HEART VALVE REPAIR DEVICE AND DELIVERY DEVICE THEREFOR - Patent application

Abstract

A handle assembly for controlling an implantable device includes an actuation element extending through the sheath, a paddle actuation control coupled to the actuation element, and a visual indicator. In some implementations, the handle includes a paddle width adjustment element and a paddle width control operable to axially move the paddle width adjustment element, thereby moving a width of at least one of a pair of paddles of the implantable device from a first width to a second width. In some implementations, a visual indicator is coupled to the actuation element or the paddle width adjustment element through the handle housing and configured to provide an indication regarding a configuration of the implantable device.

Description

[Background technology]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 315,958, filed March 2, 2022, entitled “Heart Valve Repair Devices and Delivery Devices Therefor,” which are hereby incorporated by reference in their entirety for all purposes.

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring the forward flow of blood to be properly delivered through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc., and therefore can be less effective. Such damage to the valves can lead to severe cardiovascular disorders or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant devices to treat the heart in a much less invasive manner than open-heart surgery. As one example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, up the inferior vena cava, and into the right atrium). The septum is then punctured and the catheter threaded into the left atrium. A similar transvascular technique can be used, beginning as the transseptal technique but not going as far as puncturing the septum, and instead implanting a device inside the tricuspid valve that rotates the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers toward the apex and base. The heart is a four-chambered structure, including the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure than other native heart valves. The mitral valve includes an annulus portion, which is a ring-shaped portion of native valve tissue that surrounds the mitral valve opening, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet may be larger than the posterior leaflet, and when closed together, form a generally "C" shaped boundary between the abutting sides of the leaflets.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve that can only allow blood to flow from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygen-rich blood that is collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the rising blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium, but instead is ejected out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous chordae, called chordae tendineae, anchor the leaflets to papillary muscles in the left ventricle.

[0005] Valve regurgitation involves a valve inappropriately allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of heart contraction, allowing blood to flow from the left ventricle to the left atrium. Mitral regurgitation is one of the most common conditions of valvular heart disease. Mitral regurgitation can have many different causes, such as prolapse of the leaflets, insufficient papillary muscles, stretching of the mitral annulus from dilation of the left ventricle, or a combination of these. Mitral regurgitation in the central portion of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the commissures of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and regurgitation is present. Tricuspid regurgitation can be similar, except on the right side of the heart. Summary of the Invention

[0006] This summary of the present invention is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any features included in the examples of this summary are not required by the claims unless the claims explicitly recite those features. Also, the features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure can be included in the examples summarized herein.

[0007] In some implementations, an implantable device or implant (such as, for example, an implantable device) is provided that is configured to be positioned within the native heart valve so that the native heart valve can form a more effective seal.

[0008] In some implementations, the implantable device or implant includes an anchor portion, each anchor including a plurality of paddles, each movable between an open position and a closed position.

[0009] In some implementations, a handle assembly for controlling a transvascularly implantable device includes a handle housing, a sheath extending distally from the handle housing, an actuation element extending through the sheath, a paddle actuation control (e.g., a knob, button, switch, lever, etc.) coupled to the actuation element, and at least one visual indicator coupled to the actuation element through the handle housing.

[0010] In some implementations, the paddle actuated control is configured such that actuation of the paddle actuated control can cause an actuation element to move axially and axial movement of the actuation element can cause the implantable device to move between an open position and a closed position, and the at least one visual indicator is configured to provide an indication regarding a configuration of the implantable device (e.g., open, closed, partially closed, other configuration, etc.).

[0011] In some implementations, the paddle actuation control is a knob rotatable relative to the handle housing, hi some implementations, rotation of the paddle actuation knob moves the actuation element axially relative to the handle housing and sheath.

[0012] In some implementations, the actuation element is configured to be coupled to an implantable device.

[0013] In some implementations, a handle assembly for controlling a transvascularly implantable device includes one, all, or a portion of a handle housing, a sheath extending distally from the handle housing, an actuation element extending through the sheath, a paddle actuation control (e.g., a knob, button, switch, lever, etc.) coupled to the actuation element, a paddle width adjustment element, a paddle width control (e.g., a knob, button, switch, lever, etc.) coupled to the paddle width adjustment element, and an indicator (e.g., at least one visual and / or audible indicator, etc.) coupled to the paddle width adjustment element through the handle housing.

[0014] In some implementations, the actuation element is configured to be coupled to an implantable device.

[0015] In some implementations, the paddle width adjustment element is configured to be coupled to at least one of a pair of paddles of an implantable device.

[0016] In some implementations, the paddle actuated control is configured such that actuation of the paddle actuated control can cause an actuating element to move axially, and axial movement of the actuating element can cause the implantable device to move between an open position and a closed position.

[0017] In some implementations, the paddle actuation control is a knob rotatable relative to the handle housing, hi some implementations, rotation of the paddle actuation knob moves the actuation element axially relative to the handle housing and sheath.

[0018] In some implementations, the paddle width control is configured such that, when the paddle width control is actuated, the paddle width adjustment element can move axially relative to the handle housing and the sheath, thereby moving the width of at least one of the pair of paddles of the implantable device from a first width to a second width.

[0019] In some implementations, the paddle width control is configured as a paddle width control knob, and when the paddle width control knob is rotated, the paddle width adjustment element moves axially relative to the handle housing and the sheath, thereby moving the width of at least one of the pair of paddles of the implantable device from a first width to a second width.

[0020] In some implementations, the at least one visual indicator is configured to provide an indication regarding one or more configurations of the implantable device (e.g., whether the paddle is open, closed, partially closed, width, other configuration, etc.).

[0021] In some implementations, a steerable catheter assembly is provided that includes a catheter with at least one control element for bending the catheter and a control handle coupled to the catheter.

[0022] In some implementations, the control handle includes a control (eg, a knob, button, switch, lever, etc.) coupled to at least one control element.

[0023] In some implementations, one or more visual indicators can be coupled to at least one control element through the housing.

[0024] In some implementations, actuation of the control causes at least one control element to move axially relative to the housing to move the catheter between a first straight configuration and a second curved configuration.

[0025] In some implementations, the control is configured as a control knob that is rotatable relative to a housing of the control handle, hi some implementations, rotation of the control knob moves at least one control element axially relative to the housing to move the catheter between a first straight configuration and a second curved configuration.

[0026] The one or more visual indicators are configured to provide an indication regarding one or more configurations of the implantable device (e.g., open, closed, partially closed, width, other configuration, etc. of the paddle) and / or one or more configurations of the catheter (e.g., straight, curved, partially curved, multiple curves, other configuration, etc.).

[0027] Any of the above systems, assemblies, devices, equipment, components, etc. may be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for patient use, and the above methods may include (or the additional methods may include or consist of) sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, components, etc. described herein.

[0028] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like elements bear like reference numerals and in which:

[0029] To further clarify various aspects of the implementation of the present disclosure, certain embodiments and implementations will be described in more detail by reference to various aspects of the accompanying drawings. These drawings depict only exemplary implementations of the present disclosure and therefore are not to be considered as limiting the scope of the present disclosure. Furthermore, the drawings may be drawn to scale for some embodiments, but not necessarily to scale for all embodiments. The embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0030] [Figure 1] FIG. 1 shows a cross-section of a human heart in diastole. [Diagram 2] FIG. 2 shows a cross-section of a human heart during systole. [Diagram 3] FIG. 3 shows a cross-section of a human heart during systole, showing mitral valve regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to show the natural shape of the mitral valve leaflets during systole. [Diagram 5] FIG. 5 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 6]FIG. 6 shows an incompetent mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] FIG. 8 illustrates one embodiment of an implantable device or implant at one stage of deployment. [Figure 9] FIG. 9 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 10] FIG. 10 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 11] FIG. 11 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 12] FIG. 12 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 13] FIG. 13 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 14] FIG. 14 illustrates one embodiment of an implantable device or implant at different stages of deployment. [Figure 15] FIG. 15 illustrates one embodiment of an implantable device or implant similar to the device illustrated in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] FIG. 16 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] FIG. 17 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] FIG. 18 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19] FIG. 19 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 20] FIG. 20 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] FIG. 21 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 23] FIG. 23 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 24] FIG. 24 illustrates an exemplary valve repair device with the paddle in an open position. [Figure 25A] FIG. 25A shows another exemplary valve repair device with the paddles in a closed position. [Figure 25B] FIG. 25B shows a top view of an exemplary valve repair device. [Figure 26] FIG. 26 shows a perspective view of an exemplary implantable device having paddles with adjustable width. [Figure 27] FIG. 27 is a cross-sectional view of the implantable device of FIG. 26, where the implantable device is bisected. [Figure 28] 28 is another cross-sectional view of the implantable device of FIG. 26, where the implantable device is bisected along a plane perpendicular to the plane shown in FIG. [Figure 29] FIG. 29 is a schematic diagram of an exemplary implant catheter assembly coupled to an implantable device, where the actuation elements are coupled to the paddle actuation controls and driver head of the implantable device. [Diagram 30] FIG. 30 is a view of the assembly of FIG. 29 with the implantable device rotated 90 degrees to show a paddle width adjustment element coupled to a movable member of the implantable device and coupled to a paddle width control. [Diagram 31] FIG. 31 shows the distal end of an exemplary delivery assembly including a delivery device and an implantable device. [Diagram 32]FIG. 32 shows the proximal end of the exemplary delivery assembly of FIG. [Figure 33A] 33A shows a cross-sectional view of the handle of the steerable catheter assembly of the exemplary delivery assembly of FIG. [Figure 33B] FIG. 33B shows an enlarged portion of FIG. 33A, as indicated by box 33B in FIG. 33A. [Diagram 34] FIG. 34 is a perspective view of an exemplary handle of an implant catheter assembly. [Diagram 35] FIG. 35 is a cross section of the handle in FIG. 34 perpendicular to the plane defined by line AA, with one of the clasp control tubes bisected. [Diagram 36] FIG. 36 is another cross-section of the handle in FIG. 34 perpendicular to the plane defined by line BB, where the release knob is bisected. [Figure 37] FIG. 37 is an enlarged portion of FIG. [Figure 38] FIG. 38 is a perspective view of an exemplary handle of an implant catheter assembly including a visual indicator. [Figure 39] FIG. 39 is a side view of the exemplary handle of FIG. [Figure 40A] FIG. 40A is an exemplary cross-sectional view of the exemplary handle of FIG. 39, where the visual indicator is configured to provide an indication regarding the configuration of the device. [Figure 41B] FIG. 40B is an exemplary cross-sectional view of the exemplary handle of FIG. 39, where the visual indicator is configured to provide an indication regarding the width of the paddle of the device. [Diagram 42] FIG. 41 is another exemplary handle for an implant catheter assembly that includes a visual indicator. [Diagram 43] FIG. 42 is an exploded view of an exemplary paddle width control including a visual indicator. [Diagram 44] FIG. 43 is a side view of an exemplary paddle width control including a visual indicator. [Diagram 45]44 is a cross-sectional view of the example paddle width control of FIG. [Diagram 46] FIG. 45 is a perspective view of another exemplary handle of an implant catheter assembly including two visual indicators. [Figure 47] FIG. 46 is a perspective view of another exemplary handle of an implant catheter assembly that includes two visual indicators and provides additional detail regarding the width control mechanism. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] In the following description, reference is made to the accompanying drawings which illustrate example implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0032] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations of valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or physically impossible. Furthermore, the techniques and methods herein can be performed on live animals, or on non-biological simulations such as cadavers, cadaver hearts, simulators (e.g., where body parts, tissues, etc. are simulated). The term simulation encompasses use of cadavers, computer simulators, virtual people (e.g., showing in air on a virtual heart), and the like.

