CN117677341A

CN117677341A - Sensing type heart valve repair device

Info

Publication number: CN117677341A
Application number: CN202280050653.3A
Authority: CN
Inventors: D·J·奥利弗; W·M·楚
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2021-07-20
Filing date: 2022-07-14
Publication date: 2024-03-08

Abstract

A sensing valve repair system includes a delivery system and a heart valve repair device. The delivery system is configured to deploy the heart valve repair device. The sensing valve repair system has a first sensor associated with one or more of the delivery system and the valve repair device. The first sensor is configured to sense a characteristic in an atrium. The characteristic sensed by the first sensor may be sensed at a proximal or proximal end of the valve repair device. The sensing valve repair system has a second sensor associated with one or more of the delivery system and the valve repair device. The second sensor is configured to sense a characteristic in a ventricle. The characteristic sensed by the second sensor may be at a distal or distal end of the valve repair device.

Description

Sensing type heart valve repair device

RELATED APPLICATIONS

The present application claims the benefit of U.S. provisional application No. 63/245,731 entitled "sensing heart valve repair device (Sensing Heart Valve Repair Devices)" filed on month 17 of 2021 and the benefit of U.S. provisional application No. 63/223,904 entitled "sensing heart valve repair device (Sensing Heart Valve Repair Devices)" filed on month 20 of 2021, which are incorporated herein by reference in their entirety for all purposes.

Background

Autologous heart valves (i.e., aortic, pulmonary, tricuspid and mitral valves) play a critical role in ensuring forward flow of adequate blood supply through the cardiovascular system. These heart valves may be damaged, for example, by congenital malformations, inflammatory processes, infectious disorders, diseases, etc., and thus reduce effectiveness. Such damage to the valve may result in serious cardiovascular damage or death. The damaged valve may be surgically repaired or replaced during open heart surgery. However, open heart surgery is highly invasive and complications may occur. Transvascular techniques may be used to introduce and implant prosthetic devices or implants that are much less invasive than open heart surgery. As one example, transvascular techniques that may be used to access native mitral and aortic valves are transseptal techniques. Transseptal techniques include advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, up the inferior vena cava, and into the right atrium). The septum is then pierced and the catheter is advanced into the left atrium. Similar transvascular techniques can be used to implant a prosthetic device or implant within the tricuspid valve that begins similarly to transseptal techniques, but stops before piercing the septum and instead turns the delivery catheter to the tricuspid valve in the right atrium.

Healthy hearts are generally conical in shape, tapering to a lower tip. The heart is four-chambered and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as a septum. The native mitral valve of the human heart connects the left atrium with the left ventricle. The mitral valve has a distinct anatomical structure from other native heart valves. The mitral valve includes an annular portion that is an annular portion of native valve tissue surrounding the orifice of the mitral valve, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral annulus may form a "D" shape, oval shape, or other non-circular cross-sectional shape having a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, forming a generally "C" shaped boundary between the adjoining sides of the leaflets when the leaflets are closed together.

When properly operated, the anterior and posterior leaflets act together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands (also referred to as "ventricular diastole" or "diastole"), oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular contraction" or "contraction"), the elevated blood pressure in the left ventricle pushes the sides of the two leaflets together, closing the one-way mitral valve so that blood cannot flow back into the left atrium, but is expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and doubling back towards the left atrium through the mitral valve annulus, a plurality of fibrous cords called chordae tendineae (chords) tether the leaflets to papillary muscles in the left ventricle.

Valve regurgitation involves the valve improperly allowing some blood to flow through the valve in the wrong direction. Mitral regurgitation occurs, for example, when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of the heart contracture. Mitral regurgitation is one of the most common forms of heart valve disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, papillary muscle dysfunction, left ventricular dilation leading to mitral annulus stretching, one or more of these, and so forth. Mitral regurgitation at the central portion of the leaflets may be referred to as center jet mitral regurgitation, while mitral regurgitation at one commissure near the leaflets (i.e., where the leaflets meet) may be referred to as off-center jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not centrally, and thus the valve does not close and there is regurgitation. Tricuspid regurgitation may be similar but on the right side of the heart.

Disclosure of Invention

The summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature contained in an example of this summary is not required by the claims unless the claims explicitly recite such feature. Furthermore, the features, components, steps, concepts, etc. described in the examples of this disclosure and elsewhere in this disclosure may be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples outlined herein.

Disclosed herein are sensing valve repair devices or implants and sensing valve repair systems. The sensing valve repair device or implant and sensing valve repair system include one or more sensors. The one or more sensors are configured to sense a characteristic, such as pressure.

A sensing valve repair device includes a valve repair component and one or more sensors. The sensing valve repair device is configured to sense a characteristic, such as pressure, at a proximal end of the valve repair component. The sensing valve repair device is configured to sense a characteristic, such as pressure, at a distal end of the valve repair component.

In some embodiments, a sensing valve repair device includes a valve repair component, a first sensor, and a second sensor. The valve repair component has a proximal end and a distal end. The first sensor is connected to the valve repair component and is configured to sense a characteristic at the proximal end of the valve repair component. The second sensor is connected to the valve repair component and is configured to sense a characteristic at the distal end of the valve repair component.

In some examples, a pressure gradient across a native valve (e.g., mitral valve, tricuspid valve, etc.) is determined. The valve repair device may be in a native valve such that a first end of the valve repair device is in communication with blood in the atrium and a second end of the valve repair device is in communication with blood in the ventricle. The valve repair device is utilized to sense pressure of blood in the atrium. The valve repair device is utilized to sense the pressure of blood in the ventricle.

In some embodiments, an implantable prosthetic device or implant includes at least a first sensor disposed on the device, wherein the first sensor is configured to determine a proximal pressure, determine a distal pressure, and calculate a pressure gradient based on the proximal pressure and the distal pressure.

In some embodiments, a sensing valve repair system includes a delivery system and a heart valve repair device delivered by the delivery system. In some embodiments, the sensing valve repair system includes a first sensor and a second sensor. In some embodiments, the first sensor and the second sensor are associated with and/or are part of the delivery system. In some embodiments, the first sensor is associated with and/or is part of the delivery system and the second sensor is associated with and/or is part of the valve repair device. In some embodiments, the second sensor is associated with and/or is part of the delivery system and the first sensor is associated with and/or is part of the valve repair device. The first sensor is configured to sense a characteristic at a proximal or proximal end of the valve repair device and the second sensor is configured to sense a characteristic at a distal or distal end of the valve repair device.

In some embodiments, a sensing valve repair system includes a delivery system, a valve repair device, and first and second sensors. The delivery system includes a steerable catheter and an implant catheter received inside the steerable catheter. The valve repair device is coupled to the implant catheter. The first sensor is associated with one or more of the delivery catheter, the implant catheter, and the valve repair device. The first sensor is configured to sense a characteristic at a proximal or proximal end of the valve repair device. The second sensor is associated with one or more of the delivery system and the valve repair device. The second sensor is configured to sense a characteristic at a distal or distal end of the valve repair device.

A method of sensing a pressure gradient across a native valve is disclosed. In some embodiments, the method comprises implanting a valve repair device into the native valve using a delivery system. One or more components of the delivery system and the first end of the valve repair device are in communication with blood in the atrium. At least one of a component of the delivery system and a second end of the valve repair device is in communication with blood in a ventricle. The pressure of the blood in the atrium is sensed using components of the delivery system in communication with the blood in the atrium and/or the first end of the valve repair device. The pressure of the blood in the ventricle is sensed with a component of the delivery system in communication with the blood in the ventricle and/or the second end of the valve repair device.

In some embodiments, the valve repair device may have a first sensor at a first end of the valve repair device and the valve repair device may have a second sensor at a second end of the valve repair device. Blood pressure in the atria and blood pressure in the ventricles may be sent. A gradient between the blood pressure in the atrium and the blood pressure in the ventricle may be sent. The sensed pressure in the atrium may be stored, and the sensed pressure in the ventricle may be stored. A flow rate based on the blood pressure in the atrium and the blood pressure in the ventricle may be sent. A heart rate based on the blood pressure in the atrium and the blood pressure in the ventricle may be determined.

The above-described methods may be performed on a living animal or on a mimetic, such as on a cadaver, cadaver heart, a mimetic (e.g., having a simulated body part, heart, tissue, etc.), and so forth.

A further understanding of the nature and advantages of the present invention are 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.

Drawings

To further clarify aspects of examples of the present disclosure, certain examples will be described in more detail with reference to various aspects of the drawings. It should be understood that these drawings depict only typical examples of the disclosure and are therefore not to be considered limiting of its scope. Moreover, although the drawings may be to scale for some examples, the drawings are not necessarily to scale for all examples. Examples of the present disclosure, as well as other features and advantages, will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1 shows a cross-sectional view of a human heart in diastole;

FIG. 2 shows a cross-sectional view of a human heart in a contracted stage;

FIG. 3 shows a cross-sectional view of a human heart in a systolic phase, illustrating mitral regurgitation;

FIG. 4 is a cross-sectional view of FIG. 3, annotated to show the natural shape of a mitral valve leaflet in a contracted stage;

FIG. 5 shows a healthy mitral valve with closed leaflets as viewed from the atrial side of the mitral valve;

FIG. 6 shows a dysfunctional mitral valve with visible gaps between leaflets as viewed from the atrial side of the mitral valve;

fig. 7 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve;

figures 8-14 illustrate examples of implantable devices or implants at various stages of deployment;

fig. 15 shows an example of an implantable device or implant similar to the device shown in fig. 8-14, but with the paddles being independently controllable;

FIGS. 16-21 illustrate the example implantable device or implant of FIGS. 8-14 being delivered and implanted within a native valve;

FIG. 22 illustrates a perspective view of an exemplary implantable device or implant in a closed position;

fig. 23 shows a front view of the implantable device or implant of fig. 22;

FIG. 24 shows a side view of the implantable device or implant of FIG. 22;

Fig. 25 shows a front view of the implantable device or implant of fig. 22, with a cover covering the paddle and apposition element or spacer;

FIG. 26 shows a top perspective view of the implantable device or implant of FIG. 22 in an open position;

FIG. 27 shows a bottom perspective view of the implantable device or implant of FIG. 22 in an open position;

fig. 28 shows a catch suitable for use in an implantable device or implant;

FIG. 29 shows a portion of native valve tissue grasped by a hook;

FIG. 30 illustrates a side view of an exemplary implantable device or implant in a partially open position with a catch in a closed position;

FIG. 31 illustrates a side view of an exemplary implantable device or implant in a partially open position with a catch in an open position;

FIG. 32 illustrates a side view of an exemplary implantable device or implant in a semi-open position with a catch in a closed position;

FIG. 33 illustrates a side view of an exemplary implantable device or implant in a semi-open position with a catch in an open position;

FIG. 34 illustrates a side view of an exemplary implantable device or implant in a three-quarter open position with the hooks in a closed position;

FIG. 35 illustrates a side view of an exemplary implantable device or implant in a three-quarter open position with the catch in the open position;

FIG. 36 illustrates a side view of an exemplary implantable device in a fully open or fully salvaged position with a catch in a closed position;

FIG. 37 illustrates a side view of an exemplary implantable device in a fully open or fully salvaged position with a catch in an open position;

FIGS. 38-49 illustrate the example implantable device or implant of FIGS. 30-38 including a cover being delivered and implanted within a native valve;

FIG. 50 is a schematic diagram showing the path of native valve leaflets along each side of a coaptation element or spacer of an exemplary valve repair device or implant;

FIG. 51 is a top schematic view showing the path of a native valve leaflet around a coaptation element or spacer of an example valve repair device or implant;

FIG. 52 shows a coaptation element or spacer in the gap of the native valve as viewed from the atrial side of the native valve;

fig. 53 shows the valve repair device or implant attached to the native valve leaflets, as viewed from the ventricular side of the native valve, with the coaptation element or spacer located in the gap of the native valve;

FIG. 54 is a perspective view of the valve repair device or implant attached to the native valve leaflets, shown from the ventricular side of the native valve, with the coaptation element or spacer in the gap of the native valve;

FIG. 55 illustrates a perspective view of an exemplary implantable device or implant in a closed position;

FIG. 56 shows a perspective view of an exemplary catch of an exemplary implantable device or implant in a closed position;

FIG. 57 shows a valve repair device with paddles in an open position;

FIG. 58 shows the valve repair device of FIG. 57 with the paddle in an open position and the clamping member moved to form a wider gap between the clamping member and the paddle;

FIG. 59 shows the valve repair device of FIG. 57 with the valve repair device in the position shown in FIG. 7 and valve tissue placed between the clamping member and the paddle;

FIG. 60 shows the valve repair device of FIG. 57, wherein the clamping member is moved to reduce the gap between the clamping member and the paddle;

FIGS. 61A-61B illustrate the paddles of the valve repair device of FIG. 57 moving from an open position to a closed position;

FIG. 62 shows the valve repair device of FIG. 57 in a closed position, wherein the clamping members are engaging valve tissue;

FIG. 63 shows the valve repair device of FIG. 57 after being disconnected from the delivery device and attached to valve tissue, wherein the valve repair device is in a closed and locked state;

FIG. 64 illustrates an exemplary implantable device or implant and associated sensor implanted in a native valve;

FIG. 65 illustrates an exemplary implantable device or implant and associated sensor implanted in a native valve;

FIG. 66 illustrates an exemplary implantable device or implant and associated sensor implanted in a native valve;

FIG. 67 illustrates an exemplary implantable device or implant and associated sensor implanted in a native valve;

FIG. 68 shows a perspective view of an exemplary implantable device or implant and associated sensor implanted in a native valve;

FIG. 69 shows a perspective view of an exemplary implantable device or implant and associated sensor;

fig. 70 shows a perspective view of an exemplary implantable device or implant and associated sensor.

