Coiled anchors for supporting prosthetic heart valves, prosthetic heart valves, and deployment devices

Abstract

The present invention is entitled "A Swiveled Anchor for Supporting an Artificial Heart Valve, an Artificial Heart Valve, and a Deployment Device." A swiveled anchor for docking a mitral valve prosthesis to the native mitral valve of the heart has a first end, a second end, and a central axis extending between the first and second ends, defining an internal space coaxial with the central axis. The swiveled anchor includes a swiveled core and a covering layer surrounding the core. The swiveled core comprises a biocompatible metal or metal alloy and has a plurality of rotating portions extending about the central axis in a first position. The covering layer comprises a biocompatible material that is less rigid than the metal or metal alloy of the swiveled core.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 202210750685.6, filed on June 28, 2022, entitled “A spiral anchor for supporting an artificial heart valve, an artificial heart valve, and a deployment device.” Chinese Patent Application No. 202210750685.6 is a divisional application of Chinese Patent Application No. 201910972652.4, filed on October 14, 2019, which in turn is a divisional application of Chinese Patent Application No. 2015800097315 (PCT / US2015 / 016898), filed on February 20, 2015. Technical Field

[0002] This invention generally relates to medical devices and procedures concerning artificial heart valves. More specifically, the invention relates to the replacement of heart valves that may have malformations and / or functional disorders. Embodiments of the invention relate to artificial heart valves for replacing the mitral valve in the heart, anchors that facilitate and maintain the positioning of the artificial heart valve within the native valve, and deployment devices and procedures associated with the implantation of artificial heart valves. Background Technology

[0003] First, the overall reference Figure 1 and Figure 2 The mitral valve controls the flow of blood between the left atrium and left ventricle of the heart. After the left atrium receives oxygenated blood from the lungs via the pulmonary veins, the mitral valve allows this oxygenated blood to flow from the left atrium into the left ventricle. When the left ventricle contracts, the oxygenated blood contained within it is delivered through the aortic valves and the aorta to the rest of the body. Simultaneously, the mitral valve closes during ventricular contraction to prevent blood from flowing back into the left atrium.

[0004] When the left ventricle contracts, the blood pressure in the left ventricle increases sufficiently to force the mitral valve to close. Due to the large pressure difference between the left ventricle and left atrium during ventricular systole, there is a possibility that the leaflets of the mitral valve may prolapse or evert back into the atrium. To prevent this, a series of chordae tendineae connect the mitral valve to the papillary muscles along the opposite wall of the left ventricle. Figure 1 Heart cross-section and Figure 2 The top view of the mitral valve schematically illustrates the chordae tendineae. Just before and during ventricular systole, the papillary muscles also contract and maintain tension in the chordae tendineae to keep the leaflets of the mitral valve in the closed position and prevent them from flipping inward and back into the atria, thereby also preventing the backflow of oxygenated blood into the atria.

[0005] exist Figure 2The diagram illustrates the overall shape of the mitral valve and its leaflets as seen from the left atrium. Complications of the mitral valve can potentially lead to fatal heart failure. One form of valvular heart disease is mitral leakage, also known as mitral regurgitation, characterized by the abnormal leakage of blood from the left ventricle through the mitral valve and back into the left atrium. In these cases, it may be desirable to repair the mitral valve or replace its function with that of an artificial heart valve.

[0006] In this respect, mitral valve repair has become more popular than valve replacement, where previous research and development have been limited. Few, if any, effective commercial methods exist for mitral valve replacement via catheter implantation and / or other minimally invasive or non-invasive procedures. In contrast, the field of transcatheter aortic valve replacement has been developed and has achieved widespread success. This difference stems from the fact that mitral valve replacement is more difficult than aortic valve replacement in many ways, for example, due to the physical structure of the valve and the more difficult access to it.

[0007] Because the valve is subjected to large cyclical loads, the most prominent challenge in mitral valve replacement is anchoring or holding the valve in its proper position. Especially during ventricular systole, the combination of cardiac motion and load on the valve can cause the prosthesis to drift or displace. Furthermore, kinetic and rhythmic loads can fatigue the material, leading to rupture of the implanted valve. If the orientation of the mitral valve prosthesis inadvertently drifts, blood flow between the left atrium and left ventricle can be obstructed or negatively affected. While puncturing the tissue in or around the mitral annulus to better anchor the implanted valve is an option for maintaining implant placement, this potentially leads to accidental cardiac perforation and patient injury.

[0008] Return to reference Figure 2 Another issue with mitral valve replacement is the size and shape of the native mitral valve. The aortic valve is more rounded in shape than the mitral valve. Furthermore, in many cases, the need for aortic valve replacement arises due to aortic stenosis, for example, when the aortic valve is narrowed due to causes such as calcification and / or hardening of the aortic valve leaflets. Therefore, the aortic annulus itself generally forms a more stable anchoring site for the artificial valve compared to the relatively large and non-circular mitral annulus. Thus, if a good seal is not established around the valve, a mitral valve implant that is too small and round can cause perivalvular leakage (i.e., perivalvular leakage). Conversely, a mitral valve implant that is too large and round may stretch and damage the annulus. The external shape of the valve implant can also potentially be manipulated to better fit the mitral annulus, for example, by adding a fabric sheath to the outer surface of the implant. However, these additions can limit valve delivery via catheters and / or minimally invasive procedures, as the additional fabric may be difficult to compress and deliver through a catheter. Summary of the Invention

[0009] Because many valves have been developed for the aortic location, it will be desirable to utilize these existing valve technologies and use the same or similar valves in mitral valve replacement. Therefore, it would be useful to create mitral valve anchors or docking stations for these previously existing artificial valves. An existing valve, perhaps with some modifications for the aortic location, can then be implanted into such anchors or docking stations. Some previously developed valves, such as the Edwards Lifesciences Sapien™ valve, can fit well with little or no modification.

[0010] Therefore, it is desirable to provide devices and methods that can be used in various implantation methods to facilitate docking or anchoring of such valves. Embodiments of the present invention provide a stable docking station for maintaining a mitral valve replacement prosthesis. Other devices and methods are provided to improve, for example, the positioning and deployment of such docking stations and / or replacement prostheses therein during various non-invasive or minimally invasive procedures. These devices and methods can also be used to prevent or significantly reduce backflow or leakage of blood around the replacement prosthesis, such as leakage through the commissure of the native mitral valve outside the prosthesis.

[0011] Features of the present invention relate to docking or anchoring devices for more effectively anchoring a replacement valve prosthesis in the mitral valve annulus. Other features of the present invention relate to replacement valve prostheses that interact more effectively with the anchoring device according to embodiments of the invention and with the peripheral portion of the native mitral valve and other parts of the heart. Further features of the present invention relate to docking or anchoring devices and methods for more effectively deploying different portions of the anchoring device above and below the native mitral valve annulus (i.e., deploying individual portions of the anchoring device into the left atrium and left ventricle, respectively). Further features of the present invention relate to gathering or holding the chordae tendineae together during deployment of the docking or anchoring device to more easily position the docking or anchoring device around the native valve leaflet and chordae tendineae.

