HK40039391B - Percutaneous leaflet augmentation - Google Patents

Description

Percutaneous leaflet enlargement

This application is a divisional application of Chinese Patent Application No. 2018104373339 entitled "Transcutaneous Lobe Enlargement" filed on February 13, 2015. Divisional application No. 2018104373339 is a divisional application of Chinese Patent Application No. 2015800184065.

Technical Field

This disclosure generally relates to prosthetic devices and related methods for helping to seal natural heart valves and prevent or reduce backflow therethrough, as well as devices and related methods for implanting such prosthetic devices.

Background Technology

Natural heart valves (i.e., the aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a crucial role in ensuring an adequate supply of blood flows forward through the cardiovascular system. Congenital malformations, inflammatory processes, infectious conditions, or diseases can render these heart valves less effective. Such damage to the valves can lead to serious cardiovascular damage or death. For many years, the definitive treatment for such conditions has been surgical repair or valve replacement during open-heart surgery. However, such surgeries are highly invasive and prone to numerous complications. Consequently, elderly individuals with defective heart valves and frail patients often do not receive treatment. Recently, transvascular techniques have been developed for the introduction and implantation of prosthetic devices in a much less invasive manner than open-heart surgery. Their availability has increased due to their high success rate.

A healthy heart has a generally conical shape that tapers downwards. The heart is four-chambered, comprising the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has an anatomy very different from other natural heart valves. The mitral valve consists of an annular portion, which is a ring of natural valve tissue surrounding the mitral valve orifice; and a pair of cusps, or leaflets extending downwards from the annulus into the left ventricle. The mitral valve annulus can form a D-shape, an ellipse, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet may be larger than the posterior leaflet, thus forming a generally C-shaped boundary between the adjacent free edges of the leaflets when they are closed together.

When properly functioning, the anterior and posterior leaflets together act as a one-way valve, allowing blood to flow solely 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 dilates, the 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, the increased blood pressure in the left ventricle causes the two leaflets of the mitral valve to come together, thus closing the one-way mitral valve and preventing blood from flowing back into the left atrium. Instead, it flows out of the left ventricle through the aortic valve. To prevent the two leaflets from detaching under pressure and folding backward toward the left atrium through the mitral annulus, multiple fibrous bands called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

Mitral regurgitation occurs when the natural mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of the cardiac cycle. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has various causes, such as leaflet prolapse, dysfunctional papillary muscles, and/or stretching of the mitral annulus due to left ventricular dilation. Mitral regurgitation located in the central portion of the leaflet can be called central jet mitral regurgitation, while mitral regurgitation closer to a leaflet junction (i.e., the point where the leaflets meet) can be called eccentric jet mitral regurgitation.

Some existing techniques for treating mitral regurgitation involve directly suturing portions of the natural mitral valve leaflets to each other. Other existing techniques include the use of a body implanted between the natural mitral valve leaflets. Despite these existing techniques, there remains a persistent need for improved devices and methods for treating mitral regurgitation.

Summary of the Invention

This disclosure generally relates to prosthetic devices and related methods for helping to seal natural heart valves and for preventing or reducing backflow therethrough, as well as devices and related methods for implanting such prosthetic devices.

In certain embodiments, the prosthetic device can include a body and fasteners. The body can be a relatively thin sheet of material that effectively extends the length and/or width of the natural leaflet to which it is attached. In other embodiments, the body can have sufficient thickness to function as a spacer, the spacer being configured to fill gaps along the suture line of the natural leaflet. In other embodiments, the body can be maintained in a collapsed delivery state within the delivery catheter during transvascular delivery through the patient's body to the heart, and can expand when deployed from the delivery catheter. In some embodiments, the body can also be configured to expand radially or laterally to increase the width or diameter of the body after deployment from the delivery catheter, such as by tightening sutures extending through the body.

In some embodiments, the body is thick enough to act as a spacer while also effectively extending the length and/or width of the natural leaflets. The body can be positioned within the natural valve orifice to help form a more effective seal between the natural leaflets, thereby preventing or minimizing mitral regurgitation. The body can include a structure that is impermeable to blood and allows the natural leaflets to close around the body during ventricular systole to prevent blood from flowing back from the ventricle into the atrium. The body can fill gaps between dysfunctional natural leaflets that cannot close completely naturally.

In some embodiments, the body is capable of effectively extending (one or more) leaflets and/or preventing (one or more) leaflet prolapse. In some embodiments, the body covers a large area of the atrial and/or ventricular surface of the leaflet, such as substantially the entire atrial surface, while in other embodiments, the body covers a smaller area. In some embodiments, specifically, the body covers the P2 portion of the posterior leaflet of the mitral valve. The body is capable of covering the entire length of the suture line, or a portion thereof. In some embodiments, the body covers the length of the P2 portion of the suture line adjacent to the posterior leaflet.

The body can have various shapes. In some embodiments, the body can have an elongated cylindrical shape with a circular cross-sectional shape. In other embodiments, the body can have an elliptical cross-sectional shape, a rectangular or other polygonal cross-sectional shape, a crescent-shaped cross-sectional shape, or various other non-cylindrical shapes. In some embodiments, the body can be substantially flat. The body can have an atrial end or upper end located in or adjacent to an atrium (such as the left atrium), a ventricular end or lower end located in or adjacent to a ventricle (such as the left ventricle), and a surface extending between natural valve leaflets (such as between natural mitral valve leaflets).

The fastener can be configured to secure the device to one or both of the natural lobules, such that the body is positioned between the two natural lobules. The fastener can be attached to the body at a location adjacent to the ventricular end of the body and/or to a location adjacent to the atrial end of the body. The fastener can be configured to be positioned behind the natural lobules upon implantation, such that the lobules are captured between the anchor and at least a portion of the body.

Some embodiments disclosed herein are typically configured to be fixed to only one of the natural mitral valve leaflets (posterior or anterior leaflet). However, in other embodiments, the prosthetic device can be fixed to both mitral valve leaflets. Unless otherwise stated, any of the embodiments disclosed herein can optionally be fixed to an anterior mitral valve leaflet and/or to a posterior mitral valve leaflet, regardless of whether any particular embodiment shown is fixed to a specific leaflet. Furthermore, any of the embodiments can be implanted on one or more natural leaflets of other heart valves.

Some embodiments include two or more fasteners, such as to provide additional stability. Unless otherwise stated, any embodiment including a fastener on the ventricular side can optionally include a fastener on the atrial side, regardless of whether the particular embodiment shown includes an atrial fastener. Similarly, any embodiment including a fastener on the atrial side can optionally include a fastener on the ventricular side, regardless of whether the particular embodiment shown includes a ventricular fastener.

As disclosed herein, by anchoring the prosthetic mitral valve device to one of the mitral leaflets, rather than to the left ventricular wall, left atrial wall, natural valve annulus, and/or the annular junction of the natural leaflets, the device's anchoring is independent of the movement of the ventricular and atrial walls, which are significantly affected by cardiac systole. Anchoring to the mitral leaflet provides a more stable anchorage for the prosthetic mitral valve device and eliminates the risk of tearing or otherwise trauma to the left ventricular or atrial wall caused by hook-screw-type anchors. Furthermore, when the leaflets are pivoted, the device body can remain in a more consistent position relative to the mitral leaflets, thereby eliminating undesirable movement exerted on the device due to the contractile movement of the left ventricular and atrial walls. Anchoring to the mitral leaflet also allows for a shorter body length compared to devices with other anchoring components.

In a representative embodiment, the implantable prosthetic heart valve device includes an elongated body having a first distal portion and a second distal portion, the body being implanted with the natural leaflet of the heart valve configured to surround it such that the first distal portion is on the atrial side of the leaflet and the second distal portion is on the ventricular side of the leaflet, and such that the body can engage with and move away from the opposing natural leaflet during heart valve operation. The device further includes a fastener configured to mount a suture extending from one of the first or second distal portions, through the natural leaflet, and through the other of the first or second distal portions, thereby securing the body to the natural leaflet.

In some embodiments, the body includes an intermediate portion extending between a first terminal portion and a second terminal portion, the body being configured such that when the body is secured to a natural leaflet, the intermediate portion extends beyond the free end of the natural leaflet. In some embodiments, at least one of the first terminal portion and the second terminal portion of the body includes one or more barbs capable of penetrating the natural leaflet.

In some embodiments, the body of the prosthetic device includes a tubular layer defining a lumen extending from a first end portion to a second end portion. In some embodiments, the tubular layer has a cross-sectional profile in a plane perpendicular to its length, the cross-sectional profile having a long lateral dimension and a short lateral dimension smaller than the long lateral dimension. In some embodiments, the tubular layer includes a tubular braided layer. In some embodiments, the braided layer includes a first inner braided layer and a second outer braided layer extending above the inner braided layer, the outer braided layer being relatively less permeable to blood than the inner braided layer.

In another representative embodiment, the component includes an elongated flexible guide rail having a first end and a second end, and a length sufficient to form a loop extending into the patient's body and through the natural leaflet of the heart valve, wherein the first and second ends are external to the patient's body. The component further includes an elongated catheter and an implantable prosthetic device configured to be implanted on the natural leaflet, the prosthetic device being coupled to the guide rail and the catheter such that advancing the catheter along the guide rail effectively advances the prosthetic device into the natural leaflet. The prosthetic device can be configured such that, when implanted on the natural leaflet, it can engage with and move away from the opposing natural leaflet during heart valve operation.

In another representative embodiment, the method includes implanting a flexible guide rail into the heart of a patient's body such that the guide rail forms a loop extending through the leaflet of a natural heart valve, and a first end and a second end of the guide rail are located outside the patient's body; attaching a prosthetic device to the guide rail and delivering the prosthetic device to the natural leaflet via the guide rail; and securing the prosthetic device to the natural leaflet.

In another representative embodiment, the method includes inserting an elongated catheter into the patient's body; advancing the catheter through the patient's body into the heart; penetrating a natural heart valve leaflet using a distal portion of the catheter; inserting an elongated guide rail through the catheter such that the distal end of the guide rail extends through the natural leaflet; and pulling the distal end of the guide rail outside the patient's body such that the guide rail forms a loop extending through the natural leaflet.

In another representative embodiment, the components include a first catheter configured for insertion into the patient's body and having a distal portion capable of being guided to a location adjacent to the natural leaflet of a heart valve. A second catheter is configured to extend through the first catheter and has a distal portion configured to extend through the natural leaflet. An elongated guide rail is configured to extend from a location outside the patient's body, through the second catheter, and through the natural leaflet. A snare catheter is configured to extend through the second catheter and includes a snare loop at its distal end, the snare loop being configured to capture the distal end of the guide rail extending through the natural leaflet and retract the distal end of the guide rail back into the first catheter.

Attached Figure Description

Figure 1 shows a cross-section of a heart with a prosthetic device for treating mitral regurgitation implanted on the posterior mitral valve leaflet according to one embodiment.

Figures 2A to 2F illustrate a method of implanting sutures via a femoral artery approach, with the sutures extending through the left ventricle and posterior lobule for subsequent implantation of the prosthetic device shown in Figure 1.

Figures 3A to 3H show the implantation of the prosthesis device of Figure 1 along the sutures shown in Figures 2A to 2F.

Figure 4 shows a cross-section of a heart with a prosthetic device for treating mitral regurgitation implanted on the posterior mitral valve leaflet according to another embodiment.

Figure 5 shows a cross-section of the left side of the heart with a prosthetic device for treating mitral regurgitation implanted on the posterior mitral valve leaflet according to another embodiment.

Figures 6 and 7 show a front view and a perspective view of a prosthetic device for treating mitral regurgitation according to another embodiment.

Figures 8 to 10 show perspective and side views of a prosthetic device implanted on the posterior mitral leaflet for treating mitral regurgitation according to another embodiment.

Figure 11 shows a cross-section of the left side of the heart with a prosthetic device for treating mitral regurgitation implanted on the posterior and anterior mitral leaflets according to another embodiment.

Figure 12 shows a cross-section of the left side of the heart with a prosthetic device for treating mitral regurgitation implanted on the posterior and anterior mitral leaflets according to another embodiment.

Figures 13A to 13D are cross-sections of the heart, illustrating another method of implanting a prosthetic device onto the posterior mitral valve leaflet for the treatment of mitral regurgitation.

Figures 14A to 14E show alternative methods for fixing the prosthesis devices shown in Figures 13A to 13D.

Figures 15A and 15B are cross-sections of the heart, illustrating the implantation of a suture through the posterior mitral valve leaflet according to another embodiment.

Figures 16A and 16B are cross-sections of the heart, illustrating the implantation of a suture through the posterior mitral valve leaflet according to another embodiment.

