The present invention relates to repairing or replacing a native valve, including to devices for anchoring or docking a prosthetic valve at a native valve and a corresponding installation methods.
The heart is a hollow muscular organ having four pumping chambers separated by four heart valves: aortic, mitral (or bicuspid), tricuspid, and pulmonary. Heart valves are comprised of a dense fibrous ring known as the annulus, and flexible tissue leaflets or cusps attached to the annulus.
Heart valves can be rendered less effective by congenital, inflammatory, or infectious conditions. Such conditions can eventually lead to serious cardiovascular compromise or death. For many years the definitive treatment for such disorders was the surgical repair or replacement of the valve during open heart surgery, where the prosthetic valve is sutured in place while the patient is on cardiopulmonary bypass. Such surgeries are time-consuming, dangerous and prone to complication.
Less invasive transvascular and transapical techniques can be used for introducing and implanting a prosthetic heart valve off-pump and while the heart is beating. For example, a prosthetic valve can be mounted in a crimped state on the end portion of a flexible catheter and advanced through a blood vessel of the patient until the valve reaches the implantation site. The valve at the catheter tip can then be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the valve is mounted. Alternatively, the valve can have a resilient, self-expanding stent or frame that expands the valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter. These are sutureless techniques which can greatly reduce the procedure time.
One issue with sutureless valves is the potential for valve migration. For example, when an aortic prosthetic valve is deployed, a 100-200 mmHg pressure can load on the aortic valve immediately. The pressure times the valve surface area can produce a substantial load force on the prosthetic valve and might cause valve migration towards the aortic arch.
Treatment of the mitral valve can present additional challenges, and methods and apparatuses appropriate for the aortic valve may not be well suited for use with the mitral valve. For instance, the mitral valve includes clusters of chordae tendineae extending from the valve leaflets to the walls of the ventricle that may interfere with placement of the prosthesis. The shape of the mitral valve, rather than being circular and uniform like the aortic valve, can be an oval or kidney-like shape that may not be well suited for supporting conventional stents of cylindrical configuration. Further, whereas the aortic valve annulus is often entirely surrounded by muscular tissue, the mitral valve annulus may be bounded by muscular tissue on the outer (posterior) wall only. The anterior side of the mitral valve annulus is bounded by a thin vessel wall adjacent the left ventricular outflow tract (“LVOT”), which must remain open to allow blood to pass into the aorta. As a result, the stent-type fixation may not be suitable for the mitral valve because the anterior side of the native valve has insufficient radial strength and can distort, risking occlusion of the left ventricular outflow tract. Moreover, mitral valve disease often is accompanied by (or caused by) gradual enlargement of the native annulus and/or the left ventricle. Thus, treatment approaches which rely upon radial engagement with or outward compression against the native annulus can be subject to failure as the size and shape of the annulus changes.
Despite certain advances, there remains a need for improved methods, systems, and apparatus for implanting prosthetic heart valves to the mitral annulus.
This summary is meant to provide examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features described here and elsewhere in the application can be combined in a variety of ways.
The present application discloses embodiments of an anchor device and methods used to secure a prosthetic heart valve to a native heart valve annulus. The anchor device can be a separate expandable element from the heart valve prosthesis that can be first advanced to the native annulus and deployed, after which an expandable heart valve prosthesis can be advanced to within the native annulus and/or anchor device and deployed. The combination of an anchor device and heart valve prosthesis can apply a clamping force to the heart valve leaflets which holds the prosthetic heart valve in place.
The anchor device can have a lower portion (e.g., a ventricular portion disposable/positionable in the left ventricle) and an upper portion (e.g., an atrial portion disposable/positionable in the left atrium). The lower portion can include one or more leaflet clamping portions, for example, two leaflet clamping portions opposite one another that are positioned radially outside the native valve leaflets. One, two, or more upstanding vertical posts between the clamping portions can extend upward at the valve commissures and support the upper portion, which can include one or more structures for leak prevention.