[0012] In an embodiment of the invention, a coiled anchor for fitting a mitral valve prosthesis to the native mitral valve of the heart has a first end, a second end, a central axis extending between the first and second ends, and defines an internal space coaxial with the central axis. The coiled anchor includes a coiled core and a covering layer surrounding the core. The coiled core comprises a biocompatible metal or metal alloy and has a plurality of rotating portions extending about the central axis in a first position. The covering layer comprises a biocompatible material that is less rigid than the metal or metal alloy of the coiled core. The coiled anchor is adjustable from the first position to a second position, in which at least one of the plurality of rotating portions is straightened so that the coiled anchor is delivered to the native mitral valve via a catheter, and is adjustable back from the second position to the first position. The coiled anchor can be implanted at the native mitral valve, wherein at least a portion on one side of the native mitral valve is in the left atrium of the heart and at least a portion on the opposite side of the native mitral valve is in the left ventricle of the heart, so as to support or retain the mitral valve prosthesis in the internal space when the coiled anchor is implanted at the native mitral valve.

[0013] In another embodiment, the coiled anchor can be included in a system for implantation at the mitral valve, wherein the system can further include a mitral valve prosthesis comprising an expandable frame and housing a plurality of leaflets for controlling blood flow therethrough, wherein the frame expands from a constricted first position to an expanded second position, in the constricted first position having a first outer diameter for delivering the mitral valve prosthesis through a catheter, and in the expanded second position having a second outer diameter larger than the first outer diameter. When the coiled anchor and the mitral valve prosthesis are not biased, the minimum inner diameter of the internal space defined by the coiled anchor can be smaller than the second outer diameter of the mitral valve prosthesis.

[0014] In another embodiment, a coiled anchor for docking a mitral valve prosthesis to the native mitral valve of the heart has a first end, a second end, a central axis extending between the first and second ends, and defines an internal space coaxial with the central axis. The coiled anchor includes: a first coil having a plurality of rotating portions in a first circumferential direction and extending from the first end to the second end; a second coil having a plurality of rotating portions in a second circumferential direction opposite to the first circumferential direction and extending from the first end to the second end; and a connector configured to hold the first ends of the first coil and the second coil together such that both the first and second coils are away from the connector and extend from each other along the central axis. The coiled anchor has a first position in which the respective rotating portions of the first and second coils extend about the central axis. The coiled anchor is adjustable from the first position to a second position in which at least one of the plurality of rotating portions of the first or second coil is straightened so that the coiled anchor is delivered to the native mitral valve via a catheter, and is adjustable from the second position back to the first position. The coiled anchor can be implanted at the native mitral valve, wherein at least a portion of a first coil on one side of the native mitral valve is in the left atrium of the heart and at least a portion of a second coil on the opposite side of the native mitral valve is in the left ventricle of the heart, so as to support or retain the mitral valve prosthesis in the internal space when the coiled anchor is implanted at the native mitral valve.

[0015] In another embodiment, a method for delivering a coiled anchor configured to dock a mitral valve prosthesis to the native mitral valve of the heart includes: positioning a catheter for delivering the coiled anchor at the native mitral valve; positioning a ring around the chordae tendineae; closing the ring to pull the chordae tendineae together; pushing the coiled anchor out of the catheter and advancing it around the chordae tendineae; and removing the ring and the catheter.

[0016] According to embodiments of the present invention, mitral valve replacement can be achieved through a variety of different implantation methods. Therefore, embodiments of the present invention provide flexibility in different approaches and options for implanting a replacement mitral valve. Attached Figure Description

[0017] Further features and advantages of the invention will become apparent from the description of the embodiments with reference to the accompanying drawings. In the drawings: Figure 1 A schematic cross-sectional view of the human heart is shown; Figure 2 A schematic top view of the mitral valve annulus of the heart is shown; Figures 3A to 3E Various views of the coil anchor according to an embodiment of the present invention are shown; Figure 4A and Figure 4BThese are corresponding images of the uncovered coil and the covered coil according to embodiments of the present invention; Figures 5A to 5F The process of deploying a helical coil anchor via a apex procedure according to an embodiment of the present invention is illustrated; Figures 6A to 6D The process of deploying a helical coil anchor via a mid-spacing procedure according to another embodiment of the invention is shown; Figure 7A and Figure 7B A side sectional view of a helical coil anchor deployed in the mitral valve position with and without an implanted valve prosthesis, according to an embodiment of the present invention, is shown. Figure 8A and Figure 8B A schematic perspective view of an exemplary transcatheter valve prosthesis according to an embodiment of the present invention and a cross-section of a portion of the valve prosthesis are shown respectively; Figure 9A and Figure 9B The diagrams show a valve prosthesis held in a spiral coil according to an embodiment of the present invention and the opening of the frame of the valve prosthesis according to an embodiment of the present invention, respectively. Figure 10A and Figure 10B These are corresponding images illustrating the opening effect of a valve prosthesis according to an embodiment of the present invention; Figure 11A and Figure 11B This is a schematic image showing a sleeve or protective layer added to a valve prosthesis according to other embodiments of the present invention; Figure 12 A perspective view of a helical coil anchor according to another embodiment of the present invention is shown; Figure 13A and Figure 13B The images show the locations where the device is being deployed at the mitral valve. Figure 12 The helical coil anchor and in its final deployment location Figure 12 Helical coil anchors; and Figure 14 A modified deployment system according to another embodiment of the present invention is shown. Detailed Implementation

[0018] The helical anchorage according to an embodiment of the present invention is constructed as follows: Figures 3A to 3E What we see there. Figure 3A A perspective view of the helical anchor 72 is shown. Figure 3B A side view of anchor 72 is shown, and Figure 3CA top view of the anchor 72 is shown. The helical anchor 72 includes a coil having a plurality of turns extending along the central axis of the anchor. The anchor 72 has a series of lower turns or coils 82 and a series of upper turns or coils 84. The individual turns of the lower coils 82 are spaced apart from each other with small gaps. Meanwhile, the individual turns of the upper coils 84 are wound more closely together. Furthermore, the turns of the lower coils 82 have a larger radius of curvature than the turns of the upper coils 84, and thus form a larger internal annular space. These features will be discussed in more detail below regarding the implantation of the anchor 72 at the native mitral valve. In other embodiments, the characteristics and differences between the lower coils 82 and the upper coils 84 of the anchor 72 can be arranged differently based on, for example, the patient's anatomy.

