Heart valve sealing device and delivery device therefor

Abstract

This application relates to heart valve sealing devices and delivery devices therefor. In one representative embodiment, an implantable prosthetic device includes a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion, wherein the prosthetic device is movable between a compressed configuration in which the spacer body portion is radially compressed and axially spaced apart relative to the anchor portion, and an expanded configuration in which the spacer body portion is radially expanded outward relative to the compressed configuration and overlaps at least a portion of the anchor portion.

Description

[0001] This application is a divisional application. The original application was filed on May 13, 2016, with application number 201680027130.1 and invention title "Heart Valve Sealing Device and Delivery Device Thereof". Technical Field

[0002] The present invention generally relates to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce backflow through them, as well as devices and related methods for implanting such prosthetic devices. Background Technology

[0003] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) play a crucial role in ensuring adequate forward flow of blood through the cardiovascular system. These valves can become damaged and less effective due to congenital malformations, inflammatory processes, infectious conditions, or disease. Such damage to valves can lead to serious cardiovascular harm or death. For many years, the definitive treatment for such damaged valves was surgical repair or replacement during open-heart surgery. However, open-heart surgery is highly invasive and prone to numerous complications. Consequently, elderly and frail patients with defective heart valves often go untreated. In recent years, transvascular techniques have been developed for the introduction and implantation of prosthetic devices in a much less invasive manner than open-heart surgery. One specific transvascular technique used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein, ascending along the inferior vena cava, and into the right atrium. The septum is then punctured, and the catheter is advanced into the left atrium. Due to its high success rate, the adoption rate of this type of transvascular technique has increased.

[0004] A healthy heart has a generally conical shape that gradually narrows towards the apex. The heart has four chambers: the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by walls commonly called septa. The native mitral valve of the human heart connects the left atrium to the left ventricle. This mitral valve has an anatomical structure quite different from other native heart valves. The mitral valve comprises: an annular portion, which is a ring-shaped portion of the native valve tissue surrounding the mitral valve orifice; and a pair of apexes or leaflets extending downwards from the annulus into the left ventricle. The mitral valve annulus can be D-shaped, elliptical, or (additionally) out-of-round cross-sectional shapes with a primary axis and a secondary axis. The anterior leaflet may be larger than the posterior leaflet, thus forming a generally C-shaped boundary between the adjacent free edges of the leaflets when they are closed together.

[0005] When properly functioning, the anterior and posterior leaflets work together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also known as diastole), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as systole), the increased blood pressure in the left ventricle causes the two leaflets to come together, thereby closing the one-way mitral valve. This prevents blood from flowing back into the left atrium and instead drains it out of the left ventricle through the aortic valve. To prevent the two leaflets from detaching under pressure and folding through the mitral annulus towards the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0006] Mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of cardiac contraction, causing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has various causes, such as leaflet prolapse, papillary muscle dysfunction, and / or stretching of the mitral annulus due to left ventricular dilation. Mitral regurgitation located in the central portion of the leaflet can be called central jet mitral regurgitation, while mitral regurgitation closer to a commissure of the leaflet (i.e., where the leaflets meet) can be called eccentric jet mitral regurgitation.

[0007] Some existing techniques for treating mitral regurgitation involve directly suturing portions of the native mitral valve leaflets to each other. Other existing techniques involve using spacers implanted between the native mitral valve leaflets. Regardless of these existing techniques, there is a ongoing need for improved devices and methods for treating mitral regurgitation. Summary of the Invention

[0008] This document describes embodiments of prosthetic devices and implantation methods primarily intended for implantation in one of the mitral valve region, aortic valve region, tricuspid valve region, or pulmonary valve region of the human heart. The prosthetic devices can be used to help restore and / or replace the function of a defective native mitral valve.

[0009] In one representative embodiment, an implantable prosthesis device includes: a spacer body portion configured to be placed between native lobules of the heart; and an anchoring portion configured to fix the native lobules relative to the spacer body portion, wherein the prosthesis device is movable between a compression configuration and an expansion configuration, in which the spacer body portion is radially compressed and axially spaced relative to the anchoring portion, and in the expansion configuration the spacer body portion is radially extended outward relative to the compression configuration and overlaps at least a portion of the anchoring portion.

[0010] In some embodiments, the anchoring portion includes a plurality of anchoring members, each configured to secure a corresponding native leaflet relative to the spacer body portion. In some embodiments of those embodiments, each anchoring member has a first portion, a second portion, and a joint portion disposed between the first and second portions, wherein the first portion is spaced apart from the second portion in a compressed configuration and overlaps the second portion in an expanded configuration.

[0011] In some embodiments, the prosthetic device further includes an end member axially spaced from and movable relative to the spacer body portion, wherein a first portion of an anchoring member is pivotally coupled to the end portion of the spacer body portion, a second portion of the anchoring member is pivotally coupled to the end member, and the anchoring member is configured to fold at a joint portion when the spacer body portion moves relative to the end member. In some embodiments, the anchoring member is configured to fold at the joint portion from a compressed configuration to an extended configuration when the spacer body portion moves relatively close to the end member, and the anchoring member is configured to unfold at the joint portion from an extended configuration to a compressed configuration when the spacer body portion moves relatively away from the end member.

[0012] In some embodiments, the prosthetic device further includes a fixation member having a barb coupled to one of the anchoring members, wherein the fixation member is configured to engage and secure the native lobular tissue to said one of the anchoring members. In some embodiments of those embodiments, the fixation member is pivotally coupled to the spacer body portion and the anchoring portion.

[0013] In some embodiments, the anchoring members are movable relative to each other. In some embodiments, the spacer body portion and the anchoring portion are formed of a single piece of braided material. In some embodiments, the braided material includes nitinol. In some embodiments, the spacer body portion and the anchoring portion are self-expanding. In some embodiments, the prosthetic device is configured for implantation in the native mitral valve and to reduce mitral regurgitation.

[0014] In another representative embodiment, a component is provided. The component includes: an implantable prosthesis device having a spacer body and a plurality of anchors, wherein a first end portion of the anchors is coupled to the first end portion of the spacer body; and a delivery device having a first shaft and a second shaft, wherein the first shaft and the second shaft are movable relative to each other, wherein a second end portion of the anchors is releasably coupled to the first shaft, and a second end portion of the spacer body is releasably coupled to the second shaft, wherein the delivery device is configured such that moving the first shaft and the second shaft relative to each other causes the prosthesis device to move between a first configuration and a second configuration, wherein in the first configuration the spacer body is radially compressed and axially spaced relative to the anchors, and in the second configuration the spacer body is radially extended outward relative to the compressed configuration and the anchors at least partially overlap the spacer body to capture native leaflets between the anchors and the spacer body.

[0015] In some embodiments, a first shaft of the delivery device extends through a second shaft of the delivery device and a spacer body of the prosthesis, and the first shaft is axially movable relative to the spacer body. In some embodiments, the first shaft of the delivery device is a plurality of anchoring shafts, each of which is releasably coupled to a corresponding anchor of the prosthesis and is movable relative to the other anchoring shafts.

[0016] In some embodiments, each anchor has a first portion, a second portion, and a joint portion disposed between the first and second portions, wherein the first portion is spaced relative to the second portion in a first configuration and overlaps the second portion in a second configuration. In some embodiments, the prosthetic device further includes an end member spaced from and movable relative to the spacer body, wherein the first portion of the anchor is pivotally coupled to the end portion of the spacer body, the second portion of the anchor is pivotally coupled to the end member, and the anchor folds at the joint portion as the spacer body moves relative to the end member. In some embodiments, the anchor folds at the joint portion from a compressed configuration to an extended configuration as the spacer body moves relatively closer to the end member, and unfolds at the joint portion from an extended configuration to a compressed configuration as the spacer body portion moves relatively away from the end member.

[0017] In some embodiments, the prosthetic device further includes a fixation member having barbs coupled to an anchor and configured to engage native lobular tissue to secure the anchor to the native lobule.

[0018] In another representative embodiment, a method for implanting a prosthetic device is provided. The method includes: advancing the prosthetic device in a compression configuration to an implantation location using a delivery device, wherein the prosthetic device includes a spacer body, a first anchor, and a second anchor; radially extending the prosthetic device from the compression configuration to an extended configuration; capturing a first progenitor leaflet between two surfaces of the first anchor; capturing a second progenitor leaflet between two surfaces of the second anchor; securing the first and second progenitor leaflets against the spacer body of the prosthetic device; and releasing the prosthetic device from the delivery device.

[0019] In some embodiments, the action of capturing the first native leaflet occurs before the action of capturing the second native leaflet, and the action of capturing the second native leaflet occurs before the action of fixing the first and second native leaflets against the spacer body of the prosthesis device. In some embodiments, the action of capturing the first native leaflet occurs by actuating a first member of the delivery device, and the action of capturing the second native leaflet occurs by actuating a second member of the delivery device. In some embodiments, the first and second native leaflets are fixed against the spacer body of the prosthesis device by moving the first axis of the delivery device relative to the second axis of the delivery device.

[0020] The above and other objects, features and advantages of the present invention will become more apparent from the following detailed description taken with reference to the accompanying drawings. Attached Figure Description

[0021] Figures 1-3 This demonstrates an implantable prosthesis device in various deployment phases according to one embodiment.

[0022] Figures 4-5 An implantable prosthesis device is shown at various deployment stages according to another embodiment.

[0023] Figures 6-8 An implantable prosthesis device is demonstrated for delivery and implantation within the native mitral valve according to one embodiment.

[0024] Figures 9-12 Various views show another embodiment of the implantable prosthesis device.

[0025] Figures 13-17 Demonstrating delivery and implantation within the native mitral valve Figures 9-12 The prosthetic device.

[0026] Figure 18 This is a side view of another embodiment of the implantable prosthesis device.

[0027] Figures 19a-19h The display can be used to form, for example Figures 9-12 or Figure 18The exemplary thermoforming process of those prosthetic devices shown in the image.

[0028] Figures 20-24 Various views show another embodiment of the implantable prosthesis device.

[0029] Figures 25-26 This is a side view of another embodiment of the implantable prosthesis device.

[0030] Figures 27-34 Showing different deployment stages Figures 25-26 Various views of the prosthetic device.

[0031] Figure 35 Another embodiment of an implantable prosthesis device implanted within the native mitral valve is shown.

[0032] Figure 36 Another embodiment of an implantable prosthesis device implanted within the native mitral valve is shown.

[0033] Figures 37-47 Various views show another embodiment of the implantable prosthesis device.

[0034] Figures 48-52 Various views show another embodiment of the implantable prosthesis device.

[0035] Figure 53 Another embodiment of an implantable prosthesis device is shown.

[0036] Figures 54-58 Demonstrating the various deployment stages within the native mitral valve Figure 53 The prosthetic device.

[0037] Figures 59-61 Various views show another embodiment of an implantable prosthesis device at different deployment stages.

[0038] Figure 62 It is one side of a steerable delivery device for an implantable prosthesis according to one embodiment.

[0039] Figure 63A and 63B They are Figure 62 End and side views of the expandable basket section of the delivery device.

[0040] Figure 64 yes Figure 63A and Figure 63B The image shows a side view of the basket section in the extended configuration.

[0041] Figure 65A and Figure 65B They are Figure 62 End view and side view of the intermediate shaft of the delivery device.

[0042] Figure 66 yes Figure 62 A cross-sectional view of the proximal shaft of the delivery device.

[0043] Figure 67 Demonstration and use Figure 62 The delivery device delivers the prosthetic device to the native mitral valve.

[0044] Figure 68 It is the side of a steerable delivery device for an implantable prosthesis according to another embodiment.

[0045] Figure 69 yes Figure 68 Exploded perspective view of the delivery device.

[0046] Figures 70A-71B The display can be incorporated into Figure 68 Various views of the grooved metal tube in the steerable shaft inside the delivery device.

[0047] Figures 72-74 Various views show alternative embodiments of steering control components that can be incorporated into a delivery device.

[0048] Figure 75 This is a cross-sectional view of another embodiment of a steering control component that can be incorporated into a delivery device.

[0049] Figures 76-79 Various views show alternative embodiments of steering control components that can be incorporated into a delivery device.

[0050] Figures 80-82 Various views show alternative embodiments of steering control components that can be incorporated into a delivery device.

[0051] Figures 83-85 Various views show alternative embodiments of steering control components that can be incorporated into a delivery device.

[0052] Figures 86-87 These are, respectively, an end view and a side view of a catheter position locking device according to one embodiment.

[0053] Figures 88-91 Various views showing another embodiment of the catheter position locking device.

[0054] Figures 92-96 Various views showing another embodiment of the catheter position locking device.

[0055] Figures 97-98 These are perspective and end views of another embodiment of the catheter position locking device.

[0056] Figures 99-102Various views are shown of another embodiment of a delivery device for delivering a prosthesis within the native mitral valve.

[0057] Figure 103 It is possible to merge into Figures 99-102 A perspective view of an exemplary clamp / prosthetic device holding mechanism in a delivery device.

[0058] Figures 104-106 Various views show the prosthetic device connected to the delivery device for delivery into the patient's body.

[0059] Figures 107-110 Various views are shown of another embodiment of a delivery device for delivering a prosthesis within the native mitral valve.

[0060] Figure 111 It is possible to merge into Figures 107-110 A perspective view of an exemplary clamp / prosthetic device holding mechanism in a delivery device.

[0061] Figure 112 This is a cross-sectional view of an exemplary embodiment of the non-circular shaft of the delivery device.

[0062] Figure 113 This is a cross-sectional view of another exemplary embodiment of the non-circular shaft of the delivery device.

[0063] Figure 114 Another exemplary embodiment of an implantable prosthesis device is shown.

[0064] Figure 115 Another exemplary embodiment of an implantable prosthesis device is shown.

[0065] Figure 116 Another exemplary embodiment of an implantable prosthesis device is shown.

[0066] Figure 117 An exemplary embodiment of an anchor that can be incorporated into an implantable prosthesis device is shown.

[0067] Figure 118 Another exemplary embodiment of an implantable prosthesis device is shown.

[0068] Figures 119A-119F Another exemplary embodiment of an implantable prosthesis device is shown.

[0069] Figures 120A-120C Another exemplary embodiment of an implantable prosthesis device is shown.

[0070] Figures 121A-121D Another exemplary embodiment of an implantable prosthesis device is shown.

[0071] Figures 122A-122D Another exemplary embodiment of an implantable prosthesis device is shown.

[0072] Figures 123A-123D Another exemplary embodiment of an implantable prosthesis device is shown.

[0073] Figures 124A-124F Showing at each deployment stage Figures 123A-123D The prosthetic device.

[0074] Figures 125A-125E Another exemplary embodiment of an implantable prosthesis device is shown.

[0075] Figures 126A-126J Another exemplary embodiment of an implantable prosthesis device is shown.

[0076] Figures 127A-127F Another exemplary embodiment of an implantable prosthesis device is shown.

[0077] Figure 128 An alternative embodiment of the steering control mechanism for the delivery device is shown.

[0078] Figures 129-130 Another exemplary embodiment of an implantable prosthesis device is shown.

[0079] Figures 131-133 An exemplary embodiment of an implantable prosthetic heart valve is shown.

[0080] Figures 134-135 An exemplary embodiment of a frame that can be implanted with a prosthetic heart valve is shown. Detailed Implementation

[0081] This document describes embodiments of prosthetic devices and implantation methods primarily intended for implantation in one of the mitral, aortic, tricuspid, or pulmonary valve regions of the human heart. The prosthetic devices are capable of assisting in the restoration and / or replacement of the function of a defective native mitral valve. The disclosed embodiments should not be construed as limiting in any way. Rather, the invention is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, individually or in various combinations and sub-combinations with each other.

[0082] Prosthetic spacer

[0083] The prosthetic septum device includes a septum body and at least one anchor. The body is configured to be positioned within the native mitral valve orifice to help create a more effective seal between the native leaflets to prevent or minimize mitral regurgitation. The body can include a blood-impermeable structure that allows the native leaflets to close around the sides of the body during ventricular systole to prevent blood from flowing back from the left ventricle into the left atrium. The body is sometimes referred to herein as a septum because it can fill the space between improperly functioning native mitral valve leaflets that have not closed completely naturally.

[0084] The body can have various shapes. In some embodiments, the body can have an elongated cylindrical shape with a circular cross-section. In other embodiments, the body can have an oval cross-section, a crescent-shaped cross-section, or various other non-cylindrical shapes. The body can have an atrial end or upper end located in or near the left atrium, a ventricular end or lower end located in or near the left ventricle, and an annular lateral surface extending between the original mitral valve leaflets.

[0085] The anchor can be configured to secure the device to one or both of the native mitral leaflets, such that the body is positioned between the two native leaflets. In some embodiments, the anchor can be attached to the body at a location adjacent to the ventricular end of the body. In some embodiments, the anchor can be attached to a shaft, to which the body is also attached. In some embodiments, the anchor and body can be positioned independently of each other by moving each anchor and body individually along the longitudinal axis of the shaft. In some embodiments, the anchor and body can be positioned simultaneously by moving the anchor and body together along the longitudinal axis of the shaft. The anchor can be configured to be positioned posterior to the native leaflet at implantation such that the leaflet is captured between the anchor and the body.

[0086] The prosthetic device can be configured for implantation via a delivery sheath. The body and anchor can be compressed to a radially compressed state and self-expanded to a radially expanded state upon release of the compression pressure. The device can be configured to allow the anchor to initially self-expand radially away from the still-compressed body to create a gap between the body and anchor. A native leaflet can then be positioned within this gap. The body can then be allowed to self-expand radially, thereby closing the gap between the body and anchor and capturing the leaflet between the body and anchor. Implantation methods can vary across different embodiments, and each embodiment is discussed more fully below. Additional information on these and other delivery methods can be found in U.S. Patent No. 8,449,599 and U.S. Patent Application Publications Nos. 2014 / 0222136 and 2014 / 0067052.

[0087] Some embodiments disclosed herein are generally configured to be secured to both the anterior and posterior native mitral leaflets. However, other embodiments include only one anchor and can be configured to be secured to one of the mitral leaflets. Unless otherwise stated, any of the embodiments disclosed herein that include a single anchor can optionally be secured to either the anterior or posterior mitral leaflet, regardless of whether a particular embodiment is shown as being secured to a particular leaflet.

[0088] By hooking the anchor around the leaflet, the tension from the native chordae tendineae resists high systolic blood pressure (causing the device to tilt toward the left atrium), preventing atrial embolism in some disclosed prosthetic devices. During diastole, the device is able to resist embolism into the left ventricle by relying on the compressive force applied to the leaflet trapped between the body and the anchor.

[0089] Figures 1-3 An implantable prosthesis device 10 according to one embodiment is shown. The prosthesis device 10 in the illustrated embodiment includes a ventricular portion 12, a spacer body 14, and an inner shaft 16, the ventricular portion 12 and the spacer body 14 being mounted on the inner shaft 16. The ventricular portion 12 includes a collar-like member 18 disposed on the shaft 16, and one or more (two in the illustrated embodiment) ventricular anchors 20 extending from the collar-like member 18. An end cap 22 can be attached to the distal end of the shaft 16 to retain the ventricular portion 12 on the shaft.

[0090] The proximal end of the spacer body 14 is secured to a collar or nut 24, which is mounted on a shaft 16 close to the spacer body 14. Thus, the shaft 16 extends coaxially through the collar 24, the spacer body 14, and the collar 18 of the ventricular portion 12. The device 10 may further include an outer shaft or sleeve 26, which extends coaxially over the proximal portion of the inner shaft 16 and is attached to the collar 24 at its distal end. The inner shaft 16 is rotatable relative to the outer shaft 26 and the spacer body 14 to allow axial movement of the spacer body along the inner shaft 16 toward and away from the ventricular portion 12, as further described below.

[0091] The spacer body 14 can include a blood-impermeable fabric 30 ( Figure 1 and 2 ) Covered by a ring-shaped metal frame 28 ( Figure 3 ). Figure 3The spacer body 14 of a frame 28 is shown covered by a blood-impermeable fabric 30. The frame 24 can include a mesh structure comprising multiple interconnected metal struts, such as a conventional radially compressible and expandable support. In the illustrated configuration, the frame 28 has a generally spherical shape, but in other alternative embodiments, the frame can have various other shapes (e.g., cylindrical, conical, etc.). In other embodiments, the body can include a solid block of material, for example, a flexible, sponge-like, and / or elastic material block formed from a biocompatible polymer (e.g., silicone).

[0092] Frame 24 can be formed of a self-expanding material (e.g., nitinol). When formed of a self-expanding material, frame 24 can be radially compressed into a delivery configuration and can be held in the delivery configuration by placing the device within a sheath of the delivery device. When deployed via the sheath, frame 24 can self-expand to its functional size. In other embodiments, the frame can be formed of a plastically expandable material, such as stainless steel or a cobalt-chromium alloy. When formed of a plastically expandable material, the prosthetic device can be rolled up onto a delivery device and radially expanded to its functional size via an inflatable balloon or equivalent expansion mechanism. It should be noted that any of the embodiments disclosed herein can include a self-expanding body or a plastically expandable body.

[0093] The inner shaft 16 can (for example) include a screw or helical coil with external threads (such as... Figures 1-3 (As shown in the diagram). The collar-shaped member 24 has internal threads that engage the individual turns of the coil, or, in the case where the shaft includes a screw, external threads that engage the screw. Therefore, rotation of the inner shaft 16 relative to the outer shaft 26 effectively moves the collar-shaped member 24 along the length of the shaft 16, and thus moves the spacer body 14. Rotation of the inner shaft 16 relative to the outer shaft 26 can be releasably connected to a delivery device (e.g., for example) of the inner shaft 16 by rotation. Figures 6-8 This is achieved using a rotatable torque shaft (shown in the diagram). The delivery device can have a corresponding outer shaft that is releasably connected to the outer shaft 26 and configured to limit the rotation of the outer shaft 26 when the inner shaft 16 rotates via the torque shaft.

[0094] Device 10 can be delivered percutaneously to the native heart valve (e.g., mitral valve) using a delivery device. Figure 1 Displayed on the native leaflet installed on the mitral valve ( Figures 1-3 The spacer body 14 is positioned in a pre-anchored proximal position before the primary lobule (not shown) and spaced from the ventricular portion 12. Anchors 20 are positioned in the left ventricle behind the primary lobule (e.g., desirably at the A2 and P2 regions of the lobule, as specified by Carpentier nomenclature). The spacer body 14 is then moved toward the ventricular portion 12 (e.g., by rotating the torque shaft of the delivery device) to... Figure 2The position shown in the image allows the leaflet to be captured between the anchor 20 and the spacer body 14.

[0095] When the device 10 is fixed to the two leaflets, this brings them closer together around the spacer body 14. By doing so, the device 10 reduces the total area of ​​the mitral valve orifice and divides the mitral valve orifice into two orifices during diastole. Therefore, by reducing the area through which mitral regurgitation can occur, leaflet coaptation can initiate at the location of the body 14, and the leaflets can more easily and completely coapt, thereby preventing or minimizing mitral regurgitation.

[0096] Due to the flexible nature of the main body 14, the spacer body 14 can be further expanded in circumference and / or width / diameter by rotating against the ventricular portion 12 via the inner shaft 16. This action compresses the end portion of the main body 14 between the anchor collar 24 and the collar 12, thereby causing the main body 14 to shorten axially and expand radially in the middle portion. Conversely, moving the main body 14 away from the ventricular portion 12 allows the main body to contract radially.

[0097] The adjustability of device 10 offers several advantages over existing devices. For example, device 10 can be advantageously used to modify the degree of mitral regurgitation because it can be configured to correspond to various junctions by expanding or contracting the body 14, thus reducing the need to manufacture multiple devices. Another advantage is that, for example, the physician can adjust the body 14 to the desired configuration during the initial implantation procedure without extensive pre-procedure measurements and monitoring. Existing devices require extensive pre-procedure measurements to ensure the selection of an appropriately sized implant, but now the physician can adjust the size of the body 14 during the implantation procedure by monitoring the procedure with echocardiography and adjusting the body 14 to the desired configuration and size.

