Devices, systems, and methods for collapsible and expandable replacement heart valve

Abstract

To provide devices, systems, and methods for a collapsible and expandable heart valve assembly that is highly flexible, resilient, retractable, and replaceable.SOLUTION: Disclosed herein are systems and methods for a replacement heart-valve delivery system, comprising a replacement heart valve and a delivery component. The delivery component enables control of the replacement heart valve such that it can control collapsing and expanding the heart valve. Due to the nature of the flexible wire frame making up the heart valve, as well as its size, the delivery component allows for flexibility in the delivery catheter. The claimed invention thus allows for less traumatic delivery, more precise delivery, and a greater number of options on how to deliver.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (Related Applications) This application claims the benefit of U.S. Provisional Application No. 63 / 025,881, filed May 15, 2020, entitled "Devices, Systems, and Methods For a Collapsible and Expandable Replacement Heart Valve," the entire disclosure of which is incorporated by reference into this application as if set forth in its entirety and to which priority and benefit are claimed.

[0002] (Technical field) The present disclosure relates generally to the art of replacement heart valves, and more particularly to devices, systems, and methods for highly flexible, resilient, retractable, replaceable, collapsible, and expandable heart valve assemblies. [Background technology]

[0003] Heart valve intervention, such as complete open-heart surgery, is often required to treat diseases of one or more of the four heart valves that work together to ensure proper blood flow through the heart. Heart valve replacement and / or repair is often required when a valve "leaks" (e.g., there is mitral regurgitation) or when the valve narrows and does not open properly (e.g., mitral stenosis). Heart valve replacement procedures, such as mitral valve replacement, generally involve replacing the heart's original (native) valve with a mechanical and / or tissue (biological) valve. However, this can lead to problems when replacing the valve and / or the frame supporting the valve: a) deterioration of the leaflets (valve-like structures), b) breakage or malfunction of the frame, particularly the laser-cut nitinol frame, and c) undesirable size changes of the native valve annulus. Replacement heart valves can also cause additional problems after implantation. For example, replacement heart valves may move or migrate after being placed in the desired location in the heart, or their position may not allow for proper directional blood flow during delivery. Additionally, replacement heart valves are often not immediately retrieved because such retrieval could damage the surrounding heart tissue. This can be particularly problematic, for example, if the replacement heart valve is not properly and accurately positioned when implanted into the heart, as well as if the replacement heart valve begins to malfunction (which can occur years after initial implantation). Another problem is that typical replacement heart valves, particularly laser-cut valve frames, are relatively stiff and inflexible, leading to a valve that does not bend as the heart beats. Such inflexible valves are not adapted to such dynamic movement, which can cause trauma to the heart's surface and fracture the frame itself, potentially causing or exacerbating problems during or after implantation.

[0004] Additionally, although percutaneous implementation of prosthetic valves using catheters is preferred (because it avoids traumatic open surgery and provides a less tortuous transcatheter route via the aorta to the aortic valve), it also presents challenges. For example, implanting prosthetic valves into other dysfunctional native valves (e.g., the caval-transseptal route to the native mitral valve, the caval route to the tricuspid valve) poses significant challenges in terms of flexibility, as the catheter may need to rotate more than 180 degrees near the delivery site. Summary of the Invention [Problem to be solved by the invention]

[0005] Thus, there is a need for devices, systems, and methods for replacement heart valves that allow for compact and safe delivery into the heart and convenient control of the expansion and contraction of the valve as it is implanted or removed, preferably entirely via a catheter, and that ensure proper directional flow of blood through the heart during and after the valve replacement procedure. There is also a need for improved devices, systems, and methods for transcatheter delivery of prosthetic valves. [Means for solving the problem]

[0006] The following presents a brief summary of example embodiments to provide a basic understanding of some embodiments of the present disclosure. This summary is not an extensive overview of example embodiments. It is not intended to identify key or critical elements of example embodiments or to delineate the scope of the appended claims. Its sole purpose is to present some concepts of example embodiments in a simplified form as a prelude to the more detailed description that is presented later herein. It is to be understood that both the following general description and the following detailed description are exemplary and explanatory only and are not restrictive.

