or more teeth being configured to engage with a corresponding groove in the one or more grooves of the drive screw, wherein each of the one or more teeth extends from the proximal end to the distal end of the knob for only a portion of the total distance between the proximal and distal ends, wherein the portion is less than 1 / 4 of the total distance.

[0168] Example 2. A delivery device according to any of the examples herein, in particular Example 1, wherein the threaded drive screw includes one or more retaining elements arranged at the proximal end of the drive screw, wherein one or more grooves of the helical thread portion are respectively connected to corresponding retaining elements in the one or more retaining elements and extend around the drive screw from the corresponding retaining elements to the distal end of the drive screw, and wherein each tooth of the one or more teeth is configured to engage the corresponding retaining element.

[0169] Example 3. A delivery device according to any example herein, in particular Example 2, wherein each tooth is configured to cooperate with and travel along a corresponding groove when the knob is rotated about a central longitudinal axis, wherein the drive screw is configured to move linearly in an axial direction relative to the knob when the knob is rotated and the teeth travel along the corresponding grooves, wherein the knob is fixed and does not translate in the axial direction, wherein the axial direction is relative to the central longitudinal axis, wherein the knob includes a collar extending distally from a distal end of the knob to the interior of the housing of the handle portion, the collar including one or more collar grooves extending around the circumference of the collar, each collar groove cooperating with a corresponding annular protrusion, the annular protrusion extending radially from the inner surface of the housing of the handle portion, and wherein the knob is fixed and cannot translate in the axial direction and is configured to rotate about the central longitudinal axis relative to the housing of the handle portion through a mating connection between each collar groove and the corresponding annular protrusion.

[0170] Example 4. A delivery device according to any example herein, in particular any example 2-3, wherein the drive screw is linearly movable between a starting locking configuration and a release configuration, wherein in the starting locking configuration, each tooth is coupled to a corresponding retaining element and the entire helical thread portion of the drive screw is arranged inside the knob and handle portion, and in the release configuration, each tooth cooperates with a distal portion of a corresponding groove, the distal portion is arranged closer to the distal end than the proximal end of the drive screw, and most of the helical thread portion of the drive screw extends outward from the proximal end of the knob in an axial direction.

[0171] Example 5. A delivery device according to any of the examples herein, in particular Example 4, wherein each retaining element includes a protruding member, a first linear threaded portion arranged on a first side of the protruding member, and a second linear threaded portion arranged on a second side of the protruding member, the second linear threaded portion being connected to and continuous with a corresponding groove in one or more grooves of the drive screw.

[0172] Example 6. The delivery device of any example herein, in particular example 5, wherein in the initial locked configuration, each tooth is arranged within the first linear threaded portion of the corresponding retaining element.

[0173] Example 7. The delivery device according to any example herein, in particular any example 2-6, further includes a rod comprising a distal end fixedly coupled to an inner surface of the handle portion, and wherein the drive screw includes an extension portion extending axially outward from the distal end of the drive screw, the extension portion including an inner hole mounted around the rod and configured to slide linearly along the rod.

[0174] Example 8. A delivery device according to any of the examples herein, in particular Example 7, wherein the proximal end of the rod includes a stop element that is wider than the maximum width of the inner hole of the drive screw, and wherein the stop element is arranged in an open cavity inside the drive screw, and the open cavity is arranged between the proximal end and the distal end of the drive screw.

[0175] Example 9. A delivery device according to any of the examples herein, in particular any of Examples 7-8, wherein the extension portion further comprises a central hole centered along the central longitudinal axis, wherein the inner hole is radially offset from the central hole, and wherein the central hole is configured to receive an inner shaft of the delivery device therethrough.

[0176] Example 10. A delivery device according to any example herein, in particular any of Examples 1-9, wherein the component of the delivery device whose linear orientation is adjusted by the release mechanism comprises one or more release members removably coupled to the implantable medical device.