Figures 17A to 17C are cross-sections of the heart, showing various ways in which sutures are inserted through the anterior mitral valve leaflets.

Figures 18A to 18F are cross-sections of the heart, illustrating a method of implanting a suture through the posterior mitral leaflet via a septum according to another embodiment, and of implanting a prosthetic device at the posterior mitral leaflet using the suture.

Figure 19 is a cross-section of a mitral valve, which includes a mitral valve with a prosthetic device for treating mitral regurgitation according to one embodiment, the prosthetic device having increased stiffness to facilitate valve opening.

Figure 20 shows the reduced leakage rate of a mitral valve fitted with the prosthesis disclosed herein.

Figure 21 shows a cross-section of the heart with an example of a suture guide extending from the inferior vena cava through the diaphragm and across the posterior leaflet of the mitral valve.

Figure 22 is a side view of a delivery catheter used in a suture guide for implantation through natural valve tissue, according to one embodiment.

Figure 23 is a side view of an embodiment of a laser-cut tube that can be used in the maneuverable segment of the delivery catheter shown in Figure 22.

Figure 24 is a cross-sectional view of the delivery catheter of Figure 22 taken along line 24-24.

Figure 25 is an enlarged side view of the axis of the delivery catheter in Figure 22.

Figure 26 is a perspective view of an embodiment of a transmissive catheter that can be used together with the delivery catheter of Figure 22 to pass through a natural valve tissue implantation suture guide.

Figure 27 is a perspective view of an embodiment of a needle thread used to pierce natural valve tissue.

Figures 28 and 29 are perspective views of two different embodiments of a snare catheter that can be used with the delivery catheter of Figure 22 when a suture guide is implanted through natural valve tissue.

Figure 30 is a side view of an embodiment of a suture-feeding device capable of propelling a suture guide rail through a delivery catheter.

Figures 31A to 31H show cross-sections of the heart, illustrating the implantation of a suture guide through the posterior leaflet of the mitral valve using the tools shown in Figures 22 to 29.

Figures 32A to 32D are various views of another embodiment of a prosthetic device for treating mitral regurgitation.

Figures 33A to 33C are additional views of the prosthetic device shown in Figures 32A to 32D.

Figure 34 is a perspective view of another embodiment of a prosthetic device for treating mitral regurgitation, shown as being advanced along a suture guide.

Figure 35 is a cross-sectional view of the mitral valve implanted with the prosthetic device of Figure 34.

Figure 36 is a side view of the prosthetic device of Figure 34, shown in an unfolded state.

Figures 37 and 38 are enlarged views of the proximal portion of the prosthetic device shown in Figure 34.

Figure 39 is a cross-sectional view of the mitral valve implanted with the prosthetic device of Figure 34.

Figure 40 is an enlarged view of the proximal and distal portions of the prosthetic device in Figure 34 after the device has unfolded around the natural leaflet.

Figure 41 is a cross-sectional view of the mitral valve of the prosthetic device of Figure 34, which is arranged around the cusp of the cusp.

Figure 42 is a perspective view of an embodiment of the delivery catheter and the prosthetic device of Figure 34 connected to the delivery catheter for delivery to the natural leaflet.

Figure 43 is an enlarged view of the distal portion of the delivery catheter and the prosthetic device shown in Figure 42.

Figure 44 is a perspective cross-sectional view of the distal portion of the delivery catheter shown in Figure 42.

Figure 45A is a cross-sectional view of the delivery catheter in Figure 42.

Figure 45B is an enlarged cross-sectional view of the distal portion of the delivery catheter of Figure 45A.

Figure 45C is a cross-sectional view of the delivery catheter of Figure 45B taken along line 45C-45C.

Figures 46A to 46C are various views of another embodiment of a prosthetic device for treating mitral regurgitation.

Figures 47 and 48 are end views of two different embodiments of an untwisting catheter capable of untwisting suture rails extending into a patient's vascular system.

Figures 49A to 49C are cross-sectional views showing the use of the untwisting catheter of Figure 47 or Figure 48.

Figure 50 is a side view of another embodiment of a prosthetic device for treating mitral regurgitation.

Figure 51 shows the prosthetic device of Figure 50 implanted on a natural leaflet.

Figure 52 shows a modification of the prosthetic device of Figure 50.

Figures 53 and 54 are end and bottom views, respectively, of another embodiment of a prosthetic device for treating mitral regurgitation.

Figures 55A to 55E illustrate a method for implanting a prosthetic heart valve in the mitral valve position using a prosthetic device mounted on one of the natural leaflets as a support structure for the prosthetic valve.

Figures 56A to 56E illustrate another method for implanting a prosthetic heart valve in the mitral valve position using two prosthetic devices mounted on the natural leaflet as support structures for the prosthetic valve.

Figures 57A to 57D illustrate another method for implanting a prosthetic heart valve in the mitral valve position using a guide rail extending through one of the natural leaflets as a support structure for the prosthetic valve.

Figures 58A to 58E illustrate another method for implanting a prosthetic heart valve in the mitral valve position using a prosthetic device mounted on one of the natural leaflets as a support structure for the prosthetic valve.

Figure 59 is a side view of another embodiment of a prosthetic device for treating mitral regurgitation.

Detailed Implementation

This document describes embodiments of a prosthetic device primarily intended for implantation in one of the mitral, aortic, tricuspid, or pulmonary valve regions of the human heart, as well as devices and methods for implanting the prosthetic device. The prosthetic device can be used to help restore and/or replace the function of a defective natural mitral valve. The disclosed embodiments should not be construed as limiting in any way. Rather, this disclosure refers to all novel and non-obvious features and aspects of the various disclosed embodiments, individually or in various combinations and sub-combinations of these features and aspects.

Figure 1 shows a cross-sectional view of a heart with a prosthetic device 100 fixed to the posterior leaflet 8 of the mitral valve according to one embodiment. The device can include a body 102 (which can be a strip as shown), a fastener 104 (e.g., a suture clip shown on the ventricular side in this example, and thus can be referred to as a ventricular-side fastener), and (at least) a suture 106 extending through the posterior leaflet 8 between the body 102 and the fastener 104. The body 102 can be wound around the leaflet such that the body 102 is securely engaged to a first end portion 108 of the suture 106 covering the atrial surface of the leaflet 8, while a second end portion 110 covers the ventricular surface of the leaflet 8. The suture 106 can extend sequentially from the fastener 104 through the second end portion 110, the leaflet 8, and the first end portion 108. In one embodiment, the fastener 104 can be positioned at the P2 region of the posterior leaflet 8.

Fastener 104 can be a suture clip or another type of fastener capable of unfolding from a catheter and securing it into the patient's body. Various suture clips that can be used in the methods disclosed in this application and unfolding techniques for suture clips are disclosed in U.S. Publications Nos. 2014/0031864 and 2008/0281356 and U.S. Patent No. 7,628,797. In the case of a slidable fastener, fastener 104 is movable along the suture 106 in the direction of the posterior leaflet 8 and is configured to resist movement along the suture 106 in the opposite direction.

The body 102 is configured to treat or minimize mitral regurgitation by facilitating engagement with the opposing leaflet (in this case, the anterior leaflet). For example, the first distal portion 108 (on the atrial side in this example) is capable of having a thickness sufficient to act as a gap filler to treat or prevent mitral regurgitation. In some embodiments, the entire body 102 has substantially the same thickness. In other embodiments, at least a portion or segment of the body 102 has a thickness different from that of another portion or segment, for example, thicker in the central region and thinner at the first distal portion 108 and the second distal portion 110.

In some embodiments, a portion of the main body 102 is relatively thicker in the area where it engages with the opposing leaflet (the anterior leaflet in FIG. 1), thereby demonstrating improved engagement. The device 100 is also capable of effectively extending the length of the natural leaflet to facilitate engagement, which can be useful for treating or preventing functional mitral regurgitation (FMR). In this way, the prosthetic device 100 (and other prosthetic devices disclosed herein) increases the overall size of the natural leaflet on which the prosthetic device 100 is mounted and enhances its normal function. Therefore, the prosthetic device 100 (and other prosthetic devices disclosed herein) can be referred to as a prosthetic leaflet enlargement device.

Device 100 is centered between the two bundles of tendineae below the mitral valve. In various embodiments, the geometry of device 100 can be modified to address specific geometries of an unhealthy natural mitral valve, including any pathological changes in the suture line.

The main body 102 of the device 100 can be made of any of a variety of suitable materials, including but not limited to ePTFE silicone, polyurethane, polyethylene terephthalate (PET), or other polymeric materials, or biological materials, such as pericardial tissue, or composites thereof.

Figures 2A through 2F illustrate placement of an exemplary ring or rail delivery system 30 (e.g., via a femoral artery approach) for subsequently introducing device 100 into the heart. The ring delivery system 30 may include an external catheter 32, an internal catheter 34 extending through the lumen of the external catheter 32, and a rail in the form of a guide suture 36 extending through the external catheter 32 and the internal catheter 34. The rail 36 may comprise any type of flexible material and is used for subsequent delivery of the prosthetic device, as detailed below, wherein the flexible material includes conventional suture materials or wires (such as those used for conventional guidewires).

As shown in Figure 2A, the ring delivery system 30 (including an external catheter 32) can be advanced into the patient's left ventricle via the aorta and aortic valve, for example, through the femoral artery. Once the external catheter 32 has been advanced into the left ventricle, the internal catheter 34 can be advanced toward the posterior lobule beyond the distal end of the external catheter 32 (Figure 2B). The distal end of the internal catheter 34 can include a hollow needle 38 to penetrate the natural lobule, ring, or muscle tissue. The internal catheter 34 can be advanced to the ventricular side of the posterior lobule 8 (e.g., at position P2), such that the needle 38 can pierce the lobule 8 with additional force and form an opening in the lobule 8. The internal catheter 34 can then be further advanced such that the distal end of the internal catheter 34 can extend through this opening. In some embodiments, the internal catheter 34 and/or the external catheter 32 are sufficiently rigid to facilitate piercing of the lobule 8.

As shown in Figure 2C, the suture 36 is then advanced distally from the inner catheter 34 and into the left atrium (Figure 2C). In some embodiments, the suture 36 is capable of traveling through the inner lumen of the inner catheter and the needle. In other embodiments, the needle 38 is not hollow and/or the suture 36 does not extend through the needle 38. In some embodiments, during placement of the suture 36, a portion of the guide suture 36 is releasably attached to the inner surface of the inner catheter 34.

As shown in Figure 2D, a separate snare catheter 40 can then be inserted into the heart, for example via the femoral artery, to capture the tip of the suture 36. Alternatively, the snare catheter 40 extends through the lumen of the external catheter 32 and is advanced distally from the external catheter 32 as the suture 36 is captured. The snare catheter 40 can be manipulated to enter the left ventricle and then through the mitral valve into the left atrium to capture the suture 36 (e.g., by positioning the loop at the tip of the snare catheter around the distal portion of the suture 36). The snare catheter 40 can then be retracted to pull the suture 36 between the leaflets of the mitral valve (Figure 2E) into the left ventricle and, for example via the femoral artery, out of the patient's body (Figure 2F). In some embodiments, the snare catheter 40 (with the captured suture 36) can be configured to be pulled into the external catheter 32. In another embodiment, the snare catheter 40 and the external catheter 32 can be deployed from a shared catheter extending into the aorta or left ventricle. In other embodiments, the snare catheter 40 can be deployed from a separate external catheter extending into the aorta or left ventricle.

Then, the inner catheter 32 and outer catheter 34 can be withdrawn, leaving a loop of the guiding suture 36 (Fig. 2F). Specifically, the loop of suture 36 can enter the left ventricle via the aortic valve, extend from the left ventricular side through the posterior leaflet 8, and extend into the left atrium, then return to the left ventricle via the mitral valve and exit via the aortic valve. In various other embodiments, the directionality of the loop delivery system 30 can be reversed (i.e., suture 36 enters the posterior leaflet from the atrial side and extends into the left atrium). Furthermore, it should be noted that suture 36 does not need to extend through the natural leaflet, but can instead extend through the natural mitral valve annulus (advantageously at or near the P2 position) or through the muscle behind the natural annulus (advantageously at or near the P2 position). Thus, for any of the embodiments disclosed herein, a guide (e.g., a suture) can be implanted to extend through the natural leaflet, the natural valve annulus, or the muscle behind the natural valve annulus.

