HK40089906A - Heart valve sealing devices and delivery devices therefor - Google Patents

Description

Heart valve sealing device and delivery device

This application is a divisional application, based on divisional application number 201910806218.9. The original application was filed on May 13, 2016, with application number 201680027130.1, and the invention title was "Heart Valve Sealing Device and Delivery Device Thereof".

Technical Field

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

Figures 1-3 illustrate implantable prostheses in various deployment phases according to one embodiment.

Figures 4 and 5 illustrate the implantable prosthesis device at various deployment stages according to another embodiment.

Figures 6-8 illustrate an implantable prosthesis device delivered and implanted in the native mitral valve according to one embodiment.

Figures 9-12 show various views of another embodiment of the implantable prosthesis device.

Figures 13-17 show the prosthetic devices of Figures 9-12 delivered and implanted within the native mitral valve.

Figure 18 is a side view of another embodiment of the implantable prosthesis device.

Figures 19a-19h illustrate exemplary thermoforming processes that can be used to form prosthetic devices such as those shown in Figures 9-12 or Figure 18.

Figures 20-24 show various views of another embodiment of the implantable prosthesis device.

Figures 25-26 are side views of another embodiment of the implantable prosthesis device.

Figures 27-34 show various views of the prosthetic device of Figures 25-26 at different deployment stages.

Figure 35 illustrates another embodiment of an implantable prosthesis device implanted within the native mitral valve.

Figure 36 illustrates another embodiment of an implantable prosthesis device implanted within the native mitral valve.

Figures 37-47 show various views of another embodiment of the implantable prosthesis device.

Figures 48-52 show various views of another embodiment of the implantable prosthesis device.

Figure 53 shows another embodiment of the implantable prosthesis device.

Figures 54-58 show the prosthetic device of Figure 53 at various deployment stages within the native mitral valve.

Figures 59-61 show various views of another embodiment of the implantable prosthesis device at different deployment stages.

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

Figures 63A and 63B are end and side views, respectively, of the expandable basket portion of the delivery device in Figure 62.

Figure 64 is a side view of the basket portion in the extended configuration shown in Figures 63A and 63B.

Figures 65A and 65B are the end view and side view of the intermediate shaft of the delivery device in Figure 62, respectively.

Figure 66 is a cross-sectional view of the proximal shaft of the delivery device in Figure 62.

Figure 67 illustrates the delivery of a prosthetic device to the native mitral valve using the delivery device shown in Figure 62.

Figure 68 is a side view of a steerable delivery device for an implantable prosthesis according to another embodiment.

Figure 69 is an exploded perspective view of the delivery device in Figure 68.

Figures 70A-71B show various views of the slotted metal tube that can be incorporated into the internal steerable shaft of the delivery device in Figure 68.

Figures 72-74 show various views of alternative embodiments of steering control components that can be incorporated into the delivery device.

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

Figures 76-79 show various views of alternative embodiments of steering control components that can be incorporated into the delivery device.

Figures 80-82 show various views of alternative embodiments of steering control components that can be incorporated into the delivery device.

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

Figures 86 and 87 are end views and side views of a catheter position locking device according to one embodiment, respectively.

Figures 88-91 show various views of another embodiment of the catheter position locking device.

Figures 92-96 show various views of another embodiment of the catheter position locking device.

Figures 97 and 98 are perspective and end views, respectively, of another embodiment of the catheter position locking device.

Figures 99-102 are various views of another embodiment of a delivery device for delivering a prosthesis within the native mitral valve.

Figure 103 is a perspective view of an exemplary clamp/prosthetic device holding mechanism that can be incorporated into the delivery device of Figures 99-102.

Figures 104-106 show various views of a prosthetic device connected to a delivery device for delivery into a patient.

Figures 107-110 are various views of another embodiment of a delivery device for delivering a prosthesis within the native mitral valve.

Figure 111 is a perspective view of an exemplary clamp/prosthetic device holding mechanism that can be incorporated into the delivery device of Figures 107-110.

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

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

Figure 114 illustrates another exemplary embodiment of the implantable prosthesis device.

Figure 115 shows another exemplary embodiment of the implantable prosthesis device.

Figure 116 illustrates another exemplary embodiment of the implantable prosthesis device.

Figure 117 illustrates an exemplary embodiment of an anchor that can be incorporated into an implantable prosthesis device.

Figure 118 illustrates another exemplary embodiment of the implantable prosthesis device.

Figures 119A-119F illustrate another exemplary embodiment of the implantable prosthesis device.

Figures 120A-120C illustrate another exemplary embodiment of the implantable prosthesis device.

Figures 121A-121D illustrate another exemplary embodiment of the implantable prosthesis device.

Figures 122A-122D illustrate another exemplary embodiment of the implantable prosthesis device.

Figures 123A-123D illustrate another exemplary embodiment of the implantable prosthesis device.

Figures 124A-124F show the prosthetic devices of Figures 123A-123D at various deployment stages.

Figures 125A-125E illustrate another exemplary embodiment of the implantable prosthesis device.

Figures 126A-126J illustrate another exemplary embodiment of the implantable prosthesis device.

Figures 127A-127F illustrate another exemplary embodiment of the implantable prosthesis device.

Figure 128 shows an alternative embodiment of the steering control mechanism for the delivery device.

Figures 129-130 illustrate another exemplary embodiment of the implantable prosthesis device.

Figures 131-133 illustrate exemplary embodiments of implantable prosthetic heart valves.

Figures 134-135 illustrate exemplary embodiments of the frame for implantable prosthetic heart valves.

Detailed Implementation

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.

Prosthetic spacer

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.

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.

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.

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.

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.

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.

Figures 1-3 illustrate an implantable prosthesis device 10 according to one embodiment. 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.

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.

The spacer body 14 can include an annular metal frame 28 (Figure 3) covered with a blood-impermeable fabric 30 (Figures 1 and 2). Figure 3 shows the spacer body 14 with the blood-impermeable fabric 30 covering the frame 28. The frame 24 can include a mesh structure comprising multiple interconnected metal struts, such as conventional radially compressible and expandable supports. 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).

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.

The inner shaft 16 can, for example, include a screw or helical coil with external threads (as shown in Figures 1-3). The collar-like member 24 has internal threads that engage the individual turns of the coil, or, in the case where the shaft includes a screw, engages the external threads of the screw. Thus, rotation of the inner shaft 16 relative to the outer shaft 26 can effectively move the collar-like member 24 along the length of the shaft 16, and thus move the spacer body 14. Rotation of the inner shaft 16 relative to the outer shaft 26 can be achieved by a rotatable torque shaft of a delivery device (e.g., shown in Figures 6-8) rotatably releasably connected to the inner shaft 16. The delivery device can have a corresponding outer shaft 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.

Device 10 can be percutaneously delivered to the native heart valve (e.g., the mitral valve) using a delivery device. Figure 1 shows the spacer body 14 in a pre-anchored proximal position spaced from the ventricular portion 12 before being installed into the native leaflet of the mitral valve (native leaflets not shown in Figures 1-3). Anchor 20 is positioned in the left ventricle posterior to the native leaflet (e.g., desirably at the A2 and P2 regions of the leaflet, 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 the position shown in Figure 2, such that the leaflet is captured between the anchor 20 and the spacer body 14.

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.

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.

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.

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.

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.

Figures 4 and 5 illustrate another exemplary embodiment of the implantable prosthesis device 100. 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.

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.

Each of the support pillars 114 can be fixedly attached to a first collar-shaped member 110 corresponding to a first end of the support pillar 114, and fixedly attached to a second collar-shaped member 112 corresponding to a second end of the support pillar 114. The support pillar 114 can be fixedly attached to the collar-shaped members 110, 112, for example, by forming the support pillar 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 pillar 114 can be fixedly attached to the collar-shaped members 110, 112, for example, by adhesives, welding, fasteners, etc. Anchors 102 are 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 not shown in Figures 4 and 5, the body 104 can be covered with a blood-impermeable covering (e.g., fabric) similar to the fabric 30 shown in Figures 1 and 2.