[0033] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or may be indirect, such as through the use of one or more intermediate components. Also, references to a "member," "component," or "portion" described herein are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. Also, as used herein, the terms "substantially" and "about" are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0034] 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) that extend inwardly across their respective valve openings, which come together or "coapt" in flow to form a unidirectional fluid occlusion surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and the left ventricle LV will be described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0035] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase, or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during the contraction phase) is moved into the left ventricle LV through the mitral valve MV by the expansion of the left ventricle LV. During the contraction phase, or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described in this application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closing of the leaflets of the mitral valve to prevent, inhibit, or reduce blood from flowing back from the left ventricle LV into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that beneficially acts as a filler within the regurgitant opening to prevent or reduce backflow or reflux during systole, although this is not required.

[0036] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see Figure 5), which is a variably dense fibrous ring of tissue that surrounds the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located in the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from everting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressure required to circulate blood through the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets coapt at their free ends and the leaflets 20, 22 begin to retract or spread apart from one another. The leaflets 20, 22 spread apart toward the atrium until each leaflet contacts the mitral valve annulus.

[0037] Various disease processes can impair the proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (e.g., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathies, etc.) can distort the shape of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valve surgery, such as mitral valve MV surgery, suffer from a degenerative disease that causes the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV) to malfunction, resulting in prolapse and regurgitation.

[0038] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open completely and allow forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely, causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0039] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, II, and III insufficiencies. Carpentier's Type I insufficiency involves dilatation of the valve annulus, so that normally functioning leaflets move apart and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in the insufficiency of the Type I mechanism is leaflet perforation, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves restricted movement of one or more leaflets of the native valve, so that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilatation.

[0040] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 are coapted, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during systole, so that the edges of the leaflets 20, 22 do not contact each other. Such malcoaptation creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle LV into the left atrium LA during systole, as shown by the mitral regurgitation MR flow path in FIG. 3. With reference to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W of greater than 15 mm or even greater than 17.5 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valve regurgitation.

[0041] In any of the above mentioned situations, a valve repair device or implant that can engage the anterior leaflet 20 and the posterior leaflet 22 and close the gap 26 to prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen from FIG. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 such that backflow does not occur during systole (compare FIG. 3 to FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, etc.) of the device 10 have a generally tapered or triangular shape that naturally conforms to the shape of the native valve and its expanded (towards the annulus) nature of the leaflets. In this application, terms such as spacers, coaptation elements, and gap fillers are used interchangeably to refer to elements that are configured to fill a portion of the space between the leaflets of the native valve and / or to engage or "coapt" the leaflets of the native valve (e.g., to coapt not only to each other but also to the coaptation elements, spacers, etc.).

[0042] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the burden on the heart H and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. This is because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating blood flow throughout the body. Thus, since pressures are substantially higher in the left side of the heart, insufficiency of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0043] Dysfunctional native heart valves can be either repaired or replaced. Repair typically involves maintaining and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or pulmonary valve can be removal of the valve and replacing it with a surgically implanted heart valve, or replacing it with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, prevents the mitral valve MV or tricuspid valve TV from closing properly and allows regurgitation or backflow of blood from the ventricle into the atrium (e.g., deformation of the mitral valve MV can allow regurgitation or backflow from the left ventricle LV into the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to incompetence of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior leaflet 20 and the posterior leaflet 22 to evert, resulting in blood flowing back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be ameliorated by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0044] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein can be used to repair any native valve, as well as to repair any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit backflow of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent or inhibit backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0045] An exemplary implantable device or implant may optionally have a coaptation element (e.g., a spacer, coaptation element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, the implantable device or implant may have any combination or subcombination of the features disclosed herein without a coaptation element. The coaptation element, if included, is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the above-mentioned backflow. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left or right ventricle into the left or right atrium, respectively. The device or implant may be configured to seal against two or three native valve leaflets, i.e., the device may be used with native mitral (bicuspid) and native tricuspid valves. The coaptation elements are sometimes referred to herein as spacers because the coaptation elements may fill the space between native valve leaflets (eg, mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that do not close completely or function properly.

[0046] The optional coaptation elements (spacers, coaptation elements, gap fillers, etc.) may have a variety of shapes. In some implementations, the coaptation elements may have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements may have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation elements may have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid leaflets.

[0047] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between two native leaflets. In some implementations configured for use with a tricuspid valve, the anchors are configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors can be attached to an actuating element, such as a shaft or actuating wire, to which the coaptation element is also attached. In some implementations, the anchors and coaptation elements can be independently positioned relative to one another by separately moving each of the anchors and coaptation elements along a longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchors and coaptation elements can be simultaneously positioned by moving the anchors and coaptation elements together along a longitudinal axis of the actuating element. The anchors may be configured to be positioned behind the native valve leaflets when implanted such that the leaflets are grasped by the anchors.

[0048] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation element and anchor may be compressible to a radially compressed state and may be allowed to self-expand to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor is radially expanded away from the initially still compressed coaptation element to create a gap between the coaptation element and the anchor. The native leaflet may then be positioned within the gap. The coaptation element may be radially expanded to close the gap between the coaptation element and the anchor to capture the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation method for some implementations may vary and is described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, which are incorporated by reference in their entirety for all purposes. These methods can be performed, mutatis mutandis, on live animals or can be performed on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0049] The disclosed device or implant may be configured such that anchors are connected to the leaflets and utilize tension from the natural chordae tendineae to resist high systolic pressures that urge the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces exerted against the leaflets that are gripped by the anchors.

[0050] 8-15, a schematic representation of an implantable device or implant 100 (e.g., an implantable prosthetic device, prosthetic spacer device, valve repair device, etc.) is shown in various stages of deployment. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties. The device 100 may include any other features of another implantable device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0051] The device or implant 100 is deployed from a delivery system or other delivery means 102. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, etc. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0052] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element 110 that is slidably attached to an actuation element 112 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping element, or the like. When the actuation element 112 is actuated, the anchor portion 106 of the device 100 opens and closes to grip the native valve leaflets during implantation. The actuation element 112 (as well as other actuation elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As one example, the actuating element can be threaded such that when the actuating element is rotated, the anchor portion 106 moves relative to the interface portion 104. Alternatively, the actuating element can be unthreaded such that pushing or pulling the actuating element 112 moves the anchor portion 106 relative to the interface portion 104.

[0053] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be interfaced and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, interface element 110, and cap 114 by portions 124, 126, 128 may constrain the device to the positions and movements shown herein.

[0054] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuating element 112, which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating element 112 extends through the delivery catheter and the interface element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases, respectively, the spacing between the interface element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion). In some implementations, a collar or other attachment element (e.g., a coupler, fastener, line of suture, etc.) removably attaches, either directly or indirectly, the spacer or joint element 110 to the delivery system 102 such that the actuation element 112 slides through the collar or other attachment element, and in some implementations, through the joint element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0055] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member (e.g., a clasp, a clamp, etc.). The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, optional friction enhancing elements, other securing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and an interface portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the interface portion 138 disposed proximate to the interface element 110. The interface portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The interface portion 138 may be any suitable interface, such as a flexible interface, a spring interface, a pivot interface, or the like. In some implementations, interface portion 138 is a flexible piece of material integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains fixed or substantially fixed relative to inner paddle 122 when movable arm 134 is released to release clasp 130 and expose barb, friction enhancing element, or fastening means 136.

[0056] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend or pivot on a joint 138. The actuation line 116 extends through the delivery system 102 (e.g., through the steerable catheter and / or the implant catheter). Other actuation mechanisms are also possible.

[0057] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that the clasp 130 continues to provide a clamping force to the grasped native leaflet in the closed position. Optional barbs or frictional reinforcement elements 136 of the clasp 130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0058] During implantation, the paddles 120, 122 may be opened and closed, for example, to grip the native leaflets (e.g., leaflets of a native mitral valve, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (e.g., spacer, plug, membrane, etc.). The clasps 130 may be used to grip and / or further secure the native leaflets by engaging the leaflets with optional barbs or other optional friction enhancing elements 136 and clamping the leaflets between the movable arm 134 and the fixed arm 132. The friction enhancing elements 136 (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesives, etc.) of the clasps 130 may be configured to increase friction against the leaflets or to partially or fully pierce the leaflets. The actuation lines 116 may be actuated separately such that each clasp 130 may be opened and closed separately. Acting separately allows one leaflet to be grasped at a time, or the clasp 130 to be repositioned on a leaflet that was not adequately grasped without changing the good grip on the other leaflets. The clasp 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), allowing the leaflets to be grasped in various positions as the particular situation requires.

[0059] 8, the device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is placed at the end of the catheter of the delivery system 102 in the fully open position. In the extended state, the cap 114 is spaced apart from the interface element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 can be held closed during deployment through the delivery system. The actuation line 116 can extend to and be attached to a movable arm 134.

[0060] 9, device 100 is shown in an extended state similar to FIG. 8, but with clasp 130 in a range of about 140 degrees to about 200 degrees, in a range of about 170 degrees to about 190 degrees, or in a fully open position of about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130.

[0061] 10, the device 100 is shown in a contracted or fully closed state. To move the device 100 from the extended state to the contracted state, the actuation element 112 is retracted, pulling the cap 114 towards the interface element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained from moving, so that the compressive force acting on the outer paddle 120 from the cap 114 retracting towards the interface element 110 moves the paddle or other gripping element radially outward. The outer paddle 120 maintains an acute angle with the actuation element 112 during movement from the open position to the closed position. The outer paddle 120 can optionally be biased towards the closed position. The inner paddle 122 moves through a very large angle and crushes along the side of the closed interface element 110 because it is oriented away from the open interface element 110 during the same movement.

[0062] 11-13, the device 100 is shown in a partially open, ready-to-grasp state. To move from the fully closed state to the partially open state, the actuation element is extended to push the cap 114 away from the coaptation element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation line 116 is also retracted to open the clasp 130 so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 will close the clasp. In some implementations, the paddles 120, 122 can be independently controllable. In the embodiment shown in FIG. 15, the device 100 may have two actuating elements 111, 113 and two independent caps 115, 117 (or other mounting parts), such that one independent actuating element and cap (or other mounting part) is used to control one paddle and the other independent actuating element and cap (or other mounting part) is used to control the other paddle.

[0063] 12, one of the actuation lines 116 can be extended to close one of the clasps 130. Now, referring to FIGURE 13, the other actuation line 116 can be extended to close the other clasp 130. One or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0064] 14, the device 100 is shown in a fully closed and deployed state. The delivery system 102 and actuation element 112 are retracted and the paddles 120, 122 and clasp 130 remain in a fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal such as steel or from a shape memory alloy such as Nitinol that is fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 120 closed around the interface element 110 and the clasp 130 in a clamped state around the native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0065] Figure 15 shows an embodiment in which the paddles 120, 122 are independently controllable. The device 101 shown in Figure 15 is similar to the device shown in Figure 11, except that the device 100 of Figure 15 includes an actuation element configured as two independent actuation elements 111, 113 coupled to two independent caps 115, 117. The actuation element 111 is extended to push the cap 115 away from the interface element 110 to transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially expand. The actuation element 113 is extended to push the cap 115 away from the spacer or mating element 110 to transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control shown in Figure 15 can be implemented in any of the devices disclosed in this application. For comparison, in the embodiment shown in Figure 11, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112.