Figures 3A through 3G illustrate an exemplary process for introducing and implanting the device 100 into the left ventricle of the heart. As shown in Figure 3A, a first terminal segment 42 of the suture 36 (external to the patient) can be configured to securely engage a first terminal portion 108 of the body 102. Furthermore, a second terminal segment 44 of the suture 36 (also external to the patient) can be configured to extend through a second terminal portion 110 of the body 102. Specifically, the second terminal segment 44 can extend through a small opening or orifice in the body 102, said opening or orifice being small enough that a large amount of blood cannot flow through it. Then, as shown in Figure 3B, the body 102 and the two suture terminal segments 42, 44 can be enclosed within a delivery catheter 50 for delivery to the heart. In some embodiments, the body 102 can be housed within the catheter 50 in a compressed state. For example, in this compressed configuration, the body 102 can elastically deform such that when the body 102 is released from restraint, it elastically returns to the configuration shown in Figure 3A. The second terminal segment 44 extends proximally to the patient and is therefore usable for manipulation during the installation of device 100. The suture 36 can thus be used to guide device 100 and other delivery components to the appropriate location within the patient's vascular system.

As shown in Figure 3C, the delivery catheter 50 can be advanced into the left ventricle. Once the distal end of the catheter 50 is within the left ventricle, an inner catheter or pusher member 52, configured to extend through the delivery catheter 50 proximal to the body 102, can be advanced to push the device 100 out of the delivery catheter 50. In various embodiments, the delivery catheter 50, the inner catheter 52, and the guide suture 36 can be retracted proximally or extended distally with respect to each other. The inner catheter 52 can operate as a pusher, thereby pushing the device 100 distally along the suture 36. The inner catheter 52 can be used to push the device 100 distally along the suture 36 in the direction of the natural mitral valve (Figures 3D to 3E).

The second distal segment 44 of the suture 36 (extending externally to the patient) can be pulled simultaneously and/or in coordination with the advancement of the delivery catheter 50 and/or the internal catheter 52. This pulling of the second distal segment 44 as the body is advanced distally toward the posterior lobule 8 pulls the suture loop 36 through the body 102. Pushing the body 102 while simultaneously pulling the suture loop brings the body 102 to the appropriate orientation for installation at the posterior lobule 8 (Figure 3F). Finally, as shown in Figure 3G, the first distal portion 108 can be brought to the atrial side adjacent to the posterior lobule 8, while the second distal portion 110 can be brought to the ventricular side adjacent to the posterior lobule 8.

When the main body 102 is in its final operating position, the device 100 can be secured in place using fasteners 104 (Figures 3G to 3H), which can be deployed from the inner catheter 52, the outer catheter 50, or a separate catheter. As shown in Figures 3F to 3G, the fasteners 104 can be positioned distal to the inner catheter 52 to ultimately secure the device 100 in place on the posterior leaflet 8 when positioned. The outer catheter 50 and the inner catheter 52 can then be retracted from the implantation site within the heart and removed from the patient (Figure 3H).

In some embodiments, the placement of the body 102 can be reversed during delivery, such that the first terminal segment 42 of the suture 36 (and the first terminal portion 108 of the body 102) can rest against the ventricular side of the leaflet 8, while the second terminal segment 44 of the suture 36 (and the second terminal portion 110 of the body 102) can rest against the atrial side. In some embodiments, this placement reversal is achieved only by reversing the orientation of the body 102 during loading onto the suture 36 (e.g., in the step shown in FIG. 3A). FIGS. 18A to 18E illustrate an exemplary process for delivering the body 102, for example, septally from the right atrium through the atrial septum into the left atrium, which produces this configuration.

As shown in Figure 18A, the external catheter 32 and/or the internal catheter 34 can be inserted into the left atrium via the diaphragm, and the internal catheter 34 can bring the suture 36 between the leaflets 6 and 8 of the mitral valve into the left ventricle, and then through the posterior leaflet 8 back into the left atrium. A snare catheter 40 (which can also extend through the external catheter 32) can be inserted via the diaphragm to capture the suture 36 and bring it outside the patient's body. The body 102 can then be loaded onto the suture 36 (Figure 18B) and delivered to the posterior leaflet 8 (Figures 18C and 18D). As shown in Figures 18D to 18E, the fastener 104 can also be located on the atrial side of the leaflet 8, and the installed suture length 106 can extend sequentially from the fastener 104 through the first terminal portion 108 of the body, the posterior leaflet 8, and the second terminal portion 110.

Figure 18F shows that the tension of suture 106 can be adjusted to affect the position of the first distal portion 108 of the implant. In Figure 18F, suture 106 is not taut to pull the first distal portion 108 against the ventricular side of the posterior leaflet 8. Instead, sufficient slack in suture 106 allows the first distal portion 108 to hang or “float” below the posterior leaflet. Moreover, the tension of suture 106 can be adjusted to fit the size of the device 100 to the natural size of the leaflet 8. In this way, device 100 has the benefit of “one size fits all” and/or can otherwise be adapted for fitting around leaflets of different sizes and/or geometries.

Figures 4 through 7 illustrate an alternative device 200 according to another embodiment, including a body 202, wherein the body 202 is attached to one of the natural lobules using, for example, sutures. The body 202 can be formed from any of a variety of suitable materials, including biocompatible materials such as pericardial tissue, polymers, sponges, foams, gels, or structures filled with gel or saline, such as balloons. The material composition of the body 202 can be selected to enhance desired characteristics of the body 202 (such as performance, durability, and promotion of natural tissue growth). The body 202 can be formed in any of a variety of suitable shapes, such as rectangular, semi-elliptical, or U-shaped, or semi-elliptical. As shown in Figure 4, the body 202 can be sutured to the posterior lobule 8 via a transseptal approach using (one or more) sutures 206. Alternatively, as shown in Figure 5, the body 202 can be sutured to the posterior lobule 8 via a transapical approach using (one or more) sutures 206. In use, the opposing leaflets (the front leaflets in the illustrated embodiment) can abut against the body 202 to prevent, reduce, or minimize backflow.

Figure 6 shows the body 202 after being sewn to the leaflet 8. In this embodiment, as shown, two sutures 206 are sufficient to attach the body 202 to the leaflet 8. The sutures 206 can be positioned as shown, with one suture 206 at either end of the body 202, which spans the width of the leaflet 8. In other embodiments, additional or fewer sutures can be used, and the sutures can be located at alternative positions on the body 202 and/or on the leaflet 8.

Figure 7 illustrates an embodiment of a method for attaching a body 202 to a posterior natural leaflet 8 using a length of elongated material 206 and a pair of fasteners in the form of a sliding locking device 208. The elongated material 206 can comprise, for example, a length of thread or suture material, or metal or polymer thread, or any other material suitable for suturing (such as biological tissue). In the illustrated embodiment, a single strand of material 206 is used, but in alternative embodiments, two or more strands 206 can be used to attach the body 202 to the natural leaflet 8.

To attach the body 202 to the natural posterior leaflet 8, one or both of the sliding locking devices 208 can be guided along the strand material 206 toward the natural leaflet 8, thereby reducing the length of the strand 204 between the locking devices 208 until the body 202 is securely held against the leaflet 8 in the desired deployment configuration. Because the locking devices 208 are positioned behind the posterior leaflet 8 in this configuration (i.e., they are located between the natural leaflet 8 and the wall of the left ventricle 2), the possibility of interference between the locking devices 208 and the engagement area of the leaflet is minimized. When the body 202 is in this configuration, any excess material 210 can be trimmed to prevent material 206 from interfering with the operation of the heart valve. The locking devices 208 can be configured to slide or pass over the suture in one direction and resist movement in the opposite direction. An example of a locking device (also referred to as a suture fixation device) that can be implemented in the embodiment of FIG7 is disclosed in U.S. Publication No. 2014/0031864.

As described above, Figures 4 to 7 show the body 202 connected or fixed to the posterior leaflet 8. In an alternative embodiment, instead of the body 202 connected to the posterior leaflet 8, or in addition to the body 202 connected to the posterior leaflet 8, the body 202 can be connected to the anterior leaflet as described above.

Figures 8 through 10 illustrate another exemplary device 300 capable of being implanted at the mitral valve region for treatment of mitral regurgitation. Device 300 can include a rigid, flexible, blood-impermeable sheet of material. Device 300 can have a body 301 with an upper first distal portion 302 attached to the mitral valve annulus and/or a mitral leaflet region adjacent to the mitral valve annulus. A portion of the body 301 extending away from the first distal portion 302 is the free distal portion of the body 301. In the illustrated example, the first distal portion 302 is attached to the mitral valve annulus on the posterior leaflet 8. In other examples, the arrangement can be reversed, with device 300 attached to the anterior leaflet 6. Device 300 can be secured to natural tissue by various means, such as sutures, barbed anchors, and/or micro-anchors 318. The first distal portion 302 of the body 301 can be wider than the free distal portion of the body 301, and therefore the body 301 can have a generally trapezoidal shape.

In Figure 8, the lower end of the anterior leaflet 6 is not shown to illustrate the lower end of the posterior leaflet 8 and the lower second terminal portion 306 of the device 300, which extends downward through the mitral valve orifice and into the left ventricle 2. The second terminal portion 306 of the device can be short, long, or approximately the same length as the leaflet to which it is attached. As shown in Figures 9 and 10, in the illustrated embodiment, the second terminal portion 306 of the device can extend below the lower end of the posterior leaflet during diastole (Figure 10) and does not extend to the lower end of the anterior leaflet 6 during systole (Figure 9).

The second terminal portion 306 can be tethered to a location in the left ventricle 4. For example, the second terminal portion 306 can be tethered to the papillary muscle head 310 via a tether 308 (which can be made of, for example, suture material) and an anchor 312, as shown (similar to how a natural chordae tendineae 8 are tethered to the papillary muscle 310 by a natural chordae tendineae 314), and/or can be tethered to the tip of the left ventricle 4.

During cardiac contraction, as shown in Figure 9, device 300 expands or fills with blood from the left ventricle 4 and laterally extends towards the anterior leaflet 6. This expansion seals the lower portion of device 300 against the anterior leaflet 6, thereby preventing blood backflow into the left atrium 2. The lateral edges of device 300 can seal between the two natural leaflets near the junction where the natural leaflets are still naturally joined. A tether 308 prevents the second distal portion 306 of device 300 from moving towards and/or into the left atrium 2, and thus breaking the seal with the anterior leaflet 6. Therefore, device 300 enlarges the natural anterior leaflet and helps seal the mitral valve orifice even when the natural leaflets 6, 8 are not joined or otherwise incompletely joined, thus allowing backflow between them.

During diastole, as shown in Figure 10, device 300 collapses close to the posterior lobule 8, thereby allowing blood to flow from the left atrium into the left ventricle 4 with minimal obstruction from device 300.

Figure 11 illustrates embodiments of prosthetic devices 400, 402 capable of extending the effective length of natural leaflets 6, 8. Prosthetic devices 400, 402 can include bodies 404, 406 and one or more sutures 412 for attaching each body 404, 406 to a corresponding anterior natural leaflet 6 or posterior natural leaflet 8. In use, bodies 404, 406 have free end portions 408, 410 extending away from the ends of the natural leaflets, thereby extending the effective length of the natural leaflets and thus increasing the likelihood and degree of engagement between them, as described more fully below.

The bodies 404 and 406 can comprise materials that are sufficiently rigid to reduce leaflet prolapse and sufficiently flexible to enhance leaflet fusion. Suitable materials can include, for example, biomaterials such as pericardial tissue, ePTFE silicone, polyurethane, PET, or other polymeric materials, or composites thereof. Figure 11 shows that devices 400 and 402 can be used on each of the anterior natural leaflet 6 and the posterior natural leaflet 8, but in alternative embodiments, only one of these devices can be used. In some embodiments, a tether can be used to secure the free end portions of the bodies 404 and 406 to a location within the left ventricle 4, thereby reducing the likelihood of prosthetic devices 400 and 402 prolapse during cardiac contraction.

Figure 12 illustrates exemplary prosthetic devices 500 and 502 incorporating the features of the aforementioned prosthetic body. Prosthetic device 500 is connected to the posterior natural lobule 8, while prosthetic device 502 is connected to the anterior natural lobule 6. Prosthetic devices 500 and 502 include relatively thick upper portions 504 and 506 and relatively thin, elongated free-end portions 508 and 510, which function in a manner similar to that of devices 300, 400, and 402 described above. The free-end portions 508 and 510 may have corresponding distal portions 514 and 516 representing the effective distal end of the extended lobule.

In use, the free distal portions 508 and 510 extend the effective length of the respective leaflets and are able to promote the initiation of leaflet engagement during ventricular systole. During cardiac systole, the leaflets are pushed toward each other due to the pressure present in the left ventricle 4 and left atrium 2. Due to the effective length of the leaflet extension, the distal portions 514 and 516 are more likely to engage than the ends of natural leaflets without extensions. Once engagement begins, and blood flow from the left ventricle 4 to the left atrium 2 is thus at least partially obstructed, the pressure in the left ventricle 4 can increase, thereby further increasing the pressure gradient between the left ventricle 4 and left atrium 2, thus further pushing the leaflets 6 and 8 toward each other.