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 distal end of the shaft 106 (to the left in Figures 4 and 5). The proximal collar 112 is secured to a nut 108 having internal threads that engage with the external threads 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 strut 114, respectively.

Anchor 102 and strut 114 can be formed of a self-expanding material (e.g., nitinol). When formed of a self-expanding material, anchor 102 and strut 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 device. When deployed from the sheath, anchor 102 can be radially expanded, thereby creating a gap between anchor 102 and strut 114, as shown in Figure 4. In this configuration, the native leaflet of the heart valve can be placed in the gap between anchor 102 and strut 114. The leaflet can then be secured between anchor 102 and strut 114 by axial movement of proximal collar 112 along the shaft toward distal collar 110 via rotation of the shaft. As proximal collar 112 moves toward distal collar 110, strut 114 buckles or flexes toward anchor 102 away from the longitudinal axis of shaft 106, as shown in Figure 5. 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 cardiac systole.

Rotation of shaft 106 relative to nut 108 and body 104 can be achieved via a rotatable torque shaft of a delivery device (e.g., shown in Figures 6-8) rotatably releasable to shaft 106. The delivery device can have a corresponding outer shaft releasable to nut 108 and configured to limit rotation of nut 108 when shaft 106 is rotated by the torque shaft.

The shaft 106 shown in Figures 4 and 5 includes a rigid bolt; however, the shaft 106 may include a flexible screw or a flexible helical coil, similar to the shaft 16 shown in Figures 1-3.

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.

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.

Figures 6-8 illustrate an implantable prosthesis device 200 according to another embodiment, deployed from delivery device 202 into the mitral valve 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.

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 (as shown in Figure 6). The external catheter 212 may be advanced on a lead 226, which may 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. As further shown in Figure 6, the implantation catheter 214 and the prosthesis device 200 may 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 prosthesis device is in the left ventricle.

As shown in Figure 7, the delivery sheath 216 can subsequently retract to expose the prosthesis 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 prosthesis 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.

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 rotating torque shaft 220 and shaft 208, 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 (as shown in FIG. 8). Therefore, prosthesis device 200 can be secured to leaflet 228 by clamping leaflet 228 between anchor 206 and body 204. Subsequently, as shown in FIG. 8, nut support shaft 218 and torque conduit 220 can be released from prosthesis device, and implantation conduit can be retracted into outer conduit.

Figure 9 illustrates an exemplary implantable prosthetic device 300 according to another embodiment. The prosthetic 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 shows a guide 320 extending through the device 300. The guide 320 is usable during the device placement procedure (described below).

As shown in Figure 10, 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 that 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 fabric 30 shown in Figures 1 and 2) or coated with a flexible sealant material such as expanded polytetrafluoroethylene (commonly referred to as “ePTFE”), which allows the braided material to expand and/or bend while preventing blood flow through device 300.

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).

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

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 to its functionally extended state as shown in Figures 11 and 12. The native leaflet (not shown in Figures 11 and 12) is held between the anchor 310 and the spacer body 304 of the device 300, 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 leaflet can more easily and completely engage, thereby preventing or minimizing mitral regurgitation.

For example, Figures 13-17 illustrate the delivery of device 300 to the mitral valve using delivery device 312. Delivery device 312 may include an external catheter (not shown) and device catheter 314. 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 device 300 may be releasably connected to the shaft 318 of device catheter 314 and loaded into delivery sheath 316, thus holding device 300 in the delivery configuration.

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.

As shown in Figure 13, 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 the anchor 310 to automatically expand from the unfolded radially compressed delivery configuration (shown in Figure 10) to the folded radially extended configuration (shown in Figures 9, 11-12). 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.

As shown in Figure 14, the anchor can be positioned posterior to the ventricular portion of the leaflet 326 (e.g., desirably at positions A2 and P2). Figure 15 shows that the delivery sheath 316 of the device catheter 314 can subsequently retract further 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 ventricular and atrial portions of the leaflet 326, respectively.

With the leaflet 326 secured between the anchor and the body, the shaft 318 of the device catheter 314 can be disconnected from the proximal end 308 of the device 300 (as shown in Figure 16), and the device catheter 312 can be retracted into the outer catheter. The outer catheter and the lead 320 can then be retracted and removed from the patient, as shown in Figure 17. The 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 flow through the device 300.

Figure 18 illustrates an exemplary implantable prosthesis device 400 with an overall configuration similar to device 300, 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 lobular tissue to minimize lobular movement between the anchors 410 and the body 404 and improve tissue inward growth, as shown in Figure 18. In another embodiment, the friction elements may include a textured surface formed in and/or applied to a blood-impermeable covering of the body 404.

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).

Device 400 can be percutaneously delivered to the native heart valve (e.g., mitral valve) using delivery devices and procedures similar to those described above with respect to device 300 (see Figures 13-17).

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.

Figure 19 illustrates an exemplary thermoforming sequence for manufacturing apparatus 300, 400. Apparatus 300, 400 can be formed by placing a tubular sheet of wound, self-expanding material above a mandrel and then annealing the material in the configuration shown in Figures 19a-19h. When formed in this sequence, the apparatus expands in the same sequence as when exposed from the delivery sheath.

Figures 20-24 illustrate exemplary embodiments of an implantable prosthesis device 500 similar to device 300 according to another embodiment. 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 spacer body 504 are mounted.

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

The distal sleeve 514 can be inserted above the distal end 508 of the ventricular portion 502 and 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 distal end of the intermediate sleeve 516 (shown in FIG. 22) mounted on the shaft 506. The distal end of the spacer body 504 is attached to the proximal end of the intermediate sleeve 516, and the proximal end is attached to the distal end of the 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 enable the extension of the device during delivery of the device 500, as further described below.

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.

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.

As shown in Figure 20, the ventricular portion 502 and the spacer body 504 of device 500 can be formed of a self-expanding braided material. The braided material can be formed of 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 flow through device 500. Figure 20 shows device 500 in a radially expanded functional state. 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). When device 500 is in the delivery configuration, device 500 can be percutaneously delivered to a native heart valve (e.g., mitral valve), similar to the delivery device 312 described above.

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 within 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 shown in Figure 23. In this configuration, the anchor can be positioned relative to the ventricular portion of the native leaflet.

The leaflet can then be secured by axially retracting the proximal sleeve 518 relative to the inner shaft 506 and the delivery sheath 520, causing the body 504 to expand radially, as shown in Figure 24. With 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 occurs, 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.

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.

Figures 25-34 illustrate exemplary embodiments of an implantable prosthesis device 600 similar to device 500 according to another embodiment. 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.

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.

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.

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.

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.

The braided portion 606 of the device 600 can be formed from a single piece of braided material. The braided material can be formed from self-expanding metal wire (e.g., nitinol). For example, Figure 26 shows the braided portion 606 of the device 600 formed from a single piece of braided material, with the anchor portion 610 extending in an undisturbed configuration and the body 612 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 anchor 610 and the body 612 can be connected by attaching the proximal end of the upper leg 616 of the anchor 610 and the distal end of the body 612 to the connecting sleeve 620 (shown in Figure 25). When formed from 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 a delivery device, as shown in Figure 27. 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.

Device 600 can be percutaneously delivered to a native heart valve (e.g., mitral valve) using a delivery device. Figures 27-34 illustrate deployment of device 600 from the delivery device. The delivery device can include an external catheter (e.g., external catheter 520 of Figure 23) and an implantation catheter 622. Implantation catheter 622 can include a delivery sheath 624, an inner shaft (not shown), and an outer shaft 608 (shown in Figure 25). The inner shaft and outer shaft 608 extend coaxially through the delivery sheath 624 of the implantation catheter 622, and the inner shaft extends coaxially through the outer shaft 608 of the implantation catheter 622.