[0019] If possible Figure 3C Most clearly visible is that the anchor 72 is wound or twisted around its central axis to provide a generally circular or cylindrical space therein, which is larger than the space in the center of the anchor 72. Figure 2 The non-circular shape of the original mitral valve annulus seen in the study makes it easier to maintain and anchor a circular valve prosthesis. Therefore, if it is possible to Figure 3D As seen in the image, when the helical anchor 72 is positioned around the mitral valve 44, the helical anchor 72 provides a more robust and structurally stable docking station or site for docking or coupling the valve prosthesis to the native mitral valve annulus. A portion of the anchor 72 passes through the commissure 80 of the mitral valve 44 (as seen in the image). Figure 3D (As seen in the diagram, the process of which will be discussed in more detail below) allows for the placement of the anchor 72 above and below the mitral valve annulus to more securely anchor the valve prosthesis therein. Furthermore, the minimum internal space defined by the coil of the anchor 72 can be too small relative to the expanded diameter of the valve prosthesis, such that radial pressure is generated between the anchor 72 and the valve prosthesis when the prosthesis is expanded therein.

[0020] In one embodiment, the core 180 of the helical coil 72 is made of or comprises a shape memory material (such as nitinol). However, in other embodiments, the core 180 of the helical coil 72 can be made of or comprise other biocompatible materials (e.g., other alloys, or metals such as titanium or stainless steel). In some embodiments, the coil can have enlarged and / or rounded ends, for example, to prevent the tips at the ends of the coil 72 from damaging surrounding tissue during deployment. Figure 3A , Figure 3B and Figure 3E The best view in the middle, Figure 3EThe illustration shows a cross-section of a portion of a spiral coil 72, the core 180 of which is covered or surrounded by a foam layer 182 and a fabric cover 184. In the illustrated embodiment, the foam layer 182 is a Biomerix foam layer (e.g., a 2 mm thick layer of polyurethane sheet material), and the fabric cover 184 is made of or comprises a polymer material. In the illustrated embodiment, the respective ends of the foam layer 182 and the fabric cover 184 meet circumferentially around the coil core 180 at substantially the same location. However, in other embodiments, the foam layer 182 and the fabric cover 184 enclose the coil core 180 and are attached at different circumferential points around the coil core 180. Layers 182 and 184 can be attached together to the coil core 180 or can be attached separately to the coil core 180.

[0021] More specifically, in some embodiments, the fabric or cloth covering 184 covering the spiral coil is, for example, a polyethylene terephthalate (PET) polymer material. The fabric can have a thickness of 0.008 ± 0.002 inches and can have, for example, a density of 2.12 ± 0.18 oz / yd. 2 The density characteristics are 40 ± 5 rows per inch and 90 ± 10 rows per inch. The fabric layer can be further cut to a length or width of approximately 13 + 1 / - 0.5 inches to substantially cover the entire length of the spiral coil 72.

[0022] In some embodiments, the foam layer 182 can be cut to 19 mm × 5 mm, and the fabric cover 184 can be cut to 19 mm × 6 mm. However, other sizes of the individual layers 182, 184 can also be used, depending on, for example, the size of the spiral coil, the thickness of the respective layers, and the amount each layer is intended to cover the core 180. In some embodiments, the foam layer 182 can be attached to the fabric cover 184 with a small number of straight stitches using, for example, 22 mm polytetrafluoroethylene (PTFE) thread. The foam layer 182 and / or the fabric cover 184 can be folded around the coil core 180 and cross-stitched to the core 180 using, for example, 45 mm fiber thread. However, the invention should not be limited to these attachment properties, and any of other suture sizes and / or types, or various other attachment means or methods for effectively attaching the foam layer 182 and / or fabric cover 184 to the coil core 180, can also be used and implemented. For example, in some embodiments, the core can be a modified core having through holes, notches, or other features that can be laser-cut or otherwise formed along the core. Such features in the core can be used to interact with the sutures, increase friction, or otherwise help hold the cover layer or multiple cover layers against the core, and prevent or limit slippage or other relative movement between the cover layer and the core. In some embodiments, the core can also be formed with a non-circular cross-section to increase the contact area between the core and the cover layer. For example, a flat wire coil can be used to form the core. Furthermore, various biocompatible adhesives or other materials can be applied between the core and the cover layer to more firmly hold the cover layer in position relative to the core. In some embodiments, hydrogels or other materials that expand upon contact with blood can be applied as gap fillers between the core and the cover layer to create a stronger seal or interference fit between the core and the cover layer.

[0023] Figure 4A The core of one embodiment of the helical anchor fastener is shown before foam and / or fabric covering is applied thereon, and Figure 4B It shows having with respect to Figures 3A to 3E The description is similar to that of a helical anchor covered with a foam layer and a fabric layer. The foam and / or fabric layers are biocompatible and are generally used to promote inward growth of surrounding tissue around and into the anchor to further secure the anchor around the mitral valve annulus after the anchor and valve have been implanted. While in the above embodiments both the foam layer and the fabric layer are applied to the alloy core of the helical anchor, in other embodiments only the foam layer is applied to the core of the anchor, and in other embodiments only the fabric layer is applied to the core of the anchor.

[0024] According to embodiments of the invention, mitral valve replacement can be performed in a variety of different ways. In a catheter-based procedure, an anchorage or docking station as described above and / or an artificial valve (which may initially be radially compressed or crumpled) to be positioned in the anchorage can be delivered to the implantation site via a blood vessel. This can be achieved, for example, via arteries or veins connected to the chambers of the heart. In an exemplary embodiment (as will be shown in...), Figures 6A to 6D (As seen in the image), the catheter can be delivered into the right atrium via the inferior vena cava and then to the left atrium above the mitral valve via transseptal puncture.

[0025] In some cases, mitral valve replacement may not be performed percutaneously via distal arteries and / or veins, and may require a more open procedure. In these cases, for example, a physician may be able to make a small chest incision (open chest) to access the heart and then place a catheter-based delivery device and / or implant directly into the heart.

[0026] Now refer to Figures 5A to 5F The embodiment illustrates a transapical procedure for positioning a wound or helical anchor in the mitral valve position of a patient's heart. In this example, the anchor is delivered from the apex and through the left ventricle to the mitral valve position. Figure 5A An introducer 2 is shown inserted into the left ventricle 10 of the patient's heart 14 through an incision at the apex 6. To prevent blood leakage through the apex 6, a purse-string suture can be tightened around the introducer 2, or, among other options, a closure device can be used. A guidewire 30 is advanced from the introducer 2 through the left ventricle 10, past the papillary muscles 56, 60 and chordae tendineae 48, and between the anterior leaflet 38 and posterior leaflet 42 of the native mitral valve 44, such that a portion of the guidewire 30 is positioned in the left atrium 46.

[0027] As in Figure 5B As shown, the delivery catheter 64 is then introduced into the left atrium 46 via the guidewire 30. The delivery catheter 64 facilitates the subsequent introduction of a coil-guided catheter 68, which has a pre-formed curved shape designed to aid in the introduction of the coiled or helical anchor 72. The coil-guided catheter 68 is straightened for introduction through the delivery catheter 64, which, in contrast, can be generally straight and can be made of a stiffer material than the coil-guided catheter 68. Thus, upon exiting the delivery catheter 64, the distal end of the coil-guided catheter can deflect or return to its original pre-formed curved shape to aid in the proper introduction and positioning of the helical anchor 72. The guidewire 30 can be retracted and removed during the deployment and positioning of the coil-guided catheter 68, prior to the delivery of the helical anchor 72.

