Prosthetic heart valve devices, systems, and methods

Abstract

A heart valve prosthesis for replacing a diseased native valve in a patient. A valve prosthesis includes a compressible and expandable frame structure and an anchor attached to an outer periphery of the frame structure. The anchor includes a spiral filament having a free end. The valve may also include a valve segment mounted within and expanding with the frame structure. The frame structure may be configured to receive a valve segment.

Description

[0001] This application is a divisional application of international application PCT / US2019 / 047542, entitled “Artificial Heart Valve Devices, Systems and Methods”, which entered the Chinese national stage on April 22, 2021, with an international application date of August 21, 2019 and Chinese application number 2019800657673.

[0002] Cross Reference

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 720,853 (Attorney Docket No. 41702-704.101), filed on August 21, 2018, and entitled “Prosthetic Cardiac Valve Devices, Systems, and Methods,” which is incorporated herein in its entirety for all purposes.

[0004] Incorporated by Reference

[0005] All publications and patent applications mentioned herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0006] The present invention relates generally to the treatment of cardiac disease and more particularly to implantable valve prostheses and the treatment of cardiac valve disease. Background Art

[0007] refer to Figure 1 and 2 , the heart 2 includes four chambers connected by four valves. The upper portion of the heart 2 includes the left atrium 25 and the right atrium 5. The lower portion includes the left ventricle 26 and the right ventricle 6. The heart 2 and the cardiovascular system operate like a closed circuit. The right side of the heart 2 receives deoxygenated blood from the body and delivers the blood through the pulmonary artery 7 to the lungs, where the blood becomes reoxygenated. The oxygenated blood returns to the left side of the heart 2, called the systemic side, which delivers the oxygenated blood to the entire body.

[0008] Blood flow between the heart chambers is regulated by valves. On the left side of the heart, the mitral valve 4 is located between the left atrium 25 and the left ventricle 26, while the aortic valve 9 is located between the left ventricle 26 and the aorta 1. On the right side of the heart 2, the pulmonary valve 3 is located between the right ventricle 6 and the pulmonary artery 7, while the tricuspid valve 8 is located between the right ventricle 6 and the right atrium 5.

[0009] All four heart valves are passive one-way valves with "leaflets" that open and close in response to differential pressures. For example, during healthy heart systole, the left ventricle 26 contracts and expels blood from the aortic valve 9. In turn, the pressure in the left ventricle 26 causes the mitral valve 4 to close, preventing blood from returning to the left atrium 25 during systole.

[0010] A significant portion of the population will develop valvular disease during their lifetime. Congenital heart disease is also a significant problem. Patients with valvular disease have anatomical and / or functional abnormalities of at least one valve. Congenital valvular abnormalities may be tolerated for years and / or treated as palliatives before developing into life-threatening problems years later. However, congenital heart disease presents a risk of becoming life-threatening if not attended to. Patients may develop valvular disease from rheumatic fever, heart failure, degenerating leaflet tissue, bacterial infections, etc.

[0011] Valvular disease can be caused by Figure 3-5 The multiple factors shown. Figure 3 A healthy mitral valve is shown 4. Figure 4-5 , which shows a diseased mitral valve 4. Figure 4 The valve 4 of the left atrium suffers from insufficiency, also known as regurgitation. This valve 4 cannot close completely and allows blood to flow backwards. In this case, blood will flow back into the left atrium 25 during systole. Figure 5 Mitral valve 4 stenosis is shown. This valve 4 does not open properly. Some valves 4 can be associated with valvular insufficiency and stenosis. Other diseases may also be present, such as Barlow's disease, which prevents the valve 4 from working properly. These diseases can reduce the output of the heart 2 and force the heart 2 to work harder, increasing the risk of heart failure and choroidal failure.

[0012] While medications are available to treat the disease, in many cases the defective valve will need to be repaired or replaced at some point during the patient's life. The native valve can be replaced by a mechanical valve or a tissue valve. Mechanical valves have a disc or other component that can open and close. Although mechanical valves are made of biocompatible materials, they carry the risk of increased clotting. Therefore, patients usually need to take anticoagulants for the rest of their lives, which can bring additional complications. Tissue valves can be formed from human or animal tissue as well as polymeric materials. Unlike mechanical valves, tissue valves generally do not require long-term use of anticoagulants, but because they are formed from living tissue, they are not widely used and do not last as long as mechanical valves. Common tissue valves include porcine aortic valves mounted in a stent-like structure.

[0013] Recently, there has been increasing interest in minimally invasive procedures for prosthetic valve implantation. One percutaneous procedure involves the use of a catheter to place a prosthetic valve within a diseased or injured heart valve.