[0007] The present disclosure is directed to devices, systems, and methods for a highly flexible, resilient, retractable, and replaceable collapsible replacement heart valve assembly (referred to throughout this disclosure as a "valve assembly"). Additionally, the disclosure is directed to devices, systems, and methods for the delivery and deployment of the heart valve assembly. As disclosed herein, the valve assembly has the ability to be replaced several years after implantation if problems arise, such as recurrence of mitral regurgitation.

[0008] Further advantages, embodiments, and features of the present disclosure will become readily apparent to those skilled in the art from the following description, which shows and describes a preferred embodiment of the present disclosure, merely by way of example, of one of the best modes suitable for carrying out the present disclosure. As will be recognized below, the present disclosure is capable of other and different embodiments, all without departing from the scope of the present disclosure or limiting it, and its several details are capable of modification in various obvious embodiments. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the general description of the disclosure above and the detailed description of the drawings below, serve to explain the principles of the present disclosure. In certain instances, details that are not necessary for an understanding of the disclosure or that make other details difficult to understand may be omitted. [Brief explanation of the drawings]

[0010] [Figure 1] 1A and 1B illustrate schematically one embodiment of a collapsible heart valve assembly system disclosed herein. [Figure 2] 1 illustrates a schematic representation of one embodiment of a tubular, braided frame as disclosed herein. [Figure 3] 1 shows a schematic diagram of one embodiment of a tubular, braided frame disclosed herein; [Figure 4] 1 illustrates a schematic representation of one embodiment of a tubular, braided frame as disclosed herein. [Figure 5]1 illustrates a schematic diagram of one embodiment of a leaflet panel as disclosed herein. [Figure 6] 1 illustrates a schematic representation of one embodiment of a Z-valve insert disclosed herein. [Figure 7A] 10A-10C schematically illustrate embodiments of patterns for leaflet panels. [Figure 7B] 10A-10C schematically illustrate embodiments of patterns for leaflet panels. [Figure 7C] 10A-10C schematically illustrate embodiments of patterns for leaflet panels. [Figure 7D] 10A-10C schematically illustrate embodiments of patterns for leaflet panels. [Figure 7E] 10A-10C schematically illustrate embodiments of patterns for leaflet panels. [Figure 7F] 10A-10C schematically illustrate embodiments of patterns for leaflet panels. [Figure 7G] 10A-10C schematically illustrate embodiments of patterns for leaflet panels. [Figure 8] 1 illustrates a schematic diagram of one embodiment of a collapsible heart valve assembly system disclosed herein. [Figure 9] 1A and 1B illustrate schematically one embodiment of a collapsible heart valve assembly system disclosed herein. [Figure 10A] 1A and 1B illustrate schematically one embodiment of a collapsible heart valve assembly system disclosed herein. [Figure 10B] 1A and 1B illustrate schematically one embodiment of a collapsible heart valve assembly system disclosed herein. [Figure 11] 1A and 1B illustrate schematically one embodiment of a delivery system for a collapsible heart valve assembly disclosed herein. [Figure 12] 1A and 1B illustrate schematically one embodiment of a delivery system for a collapsible heart valve assembly disclosed herein. [Figure 13] 1A and 1B illustrate schematically one embodiment of a delivery system for a collapsible heart valve assembly disclosed herein. [Figure 14]1A and 1B illustrate schematically one embodiment of a delivery system for a collapsible heart valve assembly disclosed herein. [Figure 15] 1A and 1B illustrate schematically one embodiment of a retrieval system for a collapsible heart valve assembly disclosed herein. [Figure 16] 1A and 1B illustrate schematically one embodiment of a braided frame of a collapsible heart valve assembly disclosed herein. [Figure 17] 1A and 1B illustrate schematically one embodiment of a deployment system for the collapsible heart valve assembly system disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0011] Before the present systems and methods are disclosed and described, it is to be understood that the present systems and methods are not limited to particular methods, components, or implementations. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Various embodiments are described with reference to the drawings. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of one or more embodiments. It will be apparent, however, that various embodiments may be practiced without these specific details. In some instances, well-known structures and devices are shown in block diagram form to facilitate describing these embodiments.

[0012] Disclosed herein is a collapsible heart valve assembly system ("valve assembly") that includes at least a braided collapsible frame and leaflet assembly that together serve to provide a sealing portion. The valve assembly is delivered via a catheter and can function as either a stand-alone valve replacement or one placed into an existing recipient structure. The valve assembly can further include attachments and additional features for catheter delivery, positioning and partial deployment, and retrieval.