[0098] Furthermore, the device 10 can be advantageously adjusted after the initial placement procedure to reposition, expand, or contract the device 10 to achieve improved results relative to the initial configuration. Another advantage of the device 10 is that the anchor 12 and the body 14 can be positioned independently. This is advantageous compared to existing systems, as it is often difficult to simultaneously align the anchor and the body due to the movement of the leaflets during cardiac diastole and systole.

[0099] The body 14 of the device 10 can also be configured to address mitral backflow in central and / or eccentric jets. Such configurations can include various sizes and / or geometries of the body 14.

[0100] Figure 4 and Figure 5Another exemplary embodiment of the implantable prosthesis device 100 is shown. The device 100 includes one or more (two in the illustrated embodiment) ventricular anchors 102, a spacer body 104, a threaded shaft 106, a proximal nut 108, and a distal stop 116. The shaft 106 extends coaxially through the body 104, the nut 108, and the stop 116.

[0101] The main body 104 may include a first annular collar-shaped member 110 located distally around the shaft 106 and toward the ventricular end of the main body 104 of the device 100, a second annular collar-shaped member 112 located proximally around the shaft 106 and toward the atrial end of the main body 104 of the device 100, and a plurality of struts 114 extending between the first and second collar-shaped members 110, 112.

[0102] Each support post 114 can be fixedly attached to a first collar-shaped member 110 corresponding to a first end of the support post 114, and fixedly attached to a second collar-shaped member 112 corresponding to a second end of the support post 114. The support post 114 can be fixedly attached to the collar-shaped members 110, 112, for example, by forming the support post 114 and the collar-shaped members 110, 112 from a single piece of material (e.g., laser-cut metal tubing). In other embodiments, the support post 114 can be fixedly attached to the collar-shaped members 110, 112, for example, by adhesives, welding, fasteners, etc. The anchor 102 is also fixedly attached to the distal collar-shaped member 110, for example, by welding, fasteners, adhesives, or by forming the anchor and collar-shaped member from a single piece of material. Although Figure 4 and 5 Not shown in the figure, the main body 104 can be used in a similar manner. Figure 1 and 2 The fabric 30 shown is covered with a blood-impermeable covering (e.g., fabric).

[0103] In the illustrated embodiment, the distal stop 116 is secured to the shaft 106 and serves to prevent the distal collar 110 from moving along the shaft 106 (in... Figure 4 and 5 The distal end moves (from center to left). The proximal collar 112 can be secured to the nut 108, which has an internal thread that engages with the external thread of the shaft 106. Thus, rotation of the shaft 106 causes the nut 108 and (therefore) the proximal collar 112 to move toward and away from the distal collar 110, thereby radially expanding and contracting the support 114, respectively.

[0104] Anchor 102 and post 114 can be formed of a self-expanding material (e.g., nitinol). When formed of a self-expanding material, anchor 102 and post 114 can be radially compressed into a delivery configuration and can be held in the delivery configuration by placing the device within the sheath of the delivery equipment. When deployed from the sheath, anchor 102 can expand radially, thereby creating a gap between anchor 102 and post 114, such as... Figure 4 As shown in the diagram. In this configuration, the native leaflet of the heart valve can be placed in the gap between the anchor 102 and the strut 114. The leaflet can then be secured between the anchor 102 and the strut 114 by axial movement of the proximal collar member 112 along the shaft toward the distal collar member 110 via rotation of the shaft. As the proximal collar member 112 moves toward the distal collar member 110, the strut 114 buckles or flexes away from the longitudinal axis of the shaft 106 toward the anchor 102, as shown in the diagram. Figure 5 As shown in the diagram, the axial position of the proximal neck collar 112 can be adjusted until the anchor 102 and the strut 114 apply clamping force against the opposite side of the leaflet, so that the device 100 maintains its position relative to the leaflet during cardiac diastole and systole.

[0105] The rotation of shaft 106 relative to nut 108 and body 104 can be releasably connected to a delivery device (e.g., for example) of shaft 106 via rotation. Figures 6-8 This is achieved using a rotatable torque shaft (shown in the diagram). The delivery device can have a corresponding outer shaft that is releasably connected to the nut 108 and configured to limit the rotation of the nut 108 when the shaft 106 is rotated by the torque shaft.

[0106] Figure 4 and Figure 5 The shaft 106 shown includes a rigid bolt; however, the shaft 106 can include a flexible screw or a flexible helical coil, similar to... Figures 1-3 Shaft 16 is shown in the image.

[0107] In an alternative embodiment, the position of the entire body 104 (including the proximal collar member 110 and the distal collar member 112) can be adjusted along the length axis of the shaft 106 (in which case the stop 116 is not fixed to the shaft 106). Positioning of the body 104 along the shaft can be achieved by rotating the shaft 106 relative to the body, or vice versa. Once the desired position of the body 104 along the shaft 106 is achieved, the stop member 118 can be positioned along the shaft in an abutment relative to the stop 116 (the stop member 118 is shown spaced apart from the stop 116 in the figures) to prevent further distal movement of the body 104 along the shaft. Further rotation of the shaft 106 causes the proximal collar member 112 to move toward the distal collar member 110, thereby causing the strut 114 to extend.

[0108] In another embodiment, the distal portion of the shaft 106 is threaded in one direction, and the proximal portion of the shaft 106 is threaded in the opposite direction. The threads of the proximal portion of the shaft engage the internal threads of the nut 108. Similarly, the stop 116 can include a nut having internal threads that engage the threads of the distal portion of the shaft. In this way, rotation of the shaft relative to the body 104 in a first direction causes the distal collar 110 and the proximal collar 112 to move toward each other, and rotation of the shaft relative to the body 104 in a second direction (opposite to the first direction) causes the distal collar 110 and the proximal collar 112 to move away from each other, similar to a turnbuckle.

[0109] Figures 6-8 An implantable prosthesis device 200 according to another embodiment is demonstrated to be deployed into the mitral valve from a delivery device 202 via a transseptal technique. The prosthesis device 200 may include an expandable spacer body 204, one or more (two in the illustrated embodiment) ventricular anchors 206 coupled to and extending from a distal portion of the spacer body 204, a shaft 208 extending through the spacer body 204, and a nut 210 disposed on the shaft 208. The nut 210 may have internal threads that engage external threads on the shaft 208, and may be restricted to rotational movement such that rotation of the shaft 208 causes axial movement of the nut 210 along the length of the shaft 208.

[0110] The delivery device 202 may include an external catheter 212 and an implantation catheter 214. The implantation catheter 214 may include a delivery sheath 216, a nut support shaft 218, and a torque shaft 220. Before insertion into the patient's body, the prosthesis device 200 may be connected to the nut support shaft 218 and the torque shaft 220 and loaded into the delivery sheath 216. The external catheter 212 may be advanced through the femoral vein, the inferior vena cava, into the right atrium, across the septum 222, and into the left atrium 224 (e.g., Figure 6 (As shown in the diagram). The external catheter 212 can be advanced over the guide wire 226, which can be inserted into the patient's vascular structure and used to cross the septum 222 before the external catheter 212 is introduced into the patient's body. Figure 6 The diagram further demonstrates that the implanted catheter 214 and prosthetic device 200 can be inserted through the external catheter 212 and into the left atrium 224. The implanted catheter 214 can be advanced across the native mitral valve leaflet 228 until the anchor 206 of the prosthetic device is in the left ventricle.

[0111] like Figure 7As shown, the delivery sheath 216 can subsequently retract to expose the prosthetic device 200. The spacer body 204 can self-extend to a radially extended state after deployment from the delivery sheath 216. Alternatively, when the spacer body is deployed from the sheath 216, the spacer body 204 can be held in a radially compressed state by the nut-supported shaft 218. After deployment of the prosthetic device 200 from the sheath 216, the torque shaft 220 can be rotated to open the anchor 206 to an ideal position for capturing the leaflet 226.

[0112] Anchor 206 can be positioned behind leaflet 228 (e.g., desirably at positions A2 and P2). Leaflet 228 can then be secured between anchor 206 and spacer body 204 by rotational torque shaft 220 and shaft 208, thereby causing nut 210 to move axially along anchor 206 in the proximal direction. The movement of nut 210 effectively pushes anchor 206 inwardly radially against leaflet 228 (e.g., ...). Figure 8 (As shown in the diagram). Therefore, the prosthesis device 200 can be fixed to the leaflet 228 by clamping the leaflet 228 between the anchor 206 and the body 204. Subsequently, as shown in the diagram... Figure 8 As shown, the nut support shaft 218 and torque conduit 220 can be released from the prosthesis device, and the implanted conduit can be retracted into the outer conduit.

[0113] Figure 9 An exemplary implantable prosthesis device 300 according to another embodiment is shown. The prosthesis device 300 in the illustrated embodiment includes a ventricular portion 302, a spacer body 304, a shaft 306, and a proximal end 308. The ventricular end portion 302 includes one or more (two in the illustrated embodiment) anchors 310 extending from the ventricular end of the shaft 306. Figure 9 Also shown is a wire 320 extending through the device 300. The wire 320 can be used during the device placement procedure (described below).

[0114] like Figure 10 As shown, device 300 can be formed from a single piece of material. In some embodiments, individual components of device 300 can be formed from a single piece of material, which can be securely fastened together by adhesives, welding, fasteners, etc. Device 300 can be formed from a self-expanding braided material. The braided material can be formed from metal wire (e.g., nitinol). When formed from a braided material, device 300 can be covered with a blood-impermeable covering (similar to...). Figure 1 and 2 The fabric 30 shown is covered or coated with a flexible sealant material such as expanded polytetrafluoroethylene (commonly known as “ePTFE”), which allows the braided material to expand and / or bend while preventing blood flow through the device 300.

[0115] In the illustrated embodiment, the body 304 of device 300 has a generally spherical shape, but in other embodiments, the body 304 can have various other shapes (e.g., cylindrical, conical, etc.). The body 304 of device 300 can also be configured to address central and / or eccentric jet mitral backflow. Such configurations can include various sizes and / or geometries of the body 304. As shown, the body 304 of device 300 can be a monolithic component of device 300 formed from a single piece of self-expanding braided material (e.g., braided nitinol). In other embodiments, the body 304 can be formed from a single piece of material, including different materials such as plastically expandable materials or polymeric materials (similar to those materials described above with reference to spacer body 14).

[0116] When formed from a self-expanding braided material, the device 300 is capable of radial compression into a delivery configuration. Figure 10 (As shown in the image), and can be held in a delivery configuration by placing the device 300 in the sheath of the delivery device. The device 300 can be axially elongated by deploying the anchor 310 so that the anchor 310 extends parallel to the shaft 306 from the ventricular end away from the proximal end 308, and the device 300 can be radially compressed by radially compressing the spacer body 304 to approximately the same diameter as the shaft 306, such as... Figure 10 As shown in the figure. When the device 300 is in the delivery configuration, the device 300 is able to be percutaneously delivered to the native heart valve (e.g., the mitral valve) using a delivery device.

[0117] Once the device 300 is percutaneously delivered to the native heart valve using the delivery device, the delivery sheath can be removed from the device 300, allowing the device 300 to fold and expand. Figure 11 and 12 The text describes the expanded functionality of the software. It mentions the native leaflet (…). Figure 11 and 12 (Not shown) The spacer body 304 of the device 300 is held between the anchor 310 and the spacer body 304, making it more tightly packed together around the spacer body 304. By doing so, the device 300 reduces the total area of ​​the mitral valve orifice and divides the mitral valve orifice into two orifices during diastole. Therefore, by reducing the area through which mitral regurgitation can occur, leaflet engagement can initiate at the location of the body 304, and the leaflets can more easily and completely engage, thereby preventing or minimizing mitral regurgitation.

[0118] For example, Figures 13-17The device 300 is delivered to the mitral valve using a delivery device 312. The delivery device 312 may include an external catheter (not shown) and a device catheter 314. The device catheter 314 may include a delivery sheath 316 and a shaft 318. Before insertion into the patient's body, the proximal end 308 of the device 300 may be releasably connected to the shaft 318 of the device catheter 314 and loaded into the delivery sheath 316, thus holding the device 300 in a delivery configuration.

[0119] Lead 320 can be advanced through the patient's femoral vein and inferior vena cava, into the right atrium, across the septum 322, into the left atrium 324, across the mitral valve leaflet 326, and into the left ventricle 328. The external catheter can be advanced over lead 320 and into the left atrium 324. Device catheter 314, together with device 300, can be advanced over lead 320, through the external catheter, and into the left atrium 324. Device catheter 314 can be advanced across the mitral valve leaflet 326 until the anchor 310 of device 300 is in the left ventricle 328.

[0120] like Figure 13 As shown, the delivery sheath 316 of the device conduit 314 can subsequently retract to expose the anchor 310 of the device 300. Exposing the anchor 310 allows for a radially compressed delivery configuration of the anchor 310 without folding. Figure 10 (As shown in the image) Self-expanding radial expansion configuration that folds ( Figure 9 , 11 (As shown in -12). With the anchor exposed, the shaft 318 of the delivery conduit 314 can be rotated to orient the anchor 310 to an ideal position for capturing the leaflet 326.

[0121] like Figure 14 As shown, the anchor can be positioned behind the ventricular portion of leaflet 326 (e.g., desirably at positions A2 and P2). Figure 15 The delivery sheath 316 of the demonstration device catheter 314 can then be further retracted to expose the spacer body 304 of the device 300, thereby allowing the body 304 to self-extend to a radially extended configuration. In the extended configuration, the body 300 of the device 300 contacts the atrial portion of the leaflet 326. Thus, the leaflet 326 is secured between the anchor 310 and the body 304 by utilizing the compressive forces applied by the anchor 310 and the body 304 to the ventricle and atrial portions of the leaflet 326, respectively.

[0122] With the leaflet 326 fixed between the anchor and the main body, the shaft 318 of the device guide tube 314 can be disconnected from the proximal end 308 of the device 300 (e.g. Figure 16(As shown in the image), and the device catheter 312 can retract into the outer catheter. The outer catheter and lead 320 can then be retracted and removed from the patient, as shown in the image. Figure 17 As shown in the diagram. Device 300 can have an inner foam core, such that when the lead 320 is retracted through the device, the inner foam seals the lead lumen to prevent blood from flowing through the device 300.

[0123] Figure 18 An exemplary implantable prosthesis device 400 with an overall configuration similar to device 300 is shown, comprising a ventricular end portion 402, a spacer body 404, a shaft 406, and a proximal portion 408. The ventricular end portion 402 includes one or more (two in the illustrated embodiment) anchors 410 extending from it. The spacer body 404 includes a plurality of friction elements 416. For example, each of the plurality of friction elements 416 may include an outwardly projecting portion capable of pressing into and / or penetrating the lobular tissue to minimize lobular movement between the anchors 410 and the body 404 and to improve tissue inward growth, such as... Figure 18 As shown in the illustration. In another embodiment, the friction element may include a blood-impermeable covering formed in the body 404 and / or a textured surface applied to the blood-impermeable covering of the body 404.

[0124] The device 400 may also include one or more (two in the illustrated embodiment) wires, threads, tethers, or chords 412 and clamps 414. Wires 412 may include a distal end 418, a proximal end 420, and an intermediate portion 422 positioned between the distal end 418 and the proximal end 420. The distal end 418 of each of the wires 412 may be securely attached to a corresponding anchor 410 of the device 400 by adhesive, welding, fasteners, etc. The proximal ends 420 of each wire 412 may be releasably connected to additional wires (not shown) of a delivery device. The intermediate portions 422 of each wire 412 extend coaxially through the shaft 406, the body 404, and the clamps 414 of the device 400. The clamps 414 may be securely attached to the proximal end 408 of the device 400 by adhesive, welding, fasteners, etc. The clamps 414 may also be adjustably connected to the wires 412 and releasably connected to a delivery device (not shown).

[0125] Device 400 can use similar methods as described above relative to device 300 (see above). Figures 13-17 The delivery devices and procedures described herein are used for percutaneous delivery to native heart valves (e.g., mitral valve).

[0126] Due to the flexible nature of the device 400 and the addition of the wire 412 and clamp 414, the clamping force on the leaflet can be further increased by applying tension to the proximal end 420 of the wire 412 (pulling the wire proximal in the direction of arrow 424) while maintaining the axial position of the clamp 414. This action pulls the anchor 410 toward the body 404, thereby reducing the space between the anchor 410 and the body 404. Tension can be applied to the proximal end of the wire 412, for example, by pulling an additional wire that can be releasably connected to the proximal end of each wire 412 of the delivery device. The clamp 414 can be configured to maintain the axial position of the wire 412 when the tension is removed. For example, the clamp 414 can be configured to allow axial movement of the wire 412 in the proximal direction 424 when the tension is removed, but prevent axial movement of the wire 412 in the opposite direction. In another embodiment, for example, the wire 412 may include teeth and the clamp 414 may include pawls to form a ratchet that only allows the wire 412 to move proximally relative to the clamp 414.

[0127] Figure 19 illustrates an exemplary thermoforming sequence for manufacturing apparatus 300, 400. This is achieved by placing tubular sheets of wound, self-expanding material above a mandrel and then... Figures 19a-19h The configuration shown in the diagram anneales the material to form apparatus 300 and 400. When formed in this sequence, the apparatus expands in the same sequence as when exposed from the delivery sheath.

[0128] Figure 20-24 An exemplary embodiment of an implantable prosthesis device 500 similar to device 300 according to another embodiment is shown. The prosthesis device 500 in the illustrated embodiment includes a ventricular portion 502, a spacer body 504, and an inner shaft 506 on which the ventricular portion 502 and the spacer body 504 are mounted.

[0129] like Figure 22 (The display device is in a compressed delivery state) for optimal display, the ventricular portion 502 includes a distal end 508 and a proximal end 510 each mounted on a shaft 506. Figure 22 (as shown in the illustration), and one or more (in the illustrated embodiment, one) ventricular anchors 512 extending from the distal portion 508. In some embodiments ( Figure 21b In the illustration, the ventricular portion 502 may also include one or more openings 522 located near the distal end 508 of the ventricular portion 502. For example... Figure 21b The device 500 shown has two openings 522; however, because the openings are of the same shape and size and positioned opposite each other (circumferentially), they appear as only one opening. When the ventricular portion 502 is folded into a radially expanded functional state, such openings 522 effectively create multiple ventricular anchors 512 ( Figure 21b (Two in total), as further described below. In an alternative embodiment, the ventricular portion 502 of the device 500 may, for example, have three openings 520, thereby effectively generating three anchors for use in a heart valve comprising three native leaflets (e.g., a tricuspid valve).

[0130] The distal sleeve 514 can be inserted above the distal end 508 of the ventricular portion 502 and is mounted to the distal end of the shaft 506 to radially compress the distal end 508 against the inner shaft 506 and hold the ventricular portion 502 on the shaft 506. The proximal end 510 of the ventricular portion 502 is attached to the intermediate sleeve 516 disposed on the shaft 506. Figure 22 The distal end of the spacer body 504 is attached to the proximal end of the intermediate sleeve 516, which in turn is attached to the distal end of a proximal sleeve or shaft 518 that extends coaxially above the proximal end of the inner shaft 506. Thus, the inner shaft 506 extends coaxially through the proximal sleeve 518, the spacer body 504, the intermediate sleeve 516, the ventricular portion 502, and the end cap 514. The inner shaft 506 is movable relative to the proximal sleeve 518 and the intermediate sleeve 516 to allow for extension of the device during delivery of the device 500, as further described below.

[0131] As shown, the ventricular portion 502 and the spacer body 504 of the device 500 can be formed from a single piece of material. When the ventricular portion 502 and the spacer body 504 of the device 500 are formed from a single piece of material, the intermediate sleeve 516 can be optional. However, in an alternative embodiment, the ventricular portion 502 and the body 504 of the device 500 can be formed from separate material sheets. When the ventricular portion 502 and the spacer body 504 of the device 500 are formed from separate material sheets, the proximal end 510 of the ventricular portion 502 and the distal end of the spacer body 504 can each be connected to the intermediate sleeve 516 by adhesives, welding, fasteners, etc. Alternatively, the proximal end 510 of the ventricular portion 502 and the distal end of the spacer body 504 can be directly connected together by adhesives, welding, fasteners, etc., without using the intermediate sleeve 516.

[0132] In the illustrated embodiments, the spacer body 504 of device 500 has a generally spherical shape, but in other embodiments, the body 504 can have various other shapes (e.g., cylindrical, conical, etc.). The body 504 of device 500 can also be configured to address central and / or eccentric jet mitral reflux. It should be noted that any of the devices disclosed herein can include spacer bodies of various shapes and can be configured to address central and / or eccentric jet mitral reflux.

[0133] like Figure 20As shown, the ventricular portion 502 and the spacer body 504 of device 500 can be formed from a self-expanding braided material. The braided material can be formed from metal wire (e.g., nitinol). Similar to the device described above, the braided material of device 500 can be covered with a blood-impermeable covering or coated with a flexible sealant material to prevent blood from flowing through device 500. Figure 20 The device 500 is shown in a radially extended functional state. The device 500 can be radially compressed into a delivery configuration by moving the distal end 508 of the ventricular portion proximally away from the spacer body 504, which effectively elongates or stretches the device into a radially compressed tubular configuration (as shown in Figures 21 and 22). With the device 500 in the delivery configuration, it can be percutaneously delivered to the native heart valve (e.g., the mitral valve), similar to the delivery device 312 described above.

[0134] With the sheath 520 of the delivery device in the left ventricle, the ventricular portion 502 of the sheath advancement device 500 can be extended from the delivery sheath into the left ventricle via the inner shaft 506 and proximal sleeve 518 of the axial advancement device 500. The ventricular portion can then be folded and expanded by axially retracting the inner shaft 506 relative to the proximal sleeve 518 and the delivery sheath 520, as... Figure 23 As shown in the diagram. In this configuration, the anchor can be positioned relative to the ventricular portion of the native leaflet.

[0135] The leaflet can then be secured by axially retracting the proximal sleeve 518 relative to the inner shaft 506 and the delivery sheath 520, which causes the body 504 to expand radially, as... Figure 24 As shown in the diagram. Using this action, the leaflet is captured between the anchor 512 of the device 300 and the spacer body 504, making it more tightly packed together around the spacer body 504. By doing so, the device 500 reduces the total area of ​​the mitral valve orifice and divides the mitral valve orifice into two orifices during diastole. Therefore, by reducing the area through which mitral regurgitation can occur, leaflet engagement can initiate at the location of the body 504, and the leaflet can more easily and completely engage, thereby preventing or minimizing mitral regurgitation. With the leaflet captured and the device 500 extended to its functional state, the proximal sleeve 518 can detach from the proximal end of the body 504 and retract into the delivery sheath 520, both of which can then be retracted from the patient's body.

[0136] Although devices 300, 400, and 500 illustrate one or two anchors, in some embodiments, devices 300, 400, and 500 can, for example, have three anchors and can be delivered to a native heart valve with three leaflets (e.g., a tricuspid valve). It should be noted that any of the embodiments disclosed herein can include one or more anchors.

[0137] Figure 25-34 An exemplary embodiment of an implantable prosthesis device 600 similar to device 500 according to another embodiment is shown. The prosthesis device 600 in the illustrated embodiment includes an inner shaft 602, a distal end cap 604, a braided portion 606, and an outer shaft 608. The braided portion 606 includes one or more (two in the illustrated embodiment) anchor portions 610 and a body portion 612. The inner shaft 602 extends coaxially through the outer shaft 608, the body 612 of the braided portion 606, and the end cap 604. The end cap 604 is securely attached to the distal end of the inner shaft 602 to prevent axial movement of the end cap 604 along the inner shaft 602.

