CN101636128B - Stent-valve for valve replacement and related methods and systems for surgery - Google Patents

Abstract

Stent-valves (e.g., single stent-valves and double stent-valves) and associated methods and systems for their delivery by minimally invasive surgery are provided.

Description

Stent-valve for valve replacement and related methods and systems for surgery

Cross References to Related Applications

This application claims priority to U.S. Provisional Patent Application No. 61/843,181, filed September 7, 2006, and U.S. Patent Application No. 11/700,922, filed December 21, 2006, each of which is incorporated by reference in its entirety incorporated in this article.

technical field

Embodiments of the present invention relate to stent-valve and related methods and systems for delivering them through minimally invasive procedures.

Background technique

Traditional methods for heart valve replacement require a relatively large opening to be cut in the patient's sternum ("sternotomy") or chest cavity ("thoracotomy") in order to allow the surgeon access to the patient's heart. Additionally, these methods require stopping the patient's heart and require cardiopulmonary bypass (ie, the use of a cardiopulmonary bypass machine to oxygenate and circulate the patient's blood). Although invasive, these surgical methods can be quite safe for a first intervention. However, tissue adhesion caused by the first procedure can increase the risks (eg, death) associated with subsequent valve replacement procedures. See "Risk of Reoperative Valve Replacement for Failed Mitral and Aortic Bioprostheses" by Akins et al., Ann Thorac Surg 1998; 65: 1545-52 (Annual Reports of Thoracic Surgery 1998, Vol. 65, pp. 1545-1552); Weerasinghe et al., "First Redo Heart Valve Replacement-A 10-Year Analysis (First Redo Heart Valve Replacement-A 10-Year Analysis)", Circulation 1999;99:655- 658 (Circulation Journal, Vol. 99, 1999, pp. 655-658), each of which is herein incorporated by reference in its entirety.

Prosthetic and bioprosthetic valves have been used for heart valve replacement with variable results. Prosthetic valves rarely fail, but lifelong anticoagulant therapy is required to prevent blood from clotting (thrombosis) in or around the replacement valve. Such anticoagulant therapy greatly restricts the patient's mobility and can lead to various other complications. Bioprosthetic valves do not require this anticoagulant treatment, but typically fail within 10-15 years. Therefore, to limit the need for reoperation on a failed bioprosthetic valve and its associated risks, traditionally only patients with less than 10-15 years of life remaining have undergone bioprosthetic replacement. Patients with longer life expectancy were treated with prosthetic valves and anticoagulants.

Attempts have been made to develop less invasive surgical methods for heart valve replacement. These surgical approaches, known as percutaneous heart valve replacement therapy (PHVT), use a catheter to deliver a replacement valve to the site of implantation by exploiting the patient's vasculature. These PHVT attempts have various disadvantages, including their inability to ensure proper positioning and stability of the replacement valve within the patient.

In view of the foregoing, there is a need to provide improved methods, systems and devices for heart valve replacement.

Contents of the invention

Certain embodiments of the invention relate to systems, methods and devices for heart valve replacement. For example, the methods, systems and devices are applicable to the full spectrum of heart valve therapy, including replacement of failed aortic, mitral, tricuspid and pulmonary valves. In certain embodiments, the present invention may facilitate surgical procedures by which surgery is performed on a beating heart without the need for thoracotomy and cardiopulmonary bypass. This minimally invasive surgical approach reduces the risks associated with initially replacing a failed native valve, as well as the risks associated with a second or subsequent procedure to replace a failed artificial (eg, biological or prosthetic) valve.

A stent-valve according to some embodiments of the invention may include a valve component and at least one stent component. The valve member may comprise a biological or artificial (eg, mechanical) valve and/or any other suitable material. The stent member may include a first portion (eg, a proximal portion), a second portion configured to receive a valve member, and a third portion (eg, a distal portion). The stent and valve portions can be in at least two configurations: a collapsed configuration (eg, during delivery) and an expanded configuration (eg, after implantation).

In some embodiments, the first portion of the stent-valve may include a fixation element. Such fixation elements may include, for example, annular grooves for securing the stent-valve in place at the implantation site. When the stent-valve includes a single stent ("single-stent-valve"), the annular groove may be configured to receive the annulus of the valve in need of replacement. When the stent-valve comprises two stents ("dual-stent-valve"), the annular groove of the first stent component may be configured to be matably attached to the complementary (complimentary) annular protrusion of the second stent component (i.e., the positioning stent). get up. Instead, the second stent component may be anchored at the implantation site, for example, to the valve and/or proximal structure to be replaced.

Alternatively or additionally, in some embodiments, the third portion of the stent member may include at least one attachment element. The various attachment elements of the stent-valve may include, for example, geometrically shaped openings (eg, circular or oval), hooks, or straps configured for removably attaching to a complimentary structure of the delivery device. Furthermore, each attachment element may correspond to all or a portion of a commissure stem to which the commissure between two valve leaflets may be attached. The attachment elements may allow the stent-valve to partially expand within the patient's body while the stent-valve remains attached to the delivery device. This may allow the stent-valve to return to the collapsed configuration and reposition within the patient's body when it is determined that fully deploying the stent-valve would result in incorrect installation of the stent-valve. Alternatively or additionally, when it is determined that the stent-valve is not functioning properly (eg, not allowing sufficient flow), this may allow the stent-valve to return to the collapsed configuration and be removed from the patient. In some embodiments, the stent-valve may include an attachment element. In other embodiments, the stent-valve may include at least two, three, six, or any other suitable number of attachment elements. In certain embodiments, the fully deployed stent diameter in the region of the attachment elements may be smaller than the diameter of the region housing the associated valve. This may reduce the risk of injury to the patient's body by the attachment element, such as perforation of the aorta, and/or may make it easier to secure the attachment element to a complementary structure of the delivery device.

In certain embodiments, the stent member of the stent-valve may comprise a lattice structure having a plurality of cells. The lattice structure may be formed of, for example, a shape memory alloy such as nitinol or any other suitable material. The cells in the lattice structure may be densest in the portion of the stent member that includes the fixation elements. This can provide more additional support for the fixation element and improve the stability of the stent-valve. In certain embodiments, the lattice structure can form at least one elongated strut (eg, engagement rod) extending distally along the stent member toward the at least one attachment element. The at least one post may be directly connected to the at least one attachment element. Alternatively, the lattice structure may form at least one support element for connecting the at least one mast to at least one attachment element. In certain embodiments, all cells in the lattice structure may be closed cells, which may facilitate retraction of the stent-valve from a partially expanded configuration to a collapsed configuration.

)紧固系统将瓣膜构件固定到支架构件上。Still other embodiments of the invention relate to methods for replacing valves. A stent valve is provided, which includes a stent member having an annular groove, and the stent valve is axially fixed to the annulus of a valve to be replaced. In some embodiments, providing the stent-valve may include suturing the valve component to the stent component. Alternatively or additionally, providing the stent-valve may include deploying the valve member within the stent member so as to form a friction fit. In some embodiments, providing the stent-valve may include the use of hook and loop (such as VELCRO

) fastening system secures the valve component to the stent component.

In other embodiments of the present invention, a method for replacing a valve is provided by which a first stent member comprising an annular element is implanted such that at least a portion of the first stent member is received in a valve in need of replacement. Inside. A stent-valve comprising a second stent component is positioned within the first stent component by matingly attaching a complementary annular element of the second stent component to the annular element of the first stent component.

In still other embodiments of the present invention, a stent-valve delivery system is provided. A first assembly including an outer sheath and a guidewire tube is provided. The delivery system also includes a second assembly including a stent anchor configured for removably attaching to the at least one attachment element of the stent-valve. The stent-valve can be positioned over the guide wire of the first assembly. The first component and the second component may be configured for relative movement relative to each other for transitioning from the closed position to the open position. In the closed position, the outer sheath may surround the stent-valve while still attached to the stent anchor, and thereby limit expansion of the stent-valve. In the open position, the outer sheath may not restrict expansion of the stent-valve, and thus the stent-valve may be detached from the stent holder and expanded to a fully deployed configuration.

In some embodiments, the first assembly and the second assembly can be configured to transition from a closed position to a partially open position to an open position. In the partially open position, the stent-valve may be partially deployed, but not detached from the stent holder, as the outer sheath may still surround the at least one attachment element of the stent-valve and the stent holder. When the stent-valve is in the partially deployed configuration, it can be determined whether the stent-valve will position correctly if the stent-valve is expanded to the fully deployed configuration. Alternatively or additionally, the functionality of the stent-valve may be tested (eg, to determine whether the stent-valve will allow sufficient blood flow) while it is in the partially deployed configuration.