[0013] FIG. 1 schematically illustrates one embodiment of the collapsible heart valve assembly system disclosed herein. In a preferred embodiment, as shown in FIG. 1, the valve assembly 100 includes a tubular braided frame 110 and a leaflet assembly 120 integrated into the frame 110. The frame 110 may include one or more commissure posts 140. The commissure posts 140 may define attachment points for downstream portions of the leaflet assembly 120. In a preferred embodiment, the frame includes three commissure posts, although it is common for a frame to have two or four commissure posts. The commissure posts 140 need not be symmetrically positioned around the valve or be of the same height. Additionally, when compressed, the commissure posts elastically deform to accommodate the inflexible leaflet material without deformation.

[0014] The valve assembly 100 may further include one or more tabs 130, which are sewn to the commissure posts 140. The valve assembly 100 may also include base stitches 150 along the row of fixed intersections of the frame 110, which join the frame 110 to the leaflet assembly 120 circumferentially about a centerline 160 of the leaflet assembly. The base stitches 150 may be defined as the stitching line that delineates the inflow end of the functional valve assembly 100.

[0015] The valve assembly disclosed herein is novel and an improvement over the prior art because it combines a minimal braided wire structure with a novel leaflet assembly design, strategically integrating the two together to provide a valve that can be compressed to a much smaller size and lower profile than other existing percutaneously delivered valves. Additionally, the valve assembly design provides options for ease of removal, either via percutaneous or minimally invasive surgical techniques. Furthermore, the valve assembly can be delivered into a pre-placed receptacle, and the valve can have a minimal wire structure and attachment strategy combined with the leaflet assembly.

[0016] Advantages of the present disclosure over the prior art include, but are not limited to, the minimally invasive and less traumatic puncture required to accommodate valve delivery. Additionally, the strategic combination of valve geometry with the wire braid frame, leaflet assembly, and attachment strategy allows for a more flexible delivery system due to the flexible wire frame characteristics, the relatively short valve, and the delivery system features that allow for flexibility in the delivery catheter. The combination of these factors allows for less traumatic delivery, more precise delivery, and more options for delivery methods.

[0017] Additionally, a unique advantage of this valve assembly is that it can be removed via percutaneous or minimally invasive techniques. Current state-of-the-art implanted valves, if they malfunction or become ineffective, require extensive surgical removal or the implantation of a second valve into the malfunctioning valve. Both procedures have significant drawbacks. Extensive surgery is often avoided due to the patient's age or physical condition. And implanting a valve into an existing valve puts the newly implanted valve at risk, reducing options if it does not function as intended.

[0018] FIG. 2 schematically illustrates an embodiment of a tubular braided frame disclosed herein. A braided valve frame can be defined as a single-wire or multi-wire, braided, self-expanding frame that supports the leaflets and provides a seal. As shown in FIG. 2, a tubular frame 200 having a corresponding length, diameter, distal end, and proximal end includes one or more commissure posts 210 at the distal end and loops 220 at both the distal and proximal ends. The commissure posts 210 typically extend outward from the tubular frame 200 a minimal amount, e.g., 10% to 30% of the length of the frame 200. The loops 220 can be simple 300-360 degree loopbacks of the material comprising the frame 200, or can encompass more than 360 degrees, i.e., two revolutions of the frame material. The loops 220 provide a stable end for the frame 200, provide a means for looping sutures for the delivery mechanism, provide an attachment means for the leaflet structure 120, and reduce peak stress / strain at the turns. These features can be designed to strengthen or reduce radial forces in the system. Additionally, the loops 220 can be used to position radiopaque markers for visualization under fluoroscopy.

[0019] FIG. 3 schematically illustrates one embodiment of a tubular braid frame disclosed herein. As shown in FIG. 3, the braid frame 300 may vary in size. For example, the commissure posts 310 may extend further from the distal end of the frame 300. In this embodiment, the commissure posts 310 have loops 320 that are greater than 360 degrees, forming approximately two complete loops. A central portion 330 of the frame 300 body provides a rigid centerline between the distal and proximal ends of the frame 300, where a suture line can be created for sewing to the proximal end of the leaflet structure. This embodiment is braid fixation, defined as the suture line used to constrain movement of the braid intersections, and can be oriented horizontally and / or vertically. The proximal end of the frame 300 typically provides a structure for connecting the leaflet structure with a 360-degree suture line, which can be used to form a seal zone for valve function when the valve is inserted into a receptacle. The sealing zone generally refers to the area on the outside of the frame between the inflow stitch (see 540 disclosed below, which is generally parallel to the inflow side of the base stitch and serves to attach the leaflet assembly to the frame or cuff) and the base stitch (see 150 disclosed above), to provide a larger area over which sealing can occur. Sealing, such as by use of a sealing ring, refers to the prevention of blood flow from both sides while the leaflets provide flow control. This centerline is stable because as the braided structure stretches when compressed for delivery, the proximal and distal ends move away from each other equidistant from the center.