[0066] 16-21, the implantable device 100 of Figures 8-14 is shown delivered and implanted within the native mitral valve MV of the heart H. With reference to Figure 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in Figure 16. The actuating element 112 is then retracted, moving the implant / device to a fully closed state as shown in Figure 17.

[0067] As can be seen from Figure 18, the implant / device can be moved into position within the mitral valve MV and into the ventricle LV and partially opened to grasp the leaflets 20, 22. For example, the steerable catheter can be advanced and steered or bent to position the steerable catheter as Figure 18 shows. An implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant as Figure 18 shows.

[0068] 19, the implant catheter may be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The actuating line 116 is extended to close one of the clasps 130, capturing the leaflet 20. FIG. 20 shows the other actuating line 116 then being extended to close the other clasp 130, capturing the remaining leaflet 22. Finally, as can be seen from FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating element 112 and actuating line 116 are then retracted and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0069] Any of the features disclosed herein may be used in a wide variety of different valve repair devices. Figures 22-24 show examples of valve repair devices that may be modified to include any of the features disclosed herein. Any combination or subcombination of the features disclosed herein may be combined with, substituted for, and / or added to any combination or subcombination of the features of the valve repair devices shown in Figures 8-24.

[0070] 22, an embodiment of an implantable device or implant 200 is shown. The implantable device 200 is one of many different configurations that the device 100, shown generally in FIGS. 8-14, may take. The device 200 may include any of the other features of an implantable device or implant described herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein. The device / implant 200 may be an artificial spacer device, a valve repair device, or another type of implant that attaches to the leaflets of a native valve.

[0071] In some implementations, the implantable device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaptation element, plug, membrane, sheet, gap filler, etc.) for implantation between the leaflets of the native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism (e.g., a coupler, fastener, clamp, line or suture, etc.) of a delivery system. The delivery system for device 200 may be the same as or similar to delivery system 102 described above and may comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, and the like.

[0072] In some implementations, the joint elements 210 and paddles 220, 222 are formed from a flexible material, which may be a metal fabric formed as a mesh, woven fabric, braided fabric, or the like, or in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire, such as Nitinol, to provide shape setting capabilities, or any other flexible material suitable for implantation within the human body.

[0073] An actuation element (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) may extend from the delivery system and engage the implantable device or implant 200 to enable actuation thereof. In some implementations, the actuation element extends through the proximal collar 211 and the interface element 210 and engages the cap 214 of the distal portion 207. The actuation element may be configured to releasably engage the cap 214, such as with a threaded connection, such that the actuation element may be disengaged and removed from the device 200 after implantation.

[0074] The coaptation element 210 extends from a proximal collar 211 (or other attachment element) to an inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated, circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above, a tapered shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 may also be seen to substantially follow or approximate the shape of the paddle frame 224 when viewed from above.

[0075] The size and / or shape of the coaptation element 210 may be selected to minimize the number of implants required per patient (preferably one) while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element is about 10 mm. In some implementations, the overall geometry of the device 200 may be based on these two dimensions and the overall shape plan described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in a device with different dimensions. Additionally, using other dimensions and the shape plan described above will also result in a device with different dimensions.

[0076] In some implementations, the outer paddle 220 is joinably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is joinably attached to the joint element by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg, in that the inner paddle 222 is like an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0077] In some implementations, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is rigidified by a stiffening member (e.g., a bar, plate, rod, etc.) or a fixed portion of the fastener 230. The inner paddle 222, the outer paddle 220, and the interface elements may all be interconnected as described herein.

[0078] In some implementations, the paddle frame 224 is attached to the cap 214 at the distal portion 207 and extends to a connection portion 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a material that is stiffer and harder than the material forming the paddles 222, 220 such that the paddle frame 224 provides support for the paddles 222, 220.

[0079] The paddle frame 224 may provide additional clamping force between the inner paddle 222 and the coaptation element 210 and may help wrap the leaflets around the sides of the coaptation element 210. That is, the paddle frame 224 may be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 may constrain each of these components to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222, and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner and outer paddles 222 and 220) and by its attachment to the cap 214.

[0080] Configuring the paddle frame 224 in this manner widens the surface area, as compared to only the inner paddle 222. The increased surface area may also distribute the clamping force of the paddles 220 and paddle frame 224 against the native leaflet over a larger area of ​​the native leaflet to further protect the native leaflet tissue.

[0081] Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) is incorporated herein by reference in its entirety. The methods in these references may be adapted for use with the concepts herein and, mutatis mutandis, may be performed on live animals or may be performed on simulations such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0082] 23, one embodiment of an implantable device or implant 300 is shown. The implantable device 300 is one of many different configurations that the device 100 may assume, as shown generally in Figures 8-14. The device 300 may include any of the other features of an implantable device or implant described herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein.

[0083] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a coaptation portion 304, which optionally includes a coaptation element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors can also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging a capture mechanism of a delivery system.

[0084] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by sutures, by adhesive, by links, by latches, by integral formation, by combinations of any or all of these, etc.) In some implementations, the anchors 308 are attached to the interface element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0085] The anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to the cap 314 or other mounting portion. In this manner, the anchor 308 is configured similar to a leg, in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of a leg.

[0086] In some implementations including the interface element 310, the interface element 310 and the anchor 308 may be coupled together in a variety of ways. As shown in the illustrated embodiment, the interface element 310 and the anchor 308 may be coupled together by integrally forming the interface element 310 and the anchor 308 as a single, unitary component. This may be accomplished, for example, by forming the interface element 310 and the anchor 308 from a continuous piece 301 of braided or woven material, such as braided or interwoven Nitinol wire. In the illustrated embodiment, the interface element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous piece of fabric 301.

[0087] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 may be configured to move between various configurations by axially moving a distal end of the device (e.g., cap 314, etc.) relative to a proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement may be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0088] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or coaptation element 310. From the straight configuration, the anchor 308 can be moved to a fully collapsed configuration (e.g., FIG. 23), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device.

[0089] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 330 includes a base or fixed arm 332, a movable arm 334, a friction enhancing element 336 (e.g., barbs, grooves, protrusions, textured surfaces, etc.), and an interface portion 338. The fixed arm 332 is attached to the inner paddle 322 with the interface portion 338 disposed proximate to the interface element 310. The interface portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in a closed state.

[0090] The fixed arm 332 is attached to the inner paddle 322 by sutures through a hole or slot. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the clasp 330 and expose the optional barb 336. The clasp 330 is opened by applying tension to an actuation line attached to the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend on the interface 338.

[0091] In summary, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the joint element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, in the cap 314, and in the paddle frame 324 that are configured to receive the continuous piece of material 301. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of material 301, and other portions are formed from multiple overlapping or overlapping layers of the piece of material 301.

[0092] For example, Figure 23 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of material strips 301. The single continuous piece of material 301 may begin and end at various locations on the apparatus 300. The ends of the piece of material 301 may be at the same location or at different locations on the apparatus 300. For example, in the illustrated embodiment of Figure 23, the piece of material 301 begins and ends at the location of the inner paddle 322.

[0093] As with the implantable device or implant 200 described above, the size of the coaptation element 310 may be selected to minimize the number of implants required per patient (preferably one), while at the same time maintaining a low transvalvular gradient. Notably, by forming many of the components of the device 300 from a single piece of material 301, the device 300 may be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance at the widest point of the device 300 (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is approximately 5 mm.

[0094] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) is incorporated herein by reference in its entirety. The methods in these references may be adapted for use with the concepts herein and, mutatis mutandis, may be performed on live animals or may be performed on simulations such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0095] 24 illustrates another embodiment of one of many valve repair systems 400 for repairing a patient's native valve to which the concepts of the present application may be applied. The valve repair system 400 includes a delivery device 401 and a valve repair device 402.

[0096] The valve repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408. In one embodiment, the paddles 406 may be integrally formed with the base assembly. For example, the paddles 406 may be formed as an extension of a link of the base assembly. In the illustrated embodiment, the base assembly 404 of the valve repair device 402 includes a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406 such that moving the coupler 405 along the shaft 403 moves the paddles between an open position and a closed position. In this manner, the coupler 405 serves as a means for mechanically coupling the paddles 406 to the shaft 403 and for moving the paddles 406 between their open and closed positions when moved along the shaft 403.

[0097] In some implementations, the gripping member 408 is pivotally connected to the base assembly 404 such that the gripping member can be moved to adjust the width of the opening 414 between the paddle 406 and the gripping member 408 (e.g., the gripping member 408 can be pivotally connected to the shaft 403 or any other suitable member of the base assembly). The gripping member 408 can include an optional barbed portion 409 for attaching the gripping member to the valve tissue when the valve repair device 402 is attached to the valve tissue. When the paddle 406 is in the closed position, the paddle engages the gripping member 408 such that when the valve tissue is attached to the optional barbed portion 409 of the gripping member, the paddle secures the valve repair device 402 to the valve tissue. In some implementations, the gripping members 408 are configured to engage the paddles 406 such that the optional barbed portions 409 engage the valve tissue and the paddles 406 to secure the valve repair device 402 to the valve tissue. For example, in certain circumstances it may be advantageous to have the paddles 406 maintain an open position and have the gripping members 408 move outwardly toward the paddles 406 to engage the valve tissue and the paddles 406.

[0098] Although the embodiment shown in FIG. 24 shows a pair of paddles 406 and a pair of gripping members 408, it will be understood that the valve repair device 402 may include any suitable number of paddles and gripping members.

[0099] In some implementations, the valve repair system 400 includes a placement shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the valve repair device 402. The placement shaft 413 is detached from the shaft 403 after the valve repair device 402 is secured to the valve tissue, removing the valve repair device 402 from the remainder of the valve repair system 400 such that the valve repair device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0100] The valve repair system 400 may also include a paddle control mechanism 410 (e.g., wires, rods, shafts, tubes, etc.), a gripper control mechanism 411 (e.g., lines, sutures, wires, etc.), and a lock control mechanism 412 (e.g., lines, sutures, wires, rods, etc.). The paddle control mechanism 410 is mechanically attached to the coupler 405 such that moving the coupler along the shaft moves the paddles 406 between the open and closed positions. The paddle control mechanism 410 may take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism may comprise a hollow shaft, a catheter tube, or a sleeve that fits over the mounting shaft 413 and over the shaft 403 and is connected to the coupler 405.

[0101] Gripper control mechanism 411 is configured to move gripping member 408 such that the width of opening 414 between the gripping member and paddle 406 may be altered. Gripper control mechanism 411 may take any suitable form, such as, for example, a line, suture or wire, a rod, a catheter, etc.

[0102] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 serves as a locking means for locking the coupler 405 in a stationary position relative to the shaft 403 and can take a wide variety of different forms, and the type of lock control mechanism 412 can be dictated by the type of lock used. In embodiments where the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to move the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 412 can be, for example, a rod, suture, wire, or any other member capable of moving the pivotable plate of the lock 407 between the tilted position and the substantially non-tilted position.

[0103] The valve repair device 402 is movable from an open position to a closed position. The base assembly 404 includes a link that is moved by a coupler 405. The coupler 405 is movably attached to a shaft 403. To move the valve repair device from the open position to the closed position, the coupler 405 is moved along the shaft 403, thereby moving the link.

[0104] The gripper control mechanism 411 moves the gripping members 408 to provide a wider or narrower gap at the opening 414 between the gripping members and the paddle 406. In the illustrated embodiment, the gripper control mechanism 411 includes a line, such as a suture, wire, or the like, that is connected to an opening in the end of the gripper members 408. When the line is pulled, the gripping members 408 move inward, causing the opening 414 between the gripping members and the paddle 406 to become wider.