Fig. 71 shows a perspective view of an exemplary implantable device or implant and associated sensor.

Fig. 72 shows a perspective view of an exemplary implantable device or implant and associated sensor.

Fig. 73 shows a perspective view of an exemplary implantable device or implant and associated sensor.

Fig. 74 shows a perspective view of an exemplary implantable device or implant and associated sensor.

Fig. 75 shows a perspective view of an exemplary implantable device or implant and associated sensor.

Fig. 76 shows a perspective view of an exemplary implantable device or implant and associated sensor.

Fig. 77 shows a perspective view of an exemplary implantable device or implant and associated sensor.

Fig. 78 illustrates an exemplary valve repair system and associated sensors.

Detailed Description

The following description refers to the accompanying drawings, which illustrate exemplary embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

Exemplary embodiments of the present disclosure relate to systems, devices, methods, etc. for repairing defective heart valves. For example, various embodiments of implantable devices, valve repair devices, implants, and systems (including systems for delivering the same) are disclosed herein, and any combination of these options may be used unless specifically excluded. In other words, the various components of the disclosed devices and systems may be combined unless mutually exclusive or otherwise physically impossible. Furthermore, the techniques and methods herein may be performed on living animals or on simulators, such as on cadavers, cadaveric hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.), and the like.

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

Fig. 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right and left ventricles RV and LV are separated from the right and left atria RA and LA by tricuspid and mitral valves TV and 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 fig. 3-6 and leaflets 30, 32, 34 shown in fig. 7) that extend inwardly across the respective orifices, and that aggregate or "coapt" in the flow stream to form a unidirectional fluid blocking surface. The native valve repair systems of the present application are often described and/or illustrated with respect to the mitral valve MV. Thus, the anatomy of the left atrium LA and left ventricle LV will be explained in more detail. However, the devices described herein may also be used to repair other native valves, for example, the devices may be used to repair tricuspid valve TV, aortic valve AV, and pulmonary valve PV.

The left atrium LA receives oxygenated blood from the lungs. During the diastole phase or diastole, as shown in fig. 1, blood previously collected in the left atrium LA (during the systole phase) moves through the mitral valve MV and into the left ventricle LV through expansion of the left ventricle LV. During the systolic phase or period, as shown in fig. 2, the left ventricle LV contracts to force blood into the body through the aortic valve AV and ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV and back into the left atrium LA, and blood is collected in the left atrium from the pulmonary veins. In some embodiments, the devices described herein are used to repair the function of a defective mitral valve MV. That is, these devices are configured to help close the leaflets of the mitral valve to prevent or inhibit backflow of blood from the left ventricle LV and back into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure native leaflets around a coaptation element or spacer that advantageously acts as a filler in a backflow orifice to prevent or inhibit backflow or regurgitation during contraction, but this is not required.

Referring now to fig. 1-7, the mitral valve MV comprises two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also comprises an annulus 24, which is a variably dense fibrous ring of tissue surrounding the leaflets 20, 22. Referring to fig. 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. Chordae tendineae CT are chordae tendineae that connect the papillary muscles PM (i.e., the muscles located at the base of the chordae tendineae CT and within the wall of the left ventricle LV) with the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM serve to limit the movement of the leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from reversing. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. The papillary muscles PM instead support or support the leaflets 20, 22 against the high pressures required to circulate blood throughout the body. The papillary muscles PM and chordae tendineae CT together are referred to as subvalvular structures, whose function is to prevent prolapse of the mitral valve MV into the left atrium LA when the mitral valve is closed. As seen from the Left Ventricular Outflow Tract (LVOT) view shown in fig. 3, the anatomy of the leaflets 20, 22 is such that the inner sides of the leaflets coapt at the free end portions and the leaflets 20, 22 begin to recede or diverge from each other. The leaflets 20, 22 diverge in the atrial direction until each leaflet meets the mitral valve annulus.

Various disease processes can impair the normal function of one or more of the native valves of heart H. These disease processes include degenerative processes (e.g., barohte's disease, defects in fiber elasticity, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left or right ventricle LV, RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) can distort the geometry of the native valve, which can lead to native valve dysfunction. However, most patients undergoing valve surgery (e.g., surgery on mitral valve MV) suffer from degenerative diseases that cause dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), which results in prolapse and regurgitation.

Generally, native valves may malfunction in different ways: comprises (1) valve stenosis; and (2) valve regurgitation. Valve stenosis occurs when the native valve is not fully open and thus causes obstruction of blood flow. Typically, valve stenosis is caused by the accumulation of calcified material on the valve leaflets, which causes the leaflets to thicken and impair the ability of the valve to fully open to permit forward blood flow. Valve regurgitation occurs when the valve flaps She Weiwan of the valve are fully closed, causing blood to leak back into the previous chamber (e.g., causing blood to leak from the left ventricle to the left atrium).

There are three main mechanisms by which the native valve becomes regurgitated (or incompetent), including Carpentier type I, type II and type III dysfunctions. Type I Carpentier dysfunction involves the expansion of the annulus such that the leaflets that work properly separate from each other and do not form a tight seal (i.e., the leaflets do not coapt properly). Type I mechanical dysfunction includes leaflet perforation present in endocarditis. Type II dysfunctions of Carpentier involve prolapse of one or more leaflets of the native valve above the coaptation plane. Carpentier type III dysfunction involves restricting the movement of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Rheumatic disease (Ma) or ventricular dilatation (IIIb) may cause the valve She Shouxian.

Referring to fig. 5, when the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to fig. 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 such that the edges of the leaflets 20, 22 do not contact each other. This failure to coapt causes a gap 26 to appear between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow from the left ventricle LV back into the left atrium LA during systole, as shown by the mitral regurgitation MR flow path shown in fig. 3. Referring to fig. 6, gap 26 may have a width W of between about 2.5mm and about 17.5mm, between about 5mm and about 15mm, between about 7.5mm and about 12.5mm, or about 10 mm. In some cases, the gap 26 may have a width W greater than 15 mm. As described above, the leaflets (e.g., leaflets 20, 22 of mitral valve MV) can malfunction in several different ways, which can thus lead to valve regurgitation.

In any of the above cases, it is desirable for the valve repair device or implant to be able to engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit backflow of blood through the mitral valve MV. As can be seen in fig. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown between implanted leaflets 20, 22 such that no regurgitation occurs during contraction (compare fig. 3 with fig. 4). In some embodiments, the apposition elements (e.g., spacers, engagement elements, gap fillers, etc.) of the device 10 have a generally conical or triangular shape that naturally accommodates the native valve geometry and its expanded valve She Xingzhi (toward the annulus). In this application, the terms spacer, coaptation element, spacer, and gap filler are used interchangeably and refer to an element that fills a portion of the space between native valve leaflets and/or is configured to coapt or "coapt" the native valve leaflets (e.g., to coapt the native valve leaflets with the coaptation element, spacer, etc., rather than just with each other).

Although stenosis or regurgitation may affect any valve, stenosis is primarily found to affect aortic valve AV or pulmonary valve PV, and regurgitation is primarily found to affect mitral valve MV or tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and can lead to very serious conditions if left untreated; such as endocarditis, congestive heart failure, permanent heart injury, cardiac arrest, and ultimately death. Since the left side of the heart (i.e., left atrium LA, left ventricle LV, mitral valve MV, and aortic valve AV) is primarily responsible for circulating blood throughout the body. Thus, cardiac dysfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life threatening, as the pressure on the left side is substantially higher.

The native heart valve of the organic dysfunction may be repaired or replaced. Repair generally involves the preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical replacement. In general, aortic valve AV and pulmonary valve PV are more prone to stenosis. Since the stenotic lesions to which the leaflets are subjected are irreversible, treatment of a stenotic aortic valve or stenotic pulmonary valve may be removal of the valve and replacement of the valve with a surgically implanted heart valve, or replacement of the valve 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, may prevent the mitral valve MV or tricuspid valve TV from closing properly and allow blood to flow back or flow back from the ventricle into the atrium (e.g., the deformed mitral valve MV may allow back or flow back from the left ventricle LV into the left atrium LA, as shown in fig. 3). Regurgitation or backflow of blood from the ventricles to the atria results in valve insufficiency. Deformation of the structure or shape of the mitral valve MV or tricuspid valve TV is typically repairable. In addition, as chordae CT become dysfunctional (e.g., chordae CT may stretch or rupture), regurgitation may occur, which allows the anterior and posterior leaflets 20, 22 to reverse, allowing blood to flow back into the left atrium LA. Problems arising from chordae CT dysfunction may be repaired by repairing the structure of chordae CT or mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portions of the mitral valve).

The devices and procedures disclosed herein generally relate to repairing the structure of a mitral valve. However, it should be understood that the devices and concepts provided herein may be used to repair any native valve as well as any component of a native valve. Such devices may 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. For tricuspid TV (fig. 7), any of the devices and concepts herein may be used between any two of the anterior 30, septal 32, and posterior 34 leaflets to prevent or inhibit backflow of blood from the right ventricle into the right atrium. Additionally, any of the devices and concepts provided herein can be used together on all three of the leaflets 30, 32, 34 to prevent or inhibit backflow of blood from the right ventricle to the right atrium. That is, the valve repair devices or implants provided herein may be centrally located between the three leaflets 30, 32, 34.

An exemplary implantable device (e.g., implantable prosthetic device, etc.) or implant may optionally have a apposition element (e.g., spacer, engagement element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some embodiments, the implantable device or implant may have any combination or sub-combination of features disclosed herein without a apposition element. When included, the coaptation element (e.g., coaptation element, spacer, etc.) is configured to be positioned within a native heart valve orifice to help fill the space between the leaflets and form a more effective seal to reduce or prevent the backflow described above. The coaptation element can have a structure that is impermeable to blood (or prevents blood from flowing therethrough) and allows the native leaflets to close around the coaptation element during ventricular contraction to prevent blood from flowing back 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; that is, the device may be used for both the autologous bicuspid (mitral or bicuspid) valve and the tricuspid valve. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill the space between non-properly functioning native leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that are not fully closed.

The optional apposition elements (e.g., spacers, engagement elements, etc.) may have various shapes. In some embodiments, the apposition element may have an elongated cylindrical shape having a circular cross-sectional shape. In some embodiments, the coaptation element can 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 embodiments, the coaptation element can have an atrial portion positioned in or adjacent to the atrium, a ventricular portion or lower portion positioned in or adjacent to the ventricle, and a side surface extending between the native leaflets. In some embodiments configured for use in the tricuspid valve, the atrial portion or upper portion is positioned in or adjacent to the right atrium, and the ventricular portion or lower portion is positioned in or adjacent to the right ventricle, and the side surfaces extend between the native tricuspid valve leaflets.

In some embodiments, 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 the two native leaflets. In some embodiments configured for use in a tricuspid valve, the anchors are configured to secure the device to one, two, or three of the tricuspid valve leaflets such that the coaptation element is positioned between the three native valve leaflets. In some embodiments, the anchor may be attached to the coaptation element at a location adjacent to a ventricular portion of the coaptation element. In some embodiments, the anchor may be attached to an actuation element (e.g., a shaft or actuation wire) to which the apposition element is also attached. In some embodiments, the anchor and the apposition member may be independently positioned relative to each other by moving each of the anchor and the apposition member individually along a longitudinal axis of an actuation member (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some embodiments, the anchor and the apposition member may be positioned simultaneously by moving the anchor and the apposition member together along the longitudinal axis of the actuation member (e.g., shaft, actuation wire, etc.). The anchor may be configured to be positioned behind the native leaflet when implanted such that the leaflet is grasped by the anchor.

The device or implant may be configured to be implanted via a delivery system or other device for delivery. The delivery system may include one or more of a guide/delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, a combination of these, and the like. The apposition element and anchor are compressible to a radially compressed state and self-expandable to a radially expanded state upon release of the compression pressure. The device may be configured to initially radially expand the anchor away from the apposition element, which is still compressed, so as to create a gap between the apposition element and the anchor. The native leaflet can then be positioned in the gap. The coaptation element can radially expand, closing the gap between the coaptation element and the anchor, and capturing the leaflet between the coaptation element and the anchor. In some embodiments, the anchor and the apposition element are optionally configured to be self-expanding. The implantation methods of the various embodiments may be different and are discussed more fully below with respect to each embodiment. Additional information regarding these and other delivery methods can be found in U.S. patent No. 8,449,599 and U.S. patent application publication nos. 2014/0222136, 2014/0067052, 2016/0331523, and PCT patent application publication No. WO2020/076898, each of which is incorporated herein by reference in its entirety. After the necessary changes, the methods may be performed on living animals or on simulators, such as cadavers, cadaveric hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.), and the like.

The disclosed devices or implants may be configured such that the anchors are connected to the leaflets, thereby taking advantage of tension from the native chordae tendineae to resist high systolic pressure pushing the device to the left atrium. During diastole, the device may rely on compressive and retaining forces exerted on the leaflets gripped by the anchors.

Referring now to fig. 8-15, an implantable device or implant 100 (e.g., a prosthetic spacer device, a valve repair device, etc.) is schematically illustrated at various stages of deployment. The device or implant 100 and other similar devices/implants are described in more detail in PCT patent application publications nos. WO2018/195215, WO2020/076898 and WO 2019/139904, which disclosures are incorporated herein by reference in their entirety. The device 100 may include any of the other features of the implantable devices or implants discussed in the present application or the above-identified application, and the device 100 may be positioned to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application or the above-identified application).

