One aspect of the disclosure is a valve-modification and support device, suitable for modifying a prosthetic aortic valve in order that it may be implanted and used as a replacement (prosthetic) mitral valve, such that after attachment of the modification device to the aortic replacement valve, said valve is readily implantable via endovascular delivery in a mitral position, said modification device comprising first and second support elements, wherein said first and second support elements each have a collapsed delivery configuration and a deployed configuration, and wherein at least two bridging members extend from the first support element to the second support element, said bridging members having a delivery configuration and a deployed configuration, wherein said bridging members either extend radially inward from the first and second support elements in the deployed configuration or are entirely straight and devoid of any visible curvature when in said deployed configuration.

In some embodiments the bridging members extend from discrete locations around adjacent support elements, and can be arranged symmetrically around the circumference of said support elements. Thus, in one embodiment, the first and second bridging members can extend from the adjacent support elements at points separated by about 180 degrees along the circumference of said support elements.

In certain other embodiments, the valve modification device may optionally further comprise secondary bridging members that mutually interconnect two or more main bridging members. In other embodiments, secondary bridging members are used to connect one or more of the main bridging members with the support elements. The term ‘secondary bridging members’ is used in this context to distinguish said optional, additional bridges from the main bridging members that connect the first and second support elements, as disclosed hereinabove.

In another aspect, the prosthetic valve modification device comprises a single support element, wherein said support element has a collapsed delivery configuration and a deployed configuration. In one embodiment, the single support element is provided in the form of a flat annular ring, preferably constructed from a material having superelastic and/or shape memory properties. One example of such a suitable material is Nitinol, which possesses both of the aforementioned physical properties. These properties may be utilized in order to permit said device, following its delivery in a collapsed conformation, to return to an expanded memory configuration after being heated above its transition temperature. This embodiment of the modification device is also referred to herein as the ‘single-ring’ valve modification device, while the embodiment having two support elements connected by bridging members disclosed hereinabove, is also sometimes referred to as the ‘two-ring’ modification device.

In some embodiments at least one of the support elements (or the single support element in the case of the one-ring device) has an annular shape.

In some embodiments the bridging members and/or support elements are fitted with replacement valve engagement means adapted to securely engage a replacement heart valve. In some embodiment, the engagements means can have anchoring and/or locking elements adapted to securely lock with a portion of a replacement heart valve. In other embodiments, the replacement valve engagement means are formed from a soft biocompatible material (such as a biocompatible fabric, silicon, PET etc.) which are fitted to the external surface of portions of the support elements and/or bridging members. In these embodiments, the soft, compressible nature of the biocompatible material permits certain portions thereof to be compressed by the struts or other structural elements of the replacement valve, upon expansion within the lumen of the valve support. Other portions of the soft biocompatible material which are not compressed by the expanded replacement valve protrude into the internal space of said valve between the struts and/or other structural elements. The protrusions formed in this way engage and grip the replacement valve thereby preventing its movement in relation to the valve support. In other embodiments, the replacement valve engagement means comprise rigid anchors of a size and shape such that they are capable of entering the internal space of the replacement valve between its struts and/or other structural elements, upon expansion of said valve within the internal space of the valve support.

In some embodiments, the support elements and/or bridging members are fitted with heart tissue anchoring means adapted to securely anchor said support elements to the heart wall. Non-limiting examples of such anchoring means include hooks and spirals.

In some embodiments, the valve-modification device further comprises one or more stabilizing elements, the function of which is to provide additional stabilization of said support within the ventricle and/or atrium. Thus, in some embodiments, the valve-modification device comprises one or more intra-ventricular stabilizing elements, one or more intra-atrial stabilizing elements. In other embodiments, the cardiac valve support will be fitted with at least one intra-ventricular stabilizing element and at least one intra-atrial stabilizing element.

In some embodiments the support element(s) are adapted to preferentially bend at at least one location.

In some embodiments the support element(s) have a curved portion in their deployed configurations, wherein the curved portions are adapted to assume a tighter curved configuration in the collapsed delivery configurations.