In certain embodiments, the stent-valve delivery system can include at least one balloon (eg, a proximal stent-valve or other stent to be delivered) configured to cause deployment of the stent-valve or position the stent upon inflation of the at least one balloon.

In some embodiments, the stent-valve delivery system can include a push handle that causes relative movement of the first component and the second component. Alternatively, the stent-valve delivery system may include a screw mechanism for converting rotational motion of the handle into relative motion of the first and second components.

In certain embodiments, the stent-valve delivery system can include an integrated introducer within which the first component and the second component are positioned during delivery of the stent-valve to the implantation site. The integrated introducer can be configured to remain in the patient's body even after the first and second components are removed, for example to allow introduction of a light limiter.

In certain embodiments, after the stent-valve expands to the fully expanded configuration, the delivery system can be configured to return to the closed position by passing the second component through the stent-valve toward the distal end of the first component.

Still other embodiments of the invention relate to methods for delivering a stent-valve to an implantation site, by which the stent-valve is removably attached to a delivery device, and the stent-valve is delivered to the implantation site in a collapsed configuration. The stent-valve may be partially deployed while the stent-valve remains attached to the delivery device. Determinations regarding the stent-valve may be made when the stent-valve is in a partially deployed configuration. When this determination yields a positive response, the stent-valve may be expanded to its fully expanded configuration by detaching the stent-valve from the delivery device.

In a particular embodiment, it can be determined whether the stent-valve is correctly positioned at the implantation site. When the stent-valve is not properly positioned at the implantation site, the stent-valve can revert to the collapsed configuration.

Alternatively or additionally, it may be determined whether the valve member of the stent-valve is functioning correctly, for example, by testing whether the valve member will allow sufficient blood flow. When the stent-valve is not functioning properly, the stent-valve can return to the collapsed configuration and be removed from the patient.

In certain embodiments, delivering the stent-valve to the implantation site may include delivering the stent-valve to the heart to replace the heart valve. The delivery may include entering the patient's body through an intercostal space, such as the fifth intercostal space, and penetrating the left ventricle at the apex of the heart.

Brief description of the drawings

For a better understanding of the present invention, reference is made to the following description taken in conjunction with the accompanying drawings, wherein like reference numerals refer to like components throughout, and wherein:

Figure 1A shows a valve component in an expanded configuration, according to some embodiments of the invention;

Figure 1B shows a valve member in a collapsed configuration, according to some embodiments of the invention;

Figure 2A shows a stent member in an expanded configuration, according to some embodiments of the invention;

Figure 2B shows a single stent valve including a stent member and a valve member in an expanded configuration, according to some embodiments of the present invention;

Figure 2C shows a single-stent valve in a collapsed configuration, according to some embodiments of the invention;

Figure 3A shows a stent member in an expanded configuration, according to some embodiments of the invention;

Figure 3B shows a stent member in a collapsed configuration, according to some embodiments of the invention;

Figure 4 shows a dual stent valve comprising two stent components and a valve component in an expanded configuration, according to some embodiments of the present invention;

5A-7B illustrate the use of a single-stent valve to replace a failed biological (artificial) valve, according to certain embodiments of the invention;

8A and 8B illustrate a stent component including attachment elements for securing the stent to a delivery device and fixation elements for securing the stent at an implantation site, according to some embodiments of the present invention;

Figure 8C shows a stent member having a smaller diameter in the region of the attachment elements than the diameter of the region of the stent housing the associated valve, according to some embodiments of the present invention;

Figure 8D shows a stent component including independently bendable elements for positioning/fixing the stent to the geometry/topology at the implantation site, according to some embodiments of the present invention;

Figure 8E shows a stent component including locking elements in a coronal configuration and fixation elements for securing the stent at the implantation site, according to some embodiments of the present invention;

Figure 8F shows a stent component comprising a plurality of struts for delivering a valve component to a region closer to the stent component, including attachment elements for attaching the stent component to a delivery device;

9A-16 show further embodiments of stent components according to the present invention comprising attachment elements for securing the stent to the delivery device and/or fixation elements for securing the stent at the implantation site;

Figures 17/18, 19 and 20 show additional examples of dual-stent valves according to certain embodiments of the invention;

Figure 21A shows a stent-valve shaped as an opposing bicoronary, according to some embodiments of the present invention;

Figures 21B-E show views of biconical stents according to some embodiments of the invention;

22A-22D illustrate a delivery system for delivering a self-expanding stent-valve to an implantation site, according to some embodiments of the present invention;

23A-23D show a delivery system with an inflatable balloon, according to some embodiments of the invention;

24A-24D illustrate a delivery system with a proximal outer shaft of increased diameter, according to some embodiments of the present invention;

25A-25C show a delivery system with an inflatable balloon, according to some embodiments of the invention;

26A-26C show a delivery system with an integrated introducer, according to some embodiments of the invention;

Figure 27 is a flowchart of the illustrative stages involved in replacing a failed native or prosthetic valve, according to some embodiments of the invention; and

28A-C illustrate replacement of a failed valve through use of a delivery system, according to some embodiments of the invention.

Detailed ways

1A-3B show components 100, 200 for replacing, for example, failed (eg, degenerated) aortic valves, mitral valves, and pulmonary valves (eg, in pediatric patients) according to certain embodiments of the invention. and 300. More specifically, valve component 100 is shown in FIGS. 1A and 1B . 2A-2C show a stent member 200 for receiving a valve member 100 . 3A and 3B show stent member 300 for receiving stent member 200 and valve member 100 . A device comprising components 100 and 200 may be referred to as a single-stent valve. A device that additionally includes member 300 may be referred to as a dual-stent valve.

Figure 4 illustrates a dual stent valve 400 comprising valve component 100, stent component 200, and stent component 300, according to some embodiments of the invention. Dual stent valve 400 can replace a failed native or artificial valve. As used herein, "native valve" refers to a valve that is naturally present in a patient. A failed native valve can be, for example, a stenotic valve. "Prosthetic valve" refers to a biological or artificial (eg, mechanical) valve that is surgically introduced into a patient's body. The implantation site for device 400 (or other replacement valve) typically includes at least a portion of the region within the failed valve and/or along at least a portion of the proximal structure. For example, to replace a failed aortic valve, device 400 may be implanted in a patient such that substantially all of device portion 402 is positioned within the failed aortic valve. Portion 404 of device 400 may extend along at least a portion of the aorta. Portion 406 of device 400 may extend into at least a portion of the left ventricle of the patient's heart.

Dual-stent-valve 400 may be delivered to the implantation site using any suitable delivery method. In some embodiments of the invention, device 400 may be substantially completely assembled from components 100, 200, and 300 outside the patient's body prior to delivery of device 400 to an implantation site. In other embodiments of the invention, components 100, 200, and 300 of device 400 may be delivered to the implantation site individually in multiple steps. For example, stent component 300 may be delivered and installed at the implantation site, followed by delivery and installation of stent component 200 and valve component 100 in one or more separate steps. In one embodiment, components 100 and 200 may be assembled outside of the patient's body, then delivered and installed within component 300 simultaneously. In another embodiment, stent component 200 may be delivered and installed within stent component 300, followed by delivery and installation of valve component 100 in a separate step. Additional embodiments of dual-stent valves are described in conjunction with FIGS. 17-20.

In certain embodiments of the invention, a single-stent valve (FIG. 2B) comprising valve component 100 and stent component 200 (but not stent component 300) may be used to replace a failed native or prosthetic valve. For example, in one specific example, a single-stent valve can replace a failed biological valve introduced into a patient during a previous valve replacement procedure. Thus, a procedure involving the single-stent valve shown in Figure 2B may be a second or subsequent valve replacement procedure. Although in this embodiment no new stent component 300 can be introduced into the patient's body, a single stent valve comprising components 100 and 200 can be accommodated by the stent and/or valve remaining at the implantation site from a previous valve replacement procedure . In certain embodiments, at least a portion of the stent and/or valve from a previous procedure may be removed prior to installation of the single-stent valve at the implantation site. Additional details regarding the replacement of a failed biological valve with a single-stent valve are described in conjunction with FIGS. 5A-7B .

In some embodiments of the invention, the valve member 100 can be flexible and collapsible such that it can collapse during delivery to the implantation site, eg, by a catheter. Various embodiments of delivery systems and surgical methods for minimally invasive surgery are described below in conjunction with FIGS. 22A-26C . Upon delivery, the valve member may at least partially expand. FIG. 1A is a perspective view of valve component 100 in an expanded configuration. Figure IB is a perspective view of valve component 100 in a collapsed configuration. As used herein, "collapsed configuration" and "expanded configuration" refer to, for example, relative differences in diameter and/or any other physical characteristics (eg, length, width) of members. For example, the collapsed valve component shown in Figure IB has a reduced diameter and may or may not have a greater length than the expanded valve component shown in Figure IA.