[0138] Each of the anchors 610 of the braided portion 606 includes a lower leg portion 614, an upper leg portion 616, and a joint 618, respectively positioned between each lower leg 614 and upper leg 616, defined by a fold in the leg portion during deployment. The distal ends of the lower legs 614 can be securely secured to end caps 604 to hold them on the inner shaft 602 and prevent axial movement relative to the inner shaft 602. The proximal ends of the upper legs 616 can be attached to the distal end of the body 612 of the braided portion 606. The proximal end of the body 612 of the braided portion 606 can be releasably attached to the distal end of the outer shaft 608 by inserting the proximal end of the body 612 into the distal end of the outer shaft 608 or by coupling the proximal end of the body to the end of the outer shaft 608 using a separate holding device. The outer shaft 608 and (therefore) the main body 612 are axially movable relative to the inner shaft 602 to achieve the configuration of the device 600 during the device placement procedure, as further described below.

[0139] The end cap 604 can be fixedly attached to the distal end of the inner shaft 602, for example, by adhesive, welding, fasteners, etc. Alternatively, the end cap 604 can be fixedly attached to the distal end of the inner shaft 602, for example, by forming the end cap 604 and the inner shaft 602 from a single piece of material.

[0140] In some embodiments, the anchors 610 are movable independently of each other. For example, the device 600 may have a plurality of inner shafts 602 that are movable independently of each other, and each of the anchors 610 may be coupled to a respective inner shaft 602.

[0141] The outer shaft 608 can be adjusted axially moved relative to the inner shaft 602, for example, by pushing or retracting the outer shaft 608 relative to the inner shaft, or vice versa. In an alternative embodiment, for example, the inner shaft 602 can include external threads, and the outer shaft 608 can include internal threads that engage with the external threads of the inner shaft 602. Thus, rotation of the outer shaft 608 relative to the inner shaft effectively moves the outer shaft 608 along the length of the inner shaft 602 and (therefore) moves the spacer body 612.

[0142] The braided portion 606 of the device 600 can be formed from a single piece of integral braided material. The braided material can be formed from self-expanding metal wire (e.g., nitinol). For example, Figure 26 The braided portion 606 of the display device 600 is formed from a single piece of braided material, and the anchor portion 610 extends in an undisturbed configuration, while the body 612 is slightly extended. In an alternative embodiment, the anchor 610 and the body 612 can be formed from a single piece of braided material, in which case the proximal end of the upper leg 616 of the anchor 610 and the distal end of the body 612 can be attached to the connecting sleeve 620. Figure 25 (As shown in the image), to connect the anchor 610 and the body 612. When formed of a self-expanding material, the braided portion 606 can be radially compressed into a delivery configuration and can be held in the delivery configuration by placing the device 600 in the sheath of the delivery device, as shown in the image. Figure 27 As shown in the diagram. When deployed from the delivery sheath, the winding portion 606 of the device 600 can be automatically expanded to a functional configuration, as further described below.

[0143] The device 600 can be percutaneously delivered to the native heart valve (e.g., the mitral valve) using a delivery device. Figures 27-34 A delivery device deployment apparatus 600 is shown. The delivery device can include an external conduit (e.g., Figure 23 The external catheter 520 and the implantation catheter 622. The implantation catheter 622 may include a delivery sheath 624, an inner shaft (not shown), and an external shaft 608. Figure 25 (As shown in the image). The inner shaft and outer shaft 608 extend coaxially through the delivery sheath 624 of the implant catheter 622, and the inner shaft extends coaxially through the outer shaft 608 of the implant catheter 622.

[0144] Before insertion into the patient's body, the proximal ends of the inner shafts 602 of the prosthetic device 600 can be respectively connected to the distal ends of the inner shafts (not shown) of the implantation catheter 622, and the outer shaft 608 can be coupled to the proximal end of the spacer body 612, after which the prosthetic device 600 can be loaded into the delivery sheath 624. The delivery device can then be delivered via, for example, the transseptal technique described above (see...). Figures 6-8 It propels the device into the patient's heart (not shown). Figure 27 The sheath 624 of the implantable catheter 622 confines the prosthetic device 600 in a delivery configuration in which the implantable catheter can be advanced across the native mitral valve leaflet of the heart (not shown) until the distal end of the inner shaft 602 and the end cap 604 of the device 600 is in the left ventricle (similar to...). Figure 6 (The location shown in the image).

[0145] like Figure 28 As shown, the inner and outer shafts 608 of the implantation catheter 622 can be advanced distally relative to the delivery sheath 624 and / or retracted relative to the inner and outer shafts 608, thus forcing the anchor 610 away from the sheath 624 and exposing the anchor 610 of the braided portion 606 of the device 600. Once exposed from the sheath 624, the connector 618 of the anchor 610 can extend radially away from the inner shaft 602, as... Figure 29 As shown in the diagram. The anchor 610 can be folded by retracting the inner shaft of the implantation catheter 622 (which is connected to the inner shaft 602 of the implant 600) relative to the outer shaft 608 and sheath 624. This, in turn, causes the inner shaft 602 to retract, resulting in the anchor 610 bending at the joint and the upper leg 616 folding inward toward the inner shaft 602, as shown in the diagram. Figure 30 and 31 As shown in the diagram. In this configuration, the anchor 610 can be positioned posterior to the ventricular portion of the leaflet (e.g., desirably at positions A2 and P2).

[0146] The delivery sheath 624 can be further retracted relative to the inner and outer shafts of the implanted catheter (e.g., Figure 32 (as shown in the diagram) and / or propel the shaft distally relative to the sheath 624, exposing the body 612 of the winding portion 606 of the device 600, which allows the body 612 to expand radially (as shown in the diagram). Figure 33 (As shown in the diagram) thereby capturing the leaflet between the upper leg 616 of the anchor 610 and the spacer body 612. The leaflet can then be secured between the upper leg 616 of the anchor 610 and the braided portion of the spacer body 612 by advancing the outer shaft 608 of the implantation catheter 622 relative to the inner shaft 602 and the delivery sheath 624 of the implantation catheter 622, causing the spacer body 612 to move axially toward the distal end of the inner shaft 602 until its adjacent end cap 604, at which point the outer shaft is further advanced to compress the end portion of the spacer body 612 between the end cap 604 and the outer shaft 608.

[0147] The axial perspective of the end of the compression spacer body 612 shortens the spacer body 612 and expands the spacer body 612 radially, which forces the spacer body 612 to abut against the leaflet radially outward, such as Figure 34As shown in the diagram. Therefore, the device 600 can be secured by clamping the leaflet between the upper support leg 616 of the anchor 610 of the braided portion 606 and the spacer body 612 of the braided portion 606. Subsequently, the inner and outer shafts of the implanted catheter 622 can be released from the device 600, and the delivery device can be removed from the patient.

[0148] Figure 35 An exemplary embodiment of an implantable prosthesis device 900, similar to device 600, including a braided portion 906 according to another embodiment, is shown. The braided portion 906 of device 900 includes one or more anchors 910 (two are shown in the illustrated embodiment) and a spacer body 912. As shown, the anchors 910 of the braided portion 906 of device 600 can be formed from a braided material sheet separate from the braided material sheet forming the spacer body 912. Each anchor 910 includes a lower leg 914 and an upper leg 916. Each upper leg 916 can be inserted into and attached to an end cap 904, which is located at the distal end of an inner shaft (not shown) of device 900. Each lower leg 914 can be connected to the other lower leg 914. For example, in some embodiments, the lower leg 914 of the anchor 910 can be formed from a single piece of continuous braided material, which in Figure 35 The image shows a transversely extending section perpendicular to the spacer body 912. In some embodiments (where each anchor 910 is formed from a separately wound sheet of material), the lower support leg 914 can be connected, for example, by inserting the end of the lower support leg 914 into a coupler or sleeve that compressively secures the end of the lower support leg 914 within the coupler.

[0149] Figure 36 Another exemplary embodiment of the implantable prosthesis device 700 is shown. The device 700 includes one or more (two in the illustrated embodiment) ventricular anchors 702, a spacer body 704, and one or more anchor actuation wires 706. Figure 36 Two actuator lines are shown, along with a traction line 708. The actuator line 706 and the traction line 708 extend coaxially through the main body 704.

[0150] Anchor 702 can include multiple leaflet retaining elements 712. For example, Figure 36 The retaining element 712 may include outwardly extending protrusions or barbs that can press into and / or penetrate the lobular tissue to secure the anchor 702 to the lobule. In another embodiment, the retaining element may include a textured surface formed in and / or applied to the anchor 702 of the device 700.

[0151] The spacer body 704 may include a collar-like member 710 positioned toward the ventricular end of the body 704 of the device 700 and the braided portion 714. Although the braided portion has a generally cylindrical shape when in the extended configuration shown in the illustrated embodiment, in other alternative embodiments the braided portion can have various other shapes. For example, the braided portion can be extended into a generally spherical shape (similar to...). Figure 20 (The main body of 504).

[0152] The braided portion 714 can be securely fixed to the collar-shaped member 710, for example, by adhesives, welding, fasteners, etc. The anchor 702 can also be securely fixed to the collar-shaped member 710. In some embodiments, the anchor can be securely fixed to the collar-shaped member 710, for example, by welding, fasteners, or adhesives. In alternative embodiments, the anchor 702 can be securely fixed to the collar-shaped member 710, for example, by forming the anchor 702 and the collar-shaped member 710 from a single piece of material (e.g., laser-cut metal tubing).

[0153] The anchor actuator wire 706 can be a conductor or thread made of various materials such as nylon, polyester, PVDF, polypropylene, stainless steel, etc. Each wire 706 includes a first end 716 fixedly fixed or coupled to a corresponding free end of the anchor 702, a second end (not shown) fixedly fixed or coupled to the distal end of the traction wire, and an intermediate portion positioned between the first end 716 and the second end. In the illustrated embodiment, each wire 706, starting at the first end 716 and moving toward the second end, extends outward away from the free end of the anchor 702, extends downward toward the collar-shaped member 710 of the body 704, extends coaxially through the collar-shaped member 710, and extends coaxially into the braided portion 714 of the body 704, and is fixed to the traction wire 708 within the braided portion 714 of the body 704.

[0154] Anchor 702 can be formed of a self-expanding material (e.g., nitinol). The braided portion 714 of the body 704 can also be formed of a self-expanding material (e.g., braided nitinol). When formed of a self-expanding material, anchor 702 and the braided portion 714 of the body 704 can be radially compressed into a delivery configuration and can be held in the delivery configuration by placing the device 700 in the sheath of the delivery device.

[0155] When deployed from the sheath, the anchor 702 and the braided portion 714 can expand radially, thereby creating a gap between the anchor 702 and the braided portion 714 of the body 704, in which the native leaflet 718 of the heart valve can be placed, such as Figure 36As shown in the diagram. The leaflet 718 can then be secured between the anchor 702 and the braided portion 714 by applying tension to the traction line 708 and (thereby) the line 706, causing the free end of the anchor 702 to bend outwards and the portion of the anchor 702 (i.e., the middle portion) positioned between the free and fixed ends of the anchor 702 to buckle inwards, which forces the retaining element into the leaflet 718. With the retaining element 712 inserted into the leaflet 718, the device 700 is able to maintain its position relative to the leaflet during cardiac diastole and systole.

[0156] Figures 37-47 Another exemplary embodiment of an implantable prosthesis device 800 and its components is shown. In the illustrated embodiment, device 800 includes one or more (two in the illustrated embodiment) ventricular anchors 802, a spacer body 804, and an internal shaft portion 806. The internal shaft portion 806 extends coaxially through the spacer body 804. The anchors 802 are pressed radially inward toward the internal shaft 806 to generate a clamping force between the anchors 802 and the spacer body 804, as further described below.

[0157] Figures 41-44 The anchor 802 and the spacer body 804 of the display device 800 are in an extended functional state. Figure 45 The anchor 802 and spacer body 804 of the display device 800 are in a curled or compressed delivery state. Figure 46 The anchor 802 of the display device 800 is in a functional state.

[0158] Figure 37 The spacer body 804 can include a metal frame comprising: a distal first annular collar-like member 808 positioned around the shaft 806 and toward the ventricular end of the spacer body 804 of the device 800; a proximal second annular collar-like member 810 positioned around the shaft 806 and toward the atrial end of the spacer body 804 of the device 800; and a plurality of interconnecting struts 812 extending between the first collar-like member 808 and the second collar-like member 810. The struts 812 can be fixedly attached to the collar-like members 808, 810, for example, by forming the struts 812 and the collar-like members 808, 810 from a single piece of material (e.g., laser-cut metal tubing). In other embodiments, the struts 812 can be fixedly attached to the collar-like members 808, 810, for example, by adhesives, welding, fasteners, etc. Although... Figures 37-47 Not illustrated, the frame can be covered with a blood-impermeable covering (e.g., fabric) or coated with a flexible sealant (e.g., ePTFE).

[0159] Figure 37The device 800 also demonstrates that the anchors 802 can each include a flexible tubular portion 814. The tubular portion 814 can be formed from alloy tubing such as nitinol, stainless steel, or cobalt-chromium. The proximal end of the tubular portion 814 can be securely fixed or coupled to the distal neck-shaped member 808, for example, by adhesives, welding, fasteners, etc. The tubular portion 814 can also be configured to allow it to bend more easily in the desired direction and / or have a more compact bending radius without plastic deformation (e.g., kinking). For example, as shown, a portion of the circumference of the tubular portion 814 can be formed (e.g., by laser cutting) such that the cross-section of the tubular portion includes a plurality of axially spaced circumferential ribs 830 on a first cut side of the tubular portion, and a solid portion or spine 832 (relative to the circumference of the tubular portion) on a second uncut side opposite the cut side. By cutting the tube on one side, the tube 814 can be bent more easily relative to the side with the spine 832 in the direction of the side with the ribs 830 of the tube.

[0160] The fitting 814 can also be cut asymmetrically relative to its longitudinal axis, such that the ribs 830 are oriented on different sides of the fitting 814 for different axial sections. For example, as shown, each fitting 814 includes a first cut section 838 located near the proximal end of the fitting 814 (end-fixed to the distal neck member 808), wherein when the fitting is in a coiled or delivery configuration ( Figure 45 When the tube is extended or straightened in the configuration shown in the diagram, the ribs 830 face outwards (i.e., away from each other); and the second cut section 840 is positioned further distally relative to the first cut section 838, wherein when the tube is extended or straightened in the coiled or delivered configuration, the ribs 830 face inwards (i.e., towards each other). The first cut section 838 and the second cut section 840 can be connected, for example, through a non-cut transition portion 834 (…). Figure 37 Separate them.

[0161] In some embodiments, different axial sections can be formed from a single piece of material. In other embodiments, different axial sections can be formed from individual sheets of material fixedly attached or coupled together. Furthermore, the ribs of different axial sections can have different dimensions to allow the respective axial sections to be more or less compactly bent. For example, as shown, in the proximal section 838, the rib 830 of the pipe 814 can be relatively thinner than the rib 830 of the second distal section 840 (i.e., a larger portion of the pipe has been removed during the cutting process), thereby allowing the first section 838 to have a smaller bending radius relative to the second section 840. Therefore, by cutting the pipe 814 and the directional ribs 830, the manner and sequence of bending / bending and stretching / straightening of the pipe can be controlled, as further described below.

[0162] Figure 38The apparatus 800 in which the fitting 814 of the anchor 802 has been removed is shown, thus exposing the traction wires 816 (two shown) of the anchor 802. The traction wires 816 are each capable of extending coaxially within the corresponding fitting 814 of the anchor 802, and are capable of extending at a first proximal end 842 of the traction wire 816. Figure 40 The anchor 802 is fixedly attached to the shaft portion 806 at the second distal end 844 of the traction line 816, and is also fixedly attached to the inner portion of the tube 814 near the distal end of the tube 814, as further described below. The traction line 816 can be used, for example, to move the anchor 802 from a coiled delivery state ( Figure 45 (Displayed in the middle) Move to extended functionality state ( Figure 37 (as shown in the image), and / or fix the native leaflet between the anchor 802 and the spacer body 804, as further described below.

[0163] like Figures 39-40 In the best-illustrative configuration, the shaft assembly 806 of the device 800 includes a threaded bolt 818, a washer 820, and a shaft or washer support sleeve 822. The threaded portion of the bolt 818 extends coaxially through the washer 820 and the sleeve 822 of the shaft 806. The bottom (distal) surface of the head portion of the bolt 818 abuts the top (proximal) surface of the washer 820. The bottom (distal) surface of the washer 820 abuts the proximal end of the sleeve 822 of the shaft assembly 806 and the proximal end of the proximal neck collar 810 of the spacer body 804. The sleeve 822 can be securely fixed at its respective ends to the inner surfaces of the neck collars 808, 810 of the spacer body 804.

[0164] The shaft 806 assembly can also include a nut 824 and a nut support rail 826 (two shown), such as Figure 40 The best view is shown below. Nut 824 is seated on the threaded portion of bolt 818 and within sleeve 822. Nut 824 may include internal threads corresponding to the threaded bolt 818. Nut 818 may also include a plurality of axially extending external notches or grooves 828 through which a rail 826 and a traction line 816 extend, thereby preventing nut 818 from rotating relative to bolt 818, thereby allowing axial movement of the nut after bolt rotation. Rail 826 may be securely fixed to sleeve 822, thereby preventing rail 826 and (therefore) nut 824 from rotating relative to spacer body 804.

[0165] By rotating bolt 818, nut 824 can slide axially along track 826 and move axially along the threaded portion of bolt 818 proximally or distally (depending on the direction of rotation) without rotation. The proximal end of traction line 816 of anchor 802 can be securely attached to nut 824. Therefore, rotating bolt 818 moves nut 824 proximally or distally (depending on the direction of rotation) and (therefore) traction line 816. Rotating bolt 818 causes traction line 816 to move proximally (in the direction of arrow 846), applying compressive force to fitting 814, thereby causing fitting 814 of anchor 802 to bend or buckle from a straightened delivery configuration to a functional state.

[0166] As shown, the traction line 816 is rigid enough to apply a pushing force. Therefore, rotating the bolt 818 to move the traction line 816 distally applies a pulling force to the fitting 814, thereby causing the fitting to extend and / or pull until the delivery configuration is reached. Figure 45 (As shown in the diagram). In an alternative embodiment, the tube 814 can be formed from a shape memory material (e.g., nitinol) that has already been pre-formed in the straightening delivery configuration. Therefore, rotating the bolt 818 to move the traction line 816 to the distal end removes the compressive force from the tube 814, thereby allowing the tube 814 to be straightened to the delivery configuration.

[0167] Device 800 can, for example, use prosthesis device 200 and delivery device 202 ( Figures 6-8 The transseptal technique described in the illustration utilizes a delivery device (not shown) for percutaneous delivery to the native heart valve (e.g., the mitral valve). Device 800 and the associated delivery device are capable of being advanced across the native mitral valve leaflet 836 until the anchor 802 of device 800 is in the left ventricle (similar to...). Figure 6 (Configuration shown in the image). The device 800 is capable of being advanced from a delivery sheath (not shown, but similar to sheath 216) to expose the anchor 802.

[0168] In some embodiments, the anchor 802 can be self-expanding (e.g., formed of a shape memory material such as nitinol), such that when used in a similar manner to device 300 (e.g., Figure 13 and Figure 14 The anchors can be deployed from the delivery configuration (as shown in the diagram) during the delivery of the sheath. Figure 45 The best display in the middle) is transformed into a leaf capture configuration ( Figure 47(Best shown in the image). When formed of a self-expanding material, the shaft 806 and traction line 816 can be used to secure the leaflet, as further described below. In some embodiments, the anchor 802 can be plastically deformable (e.g., formed of stainless steel). When formed of a plastically deformable material, the anchor 802 can be extended from a delivery configuration to a leaflet capturing configuration by rotating the bolt 818 using a torque shaft (not shown, but similar to torque shaft 220), thereby causing the anchor 802 to bend, as shown below. Figure 46 The best presentation is shown above in detail.

[0169] The spacer body 804 can then be deployed by further retracting the delivery sheath, thereby allowing the spacer body to expand radially and capturing the native leaflet 836 between the anchor 802 and the spacer body 804, as follows. Figure 47 As shown in the diagram. The leaflet 836 can then be tightly secured between the anchor 802 and the spacer body 804 by rotating the torque shaft and bolt 818, causing the nut 824 and the guide wire 816 to move proximally along the threaded shaft portion 806. This movement of the guide wire effectively causes the tube 814 to bend and further push the anchor 802 against the leaflet 836. Therefore, the prosthetic device 800 can be secured to the leaflet 836 by clamping the leaflet between the anchor 802 and the spacer body 804, as... Figure 47 As shown in the image. Subsequently, the delivery device can be removed from the patient's body.

[0170] With the device 800 fixed to the two leaflets 836, this brings them closer together around the spacer body 804. By doing so, the device 800 reduces the total area of ​​the mitral valve orifice and divides the mitral valve orifice into two orifices during diastole. Therefore, by reducing the area through which mitral regurgitation can occur, leaflet engagement can initiate at the location of the body 804, and the leaflets can more easily and completely engage, thereby preventing or minimizing mitral regurgitation.

[0171] Figures 48-52 Another exemplary embodiment of an implantable prosthesis device 1000, similar to device 800, is shown. In the illustrated embodiment, device 1000 includes one or more (two in the illustrated embodiment) ventricular anchors 1002, a spacer body 1004, and an internal shaft assembly (not shown, similar to shaft assembly 806 of device 800). The internal shaft assembly extends coaxially through the body 1004. The anchors 1002 are pressed radially inward toward the internal shaft to generate a clamping force between the anchors 1002 and the spacer body 1004, as further described below.

[0172] like Figure 49As best shown, the spacer body 1004 can include a metal frame comprising: a distal first annular collar-like member 1008 disposed around a shaft assembly (not shown) and positioned toward the ventricular end of the spacer body 1004; a proximal second annular collar-like member 1010 disposed around the shaft assembly and positioned toward the atrial end of the spacer body 1004 of the device 1000; and a plurality of interconnecting struts 1012 extending between the first collar-like member 1008 and the second collar-like member 1010. In some embodiments, the struts 1012 can be fixedly attached to the collar-like members 1008, 1010, for example, by forming the struts 1012 and the collar-like members 1008, 1010 from a single piece of material (e.g., laser-cut metal tubing). In other embodiments, the struts 1012 can be fixedly attached to the collar-like members 1008, 1010, for example, by adhesives, welding, fasteners, etc. Although Figures 48-52 As not shown in the figure, the spacer body 1004 can be covered with a blood-impermeable covering (e.g., fabric) and coated with a flexible sealant (e.g., ePTFE).

[0173] As shown, the anchors 1002 of the device 1000 can each include a flexible tube portion 1014. The tube 1014 can be formed from alloys such as nitinol, stainless steel, or cobalt-chromium. The proximal end 1020 of the tube 1014 ( Figure 52 It can be fixed or coupled to the distal neck collar 1008, for example by means of adhesives, welding, fasteners, etc.

[0174] The fitting 1014 can also be configured to allow for easier bending in a desired direction and / or a more compact bending radius without plastic deformation (e.g., kinking). For example, as shown, a portion of the circumference of the fitting 1014 can be constructed (e.g., by laser cutting) such that the cross-section of the fitting includes a plurality of ribs 1016 on a first cut side of the fitting and a solid portion or spine 1018 (relative to the circumference of the fitting) on ​​a second uncut side opposite the cut side. By cutting the fitting on one side, the fitting 1014 can be bent more easily in the direction of the side of the fitting with ribs 1016 relative to the side having the spine 1018. The fitting 1014 can also be cut asymmetrically relative to the longitudinal axis of the fitting 1014, such that the ribs 1016 are oriented on different sides of the fitting 1014 for different axial sections, such as... Figure 52 The best display is achieved in the middle. Therefore, by cutting the tube 1014 and the directional ribs 1016, it is possible to control the manner and sequence of bending / bending and extending / straightening of the tube 1014.

