Patent Application
20230099033
Failed surgical mitral valve repairs are never anticipated but frequently encountered. As a result, patients often have to undergo an additional open heart surgery to either attempt a repair or more often a valve replacement. In 2021 the FDA approved of a method to replace the mitral valve in the setting of a failed prior mitral valve repair where an annuloplasty ring was utilized. The procedure is known as a valve-in-ring (VIR) transcatheter mitral valve replacement.
Referring now to
More specifically, a VIR transcatheter mitral valve replacement involves the installation of a transcatheter heart valve within the original annuloplasty ring 100 through a percutaneous trans femoral venous approach. A catheter holds the replacement valve and is used to position the new valve inside of the original annuloplasty ring 100. A balloon may be inflated to locate and fix the position of the valve within the annuloplasty ring 100. This procedure reduces the need to perform a sternotomy or right thoracotomy and also eliminates the need for cardiopulmonary bypass. The procedure also eliminates the need for cardiac arrest and opening of the atrium of the heart to access the mitral valve.
Although the procedure is less invasive, there are complications associated with properly locating the new valve inside of the annuloplasty ring 100. For example, a common problem is the malposition of the valve within the original annuloplasty ring 100 due to the new valve not being aligned completely coaxially with the original annuloplasty ring 100 resulting in an off-axis installation. Other factors that impact a successful procedure include circularization of a D-shaped annuloplasty ring 100; paravalvular leakage between the original annuloplasty ring 100 and the new valve; paravalvular leakage around the annuloplasty ring 100 from dehiscence of the annuloplasty ring 100 from the native annulus of the mitral valve; and difficulties visualizing the location of the original annuloplasty ring 100 under fluoroscopy.
A valve-in-ring annuloplasty device according to the present technology includes a body coupled to an annuloplasty ring. The body is configured to align an artificial valve coaxially with the annuloplasty ring to reduce complications caused by misalignment of the artificial valve. A chamber wall, extending through the annuloplasty ring from a base portion configured to be attached to a valve annulus, is used to align the artificial valve during deployment. The chamber wall may include a plurality of struts configured to increase a rigidity of the chamber wall in the coaxial direction to ensure proper deployment of the artificial valve. The base portion may provide an increased suture area that decreases a likelihood for paravalvular leaking around the annuloplasty ring.
A more complete understanding of the present technology may be derived by referring to the detailed description and claims when considered in connection with the following illustrative figures. In the following figures, like reference numbers refer to similar elements and steps throughout the figures.
Elements and steps in the figures are illustrated for simplicity and clarity and have not necessarily been rendered according to any particular sequence. For example, steps that may be performed concurrently or in a different order are illustrated in the figures to help to improve understanding of embodiments of the present technology.
The present technology may be described in terms of functional block components and various processing steps. Such functional blocks may be realized by any number of components configured to perform the specified functions and achieve the various results. For example, the present technology may employ various materials, coupling mechanisms, dimensions, and geometries, which may carry out a variety of operations suited for attachment to or installation within a human heart. In addition, the technology described is merely one exemplary application for the technology. Further, the present technology may employ any number of conventional techniques for transcatheter valve placement.
Methods and apparatus for a valve-in-ring (VIR) annuloplasty device according to various aspects of the present technology may operate in conjunction with any type of artificial valve configured to be used with an annuloplasty ring, or VIR installation. Various representative implementations of the present technology may be applied to any type of valve replacement device that is insertable or otherwise intended for use within a body during a transcatheter procedure.
Referring now to
The body 202 may comprise a base portion and a chamber wall 214. An inner surface 210 of the body 202 may extend from a first edge 216 of the base portion to a second edge 306 of the chamber wall 214 Similarly, an outer surface 302 opposite the inner surface 210 may extend from the first edge 216 of the base portion to the second edge 306 of the chamber wall 214. The outer surface 302 may be positioned against and generally conform to the shape of the ring 208. Accordingly, the chamber wall 214, or inner core, itself may also match the shape of the ring 208. The chamber wall 214 is configured to protrude slightly into the atrium (or other chamber) above an annulus (not shown) where the annuloplasty device 200 is positioned.
A plurality of struts 204 may be located within the body 202 between the inner surface 210 and the outer surface 302 and extend around the periphery of the base portion and the chamber wall 214 between the first edge 216 of the body 202 and the second edge 306 of the body 202. The struts 204 may be configured to increase a rigidity of the chamber wall 214 of the body 202 along the axial (flow) direction. The increased rigidity provided by the struts 204 and the chamber wall 214 help align the replacement valve with the chamber wall 214 during placement of the replacement valve to decrease the likelihood that the replacement valve is positioned off-axis relative to the ring 208. For example, as a balloon positioned within the replacement valve is inflated the replacement valve expands within the open center of the annuloplasty device 200. As the replacement valve expands it engages the chamber wall 214 such that the outer walls of the replacement valve and the chamber wall 214 become coaligned. This allows the replacement valve to also be coaligned with the ring 208 such that the flow path through the replacement valve is more completely axial relative to the chambers on either side of the annulus and replacement valve.