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 advanced into the patient's heart (not shown) via, for example, the transseptal technique described above (see Figures 6-8). Figure 27 shows the sheath 624 of the implantation catheter 622 confining the prosthetic device 600 in a delivery configuration in which the implantation 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 are in the left ventricle (similar to the positioning shown in Figure 6).

As shown in Figure 28, the inner and outer shafts 608 of the implantation catheter 622 can be advanced distally relative to the delivery sheath 624, and/or the delivery sheath 624 can be retracted relative to the inner and outer shafts 608, thus forcing the anchor 610 away from the sheath 624, thereby 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 shown in Figure 29. 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 implantation 600) relative to the outer shaft 608 and the sheath 624, which in turn causes the inner shaft 602 to retract, thereby causing the anchor 610 to bend at the connector and the upper leg 616 to fold inward toward the inner shaft 602, as shown in Figures 30 and 31. In this configuration, the anchor 610 can be positioned behind the ventricular portion of the leaflet (e.g., desirably at positions A2 and P2).

The body 612 of the braided portion 606 of the device 600 can be exposed by further retracting the delivery sheath 624 relative to the inner and outer shafts of the implanted catheter (as shown in Figure 32) and/or by advancing the shaft distally relative to the sheath 624. This allows the body 612 to expand radially (as shown in Figure 33) and thereby capture 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 spacer body 612 of the braided portion by advancing the outer shaft 608 of the implanted catheter 622 relative to the inner shaft 602 and the delivery sheath 624 of the implanted 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 further advancing the outer shaft compresses the end portion of the spacer body 612 between the end cap 604 and the outer shaft 608.

Axial perspective view of the end of the compression spacer body 612 shortens the spacer body 612 and radially expands it, forcing the spacer body 612 to abut the leaflet radially outward, as shown in Figure 34. 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.

Figure 35 illustrates an exemplary embodiment of an implantable prosthesis device 900 similar to device 600, including a braided portion 906, according to another embodiment. 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 braided material sheets separate from the braided material sheets 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 positioned 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 continuously wound material, shown in FIG. 35 as a transversely extending section perpendicular to the spacer body 912. In some embodiments (where each anchor 910 is formed from a separate piece of wound material), the lower leg 914 can be connected, for example, by inserting the end of the lower leg 914 into a coupler or sleeve that compressively secures the end of the lower leg 914 within the coupler.

Figure 36 illustrates another exemplary embodiment of the implantable prosthesis device 700. The device 700 includes one or more (two in the illustrated embodiment) ventricular anchors 702, a spacer body 704, one or more anchor actuation wires 706 (two are shown in Figure 36), and a traction wire 708. The actuation wire 706 and the traction wire 708 extend coaxially through the body 704.

Anchor 702 may include a plurality of leaflet retaining elements 712. For example, Figure 36 shows that retaining elements 712 may include outwardly extending protrusions or barbs that can be pressed into and/or penetrate the leaflet tissue to secure anchor 702 to the leaflet. In another embodiment, retaining elements may include textured surfaces formed in and/or applied to anchor 702 of device 700.

The spacer body 704 may include a collar-like member 710 positioned toward the ventricular end of the body 704 facing 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 may have various other shapes. For example, the braided portion may be extended into a generally spherical shape (similar to the body 504 in FIG. 20).

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).

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.

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.

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, as shown in Figure 36. The leaflet 718 can then be secured between the anchor 702 and the braided portion 714 by applying tension to the traction wire 708 and (thereby) the wire 706, causing the free end of the anchor 702 to bend outward 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 inward, 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.

Figures 37-47 illustrate another exemplary embodiment of the implantable prosthesis device 800 and its components. In the illustrated embodiment, the 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.

Figures 41-44 show the anchor 802 and spacer body 804 of device 800 in an extended functional state. Figure 45 shows the anchor 802 and spacer body 804 of device 800 in a curled or compressed delivery state. Figure 46 shows the anchor 802 of device 800 in a functional state.

Figure 37 illustrates that 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 not illustrated in Figures 37-47, the frame can be covered with a blood-impermeable covering (e.g., fabric) or coated with a flexible sealant (e.g., ePTFE).

Figure 37 also shows that the anchors 802 of the device 800 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.

The tube 814 can also be cut asymmetrically relative to its longitudinal axis, such that the ribs 830 are oriented on different sides of the tube 814 for different axial sections. For example, as shown, each of the tubes 814 includes: a first cut section 838 located near the proximal end of the tube 814 (end-fixed to the distal neck member 808), wherein the ribs 830 face outward (i.e., away from each other) when the tube is extended or straightened in a coiled or delivery configuration (shown in FIG. 45); and a second cut section 840 positioned further distally relative to the first cut section 838, wherein the ribs 830 face inward (i.e., towards each other) when the tube is extended or straightened in a coiled or delivery configuration. The first cut section 838 and the second cut section 840 can be separated, for example, by a non-cut transition portion 834 (FIG. 37).

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.

Figure 38 shows an apparatus 800 in which the tube 814 of the anchor 802 has been removed, 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 tube 814 of the anchor 802, and are fixedly secured to the shaft portion 806 at a first proximal end 842 (Figure 40) of the traction wire 816, and fixedly secured to the inner portion of the tube 814 near the distal end of the tube 814 at a second distal end 844 of the traction wire 816, as further described below. The traction wires 816 can be used, for example, to move the anchor 802 from a coiled delivery state (shown in Figure 45) to an extended functional state (shown in Figure 37), and/or to secure the native leaflet between the anchor 802 and the spacer body 804, as further described below.

As best illustrated in Figures 39-40, the shaft assembly 806 of the illustrated configuration of 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.

The shaft 806 assembly may also include a nut 824 and a nut support rail 826 (two shown), best illustrated in Figure 40. The nut 824 is seated on the threaded portion of the bolt 818 and within the sleeve 822. The nut 824 may include internal threads corresponding to the threaded bolt 818. The nut 818 may also include the rail 826 and a plurality of axially extending external notches or grooves 828 through which the traction line 816 extends, thereby preventing rotation of the nut 818 relative to the bolt 818, thus allowing axial movement of the nut after the bolt has rotated. The rail 826 may be securely fixed to the sleeve 822, thereby preventing rotation of the rail 826 and (therefore) the nut 824 relative to the spacer body 804.

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.

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 tension to the fitting 814, causing the fitting to extend and/or be pulled into the delivery configuration (shown in Figure 45). In an alternative embodiment, the fitting 814 can be formed of a shape memory material (e.g., nitinol) already pre-formed in the straightening delivery configuration. Therefore, rotating the bolt 818 to move the traction line 816 distally removes compressive forces from the fitting 814, allowing the fitting 814 to be pulled into the delivery configuration.

The device 800 can be percutaneously delivered to the native heart valve (e.g., the mitral valve) using the transseptal technique described for the prosthetic device 200 and delivery device 202 (shown in Figures 6-8) via a delivery device (not shown). The device 800 and the associated delivery device can be advanced across the native mitral valve leaflet 836 until the anchor 802 of the device 800 is in the left ventricle (similar to the configuration shown in Figure 6). The device 800 can be advanced from the delivery sheath (not shown, but similar to sheath 216) to expose the anchor 802.