Therefore, a portion of leaflets 6 and 8, and their respective conjoined extensions 502 and 500, increase (both in the direction from the distal portions 514 and 516 toward the left atrium 2 and in the direction from the positions of devices 500 and 502 toward the mitral valve junction), resulting in progressively obstructed blood flow, increased pressure gradient, and increased circulation of leaflet conjoining. Thus, by facilitating the initiation of conjoining, the free-end portions 508 and 510 can help reduce backflow of blood from the left ventricle 4 to the left atrium 2 during ventricular systole. Furthermore, the upper portions 504 and 506 can further help prevent backflow in the manner described above with respect to prosthetic devices 100, 200, 300, 400, and 402.

Figure 12 shows that devices 500 and 502 can be sewn to natural leaflets 8 and 6 using suture 512, but in an alternative embodiment, devices 500 and 502 can be clamped or otherwise secured to natural leaflets 8 and 6. In an alternative embodiment, only one of devices 500 and 502 can be used instead of both.

Figures 13A to 13D illustrate embodiments of an exemplary process for introducing device 300 (which can also be used for implanting the aforementioned devices 200, 400, 402, 500, and 502). First, as described above regarding device 100, a loop delivery system can be used to propel the suture 36 into the left ventricle, through the posterior lobule 8, and into the left atrium. Similar to the use of device 100, the first terminal segment 42 of the loop suture 36 can be securely attached to the first terminal portion 302 of the body 301. However, unlike device 100, the second terminal segment 44 of the suture 36 does not extend through the second terminal portion 306 of the body 301. That is, the second terminal portion 306 is not attached to the suture 36 and therefore does not need to include an opening for the suture, guidewire, etc.

Once the guide suture 36 is in place, the device 300 can be advanced into the left ventricle and near the natural mitral valve using the external catheter 32 and internal catheter 34 as described above. During delivery, the delivery catheter 50 can be positioned adjacent to and proximal to the second distal portion 306 of the body 301. Once ejected from the catheter 50 near the natural mitral valve, the body 301 can be positioned as shown in FIG13B, with the first distal portion 302 positioned in the atrium near the atrial side of the posterior leaflet 8 (e.g., near the P2 position), while the second distal portion extends through the mitral valve into the left ventricle. To facilitate this placement, the suture 36 can be tightened by pulling the second distal segment 44 (in the direction of the arrow shown in FIG13B, simultaneously and/or in conjunction with advancing the delivery catheter 50 and/or the internal pusher catheter 52) so that the first distal portion 302 abuts against the atrial side of the posterior leaflet 8 (FIGs 13B to 13C). Then, the fastener 304 can be unfolded to secure the device 300 in the appropriate position at the posterior leaflet 8. Finally, the suture 36 can be cut near the fastener 304, and the catheters 50 and 52 can be withdrawn (Fig. 13D).

Figures 14A through 14E illustrate various alternative components for securing the device 300 to or along one or more locations within the heart. Figure 14A shows the device 300 fastened to the ventricular wall, with a fastener 304 positioned along the external lateral surface of the heart. An implanted suture 308 is capable of extending through the myocardium, into the left ventricle, and across the posterior lobule 8. Figure 14B shows the fastener 304 alternatively located externally to the heart at the apex of the left ventricle. In Figure 14C, the fastener 304 secures a first end portion 302 to the posterior lobule 8, while the suture or tether 308 connects a second end portion 306 to an anchor 312 attached to the papillary muscle head 310.

In various embodiments, the method of delivery of the device 300 can be varied such that the sutures can extend in the indicated directions. In some embodiments, the device 300 can be delivered via a transapical approach or other approach extending directly through the wall of the heart from outside the heart. In some embodiments, as shown in FIG14D, two (or more) implanted sutures 308 can be present, the sutures 308 extending through a single fastener 304 attached to the ventricular side of the posterior lobule. In some embodiments, as shown in FIG14E, two (or more) fasteners 304 attached to the ventricular side of the posterior lobule can be present, the fasteners 304 being delivered along two or more suture loops 36.

Figures 15A and 15B illustrate an embodiment of an alternative procedure for delivering the suture or guide rail 36 into the heart. Catheters 32 and 34 enable the suture 36 to pass through the femoral artery, across the aortic valve, into the left ventricle, across the posterior leaflet 8, and into the left atrium. A loop catheter 40 can then be inserted into the right atrium (e.g., via the superior vena cava), then across the atrial septum (Figure 15A) into the left atrium to capture the tip of the suture 36 and bring it back outside the patient, leaving a suture loop as shown in Figure 15B for subsequent device deployment.

As discussed, in some embodiments, the snare catheter 40 can emerge from the outer catheter 32; however, in other embodiments, the snare catheter 40 is separate from the delivery catheter. In some embodiments, the directionality of suture loop 36 delivery can be reversed (i.e., the suture enters the posterior lobule from the atrial side). In one such embodiment, the snare catheter can be inserted into the left ventricle via the femoral artery, while the delivery catheter can deliver the suture 36 through the septum into the left atrium.

Figures 16A and 16B illustrate an embodiment of another alternative method for delivering the suture or guide rail 36 into the heart, wherein the suture loop 36 extends through the atrial septum into the left atrium, then between the leaflets of the mitral valve into the left ventricle, and finally through the posterior leaflet 8 into the left atrium. A snare catheter 40 can be inserted into the left atrium via the septum (Figure 18A) to capture the tip of the suture 36 and bring it back outside the patient's body, leaving the suture loop as shown in Figure 16B for subsequent device deployment. As discussed above, in some embodiments, the directionality of delivery of the suture loop 36 can be reversed (i.e., the suture enters the posterior leaflet from the atrial side).

Figures 17A to 17C illustrate embodiments of an exemplary suture loop for delivering a device to the anterior leaflet 6 of the mitral valve. Figure 17A shows a loop 36 that extends via the aortic valve into the left ventricle, then enters the left atrium between the leaflets of the mitral valve, then extends through the anterior leaflet 6 into the left ventricle, and exits the heart via the aortic valve. Figure 17B shows a suture loop 36 that extends via the aortic valve into the left ventricle, then enters the left atrium through the anterior leaflet 6, and exits the left atrium via the septum. Figure 17C shows a loop that enters the left atrium via the septum, extends through the anterior leaflet 6 into the left ventricle, then enters the left atrium between the leaflets of the mitral valve, and finally exits the left atrium via the septum.

Figure 19 illustrates an alternative embodiment of the prosthetic device (generally designated 600). The prosthetic device 600 provides an increased downward force at the free end of the leaflet 8. The prosthetic device 600 includes a body 602 having a first end portion 604 and a second end portion 606. As shown, the body 602 can be positioned on the atrial surface of the natural leaflet and can be secured thereto using sutures or tethers 608. The sutures 608 can be secured at the first end to the first end portion 604 of the body 602, extending through the leaflet 8, and at their opposite ends to the second end portion 606 of the body.

The prosthetic device 600 further includes a rigid member 610, which is positioned on the surface of the annulus of the mitral valve 8, such as by mounting or coupling the rigid member to the suture 608. The rigid member can comprise suture segments, polymer and/or nitinol bands, or polymer and/or nitinol tubing. Other biocompatible materials of suitable stiffness can also be used. Generally, the rigid member 610 is relatively more rigid or stiff than the body 602 and the suture 608. In the illustrated embodiment, the rigid member 610 comprises a tubular or cylindrical member (e.g., a polymer tube) that can be coaxially arranged around the suture 608. The rigid member 610 can be sized such that its upper end 614 can contact or closely approach the surface of the annulus of the natural valve 8, and can have an upwardly curved lower portion 616 spaced apart from the free end of the leaflet 8.

The prosthetic device 600 can be implanted as described above in conjunction with Figures 18A to 18F, but the second end portion 606 of the rigid member 610 adjacent to the body is threaded onto the suture 608. The slack of the suture 608 during suturing (as described above in conjunction with Figure 18F) can be adjusted to generate less force in the ventricular direction. By increasing the overall stiffness of the prosthetic device and the natural leaflet, the downward force in the ventricular direction is improved, thereby enhancing the efficiency of the device and promoting a better seal with the opposing natural leaflet.

Figure 20 shows comparative data before and after implantation of prosthetic device 100 without a rigid member and prosthetic device 600 with a rigid member 610. Figure 700 shows the results for three hearts with varying degrees of mitral valve regurgitation, denoted as 710, 720, and 730. In the figures, "baseline" refers to mitral valve regurgitation without the prosthetic device, and "run" refers to mitral valve regurgitation with either prosthetic device 100 or prosthetic device 600 implanted. As can be seen, in all three examples 710, 720, and 730, the use of a rigid member further reduces regurgitation, with the most significant improvement occurring in example 720.

Figures 21 through 31 illustrate additional embodiments of a suture-rail delivery assembly and a method for unfolding a suture rail 800 through a natural leaflet for subsequent implantation of a prosthetic device (e.g., prosthetic device 100) onto a natural valve leaflet. In the illustrated embodiments, the suture-rail delivery assembly generally includes a maneuverable catheter 816, a through catheter 900, a needle suture 1000, and a loop catheter 1110.

Figure 21 illustrates a suture guide 800 unfolded within the heart. The suture guide 800 includes a suture 802, such as 2-0 monofilament polyethylene (e.g., II), or other suitable material or size. The suture 802 is capable of extending from a suitable insertion point into the vascular system, such as the femoral vein, and into the heart 804. In the example shown in Figure 21, the suture 802 extends from the peripheral vascular system through the inferior vena cava 806, into the right atrium 808, through the atrial septum 810, through the atrial side of the posterior lobule 814 adjacent to the ring 812 (advantageously at the P2 position of the lobule 814), around the free end of the lobule 814, and then follows the same path it originated from back into the peripheral vascular system, thus forming a ring extending through the lobule 814.

The suture guide 800 may also originate from a high-pressure vascular system and proceed in a retrograde direction, for example, from the femoral artery to the heart, or, for example, from the jugular vein via the superior vena cava. The suture 802 may alternatively extend through the ring 812 (such as at a location adjacent to the P2 position of the natural lobule) rather than through the lobule itself.

Figure 22 illustrates an embodiment of a tamperable catheter 816 configured to extend into the left ventricle and deliver a suture guide 800 to the region beneath the posterior leaflet 814, as described in more detail below. The tamperable catheter 816 includes a proximal portion 818 and a distal portion 820. The proximal portion 818 of the tamperable catheter 816 may include a handle 822 from which a shaft 832 extends. An access port is mounted on the shaft 832 adjacent to the handle 822, and the access port may take the form of a Y-connector 824 communicating with a side opening in the shaft and a corresponding lumen in the shaft. The Y-connector 824 may be used to allow other tools (e.g., a loop catheter 1100 or a guidewire) to be inserted into the tamperable catheter, as further described below.

The handle 822 may also include multiple other access ports, such as ports 826 and 828 extending from the proximal end of the handle 822. Access ports 826 and 828 allow other tools or conduits to be inserted into the lumen of the shaft 832. For example, as shown in FIG22, a through conduit 900 can be inserted through and through the maneuverable conduit 816 via access port 826, and a needle thread 1000 can be inserted through and through the corresponding lumen of the through conduit. The handle 822 of the maneuverable conduit 816 may further include an adjustment mechanism 830, which adjusts the curvature of the maneuverable segment 838 of the shaft 832 as further described below.

Figure 24 shows a cross-sectional view of shaft 832 according to one embodiment. In the illustrated embodiment, shaft 832 has five lumens, including a first side lumen 852, a second side lumen 854, a third side lumen, a fourth side lumen 866, and a central lumen 862. The first side lumen 852 (also referred to as the “snap-conduit lumen”) is sized and shaped to receive two segments of snap-conduit 1100 and suture 802. As shown, the snap-conduit lumen 852 can have an elliptical cross-sectional shape (in a plane perpendicular to the length of shaft 832) to better accommodate the two segments of snap-conduit 1100 and suture 802. The snap-conduit lumen 852 has a proximal end communicating with an inlet port 824 and a distal end communicating with a side opening 834 formed in the distal portion of shaft 832.

The second lumen 854 advantageously extends the entire length of the shaft and has a proximal end communicating with the inlet port 826 and a distal end forming a distal opening at the distal end of the shaft 832. Thus, as can be seen in Figures 22 and 24, the through-conduit 900 can be inserted into the inlet port 826 and advanced through the lumen 854, and the needle thread 1000 can be inserted into the lumen of the through-conduit 900 and advanced through the lumen. The lumen 854 can have a liner 856 that advantageously extends the entire length of the shaft 832. The liner 856 can comprise, for example, a braided reinforced polymer extrusion having one or more extrusion layers. The reinforced braid can be a braided sleeve (e.g., a braided metal sleeve) extending coaxially over one or more extrusion layers. In one embodiment, the liner 856 comprises a nylon 12 outer extrusion, an inner extrusion, and a braided stainless steel sleeve extending over the outer extrusion, but other suitable materials can also be used. The outer surface of the liner 856 can be firmly fixed to the inner surface of the lumen 854, for example, by using a suitable adhesive.