[0177] Example 11. The delivery device according to any of the examples herein, in particular Example 10, further comprises an inner shaft comprising a proximal end of a cap fixedly coupled to a release mechanism, the cap being coupled to the proximal end of a drive screw, wherein the inner shaft extends to a distal end of the delivery device, and wherein one or more release members are fixedly coupled to the distal portion of the inner shaft.

[0178] Example 12. A delivery device according to any of the examples herein, in particular any of Examples 1-11, wherein the thread formed by one or more grooves of the helical thread portion is a double-thread thread formed by two grooves, and wherein the drive screw has two retaining elements, each groove extending from a different one of the two retaining elements, and wherein the knob includes two teeth, each tooth being configured to cooperate with and slide along a different one of the two grooves.

[0179] Example 13. The delivery device of any example herein, in particular example 12, wherein the two teeth are spaced apart from each other around the circumference of the proximal end of the knob.

[0180] Example 14. A delivery device according to any example herein, in particular any example 1-13, wherein the handle portion further comprises a steering mechanism, the steering mechanism comprising a steering knob configured to rotate relative to the housing of the handle portion at a distal end portion of the delivery device and adjust the curvature of one or more axes of the delivery device.

[0181] Example 15. A delivery device according to any example herein, in particular Example 14, wherein the steering knob is coupled to the distal end of the housing of the handle portion and the knob of the release mechanism is coupled to the proximal end of the housing of the handle portion.

[0182] Example 16. The delivery apparatus of any example herein, in particular any of Examples 1-15, wherein the implantable medical device is a prosthetic heart valve configured to radially self-expand to a functional size of the prosthetic heart valve.

[0183] Example 17. The delivery device of any example herein, in particular any example 1-16, wherein the portion of the total distance between the proximal end and the distal end is less than 1 / 10 of the total distance.

[0184] Example 18. A method for implanting an implantable medical device using a delivery device, the method comprising: using a handle portion of the delivery device to advance a distal portion of the delivery device to a target implantation site, the implantable medical device being arranged on the distal portion to be in a radially compressed configuration; and upon reaching the target implantation site, exposing the radially compressed implantable medical device, and releasing the implantable medical device from the delivery device, the releasing comprising: from a starting position, rotating a knob of a release mechanism of the handle portion of the delivery device and moving one or more teeth of the knob along one or more corresponding grooves of a drive screw of the release mechanism to move the implantable medical device in a proximal direction. The invention further comprises the steps of: linearly translating a drive screw along an axis parallel to a central longitudinal axis of the delivery device until the drive screw reaches a release position; linearly translating an inner shaft fixedly coupled to the drive screw and one or more release members fixedly coupled to a distal portion of the inner shaft as and due to the drive screw translating in the proximal direction to release the implantable medical device from the delivery device; and actuating a steering mechanism of the delivery device to loosen the distal portion of the delivery device and passively retracting the drive screw partially into the knob in a distal direction to automatically release tension during loosening, the distal direction being opposite to the proximal direction.

[0185] Example 19. A method according to any of the examples herein, in particular Example 18, wherein rotating from a starting position includes initially rotating a knob to release each of one or more teeth of the knob from a corresponding retaining element arranged at the proximal end of the drive screw and connected to a corresponding groove in 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 cause the drive screw to translate linearly in a proximal direction.

[0186] Example 20. A method according to any of the examples herein, in particular Example 19, wherein in a starting position, each tooth is arranged in a first linear threaded portion of a corresponding retaining element and is retained in the first linear threaded portion via a protruding member of the retaining element, the protruding member protruding radially outward relative to the first linear threaded portion, and wherein the retaining element includes a second linear threaded portion that is arranged on a side of the protruding member opposite to the first linear threaded portion and is directly connected to the corresponding groove.

[0187] Example 21. The method according to any example described herein, in particular any example 19 and 20, further includes: adjusting the steering mechanism of the delivery device to flex and articulate the distal portion of the delivery device around one or more curves in the patient's body cavity during advancement of the distal portion to the target implantation site, and maintaining one or more teeth of the knob within the corresponding retaining element of the drive screw during adjustment of the steering mechanism.