[0014] Existing percutaneous valve repairs still face many challenges. These challenges limit the application of transcatheter surgery to certain patient populations and anatomies. To date, transcatheter devices have been focused primarily on aortic valve surgery and critically ill patient populations who may not be able to tolerate surgery. There is still a need for improved transcatheter devices that meet or exceed the performance and safety of surgical valves. Percutaneous valve replacement is also limited to aortic valve surgery. Although a large population suffers from tricuspid and mitral valve disease, the anatomy and function of these valves pose challenges for transcatheter replacement. The aortic valve can be accessed through the femoral artery, while the mitral valve, for example, typically requires a transseptal approach. The mitral valve anatomy is more complex than the aortic valve for transcatheter surgery. For example, Figure 4 As shown, the mitral valve 4 includes two asymmetric leaflets 4a, 4b and an irregularly shaped annulus 4c. The mitral valve 4 is also more variable than the aortic valve from patient to patient. For these and other reasons, surgical replacement and percutaneous repair are currently the only widely used commercial treatments for mitral valve disease. Summary of the invention

[0015] It is therefore desirable to provide a minimally invasive procedure for the repair and replacement of heart valves including the mitral valve, a faster surgical approach, a variety of different valve components adapted to the needs of different patients, and / or an artificial valve that can be adapted to a variety of individual patients. Not all of these aspects or advantages must be achieved by any particular embodiment. Thus, various embodiments may be implemented in a manner that achieves or optimizes one advantage or a group of advantages taught herein without having to achieve other aspects or advantages taught or suggested herein.

[0016] The present invention relates to artificial heart devices and, in some embodiments, to artificial heart valves, such as a catheter-based mitral valve.

[0017] In a first aspect, a heart valve prosthesis is provided for replacing a diseased native valve in a patient. The heart valve prosthesis includes a compressible and expandable frame structure and an anchor connected to the outer periphery of the frame structure. The anchor includes a spiral wire with a free end. The valve may also include a valve segment located within the frame structure. The valve segment may include a biocompatible one-way valve.

[0018] In a second aspect, a heart valve prosthesis for replacing a diseased native valve in a patient's heart is provided. The valve prosthesis comprises a compressible and expandable frame structure, a valve segment arranged in the frame structure, the valve segment comprising a biocompatible one-way valve, and an anchor connected to the outer periphery of the frame structure, wherein the anchor comprises a spiral wire having a free end.

[0019] In some embodiments, the free end of the helical wire can be configured to guide the helical wire through the commissures of the patient's native valve.

[0020] In some embodiments, the free end may include an atraumatic tip. For example, the free end may include a ball tip.

[0021] In some embodiments, the free end can be configured to penetrate tissue.

[0022] In some embodiments, an anchor can include a first portion and another portion, the first portion having a helical filament.

[0023] In some embodiments, the anchor may include a plurality of anchors. The plurality of anchors may include at least two helical filaments having different diameters. Alternatively, or in combination, the plurality of anchors may include at least two helical filaments having different winding pitches.

[0024] In some embodiments, the helical filament may have a generally tubular shape.The free end of the helical filament may extend radially outward from the tubular shape.

[0025] In some embodiments, the helical filament may have a generally truncated cone shape. The free end of the helical filament may extend radially outward from the truncated cone shape.

[0026] In some embodiments, the framework structure can be configured to expand within the patient's native valve.

[0027] In some embodiments, the framework structure can have a compressed state sized and dimensioned for percutaneous insertion and an expanded state sized and dimensioned for implantation within a patient's native valve.

[0028] In some embodiments, the frame structure can include opposing first and second ends, the first end extending above the native valve and the second end extending below the native valve when the valve prosthesis is positioned across the native valve.

[0029] In some embodiments, the framework structure can include an expandable stent.

[0030] In some embodiments, the framework structure can include a generally tubular expanded shape.

[0031] In some embodiments, the framework structure may include an expanded outer periphery and an outer periphery that is compressed when subjected to an external radial force. The diameter of the compressed outer periphery may be slightly smaller than the expanded outer periphery.

[0032] In some embodiments, the framework structure can be balloon expandable.

[0033] In some embodiments, the framework structure can be self-expanding.

[0034] In some embodiments, at least a portion of the valve segment can be positioned within at least a portion of the frame structure.

[0035] In some embodiments, the valve segment can include at least one leaflet having an inner layer and an outer layer.The frame structure can be attached to the outer layer at one or more ends of the frame structure.

[0036] In some embodiments, a valve segment can include multiple leaflets. For example, a valve segment can include two leaflets.

[0037] In some embodiments, the helical wire may include a second end, and wherein the second end is attached to the frame structure. The helical wire may be attached to the frame structure only at the location of the second end.

[0038] In some embodiments, the anchor and framework structure can be adapted to expand independently and separately.

[0039] In another aspect, a method for replacing a diseased native valve of a patient is provided. The method includes loading a valve prosthesis into a delivery catheter, the valve prosthesis including an expandable frame structure carrying a biocompatible valve segment and an anchor attached to the outer periphery of the frame structure, the anchor including a wire having a free end; delivering the valve prosthesis to a target position above the native valve; inserting the valve prosthesis through the native valve to a position in front of the native valve; rotating the wire so that the free end is wrapped around at least a portion of the chordae tendineae under the valve; and expanding the frame structure including the valve segment within the native valve.

[0040] In some embodiments, the method can further include anchoring the valve prosthesis by rotating the wire until the framework structure is positioned within the leaflets of the native valve.

[0041] In some such embodiments, the method may further include anchoring the valve prosthesis by rotating the wire until the wire is tightened around the chordae tendineae.

[0042] In some embodiments, the framework structure may be balloon expandable. Expanding the framework structure may include expanding a balloon within the framework structure.