The central lumen 862 serves as a drawwire lumen, allowing the drawwire 864 to pass through. The third and fourth side lumens 866 can be open lumens or "dummy" lumens 866, extending along completely opposite sides of the central lumen 864. The lumens 866 can be cannulated or otherwise sealed to maintain hemostasis. Alternatively, one or both lumens can be used to pass a guidewire or other tool into the shaft 832. The lumens 866 contribute to providing uniform stiffness around the central axis of the shaft 832, which in turn provides a smoother torque response to the shaft when it twists in a deflected state.

The drawing element 864 has a proximal end operatively connected to the adjustment mechanism 830 and a distal end fixed within the shaft 832 at the distal end 868 of the steerable segment 838. The adjustment mechanism 830 is configured to increase and decrease the tension of the drawing element to adjust the curvature of the steerable segment 838 of the shaft 838. For example, rotating the adjustment mechanism 830 in a first direction (e.g., clockwise) increases the tension of the drawing element, which causes the steerable segment 838 to bend or deflect into a bent configuration (as shown in FIG. 22). Rotating the adjustment mechanism in the opposite direction (e.g., counterclockwise) decreases the tension of the drawing element, which allows the steerable segment 838 to return to its undeflected configuration by its own elasticity. In the illustrated configuration, as shown in FIG. 22, the steerable segment 838 is capable of bending 180 degrees to allow navigation around the rear leaflet 814 and to position the distal end 840 of the shaft 832 at the sub-annular groove region of the rear leaflet 814, as further described below.

The operable segment 838 can be made of a material that is relatively more flexible than the axial portion of the proximal end of the operable segment, or can otherwise be configured to be relatively more flexible than the axial portion of the proximal end of the operable segment. In this way, when the curvature of the operable segment is adjusted by applying tension from the drawing wire, the curvature of the proximal portion can remain substantially unchanged. Further details of the construction of the handle and adjustment mechanism are described in U.S. Patent Application Publications Nos. 2013/0030519, 2009/0281619, 2008/0065011, and 2007/0005131.

The steerable segment 838 can include a slotted metal tube 842 (FIG. 23) covered by a polymer sheath or outer layer. As shown in FIG. 23, the slotted tube 842 in the illustrated configuration includes a proximal portion 844, a distal portion 846, an intermediate portion 848 extending between the proximal and distal portions, and a plurality of circumferentially extending, axially spaced slots 850 formed in the intermediate portion 848, the slots 850 imparting flexibility to the steerable segment. The tube 842 can be made of nitinol or another suitable biocompatible metal with sufficient rigidity. The tube 842 can be formed, for example, by laser-cutting the slots 850 in a tubular metal piece. The distal end of the wire 864 can be attached to the distal portion 846 of the tube by means such as welding. Except where the distal end of the drawing 864 is attached to the distal portion 846, the drawing can “float freely” within the larger lumen of the tube 842, meaning that the drawing can slide easily relative to the inner surface of the lumen with minimal friction, thereby preventing or at least minimizing kinking of the drawing.

Conventional steerable catheters have a drawstring located within the drawstring lumen, offset to one side of the catheter's central longitudinal axis. A drawback of this design is that the catheter experiences a phenomenon known as "jittering" when it is twisted or rotated relative to its central longitudinal axis to adjust the rotational position of the distal portion, while the catheter is in a wavy configuration that follows the anatomical path through which it extends. When the catheter rotates in this wavy configuration, the drawstring exerts uneven forces along the length of the delivery device, causing the delivery device to become unstable and spring back to its untwisted, low-energy state.

As described above, the wire 864 extends through a centrally positioned lumen 862, which extends along the central longitudinal axis of the shaft 832. Advantageously, placing the wire in the centrally positioned lumen prevents the so-called "jittering" phenomenon of the shaft when torsional forces are applied, thereby allowing the shaft 832 to undergo controlled 360-degree torsion; that is, the distal end of the shaft can rotate 360 degrees relative to the central longitudinal axis in three-dimensional space to any position.

Figure 25 illustrates the construction details of a specific embodiment of shaft 832. In the illustrated configuration, shaft 832 includes a first segment 870, a second segment 872, a third segment 874, and a fourth segment 876. The fourth segment 876 includes a maneuverable segment 838 and a tip portion 878 distal to the maneuverable segment. The first segment 870 is connectable to a handle 820 (not shown in Figure 25). The first segment 870 has a length _L1 , which is variable depending on the patient's height or the point of vascular access. The first segment 870 may comprise a polymer extrusion formed of one or more layers of different materials. In a specific embodiment, for example, the first segment 870 includes an inner layer made of nylon or ProPell and an outer layer made of 72D or ProPell.

The second segment 872 has a length _L2 , which in some embodiments can be approximately 10 cm to 12 cm. The second segment 872 can comprise a polymer extrusion formed of one or more layers of different materials. In a specific embodiment, for example, the second segment 872 includes an inner layer made of 72D or ProPell and an outer layer made of 72D or ProPell.

The third segment 847 has a length _L3 , which in some embodiments can be approximately 8 cm. The third segment 874 can comprise a polymer extrusion formed of one or more layers of different materials. In specific embodiments, for example, the third segment 874 comprises an inner layer made of 55D or ProPell and an outer layer made of 55D or ProPell.

Shaft 832 may further include a braided outer layer or sleeve extending over one or more of the first segment 870, second segment 872, and third segment 874. In a particular embodiment, the braided layer extends over the entire length of the first segment 870 and the second segment 872, and on the third segment 874 extends from a first position connecting the third segment to the second segment to a second position just near the proximal end of the opening 834. Thus, the third segment 874 may be further divided into braided segments 876 and unbraided segments 878. The braid may comprise, for example, 304V stainless steel wire with a size of approximately 1 mil × 5 mil. In a standard 1-over-2-under-2 pattern, the braid may have 16 carriers with a weft count of 55 threads per inch (PPI). In another embodiment, the braided layer may extend over the entire length of shaft 832 or substantially over the entire length of shaft 832.

The operable segment 838 may include a slotted metal tube 842 and an outer tube or sheath, for example, made of 32D or ProPell. In a particular embodiment, the operable segment 838 has a bending radius of approximately 10 mm to 14 mm and is capable of bending upwards to at least 180 degrees. The outer sheath of the operable segment may be corrugated or ridged to facilitate bending. When the operable segment 838 is fully deflected such that the tip portion 878 extends substantially parallel to the third segment 874, the distance _D1 from the farthest position of the operable segment 838 to the distal end 840 of the shaft may be approximately 2 cm. The longitudinal spacing between the distal end 840 of the shaft and the side opening 834 extends by a distance _D2 , which may be approximately ₁ cm.

Figure 26 illustrates a transfeeding conduit 900 according to one embodiment, configured to pass through or extend through the natural leaflet or ring 812 of the mitral valve for subsequent placement of suture 802. The transfeeding conduit 900 includes an elongated shaft 902 capable of having a lumen extending along its length for receiving needle suture 1000. The transfeeding conduit 900 may further include a luerfitting fitting 904, which is attached to the proximal end of the shaft to facilitate insertion of the needle suture 1000 into the lumen of the shaft. The fitting 904 can also be configured to lock or retain the needle suture in place relative to the transfeeding conduit. The shaft 902 advantageously has a pre-shaped or pre-bent distal portion 906, which helps prevent or minimize kinking that occurs when the shaft is advanced through the maneuverable segment 838 of the maneuverable conduit, when the maneuverable segment is placed in a bent configuration.

In a particular embodiment, the shaft 902 of the transcatheter 900 has an outer diameter of approximately 0.27 inches, an inner diameter (lumen diameter) of approximately 0.18 inches, and a total length of approximately 69 inches or greater. The shaft 902 can comprise one or more layers of polymer extrusion and can have a braided sheath or outer layer extending on the extrusion. In one specific embodiment, the shaft 902 can comprise a multi-layer extrusion comprising an inner layer made of ProPell, an intermediate layer made of nylon 12, and an outer layer made of ProPell. In another embodiment, the extrusion comprises a PTFE inner layer and the outer layer can contain barium sulfate. Barium sulfate can provide contrast during fluorescence microscopy. In addition to the advantageously stiffer transcatheter shaft 902, the braided sheath can be similar to the braid described above for the shaft 832 of the maneuverable conduit. Thus, for example, 5 mil × 25 mil 304V stainless steel wire can be used to form the braid. The PPI of the braid can be approximately 80 to 90. The distal portion 906 can be pre-bent to approximately 1 inch in diameter.

Figure 27 illustrates an example embodiment of a needle thread 1000 for piercing the natural leaflet or annulus 812 of the mitral valve 814. The needle thread 1000 includes a proximal portion 1002, a distal portion 1004, and a sharp tip 1006 configured to pierce natural tissue such as the annulus 812 or leaflet 814. The proximal portion 1002 is substantially straight in its undeflected state, while the distal portion 1004 is bendable in its undeflected state. The distal portion 1004 can be, for example, shaped or pre-bent to form a 360-degree curve with a diameter of, for example, approximately 19 mm. The total length of the needle thread 1000 is preferably longer than the transect duct 900 to allow for insertion and manipulation. In one specific embodiment, the needle thread 1000 has a length greater than 75 inches, is made of rigid nitinol, and has an outer diameter of approximately 0.16 inches to allow for insertion through the transect duct 900.

Figures 28 and 29 illustrate different embodiments of a snare catheter capable of capturing the end of suture 802 once it has passed through the natural leaflet or ring 812. Figure 28 illustrates an embodiment of a snare catheter 1100, which includes an elongated shaft 1102 and a snare ring 1104 extending from the distal end of the shaft 1102. The snare ring 1104 can be radially extended from a collapsed delivery state to an extended functional state (shown in Figure 28) for capturing the end of suture 802. In the delivery state, the opposite sides 1108 of the ring 1104 are compressed toward each other such that the sides 1108 are substantially straight and close together, allowing the snare catheter 1100 to be advanced through the lumen 852 of a steerable catheter 816. As the snare ring 1104 is advanced from the distal opening 834 of the steerable catheter 816, the snare ring 1104 can expand to its functional size for capturing suture 802, as further described below.

The loop 1104 can extend from the axis 1102 at an angle of less than 180 degrees (such as 90 degrees) to help place the loop at the desired location inside the heart when capturing the suture 802. The loop 1104 can be generally elliptical in shape and can have radially projecting segments 1106 that are radially opposite to the position where the loop is attached to the axis. When the opposite sides 1108 of the loop are pressed toward each other, the projecting segments 1106 help the loop 1104 collapse from an expanded state to a delivered state. In one embodiment, the loop 1104 can be constructed from 8 mil shape-defined nitinol wire. The loop 1104 can also be constructed from gold-plated tungsten or other suitable materials that allow for flexibility, shape memory, and/or contrast under fluorescence microscopy.

Figure 29 illustrates an alternative embodiment of a snare catheter 1150, which includes an elongated shaft 1152 and a snare ring 1154 extending from the distal end of the shaft 1152. The snare ring 1154 can be shaped to define a distal protrusion 1156 and a recessed portion 1158. In the extended state of the ring (shown in Figure 29), the recessed portion 1158 partially wraps around or extends around an imaginary line portion extending along the central longitudinal axis of the shaft 1152. The recessed portion 1158 can facilitate suture capture within the body. The shapes of the snare catheters 1100 and 1150 are not limited to those shown above and in the figures. Other shapes of the snare ring can be used, such as multiple rings, baskets, hexagonal rings, or asymmetrical rings.

Feeding a flexible suture through a relatively long catheter can be difficult. Because the suture is not ridged, pushing it through the catheter lumen can cause it to twist at the insertion point (usually a Luer fitting) and prevent it from unraveling at the other end of the catheter. To prevent twisting, suture 802 can be attached to one end of a small-diameter filament. A filament with a higher breaking strength than the suture can be used to pull the suture distally through the maneuverable catheter 816. The filament can be, for example, nitinol filament, which has a diameter approximately the same as the suture diameter.

In some embodiments, the distal end of the suture can be advanced through a transect catheter 900 (which extends through a manipulable catheter 816) and captured inside the heart via a snare catheter 1100. The distal end of the suture can be retracted by the snare catheter and pulled into the manipulable catheter 816 via a distal opening 834. The suture, together with suture 802, can be pulled proximally through the lumen 852 of the manipulable catheter 816 until the distal end of suture 802 exits the manipulable catheter via an opening in a Y-connector 824. Alternatively, a short suture can be attached to the distal end of the suture to facilitate capture via the snare catheter 1100.