[0105] To move the valve restoration device 402 from an open position to a closed position, the lock 407 is moved to an unlocked state by the lock control mechanism 412. Once the lock 407 is in the unlocked state, the coupler 405 can be moved along the shaft 403 by the paddle control mechanism 410.

[0106] After the paddle 406 is moved to the closed position, the lock 407 is moved to a locked state by the lock control mechanism 412 to maintain the valve repair device 402 in the closed position. After the valve repair device 402 is maintained in the locked state by the lock 407, the valve repair device 402 is removed from the delivery device 401 by decoupling the shaft 403 from the mounting shaft 413. Additionally, the valve repair device 402 is removed from the paddle control mechanism 410, the gripper control mechanism 411, and the lock control mechanism 412.

[0107] Additional features of the device 402, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) is incorporated herein by reference in its entirety. The methods in these references may be adapted for use with the concepts herein and, mutatis mutandis, may be performed on live animals or may be performed on simulations such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0108] The clasp or leaflet grasping device disclosed herein can take a wide variety of different forms. An example of a clasp is disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Any combination or subcombination of the features disclosed by this application can be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201) is incorporated herein by reference in its entirety.

[0109] 25A and 25B, an exemplary implementation of the valve repair device 402 has a coaptation element 3800. The valve repair device 402 may have the same configuration as the valve repair device shown in FIG. 24 with the addition of the coaptation element. The coaptation element 3800 may take a wide variety of different shapes. The coaptation element 3800 may be compressible and / or expandable. For example, the coaptation element may be compressed to fit within one or more catheters of a delivery system, may expand when moved out of the one or more catheters, and / or may be compressed by paddles 406 to adjust the size of the coaptation element. In the embodiment shown in FIG. 25A and 25B, the size of the coaptation element 3800 may be decreased by squeezing the coaptation element with the paddles 406 and increased by moving the paddles 406 away from each other. The coaptation element 3800 may extend beyond the outer edge 4001 of the gripping member or clasp 408 as illustrated to provide additional surface area for closing the gap of the mitral valve.

[0110] The coaptation element 3800 may be coupled to the valve repair device 402 in a variety of different ways. For example, the coaptation element 3800 may be fixed to the shaft 403, slidably disposed about the shaft, connected to the coupler 405, connected to the lock 407, and / or connected to a central portion of the catch or gripping member 408. In some implementations, the coupler 405 may take the form of the coaptation element 3800. That is, a single element may be used as the coupler 405, which moves the paddle 406 between the open and closed positions, and the coaptation element 3800, which closes the gap between the leaflets 20, 22 when the valve repair device 402 is attached to the leaflets.

[0111] The interface element 3800 can be disposed about one or more of the shafts or other control elements of the valve repair system 400. For example, the interface element 3800 can be disposed about the shaft 403, the shaft 413, the paddle control mechanism 410, and / or the lock control mechanism 412.

[0112] The valve repair device 402 may include any other features for the valve repair device discussed in this application, and the valve repair device 402 may be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additional features of the device 402, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. 2019139904). The methods in these references may be adapted for use with the concepts herein and, mutatis mutandis, may be performed on live animals or may be performed on simulations such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0113] 26-30 show another embodiment of one of many valve repair systems for repairing a patient's native valve to which the concepts of the present application may be applied. With reference to FIGS. 29 and 30, the valve repair system includes an implant catheter assembly 1611 and an implantable valve repair device 8200. With reference to FIGS. 26-28, the implantable device 8200 includes a proximal or attachment portion 8205, a paddle frame 8224, and a distal portion 8207. The proximal portion 8205, the distal portion 8207, and the paddle frame 8224 may be configured in a variety of ways.

[0114] 26, the paddle frame 8224 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetrical about the axis YY. Further, with reference to FIG. 26, the paddle frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0115] In some implementations, the connector 8266 (e.g., a shaped metal component, a shaped plastic component, a tether, wire, post, line, cord, suture, etc.) is attached to the outer frame portion 8256 at an outer end of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 (see FIG. 28 ). Between the connector 8266 and the proximal portion 8205, the outer frame portion 8256 forms a curved shape. In the illustrated example, the shape of the outer frame member 8256 resembles an apple shape, with the outer frame member 8256 being wider toward the proximal portion 8205 and narrower toward the distal portion 8207. However, in some implementations, the outer frame portion 8256 may be shaped in other ways.

[0116] The inner frame portion 8260 extends from the proximal portion 8205 towards the distal portion 8207. The inner frame portion 8260 then extends inwardly to form a retaining portion 8272 that is attached to the actuation cap 8214. The retaining portion 8272 and the actuation cap 8214 can be configured to be attached in any suitable manner.

[0117] In some implementations, the inner frame portion 8260 is a rigid frame portion while the outer frame portion 8256 is a flexible frame portion. As shown in FIG. 26 , a proximal end of the outer frame portion 8256 connects to a proximal end of the inner frame portion 8260.

[0118] A width adjustment element 8211 (e.g., a width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move the outer frame portion 8256 from an expanded position to a narrowed position by pulling the inner end 8968 ( FIG. 28 ) and a portion of the connector 8266 on the actuation cap 8214. The actuation element 8102, according to some implementations disclosed herein, is configured to move the inner frame portion 8260 to open and close the paddles.

[0119] As shown in FIGS. 27 and 28 , the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a cylinder, a raceway, etc.) to move the outer frame portion 8256 between a constricted position and an expanded position. In the illustrated embodiment, the inner end 8968 includes a post 8970 that is attached to the outer frame portion 8256 and a coupler 8972 that extends from the post 8970. The coupler 8972 is configured to be attached to and detached from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a wide variety of different forms. For example, the coupler 8972 may include one or more of a threaded connection, a mechanism that mates with a thread, an outwardly biased arm, a detent connection such as a wall, or other portion. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver. When the coupler 8972 is removed from the width adjustment element 8211, the coupler is secured to the receiver. However, the inner end 8968 of the connector may be configured in a variety of ways. Any configuration may be used that can suitably attach the outer frame portion 8256 to the coupler so that the width adjustment element 8211 can move the outer frame portion 8256 between the constricted position and the expanded position. The coupler may be similarly configured in a variety of ways and may be a separate component or may be integrated with another portion of the device, such as the connector or another portion of the inner end of the connector.

[0120] The width adjustment element 8211 allows a user to expand or contract the outer frame portion 8256 of the implantable device 8200. In the embodiment shown in FIGS. 27 and 28 , the width adjustment element 8211 includes a male threaded end that screws into the coupler 8972. The width adjustment element 8211 moves the coupler into the receiver 8912 to adjust the width of the outer frame portion 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame portion 8256.

[0121] In some implementations, the receiver 8912 may be integrally formed with the distal cap 8214. Moving the cap 8214 relative to the body of the mounting portion 8205 opens and closes the paddle. In the illustrated example, the receiver 8912 slides inside the body of the mounting portion. When the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. Moving the cap may open and close the device in the same manner disclosed above.

[0122] In the illustrated embodiment, the driver head 8916 is disposed at a proximal end of the actuation element 8102. The driver head 8916 removably couples the opening and closing actuation element 8102 to the receiver 8912. In the illustrated embodiment, the width adjustment element 8211 extends through the actuation element 8102. The actuation element is advanced axially in the opposite direction to the Y direction to move the distal cap 8214. As shown by the arrows in FIG. 27, movement of the distal cap 8214 relative to the mounting portion 8205 is effective to open and close the paddle. That is, when the distal cap 8214 is moved in the Y direction, the device is closed, and when the distal cap is moved in the opposite direction to the Y direction, the device is opened.

[0123] 27 and 28, the width adjustment element 8211 extends through the actuation element 8102, the driver head 8916, and the receiver 8912 and engages a coupler 8972 attached to the inner end 8968. When the outer frame portion 8256 is moved to the stenotic position, the device or implant 8200 may be more easily maneuvered into position for implantation into the heart by reducing contact and / or friction between the native structures of the heart (e.g., chordae tendineae) and the device 8200. When the outer frame portion 8256 is moved to the expanded position, the anchor portions of the device or implant 8200 are provided with a larger surface area to engage and capture the leaflets of the native heart valve.

[0124] 29 and 30, an implementation of an implant catheter assembly 1611 is shown in which the clasp actuation line 624 extends through the handle 1616, the actuation element 8102 is coupled to a paddle actuation control 1626, and the width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of the shaft or catheter of the implant catheter assembly 1611 may be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter may be coupled to the implantable device 8200. The actuation element 8102 may extend distally from the paddle actuation control 1626, through the handle 1616, through the shaft or catheter of the implant catheter assembly 1611, and through the proximal end of the device 8200, where the actuation element couples with a driver head 8916. The actuation element 8102 may be axially movable relative to the outer shaft of the implant catheter assembly 1611 and handle 1616 to open and close the device.

[0125] The width adjustment element 8211 may extend distally from the paddle width control 1628, through the paddle actuation control 1626, through the actuation element 8102 (and consequently through the handle 1616, the outer shaft of the implant catheter assembly 1611, and the device 8200), where the width adjustment element couples with the movable coupler 8972. The width adjustment element 8211 may be axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611, and the handle 1616. The clasp actuation line 624 may extend through and be axially movable relative to the handle 1616 and the outer shaft of the implant catheter assembly 1611. The clasp actuation line 624 may also be axially movable relative to the actuation element 8102.

[0126] 29 and 30, the width adjustment element 8211 can be removably coupled to the coupler 8972 of the device 8200. The width adjustment element 8211 is advanced and retracted via the paddle width control 1628 to increase or decrease the width of the paddle. The actuation element 8102 is advanced and retracted via the paddle actuation control 1626 to open and close the paddle of the device.

[0127] 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongate shaft extending axially between a proximal end portion 1622a that is coupled to the handle 1616 and a distal end portion 1622b that is coupled to the device 8200. The outer shaft of the implant catheter assembly 1611 may also include an intermediate portion 1622c disposed between the proximal end portion 1622a and the distal end portion 1622b.

[0128] In some implementations, the delivery device is configured to move the implantable device or implant between various configurations and / or to implant the implantable device or implant into a native heart valve. For example, controls on a handle used in the delivery assembly can be configured to allow for improved control of the implantable device or implant, as described below.

[0129] 31 and 32 show implementations of a delivery assembly 600 and its components. With reference to FIG. 31, the delivery assembly 600 may include a delivery device 602 and an implantable device 604. The delivery device 602 may include multiple catheter assemblies and optional catheter stabilizers (not shown in FIGS. 31 and 32). For example, in the illustrated embodiment, the delivery device 602 includes a delivery catheter assembly 606, a steerable catheter assembly 608, and an implant catheter assembly 610. The steerable catheter assembly 608 extends coaxially through the delivery catheter assembly 606, and the implant catheter assembly 610 extends coaxially through the steerable catheter assembly 608 and the delivery catheter assembly 606. The implantable device 604 may be removably coupled to a distal portion of the implant catheter assembly 610, as described further below. It will be understood that the implantable device 604 may be any device described herein.

[0130] 32, each of the delivery catheter assembly 606, the steerable catheter assembly 608, and the implant catheter assembly 610 includes a sheath or shaft 607, 609, 611 extending from a handle 612, 614, 616, respectively. The handles 612, 614, 616 are located at the proximal end of each of the corresponding sheaths or shafts and include one or more control members (knobs, sliders, switches, levers, etc.) that allow a user to manipulate the catheter assembly (e.g., bend or rotate the sheath or shaft of the catheter assembly) and / or control components coupled to the corresponding catheter assembly (e.g., control wires extending through the shaft of the catheter assembly).

