Patent Description:
The present disclosure relates to implantable prosthetic devices. More specifically, the disclosure is directed to an improved prosthetic device implantable by catheter for the treatment of mitral or tricuspid regurgitation.

Mitral Regurgitation is a valvular dysfunction that causes blood volume to flow during systole (during left ventricular contraction) from the left ventricle to the left atrium. In contrast, in a healthy heart, this direction of flow is blocked by the mitral valve. The reverse flow during systole causes pressure to rise in the left atrium, and maintaining a normal cardiac output results in an increased pressure in the left ventricle.

Treating patients with MR (mitral regurgitation) or TR (tricuspid regurgitation) could require valve replacement in order to reduce or eliminate the regurgitation. For many years, the commonly accepted treatment was surgical repair or replacement of the native valve during open heart surgery. In recent years, a trans-vascular technique has been developed for introducing and implanting a prosthetic heart valve using a flexible catheter in a manner that is less invasive than open heart surgery.

In the trans-vascular technique, a prosthetic valve is delivered to the target site (e.g., aortic valve, mitral valve, tricuspid valve, or other valve) through a catheter while the valve is crimped to a low diameter shaft. The valve is then expanded/deployed to a functional size when it is located in the correct position. Examples of such prosthetic valves, and related processes for delivering the valves through a catheter, are described in <CIT>.

Advancing the catheter to the target site can be achieved through: (a) The vascular system where a catheter is advanced from the femoral vein/artery, or any other blood vessel that allows access to the target site; (b) Trans-apically where a catheter is advanced through a small incision made in the chest wall and then through the apex; or (c) Trans-atrially where a catheter is advanced through a small incision made in the chest wall and then through the left or right atrium. <CIT> discloses an annuloplasty ring with an anchor member configured to move a plurality of anchors with respect to a plurality of windows in an outer hollow member to deploy the plurality of anchors through the respective windows.

The invention is a prosthetic valve ring assembly as defined in claim <NUM>. Embodiments herein are directed to various prosthetic valve ring assemblies for use in repairing cardiac valves suffering from, for example, mitral or tricuspid regurgitation.

A prosthetic valve ring assembly is described herein. The prosthetic valve ring assembly includes an outer tube that includes a plurality of windows; and a plurality of anchors positioned inside the outer tube and about a perimeter of the outer tube. The plurality of anchors are configured to be emitted outward from the plurality of windows to anchor the prosthetic valve ring assembly to annulus tissue of a patient. The anchors are configured to be emitted in different directions. A first portion of the anchors are configured to be emitted to a ventricular side of the annulus tissue of the patient and a second portion of the anchors are configured to be emitted to an atrial side of the annulus tissue of the patient.

In some embodiments, the anchors may be created using a laser cutting technique. In an embodiment, the laser cutting technique may include cutting according to a laser cut pattern to define a plurality of windows through which the plurality of anchors are configured to be emitted.

In some embodiments, the prosthetic valve ring assembly may further include a closure device configured to lock a distal side and a proximal side of the prosthetic valve ring assembly. In some embodiments, the prosthetic valve ring assembly may further include a post adjustment mechanism that includes a flexible connection configured to move an anterior portion of the prosthetic valve ring assembly relative to a posterior portion of the prosthetic valve ring assembly, thereby changing at least one of a size and a geometry of the prosthetic valve ring assembly.

In some embodiments, the prosthetic valve ring assembly may further include a closure device configured to lock a distal side and a proximal side of the prosthetic valve ring assembly; and an unlocking mechanism configured to unlock the closure device, thereby enabling repositioning or retrieval of the prosthetic valve ring assembly from a patient through a catheter. In some embodiments, the prosthetic valve ring assembly may further include one or more bumps positioned on a perimeter of the prosthetic valve ring assembly and configured to apply additional pressure to trigones of the annulus tissue of the patient, thereby providing improved anchoring of the prosthetic valve ring assembly.

Aspects, features, benefits and advantages of the embodiments described herein will be apparent with regard to the following description, appended claims, and accompanying drawings where:.

This disclosure is not limited to the particular systems, devices and methods described, as these may vary. The terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope.