[0175] Although not shown, the internal shaft assembly of device 1000 can be similar to the shaft portion 806 of device 800, including substantially the same components. Furthermore, anchor 1002 can include an anchor traction line (not shown, but similar to conductor 816), which is fixedly attached at a first proximal end to a nut (not shown) on the shaft and at a second distal end to the distal end of the tube 1014, similar to conductor 816. Therefore, device 1000 can function substantially similarly to device 800. However, the anchor 1002 of device 1000 can laterally contact the native leaflet (not shown).

[0176] Relative to device 1000, the term "lateral" means generally perpendicular to the longitudinal axis of the prosthetic device 1000 that extends through the distal and proximal collar-like members 1008, 1010. For example, Figure 49 The anchor extends laterally across the spacer body 1004, with its longitudinal axis extending coaxially through the collar-shaped members 1008 and 1010. Thus, each anchor 1002 can extend laterally across and into contact with the ventricular side of the corresponding primary lobule.

[0177] It should be noted that although, as described above, the anchors 802 and 1002 of the corresponding devices 800 and 1000 can be actuated simultaneously (e.g., moved from a delivery configuration to a functional configuration and / or secured to a native leaflet), in some embodiments each anchor can be actuated individually. For example, one of the anchors 802 and 1002 can be moved from a delivery configuration to a functional configuration and secured to a native leaflet, and then the other anchor 802 and 1002 can subsequently be moved from a delivery configuration to a functional configuration and secured to a native leaflet.

[0178] To allow for individual actuation of anchors, the shaft assembly (similar to shaft assembly 806) can, for example, include multiple bolts and nuts (similar to bolt 818 and nut 824), where each bolt and nut corresponds to a separate traction line for the respective anchor. With separate bolts and nuts for each traction line, each anchor can be actuated by rotating the bolt corresponding to the anchor, causing the nut to move axially along the threaded portion of the bolt, and the anchor folding / bending or extending / straightening according to the direction of bolt rotation.

[0179] Figures 53-58Another exemplary embodiment of the implantable prosthesis device 1100 is shown. In the illustrated embodiment, the device 1100 includes a ventricular portion 1102, a spacer body 1104, an inner shaft 1106, and an outer shaft 1108. The inner shaft 1106 extends coaxially through the outer shaft 1108, and the inner and outer shafts 1106 and 1108 extend coaxially through the spacer body 1104. The outer shaft 1108 is axially movable relative to the inner shaft 1106 and the spacer body 1104 (proximal and distal). The distal direction is indicated by arrow 1120 (…). Figure 53 The proximal direction is generally opposite to the distal direction. The spacer body 1104 is axially movable relative to the inner shaft 1106 and the outer shaft 1108 (towards the proximal and distal ends).

[0180] The ventricular portion 1102 includes one or more (two in the illustrated embodiment) external anchoring members 1110, one or more (two in the illustrated embodiment) internal anchoring members 1112, and one or more (two in the illustrated embodiment) cross members 1114. The external anchoring members 1110 may be pivotally connected (e.g., pin, fastener, ball joint, etc.) at a first distal end to the distal end of the internal shaft 1106, thereby forming a first pivotable joint 1116. The external anchoring members 1110 extend from the first joint 1116 to a second proximal end of the external anchoring members 1110. The internal anchoring members 1112 may be pivotally connected at a middle portion to a corresponding external anchoring member 1110, thereby forming a second pivotable joint 1118. The transverse member 1114 is pivotally connected at its first inner end to the distal end of the outer shaft 1108, thereby forming a third pivotable joint 1122. The transverse member 1114 is pivotally connected at its second end (opposite to the first end) to the corresponding distal end of the inner anchor 1112, thereby forming a fourth pivotable joint 1124.

[0181] The transverse member 1114 can also be slidably connected to the corresponding external anchor 1110 using the connecting element 1126. For example... Figure 53 As best shown, the connecting element 1126 can be positioned on the corresponding outer anchor 1110 between pivotable joints 1116 and 1118, and on the transverse member 1114 between pivotable joints 1122 and 1124. The connecting element 1126 can be, for example, a groove formed in the outer anchor 1110 through which the transverse member 1114 extends.

[0182] The spacer body 1104 may include an annular metal frame (not shown, but similar to frame 28) covered with a blood-impermeable fabric 1128. The frame may include a mesh structure comprising multiple interconnected metal struts, or may include metal braids. The frame may be formed of a self-expanding material such as nitinol. In other embodiments, the frame may be formed of a plastically expandable material such as stainless steel or a cobalt-chromium alloy.

[0183] Due to the adjustable nature of the ventricular portion 1102 and the flexible nature of the spacer body 1104, the device 1100 can be radially compressed into a delivery configuration. Figure 54 It can be kept in the delivery configuration by placing the device in the sheath of the delivery device.

[0184] like Figures 54-58 As shown, the device 1100 can be used, for example, with the prosthesis device 200 and the delivery device 202 ( Figures 6-8 The transseptal technique described herein utilizes a delivery device (not shown) to percutaneously deliver to the native heart valve (e.g., the mitral valve). Although not shown, the delivery device may include a sheath (similar to sheath 216) to which the prosthetic device 1100 can be loaded, inner and intermediate shafts releasably connected to respective inner and outer shafts 1106, 1108 of the device 1100, and an outer shaft releasably connected to the spacer body 1104 of the device 1100.

[0185] Device 1100 and delivery device are capable of advancing across the native mitral valve leaflet 1130 until the ventricular portion 1102 of device 1100 is in the left ventricle (e.g. Figure 55 As shown in the image, and similar to Figure 6 (The configuration shown in the diagram). The ventricular portion 1102 is exposed from the delivery sheath by advancing the inner shaft of the delivery device distally relative to the sheath of the delivery device and (therefore) the inner shaft 1106 of the device 1100 and / or by retracting the delivery sheath relative to the inner shaft.

[0186] The anchor 1102 can be extended from a delivery configuration to a leaflet capture configuration by advancing the outer shaft and (therefore) outer shaft 1108 of the delivery device distally relative to the inner shaft 1106, and thus moving the joint 1122 distally (i.e., toward the joint 1116) along the inner shaft 1106, such that the transverse member 1114 extends laterally and perpendicularly to the inner shaft 1106 (e.g.) Figure 55 (As shown in the diagram), the transverse member 1114 forces the outer anchor 1110 to expand radially relative to the inner shaft 1106 and the inner anchor 1112 to expand or open relative to the outer anchor 1110, as... Figure 55As shown in the diagram. With anchors 1110 and 1112 extended and opened, leaflets 1130 (e.g., desirablely at positions A2 and P2) can be positioned within anchors 1110 and 1112 by retracting the inner shaft 1106 proximally, as illustrated. Figure 56 As shown in the image.

[0187] The leaflet 1130 can then be secured between anchors 1110 and 1112 by further advancing the outer shaft 1108 distally relative to the inner shaft 1106, thereby causing the joint 1122 to move distally along the inner shaft 1106, such that the joint 1122 is distal to joints 1124 and 1126. The movement of the outer shaft 1108 and the transverse member 1114 effectively moves the distal end of the inner anchor 1112 inward toward the inner shaft 1106, thereby causing the inner anchor 1112 to pivot about the joint 1118, forcing the proximal end of the inner anchor 1112 toward the proximal end of the outer anchor 1110, as... Figure 57 As shown in the image.

[0188] Figure 57 It also demonstrates the ability to subsequently deploy the spacer body 1104 via a retractable delivery sheath. When formed of a self-expanding material, the frame is capable of self-expanding to its functional dimensions. Figures 57-58 When formed from a plastically expandable material, the prosthetic device can be rolled up onto a delivery device and radially expanded to its functional dimensions via an inflatable balloon or equivalent expansion mechanism. The spacer body 1104 can then be positioned by advancing the outer shaft of the delivery device relative to the inner shaft 1106 and outer shaft 1108 of the device 1100, and (therefore) advancing the spacer body 1104. Figure 58 As shown in the diagram. Although, as shown, the spacer body 1104 is only partially extended, the spacer body 1104 can be further extended to allow the leaflet to contact the spacer body 1104. The shaft of the delivery device can then be released from the device 1100 and retracted into the sheath of the delivery device. The delivery device can then be removed from the patient's body.

[0189] In some embodiments, as shown, the transverse members 1114 of the device 1100 can each be connected to the same outer shaft 1108, thus allowing simultaneous actuation of two anchors. For example, such a configuration provides a simpler device to use because there are relatively fewer steps for the physician to perform to implant the device. This can, for example, help reduce the complexity and / or time required to perform the placement procedure.

[0190] In some embodiments, the transverse members 1114 of the device 1100 can each be connected to a separate outer shaft, thus allowing the anchors to be actuated individually. This configuration can, for example, allow a physician to more easily capture the native leaflet, as the physician can capture one side at a time. This can be helpful, for example, due to the dynamic nature of the leaflet during the heart's diastolic and systolic cycles. Furthermore, in some embodiments, the spacer body 1104 can be secured to the outer shaft 1108, thereby allowing simultaneous positioning of the spacer body 1104 and the ventricular portion 1102, which can advantageously reduce the time required to perform the placement procedure, for example.

[0191] Figures 59-61 Another exemplary embodiment of an implantable prosthesis device 1200 similar to device 1100 is shown. In the illustrated embodiment, device 1200 includes at least one anchor 1202 (one is shown for illustrative purposes, but multiple anchors 1202 are possible), a spacer body (not shown, but similar to spacer body 1104), a shaft 1206, and a sleeve 1208 coaxially and slidably mounted on the shaft 1206. The shaft 1206 extends coaxially through the spacer body and the sleeve 1208. The spacer body is located on the shaft 1206, adjacent to the sleeve 1208.

[0192] Sleeve 1208 is axially movable relative to shaft 1206 (proximal and distal). The distal direction is determined by… Figure 59 Arrow 1204 indicates that the proximal direction is opposite to the distal direction. The spacer body is axially movable relative to the shaft 1206 (proximal and distal). In some embodiments, the spacer body is also axially movable relative to the sleeve 1208, thereby allowing the spacer body to be deployed and / or positioned separately from the anchor 1202. In some embodiments, the spacer body is fixed or connected to the sleeve 1208, thereby allowing the spacer body to be deployed and / or positioned simultaneously with the anchor 1202.

[0193] like Figure 60As best illustrated, anchor 1202 can be a truss structure comprising an outer member 1210, an inner member 1212, and a cross member 1214. The outer member 1210 can be pivotally connected (e.g., by a pin, fastener, etc.) at a first distal end of the outer member 1210 to the distal end of the shaft 1206, thereby forming a first pivotable joint 1216. The outer member 1210 extends from the first joint 1216 to a second proximal end of the outer member 1210. The inner member 1212 can be pivotally connected to the outer member 1210 at a middle portion toward the distal end of the outer member 1210, thereby forming a second pivotable joint 1218. The cross member 1214 can be pivotally connected at a first end of the cross member 1214 to a sleeve 1208, thereby forming a third pivotable joint 1220. The transverse member 1214 can also be pivotally connected at a second end (opposite to the first end) to the distal end of the inner member 1212, thereby forming a fourth pivotable joint 1222. The outer member 1210 can also include an opening 1224, thereby allowing the inner member 1212 and the transverse member 1214 to extend through the outer member 1210 when the device is in a leaflet capture configuration, such as... Figure 60 As shown in the image.

[0194] Although not illustrated, the spacer body can include an annular metal frame (similar to frame 28) covered with a blood-impermeable fabric (similar to fabric 1128). The frame can include a mesh structure comprising multiple interconnected metal struts, or can include metal braids. The frame can be formed of a self-expanding material such as nitinol. In other embodiments, the frame can be formed of a plastically expandable material such as stainless steel or a cobalt-chromium alloy.

[0195] Due to the adjustable nature of the anchor 1202 and the flexible nature of the spacer body, the device 1200 can be radially compressed into a delivery configuration. Figure 59 As shown, the transverse member 1214 can be configured to nest within the inner member 1214, and the inner member can be configured to nest within the outer member 1210, thereby reducing the profile of the device 1200 in the delivery configuration.

[0196] Although not illustrated, device 1200 can, for example, be used with device 1100 ( Figures 54-58 The transseptal technique described in the illustration utilizes a delivery device to deliver percutaneously to the native heart valve (e.g., the mitral valve). Figure 59 Displaying the device in the delivery configuration (similar to) Figure 54 (Device 1100 in the middle). Figure 60 Displaying the device 1200 in the leaf capture configuration (similar to) Figures 55-56 (Device 1100 in the middle). Figure 61Display function or small leaf fixed configuration of device 1200 (similar) Figures 57-58 (Device 1100 in the middle).

[0197] Delivery systems and devices

[0198] Delivery systems and / or devices for percutaneous delivery of prosthetic implants (e.g., prosthetic septum devices) can include an introducer sheath, one or more catheters (e.g., an external catheter, a guiding catheter, and / or an implantation catheter), and other devices. Typically, the introducer sheath can be inserted into the patient's body, providing an access point for introducing other devices (e.g., catheters) into the patient's body. For example, during a transseptal procedure, the introducer sheath can be inserted into the patient's right femoral vein, through which an external catheter can be inserted. The external catheter can be advanced through the femoral vein, up the venous lumen, and into the right atrium. The septum is then punctured with the external catheter, allowing it to extend into the left atrium. The external catheter can then be placed at the septal opening.

[0199] An intermediate or guiding catheter can be inserted through an external catheter to achieve the desired positioning for the procedure. For example, a guiding catheter can be used to achieve positioning relative to the mitral valve. In certain embodiments, the guiding catheter can also function as an implantation catheter, configured to advance a prosthetic device through the patient's blood vessels and deploy the prosthetic device at the desired implantation site. For example, the distal portion of the guiding catheter can include a delivery sheath configured to hold the prosthetic device in a compressed delivery state as it is advanced through the patient's body. In alternative embodiments, an internal or implantation catheter can be inserted through the guiding catheter to deploy, secure, and release the prosthetic implant.

[0200] Some embodiments of the delivery systems disclosed herein allow for preloading of the implantation catheter (i.e., insertion through the guide catheter before the guide catheter is advanced to the outer catheter) or loading during the procedure (i.e., insertion through the guide catheter after the guide catheter has been advanced to the left side of the patient's heart). Some embodiments of the delivery systems disclosed herein include an intermediate or guide catheter having a flexible, steerable distal portion and control members on or near a handle capable of bending, flexing, and / or orienting said distal portion. Some of the disclosed delivery systems include various locking, rotational, and / or anti-rotation and / or coupling features.

[0201] The delivery systems disclosed herein can, for example, significantly improve the ability of physicians to deliberately orient and fix the catheters used, such as in transseptal procedures for implanting prosthetic devices. These systems can also, for example, significantly improve the safety, duration, and effectiveness of prosthetic implant placement procedures.

[0202] Figure 62An exemplary steerable flexible prosthetic implant delivery device 1300 according to one embodiment is shown. In the illustrated embodiment, the delivery device 1300 generally includes an implant cover or sheath 1302, a flexible radially expandable basket portion 1304, an intermediate shaft 1306, a basket expander mechanism 1308, a proximal shaft 1310, a steering control member 1312, and multiple (in the illustrated embodiment, four, but...) Figure 62 Only two basket extender wires 1314 are shown in the illustration, and multiple (four in the illustrated embodiment, but...) Figure 62 (Only two are shown in the image) Steering control wire 1316.

[0203] The basket portion 1304 of the delivery device 1300 can be disposed between the sheath 1302 and the intermediate shaft 1306. The basket portion 1304 can be fixedly secured or coupled (e.g., using adhesives, fasteners, etc.) to the sheath 1302 at a first distal end and fixedly secured or coupled to the intermediate shaft 1306 at a second proximal end. An extender mechanism 1308 can be disposed between the intermediate shaft 1306 and the proximal shaft 1310. The extender mechanism 1308 can be connected to the intermediate shaft 1306 at a first distal end and to the proximal shaft 1310 at a second proximal end, as further described below.

[0204] Steering control member 1312 can be positioned proximally on proximal shaft 1310 relative to extender mechanism 1308. Basket extender wire 1314 can extend coaxially through sheath 1302, basket portion 1304, intermediate shaft 1306, basket extender mechanism 1308 and proximal shaft 1310. Extender wire 1314 can be fixedly secured (e.g., using adhesive) to sheath 1302 at a first distal end 1318 of the respective extender wire 1314 and fixedly secured to proximal shaft 1306 at a second proximal end 1320 of the respective extender wire 1314.

[0205] The control wire 1316 can extend coaxially through the sheath 1302, reach above the basket portion 1304, and pass through the intermediate shaft 1306, the extender mechanism 1308, and the proximal shaft 1310. The control wire 1316 can be fixedly attached to the sheath 1302 at a first distal end 1322 of the corresponding control wire 1316, and fixedly attached to the control member 1312 at a second proximal end 1324 of the corresponding control wire 1316.

[0206] The sheath 1302 of the delivery device 1300 can be configured to receive various prosthetic implantation devices and / or hold the prosthetic implantation devices in a delivery configuration. For example, the sheath 1302 can receive a prosthetic spacer device (e.g., a prosthetic spacer described herein) and hold the prosthetic device in a delivery configuration (e.g., Figure 67 (As shown in the image). Sheath 1302 can also accommodate, for example, prosthetic heart valves, stents, etc.

[0207] The basket 1304 of the delivery device 1300 is expandable, allowing the basket 1304 to be placed in a non-expandable delivery configuration. Figure 63B (best shown in the image), thus allowing the device 1300 to have a relatively small face when space is limited (e.g., when passing through another catheter or blood vessel). When space is not limited (e.g., when advancing from another catheter into the left atrium or another chamber of the heart), the basket 1304 can be radially expanded to a functional configuration ( Figure 64 (Best shown in the image). The basket 1304 applies flexibility to the distal portion of the device, thereby providing the physician with a greater range of motion and steerability at the distal end of the device 1300, and thus providing a greater degree of control over the prosthesis implant during the implant placement procedure. In certain embodiments, the basket 1304 includes a mesh or braided construction, such as polymer braiding (e.g., Nylon) or metal braiding (e.g., Nitinol or stainless steel).

[0208] like Figure 65A As best illustrated, the intermediate shaft 1306 of the delivery device 1300 can include an implantable or working lumen 1326 centrally located (relative to the longitudinal axis of the device), and a plurality (eight in the illustrated embodiment) of guide tube lumens 1328 radially outwardly disposed within the sidewall of the shaft and annularly distributed around the implantable lumen 1326. The guide tube lumens 1316 can be angularly spaced from each other at approximately 45 degrees. The respective lumens 1326, 1328 can extend axially through the intermediate shaft 1306.

[0209] The implantation lumen 1326 allows, for example, a device implantation catheter (not shown, but similar to implantation catheter 214) to be inserted through the implantation lumen 1326. Leads 1314 and 1316 can each extend through a corresponding lead lumen 1328. Four expander leads 1314 can occupy four of the lead lumen 1328 in an alternating pattern, such that the expander leads 1314 are spaced approximately 90 degrees apart. Four control leads 1316 can occupy the four remaining unoccupied lumens 1328 in an alternating pattern, such that the control leads 1316 are spaced approximately 90 degrees apart.

[0210] like Figure 62As shown, the intermediate shaft 1306 may also include a plurality of (in the illustrated embodiment, four, but...) positioned toward the distal end of the intermediate shaft 1306 but close to the basket 1304. Figure 62 Only two radially extending side openings or ports 1330 are shown in the image. The ports 1330 can be circumferentially distributed around the intermediate shaft 1306 (e.g., spaced 90 degrees apart) and configured to correspond to the wire lumen 1328 occupied by the control wire 1316, thereby allowing the control wire 1316 to enter the corresponding wire lumen 1328 via the respective side opening 1330. The intermediate shaft 1306 can be made of, for example, polyether block amide (e.g., ...). Biocompatible polymers such as […] are formed.

[0211] The intermediate shaft 1306 can be comprised of different axial sections with varying hardness and / or stiffness. For example, such as Figure 65B As shown, the intermediate shaft 1306 can include a first distal section 1332 and a second proximal section 1334. The distal section 1332 of the intermediate shaft 1306 can, for example, include a material softer than the material of the proximal section 1334 of the intermediate shaft 1306. In some embodiments, for example, sections 1332 and 1334 of the intermediate shaft 1306 can include materials having Shore D hardness values ​​of 55 and 72, respectively. An intermediate shaft with a softer distal end can, for example, allow the distal end of the intermediate shaft 1306 to bend and / or flex more easily without kinking or other plastic deformation.

[0212] The basket expander mechanism 1308 of the delivery device 1300 may include a distal nut 1338, a proximal nut 1340, and an outer nut or sleeve 1342, such as Figure 62 As shown in the diagram. The distal nut 1338 is securely attached to the proximal end of the intermediate shaft 1306 and includes external threads oriented in a first direction. The proximal nut 1340 is securely attached to the distal end of the proximal shaft 1310 and includes external threads oriented in a second direction opposite to the first direction of the threads of the distal nut 1338. The outer nut 1342 may include a first internal thread 1344 along the distal portion of the outer nut 1342 that corresponds to and engages the threads of the distal nut 1338, and a second proximal internal thread 1346 along the proximal portion of the outer nut 1342 that corresponds to and engages the threads of the proximal nut 1340.

[0213] In use, rotation of the outer nut 1342 relative to the distal nut 1338 and the proximal nut 1340 in a first direction causes the distal nut 1338 and the proximal nut 1340, and (therefore) the intermediate shaft 1306 and the proximal shaft 1310, to move toward each other, and rotation of the outer nut 1342 relative to the distal nut 1338 and the proximal nut 1340 in a second direction (opposite to the first direction) causes the distal and proximal nuts 1338, 1340, and (therefore) the intermediate shaft 1306 and the proximal shaft 1310 to move away from each other, similar to a turnbuckle.

[0214] The rotation of the outer nut 1342 relative to the distal nut 1338 and the proximal nut 1340 in a first direction causes the intermediate shaft 1306 to move towards the proximal shaft 1310 in the proximal direction, and also causes the intermediate shaft 1306 to move away from the sheath 1302 in the proximal direction. Furthermore, the rotation of the outer nut 1342 relative to the distal nut 1338 and the proximal nut 1340 in a second direction causes the intermediate shaft 1306 to move away from the proximal shaft 1310 in the distal direction, and thus moves the intermediate shaft 1306 towards the sheath 1302 in the distal direction.

[0215] Due to the flexible nature of the basket 1304, the rotation of the outer nut 1342 relative to the distal nut 1338 and the proximal nut 1340 in the first direction (i.e., the movement of the intermediate shaft 1306 proximally away from the sheath 1302) causes the basket 1304 to be axially elongated and radially compressed into the delivery configuration. Figure 63B (As shown in the image). The rotation of the outer nut 1342 relative to the distal nut 1338 and the proximal nut 1340 in the second direction (i.e., the movement of the intermediate shaft 1306 distally toward the sheath 1302) causes the basket to shorten axially and expand radially into its functional configuration. Figure 62 , Figure 64 , Figure 67 (as shown in the image).

[0216] The proximal shaft 1310 of the delivery device 1300 can have a configuration generally similar to that of the intermediate shaft 1306, including an implantation lumen 1348 centrally positioned (relative to the longitudinal axis). Figure 66 (As shown in the illustration), and a plurality of (eight in the illustrated embodiment) lead lumens (not shown, but similar to lead lumen 1328) arranged radially outward from the implantation lumen 1348 and circumferentially distributed around the implantation lumen 1348 within the sidewall of the shaft 1310. The respective implantation lumens and lead lumens are capable of extending coaxially through the proximal shaft 1310. The respective implantation lumens and lead lumens of the proximal shaft 1310 and the intermediate shaft can be configured for axial alignment, thereby allowing leads 1314, 1316 to extend axially through the shafts 1306, 1310.