Anchor devices herein can be for securing a prosthetic valve at a native valve (e.g., a native valve between an atrium and a ventricle such as a mitral or tricuspid valve). The Anchor devices can comprise a lower or ventricular portion and an upper or atrial portion. The lower or ventricular portion can be below the upper or atrial portion. The lower or ventricular portion can have an expandable tubular body about a vertical axis and can comprise struts (e.g., undulating struts). The tubular body can define one, two, three, or more leaflet clamping portions (e.g., two leaflet clamping portions opposite one another). Each can be defined by at least one peak extending upward. There can also be a downward valley on opposite sides of the lower or ventricular portion or the peak (e.g., between two leaflet clamping portions). The anchor device can be configured to receive and/or optionally include an expandable prosthetic valve expanded within the anchor device.
The anchor devices can further include one or more upstanding vertical posts, for example, an upstanding vertical post commencing at each valley of the undulating struts and extending upward beyond a maximum height of the peaks of the two leaflet clamping portions and terminating in the upper or atrial portion. The vertical posts can be located less than 180° from each other around a circumference of the anchor device (e.g., if only two posts are used, they can but do not need to be 180° apart). The upper or atrial portion can include an annular ring of porous material attached to top ends of the vertical posts. The annular ring of porous material can be selected from the group consisting of polyester fabric, porous polymer material, ePTFE, foam, other materials, or some or all of the foregoing. The upper or atrial portion can include a pair of Y-shaped struts at a terminal end of each vertical post, which can optionally include a cover. The atrial portion can include a wire ring at a terminal end of each vertical post, which can optionally include a cover.
The clamping portions can each include at least two peaks and one valley therebetween. The clamping portions can be covered (e.g., with fabric, a coating, a polymer material, and/or other material).
Each strut can have a variety of shapes, the same or different. As one example each strut can include an undulating S-shape and terminate in an asymptotic manner at each end at a peak and a valley. The struts can also define a sinusoidal pattern.
The lower or ventricular portion can include one or more integrally formed downwardly extending legs that terminate below the valleys in buckles to facilitate manipulation and deployment of the anchor device. The legs can each extend downward from one of the peaks of the clamping portions. In one embodiment, there are three of the legs and three buckles. The buckles can form squares or rectangles or another shape with a hole therethrough.
Additional features and/or components described elsewhere herein can also be used.
Methods herein (e.g., a beating heart method) can be for securing a prosthetic valve at a native valve (e.g., a native valve between an atrium and a ventricle). The native valve has native leaflets (and, optionally, attached chordae in the ventricle), and commissures between the leaflets at a native annulus of the native valve. The Methods can comprise advancing an anchor device to the native valve, the device having a lower (e.g., ventricular) portion and an upper (e.g., atrial) portion. The lower or ventricular portion can have an expandable tubular body about a vertical axis comprising undulating struts.
In one embodiment, the tubular body has two leaflet clamping portions opposite one another. The two leaflet clamping portions each defined by at least one peak and two valleys in between the two leaflet clamping portions. The anchor device further including two upstanding vertical posts each commencing at a separate valley of the undulating struts and extending upward beyond a maximum height of the peaks of the two leaflet clamping portions and terminating in the upper or atrial portion. The anchor device struts can be Nitinol, and each clamping portion can have at least two peaks and one valley therebetween. The clamping portions can be covered with fabric.
The atrial portion can be formed in a variety of ways. For example, the atrial portion can comprise a tubular foam member. The atrial portion can also include a pair of Y-shaped struts at a terminal end of each vertical post. A fabric cover can be included across each pair of Y-shaped struts. Optionally, the atrial portion includes a wire ring at a terminal end of each vertical post. A cover can be included across the wire rings.
The methods can also comprise expanding the lower or ventricular portion of the device below the annulus (e.g., in a ventricle) and positioning the two leaflet clamping portions radially outside respective leaflets of the native leaflets. The methods can also comprise positioning the upstanding posts such that they project upward at valve commissures (e.g., two upstanding posts at two valve commissures) and support the upper or atrial portion above the native annulus (e.g., in the atrium).