[0188] Example 22. The method of any example herein, in particular any of Examples 18-21, wherein in the starting position, the release member is coupled to the implantable medical device.

[0189] Example 23. A method according to any of the examples herein, in particular any of Examples 18-22, wherein the one or more grooves of the drive screw include two spiral grooves curved around the outer surface of the body of the drive screw from the proximal end to the distal end of the body, wherein the drive screw has a double-thread thread formed by the two grooves, and wherein the one or more teeth of the knob include two teeth spaced apart from each other around the circumference of the proximal end of the knob.

[0190] Example 24. The method of any example herein, in particular example 23, wherein the lead of the double start thread is at least one inch.

[0191] Example 25. A method according to any of the examples herein, in particular any of Examples 18-24, wherein each of the one or more teeth of the knob is arranged at the proximal end of the knob and extends only a portion of the total length of the inner surface of the knob, the length extending in an axial direction from the proximal end of the knob to the distal end of the knob, the axial direction being parallel to the central longitudinal axis, wherein the portion is less than 1 / 4 of the total length, and wherein each of the one or more grooves curves around the outer surface of the body of the drive screw from the proximal end to the distal end of the body, the body being longer than the inner surface of the knob.

[0192] Example 26. A method according to any of the examples herein, in particular any of Examples 18-25, wherein in the release position, each of the one or more teeth of the knob engages with a corresponding groove in one or more grooves of the drive screw at a distal portion of the body of the drive screw, wherein the one or more grooves are provided in the body.

[0193] Example 27. A method according to any of the examples herein, in particular any of Examples 18-26, wherein linearly translating the drive screw in the proximal direction includes sliding an inner hole arranged in an outwardly extending extension portion of the drive screw from the distal end of the body of the drive screw in the distal direction, the body including one or more spiral grooves located therein, along a rod coupled to an interior of the handle portion at the distal end of the rod, and wherein in a released position, a stop element arranged at the proximal end of the rod is arranged to be adjacent to an inner surface of the distal end of the body of the drive screw, the inner surface being arranged perpendicular to the rod.

[0194] Example 28. A method according to any example herein, in particular any of Examples 18-27, wherein in the released orientation the release member is arranged away from and separated from the implantable medical device.

[0195] Example 29. A method according to any of the examples herein, in particular any of Examples 18-28, wherein 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 portion of the inner shaft reaches a spool stop of a delivery device that is axially fixed relative to the inner shaft.

[0196] Example 30. A method according to any of the examples herein, in particular any of Examples 18-29, wherein passively retracting the drive screw includes retracting the drive screw in the distal direction in response to a force pulling the inner shaft in the distal direction during loosening, and returning to the interior of the knob and moving one or more teeth of the knob 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.

[0197] Example 31. The method according to any example described herein, in particular any example 18-30, further includes: during advancement of the distal portion to the target implantation site, adjusting the steering mechanism of the delivery device to flex and articulate the distal portion of the delivery device around one or more curves in the patient's body cavity on the way to the target implantation site.

[0198] Example 32. A method according to any example herein, in particular Example 31, wherein the steering mechanism includes a steering knob coupled to the distal end of the housing of the handle portion, and wherein the knob of the release mechanism is coupled to the proximal end of the housing of the handle portion.

[0199] Example 33. The method according to any example herein, in particular any example 18-32, further comprising removing the delivery device from the implantation site after loosening the distal portion of the delivery device.

[0200] Example 34. A method according to any of the examples herein, in particular any of Examples 18-33, wherein exposing the radially compressed implantable medical device includes retracting a capsule coupled to an outer shaft of the delivery device away from the radially compressed implantable medical device in response to actuation of one or more buttons on a handle portion.

[0201] Example 35. The method of any example herein, in particular any of Examples 18-34, wherein the implantable medical device is a self-expanding prosthetic heart valve.

