Patent ID: 12193932

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the disclosed device, delivery system, and method will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention.

As used herein, like numbers refer to like elements.

FIG.1provides an illustration of the anatomical heart, herein represented by an anterior aspect10of the heart. Anterior views of various structures of the anatomical heart are also presented. The superior vena cava50, right atrium40, and right ventricle20are shown on the (viewer's) left side of said anterior aspect10, with superior and inferior structures being separated by the right coronary artery120. A cross-section line A-A divides the cardiac anatomy into side sections and is further discussed inFIG.2. Moving to the (viewer's) right side of the heart, an anterior view of the aorta60can be seen in a superior position to the pulmonary trunk90. Beneath the pulmonary trunk90are the left atrium70and left atrial appendage80. Beneath and flanking to the (viewer's) left and right of the left atrial appendage80are the left anterior descending coronary artery100and the intermediate coronary artery110, respectively. Finally, inferior to all previously mentioned elements is the left ventricle30.

FIG.2shows the internal structures of the heart after sectioning the anterior aspect10(as shown inFIG.1) of the heart along cross-section A-A. The cross-section A-A is bounded by a hatched zone130that represents the plane of sectioning. Beginning at the superior-most element, the aorta140is depicted in a posterior aspect. Below and behind the aorta140is the right atrium180. An interior view of the left atrium150is shown, revealing where a prosthetic mitral valve210may be located after implantation. The inflow region220of the prosthetic mitral valve210and the outflow region230of the prosthetic mitral valve can also be seen. An anterior aspect170of the prosthetic mitral valve210may be adjacent to a zone190of the left ventricular outflow tract200(LVOT). An anterior anchoring tab240may be located in a position that avoids blockage of the LVOT200. As systole occurs, and blood is shunted towards the LVOT200from beneath the prosthetic mitral valve210, there may be a capacious channel leading directly to the aorta140, due to the large area of the zone190. This configuration may leave the LVOT200free of obstruction from extraneous prosthesis bulkage or projections.

The prosthetic mitral valve may comprise one or more tabs. The prosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 tabs. A posterior anchoring tab250may be located opposite the anterior anchoring tab240of the prosthetic mitral valve210. The posterior anchoring tab250may abut the native anatomy and rest against a posterior ventricular shelf region160, which is formed within the ventricle at the junction of the ventricle and posterior mitral annulus (seeFIG.4for a clearer depiction). A third anchoring tab is hidden is the depiction ofFIG.2. A valve leaflet260, typically constructed from chemically-preserved pericardial tissue harvested from various species such as bovine, porcine, or ovine species, may be located between the anterior anchoring tab240and the posterior anchoring tab250. Further details relating to the prosthetic mitral valve210are provided beginning withFIG.5.

FIG.3provides an illustration of the anatomical heart, herein represented by a posterior aspect265of the heart. Posterior views of various structures of the anatomical heart are also presented. Beginning with the most superior elements, a posterior aspect of the superior vena cava380is adjacent to a posterior aspect of the aorta370and above a posterior aspect of the pulmonary trunk390. Further depicted posteriorly are the right atrium270, the left atrial appendage280(appearing to the viewer's left), the left atrium340, the right pulmonary veins350, and the left pulmonary veins360(appearing to the viewer's right). A cross-section line B-B divides the presented cardiac anatomy into superior and inferior sections and is further discussed inFIG.4. The coronary arteries and relevant branches include the left marginal branch290, the circumflex branch300, the posterior left ventricular branch310of the left coronary artery, and the posterior interventricular branch320of the right coronary artery. Finally, in the most inferior position of the elements is the apex of the heart330.

FIG.4shows the internal structures of the heart after sectioning the posterior aspect265(as shown inFIG.3) of the heart along cross-section B-B. The cross-section B-B is bounded by a hatched zone400that represents the plane of sectioning. Beginning at the top of the figure, the posterior ventricular shelf470is adjacent to and connected by tissue with the fixed end of the posterior mitral leaflet450. This shelf may provide a location for a posterior anchoring tab of a prosthetic mitral valve, as described herein. An arcade of posterior chordae tendineae455are located adjacent to and connected by tissue with the posterior mitral leaflet450, finding their insertion points along the free edge of the leaflet. The fixed ends of the chordae455find insertion points in both the antero-lateral papillary muscles430and postero-medial papillary muscles440. The papillary muscles430and440act as muscular support bases for the tethering effect provided by said chordae, spanning the distance between leaflet free edge insertion and papillary muscle insertion while under dynamic tension. Directly opposing the posterior mitral leaflet450is an anterior mitral leaflet460. During systole, the posterior mitral leaflet450and the anterior mitral leaflet460are brought into communication as their free edges shut against each other, in order to prevent retrograde blood flow into the left atrium. The free edge of the anterior leaflet460is also adjacent to and connected by tissue with an arcade of anterior chordae tendineae465, which also find fixed end insertion points in both the antero-lateral430and postero-medial440papillary muscles, mirroring the chordal structure of the posterior leaflet.

The fixed end of the anterior leaflet460is directly adjacent and connected by tissue with the inflow of the aortic valve500. This adjacency is commonly known as the aorta-mitral continuity. It is in this region that a risk for outflow tract obstruction presents itself, necessitating the present invention, which aims to minimize LVOT obstruction. Flanking the fixed end of the anterior leaflet460are regions of dense cartilaginous tissue known as the fibrous trigones, which act as skeletal-like structures for the heart-at-large. The antero-septal fibrous trigone480and the antero-lateral fibrous trigone490are represented by triangles, which demarcate landing zones on which the anterior anchoring tabs of the prosthetic mitral valve (not shown) may abut during valve deployment. For reference, the tricuspid valve410and the aorta420are shown at the bottom of the figure.

FIG.5illustrates the present invention in perspective, showing a prosthetic mitral valve510(210, as shown inFIG.2) with a large anterior leaflet. The prosthesis may comprise an atrial region, an annular region, a valvular region, and an anchoring region. A frame525may provide the structural means on which the entirety of the prosthetic valve may be erected, and is shown by dashed lines inFIG.5. The frame may be a nitinol frame. The frame525may be layered within various biocompatible fabrics that provide excellent scaling properties. The biocompatible fabrics may comprise polyester, nylon, or any other biocompatible fabric as is known to one having skill in the art. Medical grade suture may used to sew the various fabrics onto the frame525to construct the prosthesis. The atrial region of the prosthesis may comprise an atrial skirt520which acts as a flange and allows the inflow region of the valve (220, as shown inFIG.2) to register and seal against the native mitral annulus, upon the floor of the left atrium. The atrial skirt520may traverse the entire circumference of the inflow region (220, as shown inFIG.2) of the prosthetic valve, and may be in communication with and connected to an annular region530that also traverses the circumference of the prosthetic valve. In this representation, the anterior surface of the prosthetic valve is shown facing away and to the right, from the viewer. As such, an anterior leaflet580is shown facing away and to the right. One or more valve leaflets may form the valvular region of the prosthesis. The leaflets may comprise the anterior leaflet580, a postero-septal leaflet570, and a postero-lateral leaflet590. The anterior leaflet580may comprise an anterior leaflet inflow surface, as described herein. The postero-septal leaflet570may comprise a postero-septal leaflet inflow surface, as described herein. The postero-lateral leaflet590may comprise a postero-lateral leaflet inflow surface, as described herein.

One or more of the plurality of leaflets may comprise chemically-preserved pericardial tissue. The chemically-preserved pericardial tissue may be treated with chemical preservatives that promote polymer cross-linking, render the tissue inert and biocompatible to humans, and/or prepare the tissue for further sterilization treatments. The leaflet tissue may be derived from bovine, porcine, or ovine sources, but shall not be limited to the aforementioned species. In the closed configuration, the free ends of each of the anterior leaflet580, postero-septal leaflet570, and postero-lateral leaflet590may meet at a triple-point of leaflet coaptation600. Conversely, the fixed end of each leaflet may be sutured to both the annular region of the valve, and to the next adjacent leaflet at a specific location that provides increased structural resilience, as described herein. AlthoughFIG.5shows three leaflets, the prosthetic mitral valve may comprise any number of leaflets. For instance, the prosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 leaflets.

Each leaflet may be successively joined to the next adjacent leaflet at a commissure attachment point, through a commissure suture pad. Thus, the prosthetic mitral valve may comprise one or more commissure attachment points and one or more commissure suture pads. Specifically, the postero-septal570and anterior580leaflets may be joined together and attached to an antero-septal commissure attachment point550through an antero-septal commissure suture pad560, the anterior580and postero-lateral590leaflets may be joined together and attached to an antero-lateral commissure attachment point625through an antero-lateral commissure suture pad615, and the postero-lateral590and postero-septal570leaflets may be joined together and attached to a posterior commissure attachment point645through a posterior commissure suture pad640. AlthoughFIG.5shows three commissure attachment points and three commissure suture pads, the prosthetic mitral valve may comprise any number of commissure attachment points. For instance, the prosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissure attachment points and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissure suture pads.