In some embodiments of the two-ring modification device the first and second bridging members are generally C-shaped in their deployed configurations.

In some embodiments the support element has at least one coupling element adapted to reversibly couple to a delivery system. The at least one coupling element can be a threaded bore.

In some embodiments of the two-ring prosthetic valve modification device, the second support element has a dimension in the deployed configuration that is larger than a dimension of the first support element in the deployed configuration with or without one or more fixation elements attached and radially engaging in cardiac tissue when needed.

In some embodiments of the two-ring prosthetic valve modification device, the first and second support elements are connected by only two bridging members.

One aspect of the disclosure is a system adapted for endovascular or transapical delivery to replace a mitral valve, comprising: either a two-ring prosthetic valve modification device or a single-ring prosthetic valve modification device as disclosed hereinabove and a replacement heart valve comprising an expandable anchor and a plurality of leaflets adapted to be secured to the cardiac valve support. For the sake of clarity of description, the above disclosure of a delivery system comprising a two-ring prosthetic valve modification device relates to an embodiment of said device in which the two support elements are connected by two bridging members. However, it is to be recognized that the endovascular delivery system of the present invention may be used to deliver cardiac valve supports in which more than two bridging members mutually connect the two support elements.

In some embodiments the bridging members and/or support elements are adapted to securingly engage the replacement heart valve. In one such embodiment, the bridging members are formed such that at least one portion thereof comprises a series of folds or pleats (e.g. z-shaped pleats), the purpose of which is to increase the surface area of the bridging members that are available for interacting with the prosthetic replacement valve. An additional benefit of this embodiment is that the pleated region also assists in the transition between the delivery (closed) conformation of the valve modification device and the deployed (open) conformation thereof. In other embodiments, the replacement valve securing means comprise attachment means, such as hooks or other mechanical anchors that are connected, at one of their ends, to the support elements and/or bridging members, and have a free end for attachment to the replacement valve.

In some embodiments of the invention, the system disclosed hereinabove further comprises pressure measuring elements. These elements may be situated anywhere in the system—including on the surface of the valve modification device, attached to the replacement valve, as well as within the guide catheter. In another embodiment, the system of the invention further comprises connection terminals that permit the connection of pacemaker leads to various parts of said system.

One aspect of the disclosure is a method of replacing a patient’s mitral valve, comprising: attaching a valve-modification device to an aortic replacement valve (either at the product manufacture or assembly site—e.g. in the factory—or in the hospital or other clinical setting prior to the procedure), the valve-modification device comprising a first support element a second support element, and at least two bridging members extending from the first and second support elements; Implanting the interconnected replacement valve and valve-modification device in the mitral valve annulus.

Similarly, the invention is also directed to a method of replacing a patient’s mitral valve, comprising: the ex vivo attachment of a valve-modification device to an aortic replacement valve (either at the product manufacture or assembly site—e.g. in the factory—or in the hospital or other clinical treatment room prior to the procedure), the valve-modification device comprising a single support element; Implanting the interconnected replacement valve and valve-modification device in the mitral valve annulus.

In one embodiment, the above-defined methods may be employed to deliver the prosthetic valve and modifying device by an endovascular route. In another embodiment, the methods may be used to deliver the valve and modifying device by a transapical route.

The valve-modification device may be self expanding, or may be balloon expandable.

In a preferred embodiment the modifying device is self expandable and is constructed from biocompatible metals such as Nitinol, Cobalt based metal, Stainless steel.

In other embodiments, the above-defined method further comprises the step of causing intra-ventricular stabilizing elements and/or intra-atrial stabilizing elements to engage, respectively, the inner ventricular wall and/or inner atrial wall.

For the sake of clarity of description, the above disclosure of a method for replacing a patient’s mitral valve using a two-ring prosthetic valve modification device relates to a method that uses a cardiac valve-modification device in which the two support elements are mutually connected by two bridging members. However, it is to be recognized that the endovascular delivery system of the present invention may be used to deliver cardiac valve supports containing more than two support elements and more than two bridging members.