In some embodiments, the anchor 802 is self-expandable (e.g., formed of a shape-memory material such as nitinol) so that when deployed from the delivery sheath in a manner similar to device 300 (as shown in Figures 13 and 14), the anchor can be switched from a delivery configuration (best shown in Figure 45) to a leaflet-catching configuration (best shown in Figure 47). When formed of a self-expandable material, the shaft 806 and the traction line 816 can be used to secure the leaflet, as further described below. In some embodiments, the anchor 802 is plastically deformable (e.g., formed of stainless steel). When formed of a plastically deformable material, the anchor 802 can be switched from a delivery configuration to a leaflet-catching configuration by rotating the bolt 818 using a torque shaft (not shown, but similar to torque shaft 220), causing the anchor 802 to bend, as best shown in Figure 46 and described in detail above.

The spacer body 804 can then be deployed by further retracting the delivery sheath, allowing the spacer body to expand radially and trapping the native leaflet 836 between the anchor 802 and the spacer body 804, as shown in Figure 47. The leaflet 836 can then be firmly secured between the anchor 802 and the spacer body 804 by rotating the torque shaft and bolt 818, causing the nut 824 and 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. Thus, the prosthesis device 800 can be secured to the leaflet 836 by clamping the leaflet between the anchor 802 and the spacer body 804, as shown in Figure 47. The delivery device can then be removed from the patient's body.

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.

Figures 48-52 illustrate another exemplary embodiment of an implantable prosthesis device 1000 similar to device 800. 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 create a clamping force between the anchors 1002 and the spacer body 1004, as further described below.

As best shown in Figure 49, the spacer body 1004 can include a metal frame comprising: a distal first annular collar 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 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 member 1008 and the second collar member 1010. In some embodiments, the struts 1012 can be fixedly attached to the collar members 1008, 1010, for example, by forming the struts 1012 and the collar 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 members 1008, 1010, for example, by adhesives, welding, fasteners, etc. Although not illustrated in Figures 48-52, the spacer body 1004 can be covered with a blood-impermeable covering (e.g., fabric) and coated with a flexible sealant (e.g., ePTFE).

As shown, the anchors 1002 of the device 1000 can each include a flexible tube portion 1014. The tube 1014 can be formed from alloy tubes such as nitinol, stainless steel, or cobalt-chromium. The proximal end 1020 (FIG. 52) of the tube 1014 can be fixedly secured or coupled to the distal neck collar 1008, for example by adhesives, welding, fasteners, etc.

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 relative to the side with the spine 1018 in the direction of the side with the ribs 1016. 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, as best shown in Figure 52. Therefore, by cutting the fitting 1014 and the directional ribs 1016, it is possible to control the manner and sequence of bending/bending and stretching/straightening of the fitting 1014.

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).

In relation to device 1000, the term "lateral" means generally perpendicular to the longitudinal axis of the prosthetic device 1000 extending through the distal and proximal collar members 1008, 1010. For example, Figure 49 shows an anchor extending laterally across the spacer body 1004, with its longitudinal axis extending coaxially through the collar members 1008, 1010. Thus, in this way, each anchor 1002 can extend laterally across and into contact with the ventricular side of the corresponding native leaflet.

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.

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.

Figures 53-58 illustrate another exemplary embodiment of the implantable prosthesis device 1100. In the illustrated embodiment, 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 (proximal and distal) relative to the inner shaft 1106 and the spacer body 1104. The distal direction is indicated by arrow 1120 (Figure 53), and the proximal direction is generally opposite to the distal direction. The spacer body 1104 is axially movable (proximal and distal) relative to the inner shaft 1106 and the outer shaft 1108.

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.

The transverse member 1114 can also be slidably connected to the corresponding outer anchor 1110 using a connecting element 1126. As best shown in FIG53, the connecting element 1126 can be positioned on the corresponding outer anchor 1110 between pivot joints 1116 and 1118, and on the transverse member 1114 between pivot 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.

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.

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 (FIG. 54) and can be held in the delivery configuration by placing the device in the sheath of the delivery device.

As shown in Figures 54-58, device 1100 can be percutaneously delivered to a native heart valve (e.g., a mitral valve) using a delivery device (not shown), for example, the transseptal technique described for prosthetic device 200 and delivery device 202 (shown in Figures 6-8). Although not shown, the delivery device can include a sheath (similar to sheath 216) to which prosthetic device 1100 can be loaded, inner and intermediate shafts releasably connected to respective inner and outer shafts 1106, 1108 of device 1100, and an outer shaft releasably connected to a spacer body 1104 of device 1100.

The device 1100 and delivery device are capable of advancing across the native mitral valve leaflet 1130 until the ventricular portion 1102 of the device 1100 is in the left ventricle (as shown in Figure 55, and similar to the configuration shown in Figure 6). The ventricular portion 1102 can be exposed from the delivery sheath by advancing the inner shaft of the delivery device distally relative to the sheath of the delivery device and/or by retracting the delivery sheath relative to the inner shaft.

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, thereby moving the connector 1122 distally (i.e., toward the connector 1116) along the inner shaft 1106, such that the transverse member 1114 extends laterally and perpendicularly to the inner shaft 1106 (as shown in FIG. 55). 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 shown in FIG. 55. With anchors 1110 and 1112 expanded and open, leaflets 1130 (e.g., desirably at positions A2 and P2) can be positioned within anchors 1110 and 1112 by retracting the inner shaft 1106 proximally, as shown in FIG. 56.

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 shown in Figure 57.

Figure 57 also shows that the spacer body 1104 can then be deployed via a retracted delivery sheath. When formed of a self-expanding material, the frame can self-expand to its functional dimensions (Figures 57-58). When formed of a plastically expandable material, the prosthetic device can be rolled onto the 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, as shown in Figure 58. Although, as shown, the spacer body 1104 is only partially expanded, it can be further expanded to allow the leaflets 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.

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.

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.

Figures 59-61 illustrate another exemplary embodiment of an implantable prosthesis device 1200 similar to device 1100. 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.

Sleeve 1208 is axially movable relative to shaft 1206 (proximal and distal). The distal direction is indicated by arrow 1204 in FIG. 59, and the proximal direction is opposite to the distal direction. Spacer body is axially movable relative to shaft 1206 (proximal and distal). In some embodiments, spacer body is also axially movable relative to sleeve 1208, thereby allowing spacer body to be deployed and/or positioned separately from anchor 1202. In some embodiments, spacer body is fixed or connected to sleeve 1208, thereby allowing spacer body to be deployed and/or positioned simultaneously with anchor 1202.

As best illustrated in Figure 60, 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, as shown in FIG60.

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.

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 (FIG. 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.

Although not illustrated, device 1200 can be percutaneously delivered to the native heart valve (e.g., the mitral valve) using a delivery device, for example, the transseptal technique described for device 1100 (shown in Figures 54-58). Figure 59 illustrates the device in a delivery configuration (similar to device 1100 in Figure 54). Figure 60 illustrates device 1200 in a leaflet capture configuration (similar to device 1100 in Figures 55-56). Figure 61 illustrates device 1200 in a functional or leaflet fixation configuration (similar to device 1100 in Figures 57-58).

Delivery systems and devices

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.

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.

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.

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.

Figure 62 illustrates an exemplary steerable flexible prosthetic implant delivery device 1300 according to one embodiment. 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, a plurality of (four in the illustrated embodiment, but only two are shown in Figure 62) basket expander leads 1314, and a plurality of (four in the illustrated embodiment, but only two are shown in Figure 62) steering control leads 1316.

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.

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.

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.

The sheath 1302 of the delivery device 1300 can be configured to receive various prosthetic implants and/or hold them 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 (as shown in Figure 67). The sheath 1302 can also receive, for example, prosthetic heart valves, stents, etc.

The basket 1304 of the delivery device 1300 is expandable, allowing it to be placed in a non-expandable delivery configuration (best shown in FIG. 63B), thus allowing the device 1300 to have a relatively small facet when space is limited (e.g., when passing through another catheter or blood vessel). When space is not limited (e.g., when advancing away from another catheter into the left atrium or another chamber of the heart), the basket 1304 can be radially expanded into a functional configuration (best shown in FIG. 64). 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 prosthetic implant during the implantation 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).