As used in this document, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Nothing in this disclosure is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term "comprising" means "including, but not limited to.

When implanting a replacement valve (e.g., an aortic valve, mitral valve, tricuspid valve, or other valve), the replacement valve can include a prosthesis attachment. The prosthesis can be configured to secure the replacement valve in a patient's heart. An example of such a prosthesis is the AMEND™ Mitral Valve Repair Annuloplasty ring developed by Valcare Medical. The AMEND™ ring is a D-shaped ring configured to emulate the total valve replacement for patients who suffer from Mitral Regurgitation (MR, as described above). Additional detail related to prosthetic valves for mitral or tricuspid valve replacement can be found in <CIT>.

As described herein, a prosthetic ring can be configured to include various anchor zones on a posterior side. The anchor zones are positioned to emit anchors in different directions and/or angles from two or more windows on the cross section of the ring. A portion of the anchors are emitted to the ventricular side of the annulus tissue, and a portion of the anchors are emitted to the atrial side of the annulus tissue. Such an arrangement can provide for improved anchoring of the ring into the annulus tissue as compared to conventional mitral valve rings.

It should be noted that, while the following detailed description of the figures is directed to a prosthetic ring configured to anchor a replacement valve such as the AMEND™ ring as described above, the techniques, ideas, and processes described herein can be applied to any mitral valve ring.

<FIG> illustrate various views of an improved mitral valve ring <NUM>. In certain implementations, the ring <NUM> can include posterior side anchor zones that are configured to emit anchors in different directions and/or angles from two or more windows on the cross section of the ring. A portion of the anchors are configured to be emitted to the ventricular side of a patient's annulus tissue, while a second portion of the anchors are configured to be emitted to the atrial side of the annulus tissue. Thus, two or more anchors can be emitted from one window in different directions.

<FIG> illustrates a top view of the ring assembly <NUM>. The ring assembly <NUM> includes an outer tube <NUM> that defines the shape of the ring assembly. The outer tube <NUM> includes one or more windows about its circumference as well as one or more windows in its cross-section. Anchors are positioned and configured to extend through these windows. The ring assembly <NUM> can also include a set of posterior zone anchors <NUM>. As shown in <FIG>, the posterior zone anchors <NUM> are generally positioned on the posterior of the ring assembly <NUM>. The ring assembly <NUM> can further include anterior zone anchors <NUM> generally positioned on the anterior of the ring assembly.

Each anchor zone (including both posterior zone anchors <NUM> and anterior zone anchors <NUM>) includes atrial side anchors <NUM> as well as ventricular side anchors <NUM> (not shown in <FIG> but illustrated in, for example, <FIG>). As noted above, in certain implementations, upon insertion of the ring assembly <NUM>, the atrial side anchors <NUM> are configured to be emitted into the atrial side of the patient's annulus tissue and the ventricular side anchors are configured to be emitted into the ventricular side of the patient's annulus tissue.

As further shown in <FIG>, the ring assembly <NUM> can include a closure device <NUM>. The closure device <NUM> can be configured to lock a distal end of the ring assembly <NUM> to a proximal end of the ring assembly. The closure device <NUM> can also be designed and configured to removably attach to a delivery system for the valve replacement implant. For example, in certain implementations, the closure device <NUM> can include a pivot pin <NUM> that is configured to removably attach the ring assembly <NUM> to a delivery device as well as provide for rotation of the ring assembly when emitted from the delivery device. For example, the pivot pin <NUM> can be configured to provide for <NUM> degrees of rotation of the ring assembly <NUM>. In other implementations, the pivot pin can be configured to provide for additional ranges of rotation such as <NUM>-<NUM> degrees of rotation, <NUM>-<NUM> degrees of rotation, and other similar ranges of rotation.

The ring assembly <NUM> can further include a set of pins <NUM>. The pins <NUM> can be positioned and configured to connect the outer tube <NUM> to the closure device <NUM>. In certain implementations, the pins <NUM> can be further positioned and configured to provide for routing of sutures as well as to function as a pulley while providing for rotation of a suture (e.g., <NUM> degree rotation) with minimal friction.