[0043] In some embodiments, the framework structure can be self-expanding. Expanding the framework structure can include removing a sheath of the delivery device from the framework structure.

[0044] In some embodiments, the filament can be a helical filament.

[0045] In some embodiments, inserting the valve prosthesis can include guiding the free end of the wire through the commissures of the native valve. In some embodiments, rotating the wire can include rotating the wire through the commissures.

[0046] In another aspect, a heart valve prosthesis is provided for replacing a diseased native valve of a patient. The valve prosthesis includes a compressible and expandable frame structure, a valve segment disposed within the frame structure and including a biocompatible one-way valve, and an anchor connected to the frame structure and disposed radially outward from the frame structure, wherein the anchor includes a helical member having a free end.

[0047] In some embodiments, the second end of the anchor may be connected to the frame structure.

[0048] In some embodiments, the helical member may comprise a wire or a flat ribbon.

[0049] These and other embodiments are described in more detail in the following description and with respect to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The novel features of the invention are particularly set forth in the appended claims. A better understanding of the features and advantages of the invention will be obtained by reference to the following detailed description provided with reference to exemplary embodiments, in which the principles of the invention are employed, and in the accompanying drawings:

[0051] Figure 1 A diagram of the human heart showing the path blood takes through it.

[0052] Figure 2 is a cross-section of the heart looking down through the mitral valve, aortic valve, and aorta.

[0053] Figure 3 is a schematic diagram of a healthy mitral valve.

[0054] Figure 4 and 5 is a schematic diagram of a diseased mitral valve.

[0055] Figure 6-10 are multiple views of a percutaneous valve for replacing a diseased native valve in accordance with the present invention.

[0056] Fig.11 According to various embodiments Figure 6 A perspective view of the prosthetic valve leaflets of a valvular valve.

[0057] Figure 12-18 According to various embodiments Figure 6 Multiple views of the valve framework structure.

[0058] Figure 19-26 According to various embodiments, implantation Figure 6 Multiple views of the approach to the valve.

[0059] Figure 27-28 Expansion of a framework structure using a balloon is shown according to various embodiments.

[0060] Fig.29 According to various embodiments similar to Figure 6 Anterior view of another percutaneous valve of the valve.

[0061] Figures 30A-30F According to various embodiments similar to Figure 6 Anterior view of the other percutaneous valve of the valve.

[0062] The apparatus and method of the present invention have other features and advantages which will be apparent or set forth in more detail from the accompanying drawings, which are incorporated into and form a part of this specification and the following detailed description, and together serve to explain the principles of the present invention. DETAILED DESCRIPTION

[0063] In some of the detailed descriptions, reference is made to the drawings that form a part thereof. In the drawings, like reference numerals generally refer to like parts unless otherwise indicated herein. The exemplary embodiments described in the detailed description, drawings, and claims are not limiting. Other embodiments may be employed, and other changes may be made, without departing from the scope of the subject matter presented herein. It will be readily understood that the various aspects of the invention as generally described herein and illustrated in the drawings may be arranged, substituted, combined, separated, and designed in a wide variety of configurations, all of which are expressly contemplated herein.

[0064] Although certain embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or applications and modifications and equivalents thereof. Therefore, the scope of the appended claims is not limited by any specific embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any appropriate order and are not necessarily limited to any particularly disclosed order. Various operations may be described as multiple discrete operations in sequence, which may help to understand certain embodiments, but the order described should not imply that these operations are order-dependent. In addition, the structures, systems and / or devices disclosed herein may be embodied as an integral component or as separate components.

[0065] For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments will be described. It is not necessary for all of these aspects or advantages to be achieved by any particular embodiment. Thus, for example, various embodiments may be performed in a manner that achieves or optimizes one advantage or group of advantages taught herein without achieving other aspects or advantages that are also taught or suggested herein.

[0066] The present invention is described with respect to the deployment of systems, devices or methods for treating a diseased native valve of the heart, such as the mitral valve. However, one of ordinary skill in the art will appreciate that this is not intended to be limiting, and the devices and methods disclosed herein may be used in other anatomical regions and in other surgical procedures.

[0067] For ease of interpretation and accurate definition in the appended claims, the terms "upper" or "above", "lower" or "below", "inside" and "outside" are used to describe features of various embodiments with reference to the positions of such features as shown in the accompanying drawings.

[0068] In many respects, the variants of the different figures are similar to those of the latter and preceding variants, and corresponding parts are indicated by like reference numerals with the suffixes "a", "b" and "d".

[0069] Turning now to the accompanying drawings, note that Figure 1-5 , wherein identical components are denoted by similar reference numerals throughout the different drawings. Figure 1 A human heart 2 is shown and the blood flow path through the four chambers of the heart. Figure 2 2 is a human heart, showing the mitral valve 4, the aortic valve 9 and the aorta 1. The mitral valve 4 includes two leaflets 4a, 4b. The anterior (aortic) leaflet 4a is adjacent to the aorta 1. The posterior (mural) leaflet 4b is distal to the aorta 1. The aortic valve 9 includes three leaflets. In the present view, the heart 2 is in a systolic state, with the aortic valve 9 open and the mitral valve 4 closed. Figure 1 Shown is a healthy heart 2, Figure 2-5 Exemplary mitral valve 4 disease states that may be addressed by a prosthetic valve according to the present invention are shown.Prosthetic valves may also be used to treat functional regurgitation, such as functional mitral regurgitation (FMR).