[0020] Figure 4 shows a schematic diagram of one embodiment of a tubular braided frame as disclosed herein. As shown in Figure 4, braided frame 400 can include commissure posts 410 and sealing zones 420, and braided frame 400 has a significantly reduced braided tube length compared to other embodiments disclosed herein, while still providing the minimum frame required for connection to the leaflet structure.

[0021] 5 shows a schematic representation of an embodiment of a leaflet panel disclosed herein. A leaflet panel can be defined as a pattern cut from synthetic or biological material that functions as a single leaflet. For example, excised porcine or bovine pericardium can be used for the leaflet panel. Two or more leaflet panels can be combined and attached to form a leaflet assembly, such as a Z-valve insert. As shown in FIG. 5, the leaflet panel 500 can have a distal end 510 that, when assembled into the finished valve, becomes the coaptation closure zone of the valve, where the three proximal ends are forced together in a Y-shape called a "co-apt" to close the valve. The outer edge 520 of the distal end 510 has tabs for sewing the leaflet to the commissure post. Towards the proximal end, a base stitch zone 530 is used by itself or in combination with an inflow stitch zone 540 to create the seal zone. The inflow stitch 540 is generally parallel to the base stitch and on the inflow side, and serves to attach the Z-valve insert to the frame or cuff. The material between the inflow and base stitches can be a continuous part of the Z-valve insert or a separate material sewn to the Z-valve insert.

[0022] The abdominal stitch is defined as a stitch that originates at the end seam of the Z-valve insert, defines the edge of the leaflet along a wire, and optionally attaches to one of the wires of the frame and / or cuff. The wire to which the abdominal stitch is attached can be configured to further improve the durability and performance of the leaflet. The cuff is defined as additional material placed on the outside or inside of the frame and can extend along the top and bottom of the frame, but is minimally attached above and below the base stitch. The abdominal stitch serves the purpose of improving the durability and hemodynamic performance of the leaflet. The valve abdominal stitch 550 is angled from the distal outer section toward the mid-center of the leaflet and, in one embodiment, can be sewn to either the braided frame or the outer cuff. The bellows portion 560 forms the bottom of the abdomen and may or may not be sewn to the frame. The bellows portion 560 of the abdominal stitch 550 is generally in the center of the leaflet and can be defined as an attachment interruption or a continuation of the abdominal stitch that functions to improve collapsibility.

[0023] FIG. 6 schematically illustrates one embodiment of a Z-valve insert disclosed herein. As shown in FIG. 6, the Z-valve insert 600 can include three leaflet panels, with the commissure edges 610 of each leaflet panel connected and sewn along the edges to form a tubular cylindrical structure. The edges can be parallel or angled to optimize durability and hemodynamic performance. The Z-valve insert 600 can also include some tubular section on the inflow side of the base stitch, created by overlapping the bottom tabs of the Z-valve insert 600. In one embodiment, the Z-valve insert 600 is attached to the commissure posts of the tubular frame via the base stitch. The base stitch can be located along the top, middle, or bottom of the tubular frame. In another embodiment, the base stitch line and the inflow stitch line can pass through the leaflets, braid, and cuff, and the area outside the valve frame between the base stitch and the inflow stitch creates a sealing zone.

[0024] Figures 7A through 7G schematically illustrate embodiments of patterns for leaflet panels. The embodiment of Figure 7A discloses a view of a leaflet assembly 500. Figure 7B discloses a pattern combining three separate leaflets. Figure 7C is a variation of the assembly showing straight edges that allow for the attachment of additional cuff material.