[0217] like Figure 62 As shown, the proximal shaft 1310 can also include multiple (four in the illustrated embodiment, but...) Figure 62 (Only two are shown) radially extending side openings or ports 1350, which communicate with a lumen 1328 containing a control wire 1316. Side openings 1350 can be radially aligned with ports 1330 of the intermediate shaft 1306. Ports 1350 of the proximal shaft 1310 can be positioned on the proximal shaft 1310 between the proximal nut 1340 of the basket extender mechanism 1308 and the control member 1312, thereby allowing the control wire 1316 to exit the corresponding wire lumen 1328 of the proximal shaft 1310 via the respective side opening 1350. The proximal shaft 1310 can be formed of a biocompatible polymer. For example, the proximal shaft 1310 can include Pebax with a Shore D hardness value of 72.

[0218] The steering control member 1312 of the delivery device 1300 may include a pivotable control handle 1352 and a fixed sleeve portion 1354. The sleeve portion 1354 may be positioned proximally on and fixedly attached to the proximal shaft 1310 relative to the side port 1350 of the proximal shaft 1310. The sleeve portion may include a spherical or at least partially spherical outer surface 1356. The control handle 1352 may include a slot portion 1358 disposed around the outer surface 1356 of the sleeve 1354. Figure 62 In this way, the outer surface 1356 acts as the ball in the ball-in-socket joint formed by the slot portion 1358. This allows the slot 1358 and (therefore) the control handle 1352 to pivot relative to the ball 1356.

[0219] The control handle 1352 may also include multiple (in the illustrated embodiment, four, see below) Figure 66 An axially extending opening 1360, radially outwardly disposed on the control handle 1352 relative to the slot 1358, is configured to receive the proximal end 1324 of the corresponding control wire 1316, thereby allowing the proximal end 1324 of the control wire 1316 to be secured to the handle 1352. The openings 1360 can be angularly spaced from each other around the handle 1352, for example, approximately 90 degrees.

[0220] In some embodiments, as shown, the proximal end 1324 of the control wire 1316 can be secured to the handle 1352 by inserting the proximal end 1324 of the wire 1316 through the respective opening 1360 and attaching a corresponding end cap or sleeve 1362 to the proximal end 1324 of the control wire 1316 (which has a diameter exceeding the diameter of the opening 1360), thereby preventing the proximal end 1324 of the control wire 1316 from retracting through the opening 1360. In other embodiments, the proximal end 1324 of the control wire 1316 can be secured within the opening 1360 and thus secured to the handle 1352, for example, by adhesive. In some embodiments, the handle 1352 can be made of, for example, acetal (e.g., It is formed of polymeric materials such as polycarbonate. In some embodiments, the sleeve 1354 can be formed of polymeric materials such as polycarbonate.

[0221] The opposite ends 1318 and 1320 of the extender wires 1314 of the device 1300 can be fixedly attached to the sheath 1302 and the proximal shaft 1310, respectively. The wires 1314 are preferably evenly spaced from each other, for example, at 90 degrees, around the longitudinal axis of the device. Furthermore, the extender wires 1314 can each have substantially the same axial length and can be tensioned equally. The even distribution of the extender wires 1314 along the circumference and the provision of substantially uniform tension on the extender wires 1314 allow the sheath 1302, intermediate shaft 1306, and proximal shaft 1310 to maintain axial alignment, as described above, when the basket 1304 is extended after adjusting the basket extender mechanism 1308.

[0222] Similarly, the opposite ends 1322, 1324 of the control wires 1316 of the device 1300 can be fixedly attached to the sheath 1302 and the handle 1352, respectively. The control wires 1316 are preferably evenly spaced from each other, for example, at 90 degrees, around the longitudinal axis of the device. Furthermore, the control wires 1316 can each have substantially the same axial length and can be tensioned equally. The length of the control wires 1316 can be selected such that the control wires 1316 are in an axially elongated delivery configuration in the basket 1304. Figure 63B It can include relaxation when the basket 1304 is in the radial expansion function configuration, and can be tightened when the basket 1304 is in the radial expansion function configuration.

[0223] A control lead 1316 evenly distributed along its circumference and providing a substantially uniform tension on the control lead 1316 can provide multidirectional control of the sheath 1302 and (therefore) the implantation device, for example, by pivoting the handle 1352 about the ball 1356 (e.g., forward, backward, and / or left-right directions). See, for example... Figure 62Pivoting handle 1352 causes the upper portion of handle 1352 to move proximally (i.e., in the direction of arrow 1374), effectively pulling proximally the proximal end 1324 of the upper control lead 1316, which in turn causes the sheath 1302 to pivot upward relative to the intermediate shaft 1306 in the direction of arrow 1376. To move the distal end of the sheath 1302 downward, the physician can pivot handle 1352 of control member 1312, causing the lower portion of handle 1352 to move proximally (i.e., in the direction of arrow 1375), which effectively pulls proximally the proximal end 1324 of the lower control lead 1316, which in turn causes the distal end of the sheath 1302 to pivot downward relative to the intermediate shaft 1306 in the direction of arrow 1378.

[0224] The delivery device 1300 can be used, for example, for percutaneous delivery of prosthetic implants. For example, Figure 67 The delivery device 1300 is demonstrated for delivering a prosthetic spacer device 1364 into the mitral valve 1366 of the heart 1368. With the prosthetic implant preloaded into the sheath 1302, the delivery device 1300 can be advanced through the external catheter 1370 into the left atrium 1371 of the heart 1368. With the sheath 1302, basket 1304, and intermediate shaft 1306 of the device 1300 in the left atrium, the basket 1304 can be extended into a functional configuration by rotating the outer nut 1342 of the basket expander 1308 to move the intermediate shaft 1306 toward the sheath (described in more detail above). The basket 1304 of the expanded device 1300 tauts the control lead 1316 and allows the physician to subsequently orient the prosthetic spacer device 1364 desirously by pivoting the handle 1352 of the pivot control member 1312. For example, a physician can cause the sheath 1302 to rotate 90 degrees relative to the external catheter 1370 so that the prosthetic spacer device 1364 is aligned with the patient's mitral valve 1366.

[0225] Once the prosthetic device 1364 is desirablely oriented, the prosthetic spacer device 1364 can be advanced from the sheath 1302 of the device 1300 and subsequently secured to the native leaflet 1372 of the mitral valve 1366, as previously described with respect to the prosthetic spacer device described herein. Subsequently, the basket 1304 can be radially compressed back into the delivery configuration via an actuation basket expander mechanism 1308, thus allowing the delivery device 1300 to retract into the external catheter 1370 and be removed from the patient.

[0226] The implantation lumens 1348 and 1326 of the shafts 1310 and 1306 (respectively) can, for example, advantageously allow a physician to introduce additional catheters (e.g., implantation catheters) during the procedure without having to retract the delivery device from the patient. These additional catheters introduced through the implantation lumens 1348 and 1326 can, for example, be used to deploy prosthetic spacer devices.

[0227] Figure 68 Another exemplary steerable prosthetic implant delivery device 1400 according to another embodiment is shown. The delivery device 1400 may include a flexible inner shaft 1402, an intermediate shaft 1404, a slidable outer shaft 1406, a steering control member 1408, a lead tensioner 1410, a plurality of pivot control leads (not shown, but similar to lead 1316), and a hemostatic seal 1412 (e.g., a tapered Luer fitter). The inner shaft 1402, intermediate shaft 1404, and outer shaft 1406 may extend coaxially through the control member 1408 and the tensioner 1410, respectively. The inner shaft 1402 and intermediate shaft 1404 may extend coaxially through the outer shaft 1406, and the inner shaft 1402 may also extend coaxially through the intermediate shaft 1404. The inner shaft 1402 may be fixedly secured (e.g., using adhesive) to the intermediate shaft 1404. The outer shaft 1406 can be positioned around the intermediate shaft 1404 and can move axially relative to the intermediate shaft 1404 (i.e., toward the distal end or the proximal end).

[0228] The control component 1408 of the delivery device 1400 may include a ball 1414, a handle 1416, and a ring 1418. Figure 69 The ball 1412 can be disposed around the distal end of the outer shaft 1406 and fixedly (e.g., using adhesive) to the distal end of the outer shaft 1406. The handle 1416 can be disposed around the ball 1414 and pivotally connected to the ball 1414. The ring 1418 can be disposed within an annular notch or groove 1420 formed in the outer surface of the handle 1416.

[0229] The plurality of pivot control wires (not shown) of the delivery device 1400 can, for example, include four pivot control wires similar to control wire 1316. The control wires can have a first distal end fixedly attached to or attached to the distal end 1454 of the inner shaft 1402, and a second proximal end fixedly attached to or attached to the ring 1418 and (therefore) the handle 1416. The control wires can be distributed in a ring around the central axis of the inner shaft 1402 and the handle 1416, similar to the above-described combination of the sheath 1302 and the control handle 1352. Figure 62 , Figure 66 The control wires 1316 are spaced 90 degrees apart from each other. The control wires can extend proximally through the corresponding lumen of the inner shaft 1402 and outwardly through the corresponding exit ports (shown in the diagram) of the inner shaft and intermediate shafts 1402, 1404, wherein the proximally end of the control wire can be attached to ring 1418. The port of the inner shaft 1402 can be oriented to circumferentially align with the corresponding port of the intermediate shaft 1404.

[0230] The control member 1408 and the pivoting control lead allow, for example, a physician to control the distal end 1456 of the flexible tube 1402 by pivoting the handle 1416 relative to the ball 1414 in a manner similar to that described above with respect to the delivery device 1300. Sometimes, during use, the control lead can become undesirably slack and oriented to extremes due to, for example, pivoting the handle 1416, which can reduce the effectiveness of the handle 1416 in controlling the distal end 1456 of the flexible tube 1402. To alleviate and / or eliminate this problem, the delivery device 1400 can include, for example, a tensioner 1410 to remove undesirable slack in the control lead, as further described below.

[0231] The tensioner 1410 of the delivery device 1400 may include a nut guide adapter 1422, a drive nut 1424, a stop washer 1426, a wire tension adjustment knob 1428, an adjustment nut washer 1430, and an end cap 1432. The guide nut 1422 may be securely attached to the proximal end of the outer shaft 1406. The guide nut 1422 may include an external thread (not shown) configured to engage a corresponding internal thread (not shown) of the drive nut 1424. The drive nut 1424 may also include an external thread (not shown) corresponding to and engaging the internal thread (not shown) of the wire tension adjustment knob 1428.

[0232] The adjusting knob 1428 is coupled to and rotatable relative to the end cap 1432. The end cap 1432 is fixedly secured or coupled to the proximal ends of the inner shaft 1402 and the intermediate shaft 1404. In this manner, rotation of the adjusting knob 1428 relative to the guide nut 1422 and the drive nut 1424 in a first direction causes the nuts 1422, 1424 and (therefore) the outer shaft 1406, ball 1414 and handle 1416 to move proximal to the inner shaft 1402 and the intermediate shaft 1404. Rotation of the adjusting knob 1428 relative to the nuts 1422, 1424 in a second direction (opposite to the first direction) causes the nuts 1422, 1424 and (therefore) the outer shaft 1406, ball 1414 and handle 1416 to move distal to the shafts 1402, 1404. Therefore, since the control wire is secured to the sheath at its distal end and to the handle 1416 at its proximal end, rotating the adjusting knob 1428 in the first direction applies tension to the control wire and reduces slack in the control wire. It should be noted that the tensioner 1410 can be used, for example, on various delivery devices that include the delivery device 1300.

[0233] The inner shaft 1402 of the device 1400 may include a grooved metal tube 1438, such as Figures 70A-71B As shown in the image. Metal tube 1438 can be formed, for example, by laser cutting alloy tubing (e.g., nitinol, stainless steel, cobalt-chromium, etc.). Figure 71B In its best-in-class representation, the tube 1438 may include a plurality of spinal sections 1440 and a plurality of struts 1442 disposed between and interconnecting the spinal sections 1440. The tube 1438 may also include an annular collar-shaped member 1444 disposed at the distal end of the tube 1438.

[0234] The fitting 1438 can be coated with a flexible polymer coating both externally and internally. The spine portion 1440 of the fitting 1438 can include an opening 1446. Figure 71B This allows, for example, the polymer coating to be evenly distributed throughout the pipe 1438, thereby providing a desirable uniform wall thickness for the inner shaft 1402.

[0235] The fitting 1438 can be configured such that the spine portion 1440 forms an axially extending row 1454 separated by the strut 1442. For example, in the illustrated embodiment ( Figure 71B In the best-in-class display, the spinal portion 1440 is configured as four axially extending rows 1454a, 1454b, 1454c, 1454d (in... Figure 70B In 71b, for illustrative purposes, row 1454d is axially cut downwards from the center to show fitting 1438 in a flat configuration. Rows 1454a-1454d can be spaced apart at an angle (e.g., 90 degrees) from each other, and row 1454 can be configured such that the spine portion 1440 of row 1454 is axially offset relative to the spine portion 1440 of the radially adjacent row 1454. This configuration of fitting 1438 allows it to flex or bend more uniformly in all directions and reduces kinking compared to solid fittings or fittings with a single solid spine portion.

[0236] The collar-shaped member 1444 of the tube 1438 may include distally extending tabs 1446 (two in the illustrated embodiment). In embodiments where the control wire is not directly secured or attached to the distal end 1456 of the flexible shaft 1402 but is attached to a separate traction ring (not shown), the tabs 1446 may be used, for example, to orient the tube 1438 and the traction ring. The traction ring may be attached to the distal end 1456 of the flexible shaft 1402, for example, by inserting the tabs 1446 into the traction ring. In such embodiments, the collar-shaped member 1444 of the tube 1438 may also include radially extending side notches or ports 1436 (four in the illustrated embodiment), which may be used, for example, to allow the control wire to enter the tube 1438 and pass through the inner diameter of the flexible tube 1402.

[0237] The inner shaft 1402's fitting 1438 can also include different axial cross sections (three in the illustrated embodiment) 1448, 1450, and 1452, such as... Figures 70A-70BThe best representation is shown below. Different axial sections 1448, 1450, and 1452 can, for example, include struts 1442 of different sizes. Providing struts 1442 of different sizes (i.e., removing more or less material) allows different axial sections to have smaller or larger bending radii. For example, the distal section 1448 includes the thinnest struts compared to the proximal sections 1450 and 1452 (i.e., removing most of the material), thereby allowing the distal section 1448 to have the smallest bending radius relative to the proximal sections 1450 and 1452. Furthermore, the intermediate section 1450 has struts thinner than the proximal section 1452, thereby allowing the intermediate section 1450 to have a smaller bending radius than the proximal section. It should be noted that although the illustrated embodiment shows the smallest strut positioned distally and the largest strut positioned proximally relative to the other sections, the axial sections can be configured in any order or combination to achieve the desired results for a particular application.

[0238] Figures 72-74 Exemplary embodiments of control members 1500, similar to control members 1312 and 1408 of delivery devices 1300 and 1400, are shown respectively. In the illustrated embodiments, control member 1500 includes a ball 1502, a slot 1504, and at least one (two in the illustrated embodiments) clamp 1506. Slot 1504 may include a first slot portion 1504a and a second slot portion 1504b. Slot portions 1504a and 1504b are radially separable by clamp 1506. Ball 1502 may include an internal opening or lumen 1522 that allows other devices (e.g., conduit fittings) to pass through ball 1502. Slot 1504 may be positioned around ball 1502 such that slot is rotatable relative to ball (similar to a ball joint).

[0239] The slot portions 1504a and 1504b may include at least one (in the illustrated embodiment, two) configured to receive a corresponding clamp 1506. Figure 73 A radially extending cut or recessed portion 1508. Each recessed portion 1508 may contain a corresponding protrusion 1510. A clamp 1506 may be positioned within the recessed portion 1508. Each clamp 1506 may include a ball contact surface 1512, a groove or slot 1514. Figures 73-74 ) and plate 1516.

[0240] The control component 1500 may further include a fixing mechanism 1526. Figure 74The retaining mechanism 1526 extends annularly around the slot portions 1504a, 1504b and the clamp 1506, holding the slot portions 1504a, 1504b and the clamp 1506 together and pressing the slot portions 1504a, 1504b and the clamp 1506 radially inward against the abutment ball 1504. The retaining mechanism 1526 can be, for example, one or more biasing elements (e.g., O-rings or elastic strips) respectively placed within the recesses 1518, 1520 of the slot portions 1504a, 1504b and the clamp 1506. In another embodiment, the retaining mechanism can be, for example, a spring or any other force application mechanism.

[0241] The ball contact surface 1512 can be configured to press against and apply friction to the outer surface of the ball 1502 to resist movement of the slot 1504 relative to the ball 1502 when manual pressure is removed from the slot 1504 and the clamp 1506. The groove 1514 of the clamp 1506 can be positioned to abut the protrusion 1510, thereby allowing the clamp 1506 to pivot about the protrusion 1510, where the protrusion 1510 acts as a fulcrum. The clamp 1506 can pivot by pressing or clamping the tabs 1516 together (in... Figure 74 (in the direction of arrow 1528), thereby causing tab 1516 to move radially inward. In this way, the clamp 1506 is pivoted to move the ball contact surface 1512 radially outward away from the outer surface of the ball 1502, thereby allowing slot 1504 and clamp 1506 to rotate relative to the ball 1502. Releasing manual pressure from tab 1516 allows clamp 1506 to move backward against the ball under the biasing force of retaining mechanism 1526.

[0242] Therefore, the clamp 1506 of the control member 1500 can act as a locking mechanism to secure the control member 1500 in the desired orientation. For example, when the control member 1500 is used as part of a delivery device (e.g., delivery device 1300, 1400), a physician can squeeze the tab 1516 of the clamp 1506 and pivot the slot portion 1504 (relative to the ball 1502) to pull the control lead (e.g., control lead 1316) and (therefore) the sheath (e.g., sheath 1302) (as described above) into the desired orientation. The physician can then lock the slot portion 1504 and (therefore) the sheath in the desired configuration by releasing the tab 1516, allowing the ball contact surface 1512 of the clamp 1506 to press against the ball 1502 and resist movement of the slot portion 1504 relative to the ball 1502, thereby holding the sheath in the desired orientation. This can advantageously allow, for example, a physician to use one hand to orient the delivery device to the desired configuration, then release that hand from the delivery device and then use both hands to perform another task (e.g., deploying a prosthetic implant with an implantation catheter).

[0243] Figure 75 Another exemplary embodiment of a control member 1600, similar to control member 1500, is shown. Control member 1600 includes a ball 1602, a slot 1604, and a clamp 1606. The ball 1602 may include an internal opening or cavity 1620 that allows the ball to be mounted on a shaft of a delivery device. The slot 1604 may include a recess 1608 configured to receive the clamp 1606, the recess 1608 receiving a rod or shaft 1610. Each clamp 1606 includes a ball contact surface 1612, a groove or slot 1614, and a tab 1616.

[0244] Slot 1604 may further include a recess (not shown, but similar to recess 1518), and clamp 1606 may further include a recess 1618. The recesses (i.e., recess 1618) in slot 1604 and clamp 1606 may be configured to receive a retaining mechanism (e.g., an O-ring, a spring, etc.) to hold slot 1604 and clamp 1606 together and abut against ball 1602. Control device 1600 may operate in a manner generally similar to control member 1500, as described above. Therefore, control member 1600 may, for example, provide similar locking type features and advantages as described with respect to control member 1500.

[0245] Figures 76-79 An exemplary embodiment of a control member 1700 similar to control member 1600 is shown. Control member 1700 includes a ball 1702, a slot portion 1704, and a clamp 1706. The illustrated embodiment is capable of being "unlocked" (i.e., allowing the slot portion 1704 to rotate relative to the ball 1702) and "locked" (i.e., preventing the slot portion 1704 from rotating relative to the ball 1702) in a manner similar to control member 1600.

[0246] The ball 1702 of the control member 1700 may include a plurality (four in the illustrated embodiment) of pins or protrusions 1708 disposed on and extending radially outward from the outer surface of the ball 1702. The slot portion 1704 may include (two in the illustrated embodiment) axially extending recesses 1710. Figures 78-79 ), and a slide rail 1712 disposed within the recessed portion, the slide rail 1712 dividing the recessed portion 1710 into two tracks or channels 1714 ( Figures 78-79 The channel 1714 can be configured such that the protrusion 1708 of the ball 1702 can travel or move axially within the slot 1704 as the slot 1704 pivots around the ball 1702.

[0247] However, due to the positioning of the protrusion 1708 of ball 1702 in the slide rail 1712 of slot 1704, slot 1704 cannot be twisted or rotated circumferentially relative to ball 1702. This anti-torsion feature of control member 1700 advantageously prevents, for example, the physician from twisting slot 1704 and thus twisting the control wire (not shown). These features enable, for example, easier operation of control member 1700 and (therefore) delivery device, since slot 1704 can move only in the intended manner. This anti-torsion feature also advantageously reduces, for example, the possibility that the physician will unintentionally damage control member 1700 and / or delivery device due to non-intended use of control member.

[0248] Figures 80-82 An exemplary embodiment of a control member 1800, similar to control member 1600, is shown, comprising a ball 1802, a slot portion 1804, and a clamp 1806. The illustrated embodiment is capable of being "unlocked" (i.e., allowing the slot portion 1804 to rotate relative to the ball 1802) and "locked" (i.e., preventing the slot portion 1804 from rotating relative to the ball 1802) in a manner similar to control member 1600.

[0249] The ball 1802 of the control member 1800 may include a plurality of (two in the illustrated embodiment) pins or protrusions 1808 disposed on and extending radially outward from the outer surface of the ball 1802. The slot portion 1804 may include (two in the illustrated embodiment) axially extending recesses or channels 1810 configured to receive the protrusions 1808 such that the protrusions 1808 can travel or move axially within the slot 1804 as the slot 1804 pivots about the ball 1802. However, due to the positioning of the protrusions 1808 in the channels 1810, the slot portion 1804 cannot be torn or rotated circumferentially relative to the ball 1802. This anti-torsional feature can, for example, provide at least the advantages described with respect to the control member 1700.

[0250] Figures 83-85 An exemplary control member 1900 according to one embodiment is shown. The control member 1900 is capable of functioning, for example, in a manner generally similar to the control member 1408 of device 1400. In the illustrated embodiment, the control member 1900 includes a ball 1902, a slot portion 1904, and a locking member 1906. The slot 1904 may include a generally spherical surface (not shown) (similar to a ball joint) disposed around the ball 1902, an externally threaded portion 1908 at the proximal end of the slot 1904, and a flange or handle portion 1910 extending radially from the distal end of the externally threaded portion 1908, such as... Figure 83 The best display in China.

[0251] The locking element 1906 may include a generally spherical inner surface 1912 having an internal thread of an externally threaded portion 1908 configured to receive a slot 1904, and a knob 1914 disposed radially outward from the surface 1912. In this way, rotation of knob 1914 and (therefore) locking member 1906 relative to ball 1902 and slot 1904 in a first direction causes slot 1904 and locking member 1906 to move axially toward each other, thereby advancing surface 1912 of locking member 1906 relative to ball 1902 and thereby preventing slot 1904 from pivoting or rotating relative to ball 1902 (i.e., "locking" slot 1904); and rotation of knob 1914 in a second direction (opposite to the first direction) causes slot 1904 and locking member 1906 to move axially away from each other, thereby removing surface 1912 of locking member 1906 from ball 1902 and thereby allowing slot 1904 to pivot or rotate relative to ball 1902 (i.e., "unlocking" slot 1904).

[0252] Figures 86-87 An exemplary catheter position locking device 2000 according to one embodiment is shown. In the illustrated embodiment, the locking device 2000 includes a coupler or sleeve 2002 ( Figure 87 (Best shown in the middle), housing 2004 and fastener parts 2006. For example... Figure 87 In best-illustrated configuration, sleeve 2002 can extend coaxially above the distal shaft portion 2005 of housing 2004. Housing 2004 can include an axially extending lumen 2008 and a radial opening (not shown), the radial opening being generally perpendicular to the lumen 2008 and including internal threads. Fastener 2006 can include an externally threaded plug 2010 that engages the internal threads of the radial opening of housing 2004 and can extend through the radial opening into the lumen of housing. Fastener 2006 can also include a head portion or knob 2012 that is fixedly attached to the upper portion of plug 2010.