[0131] The delivery catheter assembly 606 and the steerable catheter assembly 608 may be used, for example, to access an implantation location (e.g., the native mitral valve region of the heart) and / or to position the implant catheter assembly 610 at the implantation location. Thus, in some implementations, the delivery catheter assembly 606 and the steerable catheter assembly 608 are configured to be steerable. The features of the catheter assemblies disclosed by U.S. Patent Nos. 10,653,862 and 10,646,342 may be used in the catheter assemblies 606, 608, 610. U.S. Patent Nos. 10,653,862 and 10,646,342 are incorporated herein by reference in their entireties.

[0132] In some implementations, one or more of the handles 612, 614, 616 may incorporate a visual and / or audible indicator 700 configured to provide an indication regarding the position of the corresponding sheath or shaft 607, 609, 611 and / or the configuration of the implantable device 604 (e.g., an implantable valve repair device, an annuloplasty ring, a replacement valve, a chordal repair or replacement device, an anchor configured to be implanted in the heart, etc.), as described in more detail below by more specific examples. In some implementations, the visual indicator 700 may be positioned on the catheter handle and / or configured to provide an indication regarding the position of the sheath and / or shaft used to deliver the implantable valve repair device, annuloplasty ring, a replacement valve, a chordal repair or replacement device, an anchor configured to be implanted in the heart, etc.

[0133] 32 includes visual indicators 700 on each of the handles 612, 614, and 616, it is contemplated that in some implementations, less than all of the handles 612, 614, and 616 may include visual indicators 700. Additionally, it is contemplated that one or more of the visual indicators may be replaced with an audible indicator, such as a speaker configured to emit a sound indicative of the position of the corresponding sheath or shaft 607, 609, 611, or the configuration of the implantable device 604. Thus, in any one of the implementations described herein, the visual indicators 700, including LED lights, LED displays, LCD displays, or the like included in the visual indicators, may be replaced or supplemented with an audible indicator. In some implementations, the visual and / or audible indicators 700 provide an indication regarding the position of the corresponding sheath or shaft 607, 609, 611 and / or the configuration of the implantable device 604 by changing the intensity, color, etc. of the light emitted by the indicator and / or by increasing or changing the sound emitted by the indicator.

[0134] In FIG. 32, visual indicators 700 on handles 612 and 614 are configured to provide an indication regarding the bending of the corresponding shaft or sheath 607, 609 coupled to the handle 612, 614. The visual indicators 700 may illuminate different colors (e.g., red, blue, yellow, etc.) or different intensities (e.g., dim, medium, bright, etc.) to indicate the amount of bending of the corresponding shaft or sheath 607, 609. In some implementations, the visual indicators 700 may be in the form of a light emitting diode (LED) readout, a touch screen, or other visual display configured to display an alphanumeric description (e.g., 1-10, a particular degree of bending, or "no bending," "partial bending," or "fully bending"). In some implementations in which the visual indicators 700 report a particular degree of bending, it is envisioned that the reported degree of bending may be in 5° increments to account for system limitations that may result from friction between the shaft and sheath 607, 609, 611, manufacturing variances, and other system components.

[0135] Figures 33A and 33B show cross-sectional views of the handle 614 of the steerable catheter assembly 608 shown in Figure 32. The steerable catheter assembly 608 includes a control 702. The control 702 may be configured in a variety of ways, such as, for example, a knob, a button, a switch, a lever, a gear, a worm screw, or a combination of these and / or other components.

[0136] In some implementations, the control 702 (described and / or illustrated herein as a knob 702, although a knob is only one control configuration that may be used) is actuated by being rotated relative to the housing 703 of the handle 614 (other actuation methods other than rotation may be used in some implementations). In some implementations, the knob 702 is fixedly coupled to an internally threaded tube 704 positioned within the housing 703. When the knob 702 is rotated about the axis of the handle 614, the internally threaded tube 704 rotates relative to the housing 703. In some implementations, an externally threaded retractor 706 is positioned within and engages the internally threaded tube 704. The externally threaded retractor 706 is rotationally fixed relative to the housing 703. The externally threaded retractor 706 may be rotatably fixed in a variety of different manners.

[0137] 33A and 33B, a pair of guide rods 708 extend axially within the handle 614, with each of the pair of guide rods 708 fixed to the housing 703 at opposite ends of the guide rods 708. Thus, as the female threaded tube 704 is rotated, the male threaded retractor 706 is linearly advanced axially (i.e., distally and proximally) along the pair of guide rods 708.

[0138] In some implementations, the male threaded retractor 706 is coupled to a control element (not shown), such as a wire, tube, shaft, etc., such that linear motion of the male threaded retractor 706 causes linear motion of the control element. The control element is fixedly connected to the sheath or shaft 609 at a distal end. In some implementations, the control element is coupled to a ring that is fixed within the sheath or shaft 609. In some implementations, the control element is directly coupled to an inner surface of the sheath or shaft 609. Axial movement of the control element moves the sheath or shaft 609 between a first straight configuration and a second curved configuration.

[0139] In some implementations, the female threaded tube 704 is also coupled to a switch, sensor, or the like, such as the illustrated slider 710 and sensor 711. The slider 710 and sensor 711 can take a wide variety of different forms. For example, the slider 710 can be a magnet, a material with distinct optical properties, a material with distinct acoustic properties, or any other material or configuration that can be sensed by the sensor 711. The sensor 711 can be a Hall sensor, an optical sensor, an ultrasonic sensor, a proximity sensor, or the like. One or both of the slider 710 and the sensor 711 can be annular, such that the sensor is sensed in proximity to the slider regardless of the rotational position of the knob 702.

[0140] In some implementations, the slider 710 is electronically coupled to the visual indicator 700. In some implementations, the sensor 711 may be coupled to the visual indicator 700 in a variety of different ways, such as through a microprocessor (not shown). Thus, as the knob 702 and attached threaded tube 704 are rotated, the threaded retractor 706 and slider 710 are moved axially (i.e., distally and proximally). The sensor 711 senses the movement of the slider and stimulates the visual indicator 700. As shown in FIGS. 33A and 33B, the visual indicator 700 is an LED indicator configured to emit light with varying intensities. In this implementation, the axial position of the slider 710 corresponds to the intensity of the LEDs of the visual indicator 700.

[0141] As a result of the knob 702 being coupled to both the visual indicator 700 and the control element (e.g., shaft, rod, tube, etc.) through the female threaded tube 704 and the threaded retractor 706, rotation of the female threaded tube 704 can be an effective indicator of the amount of bending of the shaft or sheath 609. For example, the shaft or sheath 609 can be in a first straight configuration with the male threaded retractor 706 coupled to a control positioned distally within the housing 703. As the knob 702 is rotated relative to the housing 703, the female threaded tube 704 rotates, thereby driving both the male threaded retractor 706 and the slider 710 in a proximal direction. As the male threaded retractor 706 moves proximally, tension is generated in the control element, pulling the control element and causing the shaft or sheath 609 to bend. The more the female threaded tube 704 rotates, the more the male threaded retractor 706 and slider 710 are driven proximally, causing the shaft or sheath 609 to bend.

[0142] 33A and 33B are described with respect to handle 614, it is contemplated that slider 710, sensor 711, and visual indicator 700 may be incorporated in the same or similar manner into other handles, such as handle 612. Additionally, it is contemplated that other actuation mechanisms may be used as an alternative to slider 710, sensor 711, and / or LED indicator. For example, other switches, controls, sensors, and / or actuators may be incorporated into the handle.

[0143] In some implementations, as shown in, for example, FIG. 32, the handle 616 of the implant catheter assembly 610 also includes a visual indicator 700. As shown in FIGS. 32 and 34, the visual indicator 700 on the handle 616 may be configured in the form of a ring adjacent to the control 626 (which in the illustrated embodiment is actuated by rotation, but which may be configured as another type of control and configured as a knob that is actuated in other manners) and may be configured to provide an indication regarding the position, status, etc. of the paddles of the implantable device 604. However, in some implementations, the visual indicator 700 may be in the form of one or more light emitting diodes (LEDs), a light emitting diode (LED) readout, a touch screen, or other visual display configured to display an alphanumeric description (e.g., 1-10 or "extended," "open," or "closed").

[0144] In the embodiment shown in Figure 34, the handle 616 includes a housing 632 to which various controls for delivering the implantable device 604 are coupled. The housing 632 may be formed from a variety of materials, including polymers such as polycarbonate, and may be formed as a unitary body (e.g., by injection molding) or may be fastened together in any of a variety of manners, including with fasteners, pins, adhesives, or the like. As shown in Figures 35-37, the housing 632 includes multiple lumens through which the clasp actuation lines 624 and actuation elements 112 extend.

[0145] 34-36, the housing 632 includes a slide lock 642 configured to slide between a first position in which the slide lock 642 is coupled to one of the clasp control members 628 (e.g., a slider, etc.) and a second position in which the slide lock 642 is coupled to both of the clasp control members 628. For example, each of the clasp control members 628 may include a flange 643 to which the slide lock 642 is slidably coupled. Thus, the slide lock 642 can be moved to a first position (indicated by the arrow shown in FIG. 34 ) in which the slide lock engages one flange 643 of the clasp control member 628 (e.g., to allow independent movement of each clasp actuation line relative to one another) and to a second position (as shown in FIG. 34 ) in which the slide lock engages both flanges 643 of the clasp control member 628 (e.g., to allow simultaneous movement of the clasp actuation lines) to selectively control relative movement between the clasp control members 628. When the slide lock is in the first position, each of the clasp control members can move axially independently relative to the other clasp control members, and when the slide lock is in the second position, the clasp control members can move axially together. Although not shown, in some implementations, each flange 643 can include a stop to limit the position of the slide lock 642 along the flange 643.

[0146] In some implementations, such as the embodiment shown in FIGS. 34 and 35, the coupler 646 includes at least one opening 647 within which the clasp control tube 648 is connected. The clasp control member 628 is slidably coupled to the housing 632, such as by an engagement channel 629 in the housing 632 and a protrusion 631 on the clasp control member 628 (see FIG. 34), and / or by the clasp control tube 648 extending through a guide passage formed in the housing (not shown). The clasp control member, the coupler 646, and the clasp control tube 648 can slide together axially (i.e., distally and proximally) relative to the housing 632 to open and close the clasp. Only a single coupler 646 and clasp control tube 648 can be seen in FIGS. 34 and 35. The clasp control tube 648 may be secured at its proximal end to a suture lock 650 that is used to secure the clasp drive line 624 to the clasp control tube 648 .

[0147] 35 , as the clasp control member 628 is moved proximally, the clasp control tube 648 also moves proximally, forcing the suture lock 650 proximally relative to the handle 616. As the suture lock 650 moves proximally, the loop of the clasp actuation line 624 extending from the distal end of the outer shaft 611 moves proximally, pulling the clasp 130. To release the clasp 130, such as gripping the leaflet, the clasp control member 628 is moved distally, which moves the clasp control tube 648 and the suture lock 650 distally, thereby moving the loop of the clasp actuation line 624 distally to allow the clasp 130 to move towards the inner paddle 122, gripping the leaflet between the clasp 130 and the inner paddle 122.