The device or implant 100 is deployed from a delivery system or other device 102 for delivery. The delivery system 102 may include one or more of a catheter, sheath, guide catheter/sheath, delivery catheter/sheath, steerable catheter, implant catheter, tube, channel, passageway, combinations of these, and the like. The device or implant 100 includes a apposition portion 104 and an anchoring portion 106.

In some embodiments, the apposition portion 104 of the device or implant 100 includes an apposition element 110 or a device for apposition (e.g., a spacer, plug, filler, foam, sheet, membrane, engagement element, etc.) adapted to be implanted between leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and slidably attached to an actuation element 112 (e.g., actuation wire, actuation shaft, actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between an open state and a closed state and can take a variety of forms, e.g., paddles, clamping elements, etc. Actuation of the means for actuating or the actuating element 112 opens and closes the anchoring portion 106 of the device 100 to grasp the native valve leaflet during implantation. The means for actuating or actuating element 112 (as well as other means for actuating and actuating elements herein) may take a variety of different forms (e.g., such as wires, rods, shafts, tubes, screws, sutures, wires, strips, combinations of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element may be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the apposition portion 104. Alternatively, the actuating element may be unthreaded such that pushing or pulling the actuating element 112 moves the anchor portion 106 relative to the apposition portion 104.

The anchor of the anchoring portion 106 and/or the device 100 includes an outer paddle 120 and an inner paddle 122, which in some embodiments are connected between the cap 114 and the device for apposition or apposition element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be joined and/or flexible to move between all positions described below. The interconnection of outer paddle 120, inner paddle 122, apposition member 110 and cap 114 via portions 124, 126 and 128 may constrain the device to the positions and movements shown herein.

In some embodiments, the delivery system 102 includes a steerable catheter, an implant catheter, and a device or actuation element 112 for actuation (e.g., actuation lead, actuation shaft, etc.). These may be configured to extend through an introducer catheter/sheath (e.g., a transseptal sheath, etc.). In some embodiments, the means for actuating or the actuating element 112 extends through the delivery catheter and the means for apposing or the apposition 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 apposition element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion). In some embodiments, a collar or other attachment element removably attaches the apposition element 110 directly or indirectly to the delivery system 102 such that the means for actuating or actuation element 112 slides through the collar or other attachment element and, in some embodiments, through the means for apposition or apposition element 110 to open and close the paddles 120, 122 of the anchor portion 106 and/or anchor 108 during actuation.

In some implementations, the anchor portion 106 and/or the anchor 108 may include an attachment portion or a clamping member. The illustrated clamping member may include a catch 130 that includes a base or fixed arm 132, a movable arm 134, optional barbs, friction enhancing elements, or other means for securing 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a tab portion 138. The fixed arm 132 is attached to the inner blade 122. In some embodiments, the securing arm 132 is attached to the inner paddle 122 with the joint portion 138 disposed proximate to the means for apposing or the apposing element 110. In some embodiments, the catch (e.g., barbed catch, etc.) has a flat surface and does not fit in the recess of the inner blade. Instead, the flat portion of the catch is disposed against the surface of the inner blade 122. The tab portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the catch 130. The connector portion 138 may be any suitable connector, such as a flexible connector, a spring connector, a pivot connector, or the like. In some embodiments, the tab portion 138 is a piece of flexible material integrally formed with the fixed arm 132 and the movable arm 134. The securing arm 132 is attached to the inner blade 122 and remains stationary or substantially stationary relative to the inner blade 122 when the movable arm 134 is opened to open the catch 130 and expose the optional barb, friction enhancing element, or means for securing 136.

In some embodiments, the catch 130 is opened by applying tension to the actuation wire 116 attached to the movable arm 134, thereby articulating, flexing, or pivoting the movable arm 134 on the tab portion 138. Actuation wire 116 extends through delivery system 102 (e.g., through a steerable catheter and/or an implant catheter). Other actuation mechanisms are also possible.

Actuation wire 116 may take a variety of forms, such as a wire, suture, guide wire, rod, catheter, etc. The catch 130 may be spring loaded such that in the closed position, the catch 130 continues to provide a clamping force on the grasped native leaflet. This clamping force remains constant regardless of the position of the inner blade 122. Optional barbs, friction enhancing elements, or other means for securing 136 of the catch 130 can grip, pinch, and/or puncture the native leaflet to further secure the native leaflet.

During implantation, the paddles 120, 122 may open and close, for example, to grasp native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles 120, 122 and/or between the paddles 120, 122 and the means for coaptation or the coaptation element 110. The catch 130 can be used to grasp and/or further secure the native leaflet by engaging the leaflet with optional barbs, friction enhancing elements, or means for securing 136 and pinching the leaflet between the movable arm 134 and the fixed arm 132. Barbs, friction enhancing elements, or other means 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.) for securing the hooks or barbed hooks 130 increase friction with the leaflet or may partially or completely pierce the leaflet. The actuation wire 116 may be actuated individually such that each catch 130 may be opened and closed individually. The separate operation allows grasping one leaflet at a time or repositioning the insufficiently grasped hooks 130 on the leaflet without changing the successful grasp of the other leaflet. The catch 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 leaflet to be grasped in a variety of positions as the case may be.

Referring now to fig. 8, the device 100 is shown in an elongated or fully open state for deployment from an implant delivery catheter of the delivery system 102. In the fully open position, the device 100 is disposed at the end of the catheter of the delivery system 102 because the fully open position occupies minimal space and allows for the use of the smallest catheter (or the largest device 100 for a given catheter size). In the elongate state, the cover 114 is spaced apart from the means for apposing or the apposing element 110 such that the paddles 120, 122 are fully extended. In some embodiments, the angle formed between the interior of the outer blade 120 and the inner blade 122 is approximately 180 degrees. During deployment through the delivery system 102, the hooks 130 remain in a closed state such that optional barbs, friction enhancing elements, or other means for securing 136 (fig. 9) do not snag or damage tissue in the delivery system 102 or the patient's heart.

Referring now to fig. 9, the device 100 is shown in an extended detangling state, similar to fig. 8, but with the catch 130 in a fully open position, the angle between the fixed portion 132 and the movable portion 134 of the catch 130 ranges from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees. It has been found that fully opening the paddles 120, 122 and the catches 130 may improve the ease of disentanglement or separation from the patient's anatomy (e.g., chordae CT) during implantation of the device 100.

Referring now to fig. 10, the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To move the device 100 from the elongated state to the shortened state, the means for actuating or actuating element 112 is retracted to pull the cap 114 toward the means for apposing or apposing element 110. Movement of the connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained such that compressive forces acting on the outer paddle 120 from the cover 114 retracted toward the means for apposition or apposition element 110 cause the paddles or gripping elements to move radially outward. During movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the means for actuation or the actuation element 112. The outer paddle 120 may optionally be biased toward the closed position. When the inner paddle is oriented away from the means for coaptation or the coaptation element 110 in the open state and folded along the side of the means for coaptation or the coaptation element 110 in the closed state, the inner paddle 122 moves through a substantial angle during the same motion. In some embodiments, the inner paddle 122 is thinner and/or narrower than the outer paddle 120, and the connection portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddle 122 may be thinner and/or more flexible. For example, this increased flexibility may allow for more movement than the connection portion 124 that connects the outer paddle 120 to the cover 114. In some embodiments, the outer blades 120 are narrower than the inner blades 122. The connection portions 126, 128 connected to the inner paddle 122 may be more flexible, for example, to allow more movement than the connection portion 124 connecting the outer paddle 120 to the cover 114. In some embodiments, the inner paddles 122 may have the same or substantially the same width as the outer paddles.

Referring now to fig. 11-13, the device 100 is shown in a partially open, ready to grasp state. To transition from the fully closed state to the partially open state, the means or actuation element for actuating (e.g., actuation wire, actuation shaft, etc.) extends to push the cap 114 away from the means or apposition element for apposition 110, pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portion 106 to partially deploy. The actuation wire 116 also retracts to open the catch 130 so that the leaflet can be grasped. In some embodiments, a pair of inner paddles 122 and outer paddles 120 are moved in unison by a single means for actuation or a single actuation element 112, rather than independently. Also, the position of the catch 130 depends on the position of the blades 122, 120. For example, referring to fig. 10, the closing paddles 122, 120 also close the catch. In some embodiments, the paddles 120, 122 may be independently controlled. For example, the device 100 may have two actuating elements and two separate covers (or other attachment portions) such that one separate actuating element (e.g., wire, shaft, etc.) and cover (or other attachment portion) are used to control one blade and the other separate actuating element and cover (or other attachment portion) are used to control the other blade.

Referring now to fig. 12, one of the actuation wires 116 extends to allow one of the hooks 130 to close. Referring now to fig. 13, the other actuation wire 116 extends to allow the other catch 130 to close. Either or both of the actuation wires 116 can be repeatedly actuated to repeatedly open and close the catch 130.

Referring now to fig. 14, the device 100 is shown in a fully closed and deployed state. The delivery system or means for delivery 102 and means for actuation or actuation element 112 are retracted and the paddles 120, 122 and catch 130 remain in a fully closed position. Once deployed, the device 100 may be held in a fully closed position with a mechanical latch or may be biased to remain closed through the use of a spring material, such as steel, other metals, plastics, composites, etc., or a shape memory alloy, such as nitinol. For example, the connection portions 124, 126, 128, the joint portion 138, and/or the inner and outer paddles 122, and/or additional biasing members (not shown) may be formed of metal (produced as wire, sheet, tube, or laser sintered powder) such as steel or shape memory alloy (e.g., nitinol) and biased to keep the outer paddles 120 closed about the means for apposition or apposition element 110 and the hooks 130 about the self-flap She Gajin. Similarly, the fixed arm 132 and the movable arm 134 of the catch 130 are biased to grip the leaflet. In some embodiments, the attachment or connection portions 124, 126, 128, the joint portion 138, and/or the inner and outer paddles 122, and/or additional biasing members (not shown) may be formed of any other suitable resilient material, such as a metal or polymeric material, to maintain the device 100 in a closed state after implantation.

Fig. 15 shows an example in which the blades 120, 122 are independently controllable. The device 101 shown in fig. 15 is similar to the device shown in fig. 11, except that the device 101 of fig. 15 comprises an actuation element configured as two separate actuation elements 111, 113 coupled to two separate covers 115, 117. To transition the first inner paddle 122 and the first outer paddle 120 from the fully closed state to the partially open state, the means for actuating or actuating element 111 is extended to push the cap 115 away from the means for apposing or apposing element 110, pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially deploy. To transition the second inner paddle 122 and the second outer paddle 120 from the fully closed state to the partially open state, the means for actuating or actuating element 113 is extended to push the cap 115 away from the means for apposing or apposing element 110, pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially deploy. The individual blade control shown in fig. 15 may be implemented on any of the devices disclosed herein. For comparison, in the example shown in fig. 11, a pair of inner paddles 122 and outer paddles 120 are moved in unison by a single means for actuation or a single actuation element 112, rather than independently.

Referring now to fig. 16-21, the implantable device 100 of fig. 8-14 is shown being delivered to and implanted within the native mitral valve MV of the heart H. Referring to fig. 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 fig. 16. The means for actuating or actuating element 112 is then retracted to move the implant/device to the fully closed state shown in fig. 17.

As can be seen in fig. 18, the implant/device is moved to a position within the mitral valve MV in the ventricle LV and is partially opened so that the leaflets 20, 22 can be grasped. For example, as shown in fig. 18, the steerable catheter may be advanced and steered or deflected to position the steerable catheter. As shown in fig. 18, an implant catheter connected to the implant/device can be advanced from within the steerable catheter to position the implant.

Referring now to fig. 19, the implant catheter may be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 in the hooks 130. The actuation wire 116 extends to close one of the hooks 130, thereby capturing the leaflet 20. Fig. 20 shows a further actuation wire 116 which is then extended to close the further catch 130, thereby capturing the remaining leaflet 22. Finally, as can be seen in fig. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), the means or actuation element 112 for actuation, and the actuation wire 116 are then retracted, and the means or implant 100 is fully closed and deployed in the native mitral valve MV.

Referring now to fig. 22-27, an example of an implantable device or implant 200 is shown. Implantable device 200 is one of many different configurations that device 100, shown schematically in fig. 8-14, may take. The device 200 may include any other feature of the implantable device or implant discussed herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein). The device/implant 200 may be a prosthetic spacer device, a valve repair device, or another type of implant attached to the leaflets of a native valve.

In some embodiments, the implantable device or implant 200 includes a apposition portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some embodiments, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., spacer, coaptation element, plug, membrane, sheet, etc.) for implantation between leaflets of a native valve. In some embodiments, the anchor portion 206 includes a plurality of anchors 208. The anchors may be configured in a variety of ways. In some embodiments, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a catch 230. In some embodiments, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engagement with a capture mechanism 213 (fig. 43-49) of the delivery system 202 (fig. 38-42 and 49). The delivery system 202 may be the same or similar to the delivery system 102 described elsewhere and may include one or more of catheters, sheaths, guide catheters/sheaths, delivery catheters/sheaths, steerable catheters, implant catheters, tubes, channels, passageways, combinations of these, and the like.

In some embodiments, the apposition element 210 and paddles 220, 222 are formed of a flexible material, which may be a metal fabric (e.g., mesh) woven, braided, or formed in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material is cloth, a shape memory alloy wire (e.g., nitinol) to provide a shaping capability, or any other flexible material suitable for implantation into the human body.