[0253] In use, rotation of the head 2012 and (therefore) the plug 2010 relative to the housing 2004 in a first direction causes the plug 2010 06 to move radially inward, thereby blocking the cavity 2008 of the housing 2004, and rotation of the head 2012 of the fastener 2006 relative to the housing 2004 in a second direction (opposite to the first direction) causes the plug 2010 to move radially outward, thereby removing the plug 2010 from the cavity 2008 of the housing 2004.

[0254] The device 2000 can, for example, be used to allow one catheter or sheath to be desirablely positioned relative to another catheter or sheath and then secured in the desired location. For example, Figure 87The device 2000 is used in conjunction with an introductory sheath 2014 and an external catheter 2016. In some embodiments, as shown, the device 2000 can be securely fixed or coupled to the proximal end of the introductory sheath 2014 by advancing the distal end of the sleeve 2002 of the device 2000 above the sheath 2014. In other embodiments, the device 2000 can be securely fixed or coupled to the proximal end of the introductory sheath by means of adhesives, fasteners, or the like.

[0255] With the axial opening 2008 of the device 2000 cleared or open (i.e., the plug 2010 of the fastener 2006 does not obstruct the axial opening 2008), the outer conduit 2016 can be advanced through the device 2000 and the introducer sheath 2014. In this open or cleared configuration, the outer conduit 2016 can be axially (i.e., distally or proximally) twisted / rotated and / or moved relative to the device 2000 and (therefore) the introducer sheath 2014, thereby allowing the outer conduit 2016 to be desirablely positioned. Once the outer conduit 2016 is desirablely positioned, the plug 2010 can be moved inward and pressed against the outer conduit 2016 by rotating the head 2012 of the fastener 2006 in a first direction (e.g., as shown in the image). Figure 86 (Best shown in the image) The device secures the external catheter in the desired position, thereby preventing the external catheter from twisting / rotating and / or moving axially relative to the introducer sheath 2014. Therefore, the device 2000 advantageously allows, for example, the physician to adjust and secure the catheter during the procedure, making the procedure significantly safer and easier to perform.

[0256] Figures 88-91 An exemplary catheter position locking device 2100 according to another embodiment is shown. In the illustrated embodiment, the locking device 2100 includes a fixed portion 2102 and a movable portion 2104 connected to the fixed portion 2102, wherein the movable portion 2104 is rotatable relative to the fixed portion 2102. The fixed portion 2102 of the device may include a centrally located opening 2106, an axially extending sleeve 2108 radially outward from the opening 2106, and a circumferentially extending notch or groove 2110 radially outward from the sleeve 2108. The movable portion 2104 may include a centrally located opening 2112 and an axially extending pin 2114 radially outward from the opening 2112. The pin 2114 of the movable portion 2104 may be configured to extend axially through a corresponding groove 2110 of the fixed portion, such as... Figure 88 The best display in China.

[0257] It should be noted that although openings 2106 and 2112 are shown to have a generally square cross-section, openings 2106 and 2112 can include a variety of other shapes.

[0258] like Figures 90-91In the optimal display, the openings 2106 and 2112 of the corresponding parts 2102 and 2104 can be configured such that the movable part 2104 can be rotated to the first unlocked position relative to the fixed part 2102, so that the opening 2112 of the movable part 2104 is aligned with the opening 2106 of the fixed part 2102. Figure 90 The movable part 2104 is rotated relative to the fixed part 2102 to a second locking position, causing the opening 2112 of the movable part 2104 to become misaligned with the opening 2106, so that the movable part 2104 interferes with or partially blocks the opening 2106 of the fixed part 2102. Figure 91 ).

[0259] Although not illustrated, the device 2100 can be used, for example, with an introductory sheath and external catheter similar to sheath 2014 and catheter 2016. The sleeve 2108 of the retaining portion 2102 of the device 2100 can be securely fixed or coupled (e.g., using adhesives, fasteners, etc.) to the proximal end of the introductory sheath. With the movable portion rotated to a first aligned position, the external catheter can be advanced through the device 2100 and the introductory sheath. With the movable portion 2104 in the aligned position, the external catheter can be twisted / rotated and / or axially moved relative to the device 2100 and the introductory sheath to a desired position. Once desiredly positioned, the movable portion 2104 can be rotated to a second misaligned position, causing the movable portion 2104 to press relative to the external catheter, thereby preventing twisted / rotated and / or axially moved external catheter relative to the introductory sheath.

[0260] Figures 92-96 An exemplary catheter position locking device 2200 according to another embodiment is shown. In the illustrated embodiment, the locking device 2200 includes a shaft portion 2202, a cam portion 2204, and a handle portion 2206 including a rotatable knob. Figure 93 In best presentation, the shaft 2202 of the device 2000 may include an opening or cavity 2208 extending axially through the shaft 2202, and a flange portion 2210 at the proximal end of the shaft 2202. Figure 93 It also demonstrates that the shaft portion 2202 and the cam portion 2204 can be connected by inserting the flange portion 2210 into the annular recess portion 2212 formed in the distal end of the cam portion 2204.

[0261] The cam portion 2204 is rotatable relative to the shaft portion 2202. The cam 2204 may further include an annular notch or groove 2214 disposed near its proximal end. Figures 92-93 ), and offset opening 2216 (i.e., offset or having an axis different from that of the lumen 2208 relative to the shaft 2202) Figure 94(Best shown in the image). The handle 2206 may include an opening 2218 extending axially through the handle 2206. The handle portion 2206 can be positioned around and attached to the cam 2204 by inserting a fastener (not shown, such as a screw or bolt) through a corresponding radially extending and internally threaded port 2220 in the handle 2206. The fastener and port 2220 can be configured such that the fastener extends through the handle 2206 and engages the cam 2204 within a recess 2214, thus fixing the handle 2206 relative to the cam 2204. Therefore, rotating the handle 2206 causes the cam 2204 to rotate.

[0262] Due to the offset opening 2216, the handle 2206 and (therefore) the cam 2204 can rotate relative to the shaft 2202 to a first unlocked position, in which the opening 2216 of the cam 2204 is aligned with the cavity 2208 of the shaft 2202. Figure 95 ); and rotated to a second locking position, in which the opening 2216 of the cam 2204 is misaligned with the cavity 2208 of the shaft 2202, causing the cam 2204 to interfere with or block the cavity 2208 of the shaft 2202. Figure 96 ).

[0263] Although not illustrated, device 2200 is capable of, for example, using Figure 87 The method shown is used with an introducing sheath and external catheter similar to sheath 2014 and catheter 2016. The shaft 2202 can be securely fixed or coupled (e.g., using adhesives, fasteners, etc.) to the proximal end of the introducing sheath. With the opening 2216 of the cam 2204 aligned with the lumen 2208 of the shaft 2202, the external catheter can be advanced through the device 2200 and the introducing sheath. In this aligned configuration, the external catheter can be twisted / rotated and / or axially moved relative to the device 2200 and the introducing sheath to a desired position. Once desiredly positioned, the handle 2200 can be rotated to a second misaligned position, causing the cam 2204 to press against the external catheter, thereby preventing twisting / rotation and / or axial movement of the external catheter relative to the introducing sheath.

[0264] Figures 97-98 An exemplary catheter position locking device 2300 according to another embodiment is shown. Device 2300 includes a locking sleeve 2302 and a keyed rod or fitting 2304. (As shown...) Figure 98As best illustrated, the locking sleeve 2302 includes an axially extending opening 2306 containing at least one (two in the illustrated embodiment) tab or pin 2308 extending radially inward within the opening 2306. The key fitting 2304 includes at least one (two in the illustrated embodiment) recess or notch 2310. The notch 2310 of the key fitting 2304 can be configured to correspond to the pin 2308 of the locking sleeve 2302, such that the key fitting 2304 can be inserted and axially moved within the opening of the locking sleeve 2302 by aligning the notch of the key fitting 2304 with the pin 2308 of the locking sleeve 2302.

[0265] As shown, the pin 2308 of the locking sleeve 2302 and the corresponding notch 2310 of the key tube 2304 can be symmetrically arranged around the opening 2306 of the locking sleeve 2302 and the key tube 2304, respectively. When symmetrically arranged, the key tube 2304 can be inserted into the locking sleeve 2302 in multiple orientations (two orientations in the illustrated embodiment). Although not shown, it should be noted that the pin 2308 of the locking sleeve 2302 and the corresponding notch 2310 of the key tube 2304 can be asymmetrically arranged around the opening 2306 of the locking sleeve 2302 and the key tube 2304, respectively, such that the key tube 2304 can be inserted into the locking sleeve 2302 in only one orientation.

[0266] Device 2300 can be used, for example, with a prosthetic implant delivery system or device to prevent one catheter from twisting or rotating relative to another. For example, device 2300 can be used to prevent intermediate or guiding catheter 2312 from twisting or rotating relative to an outer catheter (not shown, but similar to outer catheter 2016), or vice versa. Locking sleeve 2302 can be securely attached to the proximal end of the outer catheter. For example, the distal end of locking sleeve 2302 can be advanced over the proximal end of the outer catheter, and locking sleeve 2302 is securely attached to the outer catheter using adhesives, fasteners, etc. Key fitting 2304 can be securely attached to the shaft of guiding catheter 2312.

[0267] With the locking sleeve 2302 and key fitting 2304 fixedly attached to the outer conduit and guide conduit 2312, respectively, the guide conduit 2312 can be advanced through the outer conduit until the key fitting 2304 enters the locking sleeve 2302. In this configuration, the pin 2308 of the locking sleeve 2302 engages the notch 2310 of the key fitting 2304, thereby preventing the guide conduit 2312 from twisting or rotating relative to the outer conduit, or vice versa. Alternatively, in other embodiments, using the delivery device 1300 as an example, the key fitting 2304 can be fixedly attached to the intermediate shaft and positioned on the intermediate shaft between the basket 1304 and the basket expander 1308, preferably close to the basket expander 1308. In another embodiment, using delivery device 1400 as an example, key tube 2304 can be fixedly attached to and positioned on intermediate shaft 1404, toward the distal end of control member 1408, but preferably close to control member 1408.

[0268] By preventing the guide catheter from twisting or rotating, the delivery system can be made significantly safer to use, for example, because it helps prevent unintentional twisting of the guide catheter during the procedure. This makes the delivery device significantly easier to use because improper movement is deliberately prevented or eliminated, thereby reducing the number of steps required to perform the procedure and wasted movement. By incorporating the key fitting at a preset position and / or orientation on the shaft of the guide catheter, the device 2300 is also able to make the device easier to use, reducing procedure time and / or errors, by reducing or eliminating the need for the physician to determine how far the guide catheter should be advanced and / or oriented relative to the external catheter.

[0269] Figures 99-102 An exemplary prosthetic implant delivery device 2400 is shown according to one embodiment. The delivery device 2400 includes an outer shaft 2402, an annular collar-like member or clamp 2404, and an inner shaft 2406, such as... Figures 99-100 The best view is shown below. The collet 2404 can be fixedly secured or coupled to the distal end of the outer shaft 2402, and the inner shaft 2406 can extend coaxially through the outer shaft 2402 and the collet 2404. The inner shaft 2406 can move axially (i.e., distally or proximally) relative to the outer shaft 2402 and the collet 2404.

[0270] The chuck 2404 of the delivery device 2400 may include a sleeve portion 2408 located at the proximal end of the chuck 2404, and a plurality of (two in the illustrated embodiment) forks or teeth 2410 extending axially away from the distal end (i.e., distally) of the sleeve portion 2408. Each tooth 2410 may include a corresponding radial protrusion 2412 disposed at or near the distal end of the tooth 2410 and extending radially outward from the tooth 2410. The protrusions 2412 of the teeth 2410 may be configured to connect to the proximal end of a prosthetic spacer device or another percutaneous delivery prosthetic device. For example, the prosthetic spacer device may have an annular collar-like member (similar to collar-like member 112) disposed proximally, which includes a plurality of radial openings configured to receive the protrusions 2412 of the delivery device 2400, thereby connecting the prosthetic spacer to the delivery device 2400.

[0271] The chuck 2404 of the delivery device 2400 can be formed of a material that allows the teeth 2410 to be elastically expandable and compressible in the radial direction. For example, the chuck 2404 can be formed of stainless steel. When formed of an elastically expandable and compressible material, the teeth 2410 can be released from a release configuration ( Figures 101-102 Radial extension to attachment or delivery configuration ( Figures 99-100 And vice versa, as will be further described below.

[0272] Delivery device 2400 can be used to percutaneously deliver prosthetic spacer device 2414 to a native heart valve (e.g., mitral valve), such as Figures 99-102 As shown in the figure. The prosthetic spacer 2414 may include anchors 2416. The delivery device 2400 may be used, for example, as part of a delivery device that includes an external catheter (not shown, but similar to external catheter 212), an intermediate or guiding catheter (not fully shown, but similar to guiding catheters 1300, 1400) and the delivery device 2400.

[0273] The external catheter can be used, for example, to cross the septum wall, leading to the left atrium of the heart. An intermediate or guiding catheter, including an implant cover or sheath 2418, can be advanced, for example, along with a delivery catheter 2400, through the external catheter and into the mitral valve, such that the anchor 2416 is positioned in the left ventricle. Figure 99 As shown in the diagram. The spacer 2414 can then be deployed from within the sheath 2418 by subsequently advancing the delivery catheter 2400 distally relative to the sheath 2418, or by retracting the sheath proximally relative to the delivery catheter, as illustrated. Figure 100 As shown in the figure. The delivery device 2400 can be used to desirably position the spacer 2414 relative to the original leaflet 2420. For example, the spacer 2414 can be twisted or rotated and / or axially moved by rotating or twisting and / or advancing or retracting the outer shaft 2402, respectively.

[0274] Once the spacer 2414 is properly positioned and secured to the original leaflet, it can be released from the delivery device 2400. This is achieved by retracting the inner shaft 2406 relative to the chuck 2404 and the outer shaft 2402, allowing the teeth 2410 to compress radially and the protrusion 2412 to move radially inward away from the spacer 2414, thus disengaging the protrusion 2412 from the spacer 2414 and releasing the spacer 2414 from the delivery device 2400. Figure 101 As shown in the diagram. When the protrusion 2412 disengages from the spacer 2414, the spacer 2414 is released, and the delivery device 2400 and sheath 2418 can retract through the external catheter, as illustrated. Figure 102 As shown in the image.

[0275] However, if the physician wishes to reposition the spacer 2414 after releasing the delivery device 2400, the physician can reattach the delivery device 2400 to the spacer 2414 by reversing the steps described above for releasing the spacer 2414.

[0276] Figure 103 Exemplary embodiments of an annular collar-like member or chuck 2500 for delivering catheters, similar to a chuck 2404 of delivery device 2400, are shown. The chuck 2500 may include a sleeve 2502 and a plurality (four in the illustrated embodiment) of teeth 2504 extending axially away from a distal portion of the sleeve 2502. As shown, each tooth 2504 may include a protrusion 2506 extending radially outward from the distal end of the respective tooth 2504. Each protrusion is configured to extend into a corresponding opening of the implant to be delivered. The chuck 2500 can function and be used in a manner generally similar to the chuck 2404 of delivery device 2400.

[0277] Figures 104-106 Another exemplary embodiment of a prosthesis implant delivery device 2600, similar to delivery device 2400, is shown. Delivery device 2600 includes an outer shaft (not shown, but similar to outer shaft 2402), an annular collar or clamp 2602, and an inner shaft 2604, as shown... Figure 104 The best view is shown below. The collet 2602 can be fixedly secured or coupled to the distal end of the outer shaft, and the inner shaft 2604 can extend coaxially through the outer shaft and the collet 2602. The inner shaft 2604 can move axially (i.e., distally or proximally) relative to the outer shaft 2402 and the collet 2404.

[0278] The chuck 2602 of the delivery device 2600 may include a sleeve portion 2606 located at the proximal end of the chuck 2602, and a plurality of (two in the illustrated embodiment) forks or tines 2608 extending axially (i.e., distally) away from the distal end of the sleeve portion 2606. Each tine 2608 may include a corresponding protrusion 2610 disposed at or near the distal end of the tine 2608 and extending radially outward from the tine 2608. The protrusions 2610 of the tines 2608 may be configured to connect to the proximal end of a prosthetic implant device (e.g., a prosthetic spacer). For example, the prosthetic spacer device may have an annular collar 2612 disposed proximally, the annular collar 2612 including a plurality of radial openings 2614 configured to receive the protrusions 2610 of the delivery device 2600.

[0279] Similar to delivery device 2400, delivery device 2600 can be coupled to the collar-like component 2612 of the prosthetic implant by retracting the inner shaft 2604 proximally relative to the clamp 2602 and the outer shaft (not shown), such that the distal end of the inner shaft 2604 is located proximally within the sleeve 2606 of the clamp 2602. Figure 105 As shown in the image. The retracted inner shaft 2604 allows for radial compression of the tooth 2608 (see...). Figure 105 This allows the tooth 2608 to be inserted into the collar-shaped part 2612 of the prosthesis implant.

[0280] like Figure 106 As shown, an implant can be secured to the delivery device 2600 by aligning the protrusion 2610 of the delivery device 2600 with the opening 2614 of the implant and advancing the inner shaft 2604 distally relative to the clamp 2602 and the outer shaft (not shown), such that the inner shaft 2604 extends axially through the teeth 2608. Advancing the inner shaft 2604 through the teeth 2608 causes the teeth 2608 to expand radially and forces the protrusion 2610 into the opening 2612 of the implant, thus securing the implant to the delivery device 2600.

[0281] Figures 107-110 An exemplary prosthetic implant delivery device 2700, similar to delivery device 2400 according to one embodiment, is shown. Delivery device 2700 includes an outer shaft 2702, an annular collar-like member or clamp 2704, and an inner shaft 2706, such as... Figures 109-110 The best view is shown below. The collet 2704 can be fixedly secured or coupled to the distal end of the outer shaft 2702, and the inner shaft 2706 can extend coaxially through the outer shaft 2702 and the collet 2704. The inner shaft 2706 can move axially (i.e., distally or proximally) relative to the outer shaft 2702 and the collet 2704.

[0282] The chuck 2704 of the delivery device 2700 may include a sleeve portion 2708 located at the proximal end of the chuck 2704, and a plurality of (two in the illustrated embodiment) forks or teeth 2710 extending axially away from the distal end (i.e., distally) of the sleeve portion 2708. Each tooth 2710 may include a corresponding protrusion 2712 disposed at or near the distal end of the tooth 2710 and extending radially inward from the tooth 2710. The protrusions 2712 of the teeth 2710 may be configured to connect to the proximal end of the prosthetic spacer device. For example, the prosthetic spacer device may have an annular collar-like member (similar to collar-like member 112) disposed proximally, which includes a plurality of radial openings configured to receive the protrusions 2712 of the delivery device 2700, thereby connecting the prosthetic spacer to the delivery device 2700.

[0283] The chuck 2704 of the delivery device 2700 can be formed of a material that allows the teeth 2710 to be elastically expandable and compressible in the radial direction. For example, the chuck 2704 can be formed of stainless steel. When formed of an elastically expandable and compressible material, the teeth 2710 can be extended from the attachment delivery configuration ( Figures 107-108 Radial extension to release configuration ( Figures 109-110 And vice versa, as will be further described below.

[0284] Delivery device 2700 can be used to percutaneously deliver prosthetic spacer device 2714 to a native heart valve (e.g., mitral valve), such as Figures 107-110 As shown in the figure. The prosthetic spacer 2714 may include an anchor 2716 and an annular collar 2718. The delivery device 2700 may be used, for example, as part of a delivery device that includes an external catheter (not shown, but similar to external catheter 212), an intermediate or guiding catheter (not fully shown, but similar to guiding catheters 1300, 1400), and the delivery device 2700.

[0285] The external catheter can be used, for example, to cross the septum wall, leading to the left atrium of the heart. An intermediate or guiding catheter, including an implant cover or sheath 2718, can be advanced, for example, along with a delivery catheter 2700, through the external catheter and into the mitral valve, such that the anchor 2716 is positioned in the left ventricle. Figure 107 As shown in the diagram. The delivery catheter 2700 can then be deployed from within the sheath 2718 by subsequently advancing the delivery catheter distally relative to the sheath 2718, or by retracting the sheath proximally relative to the delivery catheter, as illustrated. Figure 108 As shown in the figure. The delivery device 2700 can be used to desirably position the spacer 2714 relative to the original leaflet 2720. For example, the spacer 2714 can be twisted or rotated and / or axially moved by rotating or twisting and / or advancing or retracting the outer shaft 2702, respectively.

[0286] Once the spacer 2714 is properly positioned and secured to the original leaflet, the spacer 2714 can be released from the delivery device 2700. The spacer 2714 can be released from the delivery device 2700 by advancing the inner shaft 2706 distally relative to the chuck 2704 and the outer shaft 2702, causing the teeth 2710 to expand radially and the protrusion 2712 to move outwardly radially away from the spacer 2714, thus disengaging the protrusion 2712 from the spacer 2714. Figure 109 As shown in the diagram. When the protrusion 2712 disengages from the spacer 2714, the spacer 2714 is released, and the delivery device 2700 and sheath 2718 can retract through the external catheter, as illustrated. Figure 110 As shown in the image.

[0287] However, if the physician wishes to reposition the spacer 2714 after releasing the delivery device 2700, the physician can reattach the delivery device 2700 to the spacer 2714 by reversing the steps described above for releasing the spacer 2714.

[0288] Figure 111 An exemplary embodiment of an annular collar-shaped member or chuck 2800, similar to the chuck 2704 of the delivery device 2700, is shown. The chuck 2800 may include a sleeve 2802 and a plurality (four in the illustrated embodiment) of teeth 2804 extending axially away from the distal portion of the sleeve 2802. As shown, each tooth 2804 may include a protrusion 2806 extending radially inward from the distal end of the corresponding tooth 2804. The chuck 2800 can function and be used in a manner generally similar to the chuck 2704 of the delivery device 2700.

[0289] Figure 112 A cross-sectional view of an exemplary non-circular shaft 2901 of a delivery device 2900 according to one embodiment is shown. As shown, the shaft 2901 can include a non-circular cross-sectional profile in a plane perpendicular to the longitudinal axis of the shaft. For example, the shaft 2901 includes an elliptical cross-sectional profile comprising a primary axis (indicated by dashed line 2902) and a secondary axis (indicated by dashed line 2904). Due to the elliptical cross-sectional shape, the delivery system 2900 can bend more easily, for example, around the primary axis 2902 than around the secondary axis 2904. In this way, the delivery device 2900 can be advanced through a tortuous path (e.g., a blood vessel) by rotating the conduit as needed at each successive bend in the path such that the primary axis is substantially perpendicular to the direction of the bend in the path.

[0290] Figure 113A cross-sectional view of an exemplary non-circular delivery device 3000 according to another embodiment is shown. As shown, the delivery device 3000 may include a shaft 3002 having a "D" shaped cross-sectional profile.

[0291] Using non-circular delivery devices (e.g., devices 2900, 3000) and non-circular prosthetic devices (prosthetic devices having a non-circular cross-sectional profile in a plane perpendicular to the longitudinal axis of the prosthetic device) can advantageously allow, for example, more controlled deployment (due to more uniform deployment force). For instance, pairing an elliptical prosthesis with an elliptical delivery system allows for a more uniform deployment force in the radial direction relative to the circumference of the prosthesis. This uniformity can, for example, provide greater predictability and (therefore) control during the deployment procedure.