Valve component 100 may comprise biological materials (eg, tanned, untanned, heterogeneous, or autologous), non-biological materials, artificial materials (eg, polymers such as polyurethane and/or silicon), or combinations thereof. In certain embodiments, valve component 100 may comprise preserved biological tissue, such as, for example, human tissue (eg, valve tissue homograft, autograft) or animal tissue (xenograft or allograft valve tissue). In some embodiments, valve component 100 may be a mechanical valve. For example, when valve component 100 is a biological valve, deployment of valve component 100 from the collapsed configuration to the expanded configuration may require self-deployment of fixed stent component 200 . In contrast, prosthetic valve component 100 is capable of self-deployment. Valve component 100 may have a shape/form (eg, length, width, diameter, etc.) corresponding to the shape/form (eg, length, width, diameter, etc.) of a desired valve application (eg, tricuspid, pulmonary, mitral, or aortic). In FIGS. 1A and 1B , valve component 100 is a tricuspid valve having three flaps. This particular configuration may be particularly useful, for example, in the replacement of a failed aortic valve. In other embodiments, valve component 100 may have any other suitable number of flaps and/or other physical characteristics (eg, diameter, length, width, etc.).

Figure 2A is a perspective view of a stent member 200 according to one embodiment of the present invention. As shown in FIG. 2B , stent component 200 houses valve component 100 . In certain embodiments, at least a portion of stent member 200 may be substantially cylindrical in shape. Alternatively or additionally, the stent member 200 may have, for example, an indentation (eg, an annular groove) or other fixation element 202 for securing the stent in place at the implantation site. For example, when the stent component 200 is part of a dual stent valve 400 ( FIG. 4 ), the fixation element 202 may be matably attached to a supplemental fixation element 302 of the stent component 300 (such as the inward annular protrusion of FIG. 3A ). . When stent component 200 is part of a single-stent valve (FIG. 2B), fixation element 202 can be secured to at least a portion of the failed valve. Additional embodiments of stent components that may include fixation elements are described in conjunction with FIGS. 6A and 8A-16.

In certain embodiments of the invention, stent component 200, like valve component 100, can be in at least two configurations: a first, collapsed configuration (eg, during delivery) and a second, expanded configuration (eg, after installation). FIG. 2A shows stent component 200 in an illustrative deployed configuration. FIG. 2C shows stent component 200 in an illustrative collapsed configuration, with collapsed valve component 100 contained within stent component 200 , for example, for simultaneous delivery of both components to the implantation site. In some embodiments, stent member 200 may be made from wire, or may be laser cut from a tube, sheath, or the like. Stent component 200 may comprise a shape memory alloy material, such as Nitinol. The shape memory alloy can allow the stent component 200 (and/or the valve component 100) to be compressed into a first configuration, for example, to deliver the stent component 200 through a small opening in the patient's body, and to expand the stent component 200 during installation into Second construction. For example, members 100 and/or 200 may be held in the collapsed configuration with, for example, a sheath or shroud. The sheath/shroud may be removed to allow members 100 and/or 200 to reconfigure into the second configuration.

Valve component 100 may be secured to stent component 200 by any suitable securing mechanism or combination of securing mechanisms. For example, in one embodiment, valve component 100 may be sutured to stent component 200 with one or more stitches. In another embodiment, valve component 100 may be secured to bracket component 200 by a friction fit. For example, valve component 100 may have a fully deployed diameter that is slightly larger than the deployed diameter of stent component 200 so that when component 100 is deployed within component 200, components 100 and 200 fit securely together. In yet another embodiment, hook and loop type (such as VELCRO ) fastening system may be used to secure the valve component 100 to the stent component 200. For example, stent component 200 may include microscopic hooks and valve component 100 may include corresponding microscopic rings (or vice versa). Such hook and loop fastening systems may include microvelvet material, which has previously been used in surgical applications to modify ingrown tissue. Such a hook and loop fastening system may allow for fine-tuning of the position of valve component 100 relative to the position of stent component 200, for example after components 100 and 200 have been implanted in a patient. The hook/loop may also facilitate blood clotting and the formation of a seal at the junction between the valve component 100 and the stent component 200 . To avoid premature clot formation (eg, excessive clot formation before installation is complete), the patient may be offered anticoagulant monitoring and/or treatment. Reliable hook-and-loop connections can still be achieved in the presence of premature clot formation, but may require higher activation pressures (described below). Preliminary evaluations revealed that reliable hook-and-loop junctions can form in the presence of water, colloidal substances, liquid soap, and/or coagulated proteins. In certain embodiments, such a hook and loop fastening system may alternatively or additionally be used to secure stent member 200 to stent member 300 (e.g., with microscopic hooks attached to the outer surface of stent member 200 ). and a corresponding microring attached to the inner surface of the stent member 300, or vice versa).

Any suitable mechanism or combination of mechanisms (such as direct or indirect application of mechanical compression) may be used to provide the activation pressure required to attach the microhooks to the microrings. For example, in some embodiments, one or more balloons may be placed adjacent to valve component 100 and/or stent component 200 (eg, within valve component 100), and they may be temporarily inflated so that the microscopic hooks interact with The microrings make contact. Such a balloon may be placed within valve component 100 and/or stent component 200 following delivery of the stent and/or valve to the implantation site. Alternatively, in some embodiments, prior to delivery of the stent and/or valve to the implantation site (e.g., prior to loading the stent and/or valve into the delivery device), the balloon may be mounted (e.g., removably mounted) ) into the valve component 100 and/or stent component 200. The use of such balloons is not limited to embodiments in which the valve and stent are secured to each other by a hook/loop manner. Rather, such balloons may be used whenever it is necessary or desirable to assist deployment and/or engagement of the stent and/or valve at the implantation site (eg, when the valve is sutured to the stent). In some embodiments, a self-expanding valve member 100 may be provided that self-expands within the stent member 200 such that the microscopic hooks contact the microscopic rings.

Figure 3A is a perspective view of a stent member 300 according to one embodiment of the present invention. As previously mentioned, the stent component 300 may have a fixation element 302 (eg, an inward annular protrusion) that is matably attached to the supplemental fixation element 202 of the stent component 200 ( FIG. 2A ). One embodiment of such a matable attachment is shown in FIG. 4 , where member 300 accommodates both members 100 and 200 to form a dual-stent valve 400 . The geometry (eg, length, width, diameter, etc.) of stent component 300 may be particularly suited for use in, for example, aortic valve replacement. In other embodiments, other geometries and configurations of the stent member 300 may be provided.

Stent member 300 may be secured in place at the implantation site using any suitable fixation mechanism or combination of fixation mechanisms. For example, in some embodiments, fixation element 302 may form a groove (eg, an outer annular groove) for receiving at least a portion of a failed valve. In certain embodiments, stent component 300 may have a diameter slightly larger than the diameter of the implantation site such that delivery and deployment of stent component 300 at the implantation site secures stent component 300 in place by means of a friction fit. In certain embodiments, the stent component 300 can include one or more protrusions (such as spikes) or buckles for anchoring the stent component 300 to the failed valve and/or proximal structure at the implantation site. hook.

5A-7B illustrate an embodiment of the present invention for replacing a failed artificial (eg, biological) valve (eg, a stent-valve) introduced into a patient's body during a previous surgical procedure. 5A is a perspective view of a failed biological valve 500 in which the leaflets 502 of the valve fail to close. Figure 5B is a perspective view of a failed biological valve 500 after implantation of the stent-valve shown in Figure 2B. As shown, the failed biological valve 500 (eg, and/or its accompanying stent) holds the new stented valve in place at the implantation site. More specifically, the fixation element 202 ( FIGS. 2A and 2B ) of the stent-valve, which may be an annular groove forming the narrowest portion of the stent-valve, may receive the annulus of the failed biological valve 500, thereby holding the stent-valve in place. . In other embodiments of the invention, at least a portion of the failed biological valve 500 (e.g., the failed valve itself) may be removed from the patient's body, while other portions of the failed valve (e.g., the support stent) may be left at the implantation site . In yet other embodiments, the failed biological valve 500, including all of its associated components, may be substantially completely removed from the implantation site prior to installation of a new stent-valve.