<FIG> illustrates a first side view of the ring assembly <NUM>, shown from the posterior and further illustrating the closure device <NUM>. <FIG> further illustrates the alternate emitting directions of the atrial side anchors <NUM> and the ventricular side anchors <NUM>.

<FIG> illustrates a bottom view of the ring assembly <NUM>. In contrast to <FIG>, <FIG> illustrates the ventricular side anchors <NUM>. <FIG> further illustrates additional anterior side anchors <NUM> that were obscured from view in <FIG>.

Additionally, in certain embodiments, various anchors can be configured such that portions of the anchors can cross one another in different directions, thereby creating a closed loop and stapling effect of the tissue. For example, anchors <NUM> and <NUM> as shown in <FIG> are configured to cross one another in different directions, thereby having a stapling effect on the adjacent tissue, securely locking the ring assembly <NUM> into position.

<FIG> illustrates a second side view of the ring assembly <NUM>, shown further illustrating the crossing anchors <NUM> and <NUM>.

The raw materials of the ring assembly <NUM> and various components included therein can be selected from various materials, such as various polymers, shape memory materials such as Nitinol, metals such as stainless steel, or other similar materials safe for implanting into or adjacent to living tissue. In certain implementations, the ring assembly <NUM> can include a combination of two or more different materials, such as stainless steel <NUM>/<NUM> and Nitinol. This combination is provided by way of example only, and other materials can be used alternately or additionally,.

In order to create the ring assembly <NUM> as described above, the outer tube <NUM> is manufactured such that multiple windows are defined. The windows are positioned to facilitate deployment of the various anchors as described above. <FIG> illustrates an example cut pattern <NUM> for creating the outer tube <NUM> as described above. For example, the pattern <NUM> shows an example cut pattern of a ring tube <NUM> with several windows 204A, 204B, 204C and 204D that allow deployment of anchors in different directions. For example, anchors can be emitted in the atrial side from windows 204D, and anchors can be emitted from the ventricular side from windows 204C.

In an alternate embodiment, more than one anchor can be emitted from one window with one or more anchors in the atrial side and one or more anchors in ventricular side. In another embodiment, one or more anchors can be emitted from different windows in the same direction. For example, two windows (e.g., 204A and 204B) can be configured to provide for simultaneous deployment of anchors towards the ventricular side.

<FIG> illustrate example cut patterns (e.g., laser cut patterns) for the anterior and/or posterior zone anchors such as posterior zone anchors <NUM> and anterior zone anchors <NUM> as described above. Additionally, as noted above, anchors can be emitted in both the atrial and ventricle directions, such as atrial anchors <NUM> and ventricle anchors <NUM> as described above.

To achieve such a configuration, cut pattern <NUM> as shown in <FIG> can be used to create one or more anchor zones <NUM>. The cut pattern can define a set of atrial anchors <NUM> and a set of ventricle anchors <NUM> within the anchor zone <NUM>. The cut pattern <NUM> can also define an anchor stop feature <NUM>. The anchor stop feature <NUM> can be configured to lock the anchor zone <NUM> into, for example, the outer tube of a ring assembly to prevent unintentional movement of the anchor zone.

In certain implementations, the anchor stop feature <NUM> can be a passive feature that is activated as a result of a force exerted on the anchor zone <NUM> (e.g., a pulling force) causing a bending or other change to the geometry of the anchor stop feature <NUM>. In other embodiments, the anchor stop feature <NUM> can include an associated activation mechanism that facilitates activation of the anchor stop feature. For example, the activation mechanism can be an activation pulley that prevents the anchor stop feature <NUM> from bending of otherwise deforming such that a portion of the anchor stop feature exits through a corresponding hole on the outer tube of the ring assembly. Such an arrangement can lock the anchor zone <NUM> into position as the anchor stop feature <NUM> prevents any relative movement. In some examples, pulling on the activator mechanism and removing it from the designated location allows the anchor stop feature <NUM> to bend and allows relative movement of the anchor zone <NUM> in relation to the outer tube of the ring assembly.

In certain implementations, the anchor stop feature <NUM> can be located in either the ventricular side or atrial side of the anchor zone <NUM> and/or outer tube. Additionally, in various embodiments, the anchor stop feature <NUM> can be positioned in any location along the anchor zone <NUM>. The position as shown in <FIG> is shown by way of example only.