[0025] Figure 7D discloses a preferred embodiment of a valve leaflet pattern 750 having a cuff 755 at the proximal end. The cuff 755 can be wrapped over the proximal end of the frame to create an outer seal zone in addition to the inner seal zone. Figure 7E shows three leaflets combined and incorporating a cuff. Figure 7F discloses the combination of Figure 7E incorporating a larger cuff that can function to seal the complete outer frame along the length of the valve assembly. Figure 7G discloses an enlarged version of the combined three-piece leaflet.

[0026] Figure 8 shows a schematic diagram of one embodiment of a collapsible heart valve assembly system disclosed herein. The valve assembly in Figure 8 includes an expanded seal zone created by longer leaflets sewn to the structure at the centerline 160 and baseline stitches, and further sewn to the proximal braided end along the inflow stitch line 810.

[0027] FIG. 9 schematically illustrates one embodiment of a collapsible heart valve assembly system disclosed herein. As shown in FIG. 9 , the valve assembly 900 can include a tubular braided frame 110 and a leaflet structure 120 integrated into the frame 110, as well as a cuff 910 that covers a proximal portion of the valve assembly 900. The cuff 910 can be defined as a material attached to the frame 110; it can be located either on the outside or inside of the frame and can extend along the top and bottom of the frame, but is attached at least above and below the base stitches 920. In another embodiment, the cuff 900 can be attached parallel to the inflow stitch line 930. The cuff material can be 1) elastic and deform with the braid; 2) inelastic and allow the braided wire to slide in / around the attached cuff; or 3) a combination of both. The cuff can also be constructed of a polymer coating (e.g., Chronosil) or a continuous knitted, woven, or braided fabric. Additionally, the cuff can be rolled up in a seamed or tubular configuration.

[0028] In another embodiment, the continuous cuff can be sewn to the Z-valve insert at the baseline stitch location and wrapped around the inflow edge of the braided valve frame to form a cuff on the outside of the braided valve frame. Additionally, in another embodiment, the valve can have both an inner cuff and an outer cuff and / or a partial cuff that covers a discrete portion of the braided valve frame.

[0029] Generally, the cuff 910 is used to cover the wires of the frame 110 to provide a sealing zone; the sealing zone, or ring, is shaped to prevent blood flow from both sides while the leaflets provide flow control. The sealing zone may be constructed of either a flexible or non-flexible material. The cuff 910 also serves the purpose of attaching the Z-valve insert 120 to the frame 110. In a preferred embodiment, the cuff 910 is attached along the upper and lower edges of the frame 110 or along a row of crossing points. The cuff 910 can be attached to the frame 110 along all adjacent wires using stitching or the like that does not interfere with the movement of the braided crossing points.

[0030] FIG. 10A schematically illustrates one embodiment of a foldable heart valve assembly system disclosed herein. As shown in FIG. 10A , in one embodiment, the valve assembly 1010 includes a braided frame similar to that shown in FIG. 2 and a long outer cuff cover 1015. This cuff, covering the entire outer frame, can function as an extended sealing zone. The abdominal stitches 1020 can be sewn to the frame, while the abdominal stitches 1025 are not sewn to the frame. In this embodiment, the distal leaflet ends 1030 are shown coapted to close the valve in a loose Y-shape. In some embodiments, the valve coaptation area can include some "flaccidity" to ensure sufficient and effective contact between the three leaflets and ensure complete closure of the valve. The leaflets can be constructed of tissues such as porcine pericardium or other materials known in the art. In some cases, a valve, or portions thereof, excised from an animal can be sewn to the disclosed frame structure.

[0031] 10B is a schematic diagram of one embodiment of a collapsible heart valve assembly system disclosed herein. As shown in FIG. 10B, the valve assembly can include combined commissure posts and leaflet tabs 1040, leaflet edges, a coaptation zone 1030, abdominal stitches 1020, bellows stitches 1025, base stitches 1045, and inflow stitches 1050.

[0032] FIG. 11 schematically illustrates one embodiment of a delivery system for the collapsible heart valve assembly disclosed herein. Preferably, it is a proximal or inflow delivery system. As shown in FIG. 11, the delivery system can include a compressed valve 1110 and a loop 1120 slidably held by a suture line 1130. The suture line 1130 follows a path through a bushing 1140 incorporated into a delivery catheter 1150. The suture line 1130 can control the expansion and retention of the valve assembly as desired.