An actuation element 212 (e.g., an actuation shaft, actuation rod, actuation tube, actuation lead, actuation wire, etc.) extends from the delivery system 202 to engage the implantable device or implant 200 and enable actuation of the implantable device or implant. In some embodiments, the actuation element 212 extends through the capture mechanism 213, the proximal collar 211, and the apposition element 210 to engage the cap 214 of the distal portion 207. The actuation element 212 may be configured to removably engage the cap 214 using a threaded connection or the like such that the actuation element 212 may be disengaged and removed from the device 200 after implantation.

The apposition element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddle 222. In some embodiments, the apposition element 210 has a generally elongated and circular shape, although other shapes and configurations are possible. In some embodiments, the apposition element 210 has an oval shape or cross-section when viewed from above (e.g., fig. 51), and a tapered shape or cross-section when viewed from a front view (e.g., fig. 23), and a circular shape or cross-section when viewed from a side view (e.g., fig. 24). The combination of these three geometries may produce the three-dimensional shape of the illustrated apposition element 210, achieving the benefits described herein. When viewed from above, it can also be seen that the circular shape of the coaptation element 210 substantially follows or approximates the shape of the paddle frame 224.

The size and/or shape of the apposition element 210 may be selected to minimize the number of implants (preferably one) that would be required by a single patient while maintaining a low transvalve gradient. In some embodiments, the anterior-posterior distance at the top of the coaptation element is about 5mm, and the medial-lateral distance of the coaptation element at its widest point is about 10mm. In some embodiments, the overall geometry of the device 200 may be based on both these dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior and medial-lateral distances as the starting point for the device will allow the device to have different dimensions. Furthermore, the use of other dimensions and the shape strategies described above will also allow the device to have different dimensions.

In some embodiments, the outer paddle 220 is engageably attached to the cap 214 of the distal portion 207 by a connecting portion 221 and to the inner paddle 222 by a connecting portion 223. The inner paddle 222 is engageably attached to the apposition element by a connection portion 225. In this way, anchor 208 is configured to resemble a leg, because inner paddle 222 resembles an upper portion of a leg, outer paddle 220 resembles a lower portion of a leg, and connecting portion 223 resembles a knee portion of a leg.

In some embodiments, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion and/or is reinforced by a reinforcing member or securing portion 232 of the catch 230. The stiffening of the inner paddles allows the device to be moved to the various positions shown and described herein. The inner paddle 222, outer paddle 220, and apposition members may all be interconnected as described herein such that the device 200 is constrained to the movements and positions shown and described herein.

In some embodiments, the paddle frame 224 is attached to the cover 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 embodiments, the paddle frame 224 is formed of a material that is more rigid and stiff than the material forming the paddles 222, 220 such that the paddle frame 224 provides support for the paddles 222, 220.

As can be seen in fig. 51, the paddle frame 224 provides additional clamping force between the inner paddle 222 and the coaptation element 210 and helps wrap the leaflet around the sides of the coaptation element 210 to achieve a better seal between the coaptation element 210 and the leaflet. That is, the paddle frame 224 may be configured to have a circular three-dimensional shape extending from the cover 214 to the connecting portion 223 of the anchor 208. The connection between the paddle frame 224, the outer and inner paddles 220, 222, the cover 214, and the apposition element 210 may constrain each of these components to the movements and positions described herein. In particular, the connection portion 223 is constrained by its connection between the outer blade 220 and the inner blade 222 and by its connection to the blade frame 224. Similarly, the blade frame 224 is constrained by its attachment to the connection portion 223 (and thus the inner blade 222 and the outer blade 220) and the cover 214.

Configuring the blade frame 224 in this manner provides an increased surface area as compared to the outer blade 220 alone. This may, for example, make it easier to grasp and secure the native leaflet. The increased surface area may also distribute the clamping force of the paddle 220 and paddle frame 224 against the native leaflet over a relatively large surface of the native leaflet in order to further protect the native leaflet tissue. Referring again to fig. 51, the increased surface area of the paddle frame 224 may also allow for clamping of the native leaflet to the implantable device or implant 200 such that the native leaflet is fully apposed around the apposition member or element 210. This may for example improve the sealing of the native leaflets 20, 22 and thus prevent or further reduce mitral regurgitation.

In some embodiments, the catch includes a movable arm coupled to the anchor. In some embodiments, the catch 230 includes a base or fixed arm 232, a movable arm 234, an optional barb 236, and a tab portion 238. The securing arm 232 is attached to the inner paddle 222 with the joint portion 238 disposed proximate the coaptation element 210. The tab portion 238 is spring loaded such that the fixed arm 232 and the movable arm 234 are biased toward each other when the catch 230 is in the closed state. In some embodiments, the catch 230 comprises friction enhancing elements or fixtures, such as optional barbs, protrusions, ridges, grooves, textured surfaces, adhesives, and the like.

In some embodiments, the securing arms 232 are attached to the inner blade 222 with sutures (not shown) through holes or slots 231. The securing arms 232 may be attached to the inner paddle 222 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or catches, welding, adhesives, clamps, latches, and the like. When the movable arm 234 opens to open the catch 230 and expose the optional barb or other friction enhancing element 236, the fixed arm 232 remains substantially stationary relative to the inner paddle 222. The catch 230 is opened by applying tension to the actuation wire 216 attached to the aperture 235 in the movable arm 234 (e.g., as shown in fig. 43-48), thereby articulating, pivoting, and/or flexing the movable arm 234 on the tab portion 238.

Referring now to fig. 29, a close-up view of one of the leaflets 20, 22 gripped by a hook, such as hook 230, is shown. The leaflets 20, 22 are grasped between the movable arm 234 and the fixed arm 232 of the catch 230. The tissue of the leaflets 20, 22 is not pierced by the optional barbs or friction enhancing elements 236, but in some embodiments the optional barbs 236 can partially or fully pierce the leaflets 20, 22. The angle and height of the barbs or friction enhancing elements 236 relative to the movable arms 234 help secure the leaflets 20, 22 within the catch 230. In particular, the force pulling the implant away from the native leaflets 20, 22 will promote the barbs or friction enhancing elements 236 to further engage the tissue, thereby ensuring better retention. The location of the securing arms 232 adjacent the optional barb/friction enhancing element 236 further improves retention of the leaflets 20, 22 in the catch 230 when the catch 230 is closed. In this arrangement, tissue is formed into an S-shaped tortuous path by fixed 232 and movable 234 arms and optional barb/friction enhancing elements 236. Thus, the force pulling the leaflet 20, 22 away from the catch 230 will cause the tissue to further engage the optional barb/friction enhancing element 236 before the leaflet 20, 22 can be disengaged. For example, the valve She Zhangli during diastole may cause the optional barbs 236 to pull toward the end portions of the leaflets 20, 22. Thus, the S-shaped path may utilize the petals She Zhangli during diastole to more tightly engage the leaflets 20, 22 with the optional barb/friction enhancing elements 236.

Referring to fig. 25, the prosthetic device or implant 200 may also include a cover 240. In some embodiments, the cover 240 may be disposed over the apposition element 210, the outer blade 220, and the inner blade 222 and/or the blade frame 224. The cover 240 may be configured to prevent or reduce blood flow through the prosthetic device or implant 200 and/or promote autologous tissue ingrowth. In some embodiments, the cover 240 may be a cloth or fabric, such as PET, velvet, or other suitable fabric. In some embodiments, the cover 240 may include a coating (e.g., a polymer) applied to the implantable prosthetic device or implant 200, instead of or in addition to the fabric.

During implantation, the paddles 220, 222 of the anchor 208 open and close to grasp the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. By extending and retracting actuation element 212, anchor 208 is moved between a closed position (fig. 22-25) and various open positions (fig. 26-37). Extending and retracting the actuation element 212 increases and decreases, respectively, the spacing between the coaptation element 210 and the cap 214. During actuation, the proximal collar 211 (or other attachment element) and the coaptation element 210 slide along the actuation element 212 such that a change in the spacing between the coaptation element 210 and the cap 214 causes the paddles 220, 220 to move between different positions during implantation to grasp the mitral valve leaflets 20, 22.

When the device 200 is opened and closed, a pair of inner paddles 222 and outer paddles 220 are moved in unison by a single actuation element 212, rather than independently. Also, the position of the catch 230 depends on the position of the paddles 222, 220. For example, the catch 230 is arranged such that closure of the anchor 208 simultaneously closes the catch 230. In some embodiments, the device 200 may be manufactured such that the paddles 220, 222 are independently controllable in the same manner (e.g., the device 100 shown in fig. 15).

In some embodiments, the catch 230 further secures the native leaflet 20, 22 by engaging the leaflet 20, 22 with barbs and/or other friction enhancing elements 236 and clamping the leaflet 20, 22 between the movable arm 234 and the fixed arm 232. In some embodiments, the catch 230 is a barbed catch, including barbs that increase friction with the leaflet 20, 22 and/or that may partially or completely pierce the leaflet. The actuation wires 216 (fig. 43-48) can be actuated individually so that each catch 230 can be opened and closed individually. The separate operations allow grasping one leaflet 20, 22 at a time or allow repositioning of the insufficiently grasped hooks 230 on the leaflet 20, 22 without altering the successful grasping of the other leaflet 20, 22. When the inner paddle 222 is not closed, the catch 230 can be fully opened and closed, allowing the leaflets 20, 22 to be grasped in a variety of positions as the particular situation requires.

Referring now to fig. 22-25, the device 200 is shown in a closed position. When closed, the inner paddle 222 is disposed between the outer paddle 220 and the apposition element 210. The catch 230 is disposed between the inner blade 222 and the apposition element 210. After successful capture of the native leaflets 20, 22, the device 200 is moved to and held in the closed position such that the leaflets 20, 22 are secured within the device 200 by the catch 230 and pressed against the coaptation element 210 by the paddles 220, 222. The outer paddle 220 can have a wide curved shape that fits around the curved shape of the coaptation element 210 to more securely grip the leaflets 20, 22 when the device 200 is closed (e.g., as seen in fig. 51). The curved shape and rounded edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

Referring now to fig. 30-37, the implantable device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. The paddles 220, 222 of the device 200 transition between each of the positions shown in fig. 30-37 from the closed position shown in fig. 22-25 to the actuation member 212 extending upwardly from the fully retracted position to the fully extended position.

Referring now to fig. 30-31, the device 200 is shown in a partially open position. The device 200 is moved to the partially open position by extending the actuating element 212. Extending the actuation element 212 pulls the outer paddle 220 and the bottom portion of the paddle frame 224 downward. The outer blade 220 and the blade frame 224 pull the inner blade 222 downward, wherein the inner blade 222 is connected to the outer blade 220 and the blade frame 224. Because the proximal collar (or another attachment element) and the apposition element 210 are held in place by the capture mechanism 213, the inner paddle 222 is caused to articulate, pivot and/or flex in the opening direction. The inner paddle 222, outer paddle 220 and paddle frame are all flexed to the position shown in fig. 30-31. Opening the paddles 222, 220 and the frame 224 creates a gap between the coaptation element 210 and the inner paddle 222 that can receive and grasp the native leaflets 20, 22. This movement also exposes a catch 230 that is movable between a closed position (fig. 30) and an open position (fig. 31) to form a second gap for grasping the native leaflets 20, 22. The extent of the gap between the fixed arm 232 and the movable arm 234 of the catch 230 is limited to the extent that the inner blade 222 has been deployed away from the coaptation element 210.

Referring now to fig. 32-33, the device 200 is shown in a laterally extended or open position. By continuing to extend the actuation member 212 described above, the device 200 is moved to a laterally extended or open position, thereby increasing the distance between the apposition member 210 and the cap 214 of the distal portion 207. Continued extension of the actuation element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby deploying the inner paddle 222 further away from the apposition element 210. In the laterally extended or open position, the inner paddle 222 extends horizontally more than in other positions of the device 200 and forms an approximately 90 degree angle with the apposition element 210. Similarly, when the device 200 is in a laterally extended or open position, the blade frame 224 is in its maximum deployed position. The increased gap formed between the coaptation element 210 and the inner paddle 222 in the laterally extended or open position allows the catch 230 to open further (fig. 33) prior to engaging the coaptation element 210, thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

34-35, the example apparatus 200 is shown in a three-quarter extended position. By continuing to extend the actuation member 212, the device 200 is moved to the three-quarter extended position, thereby increasing the distance between the apposition member 210 and the cap 214 of the distal portion 207. Continued extension of the actuation element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby deploying the inner paddle 222 further away from the apposition element 210. In the three-quarter extended position, the inner paddle 222 opens more than 90 degrees, at an angle of about 135 degrees to the apposition element 210. The paddle frame 224 expands less than when in the laterally extended or open position and begins to move inwardly toward the actuating element 212 as the actuating element 212 extends further. The outer paddle 220 also flexes back toward the actuating element 212. As with the laterally extended or open position, the increased gap formed between the coaptation element 210 and the inner paddle 222 in the laterally extended or open position allows the catch 230 to open further (fig. 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

Referring now to fig. 36-37, the exemplary device 200 is shown in a fully extended position. By continuing to extend the actuation element 212 described above, the device 200 is moved to the fully extended position, thereby increasing the distance between the apposition element 210 and the cap 214 of the distal portion 207 to the maximum distance permitted by the device 200. Continued extension of the actuation element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby deploying the inner paddle 222 further away from the apposition element 210. The outer paddle 220 and the paddle frame 224 move to their position proximate the actuating element. In the fully extended position, the inner paddle 222 opens to an angle of approximately 180 degrees with respect to the apposition element 210. The inner and outer paddles 222, 220 are stretched straight in the fully extended position to form an approximately 180 degree angle between the paddles 222, 220. The fully extended position of the device 200 provides the maximum size of the gap between the coaptation element 210 and the inner paddle 222, and in some embodiments, allows the catch 230 to also fully open to about 180 degrees between the fixed arm 232 and the movable arm 234 of the catch 230 (fig. 37). The location of the device 200 is the longest and narrowest configuration. Thus, the fully extended position of the device 200 may be a desired position to rescue the device 200 from an attempted implantation site, or may be a desired position to place the device in a delivery catheter, etc.