[0028] In other embodiments, the coil-guided catheter 68 can be introduced into the heart as a relatively straight element and can then be manipulated to present a desired curved shape.

[0029] As in Figure 5C As shown, in the initial coil delivery position, the delivery catheter 64 has been removed, and the distal end of the coil-guided catheter 68 is positioned in the left atrium 46, near one of the mitral commissures 80, where the anterior mitral leaflet 38 meets the posterior mitral leaflet 42 near the periphery of the mitral valve 44. In other embodiments, the distal end of the coil-guided catheter can alternatively be positioned in the left ventricle 10, near the mitral valve. Figure 5C In the image, the distal end of the lower coil 82 of the helical anchor 72 can be seen extending from the distal end of the coil guide catheter 68 and returning to the left ventricle 10 through the mitral valve. The end of the anchor 72 may have a slightly downward-facing rotation or bend to facilitate posterior insertion and advancement of the end at the mitral valve 44 junction 80.

[0030] The helical anchor 72 is then further advanced by being pushed through the coil guide tube 68. Figure 5D A helical anchor 72 is shown being advanced and wound beneath or around the leaflets 38, 42 of the mitral valve 44. The helical anchor 72 is guided to travel entirely around the leaflets 38, 42 and chordae tendineae 48 of the mitral valve 44. The lower coil 82 of the anchor 72 can therefore be made slightly larger to facilitate easier gathering or guidance of the anchor 72 around the leaflets 38, 42 and chordae tendineae 48 during anchor deployment. Furthermore, the rotating portions of the lower coils 82 can be slightly spaced apart to facilitate easier advancement of the coils 82 through the native valve 44 at the junction 80. Meanwhile, smaller coils (such as those of the upper coil 84) can help to hold the valve prosthesis more securely or tightly.

[0031] After the lower coil 82 of the anchor 72 has been placed below the mitral annulus, as in Figure 5E As seen in the diagram, the upper coil 84 of the anchor 72 is then deployed from the coil guide catheter 68. In some embodiments, after the lower coil 82 has been advanced to the desired position below the mitral annulus, it may not be desirable to further push or advance the coil 72 in order to maintain or preserve the orientation and positioning of the lower coil 82 in the left ventricle 10. Therefore, the upper coil 84 of the anchor 72 can be deployed by rotating the coil guide catheter 68 backward (as by... Figure 5E The coil anchor 72 (as indicated by the arrow at the bottom) is deployed in the left atrium 46 to expose and deploy more coil anchors 72 from within the catheter 68. Other embodiments deploy and position the upper coil 82 of the anchor 72 in various different ways.

[0032] After the helical anchor 72 is fully implanted, the coil guide tube 68 is removed, if it is possible to Figure 5F Seen in the middle. Although Figure 5F The deployed anchor has approximately three coils positioned above the mitral valve 44 and two coils positioned below the mitral valve 44, but other embodiments can have different arrangements and coil positioning depending on the specific application.

[0033] It should also be noted that once the helical anchor 72 is inserted and positioned as described above and prior to the implantation of the prosthetic valve, the native mitral valve 44 continues to function substantially normally, and the patient remains stable. Therefore, the procedure can be performed on a beating heart without the need for a cardiopulmonary bypass machine. Furthermore, this allows physicians greater flexibility in timing the implantation of the valve prosthesis within the anchor 72 without the risk of hemodynamic impairment if too much time is spent between anchor and valve implantation.

[0034] Figures 6A to 6D An alternative procedure for positioning a helical anchor at the mitral valve location in a patient's heart is illustrated. In this example, the anchor 330 is delivered to the mitral valve location through the atrial septum of the heart. In one example procedure, a catheter 332 is introduced into the patient's venous system via percutaneous puncture or through a small surgical incision, such as in the patient's groin. Alternative entry sites can also be used.

[0035] As in Figure 6A As shown, catheter 332 is advanced along the inferior vena cava 212, enters the right atrium 210, crosses the interatrial septum 304, and enters the left atrium 46. Then, in Figure 6B In the middle, the coil-guided conduit 340 is deployed from the distal end of the conduit 332, and in conjunction with... Figures 5A-5F The same extension seen in the embodiment extends into the left atrium 46 near the commissure 80 of the mitral valve 44. The anchor 330 exits from the tip of the coil guide catheter 340 and is advanced below the mitral valve 44 at the commissure 80.

[0036] After the lower coil of the anchor 330 has been positioned in the desired orientation below the mitral valve 44, the upper coil of the anchor 330 can then be deployed from the coil guide conduit 340, for example, by rotating the coil guide conduit 340 in the opposite direction of the advancement of the anchor 330, as in Figure 6C As shown in the diagram. After the helical anchor 330 is inserted and placed in the desired position, the coil guide conduit 340 is removed, as shown in... Figure 6D What I saw in the middle.

[0037] Figure 7AA side sectional view of the helical anchor 72, which has been implanted in the mitral valve location of the patient's heart, is shown. Figure 7B A side sectional view is shown of a helical anchor 72 in which a valve prosthesis 120 is retained. Variations in orientation, shape, and size between the different coils of the anchors 72, other than those illustrated, may also be employed for various reasons, such as to cause the ends of the anchors 72 to press against the ventricular and / or atrial walls in order to better maintain the position of the helical anchors 72.

[0038] exist Figure 7B In this configuration, the valve prosthesis 120 is held in the mitral valve position by a helical anchor 72. The valve prosthesis 120 is preferably a modified or unmodified transcatheter heart valve, such as, for example, the Edwards Lifesciences Sapien™ valve. Generally, the valve prosthesis 120 will include an expandable frame structure 126 that accommodates multiple valve leaflets 122, 124. The expandable frame 126 can be self-expanding or balloon-expandable, and can be introduced via the same introducer and / or catheter used for introducing the anchor 72, or via a separate catheter.