Figure 6A is a perspective view of another example of a stent-valve 600 according to one embodiment of the present invention. FIG. 6B is a perspective view showing the use of stent-valve 600 to replace a failed artificial (eg, biological) valve. Stent-valve 600 includes one or more (eg, three) locking or retaining elements 602 along the outer surface of the stent member. Each locking element 602 may include directionality such that it contracts (eg, becomes flush with the outer surface of the stent member) when the locking element engages another surface (eg, the interior of a catheter). When the locking element 602 protrudes from the outer surface of the stent component, the first end 604 of the locking element can be adjacent to the outer surface of the stent component and the second end 606 of the locking member can be spaced from the outer surface of the stent component. When multiple locking elements 602 are provided, the first ends 604 of all locking members may be positioned at substantially the same vertical height/position along the central axis of the stent member (e.g., although evenly dispersed around the periphery of the stent member), And the second end 606 may be positioned at a different vertical height/position than the first end 604 . The first end 604 may be flexible (eg, allowing hinge-like movement in two dimensions) so that movement of the second end relative to the outer surface of the bracket member does not interfere with the locking mechanism.

In some embodiments of the invention, stent-valve 600 may be inserted into the interior of a failed valve in the direction of arrow 608 in Figure 6B. When the first end 604 of each locking element 602 encounters the inner diameter/annulus of the failed valve, the second end 606 of the locking element can retract toward the outer surface of the stent member. When the second end 606 of the locking element reaches the opening area of the failed valve, the second end may protrude outward, thereby locking the stent-valve 600 in place. Thus, as an alternative or in addition to the fixation element 610 (such as an annular groove) of a stent component for securing the stent-valve 600 to, for example, the annulus of a failed valve, the locking element 602 may be provided for use in The mechanism by which the new stent-valve is held in place.

7A and 7B show another embodiment of a stent member 700 with locking elements according to the present invention. Figure 7A shows that such a stent member can be made, for example, from a sheet of a suitable material such as Nitinol. Referring to FIG. 7B , a stent member 700 includes one or more locking elements 702 that extend radially from the outer surface of the stent member such that for each locking element, a first end 704 and a second end 706 of the locking element along The central axes of the bracket members have substantially the same vertical position/height. In other embodiments, such locking elements may be slightly angled such that ends 704 and 706 of the same locking element have different relative vertical positions/heights along the central axis of the stent member. In some embodiments, a stent member may be provided that includes multiple locking elements, where each locking element has ends 704 and 706 that are oriented at different angles. Different locking elements 702 may have the same or different vertical positions/heights along the central axis of the stent member.

8A-16 illustrate additional examples of suitable stent components for valve replacement, according to certain embodiments of the present invention. These stent components can be used, for example, as part of single-stent valves and double-stent valves. Each of these stent components includes one or more attachment elements for removably attaching the stent component (eg, along with the integrated valve component) to the delivery device (Figs. 22-26). In certain embodiments, the stent components may also include fixation elements (eg, similar to fixation elements 202 ( FIG. 2A )) for securing the stent components in place at the implantation site.

FIG. 8A shows a perspective view of a stent member 800 in a collapsed configuration, as well as a similar cut-away view of the stent member 800 illustrating details about its structure. Figure 8B shows stent component 800 in an expanded configuration. The stent component 800 includes: a first (e.g., proximal) portion 802 that includes a fixation element (e.g., an annular groove); a second portion 804 that can follow the contours of the valve component to be received therein; and includes one or more (e.g., three) third (eg, distal) portion 806 of attachment element 808 . In some embodiments, stent member 800 may include, for example, a lattice structure (eg, made of Nitinol), eg, portion 802 has denser lattice cells than portion 804 and/or portion 806 . This can provide additional support for the fixation elements in portion 802 and thereby improve the stability of device 800 at the implantation site. In some embodiments, stent component 800 may comprise only closed lattice cells to facilitate retrieval of stent component 800 by a delivery device when stent component 800 is in a partially deployed configuration (as described below).

In certain embodiments, each of the attachment elements 808 may include an opening (eg, circular or oval-shaped) for removably attaching the stent member 800 to a complementary element (eg, wire, strap, or hook) of a delivery device. ). Attachment element 808 may allow the stent component (e.g., along with an integrated valve component and/or another stent component) to partially deploy within the patient's body while maintaining the stent component attached to the delivery system, for example, when stent component 800 is in the When partially released from the shaft during delivery, portions 802 and 804 of stent member 800 (e.g., and a portion of portion 806) can deploy without observing a change in the relative position of attachment element 808, which is still constrained by the shaft (e.g., See "Partial Release" in Figure 28). This may allow the surgeon to reposition and/or test the functionality of the stent-valve (or dual stent-valve) within the patient prior to finalizing deployment of the stent-valve at the implantation site. Such tests of valve functionality may include peripheral pulse monitoring by which pulse waves are measurable if the valve is functioning correctly. A more reliable assessment of stent-valve function can be performed with transesophageal echocardiography (TEE), intravascular ultrasound imaging (IVUS) and/or intracardiac echocardiography (ICE). If the stent-valve fails during testing (eg, if the valve does not allow sufficient blood flow), the stent-valve can be fully recaptured by the delivery device and retrieved from the patient. In other embodiments, the stent member 800 can have a different lattice structure, the length and/or other dimensions of the attachment elements 808 can be reduced or enlarged, and/or the attachment elements 808 can be included in other positions relative to the stent member 800. location (as in section 804).

FIG. 8C shows another embodiment of a stent component with integrated attachment elements 814 configured such that the fully deployed diameter in the region of the attachment elements is smaller than the diameter of the region housing the associated valve. As shown in this example, the attachment elements project partially inwardly towards the central axis of the stent member. This may reduce the risk of the attachment element causing harm to the patient's body, such as puncture of the aorta. Alternatively or additionally, this may make it easier to secure the attachment element to the complementary structure of the delivery device. For example, the reduced diameter in the region of the attachment element may allow the attachment element to engage the stent anchor earlier when the device is shrunk to facilitate attachment to the delivery device.

Figure 8D shows yet another embodiment of a stent member according to the present invention. In this embodiment, the first (proximal) portion of the stent includes 27 individual bendable elements 816, each of which may comprise connected and/or disconnected cells that may be opened and/or closed. In this embodiment, each bendable element comprises a single closed unit. In other embodiments, other numbers and/or configurations of bendable elements may be provided. The bendable element 816 allows for precise positioning/fixation of the proximal stent portion to the geometry/topology of, for example, a calcified annulus/failed biological valve. Each element 816 can independently bend/adapt to the topology of the calcified annulus/immediate portion of the failed biological valve. The bendable elements 816 collectively form an annular groove in which the location of the bending deformation (grooved portion) for each bendable element is reduced or lengthened by a pair of attached stent struts that serve as joints. The length of rod (818,820) is controlled. The length of a single stent strut is indicated at 822 . First, the radial force/resistance of each bendable element 816 is affected by the choice of angle 824 during stent fabrication. Other design parameters such as strut thickness/width also affect radial force. An advantage of this design is that the proximal portion of the stent can more fully anchor the stent in place at the implantation site without being affected by the middle portion of the stent. Thus, the stent intermediate portion can be designed to accommodate, for example, the aortic valve without overdimensioning, thereby reducing the risk of valve failure due to long-term mechanical stress. The stent of FIG. 8D also includes compensating elements 826 (eg, including triangular undulations and two elongated arms) for adjusting for elongation mismatch (if any) within the stent during fabrication and/or bending. Figure 8D is the opposite of the embodiment shown in Figure 8C, where the absence of a dedicated pair of struts prevents the proximal portion of the stent from having independently curved elements (eg, during implantation).

Figure 8E shows another embodiment of a stent member according to the present invention. In Fig. 8E, only about 1/3 of a similar cut-away view of a stent member is shown in order to more clearly show its features. Similar to the locking/retaining element 602 shown in FIGS. 6A and 6B , the stent member shown in FIG. 8E includes a plurality of independently bendable locking elements 828 positioned generally within the region of the stent member referenced as region 804 in FIG. 8B . The locking element 828 forms a crown that can engage, for example, a failed biological valve or a calcified native annulus from the outflow side. The stent member in FIG. 8E also includes a fixation element 830 (eg, an annular groove). In FIG. 8E, the locking elements 828 are shown positioned at substantially the same position/height along the central axis of the stent member. In other embodiments, different locking elements 828 may have the same or different vertical positions/heights along the central axis of the stent member similar to, for example, the stent shown in FIG. 7B . Having different positions/heights for at least some of the locking elements 828 may facilitate engagement with, for example, different sized native valves (e.g., thin native valves engageable by locking elements spaced a small distance apart, or only engageable by spaced The thick native valve engages with the locking elements far apart).