[0148] As mentioned above, in some implementations, the handle 616 further comprises a control 626 (e.g., as a knob that is actuated by rotation, but may be configured and actuated in other ways). In some implementations, the control 626 is configured to rotate about an axis of the handle 616 and control the position of the actuation element 112 relative to the handle 616 and outer shaft 611, although the control 626 may be configured to be actuated in other ways, e.g., by pushing, toggling, swiping, etc.

[0149] As can be seen in FIGS. 35-37, in some implementations, the knob 626 may be fixedly coupled to an internally threaded tube 652 positioned within a housing 632 of the handle 616. When the knob 626 is rotated about the axis of the handle 616, the internally threaded tube 652 rotates relative to the housing 632. An externally threaded nut or retractor 654 is positioned within and engaged with the internally threaded tube 652. The externally threaded nut or retractor 654 is rotationally fixed relative to the housing 632. The externally threaded nut or retractor 654 may be rotationally fixed in a variety of different manners. In the embodiment shown in FIG. 36, a pair of guide rods 661 extend axially within the handle 616, and each of the pair of guide rods 661 is fixed to the housing 632 at both ends of the guide rod 661. A mounting bracket 663 couples the pair of guide rods 661 to the housing 632 at the distal end of each of the pair of guide rods 661. Thus, as the female threaded tube 652 is rotated, the male threaded retractor 654 is linearly advanced axially (i.e., distally and proximally) along the pair of guide rods 661.

[0150] In some implementations, the threaded retractor 654 is connected to the actuation element 112 such that linear movement of the threaded retractor 654 causes linear movement of the actuation element 112, which moves the device between a fully extended configuration, an open configuration, and a closed configuration. Translating the rotational movement of the knob 626 into linear movement of the actuation element 112 can improve control and precision, thereby increasing accuracy when opening and closing the device.

[0151] In some implementations, the female threaded tube 652 includes a non-threaded portion 657. In some implementations, the clutch spring 656 is positioned around the non-threaded proximal portion 659 of the retractor 654. The clutch spring presses against a proximal end face 655 of the threaded portion of the retractor 654. Proximal movement of the actuating element 112 after closure of the device 604 may result in over-closure or compression of the valve repair device. The location of the non-threaded portion 657 is selected to prevent or inhibit over-retraction of the actuating element 112, thereby preventing or inhibiting over-closure of the valve repair device. That is, the male threaded retractor 654 is no longer driven proximally when the male threaded nut or retractor 654 reaches the non-threaded portion 657. The clutch spring is configured to urge the male-threaded retractor 654 distally (e.g., toward the threads of the female-threaded tube 652) when the male-threaded retractor 654 reaches the end of the threads of the female-threaded tube 652.

[0152] In some implementations, continued rotation of the knob 626 after the male threads of the male-threaded retractor 654 have disengaged from the female threads of the female-threaded tube 652 provides an audible indication that the device is in the closed position. Biasing the male-threaded retractor 654 may also reduce tilt in the threaded connection, thereby improving the stability of the paddle angle. Biasing the male-threaded retractor 654 toward the female threads of the female-threaded tube 652 ensures that the male-threaded retractor 654 will be re-engaged by the female-threaded tube 652 when the knob 626 is rotated in the opposite direction corresponding to advancement of the actuation element 112.

[0153] As shown in FIGS. 36 and 37 , in some implementations, the male-threaded retractor 654 includes a central passage 683. A crimp assembly 668 is coupled within the central passage 683. The crimp assembly 668 attaches the actuation element 112, which is within an actuation tube 669, to the paddle release knob 630. The crimp assembly 668 can take a variety of different forms. In the illustrated embodiment, the crimp assembly 668 includes a collet 687 and a nut 670. The collet 687 includes male threads and the nut includes female threads. The collet and nut each have a central bore sized to receive the actuation tube 669 that surrounds the actuation element 112. The actuation element 112 can be secured to the actuation tube 669 near a proximal end of the actuation tube 669. The actuation tube 669 is secured to the crimp assembly 668, which is secured to the male-threaded retractor 654. The male threads on the exterior surface of the collet 687 engage the female threads of the nut 670. The collet 687 and nut 670, when tightened, secure the crimp assembly to both the actuation tube 669 and the shoulder 689 at the proximal end of the retractor 654. The nut is positioned within the central passage 683 of the male-threaded retractor 654. The spring 672 is also positioned within the central passage 683 of the male-threaded retractor 654 such that the nut 670 is biased against the shoulder 689. By positioning the nut 670 against the shoulder 689, the collet 687 can be easily attached to the nut 670.

[0154] In some implementations, for example, when the control 626 is configured as a knob, the knob 626 can be rotated, which rotates the female threaded tube 652 relative to the housing 632, thereby axially driving the male threaded retractor 654. Axial movement of the male threaded retractor 654 causes axial movement of the actuation element 112, which moves the implantable device between a fully extended configuration, an open configuration, and a closed configuration. One or more sensors 712 can be disposed within the housing 632 to determine the configuration of the device (e.g., a fully extended configuration, an open configuration, a closed configuration, a position therebetween, etc.). The sensor 712 can take a wide variety of different forms and can be configured and positioned in a wide variety of different ways to determine the configuration of the implantable device. The sensor 712 can be a Hall effect sensor, a proximity sensor, an optical sensor, an ultrasonic sensor, a switch, a magnetic sensor, etc.

[0155] In the embodiment shown in FIG. 37, the plurality of sensors 712 are positioned along one of the guide rods 661 such that a visual indicator 700 on the handle 616 can provide an indication as to the position or configuration of the paddles of the implantable device. Each of the plurality of sensors 712 can be coupled to a microprocessor 714. The microprocessor 714 is further coupled to the visual indicator 700 (shown in FIG. 34). A sensed component 716, such as a magnet, a material with distinct optical properties, a material with distinct acoustic properties, or any other material or configuration that can be sensed by the sensor 712, is coupled to the male threaded retractor 654. As the male threaded retractor 654 is driven axially, the sensed component 716 is also driven axially and stimulates one or more of the plurality of sensors 712 based on its axial position. The stimulated sensor 712 generates and outputs a signal that is received by the microprocessor 714. The microprocessor 714 generates and outputs a signal to the visual indicator 700 based on the signal received from the stimulated magnetic sensor 712, thereby causing the visual indicator 700 to provide a visual indication of the position of the paddle of the implantable device.

[0156] For example, in some implementations, when the implantable device is in a fully extended configuration (e.g., the male threaded retractor 654 is fully engaged with the female threaded tube 652 and in a distal position), the sensed component 716 stimulates a first sensor 712 positioned on the distal end of the guide rod 661, causing the visual indicator 700 to generate a first visual effect. The visual effect generated by the visual indicator 700 may vary depending on the particular visual indicator 700 used. For example, the visual indicator 700 may be an LED indicator configured to light up in different colors. In some implementations, the visual indicator 700 may provide a green light indicating that the implantable device is in a fully extended configuration and ready to be positioned. As the knob 626 is rotated and the male threaded retractor 654 is driven proximally to move the implantable device from the fully extended configuration to an open configuration to capture the valve leaflets, the sensed component 716 stimulates a second sensor 712 positioned on the guide rod 661.

[0157] In some implementations, the second sensor 712 is positioned proximally relative to the first sensor. Stimulation of the second sensor 712 causes the visual indicator 700 to generate a second visual effect, such as a yellow light, indicating that the implantable device is in an open configuration. The knob 626 is further rotated, thereby driving the male-threaded retractor 654 further proximally to a position where it is at least partially disengaged from the female-threaded tube 652, as shown in FIG. 37. In this position, the sensed component 716 stimulates a third sensor 712 positioned at the proximal end of the guide rod 661, which causes the visual indicator 700 to generate a third visual effect. For example, the third visual effect may be a red light, indicating that the implantable device is in a closed configuration.

[0158] In some implementations, the microprocessor 714 may receive signals from multiple sensors 712 simultaneously and may thus generate a signal based on the multiple received signals. For example, the microprocessor 714 may receive a signal from a first magnetic sensor and a second magnetic sensor when a magnet is positioned between the first magnetic sensor and the second magnetic sensor. In some implementations, the visual effect produced by the visual indicator may be the intensity of the illuminated light such that when the implantable device is in the fully extended configuration, the light is relatively dark and when the implantable device is in the closed configuration, the light is relatively bright.

[0159] In some implementations, the visual indicator 700 may include multiple LEDs 718a, 718b, 718c (generally referenced by reference number 718) that are illuminated when a circuit including the LEDs is completed, as shown in FIGS. 38-40B. As shown in FIG. 38, the visual indicator 700 is positioned on the housing of the handle 616 between a control 626 configured to control the position of the actuation element 112 relative to the handle 616 and outer shaft 611, and a paddle width control 890 configured to be actuated to move a width adjustment element to adjust the width of the paddle. In FIGS. 38 and 39, the visual indicator 700 includes four LEDs 718, although in some implementations other numbers of LEDs 718 may be included. In some implementations, three or more LEDs 718 are included: a distal LED 718a, one or more central LEDs 718b, and a proximal LED 718c. One or more of the LEDs may be illuminated to indicate how open the paddles of the device are when control 626 is actuated (e.g., rotated, etc.) and / or to indicate how wide / narrow the paddles of the device are when control 890 is actuated (e.g., rotated, etc.).

[0160] 40A, an embodiment including three LEDs, 718a, 718b, and 718c, is shown. Each LED is coupled to a corresponding LED sensor 720a, 720b, 720c. The sensors 720a, 720b, 720c can be contacts, Hall sensors, magnetic sensors, proximity sensors, optical sensors, etc. A sensed component 722, such as a contact or conductive material, a magnet, a material with distinct optical properties, a material with distinct acoustic properties, or any other material, is coupled to the male threaded retractor 654. In the embodiment shown in FIG. 40A, the sensors 720a, 720b, 720c, and the sensed component 722 are all contacts. Additionally, a circuit connecting strip contact 724 is positioned within the female threaded tube 652. The sensed component 722 can be an annular ring that can contact both the connecting strip contact 724 and one or more of the sensors 720a, 720b, 720c (depending on the location of the sensed component 722). The circuit connecting strip contact 724 is electrically coupled to the battery 726. Each of the LED sensors 720a, 720b, 720c, the sensed component 722, and the circuit connecting strip contact 724 are formed from metal or other conductive material. When one of the LED sensors 720a, 720b, 720c contacts the sensed component 722 and the circuit connecting strip contact 724, a circuit is created with the battery 726. The particular locations of the LED sensors 720a, 720b, and 720c are selected to correspond to a particular configuration of the implantable device or location of the paddle. For example, LED sensor 720a may be positioned along the threaded tube 652 at a position corresponding to the fully extended configuration of the implantable device, LED sensor 720b may be positioned along the threaded tube 652 at a position corresponding to the open configuration of the implantable device, and LED sensor 720c may be positioned along the threaded tube 652 at a position corresponding to the closed configuration of the implantable device.

[0161] Thus, as the knob 626 is rotated to drive the male threaded retractor 654 against the female threaded tube 652, the sensed component 722 remains in contact with the circuit connection strip contact 724. When the male threaded retractor 654 is positioned adjacent to the LED sensor 720a, a circuit is completed, thereby illuminating the corresponding LED 718a, indicating that the implantable device is in a fully extended configuration. As the knob 626 is further rotated to drive the male threaded retractor 654 proximally against the female threaded tube 652, the sensed component 722 moves out of contact with the LED sensor 720a, interrupting the circuit and causing the LED 718a to turn off. The sensed component 722 then moves into contact with the LED sensor 720b, completing a circuit with the LED sensor 720b and causing the corresponding LED 718b to illuminate, indicating that the implantable device is in an open configuration. As knob 626 is further rotated, driving male threaded retractor 654 proximally relative to female threaded tube 652, sensed component 722 moves out of contact with LED sensor 720b, interrupting the circuit and causing LED 718b to turn off. Then, sensed component 722 moves into contact with LED sensor 720c, completing the circuit with LED sensor 720c and causing corresponding LED 718c to illuminate, indicating the implantable device is in the closed configuration.