The methods can also comprise advancing an expandable prosthetic valve to within the native leaflets and expanding to compress the native leaflets outward against the leaflet clamping portions of the device. Optionally, the anchor device and prosthetic valve can be deployed using one access or delivery system or two separate access or delivery systems.
Additional steps described elsewhere herein can also be used, and the steps of the methods can be reordered.
A system for securing a prosthetic valve at a native valve can comprise an expandable/collapsible anchor device having a first portion or lower portion below a second portion or an upper portion, the first or lower portion having an expandable tubular body about a vertical axis and comprising struts (e.g., undulating struts, etc.), the tubular body defining a leaflet clamping portion defined by at least one peak extending upward, wherein there is a downward valley on the first or lower portion adjacent the at least one leaflet clamping portion, the device further including an upstanding vertical post commencing at the downward valley and extending upward beyond a maximum height of the at least one peak of the leaflet clamping portion and terminating in the second or upper portion.
The system can also include one or more additional leaflet clamping portions (e.g., a second leaflet clamping portion). The leaflet clamping portions can be defined by at least one peak or more than one peak extending upward. In one embodiment, the clamping portions each include at least two peaks and one valley therebetween. The leaflet clamping portion(s) can be covered with fabric.
The struts can take on a variety of shapes and configurations. In one embodiment, the device includes undulating struts and each undulating strut has an S-shape and terminates in an asymptotic manner at each end at a peak and a valley.
The system can include one or more additional vertical posts (e.g., a second upstanding vertical post). In one embodiment, the vertical posts commence at a second downward valley and extend upward beyond a maximum height of the at least one peak of the leaflet clamping portion and terminating in the second or upper portion. The vertical posts can be located less than 180° from each other around a circumference of the anchor device. This can be beneficial when native commissures are not located 180° apart from each other, for example, as installed in a mitral valve.
The lower portion can include one or more integrally formed downwardly extending legs that terminate below the valleys in buckles to facilitate manipulation and deployment of the anchor device. In one embodiment, at least one of the legs extends downward from the at least one peak of the leaflet clamping portion. In one embodiment, there are three of the downwardly extending legs and buckles. The buckles can form squares or rectangles or another shape with a hole therethrough.
The second or upper portion can include an annular ring of porous material attached to top end of the vertical post. The annular ring of porous material can be selected from the group consisting of polyester fabric, porous polymer material, ePTFE, and foam or another material. The second or upper portion can include a pair of Y-shaped struts at a terminal end of each vertical post. A fabric cover can be included across each pair of Y-shaped struts. The second or upper portion can include a wire ring at a terminal end of each vertical post. A fabric cover can be included across the wire rings.
The system can also include an expandable prosthetic heart valve, which can be expanded within the anchor device.
Additional features and/or components described elsewhere herein can also be used.
The methods herein (e.g., methods of securing a prosthetic valve at a native valve) can comprise advancing an anchor device to the native valve. The anchor device can be the same as or similar to other anchor devices described elsewhere herein. For example the anchor device can have a first portion or lower portion and a second portion or upper portion. The first or lower portion can have an expandable tubular body about a vertical axis comprising struts (e.g., undulating struts). The tubular body can have one or more leaflet clamping portions. A leaflet clamping portion can be defined by at least one peak and valleys adjacent the at least one peak. The anchor device can further include one or more upstanding vertical posts. An upstanding vertical post can commence at a valley of the undulating struts and extend upward beyond a maximum height of the at least one peak of the leaflet clamping portion and terminating in the second or upper portion. The anchor device struts can be Nitinol, and each clamping portion can have one or more peaks and valleys (e.g., at least two peaks and one valley) therebetween. The clamping portions can be covered with fabric.
The second or upper portion can include a tubular foam member. The second or upper portion can include a pair of Y-shaped struts at a terminal end of each vertical post. A fabric cover can be used across each pair of Y-shaped struts. The second or upper portion can include a wire ring at a terminal end of each vertical post and can include a cover across the wire rings.