Configuring the prosthetic device or implant 200 such that the anchor 208 can extend to a straight or approximately straight configuration (e.g., about 120-180 degrees relative to the coaptation element 210) can provide several advantages. For example, this configuration may reduce the radial crimp profile of the prosthetic device or implant 200. The configuration may also provide for easier grasping of the native leaflets 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddle 222 to grasp the native leaflets 20, 22 therein. In addition, the relatively narrow, straight configuration may prevent the prosthetic device or implant 200 from becoming entangled in the native anatomy (e.g., chordae CT shown in fig. 3 and 4) or reduce this possibility when positioning and/or retrieving the prosthetic device or implant 200 into the delivery system 202.

Referring now to fig. 38-49, an exemplary implantable device 200 is shown being delivered to and implanted within a heart H native mitral valve MV. As described above, the device 200 shown in fig. 38-49 includes an optional covering 240 (e.g., fig. 25) over the coaptation element 210, catch 230, inner paddle 222, and/or outer paddle 220. The device 200 is deployed from a delivery system 202 (which may include, for example, an implant catheter extendable from a steerable catheter and/or guide sheath) and is retained by a capture mechanism 213 (see, e.g., fig. 43 and 48) and actuated by extending or retracting an actuation element 212. The fingers of the capture mechanism 213 removably attach the collar 211 to the delivery system 202. In some embodiments, capture mechanism 213 is held closed around collar 211 by actuation element 212 such that removal of actuation element 212 allows the fingers of capture mechanism 213 to open and release collar 211 to disengage capture mechanism 213 from device 200 after device 200 has been successfully implanted.

Referring now to fig. 38, for the reasons discussed above with respect to device 100, a delivery system 202 (e.g., a delivery catheter/sheath thereof) is inserted through the septum into the left atrium LA, and device/implant 200 is deployed from delivery system 202 in a fully open state (e.g., an implant catheter holding the device/implant may be extended to deploy the device/implant from the steerable catheter). The actuating element 212 is then retracted to move the device 200 through the partially closed state (fig. 39) and to the fully closed state shown in fig. 40-41. Then, as shown in fig. 41, the delivery system or catheter is maneuvered toward the mitral valve MV device/implant 200. Referring now to fig. 42, when the device 200 is aligned with the mitral valve MV, the actuation element 212 is extended to open the paddles 220, 222 to a partially open position, and the actuation wire 216 (fig. 43-48) is retracted to open the catch 230 in preparation for grasping the leaflet. Next, as shown in fig. 43-44, the partially opened device 200 is inserted through the native valve (e.g., by advancing the implant catheter from the steerable catheter) until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and inside the open catch 230.

Fig. 45 shows the device 200 with both hooks 230 closed, but with an optional barb 236 of one hook 230 missing one leaflet 22. As can be seen in fig. 45-47, the catch 230, which is no longer in place, opens and closes again to properly catch the missing leaflet 22. When the two leaflets 20, 22 are properly grasped, the actuation element 212 is retracted to move the device 200 to the fully closed position shown in fig. 48. As shown in fig. 49, with the device 200 fully closed and the native valve implanted, the actuating element 212 is disengaged from the cover 214 and withdrawn to release the capture mechanism 213 from the proximal collar 211 (or other attachment element) so that the capture mechanism 213 can be withdrawn into the delivery system 202 (e.g., into the catheter/sheath). Once deployed, the device 200 may be held in a fully closed position with a mechanical device such as a latch, or may be biased to remain closed through the use of a spring material (e.g., steel and/or a shape memory alloy such as nitinol). For example, the paddles 220, 222 may be formed of steel or nitinol shape memory alloy (produced as wire, sheet, tube, or laser sintered powder) and biased to keep the outer paddle 220 closed around the inner paddle 222, the coaptation element 210, and/or to keep the catch 230 clamped around the native leaflets 20, 22.

Referring to fig. 50-54, once the device 200 is implanted in a native valve, the coaptation element 210 acts as a gap filler in the valve regurgitation orifice, such as gap 26 in mitral valve MV shown in fig. 6 or a gap in another native valve. In some embodiments, when the device 200 has been deployed between two opposing valve leaflets 20, 22, the leaflets 20, 22 are no longer coaptated against each other in the region of the coaptation element 210, but instead are coaptated against the coaptation element 210. This reduces the distance that the leaflets 20, 22 need to approach to close the mitral valve MV during contraction, thereby facilitating repair of functional valve disease that may cause mitral regurgitation. The reduction in leaflet approach distance can also bring several other advantages. For example, the reduced approach distance required for the leaflets 20, 22 reduces or minimizes the stress experienced by the native valve. The shorter approach distance of the valve leaflets 20, 22 may also require less approach force, which may result in less tension experienced by the leaflets 20, 22 and less diameter reduction of the valve annulus. A smaller reduction (or no reduction at all) in the valve annulus may result in less reduction in valve orifice area than a device without the apposition element or spacer. In this way, the coaptation element 210 can reduce the cross-valve gradient.

The device 200 and its components can have a variety of different shapes and sizes in order to substantially fill the gap 26 between the leaflets 20, 22. For example, the outer paddle 220 and the paddle frame 224 may be configured to conform to the shape or geometry of the apposition element 210 as shown in fig. 50-54. As a result, the outer paddle 220 and the paddle frame 224 can mate with both the coaptation element 210 and the native valve leaflets 20, 22. In some embodiments, when the leaflets 20, 22 are mated with the coaptation element 210, the leaflets 20, 22 completely surround or "hug" the entire coaptation element 210, thus preventing or inhibiting small leaks at the lateral side 201 and the medial side 203 of the coaptation element 210. The interaction of the leaflets 20, 22 and the device 200 is clearly seen in fig. 51, which shows a schematic atrial or surgeon view showing a paddle frame 224 conforming to the geometry of the coaptation element 210, which is not actually visible from a true atrial view (e.g., fig. 52). The opposing leaflets 20, 22 (the ends of which are also not visible in a true atrial view (e.g., fig. 52)) are approximated by a paddle frame 224 to completely surround or "hug" the coaptation element 210.

This apposition of the leaflets 20, 22 against the lateral side 201 and medial side 203 (shown from the atrial side in fig. 52 and the ventricular side in fig. 53) of the apposition element 210 appears to contradict the statement above (i.e., the presence of the apposition element 210 minimizes the distance that the leaflets need to approach). However, if the coaptation element 210 is placed precisely at the regurgitation gap 26 and the regurgitation gap 26 is smaller than the width (inside-outside) of the coaptation element 210, the distance that the leaflets 20, 22 need to approach is still minimized.

Fig. 50 shows the geometry of the coaptation element 210 and paddle frame 224 from an LVOT angle. As can be seen from this view, the coaptation element 210 has a tapered shape that is smaller in size in the area near the inner surface of the leaflets 20, 22 where coaptation is desired, and increases in size as the coaptation element 210 extends toward the atrium. Thus, the depicted native valve geometry is accommodated by the tapered coaptation element geometry. Still referring to fig. 50, the combination of the tapered coaptation element geometry with the illustrated (toward the valve annulus) expanded paddle frame 224 shape can help achieve coaptation on the lower end of the leaflet, reduce stress and minimize cross-valve gradients.

Referring to fig. 54, the shape of the coaptation element 210 and paddle frame 224 can be defined based on the intra-commissure view of the native valve and device 200. Two factors of these shapes are coaptation of the leaflet against the coaptation element 210 and reduced stress on the leaflet due to coaptation. Referring to fig. 54 and 24, to coapt the valve leaflets 20, 22 against the coaptation element 210 and reduce the stress applied to the valve leaflets 20, 22 by the coaptation element 210 and/or the paddle frame 224, the coaptation element 210 can have a rounded or rounded shape and the paddle frame 224 can have a full radius spanning nearly the entire paddle frame 224. The rounded shape of the coaptation element 210 and/or the illustrated fully rounded shape of the paddle frame 224 distributes the stress on the leaflets 20, 22 over a large curved coaptation region. For example, in fig. 54, when the leaflet 20 attempts to open during the diastole period, the forces acting on the leaflets 20, 22 by the paddle frame are dispersed along the entire rounded length of the paddle frame 224.

Referring now to fig. 55, an example of an implantable prosthetic device or implant 300 is shown. Implantable device 300 is one of many different configurations that device 100, shown schematically in fig. 8-14, may take. The device 300 may include any of the other features of the implantable devices or implants discussed herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some embodiments, the device/implant 300 includes a coaptation portion 304, and the coaptation portion 304 can optionally include a coaptation element 310 (e.g., 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 embodiments, each anchor 308 may 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 anchor may also include and/or be coupled to a catch 330. In some embodiments, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engagement with a capture mechanism (e.g., a capture mechanism such as the capture mechanism 213 shown in fig. 43-49) of a delivery system (e.g., a delivery system such as the systems shown in fig. 38-42 and 49).

The anchors 308 can be attached to other portions of the device and/or to each other in a variety of different ways (e.g., directly, indirectly, welded, sewn, adhesive, links, latches, integrally formed, a combination of some or all of these, etc.). In some embodiments, anchor 308 is attached to apposition member or apposition element 310 by connection portion 325 and to cap 314 by connection portion 321.

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 connection portion 323 may be attached to a blade frame 324 that is hingably attached to the cover 314 or other attachment portion. In this way, anchor 308 is configured to resemble a leg, because inner paddle 322 resembles an upper portion of a leg, outer paddle 320 resembles a lower portion of a leg, and connecting portion 323 resembles a knee portion of a leg.

In embodiments having a apposition member or apposition element 310, the apposition member or apposition element 310 and anchors 308 may be coupled together in various ways. For example, as shown in the illustrated embodiment, the apposition element 310 and anchor 308 may be coupled together by integrally forming the apposition element 310 and anchor 308 as a single, unitary component. This may be accomplished, for example, by forming the apposition element 310 and anchor 308 from a continuous strip 301 of braided or woven material (e.g., braided or woven nitinol wire). In the example shown, the apposition element 310, the outer paddle portion 320, the inner paddle portion 322 and the connecting portions 321, 323, 325 are formed from a continuous fabric strip 301.

Similar to the anchors 208 of the implantable device or implant 200 described above, the anchors 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., the cap 314, etc.) relative to the proximal end of the device (e.g., the proximal collar 311 or other attachment element, etc.), and thus the anchors 308 move relative to the midpoint of the device. This movement may be along a longitudinal axis extending between a distal end (e.g., cap 314, etc.) and a proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device, anchor 308 may be positioned in a fully extended or straight configuration (e.g., a configuration similar to device 200 shown in fig. 36).

In some embodiments, in a straight configuration, the blade portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some embodiments, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the apposition element 310 (e.g., similar to the configuration of the device 200 shown in fig. 36). For example, the anchor 308 may be moved from a straight configuration to a fully folded configuration (e.g., fig. 55) by moving the proximal and distal ends toward each other and/or toward a midpoint or center of the device. Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and/or midpoint or center of the device, anchor 308 bends at connecting portions 321, 323, 325, and connecting portion 323 moves radially outward relative to the longitudinal axis of device 300 and axially toward the midpoint and/or toward the proximal end of the device (e.g., a configuration similar to device 200 shown in fig. 34). As the cap 314 continues to move toward the midpoint and/or toward the proximal end of the device, the connecting portion 323 moves radially inward relative to the longitudinal axis of the device 300 and moves axially toward the proximal end of the device (e.g., similar to the configuration of the device 200 shown in fig. 30).

In some embodiments, the catch includes a movable arm coupled to the anchor. In some embodiments, the catch 330 (shown in detail in fig. 56) includes a base or fixed arm 332, a movable arm 334, an optional barb/friction enhancing element 336, and a joint portion 338. The securing arm 332 is attached to the inner paddle 322 with the joint portion 338 disposed proximate to the apposition element 310. The tab portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the catch 330 is in the closed state.

The securing arms 332 are attached to the inner blade 322 with sutures (not shown) through holes or slots 331. The securing arms 332 may be attached to the inner paddles 322 by any suitable means (e.g., screws or other fasteners, crimp sleeves, mechanical latches or catches, welding, adhesives, etc.). When the movable arm 334 is opened to open the catch 330 and expose the optional barb 336, the fixed arm 332 remains substantially stationary relative to the inner blade 322. The catch 330 is opened by applying tension to an actuation wire (e.g., actuation wire 216 shown in fig. 43-48) attached to an aperture 335 in the movable arm 334, thereby articulating, pivoting, and/or flexing the movable arm 334 on the tab portion 338.

Briefly, the implantable device or implant 300 is similar in configuration and operation to the implantable device or implant 200 described above, except that the apposition member 310, the outer paddle 320, the inner paddle 322, and the connection portions 321, 323, 325 are formed from a single strip of material 301. In some embodiments, the strip 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, the cap 314, and the paddle frame 324 configured to receive the continuous strip of material 301. The continuous strip 301 may be a single layer of material or may comprise two or more layers. In some embodiments, portions of the device 300 have a single layer of material strip 301, while other portions are formed from multiple overlapping or superposed layers of material strip 301.

For example, fig. 55 shows a apposition element 310 and an inner paddle 322 formed from multiple overlapping layers of a strip of material 301. A single continuous strip 301 of material may begin and end at various locations of the apparatus 300. The ends of the strip of material 301 may be located at the same location or at different locations of the device 300. For example, in the example shown in fig. 55, the strip of material 301 begins and ends at the position of the inner blade 322.