[0039] In embodiments of the invention, the folded valve prosthesis 120 is first positioned in the central channel or the internal space defined by the anchor 72, and then expanded to abut against and rest within the anchor 72. In these embodiments, at least a portion of the leaflet tissue 38, 42 of the mitral valve 44 is secured or clamped between the anchor 72 and the valve prosthesis 120 to lock the anchor 72 and the valve prosthesis 120 in place and prevent them from drifting or displacing. The tissue of the leaflets 38, 42 also creates a natural seal to prevent blood flow between the valve prosthesis 120 and the helical anchor 72. As discussed above, in some embodiments, the minimum inner diameter defined by the coil of the anchor 72 is smaller than the diameter of the valve prosthesis 120 after it has been expanded, such that radial resistance is formed between the anchor 72 and the valve prosthesis 120, which further secures the parts together. Pressure between the anchor 72 and the valve prosthesis 120 can occur above or below the mitral valve 44, or both above and below. Due to the pressure formed between the leaflets 38 and 42 of the anchor 72, valve prosthesis 120, and the anchor 72, additional sutures or attachments are generally not required between the valve prosthesis 120 and the anchor 72 or adjacent cardiac tissue. Due to the different materials used for the anchor 72 and the prosthesis 120, circumferential friction is also generated between the parts of the anchor 72 and the prosthesis 120 that are in contact with each other, thereby limiting the deployment and expansion of the anchor 72. This interaction will be referred to below. Figure 9A and Figure 9B Let's discuss this in more detail.

[0040] Figures 8A-8B An embodiment of an artificial heart valve for use with a helical anchor as previously discussed is shown. Preferably, the valve prosthesis used with the helical anchor is, for example, a modified or unmodified transcatheter heart valve, such as the Edwards Lifesciences Sapien™ valve. Figure 8A A valve with a scalable frame structure 220 and multiple leaflets 222 is shown. The frame 220 of the artificial valve can be self-expanding and can be made, for example, of a shape memory material such as nitinol, or alternatively, of a non-shape memory material. In some embodiments, the valve prosthesis is balloon-expandable and intended for expansion within a previously positioned helical anchor. The leaflets 222 can be made, for example, of flexible animal tissue (such as bovine, porcine, or equine pericardial or valvular tissue) or of any other suitable material.

[0041] The valve prosthesis further includes an annular ring or sleeve 224 attached or integrally formed along the distal or lower end of the frame 220, said annular ring or sleeve 224 being made of or generally comprising a material less rigid than the material of the frame 220. For simplicity, Figure 8A The shape of the annular sleeve 224 is shown only schematically without any additional attachment features, while Figure 8B A cross-section of the lower portion of the valve prosthesis, including additional attachment features such as sleeve 246 that holds the sheath in place on the frame, is shown. Figure 8B In the embodiment shown, the annular sleeve 224 at least substantially surrounds the bottom corner 226 of the expandable stent frame 220 of the valve prosthesis. The annular sleeve 224 includes a foam layer 242 surrounding the bottom corner 226 of the frame 220, a fabric layer 244 covering the foam layer 242, and an additional sleeve retention sleeve or layer 246 for holding the foam layer 242 and the fabric layer 244 in place. One or more stitches or seams 248 are made between the sleeve layer 246 and one or more portions of the frame 220 to hold the respective portions of the sleeve 224 in place on the frame 220. Figure 8A and Figure 8BIn one embodiment, stitches 248 are made at two different axial regions along frame 220. However, in other embodiments, more or fewer stitches 248 may be employed as needed to retain sleeve 224 on frame 220, or any other suitable retention means may be used instead of sleeve layer 246 and stitches 248 to hold foam layer 242 and fabric layer 244 in proper position on frame 220. Furthermore, in other embodiments, only foam layer 242 is used without fabric layer 244, or only fabric layer 244 is used without foam layer 242, or any other suitable annular material may be used to form annular sleeve 224. One or more layers of annular sleeve 224 will generally be made of one or more biocompatible materials, and will generally be made of one or more materials that are softer and less rigid than the materials or alloys used in support frame 220.

[0042] Figure 9A An extended valve prosthesis 120, anchored in a helical anchor 72, is shown according to an embodiment of the invention. Figure 9B The illustration schematically depicts the tendency of the top and bottom ends of the valve prosthesis 120 to advantageously open radially outward (e.g., in the direction of the arrows) after the prosthesis 120 is deployed in the helical anchor 72, due to the friction and resistance between the various parts of the prosthesis 120 in contact with each other and the anchor 72. (See above regarding...) Figures 3A to 3E The anchor 72 discussed herein, according to an embodiment of the invention, has a core covered with a foam layer and / or a fabric layer, both of which are used to promote inward growth after the anchor is implanted in the mitral valve location. Furthermore, the foam or fabric covering of the anchor 72 can be used to prevent or reduce damage to the tissue surrounding and in contact with the anchor 72.

[0043] Furthermore, the foam layer and / or fabric layer further serve to generate additional friction after contact between the anchor 72 and the frame of the valve prosthesis 120 anchored therein. In the absence of a further foam layer and / or fabric layer included thereon, the material of the metal-based anchor or docking station may be similar to or the same as the material of the support frame for the valve prosthesis. In these cases, minimal or low frictional resistance may exist between the support frame and the coil anchor when the valve prosthesis is expanded in the coil anchor and the support frame of the prosthesis begins to contact the coil anchor. Since the unbiased inner diameter of the coil anchor is generally smaller than the outer diameter of the expanded valve prosthesis, and due to the general winding structure of the helical coil, the expansion of the valve prosthesis against the helical coil will at least force the minimum diameter rotating portion of the coil anchor to extend radially outward and partially unfold. This, in turn, can lead to potentially undesirable slight displacement or drift of the anchor within the mitral annulus, resulting in less effective functionality of the implanted valve prosthesis, or, in the worst case, weaker anchorage of the valve prosthesis in the coil anchor and potential embolism of the valve prosthesis exiting the mitral annulus and entering the left atrium or left ventricle.

[0044] According to embodiments of the invention, the foam and / or fabric or woven material-covered coil anchor 72 is used to increase friction between the coil anchor 72 and the valve prosthesis 120 after contact between the respective parts. Initially, when the valve prosthesis 120 is expanded in the coil anchor 72 during valve replacement implantation, the metal or metal alloy frame 220 of the valve 120 will contact the foam layer 182 or fabric layer 184 of the coil anchor 72, and the circumferential friction between the contact surfaces prevents the coil anchor 72 from sliding or unfolding under the radially outward force exerted by the expanded frame 220. Such frictional forces can be generated, for example, due to the material difference between the outer surface of the fabric or foam-covered coil 72 and the metal or alloy frame 220 of the valve prosthesis 120; due to interference between the texture of the fabric or foam-covered coil 72 and the metal or alloy surface or various edges of the expandable support frame 220 of the prosthesis 120; or interference or “capture” between the edges, transition sections or hinges, and / or seams of the fabric or foam-covered coil 72 and the outer surface of the frame 220 of the prosthesis 120. In other embodiments, other means or causes for circumferential friction or locking between the coil anchor 72 and the surface of the valve prosthesis 120 can be used or employed to prevent or reduce circumferential migration or expansion of the helical coil 72 after radially outward pressure is applied due to the expanded valve prosthesis 120.

[0045] According to embodiments of the invention, a spiral coil 72 with a predetermined opening size can be more accurately selected and implanted into the mitral valve annulus to retain or support the valve prosthesis therein. Surgeons or physicians can more accurately select the coil size and shape, as well as the desired valve type and size, resulting in more predictable and secure interactions between components after implantation. The valve prosthesis can be more firmly retained in the coil anchor 72 because there will be a tighter holding or retention force between the anchor and the prosthesis, and because there will be less expansion, drift, or migration of the anchor within the native mitral valve annulus after the prosthesis expands therein.