Instead of using thin sutures to advance the suture through the catheter lumen, or in any other way, a suture-feeding device 1250 (FIG. 30) can be used to advance the suture through the catheter lumen. As shown in FIG. 30, the suture-feeding device 1250 in the illustrated embodiment includes an inner stabilizing tube 1252 and an outer feed tube 1254, which can be telescopically translated along the inner stabilizing tube 912 in the direction of the double arrow 1256. In use, the distal end of the inner stabilizing tube 1252 is coupled to the proximal end of the catheter shaft 1260. In the illustrated embodiment, for example, the inner stabilizing tube 1252 can be connected to a Luer fitting 1258 disposed on the proximal end of the catheter shaft 1260. Alternatively, the distal end of the inner stabilizing tube 1252 can be removably attached to a Luer fitting 1258 with a tuohy borst adapter or can be directly connected to the proximal end of the catheter shaft 1260.

The inner diameter of the outer feed tube 1254 can be slightly larger than the outer diameter of the inner stabilizing tube 1252. Preferably, the inner diameter of the stabilizing tube 1252 is slightly larger than the outer diameter of the suture 802.

In use, the outer feed tube 1254 can be positioned around the inner stabilizing tube 1252, and the suture 802 can be fed into the inner stabilizing tube 912 and into the catheter shaft 1260. The feed tube 1254 is positioned such that the distal portion 1262 surrounds the inner stabilizing tube 1252, and the proximal portion 1264 surrounds a portion of the suture 802, as depicted in Figure 30. The proximal portion 1264 can be clamped, for example using a finger, hemostat, or other suitable tool, so that the proximal portion is compressed against the suture and engages the suture. Then, the feed tube 1254 is advanced distally over the inner tube 1252, thereby further pushing the suture 802 into the catheter shaft 1260. After advancing the suture, the clamping force on the outer feed tube 1254 can be released and the feed tube retracts to the distal position to repeat the process of engaging the suture 802 and advancing the suture 802 through the catheter shaft 1260.

In one embodiment, the suture-feeding device 1250 can be connected to the transect catheter 900 and used to advance the suture through the lumen of the transect catheter shaft 902 into the heart.

Figures 31A to 31H show cross-sections of the heart, illustrating the use of the suture-rail delivery assembly of Figures 21 to 30 to implant a suture-rail 800 through the posterior leaflet 814 (e.g., via a transseptal approach) for subsequent introduction of a prosthetic device (e.g., prosthetic device 100) into the heart.

Figure 31A illustrates delivery of the first external catheter 1200 into the right atrium (via the superior or inferior vena cava), through the atrial septum, and into the left atrium in an advancing direction. A second intermediate catheter 1202 is advanced through the first catheter 1200 into the left atrium and guided downwards to a region above the natural mitral valve leaflet. The first catheter 1200 and/or the second catheter 1202 may have an actuation mechanism configured to control catheter deflection, thereby facilitating catheter advancement into the left atrium. Alternatively, the distal portions of the first catheter 1200 and/or the second catheter 1202 may be pre-bent to present the curved shape shown in Figure 31A. A steerable catheter 816 can then be advanced through the second catheter 1202 and the natural mitral valve leaflet until the steerable portion 838 is advanced into the left ventricle downstream of the natural valve leaflet.

Referring to Figure 31B, the maneuverable portion 838 is then deflected and twisted as needed to position the distal end 840 of the maneuverable catheter 816 against the annular groove of the natural lobule 814. In the example shown, the maneuverable portion 838 is wrapped around the posterior lobule 814 without extending into the ventricle. With the distal end 840 positioned against the annular groove, the transdermal catheter 900 and needle suture 1000 can be advanced through the lumen 854 of the maneuverable catheter 816 (Figure 24). Alternatively, the transdermal catheter and needle suture can be inserted into the maneuverable catheter before the deflection and positioning of the distal end 840 of the maneuverable catheter 816.

As shown in Figure 31C, the transdermal catheter 900 and needle suture 1000 advance in a distal direction until they pierce and extend through the natural leaflet 814 into the left atrium. The transdermal catheter and needle suture are axially locked relative to each other (e.g., at their proximal ends), with the needle suture extending slightly beyond the distal end of the transdermal catheter to prevent relative movement between them in the axial direction as the two components are advanced through the natural leaflet. As described above, the transdermal catheter 900 and needle suture 1000 are capable of having curved distal portions that bend away from the atrial wall to avoid trauma to adjacent tissues. The curvature of the transdermal catheter 900 also helps to guide the suture 802 posteriorly toward a portion of the maneuverable catheter 816 in the left atrium, as further described below.

Once the transcutaneous catheter 900 is advanced through the natural leaflet 814, the needle can be unlocked from the transcutaneous catheter and removed from the body with the silk thread 1000, thus leaving the transcutaneous catheter in the proper position within the heart, as shown in Figure 31D.

Referring to Figure 31E, the snare catheter 1100 can then be advanced through the lumen 852 of the maneuverable catheter (Figure 24) until the snare ring 1104 appears from the distal opening 834 into the left atrium. The snare ring 1104 can be positioned around the distal portion of the transect catheter 900, as depicted in Figure 31E. With the snare ring 1104 positioned around the transect catheter 900 on the atrial side of the natural leaflet 814, the suture 802 can be advanced through the transect catheter 858 until it extends beyond the transect catheter and through the snare ring 1104 in the left atrium, as shown in Figure 31F.

With suture 802 extending through the snare 1104, the snare conduit 1100 can retract into the maneuverable conduit 816, thereby pulling suture 802 proximally into the distal opening 834, as shown in FIG31G. The snare conduit 1100 can be fully retracted from the maneuverable conduit, thereby pulling suture 802 outward from the port of the Y-connector 824 (FIG. 22). Thus, suture 802 can extend from outside the body, through the inner lumen of the through conduit 900, through the natural leaflet 814, and posteriorly through the snare lumen 852 of the maneuverable conduit 816, with both ends of the suture located outside the body.

The transcatheter 900 can then be retracted and removed from the maneuverable catheter 816, leaving the suture 802 in the appropriate position within the heart, as shown in Figure 31H. The first catheter 1200 and the second catheter 1202 can be left in the appropriate position within the left atrium for subsequent delivery and implantation of a prosthetic device on the natural lobule.

Figures 32A through 32D and Figures 33A through 33B illustrate another exemplary prosthetic device 1300 capable of enlarging heart valve leaflets to improve valve engagement and treat valvular regurgitation. As described elsewhere herein, device 1300 can be secured to and/or around heart valve leaflets (such as mitral valve leaflets) to add volume to the leaflets and/or extend their length, which can help the leaflets seal the heart valve and prevent or reduce backflow of blood through the valve. Device 1300 can be delivered and implanted using transcatheter techniques, as described elsewhere herein, and can be expanded from a coiled delivery configuration to a functional configuration when positioned intracardiaclysally.

Device 1300 includes a flexible, expandable body 1302, a first end portion 1304 coupled to one end of the body, and a second end portion 1306 coupled to the other end of the body. Body 1302 can include a generally tubular structure defining an inner lumen extending from the first end portion 1304 to the second end portion 1306. As used herein, the term "tubular" means that the body has an annular cross-section (in a plane perpendicular to the length of the body) defining the lumen, but does not necessarily require the body to have a true cylindrical shape. In fact, the body 1302 in the illustrated embodiment has a wider middle portion that tapers gradually in two directions toward opposite ends of the body.

Figure 32A shows a delivery configuration in which the device 1300 is collapsed and has a minimal cross-sectional profile, capable of being accommodated within a delivery catheter. Figure 32B shows a configuration in which the body 1302 is released from its delivery catheter and has expanded to a larger cross-sectional profile. Figure 32C shows a coiled device 1300 with end portions 1304 and 1306 positioned adjacent to each other, illustrating a configuration in which the body 1302 is coiled or wrapped around the free end of the leaflet, with end portions 1304 and 1306 positioned on opposite sides of the leaflet. In the position of Figure 32C, end portions 1304 and 1306 can be secured to the leaflet, such as by using one or more sutures or fasteners passing through the leaflet, to anchor the device 1300 to the leaflet. Figure 32D shows the device 1300 in an implantation configuration, where the body 1302 is further extended radially or laterally, which allows the body to fill the gaps between the natural leaflets and reduce backflow between the natural leaflets.

Figures 33A and 33B show two orthogonal side views of the device 1300, while Figure 33C shows an end view. In its relaxed, natural state, the body 1302 can have a generally elliptical or flat circular cross-sectional profile with a wider long lateral dimension (vertical dimension in Figure 33C) and a smaller short lateral dimension (horizontal dimension in Figure 33C). This flat profile allows the body 1302 to be easily rolled up (see Figure 32C) and positioned around the leaflet, with the flat inner surface abutting the leaflet and the long lateral dimension spreading out on the surface of the leaflet.

Device 1300 may include a channel 1312 extending longitudinally through a body 1302 and through two end portions 1304 and 1306. Channel 1312 allows device 1300 to be advanced into the heart and around a target leaflet via a guide such as a suture or cord. As described elsewhere herein, a guide suture may be positioned through the leaflet before delivery of device 1300, and device 1300 may then be advanced along the guide suture and position the first end portion 1304 on one side of the leaflet (e.g., the atrial side) and the second end portion 1306 on the other side of the leaflet (e.g., the ventricular side). The first end portion 1304 may include a lateral channel 1308 and/or the second end portion 1306 may include a transverse channel 1310, allowing the guide suture or other guide to pass laterally through the end portion rather than longitudinally. For example, in the configuration of FIG32C, the guide suture can pass laterally through the channel 1308 in the first end portion 1304 and longitudinally through the channel 1312 in the second end portion 1306 (see also FIG36).

The body 1302 can comprise a tubular braided mesh made of nitinol or other elastically deformable and/or shape-settable material that can regain a desired shape when released from an intracardiac delivery catheter. When the braided mesh shortens longitudinally, it also allows the body 1302 to expand laterally, and when the braided mesh is stretched longitudinally, it also allows the body 1302 to contract laterally. In a delivery configuration, the braided mesh can have an elongated, narrow profile without wrinkles or folds, allowing for efficient fitting within a narrow delivery catheter. When implanted around a lobule, the braided mesh can have a shortened but laterally expanded profile. The braided mesh allows the body 1302 to move between these different configurations without significant material stretching, which can occur with solid, elastic sheets of material instead of the braided mesh.

The body 1302 may also include an outer layer covering the inner braided mesh to restrict or minimize blood flow through the body 1302. The outer layer may also include a braided mesh, or it may include a more robust sheet of material. For example, the outer layer may include polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE, ePTFE), urethane, etc. The outer layer may allow a degree of porosity but can advantageously sufficiently restrict blood flow to prevent any significant blood flow through the device when the heart valves are closed. The underlying inner braided mesh can serve more as a structural support and is not necessarily non-porous, while the outer layer can be less structurally prominent and more focused on restricting blood flow.

Figures 46A and 46B illustrate an exemplary prosthetic device 1500 including a body comprising an inner tubular braided mesh layer 1506 and an outer tubular braided mesh layer 1504, together with end portions or end caps 1508 and 1510 secured to the ends of the mesh layers. The inner braided mesh 1506 can have larger openings between the strands of the mesh and can be composed of thicker, stronger strands to provide structure, while the outer braided mesh 1504 can include thinner strands and smaller openings between the braided strands to restrict blood flow through the device. The outer braided mesh 1504 can extend the entire length of the body 1502 and is secured to the end portions 1508 and 1510 together with the inner braided mesh 1506. Figure 46C illustrates the curled configuration of the device 1500 when the sutures 1520 passing through the end portions 1508 and 1510 are tightened (as indicated by arrows 1522, 1524). The outer braided mesh 1504, together with the suture 1520, is shortened in length and simultaneously expanded laterally without noticeable wrinkling or folding of the material, thereby enabling the outer surface to be sealed against natural tissue without excessive blood leakage.

The end portions 1304 and 1306 of the device 1300 can be more rigid than the main body 1302 and can include various polymer materials such as polyether ether ketone (PEEK) or metallic materials such as nitinol.

Figures 34 to 41 illustrate an exemplary prosthetic device 1400 similar to the device 1300 shown in Figures 32 and 33. Device 1400 includes a body 1402, a first end portion or end cap 1404, and a second end portion or end cap 1406. The body 1402 can have features similar to those described above for body 1302.