As with the implantable device or implant 200 described above, the size of the apposition member 310 may be selected to minimize the number of implants (preferably one) that would be required by a single patient while maintaining a low transvalve gradient. In particular, many of the components of device 300 formed from strip of material 301 allow device 300 to be manufactured smaller than device 200. For example, in some embodiments, the anterior-posterior distance at the top of the coaptation element 310 is less than 2mm, and the medial-lateral distance of the device 300 at its widest point (i.e., the width of the paddle frame 324 wider than the coaptation element 310) is about 5mm.

The concepts disclosed herein may be used with a variety of different valve repair devices. Fig. 57-63 illustrate another example of one valve repair system 400 of many valve repair systems for repairing a native valve of a patient to which the concepts of the present application may be applied. Valve repair system 400 includes a delivery device 401 and a valve repair device 402.

The valve repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of clamping members 408. In some embodiments, the paddle 406 may be integrally formed with the base assembly. For example, the paddle 406 may be formed as an extension of a link of the base assembly. In the example shown, the base assembly 404 of the valve repair device 402 has a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a fixed position on the shaft. The coupler 405 is mechanically connected to the blade 406 such that movement of the coupler 405 along the shaft 403 causes the blade to move between the open and closed positions. In this way, the coupler 405 acts as a means for mechanically coupling the paddle 406 to the shaft 403 and for moving the paddle 406 between its open and closed positions when moving along the shaft 403.

In some embodiments, the clamp member 408 is pivotally connected to the base assembly 404 (e.g., the clamp member 408 may be pivotally connected to the shaft 403 or any other suitable member of the base assembly) such that the clamp member may be moved to adjust the width of the opening 414 between the paddle 406 and the clamp member 408. The clamping member 408 may include barbed portions 409 for attaching the clamping member to valve tissue when the valve repair device 402 is attached to valve tissue. The clamping member 408 forms a means for clamping valve tissue (in particular tissue of the valve leaflet) with an adhesive means or portion, such as an optional barbed portion 409. When the paddle 406 is in the closed position, the paddle engages the clamping member 408 such that when valve tissue is attached to the barbed portion 409 of the clamping member, the paddle acts as a retaining or securing device to retain the valve tissue at the clamping member and secure the valve repair device 402 to the valve tissue. In some embodiments, the clamping member 408 is configured to engage the paddle 406 such that the optional barbed portion 409 engages the valve tissue member and the paddle 406 to secure the valve repair device 402 to the valve tissue member. For example, in some cases, it may be advantageous to hold the paddle 406 in the open position and move the clamping members 408 outwardly toward the paddle 406 to engage valve tissue and the paddle 406.

Although the example shown in fig. 57-63 illustrates a pair of paddles 406 and a pair of clamping members 408, it should be understood that the valve repair device 402 may include any suitable number of paddles and clamping members.

In some embodiments, the valve repair system 400 includes a placement shaft 413 removably attached to the shaft 403 of the base assembly 404 of the valve repair device 402. After the valve repair device 402 is secured to the valve tissue, the placement shaft 413 is removed from the shaft 403 to remove the valve repair device 402 from the rest of the valve repair system 400 so that the valve repair device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient.

Valve repair system 400 may also include a paddle control mechanism 410, a holder control mechanism 411, and a lock control mechanism 412. The blade control mechanism 410 is mechanically attached to the coupler 405 to move the coupler along the shaft, which moves the blade 406 between the open and closed positions. Blade control mechanism 410 may take any suitable form, such as a shaft or lever. For example, the blade control mechanism may include a hollow shaft, conduit, or sleeve that fits over placement shaft 413 and shaft 403 and is connected to coupler 405.

The gripper control mechanism 411 is configured to move the gripping member 408 such that the width of the opening 414 between the gripping member and the paddle 406 may be varied. The gripper control mechanism 411 may take any suitable form, such as a wire, suture or guide wire, rod, catheter, or the like.

The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 serves as a locking device to lock the coupling 405 in a fixed position relative to the shaft 403 and may take a number of different forms and the type of lock control mechanism 412 may be determined by the type of lock used. In one example, the lock 407 comprises a pivotable plate having an aperture, wherein the shaft 403 of the valve repair device 402 is disposed within the aperture of the pivotable plate. In this example, the pivotable plate engages the shaft 403 to maintain a position on the shaft 403 when the pivotable plate is in the tilted position, but is movable along the shaft (which allows the coupler 405 to move along the shaft 403) when the pivotable plate is in the substantially non-tilted position. In other words, when the pivotable plate of lock 407 is in the tilted (or locked) position, coupler 405 is prevented from moving along shaft 403 in direction Y (as shown in fig. 61A), and when the pivotable plate is in the substantially non-tilted (or unlocked) position, the coupler is allowed to move along shaft 403 in direction Y. In examples where lock 407 includes a pivotable plate, 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 may be, for example, a lever, 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. In some embodiments, the pivotable plate of lock 407 is biased in a tilted (or locked) position, and lock control mechanism 412 is used to move the plate from the tilted position to a substantially non-tilted (or unlocked) position. In some embodiments, the pivotable plate of lock 407 is biased to a substantially non-tilted (or unlocked) position, and lock control mechanism 412 is used to move the plate from the substantially non-tilted position to the tilted (or locked) position.

Fig. 61A-61B illustrate the valve repair device 402 being moved from an open position (as shown in fig. 61A) to a closed position (as shown in fig. 61B). The base assembly 404 includes a first link 1021 extending from point a to point B, a second link 1022 extending from point a to point C, a third link 1023 extending from point B to point D, a fourth link 1024 extending from point C to point E, and a fifth link 1025 extending from point D to point E. Coupler 405 is movably attached to shaft 403 and shaft 403 is fixed to fifth link 1025. The first link 1021 and the second link 1022 are pivotally attached to the coupler 405 at point a such that movement of the coupler 405 along the shaft 403 moves the position of point a and thus the first link 1021 and the second link 1022. The first link 1021 and the third link 1023 are pivotally attached to each other at point B, and the second link 1022 and the fourth link 1024 are pivotally attached to each other at point C. One blade 406a is attached to the first link 1021 such that movement of the first link 1021 causes movement of the blade 406a, and the other blade 406b is attached to the second link 1022 such that movement of the second link 1022 causes movement of the blade 406 b. In some embodiments, paddles 406a, 406b may be connected to links 1023, 1024 or an extension of links 1023, 1024.

To move the valve repair device from the open position (as shown in fig. 61A) to the closed position (as shown in fig. 61B), the coupler 405 is moved along the shaft 403 in the direction Y, thereby moving the pivot point a of the first and second links 1021, 1022 to the new position. Movement of the coupler 405 (and pivot point a) in direction Y causes the portion of the first link 1021 near point a to move in direction H and the portion of the first link 1021 near point B to move in direction J. The paddle 406a is attached to the first link 1021 such that movement of the coupler 405 in direction Y causes the paddle 406a to move in direction Z. In addition, third link 1023 is pivotally attached to first link 1021 at point B such that movement of coupler 405 in direction Y causes third link 1023 to move in direction K. Similarly, movement of the coupler 405 (and pivot point a) in direction Y causes the portion of the second link 1022 proximate point a to move in direction L and the portion of the second link 1022 proximate point C to move in direction M. The paddle 406b is attached to the second link 1022 such that movement of the coupler 405 in the direction Y causes the paddle 406b to move in the direction V. In addition, the fourth link 1024 is pivotally attached to the second link 1022 at point C such that movement of the coupler 405 in direction Y causes the fourth link 1024 to move in direction N. Fig. 61B shows the final position of the valve repair device 402 after the coupler 405 has been moved as shown in fig. 61A.

Referring to fig. 58, the valve repair device 402 is shown in an open position (similar to the position shown in fig. 61A), and the holder control mechanism 411 is shown moving the holding member 408 to provide a wider gap at the opening 414 between the holding member and the paddle 406. In the example shown, the clamp control mechanism 411 includes a wire, such as a suture, a wire, or the like, that is threaded through an opening in one end of the clamp member 408. Both ends of the wire extend through the delivery opening 516 of the delivery device 401. When the wire is pulled in direction Y through the delivery opening 516, the clamping member 408 moves inward in direction X, which widens the opening 414 between the clamping member and the paddle 406.

Referring to fig. 59, the valve repair device 402 is shown with valve tissue 20, 22 disposed in an opening 414 between the clamping member 408 and the paddle 406. Referring to fig. 60, after valve tissue 20, 22 is disposed between the clamping member 408 and paddle 406, a holder control mechanism 411 is used to reduce the width of the opening 414 between the clamping member and paddle. That is, in the example shown, the wire of the gripper control mechanism 411 is released or pushed out of the delivery member's opening 516 in direction H, which allows the gripper member 408 to move in direction D to reduce the width of the opening 414. While the holder control mechanism 411 is shown as moving the holding member 408 to increase the width of the opening 414 between the holding member and the paddle 406 (fig. 59), it should be understood that it may not be necessary to move the holding member in order to position valve tissue in the opening 414. However, in some cases, the opening 414 between the paddle 406 and the clamping member 408 may be wider in order to receive valve tissue.

Referring to fig. 62, the valve repair device 402 is in a closed position and secured to valve tissue 20, 22. The valve repair device 402 is secured to the valve tissue 20 by paddles 406a, 406b and clamping members 408a, 408 b. Specifically, the valve tissue 20, 22 is attached to the valve repair device 402 by the optionally barbed portion 409 of the clamping member 408a, 408b, and the paddles 406a, 406b engage the clamping member 408 to secure the valve repair device 402 to the valve tissue 20, 22.

To move the valve repair device 402 from the open position to the closed position, the lock control mechanism 412 moves the lock 407 to the unlocked state (as shown in fig. 62). Once lock 407 is in the unlocked state, coupler 405 may be moved along shaft 403 by blade control mechanism 410. In the example shown, the blade control mechanism 410 moves the coupler 405 along an axis in the direction Y, which causes one blade 406a to move in the direction X and the other blade 406b to move in the direction Z. Movement of the paddles 406a, 406b in directions X and Z causes the paddles to engage the clamping members 408a, 408b and secure the valve repair device 402 to the valve tissue 20, 22.

Referring to fig. 63, after paddle 406 is moved to the closed position to secure valve repair device 402 to valve tissue 20, 22 (shown in fig. 62), lock control mechanism 412 (fig. 62) moves lock 407 to the locked state to hold valve repair device 402 in the closed position. After valve repair device 402 is held in the locked state by lock 407, valve repair device 402 is removed from delivery device 401 by disconnecting shaft 403 from placement shaft 413 (fig. 62). In addition, valve repair device 402 is disengaged from paddle control mechanism 410 (fig. 62), holder control mechanism 411 (fig. 62), and lock control mechanism 412. Removing the valve repair device 402 from the delivery device 401 allows the valve repair device to remain fixed to the valve tissue 20, 22 while the delivery device 401 is removed from the patient.

Referring now to fig. 64, an exemplary valve repair device 570 is shown. Valve repair device 570 may include any combination of features of an implantable prosthetic device or implant as described herein. As shown in this example, valve repair device 570 is deployed between atrium a and ventricle V, for example in the mitral or tricuspid valve of the heart. Valve repair device 570 engages tissue, such as native valve leaflets 20 and 22, to repair native valve function (e.g., control unidirectional blood flow from atrium a to ventricle V). As described herein. Valve repair device 570 may be secured in place, for example, by paddles, hooks, barbs, anchors, etc., in any manner described herein.

In some embodiments, valve repair device 570 includes one or more sensors, such as sensor 572 and/or sensor 574. In some embodiments, sensors 572 and/or 574 are pressure sensors operable to measure pressure (e.g., blood pressure) in the vicinity of the sensors. For example, in one example, sensor 572 is configured to measure a proximal pressure (i.e., pressure in the atrium), and sensor 574 is configured to measure a distal pressure (i.e., pressure in the ventricle). Using the measured proximal (atrial) and distal (ventricular) pressures, it is possible to calculate a pressure gradient that provides insight as to the function of the valve repair device and the condition of the device in the patient. Although primarily described herein as relating to pressure, in some examples, one or more sensors may be configured to measure, collect, interpret, and/or transmit pressure-related and non-pressure-related data, such as heart rate, physical activity, blood flow, pressure gradients, and the like. In addition, the ability to view and collect the above data in real-time or near real-time enables a physician or other medical professional to quickly determine the operational effectiveness of the valve repair device.

Certain sensor(s) described herein may be configured to measure, collect, interpret, and/or transmit multiple types of data within a single sensor device. It should be appreciated that different sensors are contemplated, such as pressure plate sensors, capacitance-based sensors, inductance-based sensors, and the like. The sensors 572, 574 may be the same type of sensor or may be different types of sensors. It should also be appreciated that in some embodiments, the sensors 572 and 574 may be embodied in a single sensor configuration. Other configurations are contemplated, including configurations with multiple sensors. With respect to the locations of the sensors 572 and 574, it should be appreciated that, while depicted in the various locations described herein, the sensors 572 and 574 may be disposed anywhere on or near the valve repair device in some embodiments.

The sensors 572 and 574 may optionally include a transmitter for wirelessly transmitting data measured by the sensors 572 and 574 in real-time or near real-time. As shown in fig. 65, an exemplary valve repair device 580 with sensors 572 and 574 and a transmitter 582 is shown. The transmitter 582 can take a wide variety of different forms. The transmitter 582 may be an antenna. Such antennas can take a wide variety of different forms. In the example shown, the antenna extends between the sensors 572, 574. In some embodiments, the transmitter 582 is a Radio Frequency (RF) transmitter. In some embodiments, the transmitter 582 is a wi-fi transmitter. In some embodiments, the transmitter 582 is a bluetooth transmitter.