One or more commissure anchors may extend away from the valve and into free space from each of the commissure attachment points. For instance, an antero-septal commissure anchor555may extend from the antero-septal commissure attachment point560, an antero-lateral commissure anchor620may extend from the antero-lateral commissure attachment point625, and a posterior commissure anchor650may extend from the posterior commissure attachment point645. Each of the commissure anchors may comprise the means through which the prosthesis may be anchored and connected to an appropriate delivery system, as described herein. The shape of each of the plurality of commissure anchors may generally resemble the shape of an anchor or half-moon, but those skilled in the art will recognize that any shapes that allow the plurality of commissure anchors to be anchored effectively to a potential delivery system may be implied by this element. AlthoughFIG.5shows three commissure anchors, the prosthetic mitral valve may comprise any number of commissure anchors. For instance, the prosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissure anchors.

Extending away from each of the commissure attachment points, in this instance towards the valve, are one or more of anchoring tabs. Each anchoring tab may comprise a fixed end which is in communication with a commissure attachment point, and a free end which extends towards the atrial skirt and provides an anchoring means through which the prosthetic may attach itself to the native anatomy. Anterior anchoring tabs may generally rest against the native fibrous trigones of the mitral valve, while posterior anchoring tabs may generally rest against the posterior ventricular shelf of the mitral valve. An antero-septal trigonal anchoring tab540(240, as shown inFIG.2) may be connected at a fixed end to the antero-septal commissure anchor point560, and may have a free end545that is brought to rest against the antero-septal fibrous trigone (480, as shown inFIG.4). An antero-lateral trigonal anchoring tab610(260, as shown inFIG.2) may be connected at a fixed end to the antero-lateral commissure anchor point625, and may have a free end (not shown in this view) that is brought to rest against the antero-lateral fibrous trigone (490, as shown inFIG.4). Finally, a posterior anchoring tab630(250, as shown inFIG.2) may be connected at a fixed end to the posterior commissure anchor point645, and may have a free end635that is brought to rest against the posterior shelf (470, as shown inFIG.4). AlthoughFIG.5shows three anchoring tabs, the prosthetic mitral valve may comprise any number of anchoring tabs. For instance, the prosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 anchoring tabs.

FIG.6illustrates an inflow view660of a prosthetic mitral valve (510, as shown inFIG.5). The approximate “D” shape of the prosthetic mitral valve may be fully appreciated by tracing a path from the anterior aspect690of the valve inflow (flat side of the D shape) in a clockwise direction until the posterior aspect700of the valve inflow (curved portion of the D shape) is reached, and then back again to the anterior aspect690of the valve inflow. Adjacent the anterior aspect690of the valve inflow is the anterior portion670of the atrial skirt (520, as shown inFIG.5). Adjacent the posterior aspect700of the valve inflow is the posterior portion680of the atrial skirt. A plurality of frame struts740may encircle the valve inflow circumferentially. The frame struts740may provide structural support and attachment means for both the anterior670and posterior680portions of the atrial skirt to the annular region of the prosthetic mitral valve (530, as shown inFIG.5). The postero-lateral leaflet inflow surface710(corresponding to the postero-lateral leaflet590, as shown inFIG.5), anterior leaflet inflow surface720(corresponding to the anterior leaflet580, as shown inFIG.5), and postero-septal leaflet inflow surface730(corresponding to the postero-septal leaflet570, as shown inFIG.5) are also depicted. Also show are the posterior anchoring tab free end635, antero-lateral trigonal anchoring tab free end610, and antero-septal trigonal anchoring tab free end545.

FIG.7illustrates an outflow view750of a prosthetic mitral valve (510, as shown inFIG.5). The triple-point of leaflet coaptation (600, as shown inFIG.5) as previously mentioned, may be formed during systole, when a coaptation surface775of a postero-septal leaflet770(570, as shown inFIG.5), a coaptation surface765of a postero-lateral leaflet760(590, as shown inFIG.5), and a coaptation surface785of an anterior leaflet780(580, as shown inFIG.5) are brought into contact with one another through valve closure. The previously described commissures and anchoring tabs are also depicted in this outflow view750, and are identified by a posterior anchoring tab800(630, as shown inFIG.5) and associated posterior commissure anchor805(650, as shown inFIG.5), an antero-septal trigonal anchoring tab810(540, as shown inFIG.5) and associated antero-septal commissure anchor815(555, as shown inFIG.5), and an antero-lateral trigonal anchoring tab790(610, as shown inFIG.5) and associated antero-lateral commissure anchor795(620, as shown inFIG.5).

FIG.8Aillustrates an embodiment of a prosthetic mitral valve (510, as shown inFIG.5) having a single mono-leaflet830that is in the style of a duckbill valve, and is presented in an outflow view820. The duckbill style valve may be created by making an incision840at approximately the center of the single mono-leaflet830, which may create a leaflet coaptation edge on which the resultant valve may function. The prosthetic mitral valve may further comprise one or more of the anterior aspect690of the valve inflow, posterior aspect700of the valve inflow, the antero-lateral trigonal anchoring tab790and associated antero-lateral commissure anchor795, the posterior anchoring tab800and associated posterior commissure anchor805, or the antero-septal trigonal anchoring tab810and associated antero-septal commissure anchor815.

FIG.8Billustrates an embodiment of a prosthetic mitral valve (510, as shown inFIG.5) comprising a dual or bi-leaflet configuration, again shown in an outflow view850. The bi-leaflet configuration may be realized by way of a pair of leaflets, comprising an anterior leaflet870and a posterior leaflet860, which may be brought together during systole at a leaflet coaptation edge880. The prosthetic mitral valve may further comprise one or more of the anterior aspect690of the valve inflow, posterior aspect700of the valve inflow, the antero-lateral trigonal anchoring tab790and associated antero-lateral commissure anchor795, the posterior anchoring tab800and associated posterior commissure anchor805, and/or the antero-septal trigonal anchoring tab810and associated antero-septal commissure anchor815.

FIGS.8C and8Dshow an embodiment of a mono-leaflet prosthetic mitral valve (510, as shown inFIG.5) seen from the outflow view890comprising one large anterior leaflet900that may be able to span the entire valve orifice during systole, and seal against the posterior aspect of700of the valve inflow. In the open configuration, a posterior outflow region910may allow antegrade blood flow through the valve and into the left ventricle, from the left atrium. The prosthetic mitral valve may further comprise one or more of the anterior aspect690of the valve inflow, posterior aspect700of the valve inflow, the antero-lateral trigonal anchoring tab790and associated antero-lateral commissure anchor795, the posterior anchoring tab800and associated posterior commissure anchor805, or the antero-septal trigonal anchoring tab810and associated antero-septal commissure anchor815.

FIG.8Dshows that in the closed configuration920, the large anterior leaflet900has closed and that a posterior covering region925of said anterior leaflet900has sealed against a leaflet coaptation edge930that appears on the posterior aspect700of the valve inflow. The prosthetic mitral valve may further comprise one or more of the anterior aspect690of the valve inflow, posterior aspect700of the valve inflow, the antero-lateral trigonal anchoring tab790and associated antero-lateral commissure anchor795, the posterior anchoring tab800and associated posterior commissure anchor805, or the antero-septal trigonal anchoring tab810and associated antero-septal commissure anchor815.

FIG.8Eillustrates an embodiment of a prosthetic mitral valve (510, as shown inFIG.5) comprising a tri-leaflet configuration940, and formed from the plurality of leaflets that are herein described as the large anterior leaflet960, the small postero-lateral leaflet970, and the small postero-septal leaflet950. During systole, said leaflets are forced to close and contact each other along a leaflet coaptation edge980. The prosthetic mitral valve may further comprise one or more of the anterior aspect690of the valve inflow, posterior aspect700of the valve inflow, the antero-lateral trigonal anchoring tab790and associated antero-lateral commissure anchor795, the posterior anchoring tab800and associated posterior commissure anchor805, or the antero-septal trigonal anchoring tab810and associated antero-septal commissure anchor815.