The first end portion 1404 is secured to a tether 1408 passing through a hole 1409 (FIG. 36) in the first end portion 1404. The tether 1408 can be used to apply a proximal force to the device 1400, such as to keep the device within the delivery conduit, to retract the device 1400 into the delivery conduit, and/or to move the device proximal after deployment.

The first distal portion 1404 may have an internal channel as shown in Figures 38 and 40, which guides the guide suture 1410 through the first distal portion 1404 and through the device 1400. The guide suture 1410 may be a previously implanted guide suture extending through the natural leaflet, as described in detail above and shown in Figures 31A to 31H. As shown in Figures 35 and 36, the guide suture 1410 may form a loop extending through the prosthetic device 1400 and the natural leaflet. The guide suture 1410 includes a first portion 1411 extending outward from a delivery catheter 1420 positioned proximally (Figure 42), through a first lateral opening 1422 in the first distal portion 1404, and extending into the interior of the body 1402. A second portion 1412 of the guide suture 1410 extends through the body 1402 and through a longitudinal channel in the second distal portion 1406. A third portion 1414 of the guide suture 1410 extends from the second distal portion 1406, through the natural leaflet 1418, into the second lateral opening 1424 in the first distal portion 1404, and extends out through the first lateral opening 1422. A fourth portion 1416 of the guide suture 1410 extends from the first lateral opening 1422 back into the delivery catheter 1420 positioned proximally (see exemplary delivery catheters in Figures 42-45). The proximal ends of the first portion 1411 and the fourth portion 1416 of the guide suture 1410 can be located outside the patient's body.

As further shown in Figure 38, the first end portion 1404 may also include a distal notch 1428, which receives and is secured to the proximal end of the body 1402. The notch 1428 communicates internally with the lateral openings 1422 and 1424.

During delivery of the device 1400, the body 1402 can be substantially straight or slightly curved, as shown in Figures 34, 35, 37, and 38. In this configuration, two guide sutures 1410 passing through the first lateral opening 1422 are curved around an inclined surface 1423 (Figure 38) at the first end portion and extend proximally, generally parallel to the longitudinal direction of the device 1400. The inclined surface 1423 provides a gradual curvature for the sutures to minimize the risk of damage to the sutures from sharp right-angled edges at the exit of the first lateral opening 1422. Similarly, a third portion 1414 of the guide sutures passing through the second lateral opening 1424 can be curved around an inclined surface 1425, which provides a gradual curvature for the sutures to minimize the risk of damage to the sutures from sharp right-angled edges at the exit of the second lateral opening 1424.

When tension is applied to the guide suture 1410, such as by pulling one or both of the first portion 1411 and the fourth portion 1416 proximally, the body 1402 begins to curl around the leaflet into the implantation configuration shown in Figures 36, 40, and 41. As a section of the guide suture is removed from the prosthesis device (causing a reduction in the circumference of the loop extending through the body 1402 and the leaflet), the body 1402 gradually curls up. The distal end of the delivery catheter 1420 (see Figures 35 and 39) can be positioned against the first distal portion 1404 to hold the first distal portion against the leaflet in place, while the loop decreases and the second distal portion 1406 curls against the opposite side of the leaflet (Figure 41).

As shown in Figure 40, when the main body 1402 is rolled into the unfolded configuration, the second end portion 1406 is oriented laterally to the first end portion 1404. In this configuration, a portion 1414 of the guide suture is able to extend laterally through the two lateral openings 1422, 1424 of the first end portion, and is able to extend laterally from the first end portion into the delivery catheter along the other end of the guide suture 1410 and the tether 1408. As can be seen by comparing Figures 38 and 40, during the unfolding of the device 1400, the first end portion 1404 is able to rotate up to approximately 90° relative to the delivery catheter.

Figure 41 illustrates the device 1400 coiled around the mitral valve leaflet 1406 during implantation, with the distal portions 1404 and 1406 on opposite sides of the leaflet. In this position, the guide suture 1410 can be pulled and/or loosened to make the body 1402 more or less tighter around the leaflet and to become more or less voluminous. For example, the guide suture can be tightened until the body 1402 extends far enough to contact and seal against the leaflet 1419. The use of imaging techniques such as echocardiography and fluorescein microscopy to visualize the size and positioning of the device 1400, its natural anatomy, and blood flow can facilitate this process. For example, the body 1402 can be extended until no significant backflow is observed through the subject heart valve. The device 1400 can then be secured in this configuration by means of securing the guide suture using suture clips, suture locks, and/or knots, as described above.

Figures 42 through 45 illustrate an exemplary delivery catheter 1420 capable of delivering and implanting device 1400 or a similar device. The catheter 1420 includes a central lumen and at least two lateral lumens 1430 radially spaced outward from the central lumen, wherein two guide sutures 1410 pass through the central lumen and two tethers 1408 pass through the at least two lateral lumens 1430. The catheter 1420 may further include two additional lateral lumens 1431 to help provide uniform stiffness around the central longitudinal axis of the catheter. The lateral lumens 1431 may be “dummy lumens” or may be used to allow an instrument or other device to pass through the catheter into the patient’s body. The delivery catheter 1420 includes a distal notch 1436 and a distal outer edge 1438 that contacts or is adjacent to the proximal end of a first distal portion 1404 of the device 1400 during delivery of the device 1400 to the heart.

Both the prosthetic device 1400 and the delivery catheter 1420 can be accommodated within an external catheter (not shown) during transvascular delivery to the heart (e.g., in such a way that the external catheter 50 in Figures 3A to 3H is used to accommodate the internal catheter 52 and the prosthetic device 100 during delivery of the prosthetic device). Alternatively, the prosthetic device 1400 and the delivery catheter 1420 can be advanced through an external catheter pre-inserted into the body, such that the distal end of the external catheter is positioned in the heart.

As shown in Figure 44, the delivery catheter 1420 may include at least one suture clip (or suture lock) 1440 positioned in a notch 1436 at the distal end of the catheter 1420. The suture clip 1440 may be generally disc-shaped and may have one or more resiliently deformable flaps 1443 deflectable to open a channel 1441 that allows a multi-strand guide suture 1410 to pass through the suture clip between the central lumen 1432 and the device 1400. The suture clip 1440 is positioned against an annular retainer 1442 including a protrusion 1444 projecting distally through the suture clip and holding the flaps open during delivery to allow the guide suture to slide through the suture clip with minimal resistance during implantation. The annular retainer 1442 includes a central channel 1446.

The delivery catheter 1420 also includes a tubular pusher 1434 (Figures 43 and 44), which surrounds and/or defines a central lumen 1432 and is longitudinally slidable relative to the retainer 1442 and the suture clip 1440. When the device 1400 is advantageously positioned and the guide suture is advantageously tightened, the pusher 1434 is able to be advanced distally through a channel 1446 in the retainer 1442 to contact the suture clip 1440 and push the suture clip 1440 distally away from the retainer 1442 such that the protrusion 1444 disengages from the suture clip and one or more flaps 1443 of the suture clip are able to resiliently close against and engage the guide suture 1410. When released from retainer 1442 and secured to guide suture 1410, suture clip 1440 is able to withdraw from the distal end of notch 1436 of delivery catheter 1420 as the delivery catheter retracts proximally away from implant device 1400, thereby engaging one side of suture clip 1440 against the first end portion 1404 of prosthesis device 1400 adjacent to the first lateral opening 1422 with the two guide suture strands (see FIG. 40). FIG. 45B shows delivery catheter 1420 after pusher 1434 has moved distally and been pushed out of suture clip 1440.

In Figures 44, 45A, and 45B, the pusher 1434 is shown extending longitudinally only a short distance from the distal end of the catheter 1420. In some embodiments, the pusher 1434 is attached to the interior of a wire coil 1450 of the catheter, and the coil, together with the coil cover layer 1460, is longitudinally movable relative to the outer portion of the catheter to move the pusher 1434. The outer portion of the catheter 1420 may include an outer annular body or shaft 1454 defining an outer lumen 1430, 1431, one or more layers of material 1462, 1464 lining the outer shaft, and a distal outer body or tip portion 1448 including a retainer 1442 and a suture clip 1440. The inner layers 1462, 1464 may include extruded polymer layers or braided layers, as described above for catheter 816 in conjunction with Figures 22 to 25.

In an alternative embodiment, the first distal portion 1404 of the prosthesis device 1400 may include a suture locking mechanism capable of engaging the guide suture. This eliminates the need for applying suture clips from the delivery catheter or otherwise securing the guide suture, or can be used in addition to the application of suture clips. The suture locking mechanism may be located within or along the surface of the first distal portion 1404 such that both suture strands 1410 pass through the suture locking mechanism. The suture locking mechanism may include a one-way restrictor that allows proximal pulling of the suture strands through the first distal portion to tighten the sutures within the body 1402, but prevents the suture strands from sliding backward through the first distal portion after implantation. In some embodiments, the suture locking mechanism may include a ratchet mechanism. In some embodiments, the suture locking mechanism may be selectively releasable to allow a user to add slack back into the guide suture and then re-secure the locking mechanism.

Figures 47 through 49 illustrate devices capable of untying and/or straightening two strands of sutures or other cords (e.g., guide suture 1410) extending into the patient's vascular system. Figure 49A shows a configuration where suture 1620 is looped around the left end and has two strands extending to the right end. The looped end can indicate that the extension of guide suture 802 or guide suture 1410 passes through a portion of a natural leaflet (e.g., as depicted in Figure 21 or Figure 35). In Figure 49A, the two strands of suture are twisted, which can inhibit the delivery of the device on the suture strands. The suture strands can become twisted in various ways, either within or outside the patient's vascular system.

Figures 47 and 48 illustrate two exemplary devices 1600 and 1610 capable of passing through twisted multi-strand sutures 1620 to untwist and straighten them. Device 1600 includes a robust outer body or shaft 1602, a single central lumen 1604, and two radially positioned lumens 1606. The central lumen 1604 is sized to accommodate two strands of suture 1620, and the lumens 1606 form weak points along the length of the body 1602 to allow the body to peel apart in two halves, as shown in Figure 49C. Device 1610 includes a robust outer body or shaft 1612, two separate inner lumens 1614 for each suture strand, and two outer lumens 1616 similarly form weak points along the length of the body 1612 to allow the body to peel apart in two halves. The bodies 1602 and 1612 can comprise any material capable of sufficient twisting and bending, such as extruded polymer materials.

Using device 1600 as an example (device 1610 is used in the same manner), the free ends of two suture strands can be inserted into central lumen 1604 or into both central lumen 1614 (as shown in Figure 49A), and then device 1600 can advance on the two suture strands (as shown in Figure 49B) to untwist them. Untwist of the suture strands can include rotation of device 1600, such that the loop at the distal end of the suture remains fixed and does not require rotation. The loop in the suture can extend through a leaflet or other tissue/object and prevent its rotation to untwist the suture.

The free end 1622 of the suture strand (Fig. 49C) can extend from the proximal end of the device 1600 in the position shown in Fig. 49B, allowing another catheter (e.g., including the prosthetic device 1400 and the delivery catheter 1420) to be advanced over one or both suture strands while the device 1600 remains on the suture strands. This other catheter can prevent the device 1600 from being pulled proximally away from the suture strands as it is advanced distally. To remove the device 1600, the body 1602 can be peeled apart along a weak point provided by the external lumen 1606 into two halves 1602A and 1602B (not necessarily of equal size) (as shown in Fig. 49C). The peeling or tearing can occur outside the patient's body. When the two halves 1602A and 1602B are peeled apart, the device 1600 can be pulled proximally out of the main body along the suture strands until the entire device 1600 is separated from the main body and divided into two parts that are removed and discarded from the suture strands, thus untwisting the suture strands for the other catheter to be advanced on. As the device 1600 retracts and peels apart, the other catheter can be advanced along the suture strands, preventing the suture strands from twisting again.

Figure 50 illustrates a prosthetic device 1700 for treating valvular regurgitation according to another embodiment. The prosthetic device 1700 can have an overall construction similar to that of the prosthetic device 1300 of Figures 32-33, and therefore can have an elongated body 1702 and first and second opposite end portions, or end caps 1704, 1706, respectively at opposite ends of the body. One or both of the first end portion 1704 and the second end portion 1706 can have one or more barbs 1708, which can provide enhanced frictional engagement with the natural leaflet. In the illustrated embodiment, each of the first end portion 1704 and the second end portion 1706 has a plurality of barbs 1708. The barbs 1708 advantageously have pointed ends capable of penetrating the surface of the natural leaflet to facilitate engagement of the end portion with the natural leaflet.