As best shown in Figure 65A, the intermediate shaft 1306 of the delivery device 1300 may 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 may be angularly spaced from each other at approximately 45 degrees. The respective lumens 1326, 1328 may extend axially through the intermediate shaft 1306.

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.

As shown in Figure 62, the intermediate shaft 1306 may also include a plurality of radially extending side openings or ports 1330 (four in the illustrated embodiment, but only two are shown in Figure 62) positioned toward the distal end of the intermediate shaft 1306 but close to the basket 1304. The ports 1330 may 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 corresponding side opening 1330. The intermediate shaft 1306 may be formed of a biocompatible polymer, such as a polyether block amide (e.g., ...).

The intermediate shaft 1306 can comprise different axial sections with varying hardness and/or stiffness. For example, as shown in FIG65B, the intermediate shaft can comprise a first distal section 1332 and a second proximal section 1334. The distal section 1332 of the intermediate shaft 1306 can, for example, comprise 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 comprise an intermediate shaft with a softer distal end having Shore D hardness values of 55 and 72, respectively, which 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.

The basket extender mechanism 1308 of the delivery device 1300 may include a distal nut 1338, a proximal nut 1340, and an outer nut or sleeve 1342, as shown in FIG62. The distal nut 1338 may be fixedly attached to the proximal end of the intermediate shaft 1306 and includes an external thread oriented in a first direction. The proximal nut 1340 may be fixedly attached to the distal end of the proximal shaft 1310 and includes an external thread oriented in a second direction, opposite to the first direction of the thread 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 corresponding to and engaging the thread of the distal nut 1338, and a second proximal internal thread 1346 along the proximal portion of the outer nut 1342 corresponding to and engaging the thread of the proximal nut 1340.

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.

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.

Due to the flexible nature of the basket 1304, rotation of the outer nut 1342 relative to the distal nut 1338 and the proximal nut 1340 in a first direction (i.e., moving the intermediate shaft 1306 proximally away from the sheath 1302) causes the basket 1304 to elongate axially and compress radially into the delivery configuration (shown in FIG. 63B). Rotation of the outer nut 1342 relative to the distal nut 1338 and the proximal nut 1340 in a second direction (i.e., moving the intermediate shaft 1306 distally toward the sheath 1302) causes the basket to shorten axially and expand radially into the functional configuration (shown in FIG. 62, FIG. 64, and FIG. 67).

The proximal shaft 1310 of the delivery device 1300 can have a configuration generally similar to that of the intermediate shaft 1306, including a centrally located (relative to the longitudinal axis) implantation lumen 1348 (shown in FIG. 66), and a plurality (eight in the illustrated embodiment) of 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. The respective implantation lumens and lead lumens can extend 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.

As shown in Figure 62, the proximal shaft 1310 may also include a plurality of (four in the illustrated embodiment, but only two are shown in Figure 62) radially extending side openings or ports 1350 communicating with a lumen 1328 containing a control wire 1316. The side openings 1350 may be radially aligned with ports 1330 of the intermediate shaft 1306. Ports 1350 of the proximal shaft 1310 may 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 may be formed of a biocompatible polymer. For example, the proximal shaft 1310 may include Pebax with a Shore D hardness value of 72.

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 (FIG. 62) disposed around the outer surface 1356 of the sleeve 1354. In this way, the outer surface 1356 acts as the ball of a 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.

The control handle 1352 may also include a plurality of (four in the illustrated embodiment, see FIG. 66) axially extending openings 1360 disposed radially outward relative to the slot 1358 on the control handle 1352, configured to receive the proximal end 1324 of a 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 may be angularly spaced from each other around the handle 1352, for example, approximately 90 degrees.

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 to the handle 1352, for example, by an adhesive. In some embodiments, the handle 1352 can be formed of a polymeric material such as acetal (e.g., ). In some embodiments, the sleeve 1354 can be formed of a polymeric material such as polycarbonate.

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.

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 can include slack when the basket 1304 is in the axially extended delivery configuration (FIG. 63B), and can be taut when the basket 1304 is in the radially extended functional configuration.

The control leads 1316, evenly distributed along the circumference and providing a generally uniform tension on the control leads 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). For example, seeing Figure 62, pivoting the handle 1352 causes the upper portion of the handle 1352 to move proximally (i.e., in the direction of arrow 1374), effectively pulling the proximal end 1324 of the upper control lead 1316 proximally, 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 the handle 1352 of the control member 1312 so that the lower portion of the handle 1352 moves proximally (i.e., in the direction of arrow 1375), which effectively pulls the proximal end 1324 of the lower control lead 1316 proximally, 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.

The delivery device 1300 can be used, for example, for percutaneous delivery of prosthetic implants. For example, Figure 67 illustrates the delivery device 1300 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 expanded to 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 rotating 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.

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.

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.

Figure 68 illustrates another exemplary steerable prosthetic implant delivery device 1400 according to another embodiment. 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).

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

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 arranged in a ring around the central axis of the inner shaft 1402 and the handle 1416, spaced 90 degrees apart from each other in a manner similar to the control wire 1316 described above in conjunction with the sheath 1302 and the control handle 1352 (Figures 62, 66). 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 middle) of the inner shaft and intermediate shafts 1402, 1404, wherein the proximal end of the control wire can be attached to the ring 1418. The port of the inner shaft 1402 can be oriented so as to align with the corresponding port of the intermediate shaft 1404 along the circumference.

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.

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.

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.

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

The tube 1438 can be coated with a flexible polymer coating both on the outside and inside. The spine portion 1440 of the tube 1438 can include an opening 1446 (FIG. 71B), which can, for example, allow the polymer coating to be uniformly distributed throughout the tube 1438, thereby providing a desirable uniform wall thickness for the inner shaft 1402.

The fitting 1438 can be configured such that the spine portion 1440 forms axially extending rows 1454 separated by the struts 1442. For example, in the illustrated embodiment (best shown in FIG. 71B), the spine portion 1440 is configured as four axially extending rows 1454a, 1454b, 1454c, 1454d (in FIG. 70B and 71b, for illustrative purposes, row 1454d is axially cut downwards along the center to show the fitting 1438 in a flat configuration). Rows 1454a-1454d can be angularly spaced from each other (e.g., 90 degrees), 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 the 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 section.

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.

The inner shaft 1402's fitting 1438 can also include different axial sections (three in the illustrated embodiment) 1448, 1450, and 1452, best shown in Figures 70A-70B. The 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 the different axial sections to have smaller or larger bending radii. For example, the distal section 1448 includes the thinnest strut 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 embodiments show the smallest strut positioned distally and the largest strut positioned proximally relative to other cross sections, the axial cross sections can be configured in any order or combination to achieve the desired results for a particular application.

Figures 72-74 illustrate exemplary embodiments of control members 1500, similar to control members 1312 and 1408 of delivery devices 1300 and 1400, 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).

Slot portions 1504a, 1504b may include at least one (two in the illustrated embodiment) (FIG. 73) radially extending cut-off or recessed portion 1508 configured to receive a corresponding clamp 1506. Each recessed portion 1508 may contain a corresponding protrusion 1510. The 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 (FIG. 73-74), and a tab 1516.

The control member 1500 may further include a retaining mechanism 1526 (FIG. 74) extending annularly around the slot portions 1504a, 1504b and the clamp 1506. The retaining mechanism 1526 holds the slot portions 1504a, 1504b and the clamp 1506 together and presses the slot portions 1504a, 1504b and the clamp 1506 radially inward against the ball 1504. The retaining mechanism 1526 may be, for example, one or more biasing elements (e.g., O-rings or elastic strips) respectively disposed within the recesses 1518, 1520 of the slot portions 1504a, 1504b and the clamp 1506. In another embodiment, the retaining mechanism may be, for example, a spring or any other force-applying mechanism.