[0202] Example 36. A method for operating a release mechanism of a handle portion of a delivery device configured to deliver an implantable medical device to a target implantation site, the method comprising: from a starting locked position of the release mechanism, in response to rotation of the knob, moving one or more teeth of a knob of the release mechanism along one or more corresponding grooves of a drive screw of the release mechanism to linearly translate the drive screw in a proximal direction along an axis parallel to a central longitudinal axis of the delivery device until the drive screw reaches the release position, wherein in the starting locked position, a body of the drive screw including the one or more grooves is disposed within an interior of the knob, and in a released position, a majority of the body extends outside the knob; when the drive screw translates in a proximal direction, an inner shaft fixedly coupled to the drive screw and one or more release members fixedly coupled to the distal portion of the inner shaft are linearly translated to release the implantable medical device mounted on the distal portion of the delivery device from the delivery device; and in response to actuation of a steering mechanism of the delivery device, the distal portion of the delivery device is loosened, and during the loosening, the drive screw is passively retracted partially into the knob in a distal direction to automatically release the tension in the distal portion of the delivery device and enable loosening, wherein the distal direction is opposite to the proximal direction.

[0203] Example 37. A method according to any of the examples herein, in particular Example 36, wherein moving one or more teeth of a knob from a starting locking position includes initially moving each of the one or more teeth above a protruding member of a corresponding retaining element in response to rotation of the knob to reach from a first linear threaded portion of a corresponding retaining element in one or more retaining elements disposed at a proximal end of the body of the drive screw to a second linear threaded portion arranged on an opposite side of the protruding member, the second linear threaded portion being from the first linear threaded portion and connected to the proximal end of a corresponding groove in one or more grooves so as to release each of the one or more teeth from the corresponding retaining element, and then continuing to move each tooth along the corresponding groove and linearly translating the drive screw in a proximal direction.

[0204] Example 38. A method according to any example herein, in particular any of Examples 36-37, wherein in the initial locked orientation, the release member is coupled to the implantable medical device.

[0205] Example 39. A method according to any of the examples herein, in particular any of Examples 36-38, wherein the one or more grooves of the drive screw include two spiral grooves that curve around the outer surface of the body of the drive screw from the proximal end to the distal end of the body, wherein the drive screw has a double-thread thread formed by the two grooves, and wherein the one or more teeth of the knob include two teeth spaced apart from each other around the circumference of the proximal end of the knob.

[0206] Example 40. The method of any example herein, in particular example 39, wherein the lead of the double start thread is at least one inch.

[0207] Example 41. A method according to any of the examples herein, in particular any of Examples 36-40, wherein each of the one or more teeth of the knob is arranged at the proximal end of the knob and extends only a portion of the total length of the inner surface of the knob, which length extends from the proximal end of the knob to the distal end of the knob in an axial direction parallel to the central longitudinal axis, wherein the portion is less than 1 / 4 of the total length, and wherein each of the one or more grooves is curved around the outer surface of the body of the drive screw from the proximal end of the body to the distal end of the body, and the body is longer than the inner surface of the knob.

[0208] Example 42. A method according to any of the examples herein, in particular any of Examples 36-41, wherein in the release position, each of the one or more teeth of the knob engages with a corresponding groove in the one or more grooves of the drive screw at a distal portion of the body of the drive screw.

[0209] Example 43. A method according to any of the examples herein, in particular any of Examples 36-42, wherein linearly translating the drive screw in the proximal direction includes sliding an inner hole arranged in an extension portion of the outwardly extending drive screw along a rod coupled to the interior of the handle portion at the distal end of the rod from the distal end of the body of the drive screw, and wherein in the release position, a stop element arranged at the proximal end of the rod is arranged to be close to an inner surface of the distal end of the body of the drive screw, and the inner surface is arranged to be perpendicular to the rod.

[0210] Example 44. A method according to any example herein, in particular any of Examples 36-43, wherein in the released orientation the release member is arranged away from and separated from the implantable medical device.