Figure 8F shows another embodiment of a stent member according to the present invention. In Figure 8F, only about 1/3 of a similarly cut-away view of a stent member is shown in order to more clearly show its features. FIG. 8F includes a Dacron bag 832 for containing the valve components, wherein the Dacron bag is sewn along the free edge 834 of the valve. As shown, the valve member within bag 832 is housed in the embodiment of FIG. 8F closer to attachment element 836, which is identical to attachment element 808 in FIG. 8B, than in the embodiment shown in FIG. 9C. resemblance. The central inverted U-shaped strut 838 slides into the Dacron bag 832 . The valve/bag is sutured to the outer inverted U-shaped strut 840. The inner U-shaped struts 842 are positioned outside the dacron bag 832 and are used in the process of loading/releasing/recapturing the implant with the delivery device by reducing the friction between the dacron bag 832 and the outer sheath Used as a brake. The inner U-shaped struts 842 can also be sewn to the clon bag 832. In certain embodiments, the dacron bag 832 may be closed with other stitches 844 . Although the bottom of the stent is not shown in FIG. 8F, in some embodiments it may include, for example, a fixation element (eg, an annular groove) similar to fixation element 802 in FIG. 8B.

9A-9C show another example of a stent member 900 with integrated attachment elements 902 in accordance with one embodiment of the present invention. FIG. 9A shows a perspective view of stent member 900 in a collapsed configuration and a like cut view of stent member 900 illustrating details about its structure. Figure 9B is a perspective view of stent component 900 in an expanded configuration. Figure 9C shows a stent component 900 (with integrated valve component) positioned next to a scale to show its size (eg, about 4 cm). As shown, each attachment element 902 includes a circular or oval opening that is attached to the stent member 900 by two support elements 904 (eg, wires). Instead, each pair of support elements 904 is attached to a strut 906 (eg, a joint rod) within the grid structure. In contrast, each of attachment elements 808 in FIG. 8B is attached to bracket member 800 by a single support element 810 , and each support element 810 is attached to post 812 . All of the stent members shown in FIGS. 8A-16 include three struts, but it should be understood that other suitable numbers of struts or no struts at all may be provided in accordance with certain embodiments of the invention (as in FIG. 2A ). Stent component 900 also includes fixation element 908, which may be substantially similar to fixation element 202 (FIG. 2A). In the embodiment of Fig. 9C, the valve member is sewn around the circumference of its annulus. Each of the three leaflets of the valve member are also spot sutured to the scaffold to allow for valve functionality. The location of the sutures can be chosen to allow for elongation of the stent during crimping without damage to the valve or sutures. For example, the inflow can be covered with a fabric (eg, mesh) on the inside of the stent (eg, in region 802 shown in Figure 8B). The fabric and valve components may be sutured to the stent (eg, using continuous and/or interrupted techniques) in the region of the proximal annular groove (eg, along the border of stent portions 802 and 804 in FIG. 8B ). Some of the excess fabric on the inflow side can be folded onto the outside of the stent and stitched together with the valve member near the previously stitched location (eg, further toward portion 804). The commissures of the valve components may also be attached to corresponding stent stems which may have been previously covered with fabric such as Dacron. Alternatively, the stent member may be covered with pericardium or other suitable material. In certain embodiments, the valve component may be a porcine valve component that may be harvested or pooled from individual donors so as to have an optimal fit between the tricuspids. Bovine and equine valves made of pericardium can also be used. Other suitable sources of valve components may also be used.

10A-10B illustrate yet another example of a stent member 1000 with integrated attachment elements 1002 in accordance with an embodiment of the present invention. Figure 10A shows a perspective view of stent component 1000 in a collapsed configuration and a similarly cut view of stent component 1000 illustrating details regarding its structure. 10B is a perspective view of stent component 1000 in an expanded configuration. As shown, at least one pair (eg, all pairs) of attachment elements 1002 are attached to each other using support elements 1004 . Each support element 1004 may be attached on one end to the first attachment element 1002 and on the other end to the second attachment element 1002 . In some embodiments, the support element 1004 may comprise a wire shaped like a triangular wave. When all attachment elements 1002 include strut elements 1004 , strut elements 1004 may collectively form a ring around the perimeter of stent component 1000 . Stent component 1000 may be substantially the same as stent component 800 (FIG. 8B) in all other respects.

11-16 illustrate additional examples of stent components with integrated attachment elements according to certain embodiments of the present invention. Each of Figures 11-16 includes a perspective view of a stent member in a collapsed configuration and a like cut-away view of a stent member illustrating details about its structure. The following description summarizes various features of the stent components shown in FIGS. 11-16. Additional structural features of the embodiment shown in FIGS. 8A-16 will be apparent to those skilled in the art from the accompanying drawings.

Figure 11 shows a stent member comprising shorter support elements (ie shorter compared to support element 810 of Figure 8B) for attachment to a corresponding number of oval/circular attachment elements. The post for attachment to the support element in Figure 11 may be substantially the same as post 906 in Figure 9B.

Figure 12 shows a stent member comprising two support elements for attachment to each oval/circular attachment element. Each pair of support elements is attached to the mast so that the support element and the mast together form, for example, a second oval/ Round opening. The mast in FIG. 12 may be substantially the same as mast 906 in FIG. 9B.

Figure 13 shows non-circular/oval attachment members (e.g. such as wires, hooks, straps, or Combination) bracket components. The stent member in FIG. 13 also includes a greater number of attachment elements (eg, six) when compared to the number of attachment elements (eg, three) of stent member 900 ( FIGS. 9A and 9B ). In Figure 13, the attachment elements are attached directly to the struts of the stent member, with two attachment elements attached to each strut. The mast in FIG. 13 may be substantially the same as mast 906 in FIG. 9B.

FIG. 14 shows a stent member in which the wire/hook attachment elements in FIG. 13 are replaced with long narrow openings (eg, long and narrow compared to attachment elements 902 of FIG. 9A ). The mast in FIG. 14 may be substantially the same as mast 906 in FIG. 9B.

Figure 15 shows a scaffold member with a modified lattice structure including a modified strut structure. The stent member in Figure 15 also includes circular/oval attachment elements, where each attachment element is attached to the post by two support elements. Each pair of support elements and corresponding struts may form a second circular/oval opening in a manner similar to the support element/strut configuration shown in FIG. 12 .

FIG. 16 shows a stent member with modified attachment elements relative to those shown in FIG. 15 . Each attachment element in FIG. 16 comprises a wire (eg, a "U" shaped wire) where both ends of the wire are attached directly to the same post such that the attachment element/post configuration forms a substantially oval/circular opening. The mast in FIG. 16 may be substantially the same as the mast shown in FIG. 15 .

Figures 17/18, 19 and 20 show additional examples of dual stent valves according to certain embodiments of the invention. Single-stent valve 1700 of FIG. 17 includes a stent 1702 and a valve component 1704 . Figure 18 shows a dual stent-valve comprising a stent-valve 1700 and a positioning stent 1802 that can be attached together by, for example, an annular groove and a corresponding annular recess. Stent member 1802 may be covered with, for example, pericardium to prevent paravalvular leakage. The dual stent-valve of FIG. 18 may have a generally cylindrical shape suitable for, for example, pulmonary and/or aortic applications.

Referring now to FIGS. 19 and 20 , FIG. 19 shows a dual stent valve having a first stent 1902 , a second stent 1904 and a valve member 1906 . FIG. 20 shows a dual stent valve having a first stent 2002 , a second stent 2004 and a valve member 2006 . Additionally, the positioning brackets of Figures 19 and 20 may be covered (eg, with pericardium) to prevent paravalvular leakage. The stent of Figures 19 and 20 may be suitable for use, for example, in pulmonary valve replacement (eg, in the case of deformed aneurysms, and in the absence of suitable edges for replacement of grooved stent valves). More specifically, with respect to pulmonary valve applications, many candidates for pulmonary valve replacement have aneurysms or funnel-type configurations at the inflow or outflow. Thus, the first stents 1902 and 2002 can be adapted to this funnel-shaped pulmonary artery configuration and can provide round holes for securing the stent-valve (1904, 1906) or (2004, 2006). In certain embodiments, a dual stent valve similar to that of FIG. 20 may be provided, suitable for mitral and/or tricuspid applications, wherein the positioning stent has a reduced height and provides for attachment. Oval configuration to the rounded edge of the stent-valve groove (alternatively, a hook and loop fastening system can be used). Alternatively or additionally, the positioning bracket may have independently bendable elements that provide a secure fit at the implantation site. Additional structural features of the embodiment shown in Figures 17-20 and details regarding its use for valve replacement will be apparent to those skilled in the art from the accompanying drawings.