[0162] In some implementations where the implantable device includes paddles with adjustable widths, visual indicators may be used to indicate the width of the paddles in addition to or as an alternative to indicating the position of the paddles of the implantable device. In FIG. 40B, another implementation is shown that includes three LEDs, 718a, 718b, and 718c. As in FIG. 40A, each LED in FIG. 40B is coupled to a corresponding LED sensor 720a, 720b, 720c. However, in FIG. 40B, the sensed component 722 is coupled to the follower 902. The circuit connection strip contacts 724 are positioned within the guide 908. The circuit connection strip contacts 724 are electrically coupled to the battery 726. Each of the LED sensors 720a, 720b, 720c, the sensed component 722, and the circuit connecting strip contacts 724 may be formed from metal such that when one of the LED sensors 720a, 720b, 720c is in electrical communication with the sensed component 722 and the circuit connecting strip contacts 724, a circuit is created with the battery 726. In the implementation shown, each of the LED sensors 720a, 720b, 720c is positioned on the inner surface of the guide 908 at a location opposite the circuit connecting strip contacts 724. The particular locations of the LED sensors 720a, 720b, and 720c are selected to correspond to a particular width of the paddle (e.g., the full wide, full narrow, or center width of the paddle).

[0163] In some implementations, best shown in FIG. 46, the paddle width control 890 is configured as a rotatable knob that rotates about a central axis that extends through the handle 616 without interfering with the clasp control tube and / or clasp actuation line 624 (shown in FIGS. 34 and 35) that extend to the suture lock 650 at the end of the handle 616. Depending on the implementation, the paddle width control knob 890 can be spaced apart from the control or knob 626, as shown in FIGS. 38-40B, or the paddle width control knob 890 can be positioned adjacent to the control / knob 626, as shown in FIGS. 45 and 46.

[0164] As best shown in FIG. 46, in some implementations, the paddle width control 890 is coupled to a planetary gear box that includes a ring gear 892, a pair of planetary gears 894 (as shown in FIG. 46), and an elongated central gear 896. Thus, actuation of the paddle width control 890 (such as rotation relative to the handle 616) is effective to cause rotation of the elongated central gear 896, which in turn is effective to axially move the width adjustment element 8211 (FIG. 40B), thereby adjusting the width of the paddle.

[0165] In some implementations, the ring gear 892 is housed within a barrel 898 that is fixed to the paddle width control 890 such that when the paddle width control 890 is actuated or rotated, the barrel 898 and the ring gear 892 fixed within the barrel 898 rotate. In the illustrated embodiment, the axis of each planetary gear 894 is fixed. The teeth of the ring gear 892 engage with the teeth of a pair of planetary gears 894 such that when the ring gear 892 rotates, the planetary gears 894 rotate on their fixed axis. The teeth of the pair of planetary gears 894 also engage with the teeth of an elongated central gear 896 such that when the pair of planetary gears 894 rotate, the elongated central gear 896 rotates.

[0166] 40B, the follower 902 includes male threads configured to engage with the female threads of the elongated central gear 896. However, the follower 902 is rotationally fixed such that as the elongated central gear 896 is rotated, the follower 902 is driven axially relative to the elongated central gear 896. The follower 902 is further fixedly coupled to the width adjustment element 8211. Thus, axial movement of the follower 902 causes axial movement of the width adjustment element 8211, which is effective to adjust the width of the paddle, as described above.

[0167] In some implementations, the elongated central gear 896 is positioned within the handle 616 adjacent to the threaded retractor 654 and receives a shaft 904 extending from one end of the threaded retractor 654. The shaft 904 is rotatably coupled to the elongated central gear 896 adjacent to the follower 902. A width adjustment element 8211 extends through a central passage of the shaft 904 and the threaded retractor 654. A clip (not shown) axially secures the shaft 904 to the elongated central gear 896. As described above, the threaded retractor 654 is rotationally fixed to a housing of the handle 616 and is configured to open and close an implantable device coupled to the handle 616 when driven axially. The extended configuration allows the elongated central gear 896 to maintain mesh contact with the planetary gears 894 as the elongated central gear moves axially with the threaded retractor 654. Rotation of the elongated central gear 896 is effective to drive the follower 902 axially relative to the externally threaded retractor 654. Movement of the follower 902 relative to the externally threaded retractor 654 is effective to move the width adjustment element 8211 relative to the actuating portion of the device, thereby adjusting the width of the paddle.

[0168] In some implementations, a guide 908 extends around the follower 902 and is configured to prevent or inhibit the follower 902 from rotating. The guide 908 is rotationally fixed relative to the handle 616. The guide 908 and follower 902 extend through a central passage of an elongated central gear 896. As described above, rotation of the elongated central gear 896 is effective to axially drive the follower 902 because rotation of the follower 902 is prevented or inhibited by the guide 908. The external teeth of the elongated central gear 896 engage with the teeth of a pair of planetary gears 894, one of which is shown in FIG.

[0169] In some implementations, the planetary gear box also includes a carrier (not shown). The carrier may be fixedly coupled to a portion of the handle 616, such as a housing, and provides support to the shaft and gears (e.g., the pair of planetary gears 894). The carrier and the pair of planetary gears may be positioned within a barrel 898. A ring gear 892 may also be positioned within the barrel 898 for engaging the pair of planetary gears 894. An elongated central gear 896 extends between and engages the pair of planetary gears 894.

[0170] In some implementations, counterclockwise rotation of the paddle width control knob 890 rotates the ring gear 892 counterclockwise, which in turn rotates the pair of planetary gears 894 counterclockwise. Counterclockwise rotation of the pair of planetary gears 894 rotates the elongated central gear 896 clockwise. As described above, rotation of the elongated central gear 896 axially drives the width adjustment element 8211, thereby effective to adjust the width of the paddles of the implantable device.

[0171] Thus, in some implementations, as the paddle width control knob 890 is rotated and the follower 902 is driven relative to the guide 908, the sensed component 722 remains in contact with the circuit connection strip contact 724. When the follower 902 is positioned adjacent to the LED sensor 720a, a circuit is completed, causing the corresponding LED 718a to illuminate, indicating that the paddle is at its maximum width. As the paddle width control knob 890 is further rotated and drives the follower 902 proximally relative to the guide 908, the sensed component 722 moves out of contact with the LED sensor 720a, interrupting the circuit and causing the LED 718a to turn off. The sensed component 722 then moves into contact with the LED sensor 720b, completing a circuit with the LED sensor 720b and causing the corresponding LED 718b to illuminate, indicating that the paddle is at its mid-width. As the paddle width control knob 890 is further rotated, driving the follower 902 proximally relative to the guide 908, the sensed component 722 moves out of contact with LED sensor 720b, interrupting the circuit and causing LED 718b to turn off. The sensed component 722 then moves into contact with LED sensor 720c, completing the circuit with LED sensor 720c and causing corresponding LED 718c to illuminate, indicating the paddle is at its minimum width.

[0172] 41-44, an embodiment is shown that includes a visual indicator 700 in the form of a first LED 718a, a second LED 718b, and a third LED 718c. The handle 7300 shown in FIGS. 41-44 includes a paddle actuation control 7302, a paddle width control 7304, a paddle release clip 7306, and a control element connection knob 7308. The handle 7300 may be an implementation of the handle 1616 of FIGS. 29 and 30, the paddle actuation control 7302 may be an implementation of the paddle actuation control 1626 of FIGS. 29 and 30, and the paddle width control 7304 may be an implementation of the paddle width control 1628 of FIGS. 29 and 30.

[0173] In some implementations, the paddle actuation control 7302 is rotatable about an axis that extends longitudinally through the handle 7300. In some implementations, the paddle actuation control 7302 is configured as a rotatable knob, and the actuation element 8102 extends through the paddle actuation knob 7302 and is secured to a ferrule 7312, as shown in FIG. 44. The ferrule 7312 is secured to a frame 7310 that includes male threads for engaging with female threads of the paddle width control knob 7304, as described in more detail below. The distal end of the paddle actuation knob 7302 includes male threads 7314 configured to engage with female threads in the housing of the handle 7300. The paddle actuation knob 7302 is rotatable relative to both the housing of the handle 7300 and the frame 7310 and attached ferrule 7312. Thus, when the paddle actuation knob 7302 is rotated about an axis relative to the handle 7300, the paddle actuation knob 7302 drives the frame 7310 and attached ferrule 7312 (and thus the actuation element 8102) axially relative to the handle 7300, which is effective to drive the actuation element 8102 axially relative to the device 8200.

[0174] In some implementations, the paddle width control knob 7304 is also rotatable about an axis that extends longitudinally through the handle 7300. The width adjustment element 8211 extends through the actuation element 8102, the paddle actuation knob 7302, the ferrule 7312, and the paddle width control knob 7304. The width adjustment element 8211 is fixedly attached to a ferrule 7316 that is connected to the inside of the control element connecting knob 7308, as shown in FIG. 44. The ferrule 7316 is rotationally fixed with the width adjustment element 8211 and axially fixed with respect to the control element connecting knob 7308. The paddle width control knob 7304 is rotatably coupled to the control element connecting knob 7308 and to the width adjustment element 8211.

[0175] In some implementations, as shown in FIG. 44 , the paddle width control knob 7304 includes female threads that engage with male threads on the frame 7310. Thus, rotation of the paddle width control knob 7304 is effective to move the paddle width control knob 7304 axially. Because the paddle width control knob 7304 is rotatably coupled to the control element connection knob 7308, as the paddle width control knob 7304 rotates, the width adjustment element 8211 moves axially, rather than rotatably, relative to the paddle actuation knob 7302. This is effective to drive the width adjustment element 8211 axially relative to the mounting portion 8205 of the device 8200. Movement of the width adjustment element 8211 relative to the mounting portion 8205 is effective to adjust the width of the paddle, as described above.

[0176] In some implementations, the frame 7310 includes a guide shaft 7318 that is positioned at least partially circumferentially around the paddle width control 7304 such that the paddle width control 7304 extends through the guide shaft 7318 along the longitudinal axis of the handle 7300. In FIGS. 41-43, the LEDs 718a, 718b, and 718c of the visual indicator 700 are positioned at different axial positions along the guide shaft 7318. As with the previous implementations, each of the LEDs 718a, 718b, and 718c may have a corresponding LED sensor (not shown) affixed to an inner surface of the guide shaft 7318. The LED sensors are positioned at positions corresponding to various widths of the paddles based on the particular implementation. For example, the first LED 718a may have an LED sensor corresponding to a position corresponding to a maximum paddle width, the second LED 718b may have an LED sensor corresponding to a position corresponding to a median paddle width, and the third LED 718c may have an LED sensor corresponding to a position corresponding to a minimum paddle width.

[0177] In some implementations, the guide shaft 7318 also includes a circuit connection strip contact 724 on an inner surface of the guide shaft 7318, as shown in FIG. 42. The circuit connection strip contact 724 is electrically coupled to a battery (not shown) to power the circuit. The sensed component 722 is positioned on the paddle width control knob 7304. Thus, as the paddle width control knob 7304 is rotated and driven axially relative to the frame 7310 and guide shaft 7318, the sensed component 722, remaining in contact with the circuit connection strip contact 724, contacts one of the LED sensors, completing a circuit with the battery and causing the corresponding LED 718a, 718b, 718c to be illuminated depending on the axial position of the paddle width control knob 7304.