FIG.8Fdepicts an embodiment of a prosthetic mitral valve (510, as shown inFIG.5), seen from the outflow view and comprising a tetra-leaflet configuration990. The valve may be formed from the plurality of leaflets that are herein described as a posterior leaflet1000, a septal leaflet1010, an anterior leaflet1020, and a lateral leaflet1030. During systole, the leaflets may be forced to close and contact each other along a leaflet coaptation edge1040. of the prosthetic mitral valve may comprise one or more anchoring tabs and commissure anchors. Along with the antero-septal810, and antero-lateral trigonal anchoring tabs and corresponding commissure anchors (815antero-septal, and795antero-lateral), a postero-septal1060and a postero-lateral1050anchoring tab may be present, as well as the corresponding postero-septal1065and postero-lateral1055commissure anchors. The prosthetic mitral valve may further comprise one or more of the anterior aspect690of the valve inflow, posterior aspect700of the valve inflow, the antero-lateral trigonal anchoring tab790and associated antero-lateral commissure anchor795, the posterior anchoring tab800and associated posterior commissure anchor805, or the antero-septal trigonal anchoring tab810and associated antero-septal commissure anchor815.

FIG.9depicts a frame flat pattern1070, which is a representation of a toolpath that a machine-tool (such as a focused laser, router, end mill, or any other machine-tool as is known to one having skill in the art) may follow during the fashioning of a prosthetic valve (510, as shown inFIG.5). The frame may be cut from a tubular stock of material. For instance, the frame may be cut from a tubular stock of nitinol. The device may include several features discussed previously (introduced inFIG.5), such as an antero-lateral commissure anchor795(element620ofFIG.5), an antero-septal commissure anchor815(element555ofFIG.5), and a posterior commissure anchor805(element650ofFIG.5). The phrase “strut format” refers to the elements illustrated in a frame flat pattern, whereupon the elements of the frame may be undeformed (i.e., shapeset through metallurgical heat-treatments that are known to those skilled in the art) and generally resemble rectangular members or “struts.” Additional details regarding the commissure structures and their spatial relationships with the anchoring tabs are depicted inFIG.9. This flat pattern represents an embodiment of the prosthetic mitral valve depicted inFIG.5.

The prosthetic mitral valve may comprise one or more attachment rails, one or more commissures, one or more commissure attachment holes, one or more commissure slots, and one or more commissure junctions. The prosthetic mitral valve may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 attachment rails, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissures, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissure attachment holes, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissure slots, and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissure junctions.

The antero-lateral commissure anchor795may protrude directly from the antero-lateral commissure1085. The antero-lateral commissure may be the origin and insertion of the antero-lateral anchoring tab1110(610, as shown inFIG.5) via an antero-lateral commissural junction1100. One or more rows of antero-lateral commissure attachment holes1090may be located adjacent to an antero-lateral commissure attachment slot1095within the structure of the antero-lateral commissure1085. The attachment holes1090may provide a location for suture that may be used to sew the antero-lateral commissure suture pads (615, as shown inFIG.5) into place. The antero-lateral commissure suture pads may work in conjunction with the antero-lateral commissure attachment holes to help fasten the valve leaflets of the prosthetic mitral valve to the frame. A free end1111of the antero-lateral anchoring tab1110is also shown, as are a free end1116of the antero-septal anchoring tab1115and a free end1121of the posterior anchoring tab1120. A plurality of struts or attachment rails may be used to locate and fasten leaflets onto the frame. Each strut may space a space between successive adjacent commissures. Each strut may have a “u” or arc-shaped form. Specifically, an anterior leaflet attachment rail1080may span the space between the antero-lateral commissure1085and the antero-septal commissure1086. The anterior leaflet attachment-rail1080may be used to attach the anterior leaflet (not shown) to the frame. A postero-septal leaflet attachment rail1130may span the space between the antero-septal commissure1086and the posterior commissure1087. The postero-septal leaflet attachment rail1130may be used to attach the postero-septal leaflet (not shown) to the frame. The postero-lateral leaflet attachment rail1125may span the space between the posterior commissure1087and the antero-lateral commissure1085. A postero-lateral leaflet attachment rail1125may be used to attach the postero-lateral leaflet (not shown). The posterior commissure anchor805, posterior commissure1087, posterior anchoring tab1120, and the free end1121of the posterior anchoring tab1120are shown on both sides ofFIG.9to emphasize how the prosthetic mitral valve may be laid out in a frame flat configuration.

Additional structures may support radial compression against the native mitral annulus and/or help to seal the valve inflow against the left atrial floor. A plurality of rows of annular rhomboids1150may be located at the annular region1140of the frame, traversing the circumference of the frame. A plurality of atrial skirt support struts1170may emanate from the annular region1140and may act as support beams for a plurality of atrial skirt circumferential struts1165. The atrial skirt support struts may be substantially parallel to one another and may extend longitudinally. The atrial skirt circumferential struts may be substantially parallel to one another and may be substantially “v-shaped”. Each atrial skirt support struts may be connected at top and bottom to atrial skirt circumferential struts. The combination of atrial skirt support struts1170and atrial skirt circumferential struts1165may form the atrial region1160of the valve frame and may provide a location for the atrial skirt to be sutured onto the valve frame.

FIG.10illustrates an embodiment of a frame flat pattern1180. The frame flat configuration1180may comprise any or all of the elements ofFIG.9, with further modifications. The frame flat configuration1180may additionally comprise one or more strut features. The configuration may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 strut features. For instance, one or more strut features may be added, each adjacent to two of the leaflet attachment rails. A postero-lateral chordal bumper strut1190may run approximately parallel to the postero-lateral leaflet attachment rail1125. The postero-lateral chordal bumper strut1190may aid in valvular operation by pushing the native chordae away from the prosthetic valve. This may further prevent obstruction in the sub-valvular space and LVOT. The configuration may comprise one or more bumper strut attachment points. The configuration may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 bumper strut attachment points. One or more postero-lateral chordal bumper strut attachment points1195may be located at each end of the postero-lateral chordal bumper strut1190. Each postero-lateral chordal bumper strut attachment point1195may effectively connect an end of the postero-lateral chordal bumper strut1190to the adjacent commissure. A postero-septal chordal bumper strut1210may run approximately parallel to the postero-septal leaflet attachment rail1130. One or more postero-septal chordal bumper strut attachment points1200may be located at each end of the postero-septal chordal bumper strut1210. Each postero-septal chordal bumper strut attachment point1200may effectively connect and end of the postero-septal chordal bumper strut1210to the adjacent commissure. The postero-septal chordal bumper strut1210may be functionally equivalent to the postero-lateral chordal bumper strut1190. The postero-septal choral bumper strut attachment points1200may be functionally equivalent to the postero-lateral choral bumper strut attachment points1195.

FIG.11shows an embodiment of a frame flat pattern1220. The frame flat configuration1220may comprise any or all of the elements ofFIG.10, with further modifications. The frame flat configuration1220may further comprise one or more wishbone-shaped members and an absence of the previously described commissure anchors. These alterations may provide an alternative method of anchoring the valve frame to a delivery system, as described herein. The configuration may comprise one or more wishbone struts, one or more wishbone anchors, and one or more wishbone attachment points. The configuration may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 wishbone struts, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 wishbone anchors, and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 wishbone attachment points. A postero-lateral wishbone shaped strut1230may emanate from a first strut attachment point1240on the antero-lateral commissure1085. The postero-lateral wishbone shaped strut1230may arc upwardly and across the postero-lateral leaflet space until it meets a second strut attachment point1240located on the posterior commissure1087. At the apex of the postero-lateral wishbone shaped strut1230may be a postero-lateral wishbone anchor1235which may replace the previously depicted antero-lateral and posterior commissure anchors (795and805ofFIG.10, respectively). The postero-lateral wishbone anchor1235may be functionally and structurally equivalent to the antero-lateral and posterior commissure anchors. Additionally, a postero-septal wishbone shaped strut1250may emanate from a first strut attachment point1260on the antero-septal commissure1086. The postero-septal wishbone shaped strut may arc upwardly and across the postero-septal leaflet space until it meets a second strut attachment point1260located on the posterior commissure1087. At the apex of the postero-septal wishbone shaped strut1250may be a postero-septal wishbone anchor1255which may replace the previously depicted antero-septal and posterior commissure anchors (815and805ofFIG.10, respectively). The postero-septal wishbone anchor may be functionally and structurally equivalent to the antero-septal and posterior commissure anchors. The wishbone shaped struts may allow the prosthetic mitral valve to be forced into an easily compressible configuration for delivery with a catheter, as described herein. This may result in a more easily retractable and/or repositionable prosthesis. wishbone shaped strut

FIG.12shows yet an embodiment of a frame flat pattern1270. The frame flat configuration1220may comprise any or all of the elements ofFIG.11, with further modification. The frame flat configuration1270may lack certain elements ofFIG.11. For instance, the postero-lateral chordal bumper struts (1190, as shown inFIG.11) and/or postero-septal chordal bumper struts (1210, as shown inFIG.11) may be excluded from the frame flat configuration1270. Save for the absence of said bumper struts, the frame flat configuration1270may be functionally equivalent to the frame flat configuration1220ofFIG.11. A perspective view of the prosthetic mitral valve ofFIG.12can be seen inFIG.13.