[0033] FIG. 12 schematically illustrates one embodiment of the delivery system described in FIG. 11 for a collapsible heart valve assembly disclosed herein. As shown in FIG. 12, each loop 1220 has a suture 1230 threaded therethrough, which exits and returns to a bushing 1240 on the manifold 1210. The pattern of suture 1230 alternates between starting at the bushing on the opposite side of the loop, passing through the loop, and then returning to the bushing, so that the suture generates tension with a vector through the centerline. This has the advantage of avoiding a tube running through the center of the delivery catheter while providing the aforementioned centerline tension vector for each frame loop. This pattern also has the advantage of providing tension that contracts the loop and keeps it as close to the center as possible. Each suture has an end that is fixed relative to the delivery catheter and an opposite end that, when properly configured, can be pulled or released in cooperation with the remaining sutures to precisely control valve expansion. When the valve is released, the sutures can be cut / released and withdrawn. This mechanism can be used to preferentially control the expansion of the proximal valve, but can also be used to control the distal valve.

[0034] FIG. 13 schematically illustrates one embodiment of a delivery system for a collapsible heart valve assembly disclosed herein. As shown in FIG. 13 , a delivery system 1300 for distal valve control can include a distal valve loop 1310 slidably connected to a short suture 1320. The suture 1320 passes through a funnel-shaped bushing 1330, is guided through a channel 1340 in a threaded rod 1350, and terminates in a loop 1360 on a wire 1370 slidably held within a distal tip 1380. The wire 1370 is accessible at the proximal end of the delivery system. A knob 1390 is turned to push the bushing 1330 and pull the loop 1310 into a compressed position prior to delivery. The valve is released by pulling the wire 1370 to release one end of the suture 1320.

[0035] FIG. 14 schematically illustrates one embodiment of a delivery system for a collapsible heart valve assembly disclosed herein. It shows a distal cutaway side view 1400 and a distal exterior view 1495 of the combined assembly described in FIGS. 11-13 along with additional structure. FIG. 14 shows a valve 1410 in a compressed configuration with a proximal release mechanism manifold 1420. The manifold 1420 can abut against a bearing 1430, which allows for some angular articulation between the manifold 1420 and, optionally, another bushing 1440. These bushings can provide some angular articulation while allowing for the passage of sutures and a central tube. The distal valve release mechanism includes a funnel-shaped bushing 1450, a knob 1460, a threaded rod 1470, and a distal tip 1480. Also shown is an outer sheath 1485 that is pressed onto the assembly prior to delivery to ensure complete compression and a smooth outer surface of the valve for insertion into the body. The sheath can then be pulled back proximally from outside the body to expose the valve and release mechanism. The angled articulation zone is indicated by point 1490, where the structural design allows for some flexibility. In some embodiments, the sheath 1485 can be configured as a jacket with a separable seam running parallel to the central axis of the sheath 1485, the seam connected to a pull wire such that when the wire is pulled proximally from a location outside the body, the seam separates, such that release of the jacket seam allows for expansion of the valve.

[0036] FIG. 15 schematically illustrates one embodiment of a retrieval system for a collapsible heart valve assembly disclosed herein. FIG. 15 discloses an embodiment of a retrieval system 1500 for retrieving the valve from the cardiac structures and recipient after delivery. The retrieval system 1500 can include a string 1510 that can be permanently incorporated into a loop 1520 of a braided frame. In some embodiments, the string 1510 can be constructed of a radiopaque material for visualization under fluoroscopy. The string 1510 can then be captured by one or more retrieval hooks on the catheter, which can be retracted into the catheter or a specially designed retrieval tool. Tension in the string 1510 and hooks can partially compress the valve and separate it from the recipient.

[0037] FIG. 16 schematically illustrates one embodiment of a braided frame of the foldable heart valve assembly system disclosed herein. FIG. 16 discloses a braided frame 1600 with additional features, such as commissures 1610 with wire coils 1620 and 1630 having axes parallel to the tangent of the frame circumference. The coils 1620 and 1630 can act as springs to increase the strength of the commissures 1610, which in turn provides resistance to flow forces during valve closure. The coils can be designed using parameters to optimize valve performance, such as wire diameter, loop coil diameter, and number of coil turns. Additionally, the coils 1620 and 1630 can include modifications designed to create latches for removably joining the frame to a receiver. The round nature of the coils creates a spring-like latch for engaging a receiving geometry, such as a cylindrical or custom asymmetric shape. The expansion latch feature of the coil 1630 can be used in conjunction with the string 1510 to pull the latch coil 1630 towards the center of the valve axis, bending the latch coil 1630 and releasing it from the receiver.