Figure 51 illustrates a prosthetic device 1700 implanted in a natural lobule. As shown, barbs 1708 on the first distal portion 1704 engage and optionally penetrate the atrial surface of the natural lobule, while barbs 1708 on the second distal portion 1706 engage and optionally penetrate the ventricular surface of the natural lobule (for illustrative purposes, the barbs are shown slightly spaced from the natural lobule). The prosthetic device 1700 can be further secured in place against the natural lobule using sutures and fasteners as detailed above.

Figure 52 illustrates a modification of the prosthesis device 1700, wherein the second end portion 1706 includes one or more barbs 1708, and the first end portion 1704 includes one or more correspondingly shaped notches 1710, the notches 1710 being shaped to receive tissue from the natural lobule. When implanted around the natural lobule, the barbs 1708 press the tissue of the natural lobule into the notches 1710 to facilitate anchoring of the prosthesis device. In some embodiments, the barbs 1708 can be configured to completely penetrate the natural lobule and extend into the notches 1710.

In an alternative embodiment, the first end portion 1704 may have one or more barbs 1708, while the second end portion 1706 may have one or more notches 1710. Furthermore, any of the embodiments disclosed herein may include one or more barbs on one or both ends of the prosthetic device, or include one or more barbs on one end and one or more notches on the other end.

Figures 53 and 54 illustrate a prosthetic device 1800 according to another embodiment, comprising an elongated body 1802 and first and second opposing end portions 1804, 1806 at opposite ends of the body, respectively. One or both of the first end portion 1804 and the second end portion 1806 may have one or more barbs 1808 that provide enhanced frictional engagement with the natural leaflets. As shown in the end view of the prosthetic device in Figure 53, the end portions 1804, 1806 may have a flat configuration to allow them to lie flat against the surface of the natural leaflets, and thus provide enhanced stability to the prosthetic device.

Figures 55A to 55E illustrate a method for implanting a prosthetic heart valve in the mitral valve position using a prosthetic device mounted on one of the natural leaflets as a support structure for the prosthetic valve. Figure 55A shows a guide 802 implanted through the posterior leaflet 8, as previously described in detail above. Figure 55B shows a first prosthetic device 100 partially deployed around the leaflet 8, which can be delivered to the natural leaflet as previously described. The first prosthetic device 100 carries a second prosthetic device in the form of a radially expandable support ring 1800. In the illustrated embodiment, the first prosthetic device 100 can extend or surround through the support ring 1800 such that the two components are linked together like links of a chain. The support ring 1800 can include, for example, an annular support formed by interconnected struts or can include a woven structure.

As shown in Figure 55B, the support ring 1800 is positioned between the natural leaflets and receives a transcatheter prosthetic heart valve 1804. The prosthetic heart valve 1804 can be mounted on a delivery catheter 1806, which can be advanced over a guidewire 1808. As shown in Figure 55C, the first prosthetic device 100 can be fully deployed around the natural leaflets and secured in place, and the prosthetic heart valve 1804 can be radially expanded against the inner surface of the support ring 1800. The prosthetic heart valve 1804 can be held in place by frictional engagement between the prosthetic valve and the support ring. The outer surface of the support ring 1800 has a plurality of barbs or tissue engagement members 1802 that can engage the anterior leaflet 6 and/or other surrounding tissue to help anchor the support ring 1800 in place between the two natural leaflets. Figures 55D and 55E are a side view and a top view, respectively, showing a prosthetic valve 1804 extended and held in place within a support ring 1802, with all delivery devices retracted from the heart. As shown in Figure 55E, the prosthetic valve is capable of having a prosthetic leaflet 1810, which regulates blood flow through the prosthetic valve.

The prosthetic heart valve 1804 can be a self-expanding prosthetic valve or a malleably expandable heart valve, as known in the art. A self-expanding heart valve can have a self-expanding frame made of a shape memory material (e.g., nitinol) that can radially expand to its functional size upon release from a delivery sheath, as known in the art. A malleably expandable heart valve can have a frame made of a ductile or malleably expandable material (e.g., stainless steel or cobalt-chromium alloy) that can expand to its functional size by a balloon or other expansion device, as known in the art. Examples of such prosthetic heart valves that can be used in the disclosed methods and components are disclosed in U.S. Patent Application Publications Nos. 2012/0123529 and 2012/0239142.

Figures 56A to 56E illustrate a method for implanting a prosthetic heart valve in the mitral valve position using multiple prosthetic devices mounted on natural leaflets as support structures for the prosthetic valve. In this method, a first guide rail 802a is implanted through the posterior leaflet 8, and a second guide rail 802b is implanted through the anterior leaflet 6, as shown in Figure 56B. A first prosthetic device 1900a is implanted around the posterior leaflet 8 via the first guide rail 802a, and a second prosthetic device 1900b is implanted around the anterior leaflet 6 via the second guide rail 802b, as shown in Figure 56B. Each of the prosthetic devices 1900a and 1900b can be an expandable braided structure, as described above and shown in Figures 32 to 33 and Figure 46.

As shown in Figure 56C, the prosthetic heart valve 1902 can be delivered to a position between the prosthetic devices 1900a and 1900b via a delivery catheter 1904 that can be advanced over a guidewire 1906. The prosthetic heart valve 1902 can then be radially extended to its functional size and held in place against the prosthetic devices 1900a and 1900b, as shown in Figures 56D and 56E. As shown in Figure 56E, the size and shape of each of the prosthetic devices 1900a and 1900b can be set to circumferentially cut about half (about 180 degrees) of the outer surface of the prosthetic valve 1902, such that the prosthetic devices 1900a and 1900b together always surround, or substantially always surround, the prosthetic valve. In other embodiments, more than two prosthetic devices can be implanted on natural leaflets to serve as support structures for the prosthetic valve. For example, two or three such prosthetic devices can be implanted on one or two natural leaflets to serve as support structures. In another embodiment, the single prosthetic device is capable of bridging or extending across one of the mitral valve commissures, such that the single prosthetic device is at least partially implanted on both natural leaflets.

Figures 57A and 57D illustrate the use of a guide rail 802 solely as a support structure for a prosthetic heart valve. In the illustrated embodiment, the guide rail 802 is implanted through the posterior leaflet 8. For this application, the guide rail 802 advantageously comprises a relatively rigid material, such as wire. As shown in Figures 57B and 57C, the prosthetic heart valve 2000 unfolds between the natural leaflets 6 and 8, but abuts against the guide rail 802 to help secure the prosthetic valve in place. The prosthetic valve 2002 can have multiple barbs or tissue-engaging members 2002 that can engage the anterior leaflet or other tissue to enhance frictional engagement between the prosthetic valve and the natural tissue. In an alternative embodiment, a single guide rail can be implanted through the anterior leaflet 6, or multiple guide rails can be implanted through one or two leaflets to serve as a support structure for the prosthetic valve.

Figures 58A and 58E illustrate another embodiment of a method for implanting a prosthetic heart valve in the mitral valve position using a prosthetic device mounted on one of the natural leaflets as a support structure for the prosthetic valve. In this embodiment, a guide rail 802 is implanted through the posterior leaflet 8, and the prosthetic support device 2100 is implanted on the posterior leaflet via the guide rail as described above. The support device 2100 can be an expandable braided structure, such as as described above and as shown in Figures 32-33 and Figure 46.

The support device 2100 may have barbs or tissue engagement members 2102 to enhance frictional engagement between the support device and adjacent tissue. The support device 2100 may further include a lumen extending through the braided body of the support device in a direction from the left atrium toward the left ventricle. The lumen is sized to receive a prosthetic heart valve 2104, which can expand to its functional size within the lumen, as shown in Figures 58D and 58E.

Figure 59 illustrates a prosthetic device 2200 for treating valvular regurgitation according to another embodiment. The prosthetic device 2200 can have an overall construction similar to that of the prosthetic device 1300 of Figures 32-33, and therefore can have an elongated body 2202 and first and second opposite end portions or end caps 2204, 2206 at opposite ends of the body, respectively. One or both of the first end portion 2204 and the second end portion 2206 can have one or more barbs 2208, which can provide enhanced frictional engagement with the natural leaflet. In the illustrated embodiment, each of the first end portion 2204 and the second end portion 2206 has a plurality of barbs 2208, wherein the barbs of the first end portion are offset from the barbs of the second end portion. Thus, the barbs of one end portion can engage or nest within the barbs of the other end portion, with the natural leaflet in between.

The prosthetic device 2200 further includes a biasing member 2210 configured to move and hold the prosthetic device 2200 in a curled configuration surrounding the natural leaflet 8. In the illustrated embodiment, the biasing member 2210 extends through the body 2202 and has a first end fixed to a first end portion 2204 and a second end fixed to a second end portion 2206. The biasing member 2210 may comprise, for example, a leaf spring or a resilient sheet or wire biased toward the curled configuration shown in FIG. 59. The biasing member 2210 may be made of nitinol, stainless steel, or other flexible and resilient materials.

The biasing force applied by the biasing member 2210 to the distal portions 2204, 2206 of the prosthesis device causes the distal portions to abut against the tissue of the natural lobule and clamp the natural lobule therebetween. In a particular embodiment, the biasing force of the biasing member 2210 is sufficient to hold the prosthesis device on the natural lobule without the use of additional fixation mechanisms (e.g., sutures) extending through the lobule. Thus, in such embodiments, the prosthesis device 2200 can be delivered and implanted onto the natural lobule without the use of guides extending through the lobule. Alternatively, the prosthesis device can be delivered to the natural lobule along a guide, and then the guide can be completely removed from the body and no longer used to help secure the prosthesis device in place.

General considerations

For the purposes of this description, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, which are individual and in various combinations and sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the existence of any one or more specific advantages or solutions to any one or more specific problems.

Features, integers, properties, compounds, chemical parts, or groups described in connection with specific aspects, embodiments, or examples of the invention should be understood to be applicable to any other aspect, embodiment, or example described herein, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings), and/or all steps of any disclosed method or process, can be combined in any combination except for at least some mutually exclusive combinations of such features and/or steps. The invention is not limited to the details of any of the foregoing embodiments. The invention extends to any novel one or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or to any novel one or any novel combination of steps of any method or process so disclosed.

While some operations in the disclosed methods are described in a specific ordered order for ease of representation, it should be understood that this descriptive approach includes rearrangement unless the specific language requires a particular order. For example, operations described sequentially may be rearranged or performed simultaneously in some cases. Furthermore, for brevity, the figures do not show the various ways in which the disclosed methods can be combined with other methods. As used herein, the terms "an," "a," and "at least one" include one or more of the specified elements. That is, if two specific elements exist, then one of those elements also exists and therefore there is "an" element. The terms "a plurality of" and "multiple" mean two or more of the specified elements.

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

As used herein, the term “connected” generally means physically connected or linked, and in the absence of a specific opposite language, it does not preclude the existence of intermediate elements between the connected items.

Given that the principles of the disclosed invention can be applied to many possible embodiments thereto, it should be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be considered as limiting the scope of the invention. Rather, the scope of the invention is defined by the appended claims. Therefore, we claim that our invention is within the scope and spirit of these claims.

Claims (10)

1. An implantable device for treating a heart valve in a subject, the valve having an annulus, a first leaflet, and opposing leaflets, and the implantable device comprising: A body having a first distal portion and a second distal portion, the body having a compressible state for transcatheter delivery to the heart and being capable of expanding within the heart; and An anchor is configured to anchor the first end portion to the annulus of the valve, such that the body extends away from the anchor and the first end portion and toward the second end portion on the atrial side of the first leaflet, such that the second end portion (i) is free and extends toward the ventricular side of the valve beyond the length of the first leaflet into the orifice of the valve, and (ii) is capable of engaging with and moving away from the opposing leaflet during valve operation, the body being configured to enhance the seal along the engagement line of the first leaflet and the opposing leaflet during ventricular systole. 2. The implantable device of claim 1, wherein one of the first terminal portion or the second terminal portion is wider than the other of the first terminal portion or the second terminal portion. 3. The implantable device of claim 1, wherein the body comprises a material sheet comprising a blood-impermeable material. 4. The implantable device according to claim 1, wherein the main body comprises a woven mesh. 5. The implantable device of claim 4, wherein the body further comprises an outer layer covering the woven mesh. 6. The implantable device of claim 1, wherein the anchor includes one or more barbs penetrating the ring. 7. The implantable device of claim 1, wherein the first distal portion collapses against the atrial side of the first leaflet to allow unobstructed blood flow through the valve during cardiac diastole. 8. The implantable device of claim 1, wherein the second terminal portion abuts against the atrial side of the opposing leaflet to block blood flow through the valve during ventricular contraction. 9. The implantable device of claim 1, wherein the second terminal portion is tethered to a position in the ventricle on the ventricular side of the valve. 10. The implantable device of claim 1, wherein the body has sufficient thickness to function as a spacer that fills the gap between the first lobule and the opposing lobule at the junction during ventricular systole.