FIG.13shows a perspective view of the prosthetic mitral valve shown as the frame flat configuration1270inFIG.12. Any or all of the features and elements previously described inFIG.5may be present in the embodiment ofFIG.13. The embodiment ofFIG.13may be functionally and structurally equivalent to the embodiment ofFIG.5, save for the addition of one or more wishbone shaped struts and one or more wishbone attachment regions. The embodiment ofFIG.13may comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 wishbone shaped struts and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 wishbone attachment regions.1330. A postero-septal wishbone shaped strut1320may find a first insertion with the frame at an antero-septal tab wishbone attachment region1300, which may be located adjacent to the antero-septal commissure. The postero-septal wishbone shaped strut1320may find a second insertion with the frame at a posterior tab wishbone attachment region1290, which may be located adjacent to the posterior commissure. A postero-septal wishbone anchor1255may be located at the apex of the wishbone, allowing for attachment to a delivery system, as described herein. A postero-lateral wishbone shaped strut1330may find a first insertion with the frame at an antero-lateral tab wishbone attachment region1310, which may be located adjacent to the antero-lateral commissure. The postero-lateral wishbone shaped strut1330may find a second insertion with the frame at a posterior tab wishbone attachment region1290, which may be located adjacent to the posterior commissure. A postero-lateral wishbone anchor1235may be located at the apex of the wishbone, allowing for attachment to a delivery system, as described herein.

Prior minimally invasive procedures have been developed to deliver a prosthetic heart valve percutaneously over a delivery catheter through the patient's vasculature to the heart, or through the use of a transapical procedure to introduce the prosthesis through the chest wall and through the apex of the heart (330as shown inFIG.3). An exemplary prosthesis includes that described in U.S. Pat. No. 8,579,964, the entire contents of which are incorporated herein by reference in their entirety for all purposes. Further embodiments of exemplary delivery catheters and delivery systems are described and illustrated in the following figures.

FIG.14shows the prosthetic mitral valve with wishbone attachment ofFIG.13. The prosthetic mitral valve1280may comprise any or all of the elements ofFIG.13. The prosthetic mitral valve1280may be connected to a delivery system1340. The delivery system1340may comprise a completely withdrawn delivery catheter1350. It should be readily apparent that the aforementioned postero-septal commissure anchor (1255, as shown inFIG.13) and postero-lateral commissure anchor (1235, as shown inFIG.13) are presently hidden by an anchoring sleeve member1360inFIG.14. The delivery system1340is shown inFIG.14as connected to a non-specific anchoring mechanism. Embodiments of the anchoring mechanism are described inFIGS.15-19, as communicated by enlarged detail element1345.

FIGS.15A-Bshow an embodiment of an anchoring method used to anchor commissure anchors to a delivery system utilizing a plurality of threaded connectors.FIG.15Ashows a plurality of threaded connectors1370in a connected configuration. In the connected configuration, a first male threaded connector1390and a second male threaded connector1395may be in threaded connection with a first female threaded connector1375and a second female threaded connector1380, respectively. The first and second male threaded connectors (1390and1395, respectively) may each comprise a segment of male threads1400appearing at a free end of a wishbone shaped strut1410. The wishbone shaped strut may replace the plurality of commissure anchors (1255and1235, as shown inFIG.13). The male threads may be sized to fasten and mate to similarly threaded first and second segments of female thread1405. Arrows1385indicate rotation of each of the first and second female threaded connectors (1375and1380, respectively). Upon rotation in the direction of the arrows1385, the connectors may be in the state depicted inFIG.15B.

FIG.15Bshows a plurality of threaded connectors (1390and1395) in a disconnected configuration1420. It should be apparent that in the state depicted inFIG.15B, the male threaded connectors may be completely disconnected from the female threaded connectors. Upon disconnection, a prosthetic valve that was initially attached to a catheter delivery system through the wishbone connectors may be fully released from its delivery system. A further discussion of the internal mechanisms responsible for the operation of this embodiment of a delivery system begins with the description ofFIG.29.

FIGS.16A-Bshow an embodiment of an anchoring method used to anchor commissure anchors to a delivery system using a single split-threaded connector.FIG.16Ashows a split-threaded connector1430in a connected configuration. One or more male split-threaded connectors1450may be in threaded connection with one or more female split-threaded connectors1440. Each male split-threaded connector1450may comprise a segment of male thread1455appearing at a free end of a wishbone shaped strut1460. The wishbone shaped strut may replace the plurality of commissure anchors (1255and1235, as shown inFIG.13). The male threads may be sized to fasten and mate to similar threaded segments of female thread1445within the female threaded connector1440. Arrows1435indicate rotation of the individual female threaded connector1440. Upon rotation, the connectors may be in the state depicted inFIG.16B.

FIG.16Bshows the split-threaded connector1455in a disconnected configuration1470. It should be apparent that in the state depicted inFIG.16B, the male split-threaded connector may be completely disconnected from the female threaded connector. Upon disconnection, a prosthetic valve that was initially attached to a catheter delivery system through the wishbone connectors may be fully released from its delivery system. A further discussion of the internal mechanisms responsible for the operation of this embodiment of a delivery system begins with the description ofFIG.27.

FIGS.17A-Bshow an embodiment of an anchoring method used to anchor commissure anchors to a delivery using a flexing pin-connector type anchoring mechanism.FIG.17Ashows a flexing pin-connector type anchoring mechanism1480in a connected configuration. One or more flexible sleeves1490may be closed about a plurality of pinhole connectors1530. The flexible sleeves1490may comprise a plurality of flexible sleeve portions1495that may be able to snap open and shut when a translating sleeve1500is drawn over or off of them. This movement of the translating sleeve may effective encapsulating the flexible sleeve portions1495. The flexible sleeve1490may comprise a shape-settable and/or super-elastic nitinol material, as is known to those having skill in the art. Each flexible sleeve portion1495may comprise a terminal point1510, appearing at the free end of the flexible sleeve1490. The terminal points may allow connection of the flexing pin-connector type anchoring mechanism1480to wishbone shaped struts1520.

FIG.17Bshows the flexing pin-connector type anchoring mechanism1480in a disconnected configuration1540. The internal surface of each of the terminal points1510may comprise a connector pin1555which may fit into a complimentary hole for pin connection1560. Each of the wishbone shaped struts1520of the prosthetic mitral valve may terminate in a pinhole connector1530. The pinhole connectors may replace the plurality of commissure anchors (1255and1235, as shown inFIG.13). Arrows1550indicate rotation of each of the individual flexible sleeve portions1495. Upon rotation, the connector may be in the state depicted inFIG.17B. Arrow1545indicates translation of the translating sleeve1500over the flexible sleeve portions1495. It should be apparent that in the state depicted inFIG.17B, the connector pins1555may be completely disconnected from the holes for pin connection1560. Upon disconnection, a prosthetic valve that was initially attached to a catheter delivery system through the wishbone connectors may be fully released from its delivery system. A further discussion of the internal mechanisms responsible for the operation of this embodiment of a delivery system begins with the description ofFIG.24A.

FIGS.18A-Cshow an embodiment of an anchoring method used to anchor commissure anchors to a delivery system using a plurality of flexible buckle type anchoring mechanisms is employed.FIG.18Ashows a plurality of flexible buckle type connectors1570in a connected configuration. A plurality of flexible buckles1580may be in captured connection with, restrained by, or disposed within an aperture1575that is sized to accept and retain the flexible buckles1580utilizing opposing tensile forces. The aperture may be fashioned in the side of a translating sleeve1500. Each of the flexible buckles may be located adjacent to and protruding from the end of a wishbone shaped strut1520, which may replace the plurality of commissure anchors (1255and1235, as shown inFIG.13). A sheath catheter1350may be concentrically positioned over the top of the translating sleeve1500. When the translating sleeve1500is drawn against the sheath catheter1350, the mechanism of action may be achieved.

FIG.18Bdepicts the hidden structure of the flexible buckles1580, as the translating sleeve1500blocks said structure from view inFIG.18A.

FIG.18Cshows the flexible buckle type anchoring mechanisms in a disconnected configuration. When the translating sleeve1500is drawn against the sheath catheter1350, the flexible buckles1585may be forced closed by the inner surface of the sheath catheter1500, and released from constraint. It should be apparent that in the state depicted inFIG.18C, the flexible buckle type connectors may be completely disconnected from their aperture1575and associated translating sleeve1500. Upon disconnection, a prosthetic valve that was initially attached to a catheter delivery system through wishbone connections may be fully released from its delivery system. A further discussion of the internal mechanisms responsible for the operation of this embodiment of a delivery system begins with the description ofFIG.26A.