[0070] Figure 6-18 An exemplary valve prosthesis 10 (also referred to herein as a “valve device”) for use in replacing a diseased mitral valve according to the present invention is shown. The valve prosthesis 10 shown includes a frame structure 12 , valve segments 14 , and anchors 15 . Figure 6-10 Valve prosthesis 10 is shown in an expanded, deployed state. Figure 12-18 The frame structure 12 is shown without the valve segment 14. Figure 12-15 is in a collapsed state and in Figure 16-18 In the expanded state. Anchor 15 is shown in the deployed state.

[0071] Now refer to Figure 6-11An exemplary valve prosthesis 10 is described. In the illustrated embodiment, the valve prosthesis 10 is configured to replace a native mitral valve. The valve 10 includes a frame structure 12, valve segments 14, and an anchor 15. In the illustrated embodiment, the anchor includes a wire 20 formed into a helical or spiral shape around the frame structure.

[0072] An exemplary frame 12 can be configured as a stent. The frame has an expanded state and a collapsed or compressed state. The compressed state is sized and dimensioned for percutaneous insertion, and the expanded state is sized and dimensioned for implantation in a patient's native valve. In various embodiments, the frame structure 12 includes an expanded outer periphery and an outer periphery that is compressed when subjected to an external radial force, the compressed outer periphery having a diameter slightly smaller than the expanded outer periphery. The frame structure 12 is Figure 6 The frame structure 12 is shown in an expanded and deployed state. Fig.12 Shown in a collapsed, delivery state.

[0073] The exemplary framework structure 12 is a stent in the form of a diamond pattern formed of a shape memory material (e.g., NiTi). One of ordinary skill in the art will appreciate from the description herein that many other structures, materials, and configurations may be used for the framework structure 12. For example, the framework structure 12 may be formed of a polymer having sufficient elasticity. The framework structure 12 may be formed of a combination of metal and polymer, such as a metal (e.g., a shape memory material) covered in a polymer. The framework structure 12 may include various patterns other than diamonds.

[0074] The valve prosthesis 10 includes a valve segment 14 located within a frame structure 12. The exemplary valve segment 14 is expandable and collapsible. In the illustrated embodiment, the valve segment 14 is fixed within the frame structure 12 and expands and collapses together with the frame structure 12. The valve segment is somewhat interchangeable with the artificial valve leaflet and generally refers to the artificial leaflet and frame. As used herein, "artificial valve" may refer to a variety of artificial and artificial replacement valves, including tissue (biological) valves, tissue engineered valves, polymer valves (e.g., biodegradable polymer valves), and even some mechanical valves.

[0075] In the illustrated embodiment, the frame structure 12 is a closed frame such that blood flow is forced through the valve segment 14 therein. One or more skirts and / or seals may help force blood through the valve segment 14.

[0076] The valve segment 14 can be constructed as one of ordinary skill in the art will understand from the description herein. The valve segment 14 can be similar to an existing transcatheter valve. The valve segment 14 can be similar to an existing surgical tissue valve and a mechanical valve. In various embodiments, for a preferred function, the valve segment 14 includes a leaflet 16 formed of a multilayer material. At least one leaflet 16 may have an inner layer and an outer layer. In various embodiments, the leaflet 16 is fixed to the valve structure, which in turn is connected to the frame structure 12. The valve structure may be connected to the frame structure 12 before or after the frame structure 12 is adjacent to the native valve. In various embodiments, the leaflet 16 is directly attached to the frame structure 12. The leaflet 16 may have an inner layer and an outer layer, wherein the outer layer is attached to the frame structure 12. The leaflet 16 may be attached to the end of the frame structure 12. Alternatively, or in combination, the leaflet 16 may be attached to the middle portion of the frame structure 12. In various embodiments, the valve segment 14 includes a plurality of leaflets 16, such as two, three or more leaflets. In the illustrated embodiment, the valve segment 14 includes three leaflets 16 attached to the frame structure 12. The exemplary leaflets 16 are Fig.11 . The leaflets 16 are concave to allow flow in one direction. In particular, flow in one direction causes the leaflets 16 to deflect open, while flow in the opposite direction causes the leaflets 16 to close.

[0077] return Figure 6-18 , more particularly Figure 12-18 , the exemplary anchor 15 includes a spiral member, such as a wire 20, having a free end 22. The other end of the wire 20 is attached to the top of the frame structure 12. In the illustrated embodiment, one end of the wire 20 is fixed to the support of the frame structure 12. This end can be attached by appropriate means as those of ordinary skill in the art will understand from the description herein, including but not limited to welding, adhesives, and mechanical fasteners. In various embodiments, the spiral wire 20 is attached to the frame structure only at the location of the second end.

[0078] Although referred to as an anchor, it will be understood that the anchor 15 need not perform an anchoring function in the traditional sense. As described in more detail below, the anchor guides the valve prosthesis 10 into the desired position within the native valve. The anchor 15 can also counteract undesirable entanglement and interference with the chordae tendineae and the valve leaflets of the mitral valve.