[0178] 41-44 are described as incorporating individual LED sensors and sensed components, it is envisioned that some implementations may utilize magnetic sensors or electronic slider switches to activate a visual indicator based on the width of the paddle, as described above. For example, the LED contacts could be replaced with magnetic sensors and the sensed components could be replaced with magnets, and a microprocessor could be implemented to generate a signal effective to cause the LED to produce a visual effect based on a signal received from one or more of the magnetic sensors upon stimulation by a magnet.

[0179] In some implementations, multiple visual indicators may be incorporated into the handle. In FIGS. 45 and 46, the handle 616 includes a first visual indicator 700a configured to provide a visual indication regarding the position of the paddle of the implantable device and a second visual indicator 700b configured to provide a visual indication regarding the width of the paddle of the implantable device. In the implementation shown in FIGS. 45 and 46, the paddle width control element is in the form of a paddle width control knob 890. The paddle width control knob 890 is configured as a rotatable knob that rotates about a central axis that extends through the handle 616 without interfering with the clasp control tube and / or clasp actuation line 624 (shown in FIGS. 34 and 35) that extends to the suture lock 650 at the end of the handle 616 (covered by the cap 634 in FIG. 45). Each of the first and second visual indicators 700a, 700b is in the form of a ring adjacent to the corresponding knob that is the indicator (e.g., knob 626 or paddle width control knob 890). However, it is envisioned that the visual indicators 700a, 700b can take other forms, such as one or more LEDs, LED readouts, or other indications. In some implementations, the visual indicator 700a can be a first form while the visual indicator 700b can be a second form that is different from the first form (e.g., one of the visual indicators is a plurality of LEDs configured to illuminate while the other of the visual indicators is an LED ring configured to vary in intensity). In some implementations, one or both of the visual indicators can be replaced with an audible indicator, where the audible signals are different from one another to allow a user to distinguish one indication from another.

[0180] Some implementations have been described in which one or more visual indicators are incorporated into the handle of the delivery device and configured to provide an indication regarding the configuration or position of the delivery device or an implantable device coupled to the delivery device. Although the implementations described herein are described as configured as visual indicators, they may be configured to include auditory indicators as an alternative to visual indicators. Additionally, while the implementations described above have included particular handle configurations and / or described various combinations of actuation mechanisms (e.g., electronic slider switches, magnetic sensors, or circuit contacts) as indicators of particular configurations (e.g., catheter or sheath configurations, implantable device configurations, or paddle configurations), it is contemplated that other combinations are contemplated and possible based on the disclosure provided herein.

[0181] Additionally, the treatment techniques, methods, operations, steps, etc. described or suggested herein may be performed on living subjects (e.g., humans, other animals, etc.) or may be performed on non-living simulations such as, for example, cadavers, cadaver hearts, simulators, virtual persons, etc. When performed in a simulation, the body parts, e.g., hearts, tissues, valves, etc., may optionally be referred to as "simulations" (e.g., simulated hearts, simulated tissues, simulated valves, etc.) and may include, for example, computerized and / or physical representations of the body parts, tissues, etc.

[0182] Any of the various systems, assemblies, devices, equipment, etc. in this disclosure may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a patient, and the methods described herein may include (or additional methods may include or consist of) sterilization of the associated systems, devices, equipment, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0183] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in the embodiments herein, these various aspects, concepts, and features may be used in many alternatives, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Still further, although various alternatives for the various aspects, concepts, and features of the present disclosure may be described herein, such as alternative materials, alternative structures, alternative configurations, alternative methods, alternative devices, alternative components, alternatives in form, alternatives in fit, alternatives in function, and the like, such descriptions are not intended to be a complete or exhaustive list of available alternatives, whether currently known or later developed. Those skilled in the art may readily incorporate one or more of the aspects, concepts, or features of the present invention into additional embodiments and applications within the scope of the present application, even if such embodiments are not expressly disclosed herein.

[0184] Additionally, although some features, concepts, or aspects of the present disclosure may be described herein as being preferred configurations or methods, such description is not intended to imply that such features are essential or essential unless expressly stated.Furthermore, while exemplary or representative values, and even exemplary or representative ranges, may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only if so expressly stated.

[0185] Moreover, although various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the disclosure, such identification is not intended to be exclusive; rather, there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a particular disclosure, the disclosure being instead defined in the appended claims. Descriptions of exemplary methods or processes are not limited to the inclusion of every step as essential in all cases, nor is the order in which steps are presented construed as essential or essential unless expressly stated. Terms used in the claims are to be given their full ordinary meaning and are not to be limited in any way by the description of the examples herein.

Claims

1. 1. A handle assembly for controlling an implantable device, comprising: A handle housing; a sheath extending distally from the handle housing; an actuation element configured to extend through the sheath and be coupled to the implantable device; a paddle actuation control operably coupled to the actuation element, wherein actuation of the paddle actuation control causes the actuation element to move axially relative to the handle housing and the sheath, and wherein said axial movement of the actuation element causes the implantable device to move between an open position and a closed position; at least one visual indicator coupled to the actuation element through the handle housing and configured to provide an indication regarding a configuration of the implantable device.

2. The handle assembly of claim 1 , wherein the paddle actuation control is configured as a paddle actuation knob rotatable relative to the handle housing, and wherein rotation of the paddle actuation knob causes the actuation element to move axially relative to the handle housing and the sheath.

3. The handle assembly of claim 1 , wherein the at least one visual indicator comprises a ring comprising one or more LEDs positioned adjacent to the paddle-actuated control.

4. The handle assembly of claim 1 , wherein the at least one visual indicator comprises one or more LEDs, LED readouts, or visual displays.

5. A handle assembly according to any one of claims 1 to 4, wherein the instructions include instructions that the implantable device is in the open position and / or the instructions include instructions that the implantable device is in the closed position.

6. a microprocessor coupled to the at least one visual indicator; and at least one magnetic sensor positioned within the handle housing and coupled to the microprocessor; and a magnet; said axial movement of said actuation element causes said magnet to undergo axial movement relative to said at least one magnetic sensor effective to stimulate said at least one magnetic sensor; A handle assembly according to any preceding claim, wherein the microprocessor causes the at least one visual indicator to provide the indication in response to stimulation of the at least one magnetic sensor.

7. the at least one visual indicator comprises a plurality of LEDs, each of the plurality of LEDs coupled to a corresponding LED sensor; the handle assembly further comprising a circuit connection strip contact, a battery coupled to the circuit connection strip contact, and a sensed component; A handle assembly as described in any one of claims 1 to 5, wherein the axial movement of the actuating element causes the sensed component to move axially relative to the plurality of LED sensors to complete a circuit between the battery, the circuit connection strip contact, the sensed component, and at least one of the plurality of LED sensors effective to illuminate the corresponding LED, thereby providing the indication.

8. A handle assembly according to any one of claims 1 to 7, wherein the indication comprises a change in the intensity of light emitted by the at least one visual indicator, a change in the color of light emitted by the at least one visual indicator, or a change in the number of LEDs illuminated.

9. 1. A handle assembly for controlling an implantable device, comprising: A handle housing; a sheath extending distally from the handle housing; an actuation element configured to extend through the sheath and be coupled to the implantable device; a paddle actuation control operably coupled to the actuation element, the paddle actuation control configured to cause the actuation element to move axially relative to the handle housing and the sheath upon actuation, the axial movement of the actuation element causing the implantable device to move between an open position and a closed position; a paddle width adjustment element extending through the actuation element and configured to be coupled to at least one of a pair of paddles of the implantable device; a paddle width control operably coupled to the paddle width adjustment element, wherein upon actuation of the paddle width control, the paddle width adjustment element is configured to move axially relative to the handle housing and the sheath, such that the axial movement of the paddle width adjustment element moves a width of the at least one of the pair of paddles of the implantable device from a first width to a second width; at least one visual indicator coupled to the paddle width adjustment element through the handle housing and configured to provide an indication regarding a configuration of the implantable device.

10. 10. The handle assembly of claim 9, wherein the paddle actuation control is configured as a paddle actuation control knob that is rotatable relative to the handle housing, and wherein rotation of the paddle actuation control knob causes the actuation element to move axially relative to the handle housing and the sheath.

11. A handle assembly according to any one of claims 9 to 10, wherein the paddle width control is configured as a paddle width control knob rotatable relative to the handle housing, and wherein rotation of the paddle width control knob causes the paddle width adjustment element to move axially relative to the handle housing and the sheath.

12. A handle assembly according to any one of claims 9 to 11, wherein the at least one visual indicator comprises a ring adjacent the paddle width control, one or more LEDs, an LED readout, or a visual display.

13. the at least one visual indicator comprises a plurality of LEDs, each of the plurality of LEDs coupled to a corresponding LED sensor; the handle assembly further comprising a circuit connection strip contact, a battery coupled to the circuit connection strip contact, and a sensed component; A handle assembly as described in any one of claims 9 to 12, wherein the axial movement of the paddle width adjustment element causes the sensed component to move axially relative to the plurality of LED sensors to complete a circuit between the battery, the circuit connection strip contact, the sensed component, and at least one of the plurality of LED sensors effective to illuminate the corresponding LED, thereby providing the indication.

14. A handle assembly as claimed in any one of claims 9 to 13, wherein the indication comprises a change in the intensity of light emitted by the at least one visual indicator, a change in the colour of light emitted by the at least one visual indicator, or a change in the number of LEDs illuminated.

15. A handle assembly as described in any one of claims 9 to 14, wherein the at least one visual indicator coupled to the paddle width adjustment element is a first visual indicator, and the handle assembly further comprises a second visual indicator coupled to the actuation element through the handle housing and configured to provide an indication regarding the configuration of the implantable device.

16. 1. A steerable catheter assembly comprising: a catheter having at least one control element for bending the catheter; a control handle coupled to the catheter, a controller operably coupled to the at least one control element, the controller being operable to move the at least one control element axially relative to a housing of the control handle to move the catheter between a first straight configuration and a second curved configuration; A steerable catheter assembly comprising: a control handle coupled to the at least one control element through the housing; and at least one visual indicator configured to provide an indication regarding a configuration of the catheter.

17. 17. The steerable catheter assembly of claim 16, wherein the control is configured as a control knob rotatable relative to the housing of the control handle, and wherein rotation of the control knob causes the at least one control element to move axially relative to the housing and the catheter to move between the first straight configuration and the second curved configuration.

18. The steerable catheter assembly of any one of claims 16 to 17, further comprising an electronic slider switch electronically coupled to the at least one visual indicator, wherein actuation of the control unit is effective to axially move the electronic slider switch, thereby activating the at least one visual indicator.

19. The steerable catheter assembly of any one of claims 16 to 18, wherein the at least one visual indicator comprises a ring adjacent the control unit, one or more LEDs, an LED readout, or a visual display.

20. A steerable catheter assembly as described in any one of claims 16 to 18, wherein the instructions include a change in the intensity of light emitted by the at least one visual indicator, a change in the color of the light emitted by the at least one visual indicator, or a change in the number of LEDs illuminated.

21. The steerable catheter assembly of any one of claims 16 to 19, wherein the instructions include an instruction that the catheter is in the first straight configuration.

22. The steerable catheter assembly of any one of claims 16 to 20, wherein the instructions include an indication that the catheter is in the second curved configuration.

23. An assembly according to any one of claims 1 to 22, wherein one or more components of the assembly are sterilized.

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