FIGS.19A-Bshow an embodiment of an anchoring method used to anchor commissure anchors to a delivery system using a plurality of anchor shaped commissure anchors.FIG.19Ashows a plurality of anchor shaped commissure anchors1630, adjacent to and connected with the ends of a plurality of wishbone shaped struts1410, in a connected configuration. The plurality of commissure anchors1630may rest within a complimentary plurality of slots1615. The slots may act to retain the anchors and resist tensile forces that may be developed during operation of the delivery system. The slots1615may be fashioned on the anchoring end1610of an anchoring catheter1600. The plurality of commissure anchors1630depicted inFIG.19A-Bmay be identical to the plurality of commissure anchors (1255and1235, as shown inFIG.13) in design, construction, and function.

FIG.19Bshows the commissure anchors1640in an unconstrained configuration that may allow disconnection. Arrow1620indicates translation of an anchoring sleeve member1360. Upon translation, the state depicted inFIG.19Bmay be realized. It should be apparent that in the state depicted inFIG.19B, the commissure anchors1640may be unconstrained and capable of being disconnected from the slots1615of the anchoring catheter1600. Upon disconnection, a prosthetic valve that was initially attached to a catheter delivery system may be released from its delivery system. A further discussion of the internal mechanisms responsible for the operation of this embodiment of a delivery system begins with the description ofFIG.21A.

FIGS.20A-20Fdepict the successive stages of unsheathing an embodiment of a delivery system and implanting a mitral valve prosthesis. Although the resultant effects of the operation of said delivery system (such as the release of a constrained prosthetic mitral valve) are discussed with reference to the relevant elements necessary for illustration, the mechanical relationships of the various internal components necessary for the physical realization of the delivery system embodiments are not illustrated or discussed until further below, inFIGS.21-31. The deployment process as depicted inFIGS.20A-20Fproceeds as follows. A sheath catheter which may constrain a compressed prosthetic valve comprised of tissues, fabrics, sutures and a nitinol frame may be retracted from the valve while in place within the implantation zone. The physiological temperature of the blood in a patient's heart may cause the nitinol material to expand and conform to the space in which it has been implanted. As the prosthesis expands, elements of the invention that are responsible for anchoring to the native anatomy may also expand, allowing the prosthesis to remain in place in order to function as a one-way valve and support proper circulation of blood. It shall be recognized that the relevant anatomy has been previously illustrated inFIGS.1-4, but is not repeated in the following figures, leaving room to focus on the prosthesis and delivery system.

FIG.20Adepicts an embodiment of a fully loaded (sheathed and closed) delivery system1700. The delivery system may comprise a prosthetic mitral valve (shown inFIGS.20B-20F) that has been compressed and inserted into a sheath catheter1350prior to implantation. A long, tapered and flexible self-dilating dilator tip1710may aid the insertion of the delivery system within a small incision that is prepared in the prospective patient (not shown). The incision may be made in the thorax and may lead directly into and through the apex of the heart. The widest end of the dilator tip1710may be terminated by an edge1720that may register against and fits concentrically within a leading edge1725that may appear on the distal end of the sheath catheter1350. A lumen1715may be formed at the distal-most portion of the dilator tip1710, and may extend throughout the entirety of the catheter to which the dilator tip1710is attached.

FIG.20Bdepicts an embodiment1730of a loaded delivery system with the atrial skirt revealed, showing the sheath catheter1350previously described inFIG.20Atranslated a slight distance away from the dilator tip1710. Specifically, the leading edge1725of the sheath catheter1350may be moved away from the edge1720of the dilator tip1710, and may thereby reveale a partially constrained atrial skirt1750.

FIG.20Cdepicts an embodiment1760of a loaded delivery system with the anterior trigonal anchoring tabs revealed, showing the sheath catheter1350previously described inFIG.20Btranslated away from the dilator tip1710to an even greater extent. Specifically, the leading edge1725of the sheath catheter1350may be moved further away from the edge1720of the dilator tip1710, and may thereby reveale most of the structure of the encapsulated prosthetic mitral valve. An atrial skirt1770may now be approximately released, yet a still partially constrained annular region1775may remain constricted by the sheath catheter1350. The configuration ofFIG.20Cmay remove a constraint that may allow the self-expansion of a portion of the prosthetic mitral valve. Adjacent to and directly beneath the constrained annular region1775may be a constrained anterior leaflet1780, which may remain substantially compressed. Protruding from beneath the leading edge1725of the sheath catheter1350may be a plurality of trigonal anchoring tabs, such as an antero-lateral trigonal anchoring tab790(with an associated free end1790), and an antero-septal trigonal anchoring tab540(with an associated free end545).

FIG.20Ddepicts an embodiment1800of a loaded delivery system with the anterior trigonal anchoring tabs fully open, showing the sheath catheter1350previously described inFIG.20Ctranslated away from the dilator tip1710to an advanced extent. Specifically, the leading edge1725of the sheath catheter1350may be moved further away from the edge1720of the dilator tip1710, and may thereby reveale all of the structure of the encapsulated prosthetic mitral valve, except for the commissure attachment (not shown). The atrial skirt1770may now be completely unconstrained, as may an annular region1810. Adjacent to and directly beneath annular region1810may be a partially constrained anterior leaflet1825, which may be almost completely released. The anterior leaflet1825may be operational and able to coapt against any other leaflets present in this embodiment (not shown). The plurality of trigonal anchoring tabs (antero-lateral trigonal anchoring tab790and associated free end1790, and antero-septal trigonal anchoring tab540and associated free end545) may be splayed open due to the interaction between the leading edge1725of the sheath catheter1350and the still-constrained wishbone shaped struts1820to which the trigonal anchoring tabs may be directly connected. This opening effect may allow the trigonal anchoring tabs to reach around the native anterior mitral leaflet (460, as shown inFIG.4) and through the anterior chordae (465, as shown inFIG.4) in order to abut against the trigones after release. Emanating from and concentrically nested within the sheath catheter1350may be a guidewire catheter1830, which may be directly connected to and provide support for the dilator tip1710.

FIG.20Eshows an embodiment1840of a loaded delivery system, just prior to final release, showing the sheath catheter1350previously described inFIG.20Dtranslated away from the dilator tip1710to an advanced extent. Specifically, the leading edge1725of the sheath catheter1350may be moved further away from the edge1720of the dilator tip1710, and may thereby reveale all of the structure of the encapsulated prosthetic mitral valve, such as the fully deployed wishbone shaped struts1880, which may be about to be released from the delivery system. The antero-septal1860and antero-lateral1870trigonal anchoring tabs may be released from their constraint, and may now be in their final position. The anterior leaflet1850may be completely freed, and may be in an operable state spanning the native anterior leaflet.

FIG.20Edepicts final deployment1890with the delivery system removed. The wishbone shaped struts1900and associated commissure anchors1910may be entirely released and free from constraint by the delivery system. In this depiction, the prosthesis of the present invention may be fully functional, and free to operate within the native anatomy.

A thorough discussion of several relevant delivery system embodiments will now be presented, with reference to elements appearing inFIGS.21-31.

FIGS.21A-23depict an embodiment of a delivery system that corresponds to the description relating toFIGS.19A-19Band that may be compatible with the prosthetic mitral valve embodiment described inFIG.13.

FIG.21Ashows an embodiment of a fully open, extended-length delivery system1920. The delivery system may comprise a delivery system handle1940. The delivery system handle may comprise a slender, graspable member1960that may allow for the housing of various mechanical components, and may provide a location for a family of concentrically nested catheters. The delivery system handle1940may also provide an actuation mechanism, such as in the form of a rotatable (see arrow1950indicating rotation) thumbwheel1955. The thumbwheel may be substantially cylindrical and may have internal threads (not shown) that transform rotational torque applied by a user into linear force. The linear force may be used to translate certain catheters from the family of concentrically nested catheters. The previously discussed sheath catheter1350is again present and may be a substantially cylindrical tube with an inner lumen, extending from within the delivery system handle1940to a leading edge1725that may transit the distance between the edge1720of a dilator tip1710positioned at the distal-most extremity of the entire device and a set distance proximally away from the edge1720that may equate substantially to the constrained length of a prosthetic valve (not shown). An anchoring sleeve member1360may be concentrically nested within the sheath catheter1350, which may itself also have an inner lumen that extends from within the delivery system handle1940up to and slightly beyond the tip of an anchoring catheter1930. The anchoring catheter1930may itself be cylindrical and concentrically nested within the anchoring sleeve member1360. Further detail regarding the anchoring catheter1930is provided inFIG.22. The innermost concentrically nested catheter is the guidewire catheter1830, which may be connected to the dilator tip1710. There may be an inner lumen extending through the entire length of the delivery system, which may be appropriately sized to receive and transmit a guidewire (not shown) that may be placed within it. An arrow1925depicting translation shows how the sheath catheter1350may be brought toward the dilator tip1710as the thumbwheel1955is rotated.