Figure 21A shows another example of a stent-valve 2100 according to some embodiments of the present invention. The embodiment shown in Figure 21A may be suitable, for example, for mitral valve replacement. The stent-valve 2100 can be assembled from the stent component and the valve component outside the patient's body before the stent-valve 2100 is delivered to the implantation site. Stent-valve 2100 may be a self-expanding stent-valve suitable for replacing a mitral valve. As shown, the stent-valve 2100 may have a shape resembling opposing double crowns. The stent-valve 2100 may comprise a porcine pulmonary valve 2102 sewn into a Dacron catheter (prosthetic tube) with two self-expanding Nitinol Z-stents 2104 and 2106 sutured to the outer surface of the prosthesis in a manner to create two self-expanding crowns superior. The self-expanding stent-valve can be loaded for delivery into a Teflon sheath or other suitable delivery system. In this embodiment, Dacron is used to cover the stent, but in other embodiments other materials such as Teflon, silicon, pericardium, etc. may be used. In one surgical approach, a 1 cm incision can be made in the left atrium, controlled by a purse string suture. The Teflon sheath with the encased stent can be pushed over the guide wire (atrium pierced with a needle and inserted guide wire) until the middle of the stent-valve reaches the mitral annulus. The sheath can then be pulled back to deploy the ventricular side first, followed by full removal of the sheath to expose the atrial side. In Liang Ma et al., "Double-crowned valved stents for off-pump mitral valve replacement", European Journal of Cardio-Thoracic Surgery 28:194-199, June 13 , 2005 (European Journal of Cardiothoracic Surgery, published June 13, 2005, Vol. 28, pp. 194-199) describes additional details about the stent-valve 2100 and the surgical method for delivering it to the implantation site, which Incorporated herein in its entirety by reference.

、缝合线、摩擦配合、其他适当的固定机构或其组合)的基本上为圆锥形的支架(2112，2114)。图21D显示了图21B和21C所示的双圆锥形支架的截面。在其它实施例中，支架2112和2114中的至少一个可具有冠形，该冠形具有由打开或闭合的单元或Z支架形成的突出钉。第一和第二另外的支架(2112，2114)可共同形成与图2A所示的固定元件202相似的固定元件2116(图21C；如环形凹槽)。固定元件2116可允许固定在(例如)失效瓣膜的小孔中(其具有与与携带瓣膜构件2110的支架2108类似的尺寸)，或者固定到具有补充环形凸起的锚定支架上。在某些实施例中，支架2112和2114(以及可选地支架2108)可以用呈双圆锥形构造(如在固定元件2116的区中由连续区域连接的两个锥形物)的单个支架来代替。使用用于锥形物/固定元件的单独支架的优点是，锥形物/固定元件(如第一支架2112和第二支架2114)的机械应力可以至少部分地隔离包含瓣膜的支架2108。在某些实施例中，定位成接近于输送系统的尖端(如支架2112)的至少另外的支架或其部分可以由输送系统重获。为了有利于这种重获，可以使另外的支架形成为棱锥形或翼形截面构造2118(图21E)。在某些实施例中，可以在沿着与(例如)图7B所示的支架相似的支架2108的中心轴线的各个位置/高度处形成支架2112(和/或2114)的翼或钉。至少某些翼或钉具有不同的位置/高度可有利于与(例如)具有不同尺寸的自体瓣膜的接合。在某些实施例中，图21B-21E所示的支架(如支架2108)可包括用于可移除地附连到输送装置的至少一个附连元件，其与图8B所示的附连元件808相似。21B-E show views of biconical stents according to some embodiments of the invention. 21B and 21C, the biconical stent may comprise a substantially cylindrical stent 2108 carrying the valve 2110 and secured/attached to the stent 2108 (e.g. with a VELCR

, sutures, friction fit, other suitable securing mechanisms, or combinations thereof) substantially conical brackets (2112, 2114). Figure 21D shows a cross-section of the biconical stent shown in Figures 21B and 21C. In other embodiments, at least one of braces 2112 and 2114 may have a crown shape with protruding spikes formed from open or closed cells or Z braces. The first and second additional brackets (2112, 2114) may collectively form a fixation element 2116 (Fig. 21C; eg, an annular groove) similar to the fixation element 202 shown in Fig. 2A. The fixation element 2116 may allow for fixation in, for example, an orifice of a failed valve (which has similar dimensions to the stent 2108 carrying the valve member 2110), or to an anchoring stent with a supplementary annular protrusion. In some embodiments, stents 2112 and 2114 (and optionally stent 2108) can be formed with a single stent in a biconical configuration (e.g., two cones connected by a continuous region in the region of fixation element 2116). replace. An advantage of using separate stents for the cones/fixation elements is that the mechanical stress of the cones/fixation elements (eg, first stent 2112 and second stent 2114 ) can at least partially isolate the valve-containing stent 2108 . In certain embodiments, at least an additional stent, or portion thereof, positioned proximate to the tip of the delivery system (eg, stent 2112 ) can be retrieved by the delivery system. To facilitate such retrieval, additional scaffolds may be formed in a pyramidal or airfoil cross-sectional configuration 2118 (FIG. 21E). In some embodiments, the wings or spikes of the stent 2112 (and/or 2114) may be formed at various locations/heights along the central axis of the stent 2108 similar to the stent shown in, eg, FIG. 7B. Having different positions/heights for at least some of the wings or pegs can facilitate engagement with, for example, native valves of different sizes. In certain embodiments, the stent shown in FIGS. 21B-21E , such as stent 2108 , can include at least one attachment element for removably attaching to a delivery device, which is similar to the attachment element shown in FIG. 8B . 808 is similar.

22A-26C illustrate examples of delivery systems for delivering a stent-valve (eg, a single-stent-valve or a dual-stent-valve) to an implantation site, according to some embodiments of the present invention. In certain embodiments, the present invention provides minimally invasive surgical methods by which surgery can be performed on a beating heart without the need for thoracotomy and cardiopulmonary bypass. The heart can be pierced through a relatively small opening in the patient's body, for example transapically. For example, to replace a failed aortic valve, the patient's body may be accessed through the intercostal space (eg, the fifth intercostal space), which is the area between two ribs. From this access point, the left ventricle can be penetrated over the apex of the heart. In one approach, a suitable stent-valve delivery system, such as delivery system 2600 (FIGS. 26A-26C) including an integrated introducer, may first be pierced into the body/heart. In another approach, a separate introducer sheath can be used. A guide wire (hollow needle, catheter, rigid guide wire, etc.) may be inserted through the introducer to guide delivery of, for example, stent components, valve components, and/or other devices (eg, optical limiter devices). In certain embodiments, transluminal, transatrial, or transventricular access approaches may be used, for example, for tricuspid and/or mitral valve replacement. The right ventricle of the heart can also be accessed for pulmonary valve replacement. This is in contrast to other surgical approaches that deliver replacement valves through thoracotomy. In addition, as described in more detail below in conjunction with FIGS. 22A-28C , delivery systems according to some embodiments of the present invention first release the proximal portion of the stent-valve, which may be useful when, for example, entering the body transluminally. Allows testing of the valve. Once the test is successful, the distal portion of the stent-valve can be released. This is in contrast to stent delivery systems that first release the distal portion of its associated stent.

22A-22D show a delivery system 2200 comprising two concentrically arranged sections, a first assembly (comprising elements 2202-2210) and a second assembly (comprising elements 2216-2230). More specifically, the first assembly may include a tip 2202, an inner shaft 2204, an outer sheath 2206, a metal shaft 2208, and a pusher located on the distal side of the delivery system (where the guide wire is passed the length of the delivery system and out of the tip). Shank 2210. The second assembly may include an outer shaft (distal) 2216, a tapered outer shaft connector 2218, an outer shaft (proximal) 2220, a stent anchor 2222, a loop protector 2224, a grip connector 2226, a grip cup 2228 and O-ring 2230. As shown, push handle 2210 is positioned at the proximal end of the delivery system. In Figures 22A and 22B, the outer shaft 2220 has been split along its length to allow the components of the delivery system 2200 to be shown in greater detail. The valve 2212 and stent 2214 form a third component that can, for example, fit between the first and second components and can be crimped therebetween.

With respect to the first component, the inner shaft 2204 serves as a lumen for the guide wire. Tip 2202 is joined on its distal side. As used herein, bonding refers to any suitable fixing/fastening mechanism, such as, for example, adhesive bonding using cyanoacrylate or UV-curable adhesives, or thermal bonding/welding using thermal energy to melt the components to be assembled. Outer sheath 2206 can be bonded to the proximal portion of tip 2202 and can constrain the stent-valve (2212, 2214). The outer sheath 2206 may be perforated to allow flushing of the device through the handle 2210 . The proximal portion of the first component may be reinforced with a metal shaft 2208, and it may terminate distally in the handle with a luer connection for guidewire lumen irrigation.