[0079] Wire 20 is formed by a material with sufficient rigidity to maintain a predetermined shape. In an exemplary embodiment, wire 20 is formed by a shape memory material (e.g., NiTi). It can be expected that at least the end is relatively rigid so that it can apply force to move the tendon cord while always maintaining flexibility to collapse in the catheter. In various embodiments, the end (including the free end 22) only needs to be sufficiently rigid to maintain its shape and will deform under load. For example, the end can be constructed with a rigidity similar to that of a guide wire or slightly harder.

[0080] In various embodiments, the anchor 15 comprises a helical member. The helical member may comprise a helical wire or a flat ribbon. The helical member may comprise a three-dimensional surface as described herein.

[0081] In various embodiments, the anchor 15 may include a first portion and another portion, the first portion having a helical filament 20. Alternatively, or in combination, the anchor 15 may include a plurality of helical filaments 20. For example, the anchor 15 may include at least two helical filaments 20 having the same or different diameters. Alternatively, or in combination, the anchor 15 may include at least two helical filaments 20 having the same or different winding pitches.

[0082] In various embodiments, the anchor 15 can include a plurality of anchors, such as a plurality of helical filaments 20 as described herein.

[0083] In the illustrated embodiment, valve prosthesis 10 is configured for use in replacing a mitral valve, and free end 22 is configured for insertion through the commissures. Figure 1 A human heart 2 having a mitral valve 4 is shown. Figure 2 and 4 An exemplary mitral valve 4 is shown. As shown in the figure, a plurality of commissures (anterolateral commissure 4d and posteromedial commissure 4e) exist at the ends of the valve leaflets 4a, 4b.

[0084] Continue to refer Figure 6-18 , the exemplary free end 22 is sized and dimensioned for insertion through one of the commissures. In various embodiments, the free end 22 is configured to be atraumatic to avoid the risk of injuring valve tissue and leaflets. The free end 22 can be a blunt end, a ball end, a curved end (e.g., a J-end or pigtail), and other atraumatic shapes. In various embodiments, the free end 22 is configured with a sharp end for piercing tissue.

[0085] In various embodiments, the wire 20 has a varying stiffness along its length. The wire 20 may have two or more segments having different stiffnesses, and / or the stiffness may transition over its length. In various embodiments, the wire 20 is attached to the frame 12 at multiple points such that the free end 22 is relatively flexible and the portion of the wire 20 along which it is attached to the frame structure 12 is more rigid.

[0086] In various embodiments, the free end 22 extends radially outward from the remaining portion of the frame structure 12 and, in particular, the wire 20. As described below, the free end 22 is configured to surround a larger radius than the main coil of the wire 20. For example, when the main coil of the wire 20 has a generally tubular shape, the free end 22 may extend radially outward from the tubular shape. When the main coil of the wire 20 has a generally helical shape, the free end 22 may extend radially outward from the helical shape. When the main coil of the wire 20 has a generally truncated cone shape, the free end 22 may extend radially outward from the truncated cone shape. The increased diameter helps capture the valve leaflets and / or chordae tendineae within the confines of the free end 22 during rotation, as will be described in more detail below.

[0087] The method of implanting the valve prosthesis 10 according to the present invention will be referred to Figure 19-28 Although shown and described with respect to the mitral valve, it will be appreciated that the principles described herein may be equally applicable to other atrioventricular valves. Various aspects of the process, delivery tools, and implantation of valve prostheses are similar to those described in U.S. Patent Nos. 9,034,032, 9,005,273, 8,323,336, 8,075,615, 7,621,948, and 7,175,656 and U.S. Publication No. 2011 / 0288637, which are incorporated herein in their entirety for all purposes.

[0088] Prior to implantation, valve prosthesis 10 is collapsed and loaded into a delivery device 30, such as a delivery catheter. The valve system is optionally primed before or after loading into delivery catheter 30. Fig.19 A cross-sectional side view of a heart 2 is shown with a transseptal puncture 27 in its atrial septum. The leaflets 42 of the valve 4 are not completely prolapsed and the patient is experiencing regurgitation.

[0089] Next, the delivery catheter 30 is inserted through the introducer into the blood vessel. The delivery catheter 30 can be guided over the guidewire to the target location using the Seldinger technique. In the illustrated embodiment, the delivery catheter 30 is inserted through the introducer into the blood vessel. Fig. 20 The conventional approach shown is directed to the left atrium 25 via a transseptal puncture 27 .

[0090] Steering Figure 21-22 , at which point the end of the delivery catheter 30 is directed toward the mitral valve 4. The valve prosthesis 10 is then pushed out of the distal end of the delivery catheter 30. The delivery device 30 may include an outer catheter 50 and an inner catheter or shaft 52. In some embodiments, once the delivery device 30 is in place, the delivery tube 52 extends away from the outer catheter 50 to move the valve device 10 distally toward the native valve 4. As the valve prosthesis 10 exits the delivery catheter 30, an anchor 15 such as a wire 20 is deployed (e.g., from a straight shape within the delivery device 30) to its preformed deployment shape and is wrapped around the frame 12, which is held in place. Fig. 22 The valve prosthesis 10 is then aligned with the target native valve 4 so that the axis of the artificial valve 10 is aligned with the central axis of the native valve 4 .