FIG.21Bshows the device introduced inFIG.21Ain a configuration1970, with the sole differences being the position of the sheath catheter1350and the position of the anchoring sleeve member1360. The sheath catheter may be translated even further toward the dilator tip1710(as depicted by arrow1975indicating translation). The anchoring sleeve member1360may also be translated. By translating toward the dilator tip1710, the anchoring sleeve member1360may effectively cover up the anchoring catheter1930.FIG.21A. This is the same mechanical relationship depicted inFIGS.19A and19B, although in the reverse order.

FIG.21Cshows a closed delivery system1980, wherein the thumbwheel1955may be rotated to its full extent, and the sheath catheter1350may be brought to close against the dilator tip1710.

FIG.22shows the embodiment and configuration of the device as illustrated inFIG.21Awith additional detail in the form of an enlarged view1985. Specifically, a stabilizer member1990may be located between the inner surface of the sheath catheter1350and the outer surface of the anchoring sleeve member1360. The stabilizer member may take the form of a star shaped cylindrical prism. The stabilizer member may force concentricity between said catheters while still allowing blood and/or saline to flow past. The slotted end of the anchoring catheter1930is also portrayed. It may be seen that the anchoring sleeve member1360may be positioned concentrically around and in slidable communication with the anchoring catheter1930. The guidewire catheter1830is again shown exiting the anchoring catheter1930.

FIG.23illustrates an exploded view of the exemplary device ofFIGS.21A-22B. The device may comprise a delivery system handle A-side2140that may be in mated connection with a delivery system handle B-side2145. The device may effectively provide a housing and location for the family of concentrically nested catheters seen to the left side of the handle elements (and described inFIGS.22-22), and the various elements seen to the right side of the handle elements. The device may comprise a needle hub2130, which may be in mated connection with the proximal end2000of the guidewire catheter1830. The mated connection may be formed using adhesives. The needle hub2130may act as a connecting port, through which a syringe (not shown) may be attached to the device and used to flush sterile saline through the innermost lumen to remove air prior to insertion into a patient. A cylindrical anchoring nut2120may be in threaded connection with threads on the proximal end2035of the anchoring catheter2010. The cylindrical anchoring nut may be located within the plurality of handle halves2140and2145so as to fasten the anchoring catheter2010to the delivery system. An inner lumen may run the entirety of the length of the anchoring catheter2010and may allow for the concentric nesting of the guidewire catheter1830within. A spring2110may be mated to and press against a bell slider cap2100, which may itself mated to a bell slider2090. The spring2110may provide a bias force with which the bell slider2090may be moved when a leadscrew2080is brought out of contact with it. In other words, by rotating the thumbwheel1955, the leadscrew2080may be translated linearly and may be brought into contact with the distal portion of the bell slider2090, which may in turn be biased against the spring2110. The bell slider2090may act as a carriage for the proximal end2060of the bell catheter2040(previously referred to as an anchoring sleeve member1360) and may allow the distal end2050of said bell catheter2040to be brought away from the distal end2020of the anchoring catheter2010, which may be the mechanism responsible for final valve commissure release. The leadscrew2080may also be translated in an opposite direction by turning the thumbwheel1955, in order to close the delivery system and seal the valve inside. This may be achieved by way of the leadscrew's2080connection to a leadscrew cap2070, which may itself be mated to the proximal end2065of the sheath catheter1350. Thus, rotating the thumbwheel1955in a first direction may move the leadscrew2080towards the dilator tip1710, and by extension may also move the sheath catheter1350towards said dilator tip1710in order to close the device. Rotating the thumbwheel1955in a second opposite direction may move the leadscrew2080towards the bell slider2090and by extension may move both the sheath catheter1350and the bell catheter2040away from the dilator tip1710to open the device and release the prosthetic valve contained within. It should be understood that while both the sheath catheter1350and bell catheter2040may move synchronously by way of thumbwheel1955rotation, there may be a delay in contact provided by the dimensions of the relevant catheters and leadscrew2080. The delay may allow some portions of the prosthesis to be uncovered before other portions as the deployment progresses. It should also be understood that the prosthetic valve may ultimately be recaptured or obtained for repositioning or removal by simply closing the sheath catheter1350until the leading edge1725of said sheath catheter1350again contacts the edge1720of the dilator tip1710. Finally, a distal end1995of the guidewire catheter1830may be in mated connection with and anchored to the dilator tip1710.

FIGS.24A-25depict an embodiment of a delivery system corresponding to the description relating toFIGS.17A-17B. In the same manner as the illustrations depicted inFIGS.24A-24C, the relationship between thumbwheel1955rotation and sheath catheter1350translation is also depicted here. InFIG.24A, a fully open delivery system2150may be designed for a flexible connection type of attachment to a prosthetic valve (not shown). An arrow2190indicating rotation shows that as the thumbwheel1955is rotated, the sheath catheter1350may again translate (see arrow2180indicating translation) toward the dilator tip1710. In this embodiment, a plurality of flexible connector prongs2160may be subjected to a camming action due to their inherent arcuate profile and the gradually increasing level of contact between said flexible connector prongs2160and the leading edge1725of the sheath catheter1350. This may bring the flexible connector prongs2160into close contact with one another. At the distal tip of each flexible connector prong2160may be a connecting element2170, which may be a substantially cylindrical boss that may mate with a substantially cylindrical hole or cavity within the commissure element of an associated prosthetic valve (elements1530,1555, and1560show inFIG.17B).FIGS.24B and24Cshow the logical continuation of the sheathing process (2200partially open,FIG.24B, and2210fully closed,FIG.24C) whereby the leading edge1725of the sheath catheter1350may be eventually brought into contact with the edge1720of the dilator tip1710.

FIG.25shows an exploded view of the delivery system introduced inFIG.24A-24C. The components set forth in this depiction may differ only slightly from the components set forth inFIG.23. The embodiment of a delivery system as shown inFIG.25may not require a bell catheter, as the capturing mechanism may be provided by the relationship between the leading edge1725of the sheath catheter1350and the plurality of flexible connector prongs2160. Therefore, the embodiment ofFIG.25may not require a bell slider either. In order to operate the device, a user may only need to draw the sheath catheter1350back and forth with the thumbwheel1955, directly compressing the plurality of flexible connector prongs2160. It should be readily understood that the flexible connector prongs2160may be fashioned into the distal end of the flexible prong anchoring catheter2220.

FIGS.26A-26Bdepict an embodiment of a delivery system corresponding to the description relating toFIGS.18A-18C.FIG.26Ashows an exploded view of an embodiment of a delivery system that may be suitable for connecting with a prosthetic valve frame having flexible buckle type anchors. The components set forth in this depiction may differ only slightly from the components set forth inFIG.23. In the embodiment ofFIGS.26A-26B, the proximal end2035of the anchoring catheter2010may be in mated connection with the bell slider2090instead of an anchoring nut and may be able to freely translate along with the bell slider2090when contacted by the leadscrew2080. The bell slider2090may further comprise a plurality of pins2226that may transmit the force from the leadscrew2080to the bell slider2090while also providing clearance for a stationary bell catheter nut2224that may anchor and retain the stationary bell catheter2040to the delivery system. Thus, by rotating the thumbwheel1955the leadscrew2080may be brought into contact with the plurality of pins2226, forcing the bell slider2090and anchoring catheter2010proximally away from the dilator tip1710. This may effectively retracts the anchoring catheter2010into the stationary bell catheter2040. This relationship is illustrated in greater detail inFIG.26B.

InFIG.26B, an enlarged view2228is provided, which shows in detail the elements that may be present at the distal most end of the translating anchoring catheter2010and stationary bell catheter2040. When the distal end2227of the anchoring catheter2010is brought into the distal end2050of the bell catheter2040, an aperture2229that may be formed within the distal end2227of the anchoring catheter2010may also brought into said bell catheter distal end2050. This action effectively may provide the mechanism behind the embodiment illustrated inFIGS.18A-18C.

FIGS.27and28depict an embodiment of a delivery system corresponding to the description relating toFIGS.16A-16B.FIG.27shows an exploded view2230of an embodiment of a delivery system that may suitable for connecting with a prosthetic valve frame having a single threaded connector anchor. The components set forth in this depiction may differ only slightly from the components set forth inFIG.23. The embodiment may comprise a plurality of stabilizers1990. The stabilizers may improve concentricity of the concentrically nested catheters. Again, a plurality of handle halves (A-side2250, and B-side2260) may provide a location for the various internal components. The delivery system may also comprise a plurality of thumbwheels, such as a first thumbwheel1955for actuating the sheath catheter1350and a second thumbwheel2270for rotating the threaded bell catheter2040. The first and second thumbwheels may allow the catheter to connect and disconnect from the related prosthetic valve. Further, the second thumbwheel2270may contain a hole2275through which the proximal end2060of the rotating bell catheter2040may be fastened to said second thumbwheel2270. An exploded view2240of the family of concentrically nested catheters is provided, and further detail regarding the threaded mechanism at the distal end of the family of catheters is provided inFIG.28.