[0292] It should be noted that delivery devices 2900 and 3000 may include, for example, non-circular catheters and / or non-circular delivery sheaths. It should also be noted that delivery devices 2900 and 3000 may be used, for example, in conjunction with both circular and non-circular implantable prostheses.

[0293] Figures 114-127F Various embodiments of implantable prostheses with supplemental anchoring members to enhance the engagement of the anchors against the native leaflets are shown.

[0294] Figure 114 The prosthetic device 3100 is shown, comprising an annular body 3102 and an anchor 3104 extending from the body. Several pieces of friction-enhancing material 3106 can be mounted on the outer side of the body 3102 at positions opposite to the anchor 3104. In a particular embodiment, the friction-enhancing material 3106 can include, for example, hook-and-loop fasteners (e.g., The anchor 3104 is a plastic hook material. When implanted within the native valve, the anchor 3104 can compress the native leaflet against the friction-enhancing material 3106, thereby enhancing the anchor's retention force. In the illustrated embodiment, the friction-enhancing material 3106 is shown as being directly mounted (e.g., using sutures) to the frame of the body. In a particular embodiment, the body can be covered with a blood-impermeable covering (e.g., fabric), and the friction-enhancing material 3106 can be mounted on the outside of the covering.

[0295] Figure 115The prosthetic device 3200 is shown, comprising an annular body 3202, a fabric cover 3204, and an anchor 3104 extending from the body. One or more protrusions 3208 are mountable on each anchor 3206, the protrusions 3208 being formed of suture material surrounding the anchor, adhesive or other bonding agent applied to the anchor, or polymeric material beads or spheres molded or otherwise secured to the anchor. When implanted within the native valve, the anchor 3206 can abut against the native leaflet, pushing the protrusions 3208, thereby enhancing the anchor's retention force.

[0296] Figure 116 The prosthetic device 3300 is shown, comprising an annular body 3302, a fabric cover 3304, and an anchor 3306 extending from the body. One or more protrusions 3308 are mountable on each anchor 3306, the protrusions 3308 being formed by metal wires fixed to the ends of the anchors. When implanted within the native valve, the anchors 3306 can abut against the native leaflet 3308, pushing the protrusions 3308, thereby enhancing the retention force of the anchors.

[0297] Figure 117 An exemplary anchor 3400 is shown that can be secured to the body of a prosthetic device (any of the prosthetic devices disclosed herein). The anchor 3400 may include one or more barbs or protrusions 3402 that can engage and optionally penetrate the leaflet upon implantation to enhance the anchor's retention force.

[0298] Figure 118 The prosthetic device 3500 is shown, comprising an annular body 3502, a fabric cover 3504, and an anchor 3506 extending from the body. One or more barbs or protrusions 3508 extending through the cover 3504 can be mounted on the frame of the body. When implanted within the native valve, the anchor 3506 can abut against the protrusions 3508 (which can optionally penetrate the leaflet) to compress the native leaflet, thereby enhancing the anchor's retention force.

[0299] Figure 119A-119F The prosthetic device 3600 is shown, comprising an annular body 3602, a fabric covering (not shown), and anchors 3604 extending from the body. The end of each anchor 3604 is coupled to a corresponding post of the body 3602 via a corresponding sleeve 3606, the sleeve 3606 being capable of curling around the end portion of the anchor and the post of the body. One or more barbs or protrusions 3608 can be mounted on the frame of the body. In the illustrated embodiment, the free ends of the protrusions 3608 are configured to reside substantially within the body and not necessarily extend through the fabric covering (e.g., ...). Figure 118(As shown in the image). However, the protrusion 3608 can apply a retaining force against the original leaflet by means of the anchor 3604, which is shaped to hold the anchor from the open position ( Figure 119E and 119F Move to the closed position ( Figure 119A-119D This forces the native leaflet to enter the body inward in the area below the free end of anchor 3604.

[0300] Figures 120A-120C The prosthetic device 3700 is shown, comprising an annular body 3702, a fabric cover (not shown), an anchor 3704 extending from the body, a sleeve 3706 coupling the anchor to the body, and a protrusion 3708 extending from the body. Device 3700 is similar to device 3600, except that the anchor 3704 includes a central portion 3710 shaped to extend inwardly into the region below the protrusion 3708 when the anchor is in the closed position, as shown in the figure. In this way, the central portion 3710 assists in pushing the protrusion 3710 inwardly against the protrusion 3708, thereby enhancing the engagement of the device within the protrusion.

[0301] Figures 121A-121D The prosthetic device 3800 is shown, comprising an annular body 3802, a fabric cover (not shown), an anchor 3804 extending from the body, a sleeve 3806 coupling the anchor to the body, and a protrusion 3808 extending from the body. The anchor 3804 includes a central portion 3810 that abuts against the protrusion 3808 and an outwardly extending protrusion 3812 to press the original leaflet inward. The protrusion 3808 and the outwardly extending protrusion 3812 abut against the body to press the original leaflet in a region above the protrusion. In the illustrated embodiment, the opposite lower leg of the anchor 3804 includes a helical spring 3814, which acts as a spring hinge that allows the anchor to open spaced from the body while still providing a spring force relative to the body to bias the anchor when the opening force is removed from the anchor.

[0302] Figures 122A-122D The prosthetic device 3900 is shown, comprising an annular body 3902, a fabric cover (not shown), an anchor 3904 extending from the body, a sleeve 3906 coupling the anchor to the body, and a protrusion 3908 extending from the body. Similar to device 3800, the lower leg of the anchor 3904 may include a helical spring 3814 acting as a spring hinge for opening and closing the anchor. Unlike previous embodiments, the protrusion 3908 extends radially outward and downward toward the ventricular end of the body and is mounted on an outwardly curved strut member 3916 of the body, which extends outward through the anchor 3908 when pivoted to the closed position.

[0303] Figures 123A-123D The prosthetic device 4000 is shown, comprising an annular body 4002, a fabric cover (not shown), an anchor 4004 extending from the body, a sleeve 4006 coupling the anchor to the body, and a protrusion 4008 extending from the body. The anchor 4004 includes a central portion 4010 that abuts against the protrusion 4008 and an outwardly extending protrusion 4012, pressing the native leaflet inwardly. The protrusion 4008 and the outwardly extending protrusion 4012 press the native leaflet against the body in a region above the protrusion. In the illustrated embodiment, the opposite lower leg of the anchor 4004 includes a helical spring 4014 that acts as a spring hinge for opening and closing the anchor. Device 4000 is similar to device 3800, except that each of the springs 4014 has a corresponding end portion 4016 that extends upward from the coil portion 4018 and bends downward, where it is connected to the support of the body by one or more sleeves 4006. Figure 124A-124F It shows that the anchor is in the closed position. Figure 124A ), fully open position ( Figure 124D ) and the opening positions of various parts ( Figures 124B-124C , Figure 124E and Figure 124F Various views of the device 4000.

[0304] Figures 125A-125E The prosthetic device 4100 is shown, comprising a generally spherical or ball-shaped body 4102, an anchor 4104 coupled to the body, and a protrusion 4106 extending outwardly from the body. In certain embodiments, the body 4102 and the anchor 4104 may include braided or woven structures, such as metal braids or woven fabrics, as described in the embodiments above. Figure 125E (The anchors are best shown in their partially deployed position) Each anchor 4104 includes a first foldable portion 4108 having one end connected to the ventricular end of the body, and a second foldable portion 4110 having one end connected to the lower ring 4112. When the device 4100 is fully deployed, the foldable portions 4108, 4110 fold upwards along the body 4102 such that the native leaflet is captured between the body and the foldable portion 4108, wherein the protrusion 4106 engages the native leaflet. Figures 125A-125D As shown, the ring 4112 moves upward around the lower end portion of the foldable portions 4108 and 4110 to resist the movement of the anchor from the closed position, thereby keeping the device in place against the original leaflet.

[0305] Figures 126A-126JA prosthetic device 4200 is shown. Device 4200 is similar to device 4100 in that it includes a generally spherical or ball-shaped body 4202 and an anchor 4204 coupled to said body. The body 4202 and anchor 4204 can include braided or woven structures, such as metal braids or woven fabrics, as described in the embodiments above. Each anchor 4204 can include a first foldable portion 4208 having one end connected to the ventricular end of the body, and a second foldable portion 4210 having one end connected to a lower ring 4212. Unlike device 4100, a protrusion 4206 is mounted to the inner surface of the second foldable portion 4210, and the first foldable portion 4208 can be formed with a groove or opening 4214 that allows the protrusion 4206 to extend through the opening to engage the native leaflet when the anchor 4204 is moved to a closed, fully deployed position. Figure 126A Anchor 4204 is shown in a partially deployed state, with the anchor partially folded. Figure 126B Showing a detailed view of a portion of the main body 4202, such as Figure 126A The instructions are in accordance with the central government. Figure 126C-126F The anchors are shown to be in a further partial deployment stage, where the anchors are from Figure 126A The position shown in the middle is further folded. Figure 126G-126J The anchor is shown in a folded and closed state, fully deployed along the body 4202, with the protrusion 4206 extending through an opening in the first foldable portion 4208 to engage the native leaflet. Although not shown, it is possible to... Figure 126A The partially folded state shown in the image represents a further axial movement of the ring 4212 away from the main body 4202, fully deploying the anchor into the delivery configuration.

[0306] Figures 127A-127F A prosthetic device 4300 is shown. Device 4300 is similar to device 4100 in that it includes a generally spherical or ball-shaped body 4302 and an anchor 4304 coupled to said body. The body 4302 and the anchor 4304 can include braided or woven structures, such as metal braids or woven fabrics, as described in the embodiments above and as... Figure 127E and 127F The best presentation is shown below. Device 4300 includes a lower ring or sleeve 4312. Each anchor 4304 may include a first inner foldable portion 4308 connected at one end to the lower end 4314 of the body 4302, and a second outer foldable portion 4310 connected at one end to the upper end 4316 of the lower ring 4212. The first foldable portion 4308 extends upward from the lower end 4314 of the body 4302, passes through an opening in the second foldable portion 4310, and then bends outward and downward, where it connects to the upper end of the second foldable portion 4310.

[0307] During delivery, the lower sleeve 4312 is spaced from the main body so that the lower sleeve does not overlap with the anchor, and the foldable portion of the anchor folds away from the main body (similar to...). Figure 126A As the device is deployed, the native leaflet is positioned on the opposite side of the main body, and the anchors are folded upwards toward the main body to the fully deployed position. Figure 127A The native leaflet engages between the body 4302 and the first foldable portion 4308. Folding of the anchor causes the sleeve 4312 to be pulled over the lower end portion of the first foldable portion 4308 to hold the anchor in the fully deployed position.

[0308] Through such Figures 114-127F As illustrated, by incorporating supplemental anchoring components, the structural parts of the prosthetic device (e.g., the metal frame of the body and / or anchors) can be manufactured to be relatively thin and / or flexible. Therefore, the device is easier to roll up for loading into the delivery sheath and exhibits greater flexibility in tracking through small-radius rotations as it advances toward the implantation site.

[0309] Figure 128 An alternative embodiment of a steering control mechanism 4400 is shown, which can be incorporated into any of the delivery devices described above (e.g., delivery device 1300) to control the deflection of the distal portion of the delivery device. In the illustrated embodiment, the control mechanism 4400 includes a proximal control knob 4402a, a distal control knob 4402b, a first shaft 4404a and a second shaft 4404b operatively coupled to the proximal control knob 4402a, and a third shaft 4404c and a fourth shaft 4404d operatively coupled to the distal control knob 4402b, respectively. Housing 4410 ( Figure 128 The transparent part (as described in the text) can accommodate the shaft, and the control knob can be movably coupled to the housing 4410.

[0310] The first shaft 4404a and the second shaft 4404b are coupled to a proximal control knob 4402a via corresponding gears 4406a mounted on the proximal ends of the shafts. The third shaft 4404c and the fourth shaft 4404d are coupled to a distal control knob 4402b via corresponding gears 4406b mounted on the proximal ends of the shafts. In this manner, rotation of the proximal control knob 4402a causes corresponding rotational movements of the first shaft 4404a and the second shaft 4404b, and rotation of the distal control knob 4402b causes corresponding rotational movements of the third shaft 4404c and the fourth shaft 4404d.

[0311] Corresponding traction line holders 4408a, 4408b, 4408c, and 4408d are mounted on shafts. The proximal ends (not shown) of the four traction lines are fixedly attached to the traction line holders. Each of the traction line holders 4408a, 4408b, 4408c, and 4408d has an internal thread that engages with the external thread of its corresponding shaft 4404a, 4404b, 4404c, or 4404d, and is fixed to prevent rotational movement, such that rotation of the shaft after rotation of control knobs 4402a and 4402b causes the traction line holder to move axially along the shaft. The first shaft 4404a and the second shaft 4404b are screwed in opposite directions, while the third shaft 4404c and the fourth shaft 4404d are screwed in opposite directions. In this manner, rotation of the proximal control knob 4402a causes the traction line holders 4408a and 4408b to move axially in opposite directions, and rotation of the distal control knob 4402b causes the traction line holders 4408c and 4408d to move axially in opposite directions.

[0312] For example, if the proximal control knob 4402a is rotated to move the first traction line holder 4408a proximally and the second traction line holder 4408b distally, the traction line attached to the first traction line holder 4408a tightens and the traction line attached to the second traction line holder loosens, causing the delivery device to bend or deflect under the tension of the traction line attached to the first traction line holder (upward in the illustrated embodiment). Conversely, rotating the proximal control in the opposite direction will cause the delivery device to deflect under the tension of the traction line attached to the second traction line holder 4408b (downward in the illustrated embodiment). Similarly, rotating the distal control knob 4402b causes the delivery device to deflect to the left or right under the tension of the traction line attached to the traction line holders 4408c or 4408d, depending on the direction of rotation of the distal control knob. Rotation of both the proximal control knob 4402a and the distal control knob 4402b causes the delivery device to deflect under the tension of the two traction lines. Thus, as can be understood, the delivery device can deflect upward, downward, laterally (to the left or right), or in any direction in between (e.g., downward to the left or right, or upward to the left or right).

[0313] Figures 129-130 An exemplary embodiment of an implantable prosthesis device 4500, similar to prosthesis device 600, is shown. Prosthesis device 4500 may include a spacer body 4502, a plurality of (e.g., two in the illustrated embodiment) anchors 4504, a plurality of (e.g., two in the illustrated embodiment) fixation members 4506, and a locking element 4508. Figure 129(In its best-performing configuration, with the prosthetic device 4500 in a radially compressed configuration), the proximal portion 4510 of the anchor 4504 is coupled to the spacer body 4502, and the distal portion 4512 of the anchor 4504 is coupled to the locking element 4508. The proximal portion 4514 of the fixing member 4506 is coupled to the proximal portion 4510 of the anchor 4504, and the fixing member 4506 extends distally from the proximal portion 4514 to the free distal portion 4516 of the fixing member 4506.

[0314] In other embodiments, the prosthetic device 4500 may include more or fewer anchors 4504 and / or fixation members 4506. For example, in some embodiments, the prosthetic device 4500 may include three anchors 4504 and three fixation members 4506. In some embodiments, the number of fixation members 4506 may be less than or greater than the number of anchors 4504.

[0315] As shown, the spacer body 4502, anchor 4504, and / or locking element 4508 can be formed, for example, from a braided material. In such embodiments, the spacer body 4502, anchor 4504, and / or locking element 4508 may be covered with a blood-impermeable material and / or coating.

[0316] In some embodiments, two or more of the spacer body 4502, anchor 4504, and / or locking element 4508 can be formed from a single piece of material. In other embodiments, the spacer body 4502, anchor 4504, and / or locking element 4508 can be formed from individual sheets of material coupled together (e.g., by welding, adhesives, fasteners, etc.).

[0317] The spacer body 4502 of the prosthetic device 4500 can be configured to reduce and / or prevent regurgitation between native heart valve leaflets (e.g., native mitral valve leaflets) in a manner similar to that of the spacer body 612 of the prosthetic device 600.

[0318] As described above, the anchor 4504 can include a proximal portion 4510 and a distal portion 4512. The anchor 4504 of the prosthesis device 4500 can also each include a joint portion 4518 disposed between the respective proximal portion 4510 and distal portion 4512. Thus, the anchor 4504 can be configured to pivot at the joint portion 4118 using a delivery device (not shown) (e.g., similar to how the anchor 610 of the prosthesis device 600 can be bent at the joint 618 using a delivery device, such as...). Figures 27-34 (as shown in the image), from the first configuration (e.g., stationary or unbiased configuration, such as...) Figure 129 (As shown in the image) Move to the second configuration (e.g., the deflection configuration, such as) Figure 130 (As shown in the text) and vice versa.

[0319] As mentioned above, the fixing member 4506 may include a proximal portion 4514 and a distal portion 4516. The fixing member 4506 may also each include a hinge portion 4520 and a plurality of protrusions 4522. The hinge portion 4520 may be disposed between the proximal portion 4514 and the distal portion 4516. The protrusions 4522 may be coupled to the distal portion 4516 and radially (i.e., as...) from the distal portion 4516. Figure 129 The radial outward direction described in the text, and as... Figure 130 (The radial direction depicted in the text extends inwards).

[0320] The retaining member 4506 can be configured to pivot at the hinge portion 4520, enabling the delivery device to remove the retaining member 4506 from a first configuration (e.g., a stationary or unbiased configuration, such as...). Figure 129 (As shown in the image) Move to the second configuration (e.g., the compressed configuration, such as...) Figure 130 (as shown in the text), and vice versa, as further described below.

[0321] In the first configuration, the fixing member 4506 is angled at the hinge portion 4520 such that the protrusion 4522 of the fixing member 4506 does not extend into and / or through the corresponding proximal portion 4510 of the anchor 4504. In other words, the protrusion 4522 is positioned radially inward relative to the proximal portion 4510 of the anchor 4504 (i.e., as...). Figure 129 (As depicted in the illustration). This configuration can reduce and / or prevent the protrusion 4522 of the fixation member 4506 from engaging (e.g., hooking) the delivery cylinder and / or the patient's native tissue (not shown) as the prosthesis device 4500 is loaded, positioned and / or recaptured (e.g., during the implantation procedure).

[0322] This can be achieved, for example, by forming the retaining member 4506 from a relatively elastic material (e.g., nitinol), and shaping the retaining member 4506 such that the angle between the proximal portion 4514 and the distal portion 4516 is less than about 180 degrees at the hinge portion 4520. In some embodiments, the angle can be from about 135 degrees to about 175 degrees, and in one particular embodiment, the angle can be about 155 degrees.

[0323] As described above, the fixing member 4506 can be moved from a first configuration to a second configuration using a delivery device. The delivery device enables the locking element 4508 and the spacer body 4502 to move axially toward each other, such that the anchor 4504 pivots at the joint 4518 and the locking element 4508 slides over and radially overlaps the fixing member 4506 at the hinge portion 4520 and / or distal end of the fixing member 4506. Figure 130 As shown in the diagram. The locking element 4508 and the fixing member 4506 can be configured such that the locking element 4508 presses against the fixing member 4506, thus causing the fixing member 4506 to pivot radially inward at the hinge portion 4520 to a second configuration, as shown in the diagram. Figure 130 As shown in the diagram, the locking element 4508 can be configured to expand slightly radially as it slides over the fixing member 4506 when moved to the second configuration.

[0324] In the second configuration, the fixing member 4506 is angled at the hinge portion 4520, such that the protrusion 4522 at the distal portion 4516 of the fixing member 4506 extends into and through the corresponding proximal portion 4510 of the anchor 4504, as shown. Figure 130 As shown in the diagram. In other words, the protrusion 4522 can extend radially inward (i.e., as shown in the diagram). Figure 130 (As depicted in the illustration) the proximal portion 4510 extending beyond the anchor 4504. This configuration allows the protrusion 4522 to engage native tissue to secure the prosthesis device 4500 at the implantation site. For example, the protrusion 4522 is capable of engaging and / or penetrating radially positioned between the spacer body 4502 and the anchor 4504 (e.g., similar to...). Figure 17 The original leaflet is positioned (as shown in the image of the prosthetic device 300).

[0325] Once the prosthesis device 4500 is properly positioned, the locking element 4508 is secured relative to the spacer body 4502, the anchor 4504, and the fixation member 4506. This secures the prosthesis device 4500 relative to the native tissue. The prosthesis device 4500 can then be released from the delivery device by actuating the delivery device.

[0326] Before releasing the prosthesis device 4500, the locking element 4508 can be axially separated from the fixation member 4506 by moving the locking element 4508 relative to the fixation member 4506, allowing the prosthesis device 4500 to be repositioned and / or removed using a delivery device. This allows the fixation member 4506 to disengage from the native tissue and move back from the second configuration to the first position. The prosthesis device can then be moved and / or removed relative to the native tissue into the delivery cylinder of the delivery device, reducing the probability that the protrusion 4522 will engage the native tissue and / or the delivery cylinder.

[0327] Prosthetic valve

[0328] Figures 131-133 An exemplary embodiment of a prosthetic heart valve 4600 is shown. The prosthetic valve 100 may include a stent or frame 4602. Figure 133 The prosthetic valve 4600 includes a leaflet assembly 4604 supported and secured within the frame 4602, and a cover 4606 covering a portion of the frame 4602. The leaflet assembly 4604 may include one or more (three in the illustrated embodiment) tissue leaflets 4608 made of biological materials (e.g., pericardial tissue, such as bovine, porcine, or equine pericardial tissue) or synthetic materials (e.g., polyurethane). The leaflets 4608 are configured to allow blood to flow through the prosthetic valve 4600 in one direction and to prevent blood from flowing in the opposite direction. Figure 131 In the image, the leaflet 4608, shown in solid lines, depicts the closed position used to stop blood flow; while the leaflet 4608, shown in dashed lines, depicts the open position that allows blood flow through the prosthetic valve 4600.

[0329] Figure 133 A frame 4602 is shown without the leaflet assembly 4604 or the covering 4604. The frame 4602 may include an annular body 4610 (which houses the leaflet assembly 4604), one or more first anchors 4612 extending from one end of the body 4610, and one or more second anchors 4614 extending from the opposite end of the body 4610. In the illustrated example, the prosthetic valve 4600 includes a prosthetic mitral valve implantable in the native mitral valve annulus, the first anchors 4612 including ventricular anchors deployed posterior to the native mitral valve leaflet in the left ventricle, and the second anchors 4614 including atrial anchors deployed abutting against the native mitral valve annulus in the left ventricle. The illustrated prosthetic mitral valve 4600 includes two ventricular anchors 4612 and twelve atrial anchors 4614 positioned on opposite diameter sides of the outflow end of the body 4610. In other embodiments, the prosthetic valve 4600 may include more or fewer ventricular anchors 4612 and / or atrial anchors 4614.

[0330] Frame 4602 may include a shape memory material, such as nitinol (nickel-titanium alloy), to enable, for example, self-expanding from a radially compressed state to an expanded state. Although not illustrated, when constructed from a self-expanding material, the prosthetic valve 4600 can be rolled into a radially compressed state using a coiling device and loaded into the sheath of a delivery catheter for delivery to the implantation site. Upon release from the sheath, the prosthetic valve 4600 can self-expand to an expanded state at the implantation site (e.g., a native mitral valve). In alternative embodiments, for example, frame 4602 can be plastically expandable from a radially compressed state to an expanded state using an expansion device such as an inflatable balloon (not shown). Such a plastically expandable frame may include stainless steel, chromium alloy, and / or other suitable materials. When constructed from a plastically expandable material, the prosthetic valve 4600 can be rolled into a radially compressed state on or near a balloon (or other expansion device) of the delivery catheter using a coiling device. Additional details regarding the coiled prosthetic heart valve 4600 and the coiling device can be found, for example, in U.S. Patent Application Publication No. 2015 / 0336150A1.