[0211] Example 45. A method according to any of the examples herein, in particular any of Examples 36-44, wherein 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 portion of the inner shaft reaches a spool stop of a delivery device that is axially fixed relative to the inner shaft.

[0212] Example 46. A method according to any of the examples herein, in particular any of Examples 36-45, wherein passively retracting the drive screw includes: in response to a force pulling the inner shaft in a distal direction during loosening, retracting the drive screw in a distal direction, returning to the interior of the knob and moving one or more teeth of the knob along one or more corresponding grooves of the drive screw from the distal end of the one or more corresponding grooves to the proximal end.

[0213] Example 47. A method according to any example herein, in particular any example 36-46, wherein the steering mechanism includes a steering knob coupled to the distal end of the housing of the handle portion, and wherein the knob of the release mechanism is coupled to the proximal end of the housing of the handle portion.

[0214] Example 48. A method according to any example herein, in particular any of Examples 36-47, wherein the implantable medical device is a self-expanding prosthetic heart valve.

[0215] 49. A delivery device for an expandable, implantable medical device, the delivery device comprising: an inner shaft; one or more release members, each release member comprising a proximal end coupled to an outer surface of a distal portion of the inner shaft and a distal end configured to releasably couple to an implantable medical device disposed about the distal portion of the inner shaft, the distal end being distal to the location where the proximal end is coupled to the inner shaft; and a handle portion, the handle portion comprising: a steering mechanism configured to adjust the curvature of and flex the one or more shafts of the delivery device at the distal portion of the delivery device, the one or more shafts including the inner shaft; and a release mechanism configured to adjust the linear orientation of the inner shaft and the one or more release members relative to the housing of the handle portion along a central longitudinal axis of the delivery device, the release mechanism comprising: a threaded drive screw and a screw threaded portion configured to engage with the proximal end of the inner shaft and the ...

[0216] Example 50. A delivery device according to any example herein, in particular Example 49, wherein each of the one or more teeth of the release knob is less than a full thread and curves less than 45 degrees around the circumference of the proximal end of the release knob.

[0217] Example 51. A delivery device according to any of the examples herein, in particular any of Examples 49-50, wherein the body of the drive screw further comprises one or more retaining elements arranged at the proximal end of the body, wherein each of the one or more grooves of the helical threaded portion is connected to a corresponding retaining element of the one or more retaining elements and bends around the outer surface of the body and extends from the retaining element to the distal end of the body.

[0218] Example 52. A delivery device according to any of the examples herein, in particular Example 51, wherein the drive screw is linearly movable between a starting locking configuration and a release configuration, wherein in the starting locking configuration, each tooth of the one or more teeth is coupled to a corresponding retaining element of the one or more retaining elements, and the entire helical thread portion of the drive screw is arranged inside the release knob and the handle portion, and in the release configuration, each tooth cooperates with the distal portion of the corresponding groove, the distal portion being arranged closer to the distal end than the proximal end of the body, and most of the helical thread portion of the drive screw extends in the axial direction to the outside of the proximal end of the release knob.

[0219] Example 53. A delivery device according to any of the examples herein, in particular Example 52, wherein each retaining element includes a protruding member, a first linear threaded portion arranged on a first side of the protruding member, and a second linear threaded portion arranged on a second side of the protruding member, the second linear threaded portion being connected to and continuous with a corresponding groove in one or more grooves of the drive screw.

[0220] Example 54. A delivery device according to any example herein, in particular example 53, wherein in the initial locked configuration, each tooth is arranged within the first linear threaded portion of the corresponding retaining element.

[0221] Example 55. A delivery device according to any of the examples herein, in particular any of Examples 49-54, wherein the drive screw includes an extension portion extending axially outward from the distal end of the body, the extension portion including a central hole centered along the central longitudinal axis and two side holes radially offset from the central hole on each side of the central hole.

[0222] Example 56. A delivery device according to any example herein, in particular Example 55, wherein the inner shaft extends through the central hole.