Regarding the second component, a stent anchor 2222 can be coupled distally to the distal outer shaft 2216 . FIG. 22D shows a perspective view to better illustrate the arrangement between the stent-valve ( 2212 , 2214 ) and stent anchor 2222 . Distal outer shaft 2216 may be coupled proximally to proximal outer shaft 2220 via tapered connector 2218 . The abutment outer shaft 2220 can be coupled to a handle assembly, which can include a handle connector 2226 and a handle cup 2228 , via a loop protector 2224 . The handle assembly can compress the O-ring 2230 to seal the delivery system 2200 . A luer connection may allow the device to be flushed. A flushing mechanism may be used to remove trapped air from the delivery system prior to its insertion into the body. Alternatively or additionally, the irrigation mechanism may be used to cool the stent (eg, Nitinol stent) prior to release and/or retrieval of the stent by rinsing the stent with a cold saline solution. Cooling the stent can lead to a reversible modification of its structure, thus reducing its Young's modulus, and thereby reducing the stent radial force and the forces necessary for its delivery and retrieval.

The delivery system 2200 is said to be in the open position when, for example, the push handle 2210 contacts the handle cup 2228 (FIG. 22C). In the open position, the stent-valve (2212, 2214) can be detached from the stent holder 2222 and can be fully deployed at the implantation site. Before the delivery system 2200 reaches the open position, the stent-valve can be crimped over the delivery system 2200 by, for example, a crimping mechanism and held in place by the stent holder 2222 . The stent anchor 2222 may be secured to the attachment elements of the stent shown in FIGS. 8A-16. The crumpled stent-valve can be maintained in the collapsed configuration by pulling back the first component, thereby covering the attachment member/stent anchor 2222 with the outer sheath 2206 . When outer sheath 2206 is removed so that it no longer constrains the attachment members, the stent-valve may automatically detach from stent holder 2222 due to the self-expanding nature of the stent-valve. When the outer sheath 2206 completely surrounds the stent-valve (2212, 2214), the delivery system 2200 is said to be in the closed position (FIGS. 22A and 22B), such that deployment of the stent-valve does not occur.

Delivery system 2200 is said to be in a partially open position when push handle 2210 is partially pushed, eg, toward grip cup 2228 . In this particular open position, the stent-valve (2212, 2214) is proximally deployed, and it is still distally attached to the stent anchor 2222 by the attachment elements. This allows precise implantation/positioning of the stent. For example, the stent-valve can be partially released close to the intended implantation site and can be pushed slightly distally until resistance is felt. Final release of the stent-valve (2212, 2214) can occur by fully pushing the push handle toward the handle cup 2228 such that the delivery system 2200 reaches the open position. Such a partially open position is illustrated in Figure 28B. In some embodiments, an imaging mechanism can be used to determine whether the stent is properly positioned at the implantation site. For example, angiography, intravascular ultrasound imaging (IVUS), intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), or other mechanisms or combinations thereof can be used to achieve fluoroscopy imaging , by which the imaging mechanism may be at least partially integrated with or separate from the delivery system.

When a stent-valve (2212, 2214) is implanted, the delivery system 2200 can return (for example) by holding the first component and pushing the second component distally towards the tip 2202/outer sheath 2206 before being withdrawn from the patient to the closed position. In other embodiments, the handle for releasing the stent-valve may include a screw mechanism for converting rotational motion of the handle into translational motion of the outer sheath. This type of release system may allow for gradual, more precise release and recapture of the stent, as well as reduced release force felt by the surgeon.

23A-23D show another example of a delivery system 2300 according to one embodiment of the invention. Delivery system 2300 can be substantially similar to delivery system 2200 ( FIG. 22 ) (closed as in FIGS. 23A and 23B ), except that delivery system 2300 can additionally include one or more folded balloons 2302 (such as proximal to the stent-valve). position; the open position of Figure 23C). Unless otherwise indicated, like features in FIGS. 23A-23D correspond to like reference numerals in FIGS. 22A-22D , but reference numerals have not been reproduced in FIGS. 23A-23D to avoid over-complicating the drawing. The same applies to the stent delivery systems shown in Figures 24A-D, 25A-C and 26A-C. The balloon 2302 can be inflated/deflated through an additional lumen in the proximal outer shaft 2304, for example, to anchor a stent-valve (eg, a non-self-expanding stent-valve) in place at the implantation site. Figure 23D shows a cross-sectional view "A-A" of the lumen structure shown in Figure 23C. The lumen structure includes five lumen tubes 2306 and an inner shaft 2308 . In other embodiments, other configurations for lumen tube 2306 may be used (eg, a dual lumen tube, where a second lumen is used for balloon inflation and deflation). The delivery system 2300 may also include an access mechanism 2310 for balloon inflation/deflation, which may allow attachment of a syringe or inflation device to inflate/deflate the balloon. Alternatively or additionally, a tube with an attached stopcock may be connected to the access mechanism 2310 .

24A-24D show another example of a delivery system 2400 according to one embodiment of the invention. In delivery system 2400, proximal outer shaft 2402 can have an increased diameter compared to the diameter of proximal outer shaft 2220 (FIG. 22). The increased diameter reduces bleeding when the delivery system is used without an introducer. Alternatively, when an introducer is used, the increased diameter may match the inner diameter of the introducer, which in turn may depend on the outer diameter of the outer sheath. Having no gap between the introducer and the delivery system can reduce the risk of potential problems retrieving the delivery system through the introducer due to entrained blood. Accordingly, the delivery system 2400 may include a floating tube 2404 that fills the gap between the inner and outer components, thereby reducing the risk of the inner component twisting under compression, which would cause tension within the delivery system during stent retrieval. Higher friction. The delivery system 2400 may be substantially similar to the delivery system 2200 in all other respects (closed position, Figures 24A and 24B; open position, Figure 24C).

25A-C show another example of a delivery system 2500 according to one embodiment of the invention. Delivery system 2500 may include one or more balloons 2536 distal to the stent-valve. Having a balloon distal to the stent-valve avoids having to introduce the delivery system deeper into the body (e.g. into the ascending aorta) in order to perform inflation, thereby reducing the risk of damage to the body and improving device handling (e.g. over the aortic arch bending without a rigid device). Balloon 2536 may be used, for example, for valvuloplasty prior to stent-valve implantation and/or post-expansion of an implanted stent-valve to improve anchoring of the stent. Figures 25B and 25C show balloon 2536 in a closed and open position, respectively.

A first component of delivery system 2500 may include tip 2502 , inner balloon shaft 2504 , outer sheath 2506 and float tube 2508 . The second assembly can include inner shaft (distal) 2510 , stent anchor adapter 2512 , stent anchor 2514 , sleeve 2516 , tapered transition shaft connection 2518 and outer shaft (proximal) 2520 . The handle assembly may include a handle connector 2522 , a handle cup 2524 , an O-ring 2526 , a metal shaft 2528 and a push handle 2530 . The balloon assembly can include an outer shaft 2532 , an inner shaft 2534 , a balloon 2536 and a Y-shaped connector 2538 .

26A-C show another example of a delivery system 2600 according to one embodiment of the invention. The delivery system 2600 can include an integrated introducer 2602, which can be an additional component that houses the second component. The outer sheath of the delivery system is shown at 2604. Introducer 2602 may include connection wire 2606 , stopcock 2608 and housing 2610 for sealing membrane 2612 . Stopcock 2608 may serve as an entry point for, for example, a syringe containing a fluid such as saline. Connecting line 2606 can be used to transfer fluid from the syringe into the lumen of the introducer, and sealing membrane 2612 can seal the introducer from the outside environment. When implanting a stent-valve, with the exception of introducer 2606, components of delivery system 2600, such as the first component and the second component, may be retrieved through the introducer. Another medical device may then be introduced through introducer 2602, such as, for example, a closure device. As another example, an intravascular ultrasound imaging (IVUS) device (eg, a microprobe) may be introduced through introducer 2602 . Delivery system 2600 may be substantially similar to delivery system 2200 in all other respects.