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, which acts as a fulcrum. The clamp 1506 can pivot by squeezing or pinching the tabs 1516 together (in the direction of arrow 1528 in FIG. 74), causing the tabs 1516 to move radially inward. Pivoting the clamp 1506 in this manner moves the ball contact surface 1512 radially outward away from the outer surface of the ball 1502, thereby allowing rotation of the slot 1504 and the clamp 1506 relative to the ball 1502. Releasing manual pressure from tab 1516 allows clamp 1506 to move backward in contact with the ball under the biasing force of retaining mechanism 1526.

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).

Figure 75 illustrates another exemplary embodiment of a control member 1600 similar to control member 1500, which 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.

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.

Figures 76-79 illustrate an exemplary embodiment of a control member 1700 similar to control member 1600, which 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.

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 slide rails 1712 disposed within the recesses, the slide rails 1712 dividing the recesses 1710 into two tracks or channels 1714 (Figures 78-79). The channels 1714 may be configured such that the protrusions 1708 of the ball 1702 can travel or move axially within the slot 1704 as the slot 1704 pivots about the ball 1702.

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.

Figures 80-82 illustrate an exemplary embodiment of a control member 1800 similar to control member 1600, which includes 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.

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.

Figures 83-85 illustrate an exemplary control member 1900 according to one embodiment. 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, as best shown in Figure 83.

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).

Figures 86-87 illustrate an exemplary catheter position locking device 2000 according to one embodiment. In the illustrated embodiment, the locking device 2000 includes a coupler or sleeve 2002 (best shown in Figure 87), a housing 2004, and a fastener portion 2006. As best shown in Figure 87, the sleeve 2002 is capable of extending coaxially over a distal shaft portion 2005 of the housing 2004. The housing 2004 may include an axially extending lumen 2008 and a radial opening (not shown) substantially perpendicular to the lumen 2008 and including internal threads. The fastener 2006 may include an externally threaded plug 2010 that engages the internal threads of the radial opening of the housing 2004 and is capable of extending through the radial opening into the lumen of the housing. The fastener 2006 may also include a head portion or knob 2012 that is fixedly attached to the upper portion of the plug 2010.

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.

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 a desired location. For example, Figure 87 illustrates the use of device 2000 with an introductor sheath 2014 and an external catheter 2016. In some embodiments, as shown, device 2000 can be securely secured or coupled to the proximal end of introductor sheath 2014 by advancing the distal end of the sleeve 2002 of device 2000 over sheath 2014. In other embodiments, device 2000 can be securely secured or coupled to the proximal end of introductor sheath by adhesives, fasteners, etc.

With the axial opening 2008 of device 2000 cleared or open (i.e., the plug 2010 of fastener 2006 does not obstruct the axial opening 2008), the outer conduit 2016 can be advanced through device 2000 and inlet 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 device 2000 and (therefore) inlet sheath 2014, thereby allowing the outer conduit 2016 to be desiredly positioned. Once the outer conduit 2016 is desiredly positioned, it can be secured in the desired position by rotating the head 2012 of fastener 2006 in a first direction, causing the plug 2010 to move inward and press against the outer conduit 2016 (best shown in Figure 86), thereby preventing twisting/rotation and/or axial movement of the outer conduit relative to inlet sheath 2014. Therefore, the device 2000 can, for example, advantageously allow physicians to adjust and fix the catheter during the procedure, thereby making the procedure significantly safer and easier to perform.

Figures 88-91 illustrate an exemplary catheter position locking device 2100 according to another embodiment. 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, as best shown in Figure 88.

It should be noted that although openings 2106 and 2112 are shown as having a generally square cross-section, openings 2106 and 2112 can include a variety of other shapes.

As best illustrated in Figures 90-91, the openings 2106 and 2112 of the corresponding portions 2102 and 2104 can be configured such that the movable portion 2104 can be rotated relative to the fixed portion 2102 to a first unlocked position, aligning the opening 2112 of the movable portion 2104 with the opening 2106 of the fixed portion 2102 (Figure 90). Rotating the movable portion 2104 relative to the fixed portion 2102 to a second locked position causes the opening 2112 of the movable portion 2104 to become misaligned with the opening 2106, thus causing the movable portion 2104 to interfere with or partially block the opening 2106 of the fixed portion 2102 (Figure 91).

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.

Figures 92-96 illustrate an exemplary catheter position locking device 2200 according to another embodiment. 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. As best shown in Figure 93, the shaft 2202 of the device 2000 may include an opening or lumen 2208 extending axially through the shaft 2202, and a flange portion 2210 at the proximal end of the shaft 2202. Figure 93 also shows that the shaft portion 2202 and the cam portion 2204 can be connected by inserting the flange portion 2210 into an annular recess 2212 formed in the distal end of the cam portion 2204.

The cam portion 2204 is rotatable relative to the shaft portion 2202. The cam 2204 may further include an annular notch or groove 2214 (Figures 92-93) disposed near its proximal end, and an offset opening 2216 (i.e., offset or having an axis different from the lumen 2208 of the shaft 2202) (best shown in Figure 94). 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 the groove 2214, thereby securing the handle 2206 relative to the cam 2204. Therefore, rotating the handle 2206 causes the cam 2204 to rotate.

Due to the offset opening 2216, the handle 2206 and (therefore) the cam 2204 are able to 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 (FIG. 95); and to a second locked 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 (FIG. 96).

Although not illustrated, the device 2200 can be used with an introductory sheath and an external catheter, such as those shown in Figure 87. The shaft 2202 can be securely fixed or coupled (e.g., using adhesives, fasteners, etc.) to the proximal end of the introductory 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 introductory sheath. In this aligned configuration, the external catheter can be twisted/rotated and/or axially moved relative to the device 2200 and the introductory 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 twisted/rotated and/or axially moved relative to the introductory sheath.

Figures 97-98 illustrate an exemplary conduit position locking device 2300 according to another embodiment. The device 2300 includes a locking sleeve 2302 and a key shaft or fitting 2304. As best shown in Figure 98, 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 a 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.

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.

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.

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.

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.

Figures 99-102 illustrate an exemplary prosthetic implant delivery device 2400 according to one embodiment. The delivery device 2400 includes an outer shaft 2402, an annular collar or clamp 2404, and an inner shaft 2406, best shown in Figures 99-100. The clamp 2404 is capable of being fixedly secured or coupled to the distal end of the outer shaft 2402, and the inner shaft 2406 is capable of extending coaxially through the outer shaft 2402 and the clamp 2404. The inner shaft 2406 is axially (i.e., distally or proximally) movable relative to the outer shaft 2402 and the clamp 2404.

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.

The chuck 2404 of the delivery device 2400 can be formed of a material that allows the teeth 2410 to be resiliently expandable and compressible in the radial direction. For example, the chuck 2404 can be formed of stainless steel. When formed of a resiliently expandable and compressible material, the teeth 2410 can be radially expanded from a release configuration (Figures 101-102) to an attachment or delivery configuration (Figures 99-100) and vice versa, as further described below.

Delivery device 2400 can be used to percutaneously deliver prosthetic spacer device 2414 to a native heart valve (e.g., mitral valve), as shown in Figures 99-102. Prosthetic spacer 2414 can include anchor 2416. Delivery device 2400 can 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 delivery device 2400.