[0223] Example 57. The delivery device according to any of the examples herein, in particular any of Examples 55-56, further comprises two rods, each rod comprising a distal end comprising an internal connecting element fixedly coupled to the handle portion and a proximal end comprising a stop element, the stop element having a dimension wider than the diameter of the rod, wherein each rod extends through a respective one of the two side holes of the drive screw, and the stop element is arranged in an open cavity inside the body of the drive screw, the open cavity being arranged between the proximal and distal ends of the body, and wherein the drive screw is configured to move linearly along the two rods.

[0224] Example 58. A delivery device according to any of the examples herein, in particular Example 57, wherein the stop element is wider than the maximum width of the side hole of the drive screw, and wherein the open cavity is formed by an inner wall of the body and an inner surface arranged between the extension portion and the distal end of the body, and the inner surface is arranged to be perpendicular to the central longitudinal axis.

[0225] Example 59. A delivery device according to any of the examples herein, in particular any of Examples 49-58, wherein the thread formed by one or more grooves of the helical thread portion is a double-thread thread formed by two grooves, and wherein the release knob includes two teeth, each tooth being configured to cooperate with and slide along a different one of the two grooves.

[0226] Example 60. A delivery device according to any example herein, in particular Example 59, wherein the two teeth are spaced apart from one another around the circumference of the proximal end of the release knob.

[0227] Example 61. A delivery device according to any example herein, in particular any of Examples 59-60, wherein the threads of the drive screw have a lead of at least 1 inch and a pitch of at least 0.5 inches.

[0228] Example 62. A delivery device according to any example herein, in particular any of Examples 59-60, wherein the threads of the drive screw have a lead in the range of 1-1.75 inches.

[0229] Example 63. A delivery device according to any of the examples herein, in particular any of Examples 49-62, wherein the steering mechanism includes a steering knob configured to rotate relative to the housing of the handle portion, and wherein the steering knob is coupled to the distal end of the housing of the handle portion, and the release knob of the release mechanism is coupled to the proximal end of the housing of the handle portion.

[0230] Example 64. A delivery device according to any of the examples herein, in particular any of Examples 49-63, wherein each of the one or more teeth of the release knob extends only a portion of the total distance between the proximal end and the distal end from the proximal end of the release knob toward the distal end of the release knob, wherein the portion is less than 1 / 10 of the total distance.

[0231] Example 65. The delivery device according to any of the examples herein, in particular any of Examples 49-64, further comprises an outer shaft comprising a proximal portion coupled to a handle portion and a distal portion, and further comprising a capsule coupled to the distal portion of the outer shaft, wherein the inner shaft is concentric with the interior of the outer shaft, and wherein the capsule is configured to accommodate an implantable medical device in a radially compressed state on the distal portion of the inner shaft.

[0232] Example 66. A delivery apparatus according to any example herein, in particular any of Examples 49-65, wherein the implantable medical device is a prosthetic heart valve configured to radially self-expand to a functional size of the prosthetic heart valve.

[0233] Example 67. A delivery device according to any of the examples herein, in particular any of Examples 49-66, wherein the release knob includes a body arranged outside the housing of the handle portion and a collar extending distally from the distal end of the body of the release knob to the interior of the housing of the handle portion, the collar including one or more collar grooves extending around the circumference of the collar, each collar groove mating with a corresponding annular protrusion extending radially from the inner surface of the housing of the handle portion, wherein the release knob is fixed so as not to translate in the axial direction and is configured to rotate about the central longitudinal axis relative to the housing of the handle portion via a mating connection between each collar groove and the corresponding annular protrusion.

[0234] Given that the principles of the disclosed technology can be applied to many feasible embodiments, it should be recognized that the illustrated embodiments are merely preferred examples of the disclosed technology and should not be considered as limiting the scope of the claimed subject matter. Instead, the scope of the claimed subject matter is defined by the appended claims and their equivalents.