As the data is measured, collected, and/or interpreted by the sensors 572 and 574, the data can be wirelessly transmitted outside the body to a compatible receiver device. It should be appreciated that the receiver device may be embodied in a variety of devices including, but not limited to, cell phones, notebook/desktop computers, tablet computers, smart watches, and the like. It should also be appreciated that the compatible receiver device may include a processor and memory operable to perform calculations, display data, etc., based on data received from the sensors 572 and 574. In some embodiments, the transmitter 582 is configured to transmit and receive data at the sensors 572 and 574. For example, in some embodiments, the receiver device is operable to configure and/or calibrate the sensors 572 and 574 via wireless communication with the transmitter 582. It should be appreciated that the transmitter 582 as described above may be integrated within the sensors 572 and 574, the valve repair device 580, or both.

In some embodiments, the sensors 572 and 574 may include a processor and memory. A processor and memory configuration may be associated with the sensors and used to perform various calculations related to the measurements at the sensors 572 and 574. In some configurations, the sensors 572 and 574 may also be associated with a memory configured to store measured data, which may then be used by the processor and/or additional memory to process calculations related to the data. It should be appreciated that the processor and memory as described above may be integrated within the sensors 572 and 574, the valve repair devices (e.g., valve repair devices 570 and/or 580), or both.

In some embodiments, the sensors 572 and 574 are battery powered. In some embodiments, the sensors 572 and 574 are configured to receive power wirelessly, e.g., via near field RF power signals. In some embodiments, the sensors 572 and 574 will be operable when in signal communication with near field RF power. In some embodiments, an exemplary receiver device may send such power signals to the sensors 572 and 574 in order to activate the sensors and facilitate the transmission of data from the sensors to the receiver device.

Fig. 66 shows an exemplary valve repair device 590 with spacers 592. The valve repair device 590 can take a wide variety of different forms. For example, valve repair device 590 may be valve repair device 100 shown in fig. 8-21 and described herein. The valve repair device 590 is shown to include hooks 594 and paddles 596. The spacers 592, hooks 594, and paddles 596 are used to position and secure the valve repair device 590 in a native valve (e.g., mitral valve, tricuspid valve, etc.) to improve, repair, and/or replace native valve function. However, in some examples, the valve repair device 590 may be used in other valves, such as the tricuspid valve, aortic valve, or pulmonary valve.

In the example shown in fig. 66, valve repair device 590 further includes sensors 572 and 574. The spacers 592, hooks 594, and/or paddles 596 may be modified from the spacers, hooks, and/or paddles of the device 100 to facilitate inclusion of the sensors 572 and 574. As shown, sensor 572 may be configured to determine a characteristic or property in atrium a, such as pressure in atrium a, and sensor 574 may be configured to determine a characteristic or property in the ventricle, such as pressure in ventricle V.

Fig. 67 shows an exemplary valve repair device 600. The valve repair device 600 can take a wide variety of different forms. For example, the valve repair device 600 may be the valve repair device 100 shown in fig. 8-21 and described herein. The valve repair device 600 may include a coaptation element or spacer 602, a catch 604, and a paddle 606. As described herein, the apposition element/spacer 602, hooks 604, and paddles 606 may be used to position and secure the valve repair device 600 in a native valve (e.g., mitral valve, tricuspid valve, etc.) to improve, repair, and/or replace native valve function. Also shown in fig. 67 are sensors 572 and 574 and a transmitter 582. The apposition member/spacer 602, catch 604 and/or paddle 606 may be modified from the apposition member/spacer, catch and/or paddle of the device 100 so as to include the sensors 572 and 574 and/or the transmitter 582. As shown, sensor 572 may be configured to determine a proximal pressure in atrium a, and sensor 574 may be configured to determine a distal pressure in ventricle V. The proximal and distal pressures may then be transmitted to a receiving device (not shown) via transmitter 582.

Fig. 68 shows an exemplary valve repair device 610 attached to native valve leaflets 20 and 22. The valve repair device 610 can take a wide variety of different forms. For example, valve repair device 610 may be valve repair device 402 shown in fig. 57-63 and described herein. The valve repair device 610 includes hooks 616 and paddles 612 for securing the valve repair device 600 in a native valve to repair native valve function. Valve repair device 610 includes a linkage 613 that moves paddle 612. The linkage 613 can be manipulated by moving the coupler 611 up and down along the shaft 615. Once the desired position of blade 612 is reached, the coupler may be secured in place by lock 618. Also shown in fig. 68 are sensors 572 and 574. Blade 612, catch 616, linkage 613, coupler, and/or lock 618 may be modified from the blade, catch, linkage, coupler, and/or lock of device 402 to facilitate inclusion of sensors 572 and 574. As shown, sensor 572 may be configured to determine a proximal pressure in atrium a, and sensor 574 may be configured to determine a distal pressure in ventricle V.

FIG. 69 shows that the atrial sensor 572 of the device 610 may be disposed at a wide variety of different locations, including but not limited to locations 6916, 6917, and/or 6923. Position 6916 shows that the atrial sensor 572 of the device 610 may be positioned on one or more of the hooks, such as at the end of one or more of the hooks 616 or along the length of one or more of the hooks. Position 6917 shows that the atrial sensor 572 of the device 610 may be positioned on the shaft 615, such as at one end of the shaft or along the length of the shaft. Position 6923 illustrates that the atrial sensor 572 of the device 610 may be positioned at one or more locations on the linkage 623 that are exposed to atrial pressure.

Fig. 70 shows that the ventricular sensor 574 of the device 610 can be arranged at a wide variety of different positions, including but not limited to position 623 and position 632. Position 632 illustrates that ventricular sensor 574 of device 610 can be positioned on one or more portions of the links of linkage 613 that are exposed to ventricular pressure. Position 632 illustrates that ventricular sensor 574 of device 610 can be positioned on one or more portions of paddle 612.

Fig. 71 and 72 illustrate an exemplary valve repair device 640. The valve repair device 640 may take a wide variety of different forms. For example, valve repair device 640 may be valve repair device 200 shown in fig. 22-53 and described herein. The valve repair device 640 further includes an outer paddle 652, an inner paddle 653, a paddle frame 654, a spacer 655, a movable catch arm 656, and a fixed catch arm 657. The paddles and hooks are used to position and secure the valve repair device 640 in the native valve to repair the native valve function. Valve repair device 640 may also include collar 658 and cover 659. Also shown in fig. 72 are sensors 572 and 574. The outer paddle 652, inner paddle 653, paddle frame 654, spacer 655, movable catch arm 656, fixed catch arm 657, collar 658, and/or cover 659 may be modified from the outer paddle, inner paddle, paddle frame, spacer, movable catch arm, fixed catch arm, collar, and/or cover of the device 402 to facilitate inclusion of the sensors 572 and 574 and/or the transmitter 582. As shown, sensor 572 may be configured to determine a proximal pressure in atrium a, and sensor 574 may be configured to determine a distal pressure in ventricle V.

Fig. 73 illustrates that the atrial sensor 572 of the device 640 may be disposed at a wide variety of different locations, including but not limited to locations 7358, 7355a, 7355b, 7356, and/or 7357. Position 7358 shows that atrial sensor 572 of device 640 may be positioned on collar 658. Positions 7355a, 7355b show that the sensor may be positioned on the spacer 655. Position 7355a shows that the sensor can be positioned on the proximal end of the spacer 655. Position 7355b shows that the sensor may be positioned on the middle portion along the length of the coaptation element/spacer 655. Positions 7356, 7357 show that the sensor can be positioned on the movable catch arm 656. Position 7356 shows that the sensor can be positioned on one end of the movable catch arm 656. Position 7357 shows that the sensor can be positioned along the length of the movable catch arm 656.

Fig. 74 illustrates that the ventricular sensor 574 of the device 640 can be disposed at a wide variety of different locations, including but not limited to locations 7452a, 7452b, 7453, and 7459. Positions 7452a, 7452b illustrate that ventricular sensor 574 of device 640 may be positioned on one or more portions of outer paddle 652 that are exposed to ventricular pressure. Position 7452a illustrates that ventricular sensor 574 of device 640 can be positioned on one or more proximal portions of outer paddle 652. Position 7452b illustrates that ventricular sensor 574 of device 640 can be positioned on one or more distal portions of outer paddle 652. Position 7453 shows that the ventricular sensor 574 of the device 640 can be positioned on one or more portions of the inner paddle 653 and/or one or more portions of the stationary catch arm 657. Position 7459 shows that ventricular sensor 574 of device 640 can be positioned on cover 659.

Fig. 75 shows an exemplary valve repair device 680. The valve repair device 640 may take a wide variety of different forms. For example, valve repair device 640 may be valve repair device 300 shown in fig. 55 and described herein. Valve repair device 680 includes outer paddle 652, inner paddle 653, paddle frame 654, spacer 655 (including top portion 655a and middle portion 655 b), movable catch arm 656 (see fig. 76 and 77), and fixed catch arm 657 (see fig. 76 and 77). The spacers, paddles, and hooks are used to position and secure the valve repair device 680 in the native valve to repair native valve function. Valve repair device 680 may also include collar 658 (fig. 77) and/or cover 659 (fig. 76). Also shown in fig. 75 are sensors 572 and 574. The outer paddle 652, inner paddle 653, paddle frame 654, spacer 655, movable catch arm 656, fixed catch arm 657, collar 658, and/or cover 659 may be modified from the outer paddle, inner paddle, paddle frame, spacer, movable catch arm, fixed catch arm, collar, and/or cover of the device 300 to facilitate inclusion of the sensors 572 and 574 and/or the transmitter 582. As shown, sensor 572 may be configured to determine a proximal pressure in atrium a, and sensor 574 may be configured to determine a distal pressure in ventricle V.

FIG. 76 shows that the atrial sensor 572 of the device 680 may be disposed at a wide variety of different locations, including but not limited to locations 7658, 7655, and/or 7456. Position 7658 shows that atrial sensor 572 of device 640 may be positioned on collar 658 (see FIG. 77). Position 7655 shows that the sensor may be positioned on the spacer 655. Position 7656 shows that the sensor can be positioned on the movable catch arm 656.

FIG. 77 illustrates that the ventricular sensor 574 of the device 680 can be arranged at a wide variety of different locations, including but not limited to locations 7752a, 7752b, 7753, and 7759. Positions 7752a, 7752b illustrate that the ventricular sensor 574 of the device 640 may be positioned on one or more portions of the outer paddle 652 that are exposed to ventricular pressure. Position 7752a illustrates that the ventricular sensor 574 of the device 640 can be positioned on one or more proximal portions of the outer paddle 652. Position 7752b illustrates that the ventricular sensor 574 of the device 640 can be positioned on one or more distal portions of the outer paddle 652. Position 7753 illustrates that the ventricular sensor 574 of the device 640 can be positioned on one or more portions of the inner blade 653 and/or one or more portions of the stationary catch arm 657. Position 7759 shows that ventricular sensor 574 of device 640 can be positioned on cover 659.

Fig. 78 illustrates an exemplary delivery system 702 for deploying a valve repair device in a human heart H. In the illustrated embodiment, one or more sensors are positioned on one or more components of the delivery system 702, as opposed to a valve repair device (e.g., valve repair device 570) that includes one or more sensors, such as sensor 572 and/or sensor 574. However, in some embodiments, the sensor 572 or sensor 574 can be included on the valve repair device in any of the ways disclosed herein, and another sensor can be included on one or more components of the delivery system. The valve repair device may be any of the valve repair devices disclosed herein, such as valve repair device 100.

Fig. 78 shows a valve repair device 100 positioned at the mitral valve MV between the left atrium LA and the left ventricle LV and engaging valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). The delivery system 702 may be configured to position the valve repair device at the mitral valve MV between the left atrium LA and the left ventricle LV in a wide variety of different ways. For example, the valve repair device may be delivered transpinally, transseptally, etc. through the atrium as shown. In fig. 78, delivery through the atrium is chosen simply because it provides the simplest illustration of the system. Additionally, the valve repair device 10 may be configured for implantation onto other native heart valves, such as the tricuspid valve.

The device or implant 100 includes a coaptation element 110 (e.g., spacer, plug, filler, foam, sheet, membrane, engagement element, etc.) adapted to be implanted between leaflets 20, 22 of a native valve (e.g., native mitral valve MV, native tricuspid valve, etc.) and slidably attached to an actuation element 112 (e.g., actuation lead, actuation shaft, actuation tube, etc.). The anchoring portion 106 of the device 100 includes one or more anchors 108 that are actuatable between an open state and a closed state and can take a wide variety of forms, e.g., paddles, clamping elements, etc. Actuation of the actuation element 112 opens and closes the anchoring portion 106 of the device 100 to grasp the native valve leaflets 20, 22 during implantation.

In some embodiments, the delivery system 702 includes a steerable catheter 704, an implant catheter 706, and an actuation element 112. These may be configured to extend through an introducer catheter/sheath (e.g., a transseptal sheath, etc.). In some embodiments, the actuating element 112 extends through the implant catheter 706 and the apposition element 110 to the distal end 714 of the anchoring portion 106.