FIG.28shows an exploded view2280focusing on the distal end of the family of nested catheters. Arrow2300indicates rotation, which corresponds to the rotation of the threaded and distal end of the bell catheter2310in order to connect or disconnect from threaded fasteners that may be present in a valve prosthesis.

FIGS.29-31depict an embodiment of a delivery system corresponding to the description relating toFIGS.15A-15B.FIG.29shows an exploded view of an embodiment of a delivery system that may be suitable for connecting with a prosthetic valve frame having a plurality of threaded type connector anchors (1400, as shown inFIG.15A). The components set forth in this depiction may be substantially similar to the components set forth inFIG.23.FIG.29shows an exploded view of the delivery handle portion of the delivery system2320and an exploded view of the concentrically nested catheters2330. A slot2390may be formed at the proximal end of both delivery system handle A-side2370, and B-side2380. The slots may allow for rotational displacement of a level2420that may be orthogonal to and originates from a cylindrical torque transmitting member2410. The torque transmitting member2410may be in mated connection with the proximal or driving end2355of a torque catheter2350, and may travel concentrically through a catheter mount2400, a leadscrew2080, a plurality of stabilizers2360, and a sheath catheter1350before terminating in a distal or driven end2352that may further transmit torque through a geared relationship and that is further described inFIG.31. The catheter mount2400may provide a lateral location and fixation for fixed ends2345of a plurality of twisting thread-connector catheters2340. The thread-connector catheters2340may be long, thin, flexible members which may be structurally rigid in compression. The thread-connector catheters may be able to be twisted about their axes when an appropriate torque is applied. In order to maintain the adjacency between the torque catheter2350and the plurality of thread-connector catheters2340, a plurality of stabilizers2360may act as journal bearings to both internally retain the placement of the torque catheter2350and to externally retain the placement of the plurality of thread-connector catheters2340. The plurality of thread-connector catheters may be concentrically nested within the sheath catheter1350. As previously described, by rotating the thumbwheel1955the leadscrew2080and by extension sheath catheter1350may be made to translate, which in turn may cause the leading edge1725of the sheath catheter1350to advance towards or retreat from the dilator tip1710.

FIG.30shows the exploded view2330ofFIG.29in greater detail and shows the nesting configuration of the family of catheters.

FIG.31shows an enlarged view2430, which illustrates in detail the mechanical interaction at the distal end of the delivery system ofFIG.29. As previously described, actuating the lever (2400, as shown inFIG.29), which may be operably coupled to the driven end2352of the torque catheter (2350, as shown inFIG.29) may cause the torque catheter to rotate, and may further cause a driving gear2490to rotate and transmit torque to a plurality of driven gears2470that are adjacent to the distal ends2342of the plurality of thread-connector catheters2340and by extension also adjacent to the threaded socket2480of each thread-connector catheter2340. It should be apparent that rotation of the driving gear2490in a first direction (as shown by arrow2460indicating rotation) may cause a rotation of each of the driven gears2470in a second direction, opposite the first (as shown by arrows2450indicating rotation). A mechanical advantage may exist between the driving2490and driven2470gears. The mechanical advantage may result in an increase in rotational displacement of the driven gears with respect to the driving gears. The mechanical advantage may provide a 4:1 increase in rotational displacement of the driven gears with respect to the driving gears. At the distal end2342of each thread-connector catheter2340may be a threaded socket (2480, as shown inFIG.31) which may be used to connectedly mate to a threaded fastener that may be anchored to an embodiment of the prosthetic valve (1390and1395, as shown inFIG.15A).

FIG.32illustrates a prosthetic valve implanted in a mitral valve of a patient's heart. With traditional methods of implantation and traditional devices, the natural blood flow path may be disrupted and blood flow may become turbulent. The blood may flow toward the apex of the heart and towards the septal wall creating turbulence.

FIG.33illustrates the desired blood flow path through the mitral valve and out the ventricle. The native mitral valve directs the blood to flow along the posterior wall of the ventricle towards the apex of the heart where the blood then continues to flow in a non-turbulent manner up the septal wall and then during heart systole the blood is ejected out of the left ventricular outflow tract (LVOT) and through the aorta to the rest of the body. In this configuration, the blood flow maintains its momentum and conserves its energy resulting in the most efficient flow.

FIG.34illustrates a prosthetic valve implanted in a native mitral valve. The prosthetic mitral valve has features which preferably avoid obstructing the left ventricular outflow tract and also may help maintain the natural blood flow path so as to conserve momentum of the blood flow and avoid turbulence. For example, the prosthetic valve preferably has a large anterior prosthetic valve leaflet3410that spans the width of the native anterior valve leaflet. This will help mimic the size and motion of the native valve leaflet thereby avoiding obstruction of the LVOT. Additionally, the prosthesis has a low profile so that it does not extend too far in to the ventricle, and an atrial flange or skirt helps anchor the prosthesis to the atrial floor. The atrial skirt3420also preferably has a low profile. The prosthesis may also include one or preferably two anterior anchoring tabs3430that extend behind (anterior of the native leaflet) the native valve leaflets and anchor the prosthesis to the fibrous trigones on the anterior portion of the valve, or anchor on tissue adjacent and anterior of the anterior leaflet. The body3440of the valve may direct blood flow to the posterior. Additional details of the anchoring tabs may be found in U.S. Pat. No. 8,579,964, the entire contents of which have been previously been incorporated herein by reference. The body of the prosthesis may be designed to avoid LVOT obstruction and this may help direct blood flow downward along the posterior wall of the heart in a circular manner toward the apex, and then upward along the septum toward the LVOT, thereby maintaining a substantially normal blood flow path that avoids turbulence and maintains momentum of the blood flow. Additional details about these and other features of the prosthesis are discussed in greater detail in this specification.

FIG.35illustrates a ventricular view of the prosthesis which preferably has a large anterior prosthetic leaflet, and two posterior leaflets. Preferably, three commissure posts are used to support the prosthetic valve leaflets and form a tricuspid prosthetic valve. The prosthesis may comprise an atrial skirt3520. Additionally, the prosthesis preferably includes two anterior anchor tabs3510and optionally one or more posterior anchor tabs3530. The anterior anchor tabs may anchor to the fibrous trigones of the valve or they may anchor to tissue that is anterior of the anterior leaflet and adjacent thereto, and in order to avoid interfering with movement of the anterior prosthetic leaflet, the anterior anchor tabs are also preferably at the same circumferential position as the commissure posts. In this exemplary embodiment, the anterior anchor tabs are located approximately at the 10 o'clock and 2 o'clock positions along with two of the commissure posts. The prosthesis is preferably D-shaped in order to conform to the native valve anatomy. Therefore, the anterior portion of the valve is preferably flat and linear so that it does not impinge on the LVOT, and the posterior of the prosthesis is preferably cylindrical so that it conforms to the native valve. In some embodiments, instead of a flat and linear anterior portion, the anterior portion may be concave or slightly convex.

FIG.36Aillustrates more clearly the two anterior anchor tabs which extend upward toward the atrium and away from the commissure posts which extend toward the ventricle, and similarly the posterior anchor also extends upward toward the atrium while the adjacent commissure post extends downward toward the ventricle. Note that in this view, only one of the anterior anchor tabs is visible. The prosthesis may comprise an atrial skirt3610.

FIG.36Billustrates an outflow view of the prosthesis ofFIG.36A, whereby both anterior trigonal anchoring tabs are present, as well as the posterior anchoring tab, and the commissures associated with each of said tabs. It should be apparent that the commissure posts and anchoring tabs are adjacent each other. The prosthesis may comprise an anterior anchor3620, an anterior leaflet3630, an anterior commissure3640, a posterior anchor3650, and a posterior commissure3660.

FIG.37illustrates two embodiments of structure on the prosthesis for coupling it to a delivery catheter. The figure shows a pattern of the anchor frame after it has been flattened and unrolled. It is formed from numerous interconnected struts which form open or closed cells that can self-expand or that may be balloon expandable. On the left side ofFIG.37, a first exemplary embodiment shows a single arcuate strut that forms a closed single cell on the atrial portion of the device. This strut may be folded radially outward to form a flanged region or atrial skirt which can anchor to the atrial floor. A commissure post with a D-shaped or mushroom head shaped, or anchor shaped portion on the opposite end of the prosthesis may be used to couple and uncouple the device from a delivery catheter as described previously in this specification and in U.S. Pat. No. 8,579,964 previously incorporated by reference, and is generally on a ventricular portion of the device. A triangular anchor tab is nested in the single cell between the commissure post and the atrial flange. Thus, the anchor tab is superior to the commissure post. The anchor tab may be formed to flare radially outward during deployment so that the anchor tab may be disposed behind a native leaflet (anterior to the anterior native leaflet, or posterior to a native posterior leaflet) and engage the anterior or posterior native anatomy as described in this specification. The commissure may have suture holes disposed therein in order to allow sutures to attach tissue or other material to the commissure posts. Nesting of the anchor tab adjacent the commissure post helps reduce overall device profile.