[0046] Furthermore, the characteristics of the fabric or foam-covered coil anchor 72 according to embodiments of the invention also facilitate easier implantation and positioning of the coil anchor 72 itself in the mitral annulus prior to the delivery of the valve prosthesis. Firstly, because the additional friction helps later maintain the structural integrity and / or overall size and shape of the coil anchor 72 against the extended valve prosthesis, the coil core can be made thinner and / or more flexible, making the initial delivery of the coil anchor 72 through the coil guide catheter and into its position within the mitral annulus easier. Furthermore, since coils with smaller diameter internal openings generally hold the valve prosthesis more securely, the coil anchor 72 can also be made slightly larger than a comparable coil anchor without a foam / fabric covering layer, as unwanted expansion of the valve prosthesis through the coil anchor 72 is prevented or reduced, and advancement of the anchor 72 around the native mitral leaflet and chordae tendineae can be more easily facilitated during deployment.

[0047] Now refer to Figure 9B The illustration schematically depicts another advantageous feature of coil anchors covered with foam and / or fabric. Figure 9B In the diagram, only the portion of the valve prosthesis 120 that has been extended within the coil anchor is shown, where, for simplicity, the coil anchor 72 has been removed to highlight the effect of the coil anchor on the valve prosthesis 120 implanted therein. (If possible...) Figure 9BAs seen in the image, the frame 220 of the valve prosthesis 120 has ends that have flared out radially. The frame 220 of the valve implant 120 used according to embodiments of the invention generally has a constant expansion width or diameter along the length of the implant. As described above, the coil anchor is generally selected to have an internal opening with a diameter smaller than the expansion diameter of the valve prosthesis 120. An interference fit is formed between the coil anchor 72 and the valve prosthesis 120 to prevent or reduce the expansion of the coil anchor, and thus also to prevent widening of the opening defined by the coil anchor. Generally, the valve prosthesis 120 will be centered or substantially centered on the coil anchor 72, wherein the coil anchor 72 guides inward forces or resistance against the central portion of the valve prosthesis 120, as in... Figure 9B The diagram is illustrated by an arrow pointing towards the center of the prosthesis. The central portion of the valve prosthesis 120 will therefore be limited to its full expansion size. It should be noted that the prosthesis valve size, the coil anchor size, or both can be selected to account for this slight under-expansion to avoid impairing hemodynamics through the artificial valve post-implantation. Meanwhile, the tip and bottom of the valve prosthesis 120, which are not in contact with the coil anchor 72, will continue to attempt to expand outward toward its full expansion size, as shown in the diagram. Figure 9B The arrow near the end of the implant further illustrates the opening at the end of the implant.

[0048] Figure 10A A valve prosthesis, according to an embodiment of the invention, is shown that has not yet been implanted in a coil anchor covered with foam or fabric, while Figure 10B This illustrates a valve prosthesis that has been expanded within a coil anchor covered by foam or fabric and then removed, resulting in an opening or widening at the end of the prosthesis as discussed above.

[0049] The opening exhibited in the valve prosthesis 120 provides numerous benefits. The locking dynamics generated between the coil anchor and the contact surface of the valve prosthesis, combined with the opening frame geometry of the prosthesis 120, increase the retention of the anchor within the coil anchor and the mitral annulus. The opening and widening of the distal end of the valve prosthesis 120 adds dimensions to the distal end of the prosthesis, dimensions designed to create additional engagement and prevent valve displacement from the coil anchor and potential embolism of the valve within the heart under elevated pressure. In preliminary tests, when pulsating pressures up to 70 mmHg and static pressures up to 150 mmHg applied against the valve prosthesis anchored in an uncovered metal coil in individual tests did not displace the prosthesis from the coil anchor, the prosthesis displaced under higher static pressures (e.g., pressures above 290 mmHg) from the uncovered anchor. Meanwhile, the prosthesis anchored in a covered coil anchor according to an embodiment of the invention was successfully retained in all the above tests. Therefore, the artificial valve can be more effectively retained in the coil anchor covered with foam and / or fabric. In addition, the opening of the sub-annular portion of the artificial valve (i.e., the portion of the valve located in the left ventricle) will also more firmly clamp or retain the native leaflet of the mitral valve against the sub-annular portion of the coil anchor, thereby further improving implant retention.

[0050] Opening of the distal end of the valve prosthesis 120 will increase contact between the prosthesis 120 and surrounding cardiac tissue, such as the native mitral valve leaflets and chordae tendineae. This could potentially lead to damage to the surrounding tissues from the sharp edges or corners of the valve frame 220. (Return to reference) Figures 8A-9B The valve prosthesis shown in the diagram has an annular sleeve 224 added to the sub-annular end of the valve prosthesis 120 to protect the surrounding tissues of the heart from the open end of the frame 220, which could potentially pierce, cut, or otherwise damage the tissue.

[0051] As seen in the previously described embodiments, the annular sleeve 224 is implemented as a continuous annular ring that at least covers one end of the stent frame 220 of the valve prosthesis at a corner. Meanwhile, Figure 11A and Figure 11B The illustration shows two alternative protective sleeve arrangements. Figure 11A In this context, the alternative sheath 264 follows the bottom (i.e., sub-annular) edge of the stent frame 220 of the valve prosthesis 120 to provide increased protection to surrounding tissues from damage along the entire bottom edge contour of the stent frame 220. Figure 11B Alternatively, another alternative protective layer 284 is achieved by a spherical or ball-shaped protector attached to the lowest corner of the support frame 220. Figure 11BThe protective layer 284 or other similar low-profile arrangements may be desirable in some applications because, for example, a stent frame with a lower profile protective layer will be easier to crumple and deliver via catheter or delivery sheath. Furthermore, while the various protective layers in the described embodiments are illustrated as being added only to the sub-annular end of the valve prosthesis 120, it should also be understood that similar sheaths or other protective layers can be added to other portions of the valve prosthesis 120 to prevent or reduce damage to other portions of surrounding tissue caused by expansion and / or opening of the stent frame 220.