[0331] The covering 4606 may comprise a blood-impermeable fabric and may extend over portions of the body 4610, atrial anchor 4614, and / or ventricular anchor 4612. The fabric may comprise a polyester material, such as polyethylene terephthalate (PET). Alternatively, the covering may comprise biological material, such as pericardial tissue or other biological tissue. Further details (e.g., construction and components) of the prosthetic valve 4600 are disclosed in U.S. Patent No. 8,449,599 and U.S. Patent Application Publication No. 2014 / 0222136.

[0332] In the extended state, the ventricular anchor 4612 extends along the outer surface of the body 4610. Therefore, once implanted at the native mitral valve, the native mitral valve leaflet is captured between the body 4610 and the ventricular anchor 4612, thereby resisting systolic pressure in the left ventricle to anchor the prosthetic valve 4600 in place. The atrial anchor 4614 extends axially and radially outward from the inlet end of the body 4610. Therefore, once implanted at the native mitral valve, the atrial anchor 4614 is positioned in the left atrium against the native mitral valve annulus, thereby resisting diastolic pressure in the left ventricle to anchor the prosthetic valve 4600 in place.

[0333] Figures 134-135A frame 4700 for a prosthetic heart valve is shown. The frame 4700 can be configured similarly to the frame 4602 of the prosthetic heart valve 4600 (e.g., for implantation in a native mitral valve annulus) and can be used, for example, with the leaflet assembly 4604 and the cover 4606 of the prosthetic heart valve 4600. The frame 4700 can include an annular body 4702, one or more first anchors 4704 (e.g., two in the illustrated embodiment, 4704a, 4704b, collectively referred to herein as "first anchors 4704") extending from one end of the body 4702, and one or more second anchors 4706 (e.g., twelve in the illustrated embodiment) extending from the opposite end of the body 4702.

[0334] In some embodiments, the first anchor 4704 can be coupled to the body 4702 using a plurality of tabs or sleeves 4708 (e.g., two in the illustrated embodiment, 4708a, 4708b, collectively referred to herein as "tabs 4708"). Tabs 4708 can be coupled to and extend from a first end 4710 of the body 4702 (e.g., an outflow end) (e.g., at a apex or junction 4716, where the two pillars of the frame 4700 are together at the frame outflow end), and are positioned relative to each other on opposite diameter sides of the body 4702. Tabs 4708 can be configured to securely receive end portions of the first anchor 4704. Figure 134 In optimal display, tab 4708a can securely receive the first end portions 4712a, 4712b corresponding to the first anchors 4704a, 4704b, and tab 4708b can securely receive the second end portions 4714a, 4714b corresponding to the first anchors 4704a, 4704b. Tab 4708 can be curled and / or welded to the end portion and apex 4716 of the first anchor 4704 to enhance the connection between the first anchor 4704 and the body 4702 of the frame 4700.

[0335] The frame 4700 is configured such that the first anchor 4704 shares a tab 4708 at its first end portion 4712 and second end portion 4714, which advantageously balances the first anchor 4704 relative to the body 4702. Thus, the forces applied to the first anchor 4704 during dynamic cardiac circulation tend to be equal and opposite to each other, and therefore cancel each other out. This reduces and / or eliminates the forces transferred from the anchor 4704 to the body 4702, and thus reduces and / or prevents the body 4702 from radially deflecting inward at the first end 4710 during dynamic cardiac circulation.

[0336] The first anchor 4704 can be configured to pivot 180 degrees relative to the body 4702, from a functional configuration (e.g., Figures 134-135 The first anchor 4704 can extend axially away from the second anchor 4706, as shown in the compression delivery configuration (not illustrated), and vice versa. Figures 134-135 The extension toward the second 4706 shown in the diagram forms a contrast. Thus, the first anchor 4704 does not increase the radial profile of the frame 4700 because the first anchor 4704 does not radially overlap with the body 4702. This can be achieved, for example, by forming the first anchor 4704 from a relatively flexible material such as nitinol, stainless steel, and / or chromium alloy. The prosthetic valve including the frame 4700 can be delivered using, for example, a delivery device disclosed in U.S. Patent Application Publication No. 2014 / 0222136, which is configured to control the pivoting movement of the first anchor 4704 between a delivery configuration and a functional configuration, wherein the native leaflet is captured between the anchors of the body.

[0337] The geometry of the first anchor 4704 can include various configurations. For example, the shape, size, etc., can be configured for a specific implantation location (e.g., native mitral valve, aortic valve, lung valve, and / or tricuspid valve) and / or for the desired coiling and / or functional radial profile.

[0338] In other embodiments, the frame 4700 may include more or fewer first anchors 4704 and / or second anchors 4706. For example, the frame 4700 may include three first anchors 4704.

[0339] General Instructions

[0340] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the invention are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. In fact, the invention is directed toward all novel and non-obvious features and aspects of the various disclosed embodiments, existing individually 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 require any one or more particular advantages or problems to be solved.

[0341] Although the operations of some of the disclosed methods are described in a specific sequential order for ease of presentation, it should be understood that this descriptive approach encompasses rearrangement unless a particular language requires a specific order. For example, in some cases, the operations described in the sequential order may be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. As used herein, the terms "a" and "at least one" cover one or more of the specified elements. That is, if two specific elements exist, then one of those elements also exists, and therefore there is "a" element. The terms "a plurality" and "plural" mean two or more of the specified elements.

[0342] As used herein, the term “and / or” used between the last two elements in the list of elements means any one or more of the listed elements. For example, the phrase “A, B and / or C” means “A”, “B”, “C”, “A and B”, “A and C”, “B and C”, or “A, B and C”.

[0343] As used in this article, the term “coupled” generally means physically coupled or linked, and does not preclude the existence of intermediate elements between the coupled items in the absence of a specific opposite language.

[0344] Given that the principles of the invention can be applied to many possible embodiments, it should be understood that the illustrated embodiments are merely preferred examples of the invention and should not be considered as limiting the scope of the invention. In fact, the scope of the invention is defined by the appended claims. We therefore claim all contents falling within the scope and spirit of these claims as our invention.

Claims

1. An implantable prosthetic device for connection to a native heart valve leaflet, comprising: The spacer body is made of a self-expanding material made of braided metal wire; The spacer body is configured to be placed between the native valve leaflets of the heart; The spacer body has a proximal end and a distal end; A shaft on which the spacer body is mounted; An end cap, which is arranged on the shaft on the distal side relative to the spacer body; At least one anchoring portion extending from the ventricular end of the spacer body, each of the at least one anchoring portion including a lower support leg portion, an upper support leg portion, and a connector located between the lower support leg portion and the upper support leg portion, wherein the upper support leg portion is coupled to the distal end of the spacer body, and wherein the lower support leg portion is coupled to the end cap. The implantable prosthesis is movable between a first configuration and a second configuration, in which the spacer body is radially compressed and axially spaced relative to the at least one anchoring portion, and in the second configuration the spacer body is radially extended outward relative to the first configuration and overlaps with at least a portion of the at least one anchoring portion to capture the leaflet of the native heart valve between the at least one anchoring portion and the spacer body. as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

2. The implantable prosthesis device of claim 1, wherein the spacer body and the at least one anchoring portion are made of a single piece of braided material formed from self-expanding metal wires.

3. The implantable prosthesis device according to claim 1, wherein the spacer body is covered by a blood-impermeable material.

4. The implantable prosthesis device of claim 1, wherein the spacer body and the at least one anchoring portion are covered by a blood-impermeable material.

5. The implantable prosthesis device of claim 1, wherein the spacer body is configured such that compressing an end of the spacer body causes the spacer body to shorten axially and expand radially.

6. The implantable prosthesis device of claim 1, wherein the spacer body and the anchoring portion are made of a single piece of wound material.

7. A component for delivering an implantable prosthetic device, comprising: The implantable prosthesis device has a spacer body configured for placement between the native valve leaflets of the heart, a shaft on which the spacer body is mounted, an end cap disposed distally on the shaft relative to the spacer body, and a plurality of anchors extending from the ventricular end of the spacer body. as well as A delivery device having a first shaft and a second shaft; The spacer body has a proximal end and a distal end; The spacer body is made of a self-expanding material made of braided metal wire; Each of the plurality of anchors includes a lower leg portion, an upper leg portion, and a joint located between the lower leg portion and the upper leg portion, wherein the upper leg portion is coupled to the distal end of the spacer body, and wherein the lower leg portion is coupled to the end cap. The plurality of anchors are releasably coupled to the first shaft; The second shaft is coupled to the proximal end of the spacer body; The movement of the first shaft relative to the second shaft causes the implantable prosthesis to move between a first configuration and a second configuration; The implantable prosthesis is movable between a first configuration and a second configuration, in which the spacer body is radially compressed and axially spaced relative to the anchor, and in the second configuration, the spacer body is radially extended outward relative to the first configuration and overlaps with at least a portion of the anchor to capture the corresponding leaflet in the native valve leaflet between each of the plurality of anchors and the spacer body. as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

8. The component of claim 7, wherein the spacer body and the plurality of anchors are made of a single-piece wound material.

9. The component of claim 7, wherein the spacer body is covered by a blood-impermeable material.

10. The component of claim 7, wherein the spacer body and the plurality of anchors are covered with a blood-impermeable material.

11. An implantable prosthetic device for repairing a patient's native valve, the implantable prosthetic device comprising: A spacer body, the spacer body being expandable and compressible, wherein the spacer body has a proximal portion and a distal portion and is configured to be placed between the leaflets of the patient's native valve; A shaft on which the spacer body is mounted; An end cap, which is arranged on the shaft on the distal side relative to the spacer body; A pair of anchors extending from the ventricular end of the spacer body, each anchor including a lower leg portion, an upper leg portion and a connector located between the lower leg portion and the upper leg portion, wherein the upper leg portion is coupled to the distal portion of the spacer body and wherein the lower leg portion is coupled to the end cap. The paired anchors are movable between an open position and a closed position; The paired anchors are configured to attach to the patient's native valve; The implantable prosthesis is movable between a first configuration and a second configuration, in which the spacer body is radially compressed and axially spaced relative to the paired anchors, and in the second configuration the spacer body is radially extended outward relative to the first configuration and overlaps with at least a portion of the paired anchors to capture the corresponding leaflet of the native valve between each anchor in the paired anchors and the spacer body. as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

12. The implantable prosthesis device of claim 11, wherein the spacer body is symmetrical about a plane that bisects the spacer body and the anchor.

13. The implantable prosthesis device of claim 11, wherein the spacer body comprises a woven material.

14. An implantable prosthetic device for connection to a native heart valve leaflet, comprising: A spacer body, the spacer body being expandable and compressible, wherein the spacer body is configured to be placed between the native valve leaflets of the heart; The spacer body has a proximal end and a distal end; A shaft on which the spacer body is mounted; An end cap, which is arranged on the shaft on the distal side relative to the spacer body; At least one anchoring portion is configured to abut against the spacer body to secure a leaflet in the native heart valve leaflet, wherein the at least one anchoring portion extends from the ventricular end of the spacer body, and wherein each anchoring portion includes a lower support leg portion, an upper support leg portion, and a connector located between the lower support leg portion and the upper support leg portion, wherein the upper support leg portion is coupled to the distal end of the spacer body, and wherein the lower support leg portion is coupled to the end cap; The implantable prosthesis is movable between a first configuration and a second configuration, in the first configuration the spacer body is radially compressed and axially spaced relative to the at least one anchoring portion, and in the second configuration the spacer body is radially outwardly extended relative to the first configuration and overlaps with at least a portion of the at least one anchoring portion to capture the leaflet in the native heart valve between the at least one anchoring portion and the spacer body; as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

15. The implantable prosthesis device of claim 14, wherein the spacer body and the at least one anchoring portion are made of a single piece of braided material formed from self-expanding metal wires.

16. The implantable prosthesis device of claim 14, wherein the spacer body is covered by a blood-impermeable material.

17. The implantable prosthesis device of claim 14, wherein the spacer body and the at least one anchoring portion are covered by a blood-impermeable material.

18. An assembly for delivering an implantable prosthetic device, comprising: The implantable prosthesis device has a spacer body that is expandable and compressible, wherein the spacer body is configured to be placed between the native valve leaflets of the heart; a shaft on which the spacer body is mounted; a plurality of anchors extending from the ventricular end of the spacer body; and an end cap disposed distally on the shaft. as well as A delivery device having a first shaft and a second shaft; The spacer body has a proximal end and a distal end; Each of the plurality of anchors includes a lower leg portion, an upper leg portion, and a joint located between the lower leg portion and the upper leg portion, wherein the upper leg portion of each of the plurality of anchors is coupled to the distal end of the spacer body; and wherein the distal end of the lower leg portion of each of the plurality of anchors is fixedly secured to the end cap. The first shaft of the delivery device is coupled to the end cap; The second shaft of the delivery device is coupled to the spacer body; The movement of the first shaft of the delivery device relative to the second shaft of the delivery device causes the anchor to move relative to the spacer body; The implantable prosthesis is movable between a first configuration and a second configuration, in which the spacer body is radially compressed and axially spaced relative to the plurality of anchors, and in the second configuration, the spacer body is radially extended outward relative to the first configuration and overlaps with at least a portion of the plurality of anchors to capture the corresponding leaflet in the native valve leaflet between each of the plurality of anchors and the spacer body. as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

19. The component of claim 18, wherein the spacer body and the plurality of anchors are made of a single piece of braided material formed from self-expanding metal wire.

20. The component of claim 19, wherein the winding material comprises nitinol.

21. The component of claim 18, wherein the spacer body is covered by a blood-impermeable material.

22. An implantable prosthetic device for repairing a patient's native valve, the implantable prosthetic device comprising: Paired anchors; A spacer body, the spacer body being expandable and compressible, wherein the spacer body is connected to the pair of anchors and configured to be disposed between the leaflets of the native valve, wherein the spacer body has a proximal end and a distal end, wherein the pair of anchors extends from the distal end of the spacer body. A shaft on which the spacer body is mounted; An end cap, which is arranged on the shaft on the distal side relative to the spacer body; and A blood-impermeable covering placed on the main body of the spacer; Each anchor includes a lower leg portion, an upper leg portion, and a joint located between the lower leg portion and the upper leg portion, wherein the upper leg portion is coupled to the distal end of the spacer body, and wherein the lower leg portion is coupled to the end cap. The paired anchors extend from the ventricular end of the shaft; The implantable prosthesis is movable between a first configuration and a second configuration, in which the spacer body is radially compressed and axially spaced relative to the paired anchors, and in the second configuration the spacer body is radially extended outward relative to the first configuration and overlaps with at least a portion of the paired anchors to capture corresponding leaflets of the native valve between each anchor in the paired anchors and the spacer body. as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

23. The implantable prosthesis device of claim 22, wherein the covering comprises fabric.

24. The implantable prosthesis device of claim 22, wherein the covering extends from the proximal end of the spacer body to the distal end of the spacer body.

25. The implantable prosthesis device according to any one of claims 22-24, further comprising a collar-like member connected to the proximal portion of the spacer body.

26. The implantable prosthesis device according to any one of claims 22-24, wherein the spacer body is hollow.

27. The implantable prosthesis device according to any one of claims 22-24, wherein the spacer body is made of a flexible mesh material, and the cover is disposed on the flexible mesh material.

28. The implantable prosthesis device according to any one of claims 22-24, further comprising a collar-like member connected to the distal portion of the spacer body.

29. The implantable prosthesis device according to any one of claims 22-24, further comprising a blood-impermeable covering disposed on each of the anchors.

30. An implantable prosthetic device for repairing a patient's native valve, the implantable prosthetic device comprising: A spacer body, the spacer body being expandable and compressible, wherein the spacer body is configured to be disposed between the leaflets of the patient's native valve, the spacer body having a proximal end and a distal end; A shaft on which the spacer body is mounted; A distal cap, which is arranged on the shaft on the distal side relative to the spacer body; One or more anchors extending from the ventricular end of the spacer body, each of the one or more anchors including a lower leg portion, an upper leg portion and a connector located therebetween; The distal cap is movable away from the spacer body to open the one or more anchors; The upper leg portion of each anchor is coupled to the distal end of the spacer body; The lower leg portion of each anchor is fixedly secured to the distal cap; The implantable prosthesis is movable between a first configuration and a second configuration, in which the spacer body is radially compressed and axially spaced relative to the one or more anchors, and in the second configuration, the spacer body is radially extended outward relative to the first configuration and overlaps with at least a portion of the one or more anchors to capture the leaflets of the native valve between the one or more anchors and the spacer body. as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

31. The implantable prosthesis device of claim 30, wherein the one or more anchors are made of nitinol.

32. The implantable prosthesis device of claim 30, wherein the one or more anchors are made of a braided material.

33. The implantable prosthesis device of claim 30, wherein the one or more anchors are made of self-expanding metal wires.

34. An implantable prosthetic device for connection to a native heart valve leaflet, comprising: A spacer body configured to be placed between the native valve leaflets of the heart; The spacer body has a proximal end and a distal end; A shaft on which the spacer body is mounted; At least one anchoring portion extends from the ventricular end of the spacer body and is configured to attach to the native heart valve leaflet; and A distal cap, which is arranged on the shaft on the distal side relative to the spacer body; Each of the at least one anchoring portion includes a lower leg portion, an upper leg portion, and a joint located between the lower leg portion and the upper leg portion, wherein the upper leg portion is coupled to the distal end of the spacer body, and wherein the lower leg portion is coupled to the end cap. The axial movement of the spacer body toward the distal cap causes the spacer body to shorten axially and expand radially. The implantable prosthesis is movable between a first configuration and a second configuration, in which the spacer body is radially compressed and axially spaced relative to the at least one anchoring portion, and in the second configuration the spacer body is radially extended outward relative to the first configuration and overlaps with at least a portion of the at least one anchoring portion to capture the leaflet in the native heart valve between the at least one anchoring portion and the spacer body. as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

35. The implantable prosthesis device of claim 34, wherein the spacer body and the at least one anchoring portion are made of a single piece of braided material formed from self-expanding metal wires.

36. The implantable prosthesis device of claim 34, wherein the spacer body is covered by a blood-impermeable material.

37. The implantable prosthesis device of claim 34, wherein the spacer body and the at least one anchoring portion are covered by a blood-impermeable material.

38. The implantable prosthesis device of claim 34, wherein the spacer body is made of braided, self-expanding metal wire.

39. A component for delivering an implantable prosthetic device, comprising: An implantable prosthesis device having a spacer body configured for placement between native valve leaflets of the heart, a shaft on which the spacer body is mounted, a plurality of anchors extending from the ventricular end of the spacer body, and an end cap disposed distally on the shaft relative to the spacer body. as well as A delivery device having a first shaft and a second shaft; The spacer body has a proximal end and a distal end; The spacer body is configured such that compressing the end of the spacer body between the end cap and the second shaft of the delivery device causes the spacer body to shorten axially and expand radially. Each of the plurality of anchors includes a lower leg portion, an upper leg portion, and a joint located between the lower leg portion and the upper leg portion, wherein the upper leg portion is coupled to the distal end of the spacer body, and wherein the lower leg portion is coupled to the end cap. The first shaft of the delivery device is releasably coupled to the lower leg portion of the plurality of anchors; The second shaft of the delivery device is releasably coupled to the proximal end of the spacer body; The movement of the first shaft of the delivery device relative to the second shaft of the delivery device causes the anchor to move relative to the spacer body. The implantable prosthesis is movable between a first configuration and a second configuration, in which the spacer body is radially compressed and axially spaced relative to the plurality of anchors, and in the second configuration the spacer body is radially extended outward relative to the first configuration and overlaps with at least a portion of the plurality of anchors to capture the corresponding leaflet in the native valve leaflet between each of the plurality of anchors and the spacer body. as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

40. The component of claim 39, wherein the spacer body and the plurality of anchors are made of a single piece of braided material formed from self-expanding metal wire.

41. The component of claim 40, wherein the spacer body is covered by a blood-impermeable material.

42. The component of claim 39, wherein the spacer body and the plurality of anchors are covered by a blood-impermeable material.

43. An implantable prosthesis device comprising: A spacer body portion configured to be disposed between the primary lobules of the heart, wherein the spacer body portion has a proximal portion, a distal portion, and a longitudinal axis extending from the proximal portion to the distal portion, wherein the spacer body portion is configured to restrict antegrade blood flow through the spacer body portion from the proximal portion to the distal portion and restrict retrograde blood flow through the spacer body portion from the distal portion to the proximal portion; A shaft on which the main body of the spacer is mounted; An end cap disposed on the shaft on the distal side relative to the spacer body portion, wherein the end cap is longitudinally spaced from the spacer body portion and is capable of longitudinal movement relative to the spacer body portion; and A plurality of anchors extending from the ventricular end of the spacer body portion, wherein each anchor has an upper leg portion, a lower leg portion and a joint portion located between the lower leg portion and the upper leg portion, wherein the upper leg portion of the anchor is coupled to the distal portion of the spacer body portion, and wherein the lower leg portion of the anchor is pivotally coupled to the end cap. The prosthetic device is movable between a compression configuration and an expansion configuration, in which the spacer body portion is radially compressed and extends axially away from the plurality of anchors, and in the expansion configuration, the spacer body portion is radially extended outward relative to the compression configuration and axially overlaps at least a portion of the plurality of anchors to capture corresponding leaflets of the original leaflets between each anchor and the spacer body portion of the plurality of anchors; and The upper support leg portion is spaced relative to the lower support leg portion in the compression configuration and overlaps with the lower support leg portion in the expansion configuration.

44. The prosthetic device of claim 43, wherein each of the anchors is configured to abut against the spacer body portion to secure a corresponding native leaflet.

45. The prosthetic device of claim 43, wherein the anchor is configured to fold at the joint portion when the spacer body portion moves relative to the end cap.

46. ​​The prosthetic device of claim 45, wherein the anchor is configured to fold from the compression configuration to the extension configuration at the joint portion when the spacer body portion moves relatively close to the end cap, and the anchor is configured to unfold from the extension configuration to the compression configuration at the joint portion when the spacer body portion moves relatively away from the end cap.

47. The prosthetic device according to any one of claims 43-46, further comprising a fixation member having a barb coupled to one of the anchors, wherein the fixation member is configured to engage native lobular tissue and fix the native lobular tissue to one of the anchors.

48. The prosthetic device of claim 47, wherein the fixing member is pivotally coupled to the spacer body portion and the anchor.

49. The prosthetic device of claim 44, wherein the anchors are capable of longitudinal movement relative to each other.

50. The prosthetic device according to any one of claims 43-46, wherein the spacer body portion and the anchor are formed from a single piece of integrally wound material.

51. The prosthetic device of claim 50, wherein the braiding material comprises nitinol.

52. The prosthetic device according to any one of claims 43-46, wherein the spacer body portion and the anchor are self-expanding.

53. The prosthetic device according to any one of claims 43-46, wherein the prosthetic device is configured to implant a native mitral valve and reduce mitral regurgitation.

54. An implantable prosthetic device comprising: A spacer body configured to be placed between the native leaflets of a heart valve, the spacer body having a proximal end and a distal end, wherein the spacer body is configured to block blood flow through the implantable prosthesis device; A shaft on which the spacer body is mounted; An end cap disposed on the shaft on the distal side relative to the spacer body, wherein the end cap is axially movable relative to the spacer body; and The ventricular portion includes a pair of anchors extending from the ventricular end of the spacer body, wherein each anchor has an upper leg portion connected to the distal end of the spacer body, a lower leg portion connected to the end cap, and a connector located between the lower leg portion and the upper leg portion. The spacer body is movable between a first configuration and a second configuration, wherein in the first configuration the spacer body is radially compressed and extends away from the ventricular portion, and in the second configuration the spacer body is wider relative to the first configuration and the spacer body is positioned between the paired anchors to capture the corresponding leaflets in the native leaflets between each anchor in the paired anchors and the spacer body; as well as The upper support leg portion is spaced relative to the lower support leg portion in the first configuration and overlaps with the lower support leg portion in the second configuration.

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