[0091] Steering Figure 23-24 , the valve 10 is anchored to the native valve 4 using an exemplary spiral wire 20. The valve prosthesis 10 (frame 12, wire 20 and valve segment 14) is slowly rotated to the native mitral valve 4. In the illustrated embodiment, a torquer is disposed within a delivery catheter 30 to rotate the valve 10. The free end 22 of the wire 20 rotates through the commissure and extends below the ring of the native valve 4. The valve prosthesis 4 is further rotated so that the free end 22 captures the chordae tendineae (also called "papillary muscles") 40 and / or the native valve leaflets 42. As the wire 20 continues to rotate, the chordae tendineae 40 are collected and pulled radially inward. The free end 22 has a radius greater than the body of the spiral coil to facilitate the capture of the chordae tendineae 40 during the rotation of the valve prosthesis 10. The frame structure 12 also moves into the native valve 4 as the wire 20 rotates. The valve prosthesis 10 is in the correct position when the chordae 40 have captured to a sufficient degree and / or the frame structure 12 is in the desired position within the native valve 40. Insertion of the device through the native valve can be aided by the natural opening and closing of the native valve during the cardiac cycle. In the illustrated embodiment, the chordae 40 are pulled inwardly into a bundle ( Fig.25 The native valve leaflets 42 are also in communication with the helical coil 20. At this stage, the valve device 10 is rigidly anchored adjacent the native valve 40 annulus.

[0092] If the physician desires to remove or reposition the valve, the helical wire 20 can be reversely rotated away from the native valve 4 and away from the device 10. The implant rotation process can then be repeated.

[0093] Once the valve 10 is located Fig.25 The frame structure 12 is expanded to the desired position shown. The frame structure 12 may include a first end and a second end opposite each other, the first end extending above the native valve and the second end extending below the native valve when the frame structure 12 is anchored to the native valve 4. In the illustrated embodiment, the frame structure 12 is provided by Figure 27-28 The balloon 48 is shown expanded. In various embodiments, the framework structure 12 is self-expanding. The self-expanding exemplary framework structure 12 is formed of a shape memory material or any material having superelastic properties. The self-expanding framework structure 12 is constructed and expanded in a manner similar to a self-expanding stent or support frame. Expanding the framework structure 12 includes removing a sheath (e.g., an outer sheath 50) of the delivery device 30 from the framework structure 12.

[0094] Once the framework structure 12 is expanded, the entire valve assembly 10 is released from the delivery catheter 30, and the delivery catheter 30 is as follows. Fig.26In some embodiments, expansion of the framework structure 12 can be performed simultaneously with release of the framework structure 12 from the delivery catheter 30 .

[0095] In the illustrated embodiment, the valve structure 14 and the frame structure 12 are deployed together. However, one of ordinary skill in the art will appreciate that the frame structure 12 may be deployed first and then receive the prosthetic valve segment 14.

[0096] In various embodiments, the valve prosthesis 10 does not include the valve segments 14. Instead, the frame structure 12 and the anchor 15 are positioned within the native valve 4. The frame structure 12 is configured to receive the valve segments 14 delivered separately. In certain embodiments, the frame structure 12 can be configured to receive one of a variety of valve sizes and types. In this way, the physician can select the appropriate valve for a single patient.

[0097] In the illustrated embodiment, the spiral wire 20 of the anchor 15 guides the valve system 10 into position adjacent to the native valve 4 along the desired axis. The wire 20 also provides initial anchoring. The valve prosthesis 10 is finally anchored when the frame structure 12 expands within the native valve 4. The frame structure 12 expands the valve leaflets 14, and the compressive force fixes the valve prosthesis 10 in place. Subsequently, tissue ingrowth ensures that the valve prosthesis 10 remains seated and does not migrate.

[0098] The valve devices according to the present invention provide multiple advantages over conventional valve systems. The embodiments described herein provide an easy-to-use, repositionable device. Unlike conventional valve systems, the valve prostheses described herein reduce the risk of injury or tearing of the chordae tendineae. Typical mitral valve replacement systems involve implanting a prosthetic ring or annulus around the valve. The ring increases the circumference of the valve and risks obstructing the inlet of the aortic valve. The valve devices described herein overcome these and other problems.

[0099] Fig.29 Another embodiment according to the present invention is shown. A valve prosthesis 10' comprises a spiral wire 20' and a frame structure 12'. The valve structure 10' is similar to the valve 10, except that the valve segments 14' are fixed to separate ends of the frame structure 12'. The wire 20' is wound around the lower portion of the frame structure 12, which has a smaller diameter than the upper portion of the frame structure 12 to which the valve segments 14' are fixed.

[0100] Figures 30A-30F Various other embodiments according to the present invention are shown. Each valve 10a-10f comprises a spiral wire and a frame. Each may optionally comprise a valve segment located within the frame.

[0101] Fig. 30AA valve prosthesis 10a is shown which is similar to valve prosthesis 10 except that free end 22a comprises an atraumatic bulb tip. Likewise, wire 20a has a tubular shape at one end and a truncated cone shape at the other end. Frame structure 12a is generally similar to frame structure 12.

[0102] Fig. 30B A valve prosthesis 10b is shown which is similar to valve prosthesis 10 except that free end 22 has a pigtail termination. Likewise, wire 20b is attached to a middle portion of frame structure 12b rather than to an end of frame structure 12b. Frame structure 12b is generally similar to frame structure 12.