The right-hand side ofFIG.37illustrates another exemplary embodiment of an anchor structure that allows the prosthesis to be coupled to the delivery catheter. On the right-hand side, multiple closed cells form the atrial region of the device which may be formed to flare radially outward and create a flanged region that may be secured to the atrial floor of the atrium. Two commissure posts include a slotted region for receiving sutures so that tissue or other material may be coupled to the device. The commissure posts are connected together with a wishbone shaped strut having a central tab that may be coupled to the delivery catheter. The wishbone may extend between two commissures or three commissures, or more commissures. Thus, in this embodiment, only a single connector is used to couple the prosthesis to the delivery catheter. The struts of the frame may be EDM machined or laser cut from tubing (e.g. hypo tube), laser cutting or photo etching a flat sheet and welding the ends together, or by other techniques known in the art.

FIG.38illustrates a perspective view of the prosthetic mitral valve. An upper portion includes an atrial skirt or atrial flange that generally takes the same form as the atrial skirt or flange described in U.S. Pat. No. 8,579,964, previously incorporated herein by reference. The prosthetic valve leaflets are also shown, and preferably include one large anterior leaflet that spans the width of the native anterior mitral valve leaflet, and may include two, or three, or more posterior prosthetic leaflets. Thus, the prosthetic valve may only have two prosthetic leaflets, or three or more prosthetic leaflets in total. Two anterior anchoring tabs also preferably share the same position as the commissure posts. This keeps the anterior commissure posts and the anterior anchor tabs out of the flow path thereby helping to avoid LVOT obstruction, and also helps keep overall profile of the device to a minimum in the collapsed configuration which is desirable during delivery.

FIG.39Ashows an anterior view of the prosthetic valve in the expanded configuration with the anchoring tabs flared outward and in the expanded configuration.

FIG.39Bshows a top view of the prosthetic valve with four prosthetic leaflets including one large anterior leaflet that spans the width of the native anterior leaflet and three posterior leaflets, all coupled together with four commissure posts that may optionally be combined with four anchor tabs. Two of these anchor tabs are preferably anterior anchoring tabs for anchoring the prosthetic valve to the fibrous trigones or any other anatomic location described herein including a region anterior of the anterior leaflet and adjacent thereto, and the two posterior tabs may anchor the prosthetic valve to the posterior shelf of the posterior annulus and posterior to the native posterior leaflet.

FIG.40shows deployment of the prosthesis by either a transseptal or by a transapical delivery system. In either, preferably an outer sheath catheter constrains the device from self-expanding and when the outer sheath catheter is retracted the device self-expands. Here, the sheath catheter is partially retracted and the anterior4010and posterior4020anchor tabs are partially deployed.

FIG.41shows a partial perspective view of the prosthetic valve with an upper saddle shaped atrial skirt for atrial anchoring along with the combined large anterior leaflet and two or three posterior leaflets and combined anchor tabs/commissure posts.

FIG.42shows a flat pattern of the combined anterior or posterior anchor tab that is nested in the commissure post. The anchors in alternative embodiments may be cut above the commissure posts and bent backward during heat treating and shape setting so they can anchor to the native heart valve anatomy as described in this specification. This may require the anchors to be deployed first, before other portions of the prosthesis, as seen inFIG.40. This may also involve anchoring of the prosthesis to the delivery catheter on both the inflow end and the outflow ends of the prosthesis for successful delivery.

FIG.43Ashows the unexpanded anchor tabs which may be triangular in the collapsed configuration and have a horizontal paddle shape in the expanded configuration in order to increase the contact area and thereby minimize tissue trauma, tissue piercing during anchoring, as illustrated inFIG.43B. Alternatively, the anchors may have pointed tips which pierce or embed in tissue to help anchor the device.

FIG.43Cshows an exemplary cut pattern of the prosthesis that provides the results seen inFIGS.43A-43B.

FIG.44illustrates a top view of the prosthetic valve with a large anterior leaflet that spans the width of the native anterior leaflet, and two posterior prosthetic leaflets. The prosthetic leaflets are coupled together with three commissure posts.

FIG.45shows portions of the prosthesis including the upper atrial skirt, an annular region and the anchor tabs which may be combined with commissure posts. The anchor tabs are preferably 10 mm-50 mm long, more preferably 20 mm-30 mm long to allow adequate length to go under and behind the native valve leaflets to reach the fibrous trigones and/or posterior annulus or to anchor on other anatomic locations described herein including regions that are anterior of the native leaflet and adjacent thereto. Optionally, the prosthetic valve may not include a posterior anchoring tab. The annular section which is preferably D-shaped may be radially expanded into engagement with the native valve annulus and thus the radial force may be adequate to prevent the posterior portion of the prosthesis from tilting or otherwise pivoting upward into the atrium. Or teeth may be used to engage and/or penetrate the posterior annulus.

In any embodiment, the prosthesis may be recaptured and resheathed if needed in order to either abort the delivery procedure or to reposition the device.

Preferred embodiments are formed from nitinol or any other biocompatible material that is self-expanding. Preferred target sizes and profiles may be dependent on patient anatomy, but are estimated to be approximately 30 mm-50 mm×40 mm-50 mm D-shaped prosthesis that may be delivered in a delivery system that is less than 45 French in size. More preferably, the prosthesis is 35 mm-45 mm×40 mm-50 mm D-shaped and delivered with a delivery system less than 40 French in size. Smaller sizes are preferred, and nominally, the prosthesis is 40 mm×45 mm D-shaped and delivered with a delivery system less than 40 French.

In some embodiments, tethers may be used to help couple the prosthesis to the delivery system for controlling delivery.

FIG.46shows a top view of a prosthetic valve with four prosthetic leaflets and four commissure posts. Optionally, four anchoring tabs may also be co-located with the four commissure posts.

FIG.47shows a top view of prosthetic valve with three prosthetic leaflets and three commissure posts. Optionally, three anchoring tabs may also be co-located with the three commissure posts.

FIG.48shows the prosthesis unrolled and flattened out and having three commissure posts with three prosthetic leaflets and three anchoring tabs. The atrial skirt is also illustrated below the commissure posts and anchor tabs.

FIG.49shows the native anterior and posterior leaflet unrolled and flattened and superimposed over the three anchoring tabs.

FIG.50shows an embodiment where the anchor tabs (triangular shaped cells) are connected to the commissure posts configured for deployment as depicted inFIG.40, where the anchor tabs are deployed first as an outer sheath when the delivery system is retracted. Alternative catheter attachment methods are depicted for this embodiment. Either the use of mushroom shaped anchor tabs at the atrial aspect of the device or a central wishbone style attachment can be used to secure the device to the catheter.

FIG.51shows a large anterior leaflet superimposed over two anterior anchor tabs and a posterior section of diamond shaped cells which may engage or pierce the posterior annulus in an exemplary embodiment that does not use a posterior anchor tab.

FIG.52illustrates another exemplary embodiment showing two anterior anchoring tabs formed and nested within the anterior commissure posts and a series of expandable diamond shaped cells which may anchor against the posterior annulus or may pierce into the posterior annulus thereby avoiding the need for a posterior anchoring tab. This embodiment includes four commissure posts.

FIG.53illustrates another exemplary flat pattern of a prosthetic valve having two anterior anchor tabs nested in two anterior commissure posts and two posterior commissure posts. The atrial flange is shown below the commissure posts.

FIG.54shows a perspective view of a prosthetic valve with four commissure posts and a large anterior prosthetic leaflet coupled to two anterior commissure posts.

FIG.55shows a native mitral valve adjacent the aortic valve and preferably the anterior leaflet moves well away from the LVOT during systole. Preferably a prosthetic anterior leaflet would have similar motion to maintain natural flow dynamics such as maintaining blood flow momentum and reducing or eliminating turbulence.

FIG.56shows another exemplary embodiment of a section of prosthetic valve having an anchoring tab nested within the commissure post and the adjacent closed cells of the frame are also shown.

FIG.57illustrates still another exemplary embodiment of a prosthetic valve having a commissure post and an anchoring tab nested with the commissure post.

FIG.58shows yet another variation of a prosthetic valve having an anchoring tab nested within the commissure post.

FIG.59shows how variable strut thickness (e.g. thicker5910and thinner5920regions) may be used to control the material properties of the prosthesis to create stiffer regions and less stiff regions.

While preferred embodiments of the present invention have been illustrated and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.