It should be noted that laser cutting the ring assemblies as described herein is provided by way of example only, and additional manufacturing techniques can be used. For example, a stamping process can be used to stamp the cut patterns as described above.

<FIG> illustrate the cut patterns <NUM> as described above in regard to <FIG> that have been, for example, heat treated and to include various bends and curves, thereby defining a specific three-dimensional shape for the anchor zones <NUM>. For example, the anchor zones <NUM> can be heat-treated and bent at an angle selected from a range of angles. For example, in certain implementations the range of angles can be from zero degrees (e.g., no additional bending) to <NUM> degrees. As shown in <FIG>, the ventricle anchors <NUM> can be heat-treated to <NUM> degrees, and the atrial anchors <NUM> can be heat-treated to <NUM> degrees.

In addition, the anchor zone can have a 3D shape that fits the zone location in the final ring assembly. For example, the posterior anchor zones can be curved to fit the posterior curvature of the ring assembly, and the anterior anchor zones can be curved to fit the anterior curvature of the ring assembly.

It should be noted that heat-treated bending and curving is provided by way of example only. Depending upon the type of material being used and the design of the individual components such as the anchor zones, alternative bending and curving techniques can be used to form the anchor zones to the geometry of the final ring assembly.

<FIG> illustrate detailed views of a closing mechanism <NUM> for a ring assembly, such as closing mechanism <NUM> as described above in regard to ring assembly <NUM>. In certain implementations, a closing mechanism can include a female component configured to lock to a male component. For example, <FIG> illustrate various views and embodiments of the female component <NUM>. As shown in <FIG>, the female component <NUM> can include a locking mechanism for releasably attaching to a male component or cup <NUM>.

The female component <NUM> can further include an unsnapping pin <NUM>. The unsnapping pin can be positioned and configured to unsnap or otherwise disconnect the female component <NUM> from the cup <NUM> of the ring assembly. Additionally, the female component <NUM> can include a pivot pin <NUM> for attaching the female component to an outer tube of the ring assembly. Additionally, the pivot pin <NUM> can be configured to function as an interface between the ring assembly and a delivery system, similar to pins <NUM> as described above.

<FIG> illustrates a cross-section of the female component <NUM>. As shown in the cross-sectional view, the female component <NUM> can include a disk <NUM>. The disk <NUM> can be positioned to abut an end of the cup <NUM> when inserted into the female component <NUM> to provide for locking of the male component to the female component. In some examples, the disk <NUM> can be held in position with a cover.

<FIG> illustrates a view of the locking mechanism <NUM> with a portion of the cup <NUM> removed, showing additional detail of the unsnapping pin <NUM>. As shown in <FIG>, the unsnapping pin <NUM> can be designed with two individual fingers extending from a central point such that, upon exerting a force (e.g., a squeezing force) upon an end of the fingers opposite the central point, the fingers deflect about the point. Upon deflection of the unsnapping pin <NUM>, the unsnapping pin can be removed, thereby releasing the male component (e.g., cup <NUM>) from the female component <NUM>.

In certain implementations, the disk <NUM> and the unsnapping pin <NUM> can be made from a shape memory alloy such as Nitinol. In some example, the other components of the female component can be made from various metallic materials such as stainless steel, aluminum, Nitinol, and titanium.

As noted above, the cup <NUM> and the female component <NUM> are attached together with the unsnapping pin <NUM>. If properly inserted and positioned, the unsnapping pin <NUM> can visually verify that the two parts are well-attached and cannot open unintentionally. Conversely, upon activation of the unsnapping pin <NUM> by pulling it in a specific direction, it allows separation of the two components. By doing this, the ring close structure is compromised and the closed shape becomes open and allows retrieval of the implant into the delivery system.

In some embodiments, the female component <NUM> can have one or more gold markers <NUM> that provide for confirmation of locking of the cup <NUM> and the female component during a clinical procedure.