[0103] Fig. 30C A valve prosthesis 10c is shown that is similar to valve prosthesis 10, except that framework structure 12c is a tubular structure rather than a support frame or stent structure. Framework structure 12c may be formed of an expandable material such as polyurethane or polycarbonate polyurethane. Wire 20c is substantially similar to wire 20. Free end 22c is substantially similar to free end 22.

[0104] Fig.30D A valve prosthesis 10d is shown that is similar to valve prosthesis 10, except that anchor 15 is formed from a three-dimensional surface 20d rather than wire 20. Three-dimensional surface 20d includes free end 22d that is substantially similar to any free end described herein.

[0105] Fig.30E A valve prosthesis 10e is shown that is similar to valve prosthesis 10, except that frame structure 12e has a conical shape rather than a tubular shape. It will be appreciated from the description herein that frame structure 12 may take a variety of shapes according to the present invention. Wire 20e is substantially similar to wire 20. Free end 22e is substantially similar to free end 22.

[0106] Fig.30F A valve prosthesis 10f similar to the valve prosthesis 10 is shown, except that the valve device 10f includes multiple wires 20f and 20f'. The use of multiple wires 20f and 20f' provides increased anchoring security. Due to the difficulty in inserting the two free ends 22f and 22f', one or both free ends 22f and 22f' may include sharp tips to puncture tissue. In this way, the sharp ends can puncture the valve ring or leaflet. Barbs or other mechanisms can be used to increase the anchoring of the wire. For example, one or more wires 20f and 20f' may include a braided surface or barbs to prevent axial dislocation when it is screwed into place.

[0107] When a feature or element is described herein as being "located "on" another feature or element, it may be located directly on the other feature or element, or there may also be intervening features and / or elements. In contrast, when a feature or element is described as being "located directly on" another feature or element, there will be no intervening features or elements. It will also be understood that when a feature or element is described as being "connected," "attached," or "coupled" to another feature or element, it may be directly connected, attached, or connected to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is described as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there will be no access features or elements. Although described or represented with respect to one embodiment, those of ordinary skill in the art will also understand that references to structures or features arranged "adjacent" another feature may have overlapping or repeated portions with adjacent features.

[0108] The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular "one", "an" and "the" are intended to also include plural forms, unless otherwise expressly specified herein. It will be further understood that the terms "include" and / or "comprise" used in the specification clearly refer to the presence of features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts and / or combinations thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the related enumerated items and can be abbreviated to " / ".

[0109] Spatially related terms such as "under", "below", "below", "above", "above", etc. may be used herein to facilitate description, thereby describing the relationship of one element or feature relative to another or feature shown in the drawings. It will be understood that spatially related terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the drawings. For example, if the device in the drawings is upside down, then the elements described as being "under" or "below" other elements or features may be oriented "above" the other elements or features. Therefore, the exemplary term "below" may include both orientations of above and below. The device may be oriented in other ways (rotated 90 degrees or located in other orientations), and the spatially related descriptions used herein are interpreted accordingly. Similarly, the terms "upward", "downward", "vertical", "horizontal", etc. are used herein for illustrative purposes only, unless otherwise expressly indicated.

[0110] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless otherwise specified herein. These terms can be used to distinguish one feature / element from another feature / element. Thus, the first feature / element described below can be referred to as the second feature / element, and similarly, the second feature / element described below can be referred to as the first feature / element without departing from the teachings of the present invention.

[0111] In this specification and the claims that follow, unless otherwise required herein, the word "comprise" and variations such as "include" and "have" mean that various components can be combined for use in the methods and articles (e.g., including components and devices of the apparatus and methods). For example, the term "comprising" will be understood to mean including any listed elements or steps, but not excluding any other elements or steps.

[0112] When a feature or element is described herein as being "located "on" another feature or element, it may be located directly on the other feature or element, or there may also be intervening features and / or elements. In contrast, when a feature or element is described as being "located directly on" another feature or element, there will be no intervening features or elements. It will also be understood that when a feature or element is described as being "connected," "attached," or "coupled" to another feature or element, it may be directly connected, attached, or connected to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is described as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there will be no access features or elements. Although described or represented with respect to one embodiment, those of ordinary skill in the art will also understand that references to structures or features arranged "adjacent" another feature may have overlapping or repeated portions with adjacent features.

[0113] The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular "one", "an" and "the" are intended to also include plural forms, unless otherwise expressly specified herein. It will be further understood that the terms "include" and / or "comprise" used in the specification clearly refer to the presence of features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts and / or combinations thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the related enumerated items and can be abbreviated to " / ".

[0114] Spatially related terms such as "under", "below", "below", "above", "above", etc. may be used herein to facilitate description, thereby describing the relationship of one element or feature relative to another or feature shown in the drawings. It will be understood that spatially related terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the drawings. For example, if the device in the drawings is upside down, then the elements described as being "under" or "below" other elements or features may be oriented "above" the other elements or features. Therefore, the exemplary term "below" may include both orientations of above and below. The device may be oriented in other ways (rotated 90 degrees or located in other orientations), and the spatially related descriptions used herein are interpreted accordingly. Similarly, the terms "upward", "downward", "vertical", "horizontal", etc. are used herein for illustrative purposes only, unless otherwise expressly indicated.