27 is a flowchart 2700 of illustrative stages involved in replacing a failed (eg, native or artificial) valve, according to some embodiments of the invention. 28A-28C illustrate (without limitation) the various stages referred to by the flowchart of FIG. 27 . At stage 2702, a stent-valve (eg, a single-stent-valve or a dual-stent-valve) can be removably attached to a delivery system. For example, one or more attachment elements of a stent component (such as attachment element 808 of FIG. 8B ) can be secured to a stent anchor of a delivery device (such as stent anchor 2222 of FIG. 22 ). A retraction element, such as outer sheath 2206 of FIG. 22, can be provided over the attachment element/stent anchor to maintain the stent-valve in the collapsed configuration and attached to the delivery system.

At stage 2704, the stent-valve can be delivered to the implantation site in the collapsed configuration. For example, FIG. 28A (“Introduction” and “Positioning”) shows that a stent-valve 2802 can be introduced over a guide wire while still attached to a delivery system via a stent anchor 2804 and fully contained within an outer sheath 2806. Introduced into the patient such that the tip 2810 of the delivery system passes through the failed valve 2812 . The delivery system can be steered forward and/or backward, for example, until it is certain that the stent-valve is properly positioned.

At stage 2706, the stent-valve may be partially deployed, eg, to determine (stage 2708) whether the stent-valve is indeed correctly positioned, and/or to test (stage 2710) whether the stent-valve is functioning correctly. For example, FIG. 28A ("Partial Release") shows that the outer sheath 2806 can be partially removed from the proximal portion 2814 of the stent-valve while the attachment element 2816 of the stent-valve is still constrained by the outer sheath 2806 to the stent anchor. 2804 on.

At stage 2712, when the stent-valve is properly positioned at the implantation site, and/or when the stent-valve is functioning properly, the stent-valve may be detached from the delivery system to expand the stent-valve to its fully expanded configuration. For example, FIG. 28C ("Final Release") shows that when the attachment element 2816 and the stent anchor 2804 are removed from the outer sheath 2806, the attachment element 2816 of the stent-valve 2802 can be automatically detached from the stent anchor 2804. (or in other embodiments in response to balloon inflation) detach, thereby expanding the stent-valve to its fully deployed configuration. The second component of the delivery device can then be rejoined with the first component/outer sheath and removed from the patient. For example, FIG. 28C ("Delivery Device Retrieval") shows that second assembly 2818 can be passed through replacement stent-valve 2802 toward the distal side of the stent-valve. The rejoined second component 2818 and first component/outer sheath 2806 may then be repassed through the stent-valve 2802 in a proximal direction before exiting the patient's body.

When the stent-valve is not properly positioned (stage 2708), at stage 2714, the stent-valve can be returned to the collapsed configuration and repositioned within the patient. An illustration of this situation ("stent retrieval/repositioning") is illustrated in FIG. 28B, where the outer sheath 2806 is slid in a proximal direction over the proximal portion 2814 of the stent-valve in order to retrieve the stent-valve. The stent-valve is then repositioned and released such that the fixation element 2820 of the stent-valve receives the annulus 2822 of the failed valve. Similarly, when the stent-valve fails in response to the test (stage 2710), at stage 2716 the stent-valve may be reverted to the collapsed configuration and removed from the patient.

It can thus be seen that stent valves (eg, single stent valves and double stent valves) and related methods and systems for surgery are provided. While specific embodiments have been described in detail herein, this has been done by way of illustration only and is not intended to limit the scope with respect to the appended claims. In particular, the applicant contemplates that various substitutions, changes and modifications can be made without departing from the spirit and scope of the present invention as defined in the claims. Other aspects, advantages and modifications are considered to be within the scope of the appended claims. The following claims are presented as representative of the invention disclosed herein. Other unclaimed inventions are also contemplated. Applicants reserve the right to continue this invention in the subsequent claims.

Claims (32)

1. replacement valve that is used in human body, using, it comprises:

Valve member;

Support element comprises: be arranged on the proximal end place of said support element and comprise retaining element first, be used to hold the second portion of said valve member, and the third part that is arranged on the distal end portion place of said support element; Wherein said third part comprises at least one attachment element, and said at least one attachment element is configured for being attached on the conveyer device removedly.

2. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises the geometric openings on the complementary elements that is configured for being attached to removedly said conveyer device.

3. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises wire rod, hook or the band on the complementary elements that is configured for being attached to removedly said conveyer device.

4. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises at least two attachment element.

5. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises at least three attachment element.

6. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises three attachment element basically.

7. replacement valve according to claim 1 is characterized in that the retaining element of said first further comprises annular groove.

8. replacement valve according to claim 1 is characterized in that, said at least one attachment element is inwardly protruded towards the central axis of said support element at least in part.

9. replacement valve according to claim 1 is characterized in that, said third part has the diameter littler than the diameter of said second portion.

10. replacement valve according to claim 1 is characterized in that said valve member is a pig valve.

11. replacement valve according to claim 1 is characterized in that, said valve member is processed by pericardium.

12. a replacement valve that is used in human body, using, it comprises:

Valve member and

Support element, said support element comprises: the first that comprises the network retaining element; Be configured to so that hold the second portion of said valve member; And the third part that comprises at least one attachment element, wherein

Said second portion is arranged between said first and the third part vertically;

Each attachment element is arranged near the outflow end of said support element;

Said valve member is sewn onto on the said support element.

13. replacement valve according to claim 12 is characterized in that, the retaining element of said first further comprises annular groove.

14. replacement valve according to claim 12 is characterized in that, said attachment element comprises wire rod, hook or the band that forms opening.

15. replacement valve according to claim 12 is characterized in that, said valve member is a pig valve.

16. replacement valve according to claim 12 is characterized in that, said valve member is processed by pericardium.

17. replacement valve according to claim 12 is characterized in that, said valve member is a tissue valve prosthesis.

18. a replacement valve that is used in human body, using comprises:

Valve member (100); With

Support element (800,900,1000) comprising: first (802); Be used to hold the second portion (804) of said valve member (100), and third part (806), wherein, said third part (806) comprises and is configured for being attached to removedly conveyer device (2300; 2400,2500,2600) at least one attachment element (808,814 on; 836,902,1002)

It is characterized in that said support element (800,900,1000) comprises network, wherein, said first (802) has than said second portion (804) and/or the more thick grid cell of said third part (806) density.

19. replacement valve according to claim 18 is characterized in that, said at least one attachment element (808,814; 836,902,1002) comprise and be configured for being attached to removedly said conveyer device (2300; 2400,2500,2600) geometric openings on the complementary elements.

20. according to claim 18 or 19 described replacement valve, it is characterized in that,

Said at least one attachment element (808,814,836,902,1002) comprises wire rod, hook or the band on the complementary elements that is configured for being attached to removedly said conveyer device (2300,2400,2500,2600).

21., it is characterized in that said at least one attachment element (808,814,836,902,1002) comprises two attachment element (808,814,836,902,1002) at least according to claim 18 or 19 described replacement valve.

22., it is characterized in that said at least one attachment element (808,814,836,902,1002) comprises three attachment element (808,814,836,902,1002) at least according to claim 18 or 19 described replacement valve.

23., it is characterized in that said at least one attachment element (808,814,836,902,1002) comprises six attachment element (808,814,836,902,1002) at least according to claim 18 or 19 described replacement valve.

24. replacement valve according to claim 18 is characterized in that, said first (802) comprises a plurality of independently bendable (816), and each bendable (816) comprises the unit of single closure of the grid cell of said first (802).

25. replacement valve according to claim 18 is characterized in that, said third part (806) comprises the support component (1004) of common formation around the annulus of the periphery of said support element (1000).

26. replacement valve according to claim 18 is characterized in that, the said network of said support element comprises:

At least one engaging lever; With

Be used for said at least one engaging lever is connected at least one supporting member on said at least one attachment element (808,814,836,902,1002).

27., it is characterized in that said at least one attachment element (808,814,836,902,1002) is at least in part inwardly towards the central axis of said support element (200,800) and protrude according to claim 18 or 19 described replacement valve.

28., it is characterized in that said third part (806) has the diameter less than the diameter of said second portion (804) according to claim 18 or 19 described replacement valve.

29. replacement valve according to claim 24 is characterized in that, said first (802) comprises retaining element, and said retaining element comprises annular groove.

30. replacement valve according to claim 29 is characterized in that,

Said annular groove can be formed by crooked independently element (816) by a plurality of, and wherein, each bendable (816) comprises flexural deformation, and its position is confirmed by the length (822) of attached a pair of pole (818,820).

31., it is characterized in that said attachment element (808,814,836,902,1002) comprises wire rod, hook or the band that forms opening according to claim 18 or 19 described replacement valve.

32., it is characterized in that said second portion (804) comprises from least one outwards outstanding locking member of the outer surface of said second portion (804) according to claim 18 or 19 described replacement valve.

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