[0038] FIG. 17 schematically illustrates one embodiment of a deployment system for the collapsible heart valve assembly system disclosed herein. As shown in FIG. 17, several methods are available for deploying the components of a replacement heart valve system into a desired target intracardiac structure. FIG. 17 depicts at least three different routes suitable for delivering components to a mitral valve structure. A "transapical" approach involves inserting a guide catheter 1710 into a vein at the groin 1720 and through the atrial septum to the mitral valve. A "transaortic" approach involves inserting a guide catheter 1710 into an artery at the groin 1730 and through the aortic valve to the mitral valve. An alternative "transapical" approach 1740 involves surgically exposing the heart and inserting the guide catheter 1710 into the apex of the target heart. Additionally, methods for delivering a heart valve assembly system can include the use of a guidewire 1750, over which the heart valve assembly system is inserted into a vein.

[0039] Other embodiments may include combinations and subcombinations of the features described or illustrated in the several figures, including embodiments corresponding to, for example, providing or applying features in an order different from that of the described embodiment, taking individual features from one embodiment and incorporating such features into another embodiment, removing one or more features from an embodiment, or removing one or more features from an embodiment while adding one or more features taken from one or more other embodiments, while still achieving the benefits of the features incorporated in such combinations and subcombinations. As used in this paragraph, "feature" or "features" may refer to the structure and / or function of an apparatus, an article of manufacture or system, and / or a method step, implementation, or method manner.

[0040] References throughout this specification to "one embodiment," "an embodiment," "exemplary embodiment," etc., indicate that the described embodiment may have particular features, structures, or characteristics, but that not all embodiments necessarily include these particular features, structures, or characteristics. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described with respect to one embodiment, it will be within the knowledge of one of ordinary skill in the art that this description affects such feature, structure, or characteristic with respect to other embodiments, whether or not explicitly described.

[0041] Unless the context clearly indicates otherwise, (1) the word "and" indicates a conjunctive meaning, (2) the word "or" indicates a disjunctive meaning, (3) when articles are presented disjunctively and are followed by the words "or both," both conjunctive and disjunctive meanings are intended, and (4) the word "and" or "or" between the last two items in a series applies to all items in the series.

[0042] When a group is designated by the term "one or more," followed by a plural noun, further use of any of that noun to refer to one or more members of the group shall refer to both the singular and the plural of that noun. For example, a group designated as having "one or more members," followed by a description of "members" of the group, shall mean "that member" if there is only one member in the group.

[0043] Non-plural nouns refer to either singular or plural. Thus, singular nouns, non-plural nouns, and nouns with at least one can be used interchangeably herein. It should also be noted that the terms "comprise," "include," and "have" can be used interchangeably.

Claims

1. 1. A replacement heart valve system comprising: a replacement heart valve having a tubular braided frame and a leaflet assembly; the tubular braided frame having an inflow end, an outflow end, a plurality of unconstrained braid crossing points, and a plurality of loops provided at one or both of the inflow end and the outflow end; the plurality of loops having at least one 360-degree turn that strengthens or weakens the radial force of the braiding frame; the leaflet assembly is connected to one or more of the loops; The system further includes a delivery system having one or more suture lines passing through the plurality of loops.

1. A replacement heart valve system comprising:

2. the tubular braided frame is a braid of one or more nitinol wires; 10. The replacement heart valve system of claim 1.

3. the one or more suture lines are connected to a knob; 3. The replacement heart valve system of claim 2.

4. the knob controls movement of the one or more suture lines and the one or more loops.

4. The replacement heart valve system of claim 3.

5. the one or more suture lines alternate in a direction through the plurality of loops, and the one or more suture lines create tension in the plurality of loops; The system of claim 2 .

6. and a retrieval system, the retrieval system comprising a string embedded in the one or more loops. The system of claim 2 .

7. The leaflet assembly includes three valve leaflets connected to form a Y-shape. The system of claim 2 .

8. the leaflet assembly is sewn to the tubular braided frame with a belly stitch that is angled from a distal outer portion of the leaflet assembly toward a medial portion of the leaflet assembly. The system of claim 2 .

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