The methods can also include expanding the first or lower portion of the device below the native valve or native valve annulus and can include positioning the leaflet clamping portion radially outside at least one leaflet of native leaflets of the native valve. The methods can also include positioning the upstanding vertical post such that it projects upward at a native valve commissure and supports the second or upper portion above the native annulus or the native valve.
The methods can also comprise advancing an expandable prosthetic valve to within the native leaflets and expanding the prosthetic valve to compress the at least one leaflet outward against the leaflet clamping portion.
The methods can include using the same access system or delivery system to deploy the anchor device and the prosthetic valve or using two separate access systems.
Additional steps described elsewhere herein can also be used, and the steps of the methods can be reordered.
Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.
The following description and accompanying figures, which describe and show certain embodiments, are made to demonstrate, in a non-limiting manner, several possible configurations of systems, platforms, devices, methods, etc. that may be used for various aspects and features of the present disclosure.
Anchor devices for assisting in implanting a prosthetic heart valve at a native valve (e.g., a mitral valve, tricuspid valve, etc.) are described. An anchor device can be separate from and separately implanted prior to the prosthetic heart valve. Once the anchor device has been installed at the native valve (e.g., mitral valve, etc.), the prosthetic heart valve is delivered and coupled thereto. This process may be accomplished using one combined or two separate catheters, delivery systems/devices, or access systems/devices. While examples are given herein with respect to the mitral valve, use of the devices, systems, methods, etc. described herein is not limited to use with the mitral valve and can be applied in other valves (e.g., aortic valve, pulmonary valve, tricuspid valve) or other locations.
The anchor devices can be used in connection with various types of expandable valves, for example, with a balloon-expandable prosthetic heart valve such as the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) made by Edwards Lifesciences of Irvine, Calif., or such as described in U.S. Pat. No. 6,730,118, which is hereby expressly incorporated herein by reference. However, these exemplary THVs should not be construed as limiting, and embodiments of the disclosed anchor device(s) can be used to secure a wide variety of THVs delivered through a variety of mechanisms (e.g., self-expanding heart valves, other balloon-expanding heart valves, mechanically-expandable heart valves, and the like). The term, “expandable heart valves” is intended to encompass all such varieties.
Exemplary delivery routes through the body and into the heart for both the anchor device(s) and prosthetic heart valve include transvascular (e.g., transfemoral) routes, transapical routes, and transaortic routes, among others. In a transvascular approach, a catheter can be inserted into the vasculature at a site that is relatively distant from the heart. An anchor device or prosthetic valve can be mounted in a crimped state on the end portion of a flexible catheter and advanced through a blood vessel of the patient until the valve reaches the implantation site. The valve at the catheter tip is then expanded to its functional size at the site of the defective native valve such as by inflating a balloon on which the valve is mounted.
Various delivery or access systems having a catheter or sheath can be used. The anchor device and prosthetic heart valve can be deployed using one access system or delivery system for near simultaneous delivery, or with two separate systems for sequential delivery. One delivery system adapted for use in introducing a prosthetic valve into a heart in a transapical procedure is disclosed in U.S. Pat. No. 8,439,970, which is incorporated herein by reference. In a transapical procedure, a prosthetic valve is introduced into the left ventricle through a surgical opening in the apex of the heart. The delivery system in the '970 patent similarly can be used for introducing a prosthetic valve into a heart in a transaortic procedure. In a transaortic procedure, a prosthetic valve is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward heart. Percutaneous or transcatheter delivery systems are also possible.
The ventricular portion 22 of the illustrated anchor device 20 includes a plurality of peaks 30 evenly alternating with the same number of valleys 32 around its circumference, in an undulating fashion. In one exemplary embodiment there are six peaks 30 spaced 60° apart, each 30° separated from adjacent valleys 32. The peaks and valleys 30, 32 desirably lie in a tubular space such that the peaks 30 are positioned above the valleys 32 along a Z-axis, generally parallel to blood flow through the mitral valve when the device is implanted.