An 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, as shown in Figure 99. The spacer 2414 can then be deployed from within the sheath 2418 by advancing the delivery catheter 2400 distally relative to the sheath 2418, or by retracting the sheath proximally relative to the delivery catheter, as shown in Figure 100. The delivery device 2400 can be used to desirably position the spacer 2414 relative to the native leaflet 2420. For example, the spacer 2414 can be twisted or rotated and/or axially moved by rotating or torsion and/or advancing or retracting the external shaft 2402, respectively.

Once the spacer 2414 is properly positioned and secured to the native leaflet, it can be released from the delivery device 2400. The spacer 2414 is released from the delivery device 2400 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, as shown in Figure 101. With the protrusion 2412 disengaged from the spacer 2414, the spacer 2414 is released, and the delivery device 2400 and the sheath 2418 can retract through the outer guide tube, as shown in Figure 102.

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.

Figure 103 illustrates an exemplary embodiment of an annular collar or chuck 2500 for delivering catheters, similar to a chuck 2404 of delivery device 2400. The chuck 2500 may include a sleeve 2502 and a plurality (four in the illustrated embodiment) of teeth 2504 extending axially away from the 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.

Figures 104-106 illustrate another exemplary embodiment of a prosthesis implant delivery device 2600, similar to delivery device 2400. 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, best shown in Figure 104. The clamp 2602 is capable of being fixedly secured or coupled to the distal end of the outer shaft, and the inner shaft 2604 is capable of extending coaxially through the outer shaft and the clamp 2602. The inner shaft 2604 is axially (i.e., distally or proximally) movable relative to the outer shaft 2402 and the clamp 2404.

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.

Similar to delivery device 2400, delivery device 2600 can be coupled to the collar-like part 2612 of the prosthetic implant by retracting the inner shaft 2604 proximally relative to the chuck 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 chuck 2602, as shown in Figure 105. Retraction of the inner shaft 2604 allows radial compression of the teeth 2608 (see Figure 105) so that the teeth 2608 can be inserted into the collar-like part 2612 of the prosthetic implant.

As shown in Figure 106, the 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.

Figures 107-110 illustrate an exemplary prosthetic implant delivery device 2700 similar to delivery device 2400 according to one embodiment. Delivery device 2700 includes an outer shaft 2702, an annular collar or clamp 2704, and an inner shaft 2706, best shown in Figures 109-110. The clamp 2704 is capable of being fixedly secured or coupled to the distal end of the outer shaft 2702, and the inner shaft 2706 is capable of extending coaxially through the outer shaft 2702 and the clamp 2704. The inner shaft 2706 is axially (i.e., distally or proximally) movable relative to the outer shaft 2702 and the clamp 2704.

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.

The chuck 2704 of the delivery device 2700 can be formed of a material that allows the teeth 2710 to be resiliently expandable and compressible in the radial direction. For example, the chuck 2704 can be formed of stainless steel. When formed of a resiliently expandable and compressible material, the teeth 2710 can be radially expanded from an attachment delivery configuration (Figures 107-108) to a release configuration (Figures 109-110) and vice versa, as further described below.

Delivery device 2700 can be used to percutaneously deliver prosthetic spacer device 2714 to a native heart valve (e.g., mitral valve), as shown in Figures 107-110. Prosthetic spacer 2714 can include anchor 2716 and an annular collar 2718. Delivery device 2700 can 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 delivery device 2700.

An external catheter can be used, for example, to cross the septum, 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 an anchor 2716 is positioned in the left ventricle, as shown in Figure 107. A spacer 2714 can then be deployed from within the sheath 2718 by advancing the delivery catheter 2700 distally relative to the sheath 2718, or by retracting the sheath proximally relative to the delivery catheter, as shown in Figure 108. The delivery device 2700 can be used to desirably position the spacer 2714 relative to the native leaflet 2720. For example, the spacer 2714 can be twisted or rotated and/or axially moved by rotating or torsion and/or advancing or retracting the external shaft 2702, respectively.

Once the spacer 2714 is properly positioned and secured to the native leaflet, it 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, disengaging the protrusion 2712 from the spacer 2714, as shown in Figure 109. With the protrusion 2712 disengaged from the spacer 2714, the spacer 2714 is released, and the delivery device 2700 and the sheath 2718 can retract through the outer guide tube, as shown in Figure 110.

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.

Figure 111 illustrates an exemplary embodiment of an annular collar-like member or chuck 2800 similar to the chuck 2704 of the delivery device 2700. 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.

Figure 112 shows a cross-sectional view of an exemplary non-circular shaft 2901 of a delivery device 2900 according to one embodiment. 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 (represented by dashed line 2902) and a secondary axis (represented 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.

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

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.

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.

Figures 114-127F illustrate various embodiments of implantable prosthetic devices with supplementary anchoring members to enhance the engagement of the device with the original leaflet.

Figure 114 illustrates a prosthetic device 3100, which includes 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 comprise a plastic hook material, such as a hook-and-loop fastener (e.g., a loop fastener). When implanted within the native valve, the anchor 3104 can abut against the friction-enhancing material 3106 to compress the native leaflet, thereby enhancing the anchor's retention force. In the illustrated embodiment, the friction-enhancing material 3106 is shown as a frame directly mounted (e.g., using sutures) to 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 outer side of the covering.

Figure 115 illustrates a prosthetic device 3200, which includes an annular body 3202, a fabric cover 3204, and an anchor 3104 extending from the body. One or more protrusions 3208 can be mounted 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 fixed to the anchor. When implanted within the native valve, the anchor 3206 can abut against the native leaflet to push the protrusions 3208, thereby enhancing the anchor's retention force.

Figure 116 illustrates a prosthetic device 3300, which includes an annular body 3302, a fabric cover 3304, and an anchor 3306 extending from the body. One or more protrusions 3308 can be mounted on each anchor 3306, the protrusions 3308 being formed by metal wires fixed to the end of the anchor. When implanted within the native valve, the anchor 3306 can abut against the native leaflet 3308, pushing the protrusions 3308, thereby enhancing the retention force of the anchor.

Figure 117 illustrates an exemplary anchor 3400 capable of being 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 engage upon implantation and optionally penetrate the leaflet to enhance the anchor's retention.

Figure 118 illustrates a prosthetic device 3500, which includes 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.

Figures 119A-119F illustrate a prosthetic device 3600, which includes an annular body 3602, a fabric cover (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, which is 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 end of the protrusion 3608 is configured to reside substantially within the body and not necessarily extend through the fabric cover (as shown in Figure 118). However, the protrusion 3608 can exert a retaining force against the native leaflet by means of the anchor 3604, which is shaped to force the native leaflet inwardly into the body in the region below the free end of the anchor 3604 when the anchor moves from an open position (Figures 119E and 119F) to a closed position (Figures 119A-119D).

Figures 120A-120C illustrate a prosthetic device 3700, which includes 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 figures. 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.

Figures 121A-121D illustrate a prosthetic device 3800, which includes 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.

Figures 122A-122D illustrate a prosthetic device 3900, which includes 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 that acts 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.

Figures 123A-123D illustrate a prosthetic device 4000, which includes 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 via one or more sleeves 4006. Figures 124A-124F are various views of device 4000 showing the anchor in the closed position (Figure 124A), the fully open position (Figure 124D), and various partially open positions (Figures 124B-124C, 124E, and 124F).

Figures 125A-125E illustrate a prosthetic device 4100, which includes a generally spherical or ball-shaped body 4102, an anchor 4104 coupled to the body, and a protrusion 4106 extending outward 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. As best shown in Figure 125E (which shows the anchor in a 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 a lower ring 4112. When the device 4100 is fully deployed, the foldable portions 4108, 4110 fold upward along the body 4102 such that a native leaflet is captured between the body and the foldable portion 4108, wherein the protrusion 4106 engages the native leaflet. As shown in Figures 125A-125D, 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.