[0052] The coil anchor 72 described in the previous embodiments is made of or includes a helical coil. Figure 12 A perspective view of a coil anchor according to another embodiment of the present invention is shown. Figure 12 In this configuration, the coil anchor 400 includes a first coil 402 wound in a first circumferential direction and a second coil 404 wound in a second circumferential direction opposite to the first circumferential direction. Therefore, the first coil 402 and the second coil 404 can be aligned close to each other along the longitudinal axis of the coils, and at least the lengths of each of the coils 402 and 404 closest to each other can be aligned or pushed against each other. In this configuration, adjacent ends of the coils 402 and 404 are joined together at a joint 406, which in one example is a crimp joint. In another example, adjacent ends of the coils 402 and 404 are joined or welded together, or held together by one of various other biocompatible means, with or without other biocompatible materials, to integrate the coils 402 and 404 into a single anchor or docking station. Coils 402 and 404 extend and wind in opposite directions from connector 406, with the first or upper coil 402 terminating at the upper distal end 408 and the second or lower coil 404 terminating at the lower distal end 410. The upper coil anchor 402 (or atrial anchor) is so named because, once deployed, the upper coil 402 will be positioned in the left atrium above the mitral annulus. Similarly, the lower coil anchor 404 (or ventricular anchor) is so named because, once deployed, most of the lower coil 404 will be advanced or supplied through the mitral valve at the junction and will be circumferentially positioned in the left ventricle below the mitral annulus. In some embodiments, coil anchor 400 may have one or more covering layers, similar to those discussed above with respect to coil anchor 72. In these embodiments, the core of coil anchor 400 may be covered, for example, by a fabric layer, a foam layer, or other biocompatible material, or a combination of such layers.

[0053] The coil anchor 400 can be initially deployed in a similar manner to the coil anchor 72 in the previously described embodiments. Figure 13A As seen, the coil guide catheter 68 is positioned in the left atrium 46, near the mitral suture 80. The coil anchor 400 is advanced and begins to extend from the distal opening of the coil guide catheter 68, and the distal end 410 of the lower coil 404 is guided at the suture 80 through the valve to a sub-annular position in the left ventricle. The coil anchor 400 can be advanced by a thrust or load, can be pushed out, the sheath can be retracted, or the anchor 400 can be delivered from the coil guide catheter 68 using one of various other known deployment methods. The lower coil 404 is then positioned similarly to the coil anchor 72 in the previous embodiment. However, during the deployment of the lower coil 404, the upper coil 402 is simultaneously pushed out from the distal end of the coil guide catheter 68 and begins to unfold in the opposite direction, extending upward into the left atrium. Due to the opposite winding directions of the upper coil 402 and the lower coil 404, the central axes of the two coils can remain substantially aligned during and after the deployment of the anchor 400. Furthermore, due to the opposite winding directions, as they exit the coil guide conduit 68, the upper coil 402 and the lower coil 404 will naturally curl or wind in opposite directions and will advance away from each other along the central axis of the coil anchor 400 during deployment. In this way, once the lower coil 404 is guided through the valve at the junction 80, the upper coil 402 will naturally move away from the junction 80 because it will be deployed upwards rather than following the direction of advancement of the lower coil 404, and will not be unintentionally guided through the valve at the junction 80.

[0054] The coil anchor 400 is advanced until the connector 406 is distal from the distal end of the coil guide catheter 68. After the coil anchor 400 has been distal from the catheter 68, further adjustments to the anchor to the final desired position can be made by the physician as needed. Figure 13B As seen in the previous embodiment, the coil anchor 400 is deployed in a manner similar to that of the coil anchor 72. Furthermore, since the upper coil 402 and lower coil 404 are deployed and positioned simultaneously, and since the coil guide catheter is able to remain in substantially the same position during the deployment of the coil anchor 400, the later step of rotating the coil guide catheter 68 to release the upper portion of the anchor into the left atrium is no longer necessary, thus simplifying the anchor implantation procedure.

[0055] In some embodiments, the upper coil 402 and lower coil 404 of the coil anchor 400 can be staggered, with the lower coil 404 being slightly longer than the upper coil 402. In this manner, the distal end 410 of the lower coil 404 is configured to exit the distal end of the coil guiding catheter 68 first, making it easier to position the distal end 410 through the valve at the junction 80. After the distal end 410 of the lower coil 404 is positioned through the valve at the junction 80, the anchor 400 can be fully advanced and positioned in place of the coil guiding catheter 68 with no adjustment or only minor adjustments. In other embodiments, the upper coil 402 and lower coil 404 are substantially the same length, or the upper coil 402 can be longer than the lower coil 404. The relative lengths of the two coils of the coil anchor 400 can be adjusted based on patient needs, physician preferences, and other factors.

[0056] As seen in previous embodiments, different coil anchors can be deployed in the mitral valve location in different ways. In each embodiment, it is important that the tip and / or distal end of the sub-annular coil (i.e., the portion of the coil anchor that advances through the mitral valve into the left ventricle) is guided completely around the native leaflet of the mitral valve and around the chordae tendineae so that the anchor remains tightly positioned to the mitral annulus. For example, if the distal end of the coil does not travel completely around the chordae tendineae and is instead advanced between the two chordae tendineae, the coil may become entangled in the chordae tendineae, and / or the sub-annular portion of the coil anchor may be held below the tissue where the two chordae tendineae meet, and thus deflected further away from the valve annulus than desired. Such a situation can have negative effects, such as damage to the coil anchor and / or the chordae tendineae or the native mitral valve leaflet, or unstable anchoring or poor positioning of the valve prosthesis held in the coil anchor.

[0057] Figure 14 A coil anchor deployment system according to an embodiment of the present invention is illustrated. In some embodiments, the deployment system has an arrangement similar to that of the previously described embodiments, having an introducer 2, a delivery conduit 64, and a helical anchor 72 through which a manipulating conduit or coil guide conduit 68 is delivered. Figure 14 In the embodiment illustrated in the figure, the introducer 2 is positioned through the left ventricle 10, but in other embodiments, the introducer 2 and / or other delivery catheters can be positioned through the atrial septum, or any other entry point suitable for delivery of helical anchors.

[0058] In addition to the catheter associated with the delivery of the helical anchor, a separate catheter 18 can also be included in the deployment system and can also be supplied and advanced through the introducer 2 or other sheaths or cannulas in the deployment system. At the distal end of catheter 18, a temporary annulus or loop 22 is provided, which is used to gather, bind, “trap,” or otherwise pull together the chordae tendineae 48 prior to deployment of the helical anchor 72. The chordae tendineae 48 then occupy a smaller cross-sectional area in the left ventricle 10, which facilitates easier subsequent deployment of the distal tip of the helical anchor 72 around the chordae tendineae and placement of the helical anchor 72 in the desired or optimal position without any chordae tendineae entanglement.