Claims

1. A delivery device for an expandable, implantable medical device, the delivery device comprising: a handle portion comprising a release mechanism configured to adjust a linear orientation of a component of the delivery device relative to a central longitudinal axis of the delivery device, the release mechanism comprising: a threaded drive screw comprising a helical threaded portion having a lead of at least one inch, wherein the helical threaded portion includes one or more grooves extending around the drive screw, the drive screw being coupled to the component; a rotatable knob surrounding and coaxial with the drive screw, the knob comprising one or more teeth disposed at a proximal end of the knob, each of the one or more teeth being configured to engage a corresponding one of the one or more recesses of the drive screw, wherein each of the one or more teeth extends from the proximal end to the distal end of the knob for only a portion of a total distance between the proximal and distal ends, wherein the portion is less than 1 / 4 of the total distance; and A cap is coupled to the drive screw, the cap having a proximal port.

2. The delivery device of claim 1 , wherein the threaded drive screw comprises one or more retaining elements disposed at a proximal end of the drive screw, wherein each of the one or more grooves of the helical threaded portion is connected to a corresponding retaining element of the one or more retaining elements and extends around the drive screw from the corresponding retaining element to a distal end of the drive screw, and wherein each of the one or more teeth is configured to engage with a corresponding retaining element.

3. The delivery device of claim 2 , wherein each tooth is configured to mate with and travel along the corresponding groove when the knob is rotated about the central longitudinal axis, wherein the drive screw is configured to move linearly in an axial direction relative to the knob when the knob is rotated and the teeth travel along the corresponding groove, wherein the knob is fixed against translation in the axial direction, wherein the axial direction is relative to the central longitudinal axis, wherein the knob includes a collar extending distally from the distal end of the knob into the interior of the housing of the handle portion, the collar including one or more collar grooves extending around a circumference of the collar, each collar groove mating with a corresponding annular protrusion extending radially from an inner surface of the housing of the handle portion, and wherein the knob is fixed against translation in the axial direction and is configured to rotate relative to the housing of the handle portion about the central longitudinal axis by a mating connection between each collar groove and the corresponding annular protrusion.

4. The delivery device of claim 2 or claim 3, wherein the drive screw is linearly movable between an initial locking configuration in which each tooth is coupled to the corresponding retaining element and the entire helical thread portion of the drive screw is disposed inside the knob and the handle portion, and a release configuration in which each tooth engages with a distal portion of the corresponding recess, the distal portion being disposed closer to the distal end than the proximal end of the drive screw, and a majority of the helical thread portion of the drive screw extends outwardly from the proximal end of the knob in the axial direction.

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

6. The delivery device of any one of claims 2-3 and 5, further comprising a rod including a distal end fixedly coupled to an inner surface of the handle portion, and wherein the drive screw includes an extension portion extending axially outward from the distal end of the drive screw, the extension portion including an inner bore mounted around the rod and configured to slide linearly along the rod.

7. The delivery device of claim 6 , wherein the proximal end of the rod comprises a stop element that is wider than a maximum width of the inner bore of the drive screw, and wherein the stop element is disposed within an open cavity within an interior of the drive screw, the open cavity being disposed between the proximal and distal ends of the drive screw.

8. The delivery device of claim 6, wherein the extension portion further comprises a central bore centered along the central longitudinal axis, wherein the inner bore is radially offset from the central bore, and wherein the central bore is configured to accommodate an inner shaft of the delivery device therethrough.

9. The delivery device of any one of claims 1-3, 5, and 7-8, wherein the release mechanism is configured to adjust the component of the delivery device in the linear orientation comprises one or more release members removably coupled to the implantable medical device.

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

11. The delivery device of any one of claims 1-3, 5, 7-8, and 10, wherein the thread formed by the one or more grooves of the helical thread portion is a double-start thread formed by two grooves, and wherein the drive screw has two retaining elements, each groove extending from a different one of the two retaining elements, and wherein the knob includes two teeth, each tooth configured to cooperate with and slide along a different one of the two grooves, the two teeth being spaced apart from each other around the circumference of the proximal end of the knob.