The struts 204 may comprise a generally L-shaped configuration with a first side being aligned with a length of the chamber wall 214 and the second side being orthogonal to the chamber wall 214 and extending outwardly laterally away from the ring 208 in the base portion towards the first edge 216.
The body 202 may comprise any suitable size or shape and may be selected according to any applicable criteria, for example, the size of the ring 208 that the body 202 will be positioned over. For example, the first edge 216 of the body 202 may form an outermost lateral edge of the VIR annuloplasty device 200 that extends outwardly from the ring 208. The body 202 may extend outwardly from the ring 208 to help prevent leakage around or through the ring 208.
In one embodiment, the body 202 may comprise a pair of flaps 206 configured to be attached to the annulus of the atrial wall. The pair of flaps 206 may comprise a size and shape to overlap or at least partially conform to the commissures and trigones of the mitral valve. The surface area of the pair of flaps 206 may encourage the development of adhesions or scar tissue to form between the VIR annuloplasty device 200 and the native annulus and surrounding atrial tissue, thereby reducing a potential for paravalvular leakage to occur.
The body 202 may comprise any suitable material and may be configured to assist with the installation of the VIR annuloplasty device 200. For example, in one embodiment, the body 202 may comprise a suture permeable fabric material that can be sutured to the atrial wall. At least a portion of the body 202 along the chamber wall 214 may also comprise a radiopaque material that may allow for a visual depiction of the VIR annuloplasty device 200 so that a height that the chamber wall 214 extends into the left atrial chamber can be seen under fluoroscopy. For example, in one embodiment, the chamber wall 214 may comprise a height of about 1 centimeter and comprise a radiopaque material distributed around its entire periphery to help visualize how far the chamber wall 214 extends into the chamber.
Referring now to
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The cover 602 may comprise any suitable material and may be formed of the same material as the rest of the body 202. The cover 602 may also be configured to be flexible or semi-rigid to help maintain a desired surface shape to improve the flow path over the top of the VIR annuloplasty device 200.
These and other embodiments for methods of creating an annuloplasty ring device may incorporate concepts, embodiments, and configurations as described above. The particular implementations shown and described are illustrative of the technology and its best mode and are not intended to otherwise limit the scope of the present technology in any way. Indeed, for the sake of brevity, conventional manufacturing, connection, preparation, and other functional aspects of the system may not be described in detail. Furthermore, the connecting lines shown in the various figures are intended to represent exemplary functional relationships and/or physical couplings between the various elements. Many alternative or additional functional relationships or physical connections may be present in a practical system.
The description and figures are to be regarded in an illustrative manner, rather than a restrictive one and all such modifications are intended to be included within the scope of the present technology. Accordingly, the scope of the technology should be determined by the generic embodiments described and their legal equivalents rather than by merely the specific examples described above. For example, the components and/or elements recited in any apparatus embodiment may be assembled or otherwise operationally configured in a variety of permutations to produce substantially the same result as the present technology and are accordingly not limited to the specific configuration recited in the specific examples.
As used herein, the terms “comprises,” “comprising,” or any variation thereof, are intended to reference a non-exclusive inclusion, such that a process, method, article, composition or apparatus that comprises a list of elements does not include only those elements recited but may also include other elements not expressly listed or inherent to such process, method, article, composition or apparatus. Other combinations and/or modifications of the above-described structures, arrangements, applications, proportions, elements, materials or components used in the practice of the present technology, in addition to those not specifically recited, may be varied or otherwise particularly adapted to specific environments, manufacturing specifications, design parameters or other operating requirements without departing from the general principles of the same. Any terms of degree such as “substantially,” “about,” and “approximate” as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. For example, these terms can be construed as including a deviation of at least ±5% of the modified term if this deviation would not negate the meaning of the word it modifies.
The present technology has been described above with reference to exemplary embodiments. However, changes and modifications may be made to the exemplary embodiments without departing from the scope of the present technology. These and other changes or modifications are intended to be included within the scope of the present technology, as expressed in the following claims.
This application claims the benefit of U.S. Provisional Patent Application No. 63/249,265, filed Sep. 28, 2021, and incorporates the disclosure of the application by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63249265 | Sep 2021 | US |