Descending and ascending circumferential struts 34, 36 connect each two adjacent peaks 30 and valleys 32. More particularly, as viewed looking down along the axis Z, a first circumferential strut 34 extends clockwise (CW) down from each one of the peaks 30 to each one of the valleys 32, and a second circumferential strut 36 extends up from the valley CW to the next peak. The circumferential struts 34, 36 can be generally S-shaped, with two distinct curvatures separated by a point of inflection. More specifically, each of the struts 34, 36 can terminate at its corresponding peak and valley in an asymptotic manner such that it is nearly aligned with the vertical Z-axis. Looking at one of the circumferential struts 34 extending between the peak 30 and the valley 32 in
In the illustrated embodiment of
The ventricular portion 22 can connect to the atrial portion 24 via one or more upstanding commissure posts 40, e.g., one, two, three, or more upstanding commissure posts. In the illustrated embodiment, there are two posts 40 diametrically opposed from each other and extending upward from two of the valleys 32 located generally opposite from one another and between clamping portions of the ventricular portion 22, as will be described below. The posts 40 extend upward beyond the upper extent of the peaks 30, and can be embedded and secured within the tubular atrial portion 24. The atrial portion 24 can comprise an annular ring of porous material, such as polyester fabric, porous polymer material, ePTFE, or foam. Means to connect the commissure posts 40 to the atrial portion 24 can be with adhesive, sutures, latches, friction, etc. Optionally, the posts 40 may have barbs or roughness of some sort to enable simple frictional holding. Still further, the posts 40 may be cloth covered or have one or more eyelets and be sutured to the atrial portion 24.
The ventricular portion 22 can further include one or more downwardly extending legs 42 that terminate in buckles 44 to facilitate manipulation and deployment of the anchor device 20. In the illustrated embodiment, the buckles 44 form squares or rectangles with a hole therethrough. The buckles 44 can be integrally formed with the ventricular portion 22 and preferably extend downward from one or more of the peaks 30. The term “integrally formed” in this regard means that the buckles 44 are either formed homogeneously with the rest of the ventricular portion 22 as a single piece, or that the buckles are secured to the ventricular portion 22 in a manner which enables manipulation of the buckles to manipulate the inner body. For example, the buckles 44 may be welded to the ventricular portion 22 after fabrication of both.
Now with reference to
An exemplary beating heart method of securing a prosthetic heart valve at the mitral valve 200 between the left atrium 234 and left ventricle 202 includes advancing the anchor device 20 to the mitral valve and expanding the ventricular portion 22 of the device in the left ventricle. Using forceps or other manipulation tools, the two leaflet clamping portions are positioned radially outside respective ones of the two leaflets 204, 206. The surgeon then positions the upstanding posts 40 such that they project upward at the two native valve commissures 220, 222 and support the atrial portion 24 above the mitral valve annulus in the left atrium. Subsequently, an expandable prosthetic heart valve is advanced to within the mitral valve leaflets 204, 206 and expanded to compress the leaflets outward against the two leaflet clamping portions of the device 20.
For instance,
While the invention has been described in terms of particular variations and illustrative figures, the invention is not limited to the variations or figures described. The features described with respect to one embodiment or variation may be used in other embodiments or variations. Methods described separately may be combined. In addition, where methods and steps described above indicate certain events occurring in certain order, the ordering of certain steps can be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Many modifications can be made to adapt a particular situation or device to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed herein, and to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well.
This Application is a Continuation of Application PCT/US2018/033086 filed on May 17, 2018. Application PCT/US2018/033086 claims the benefit of U.S. Provisional Application 62/509,278 filed on May 22, 2017. The entire contents of these applications are incorporated herein by reference in their entirety.
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Number | Date | Country | |
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20200085573 A1 | Mar 2020 | US |
Number | Date | Country | |
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62509278 | May 2017 | US |
Number | Date | Country | |
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Parent | PCT/US2018/033086 | May 2018 | US |
Child | 16691244 | US |