<FIG> illustrate various views of a ring assembly <NUM>. Similar to ring assembly <NUM> as described above, the ring assembly <NUM> includes an outer tube, a set of posterior zone anchors, a set of anterior zone anchors, and a closure device <NUM>. However, the ring assembly <NUM> as shown in <FIG> can further include additional anchors <NUM> and <NUM> positioned adjacent to the closure device and configured to improve attachment of the ring assembly <NUM> to the patient's posterior annulus tissue. In certain implementations, the anchors <NUM> and <NUM> can be configured to be emitted in different directions and/or angles from one or more windows on the cross section of the outer tube in the area of the closure device. In some examples, one or more additional anchors can be configured to be emitted to the ventricular side of the annulus tissue, and one or more of the additional anchors can be configured to be emitted to the atrial side of the annulus tissue. In some embodiments, two or more additional anchors can be configured to be emitted from one window in the outer tube in different directions to each other. In some embodiments, the anchors can include additional features such as hooks, barbs, or other similar features for increasing durability and preventing detachment.

In certain implementations, a ring assembly can further include bumps or other similar protrusions in the trigones area of the ring assembly. For example, as shown in <FIG>, a ring assembly <NUM> (shown without anchors in <FIG> and with anchors in <FIG>) can include bumps <NUM> and <NUM> positioned on the portion of the ring assembly that will be adjacent to the fibrous trigones region of a patient's heart. The bumps <NUM> and <NUM>, or other similar protrusions or added features, can provide for added contact between the ring assembly <NUM> and the patient's trigones region of the annulus tissue. In some implementations, achieving such contact can provide for better contact between the ring assembly <NUM> and the annulus tissue as compared to a ring assembly without the bumps in the trigones region. Similar to the ring assemblies as described above, various patterns and directions of anchors can be used to improve anchoring the ring assembly <NUM> to the annulus tissue as well.

In certain implementations, additional anchors can be beneficial for providing additional anchoring points for a ring assembly. In some examples, a single anchor or set of additional anchors can be emitted from an existing window in an outer tube of a ring assembly providing a more robust anchoring point as compared to the curved anchors as described above. For example, as shown in <FIG>, ring assembly <NUM> can include additional anchors configured to provide a more robust anchoring point. As shown in <FIG>, an additional anchor <NUM> can be emitted from a window for providing an additional anchoring point on the atrial side of the ring assembly <NUM>. <FIG> illustrates an additional anchor <NUM> being emitted from a similar window for providing an additional anchoring point on the ventricular side of the ring assembly <NUM>. <FIG> illustrates a set of two or more additional anchors emitting from a single window. In this example, additional anchors <NUM> and <NUM> provide additional anchoring into the atrial side and the ventricular side of the ring assembly <NUM> respectively.

In some implementations, resizing the ring assembly can be desirable as a single ring assembly can accommodate an additional range of patients and valve sizes. For example, a ring assembly can include a flexible connection that is laser cut from a similar material as the outer tube of the ring assembly. The flexible connection can be configured to contract and/or expand to allow for changing the size of the ring before, during, and/or after implantation of the ring assembly. In some examples, the ring assembly can be manufactured from separate segments or components that are configured to be attached together with a mechanism or device that controls expansion and/or contraction of each side of a ring assembly separately or simultaneously.

<FIG> illustrates a ring assembly <NUM> that is configured to be resizable as described above. The ring assembly <NUM> can include an anterior portion <NUM> and a posterior portion <NUM>. The anterior portion <NUM> and the posterior portion <NUM> can be connected together with a set of adjustable components <NUM> and <NUM>. The adjustable components <NUM> and <NUM> can be made from a flexible material configured to expand and/or contract, thereby changing the overall size of the ring assembly <NUM>. In certain implementations, the anterior portion <NUM> and/or the posterior portion <NUM> can include an adjustment mechanism that is configured to interact with the adjustable components <NUM> and <NUM> to change the size, shape and/or geometry of the ring assembly <NUM>. For example, the adjustment mechanisms can include a ratcheting feature that is configured to interact with the adjustable components <NUM> and <NUM> to change the size of the ring assembly <NUM>.

It should be noted that a ratcheting feature is provided by way of example only. Additional adjustment mechanisms such as friction-based holding devices, snap-based devices, winding devices, and other similar adjustment devices can be used. Additionally, it should be noted that two adjustable components <NUM> and <NUM> are shown by way of example. In additional implementations, various numbers of adjustable components can be used. For example, a single adjustable component can be included on one side of the ring assembly.