In some embodiments, the sensors 572, 574 are pressure sensors operable to measure pressure in the vicinity of the sensors. For example, in one example, the first sensor 572 is configured to measure a proximal pressure (i.e., pressure in the left atrium), and the second sensor 574 is configured to measure a distal pressure (i.e., pressure in the left ventricle). The first sensor 572 and the second sensor 574 can be located at any suitable location on the delivery system 702 to measure the proximal pressure and the distal pressure. Using the measured proximal (atrial) and distal (ventricular) pressures, it is possible to calculate a pressure gradient that provides insight as to the function of the valve repair device and the condition of the device in the patient. Although primarily described herein as relating to pressure, in some examples, one or more sensors may be configured to measure, collect, interpret, and/or transmit pressure-related and non-pressure-related data, such as heart rate, physical activity, blood flow, pressure gradients, and the like. In addition, the ability to view and collect the above data in real-time or near real-time enables a physician or other medical professional to quickly determine the operational effectiveness of the valve repair device.

In some embodiments, the first sensor 572 and the second sensor 574 comprise fluid-filled lumens, wherein each lumen forms a continuous fluid path, allowing for simultaneous real-time assessment of atrial and ventricular pressures, and thus, for transvalve gradient assessment. The first sensor 572 and the second sensor 574 can be disposed at any suitable location in the delivery system 702 to measure the proximal pressure and the distal pressure. In some embodiments, the first sensor 572 can be a first lumen formed in the steerable catheter 704 and extending from the distal portion 716 of the steerable catheter 704 to a first outlet pressure port 718, which can be connected to a pressure transducer (not shown) or other pressure sensing device. The fluid (e.g., saline) in the first lumen forms a continuous fluid path that is capable of relaying pressure signals along the first lumen from the distal portion 716 of the steerable catheter to the pressure transducer so that real-time pressure can be monitored. Because the distal portion 716 of the steerable catheter 704 is positioned in the left atrium LA during deployment of the device or implant 100, the first sensor 572 can measure atrial pressure.

In a similar manner, the second sensor 574 can be a second lumen formed in one or more of the implant catheter 706 and the means for actuating or the actuating element 112. For example, the means for actuating or the actuating element 112 may be an actuating tube comprising the second lumen or a portion of the second lumen. The tubular actuation element 112 extends from the distal end 714 of the device or implant 100 through the implant conduit 706. The tubular actuation element may be in fluid communication with a second outlet pressure port 720, which may be connected to a pressure transducer (not shown) or other pressure sensing device. The fluid (e.g., saline) in the second lumen forms a continuous fluid path that is capable of relaying pressure signals along the second lumen from the distal end 714 of the device or implant 100 to the pressure transducer so that real-time pressure can be monitored. Because the distal end 714 of the device or implant 100 is positioned in the left ventricle LV, the second sensor 574 can measure the ventricular pressure, which can be relayed along the implant catheter 706 and monitored in real time and simultaneously similar to the atrial pressure. In conjunction with atrial and ventricular pressure assessment, the user can assess the transvalve gradient before and after implantation of the procedure to assess procedure success.

In some embodiments, both the first lumen and the second lumen may be formed in the implant catheter 706. For example, the second sensor 574 can include an actuation element 112 and a lumen in the implant catheter disposed about the actuation element. An optional seal may be provided between the actuation element 112 and the implant conduit 706 that prevents, substantially prevents, or inhibits fluid in the atrium from entering a lumen in the implant conduit disposed about the actuation element 112, but allows the actuation element to slide relative to the implant conduit 706. A lumen in the implant catheter disposed around the actuating element and the actuating element 112 extend from the distal end 714 of the device or implant 100 and communicate with the second outlet pressure port 720 to measure the ventricular pressure. The first sensor 572 'may be a first lumen that is not formed in the steerable catheter 704, but rather is formed in the implant catheter 706, and extends from the distal portion 722 of the implant catheter 706 to an outlet pressure port 718', which may be connected to a pressure transducer (not shown) or other pressure sensing device. During deployment of the device or implant 100, the distal portion 722 of the implant catheter 706 remains in the left atrium such that the fluid (e.g., saline) in the first lumen forms a continuous fluid path that is capable of relaying pressure signals along the first lumen from the distal portion 722 of the implant catheter 706 to the pressure transducer so that real-time pressure can be monitored. Because the distal portion 722 of the implant catheter 706 is positioned in the left atrium LA, the first sensor 572' may measure the atrial pressure.

Any of the various systems, devices, apparatuses, etc. in the present disclosure may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safely used with the patient, and the methods herein may include sterilizing the associated systems, devices, apparatuses, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

While various inventive aspects, concepts and features of the disclosure may be described and illustrated herein as being embodied in combination in various examples, such various aspects, concepts and features may be used in many alternative embodiments, either alone or in various combinations and subcombinations thereof. All such combinations and sub-combinations are intended to be within the scope of the present application unless explicitly excluded herein. Still further, while various alternative embodiments as to the various aspects, concepts and features of the disclosure, such as alternative materials, structures, configurations, methods, devices and components, alternatives as to form, fit and function, and so on, may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts or features into additional embodiments and uses within the scope of the present application even if such embodiments are not expressly disclosed herein.

Additionally, although some features, concepts or aspects of the disclosure may be described herein as a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Additionally, exemplary or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.

Furthermore, while 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, but rather there may be inventive aspects, concepts and features that are fully described herein without being expressly identified or identified as part of a specific disclosure, which is instead set forth in the appended claims. The description of an exemplary method or process is not limited to inclusion of all steps as being required in all cases, nor is the order presented to be construed as required or necessary unless expressly so stated. The words used in the claims have their full ordinary meaning and are not limited in any way by the description of the embodiments in the specification.

Claims

1. A sensing valve repair device, comprising:

a valve repair component having a proximal end and a distal end;

a first sensor connected to the valve repair component, wherein the first sensor is configured to sense a characteristic at the proximal end of the valve repair component; and

a second sensor connected to the valve repair component, wherein the second sensor is configured to sense a characteristic at the distal end of the valve repair component.

2. The sensing valve repair device of claim 1, wherein the characteristic sensed by the first sensor and the characteristic sensed by the second sensor is pressure.

3. The sensed valve repair device of any one of claims 1 and 2, further comprising a transmitter configured to transmit sensed data from at least one of the first sensor and the second sensor to a receiver.

4. The sensing valve repair device of any one of claims 1-3, further comprising a processor and a memory.

5. The sensing valve repair device of claim 4, wherein the processor is configured to calculate a pressure gradient between the first sensor and the second sensor.

6. The sensing valve repair device of claim 4, wherein the processor is configured to calculate a flow rate based on the characteristics sensed by the first sensor and the second sensor.

7. The sensing valve repair device of any one of claims 1-6, wherein at least one of the first sensor and the second sensor is configured to sense heart rate.

8. The sensing valve repair device of claim 3, wherein the transmitter is configured to transmit heart rate data.

9. The sensing valve repair device of any one of claims 1-8, wherein the valve repair component is configured for implantation within a mitral valve.

10. A sensing valve repair system, comprising:

a delivery catheter;

a sensing valve repair device coupled to the delivery catheter, wherein the sensing valve repair device comprises:

a valve repair component having a proximal end and a distal end;

11. The sensed valve repair system of claim 10, wherein the characteristic sensed by the first sensor and the characteristic sensed by the second sensor is pressure.

12. The sensed valve repair system of any one of claims 10 and 11, further comprising a transmitter configured to transmit sensed data from at least one of the first sensor and the second sensor to a receiver.

13. The sensing valve repair system of any one of claims 10-12, further comprising a processor and a memory.

14. The sensing valve repair system of claim 13, wherein the processor is configured to calculate a pressure gradient between the first sensor and the second sensor.

15. The sensed valve repair system of claim 13, wherein the processor is configured to calculate a flow rate based on the characteristics sensed by the first sensor and the second sensor.

16. The sensing valve repair system of any one of claims 10-15, wherein at least one of the first sensor and the second sensor is configured to sense heart rate.

17. The sensing valve repair system of claim 12, wherein the transmitter is configured to transmit heart rate data.

18. The sensing valve repair system of any one of claims 10-17, wherein the valve repair component is configured for implantation within a mitral valve.

19. A method of sensing a pressure gradient across a native valve, the method comprising:

implanting a valve repair device into the native valve such that a first end of the valve repair device is in communication with blood in the atrium and a second end of the valve repair device is in communication with blood in the ventricle;

sensing a pressure of the blood in the atrium with the valve repair device; and

sensing a pressure of the blood in the ventricle with the valve repair device.

20. The method of claim 19, wherein the valve repair device has a first sensor at the first end of the valve repair device and the valve repair device has a second sensor at the second end of the valve repair device.

21. The method of any one of claims 19 and 20, further comprising transmitting at least one of: (i) the pressure of the blood in the atrium, (ii) the pressure of the blood in the ventricle, (iii) a gradient between the pressure of the blood in the atrium and the pressure of the blood in the ventricle, and (iv) a flow rate based on the pressure of the blood in the atrium and the pressure of the blood in the ventricle.

22. The method of any one of claims 19 to 21, further storing the sensed pressure in the atrium and storing the sensed pressure in the ventricle.

23. The method of any one of claims 19-22, further comprising determining a heart rate based on the pressure of the blood in the atrium and the pressure of the blood in the ventricle.

24. A system, comprising:

a heart valve repair device;

a delivery system for deploying the heart valve repair device;

a first sensor associated with the delivery system, wherein the first sensor is configured to sense a characteristic at a proximal or proximal end of the heart valve repair device; and

a second sensor associated with the delivery system, wherein the second sensor is configured to sense a characteristic at a distal or distal end of the heart valve repair device.

25. The system of claim 24, wherein the characteristic sensed by both the first sensor and the second sensor is pressure.

26. The system of claim 24, wherein the first sensor is located on a first component of the delivery system and the second sensor is located on a second component of the delivery system that is movable relative to the first component.

27. The system of claim 24, wherein the first sensor is a pressure sensor comprising a first lumen of a first catheter and is in fluid communication with a first pressure sensing device.

28. The system of claim 27, wherein the first lumen extends from a distal portion of the first catheter to the first pressure sensing device.

29. The system of claim 27, wherein the second sensor is a pressure sensor comprising a second lumen of the first catheter and is in fluid communication with a second pressure sensing device.

30. The system of claim 29, wherein the second lumen extends through an actuation element that opens and closes an anchoring portion of the heart valve repair device.

31. The system of claim 27, wherein the second sensor comprises a second lumen of a second catheter in fluid communication with a second pressure sensing device.

32. The system of claim 31, wherein the second lumen extends through an actuation element that opens and closes an anchoring portion of the heart valve repair device.

33. A sensing valve repair system, comprising:

A steerable catheter;

an implant catheter received inside the steerable catheter;

a valve repair device coupled to the implant catheter;

a first sensor associated with one of the delivery catheter and the implant catheter, wherein the first sensor is configured to sense a characteristic at a proximal or proximal end of the valve repair device; and

a second sensor associated with the implant catheter, wherein the second sensor is configured to sense a characteristic at a distal or distal end of the valve repair device.

34. The sensed valve repair system of claim 33, wherein the characteristic sensed by both the first sensor and the second sensor is pressure.

35. The sensing valve repair system of claim 33 wherein the first sensor is located on the implant catheter.

36. The sensing valve repair system of claim 35 wherein the first sensor is a pressure sensor comprising a first lumen of the implant catheter and is in fluid communication with a first pressure sensing device.

37. The sensing valve repair system of claim 36 wherein the first lumen extends from a distal portion of the implant catheter to the first pressure sensing device.

38. The sensing valve repair system of claim 36 wherein the second sensor is a pressure sensor comprising a second lumen of the implant catheter and is in fluid communication with a second pressure sensing device.

39. The sensing valve repair system of claim 38, wherein the second lumen extends through an actuation element that opens and closes an anchoring portion of the valve repair device.

40. The sensing valve repair system of claim 33 wherein the first sensor is a pressure sensor located on the delivery catheter.

41. The sensing valve repair system of claim 40, wherein the first sensor comprises a lumen of the delivery catheter and is in fluid communication with a first pressure sensing device.

42. The sensing valve repair system of claim 40, wherein the second sensor is a pressure sensor comprising a lumen of the implant catheter and is in fluid communication with a second pressure sensing device.

43. The sensing valve repair system of claim 42, wherein the lumen of the valve repair device extends through an actuation element that opens and closes an anchoring portion of the valve repair device.

44. The sensed valve repair system of any one of claims 33 to 43, further comprising a transmitter configured to transmit sensed data from at least one of the first sensor and the second sensor to a receiver.

45. A method of sensing a pressure gradient across a native valve, the method comprising:

implanting a valve repair device into the native valve using a delivery system such that a first end of the valve repair device is in communication with blood in the atrium and a second end of the valve repair device is in communication with blood in the ventricle;

sensing a pressure of the blood in the atrium with a first component of the delivery system; and

sensing a pressure of the blood in the ventricle with a second component of the delivery system.

46. The method of claim 45, wherein the pressure in the atrium is sensed via a lumen in a first catheter of the delivery system.

47. The method of claim 46, wherein the pressure in the ventricle is sensed via a second lumen in the first catheter of the delivery system, and wherein the second lumen extends through an actuation element that opens and closes an anchoring portion of the valve repair device.

48. The method of claim 45, wherein the pressure in the ventricle is sensed via a lumen in a second catheter of the delivery system, and wherein the lumen in the second catheter extends through an actuation element that opens and closes an anchoring portion of the valve repair device.

49. The method of any one of claims 45 to 48, further comprising transmitting at least one of: (i) the pressure of the blood in the atrium, (ii) the pressure of the blood in the ventricle, (iii) a gradient between the pressure of the blood in the atrium and the pressure of the blood in the ventricle, and (iv) a flow rate based on the pressure of the blood in the atrium and the pressure of the blood in the ventricle.