Figures 126A-126J illustrate prosthetic device 4200. Device 4200 is similar to device 4100 in that it includes a generally spherical or ball-shaped body 4202 and anchors 4204 coupled to said body. The body 4202 and anchors 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 shows anchor 4204 in a partially deployed state, with the anchor partially folded. Figure 126B shows a detailed view of a portion of body 4202, as indicated in Figure 126A. Figures 126C-126F show anchor 4204 in a further partially deployed state, with the anchor further folded from the position shown in Figure 126A. Figures 126G-126J show anchor 4204 in a fully deployed, folded and closed state along body 4202, with protrusion 4206 extending through an opening in the first foldable portion 4208 to engage the native leaflet. Although not shown, the anchor can be fully deployed into the delivery configuration by further axially moving ring 4212 away from body 4202 relative to the partially folded state shown in Figure 126A.

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

During delivery, the lower sleeve 4312 is spaced from the body such that the lower sleeve does not overlap with the anchor, and the foldable portion of the anchor folds away from the body (similar to Figure 126A). As the device is deployed, the native leaflet is positioned on the opposite side of the body, and the anchor folds upward toward the body to the fully deployed position (Figure 127A), wherein the native leaflet engages between the body 4302 and the first foldable portion 4308. The folding of the anchor causes the sleeve 4312 to be pulled above the lower end portion of the first foldable portion 4308 to hold the anchor in the fully deployed position.

By incorporating supplementary anchoring members as shown in Figures 114-127F, the structural components of the prosthetic device (e.g., the metal frame of the main body and/or anchors) can be made 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.

Figure 128 illustrates an alternative embodiment of a steering control mechanism 4400, which can be incorporated into any of the delivery devices described above (e.g., delivery device 1300) to control the deflection of a 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 operably coupled to the proximal control knob 4402a, and a third shaft 4404c and a fourth shaft 4404d operably coupled to the distal control knob 4402b, respectively. A housing 4410 (illustrated as transparent in Figure 128) is capable of accommodating the shafts, and the control knobs are movably coupled to the housing 4410.

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.

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.

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).

Figures 129-130 illustrate exemplary embodiments of an implantable prosthesis device 4500 similar to prosthesis device 600. The 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. As best shown in Figure 129 (which shows the prosthesis device 4500 in a radial compression configuration), the proximal portion 4510 of the anchor 4504 may be coupled to the spacer body 4502, and the distal portion 4512 of the anchor 4504 may be coupled to the locking element 4508. The proximal portion 4514 of the fixation member 4506 may be coupled to the proximal portion 4510 of the anchor 4504, and the fixation member 4506 may extend distally from the proximal portion 4514 to the free distal portion 4516 of the fixation member 4506.

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.

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.

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.).

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.

As described above, the anchor 4504 can include a proximal portion 4510 and a distal portion 4512. The anchor 4504 of the prosthetic 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 prosthetic device 600 can be bent at the joint 618 using a delivery device, as shown in Figures 27-34), moving from a first configuration (e.g., a stationary or unbiased configuration, as shown in Figure 129) to a second configuration (e.g., a biased configuration, as shown in Figure 130) and vice versa.

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 extend radially from the distal portion 4516 (i.e., radially outward as depicted in FIG. 129 and radially inward as depicted in FIG. 130).

The fixing member 4506 can be configured to pivot at the hinge portion 4520 such that the delivery device can be used to move the fixing member 4506 from a first configuration (e.g., a stationary or unbiased configuration, as shown in FIG129) to a second configuration (e.g., a compressed configuration, as shown in FIG130), and vice versa, as further described below.

In the first configuration, the fixation member 4506 is angled at the hinge portion 4520 such that the protrusion 4522 of the fixation 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 depicted in FIG. 129). This configuration reduces and/or prevents the protrusion 4522 of the fixation member 4506 from engaging (e.g., hooking) the delivery cylinder of the delivery device (not shown) 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).

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.

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 its distal end, as shown in FIG130. 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 the second configuration, as shown in FIG130. The locking element 4508 can be configured to slightly expand radially as it slides over the fixing member 4506 when moved to the second configuration.

In the second configuration, the fixation member 4506 is angled at the hinge portion 4520 such that a protrusion 4522 at the distal portion 4516 of the fixation member 4506 extends into and through a corresponding proximal portion 4510 of the anchor 4504, as shown in FIG130. In other words, the protrusion 4522 is able to extend radially inward (i.e., as depicted in FIG130) beyond the proximal portion 4510 of 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 able to engage and/or penetrate native leaflets radially positioned between the spacer body 4502 and the anchor 4504 (e.g., similar to the positioning of the prosthesis device 300 shown in FIG17).

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.

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.

Prosthetic valve

Figures 131-133 illustrate exemplary embodiments of the prosthetic heart valve 4600. The prosthetic valve 100 may include a stent or frame 4602 (Figure 133), a leaflet assembly 4604 supported by 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. In Figure 131, the leaflets 4608 shown in solid lines depict a closed position for preventing blood flow; and the leaflets 4608 shown in dashed lines depict an open position for allowing blood to flow through the prosthetic valve 4600.

Figure 133 illustrates a frame 4602 without leaflet assembly 4604 or cover 4604. 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 body 4610, and one or more second anchors 4614 extending from the opposite end of body 4610. In the illustrated example, 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 positioned on opposite diameter sides of the outflow end of body 4610, and twelve atrial anchors 4614. In other embodiments, the prosthetic valve 4600 may include more or fewer ventricular anchors 4612 and/or atrial anchors 4614.

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.

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.

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.

Figures 134-135 illustrate the frame 4700 of the prosthetic heart valve. 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.

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. As best illustrated in Figure 134, tab 4708a can securely receive the first end portions 4712a and 4712b corresponding to the first anchors 4704a and 4704b, and tab 4708b can securely receive the second end portions 4714a and 4714b corresponding to the first anchors 4704a and 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.

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.

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) to a compression delivery configuration (not shown), and vice versa. In the delivery configuration, the first anchor 4704 can extend axially away from the second anchor 4706, in contrast to extending towards the second 4706 as shown in Figures 134-135. 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 frame 4700 can be delivered using a delivery device, for example, 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.

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.

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.

General Instructions

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.

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.

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”.

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.

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 (10)

1. An implantable prosthetic device for connection to a native heart valve leaflet, comprising: The spacer body is made of braided, self-expanding metal wire; The spacer body is configured to be placed between the native valve leaflets of the heart and to divide the opening between the ventricle and the atrium into two openings; The spacer body has a proximal end and a distal end; At least one anchoring portion coupled to the distal end of the spacer body, wherein the at least one anchoring portion is arranged abutting against the ventricular surface of a corresponding native heart valve leaflet in the native heart valve leaflet; and A shaft extending into the spacer body, wherein the shaft is coupled to the at least one anchoring portion, and wherein the shaft is movable relative to the spacer body to open and close the at least one anchoring portion. 2. The implantable prosthesis device of claim 1, further comprising a cap coupled to the at least one anchoring portion. 3. The implantable prosthesis device of claim 1, wherein each of the at least one anchoring portion includes an upper leg portion coupled to the distal end of the spacer body and a lower leg portion connected to the upper leg portion via a connector. 4. The implantable prosthesis device of claim 2, wherein each of the at least one anchoring portion includes an upper leg portion coupled to the distal end of the spacer body and a lower leg portion connected to the upper leg portion via a connector, wherein the distal end of the lower leg portion is fixedly secured to the cap. 5. 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 self-expanding metal wire. 6. The implantable prosthesis device of claim 3, wherein the spacer body and the at least one anchoring portion are made of a single piece of self-expanding metal wire. 7. The implantable prosthesis device of claim 1, wherein the spacer body is covered by a blood-impermeable material. 8. 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. 9. The implantable prosthesis device according to claim 1, wherein the distal end of the spacer body is tapered. 10. 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.