<FIG> illustrates a ring assembly <NUM> that is configured to be resizable, similar to ring assembly <NUM> as described above. However, the ring assembly <NUM> can include an anterior portion <NUM> and two posterior portions <NUM> and <NUM>. Such an arrangement can provide for additional flexibility and sizing options when implanting the ring assembly <NUM>.

In some implementations, the anterior portion <NUM> can be connected to the posterior portion <NUM> with a first adjustable component <NUM>. Similarly, the anterior portion can be connected to the posterior portion <NUM> with a second adjustable component <NUM>. The posterior portions <NUM> and <NUM> can be configured to releasably attach to one another via a closure device such as closure device <NUM> as described above.

The ring assemblies as described above can be designed and shaped for various functions such as mitral valve replacement. However, a similar ring assembly can be designed and constructed for tricuspid valve replacement as well. However, a tricuspid ring can be designed with additional features such as a release zone positioned on the ring assembly at a location that will be adjacent to a patient's atrioventricular node or valves.

<FIG> illustrate an example tricuspid ring assembly <NUM> (<FIG> illustrating a 3D view of the assembly, while <FIG> illustrates a flat cut pattern view). The outer tube <NUM> of the ring assembly <NUM> includes multiple windows through which anchors are emitted as described above. However, the ring assembly <NUM> can further include a release zone <NUM> configured and positioned at a location that will be adjacent to a patient's atrioventricular node or valves when the ring assembly is implanted.

In certain implementations, the release zone <NUM> does not have any anchors. Rather, the alternate shape and profile of the release zone provides for interference between the ring assembly <NUM> and the patient's atrioventricular node or valves, thereby securing the ring assembly in position.

In the above detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be used, and other changes may be made, without departing from the scope of the claimed subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the Figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.

The present disclosure is not to be limited in terms of the particular embodiments described in this application, which are intended as illustrations of various aspects. Many modifications and variations can be made without departing from the scope of the claims, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as "open" terms (for example, the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," et cetera). While various compositions, methods, and devices are described in terms of "comprising" various components or steps (interpreted as meaning "including, but not limited to"), the compositions, methods, and devices can also "consist essentially of" or "consist of the various components and steps, and such terminology should be interpreted as defining essentially closed-member groups. It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present.

However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (for example, "a" and/or "an" should be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (for example, the bare recitation of "two recitations," without other modifiers, means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to "at least one of A, B, and C, et cetera" is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, "a system having at least one of A, B, and C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, et cetera). In those instances where a convention analogous to "at least one of A, B, or C, et cetera" is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, "a system having at least one of A, B, or C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, et cetera). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms.

As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, et cetera. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, et cetera. As will also be understood by one skilled in the art all language such as "up to," "at least," and the like include the number recited and refer to ranges that can be subsequently broken down into subranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member. Thus, for example, a group having <NUM>-<NUM> cells refers to groups having <NUM>, <NUM>, or <NUM> cells. Similarly, a group having <NUM>-<NUM> cells refers to groups having <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> cells, and so forth.

Claim 1:
A prosthetic valve ring assembly (<NUM>, <NUM>, <NUM>, <NUM>), comprising:
an outer tube (<NUM>) comprising a plurality of windows; and
a plurality of anchors (<NUM>, <NUM>, <NUM>, <NUM>) positioned inside the outer tube (<NUM>) and about a perimeter of the outer tube (<NUM>), wherein the plurality of anchors (<NUM>, <NUM>, <NUM>, <NUM>) are configured to be emitted outward from the plurality of windows to anchor the prosthetic valve ring assembly (<NUM>) to a patient's annulus tissue;
characterised in that the plurality of anchors (<NUM>, <NUM>, <NUM>, <NUM>) are configured to be emitted in different directions, and wherein a first portion of the plurality of anchors (<NUM>) is configured to be emitted to a ventricular side of the annulus tissue, and a second portion (<NUM>) of the plurality of anchors is configured to be emitted to an atrial side of the annulus tissue.