[0115] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless otherwise specified herein. These terms can be used to distinguish one feature / element from another feature / element. Thus, the first feature / element described below can be referred to as the second feature / element, and similarly, the second feature / element described below can be referred to as the first feature / element without departing from the teachings of the present invention.

[0116] In this specification and the claims that follow, unless otherwise required herein, the word "comprise" and variations such as "include" and "have" mean that various components can be combined for use in the methods and articles (e.g., including components and devices of the apparatus and methods). For example, the term "comprising" will be understood to mean including any listed elements or steps, but not excluding any other elements or steps.

[0117] As used herein in the specification and claims, including as used in the examples, and unless otherwise expressly indicated, all numbers can be read as if prefixed with the expression "about" or "approximately", even if the term does not appear explicitly. The expression "about" or "approximately" can be used when describing an amplitude and / or position indicating that the numerical value and / or position described is within a reasonable expected range of the numerical value and / or position. For example, a numerical value can have a value of + / -0.1% of the numerical value (or numerical range), a value of + / -1% of the numerical value (or numerical range), a value of + / -2% of the numerical value (or numerical range), a value of + / -5% of the numerical value (or numerical range), a value of + / -10% of the numerical value (or numerical range), etc. Any numerical value given herein should also be understood to include approximately or about the value, unless otherwise indicated herein. For example, if the value "10" is disclosed, then "approximately 10" is also disclosed. Any numerical range cited herein is intended to include all subranges contained therein. It is also understood that when a value is disclosed as "less than or equal to" a certain value, "greater than or equal to a certain value" and possible ranges between the values ​​are also disclosed, as understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" are also disclosed (e.g., where X is a value). It is also understood that in this application, data is provided in a variety of different formats, and that these data represent endpoints and starting points, as well as ranges for any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, as well as between 10 and 15, are contemplated for disclosure. It is also understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0118] The above description of specific embodiments of the present invention is given for the purpose of illustration and description. They are not intended to be exhaustive or to limit the present invention to the specific forms disclosed, and obviously, many variations, changes, substitutions, replacements and modifications are also possible under the above teachings. Various embodiments are selected and described to best explain the principles of the present invention and its practical application, thereby enabling other ordinary technicians in the field to best apply the present invention, and multiple embodiments with multiple variations are suitable for the specific applications envisioned. It is intended that the scope of the present invention is limited by the attached claims and their equivalents.

Claims

1. A heart valve prosthesis for replacing a diseased native valve in a patient's heart, the valve prosthesis comprising: a compressible and expandable frame structure, the compressible and expandable frame structure having a frame axis; A valve segment, wherein the valve segment is arranged in the frame structure, and the valve segment includes a biocompatible one-way valve; as well as a compressible and expandable anchor coupled to the framework structure and disposed radially outward from the framework structure, wherein the anchor includes a helical member and a free end; wherein the anchor and the frame structure are adapted to expand independently and separately; as well as The anchors are configured to concentrically surround the outer periphery of the frame structure so that when the anchors are expanded and the frame structure is compressed, the frame axis is centrally located within the spiral member.

2. The valve prosthesis according to claim 1, wherein: The helical member comprises a wire or a flat ribbon.

3. The valve prosthesis according to claim 1, wherein: The free end is configured to encircle a radius greater than the helical member when the anchor is rotated.

4. The valve prosthesis according to claim 1, wherein: The valve segment includes a plurality of leaflets.

5. The valve prosthesis according to claim 1, wherein: The free end is configured to enable the helical member to be introduced through the commissures of the patient's native valve.

6. The valve prosthesis according to claim 1, wherein: The free end comprises the atraumatic tip.

7. The valve prosthesis according to claim 1, wherein: The frame structure is configured to expand within the patient's native valve.

8. The valve prosthesis according to claim 1, wherein: The frame structure has a compressed state sized and dimensioned for percutaneous insertion and an expanded state sized and dimensioned for implantation in a patient's native valve.

9. The valve prosthesis according to claim 1, wherein: The frame structure includes opposing first and second ends, the first end being configured to extend above the native valve and the second end being configured to extend below the native valve when the valve prosthesis is positioned across the native valve.

10. The valve prosthesis according to claim 1, wherein: The framework structure includes an expandable stent.

11. The valve prosthesis according to claim 1, wherein: The frame structure includes an expanded outer periphery and an outer periphery that is compressed when subjected to an external radial force, wherein a diameter of the compressed outer periphery is slightly smaller than that of the expanded outer periphery.

12. The valve prosthesis according to claim 1, wherein: The frame structure is self-expanding.

13. The valve prosthesis according to claim 1, wherein: The valve segment includes at least one leaflet having an inner layer and an outer layer, and wherein the frame structure is attached to the outer layer at one or more ends of the frame structure.

14. The valve prosthesis according to claim 1, wherein: The spiral member is fixedly coupled to the frame structure at only one end of the spiral member.

15. The valve prosthesis according to claim 1, wherein: The free end is configured to capture chordae tendineae of a native valve when the anchor is rotated within the heart in the anchored configuration.

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