[0059] The temporary loop or ring 22 can be, for example, a suture or guidewire, or any other suitable thread or wire. In some embodiments, the ring 22 is led or guided around the chordae tendineae 48 using a grasping tool or one or more other tools, introduced, for example, via an introducer 2 or via other delivery sheaths or cannulas. In other embodiments, the ring 22 is advanced through a guide catheter with one or more segments surrounding the chordae tendineae 48. In these embodiments, the ring 22 is closed, for example, by using a clamping or grasping tool via restraint, or by one of various other attachment methods, and then the guide catheter or segments of the catheter are retracted, leaving the ring 22 in its final position around the chordae tendineae. In other embodiments, the ring 22 (such as a helical anchor 72) is pre-shaped to have curvature such that the ring 22 surrounds the chordae tendineae when deployed. In some embodiments, after the ring 22 has been closed, the opening defined by the ring 22 can be further tightened or narrowed to further bind or gather the chordae tendineae 48 more tightly together. Meanwhile, although Figure 14 The diagram shows catheter 18 and loop 22 deployed together with delivery catheter 64 and coil guide catheter 68; however, in other embodiments, any combination of catheters can be present when loop 22 is deployed around chordae tendineae 48. For example, in the previously described embodiment, delivery catheter 64 is retracted before coil anchor 72 is deployed, and a similar process can be followed here. Furthermore, in embodiments where introducer 2 is positioned at the apical inlet, loop 22 can also surround introducer and / or one or more delivery catheters or coil guide catheters. If alternatively a septal procedure is performed, the distal end of loop catheter 18 can alternatively be advanced from the left atrium through the mitral valve into the left ventricle, and loop 22 can be deployed around chordae tendineae 48 without binding or converging any additional delivery catheters or tubes therein.

[0060] After the annulus 22 is deployed around the chordae tendineae 48 and the chordae tendineae are bound or otherwise pulled together, and after the helical coil anchor 72 is fully deployed around the chordae tendineae and satisfactorily mated in the mitral valve position, the annulus 22 is removed. This can be achieved, for example, by releasing a grasping tool (if a grasping tool is used), and / or by untying or cutting the sutures, sutures, or guidewires used for the annulus 22 and then removing the annulus from the inlet site, along with other tools and catheters in the deployment system.

[0061] In embodiments using the loops described above in a coil anchor deployment system, problems arising from the coil anchor becoming entangled in the chordae tendineae during deployment, or from the coil anchor being stuck between two or more chordae tendineae and being improperly positioned, can be mitigated or prevented. In this way, the anchor can be positioned more securely, and the valve prosthesis can be deployed and implanted more securely therein.

[0062] Various other modifications or alternative configurations can be fabricated as helical anchors, valve prostheses, and / or delivery systems according to the embodiments described above. For example, in the illustrated embodiment, the coils of the helical anchor are tightly wound near the mitral valve annulus. In other embodiments, some of the coils of the anchor may be widened or opened outward to contact, for example, the atrial wall of the left atrium. Furthermore, the number of coils above and below the valve annulus can be varied based on, for example, the nature of the native mitral valve and / or the desired positioning of the valve prosthesis. In embodiments where the upper and lower coils are connected together to form the helical anchor, the two coils can be prepared, modified, and / or selected individually based on the patient's anatomy or various other factors. Furthermore, other modifications to the deployment system can be adopted to more efficiently or effectively bind the chordae tendineae during the deployment and positioning of the helical anchor. Various other coil shapes, lengths, arrangements, and modifications can also be made based on a wide range of considerations.

[0063] For the purposes of this specification, 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 may be individual and in various combinations and sub-combinations of 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 necessarily require the presence of any one or more particular advantages or problems to be solved.

[0064] Although the operations of certain disclosed embodiments are described in a specific, sequential order for ease of expression, it should be understood that this descriptive method includes rearrangement unless a specific statement requires a particular order. For example, the operations described in sequence may be rearranged or performed in parallel in some cases. Furthermore, for simplicity, the accompanying drawings may not show various methods in which the disclosed methods can be combined with other methods. In addition, the description sometimes uses terms such as "provides" or "implements" to describe the disclosed methods. These terms are highly abstract concepts of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and can be readily discerned by those skilled in the art.

[0065] Given that the principles of the disclosure can be applied to many possible embodiments, it should be understood that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of the disclosure. Rather, the scope of the disclosure is defined by the claims.

Claims

1. A spiral anchor for anchoring a mitral valve prosthesis to the native mitral valve of the heart, having a first end, a second end, a central axis extending between the first end and the second end, and defining an internal space coaxial with the central axis, the spiral anchor comprising: A spiral core comprising a biocompatible metal or metal alloy and having a plurality of rotating portions extending about the central axis in a first position; and A covering layer surrounding the core, the covering layer comprising a biocompatible material that is less rigid than the metal or metal alloy of the wound core; The wound anchor is adjustable from the first position to a second position, in which at least one of the plurality of rotating parts is straightened so that the wound anchor is delivered to the native mitral valve through a conduit, and is adjustable back from the second position to the first position; and The spiral anchor can be implanted at the native mitral valve, wherein at least a portion of one side of the native mitral valve is in the left atrium of the heart and at least a portion of the opposite side of the native mitral valve is in the left ventricle of the heart, so as to support or retain the mitral valve prosthesis in the internal space when the spiral anchor is implanted at the native mitral valve.

2. The coiled anchor of claim 1, wherein the covering layer comprises a fabric layer.

3. The spiral anchor according to claim 1 or 2, wherein the covering layer comprises a foam layer.

4. The coiled anchor according to any one of claims 1 to 3, wherein the covering layer comprises a fabric layer surrounding the foam layer.

5. The coiled anchor according to any one of claims 1 to 4, wherein the coiled core comprises a shape memory material.

6. A system for implantation at the mitral valve, comprising: The coiled anchor as described in any one of claims 1 to 5; and A mitral valve prosthesis comprising an expandable frame and housing a plurality of leaflets for controlling blood flow therethrough, wherein the frame expands from a constricted first position to an expanded second position, wherein in the constricted first position the frame has a first outer diameter for delivering the mitral valve prosthesis to a delivery catheter, and in the expanded second position the frame has a second outer diameter larger than the first outer diameter. When the coiled anchor and the mitral valve prosthesis are not biased, the minimum inner diameter of the internal space defined by the coil anchor is smaller than the second outer diameter of the mitral valve prosthesis.

7. The mitral valve implant of claim 6, wherein when the mitral valve prosthesis is held in the internal space of the coiled anchor, the coiled anchor and the corresponding portions of the frame in contact with each other are restricted to extending into the second outer diameter.

8. The mitral valve implant of claim 7, wherein a frictional force is generated between the contact between the cover layer of the coiled anchor and the frame of the mitral valve prosthesis to restrict circumferential movement between the coiled anchor and the mitral valve prosthesis, such that circumferential unfolding of the coiled anchor and radial expansion of the internal space of the coiled anchor are restricted.

9. The mitral valve implant of claim 7 or 8, wherein the frame portion not in contact with the portion of the coiled anchor having the minimum inner diameter is configured to extend radially outward to a diameter greater than the minimum inner diameter of the coiled anchor and smaller than the second outer diameter of the frame of the mitral valve prosthesis.

10. The mitral valve implant according to any one of claims 7 to 9, wherein the frame of the mitral valve prosthesis has a first end and a second end, and further includes a protective layer covering at least a portion of the second end of the mitral valve prosthesis, the at least portion of the second end of the mitral valve prosthesis being positioned furthest from the first end of the mitral valve prosthesis.

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