12. The delivery device of any one of claims 1-3, 5, 7-8, and 10, wherein the handle portion further comprises a steering mechanism comprising a steering knob configured to rotate relative to a housing of the handle portion at a distal end portion of the delivery device and adjust the curvature of one or more axes of the delivery device.

13. The delivery apparatus of any one of claims 1-3, 5, 7-8, and 10, wherein the implantable medical device is a prosthetic heart valve configured to radially self-expand to a functional size of the prosthetic heart valve.

14. The delivery device of any one of claims 1-3, 5, 7-8, and 10, 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. A delivery device for an expandable, implantable medical device, the delivery device comprising: inner shaft; one or more release members, each release member including a proximal end coupled to an outer surface of a distal portion of the inner shaft and a distal end configured to releasably couple to an implantable medical device disposed about the distal portion of the inner shaft, the distal end being distal to where the proximal end is coupled to the inner shaft; as well as The handle portion comprises: a steering mechanism configured to adjust the curvature of and flex one or more shafts of the delivery device at a distal portion of the delivery device, the one or more shafts including the inner shaft; a release mechanism configured to adjust the linear orientation of the inner shaft and the one or more release members relative to the housing of the handle portion along a central longitudinal axis of the delivery device, the release mechanism comprising: a threaded drive screw coupled to the proximal end of the inner shaft and comprising a helical threaded portion disposed in a body of the drive screw, wherein one or more grooves forming the helical threaded portion extend from a proximal end to a distal end of the 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 comprising one or more teeth disposed at a proximal end of the knob and configured to engage the one or more grooves of the drive screw, wherein the drive screw is adapted to move linearly relative to the release knob along the central longitudinal axis in response to rotation of the release knob and sliding of the one or more teeth along the one or more grooves, and wherein actuating the steering mechanism to loosen the one or more shafts of the delivery device allows the drive screw to move distally along the central longitudinal axis to release tension generated in the distal portion of the delivery device; and A cap is coupled to the drive screw and the inner shaft, the cap having a proximal port.

16. The delivery device of claim 15, wherein each of the one or more teeth of the release knob is less than a full thread and curves less than 45 degrees around the circumference of the proximal end of the release knob.

17. A delivery device according to claim 15 or claim 16, wherein the body of the drive screw further comprises one or more retaining elements arranged at the proximal end of the body, wherein each of the one or more grooves of the helical threaded portion is connected to a corresponding retaining element of the one or more retaining elements and bends around the outer surface of the body and extends from the retaining element to the distal end of the body.

18. The delivery device of claim 17 , wherein the drive screw is linearly movable between an initial locking configuration and a release configuration, wherein in the initial locking configuration, each of the one or more teeth is coupled to a corresponding retaining element of the one or more retaining elements, and the entire helical thread portion of the drive screw is disposed inside the release knob and the handle portion, and wherein in the release configuration, each tooth engages with a distal portion of a corresponding groove of the one or more grooves, the distal portion being disposed closer to the distal end than the proximal end of the body, and a majority of the helical thread portion of the drive screw extends in an axial direction to an outside of the proximal end of the release knob.

19. The delivery device of any one of claims 15-16 and 18, wherein the thread formed by the one or more grooves of the helical threaded portion is a double-start thread formed by two grooves, wherein the release knob comprises two teeth, each tooth configured to mate with and slide along a different one of the two grooves, wherein the two teeth are spaced apart from each other around the circumference of the proximal end of the release knob, and wherein the thread of the drive screw has a lead in the range of 1-1.75 inches.

20. The delivery device of any one of claims 15-16 and 18, wherein each of the one or more teeth of the release knob extends from the proximal end of the release knob to the distal end of the release knob for only a portion of the total distance between the proximal end and the distal end, wherein the portion is less than 1 / 10 of the total distance.

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