Patent Description:
A tricuspid valve (TV) is an atrioventricular valve located in the right side of the human heart, between the right atrium (RA) and the right ventricle (RV). Anatomy of the TV is constituted of three asymmetrical leaflets, septal, anterior, and posterior, supported by a complex sub-valvular apparatus constituted by the chordae tendineae and the papillary muscles. The TV is also in proximity of the tendon of Todaro, where the heart's delicate atrioventricular node is located.

Regurgitant flow occurs during the systolic phases of the cardiac cycle when the tricuspid valve becomes incompetent. The incompetence is mainly caused by the pathology-induced progressive enlargement of the valve's annulus, which prevents the leaflets from reaching full coaptation during systole (or during the systole phase of the cardiac cycle). The lack of leaflets coaptation causes the development of a regurgitant orifice within the valve through which blood can reenter the right atrium instead of exiting the right ventricle via the pulmonary valve. This condition induces a cardiac overload with subsequent enlargement of the right ventricle and the right atrium, reduction of the right ventricular stroke volume, and increase in systemic vein congestion and other symptoms of congestive heart failure. Tricuspid valve regurgitation can be isolated from or associated to other valvulopathies, and leads to congestive heart failure, with reduced functional cardiovascular capacity and ultimately increased risks of mortality.

Surgical repair or replacement are the most commonly used techniques for treating this pathology, but the clinical results (e.g. mortality and recurrence) are suboptimal. Also, due to the common presence of several comorbidities in most patients affected by tricuspid regurgitation, the majority is ineligible for surgical repair or replacement because of the high risk correlated with those procedures.

Transcatheter therapy doesn't require open-heart surgery and could be a viable safer alternative. The unique anatomical feature of the tricuspid valve is the main challenge for developing a safe and effective implant. The anchoring possibly requires burdening of the adjacent cardiac structure (e.g. superior or inferior vena cava, the atrioventricular node, the coronary sinus, the right coronary artery, the ventricular myocardium). Also, the low pressure and output of the hemodynamic flow in the right side of the heart increases the risks of inducing atrioventricular pressure gradient and thrombogenesis.

<CIT> discloses a prosthesis including a leaflet contacting member and an anchoring member. The leaflet contacting member has an outer surface and an aperture that extends through at least a portion of the leaflet contacting member. The outer surface of the leaflet contacting member can be configured to contact one or more leaflets of the heart valve during coaptation of the leaflets, and the contact of the leaflets with the outer surface can prevent the leaflets from contacting one or more wires that extend through the aperture of the leaflet contacting member.

<CIT> and <CIT> disclose a device for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve-i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

According to the present invention there is provided a device for assisting a valve of a heart, comprising:.

In some embodiments of the disclosed device, the cross sectional area during systole is greater than the cross sectional area during diastole.

In some embodiments of the disclosed device, the flow optimizer includes:.

In some embodiments of the disclosed device, the covering collapses at least partially in a direction of a hemodynamic flow during diastole.

In some embodiments of the disclosed device, the frame has a conical shape, the first end regions of the plurality of arms joining at a central axis of the conical shape.

In some embodiments of the disclosed device, the conical shape has a base adjacent to a ventricle of the heart and a vertex adjacent to an atrium of the heart.

In some embodiments of the disclosed device, the covering includes a plurality of leaflet layers each arranged concentrically about the central axis.

In some embodiments of the disclosed device, the plurality of leaflet layers include two or more leaflet layers, the two or more leaflet layers including first and second leaflet layers that at least partially overlap.

In some embodiments of the disclosed device, the first and second leaflet layers open to define a gap for hemodynamic flow during diastole.

In some embodiments of the disclosed device, the first and second leaflet layer are respectively located proximally and distally from the central axis, an atrium-facing surface of the first leaflet layer overlaps at least partially with a ventricle-facing surface of the second leaflet layer.

In some embodiments of the disclosed device, the plurality of leaflet layers include two or more leaflet layers, the two or more leaflet layers including two adjacent leaflet layers that at least partially overlap.

In some embodiments of the disclosed device, the two adjacent leaflet layers open to define a gap for hemodynamic flow during diastole.

In some embodiments of the disclosed device, the two adjacent leaflet layers include first and second leaflet layer respectively located proximally and distally from the central axis, an atrium-facing surface of the first leaflet layer overlaps at least partially with a ventricle-facing surface of the second leaflet layer.

In some embodiments of the disclosed device, the covering inflates at least partially toward native valve leaflets during systole.

In some embodiments of the disclosed device, the covering at least partially blocks the regurgitation orifice during systole.

In some embodiments of the disclosed device, the distal end region is configured to mate with an annulus of the valve at the commissures.

In some embodiments of the disclosed device, each of the one or more anchoring arms is configured to have a range of shape expansion and adapts to a geometry of the annulus of the valve at the commissures.

In some embodiments of the disclosed device, the anchoring arms are configured to rotate about the central axis of the anchoring mechanism.

In some embodiments of the disclosed device, the one or more anchoring arms rotate about the central axis to match angular distribution of the commissures.

In some embodiments of the disclosed device, the one or more anchoring arms include a first anchoring arm, the proximal end region of the first anchoring arm including a cylindrical protrusion aligned with the central axis.

In some embodiments of the disclosed device, the one or more anchoring arms include a second anchoring arm, the proximal end region of the second anchoring arm is fixedly connected to an inner core enclosed in the cylindrical protrusion and configured to rotate about the central axis relative to the first cylindrical protrusion.

In some embodiments of the disclosed device, rotating the inner core relative to the first cylindrical protrusion changes an angle between the first and second anchoring arms.

In some embodiments of the disclosed device, the one or more anchoring arms include a third anchoring arm, the proximal end region of the third anchoring arm including a central portion located between the cylindrical protrusion and the inner core and configured to rotate about the central axis relative to the inner core.

In some embodiments of the disclosed device, rotating the proximal end region of the third anchoring arm relative to the inner core changes an angle between the second and third anchoring arms.

In some embodiments of the disclosed device, the anchoring mechanism includes a locking collar configured to fix relative positions among the one or more anchoring arms.

In some embodiments of the disclosed device, the anchoring arms are configured to rotate prior to loading into a catheter, after deployment in the heart via the catheter, or a combination thereof.

In some embodiments of the disclosed device, the one or more anchoring arms include three anchoring arms, the distal end region of each of the three anchoring arms being configured to be located at a respective commissure of the native valve leaflets.

In some embodiments of the disclosed device, each of the one or more anchoring arms includes an intermediate region between the proximal end region and the distal end region, the intermediate region being configured to rest against an inner supra-annular wall of an atrium.

In some embodiments of the disclosed device, the anchoring mechanism includes a height adjustment mechanism configured to individually control a shape of each of the one or more anchoring arms.

In some embodiments of the disclosed device, the height adjustment mechanism includes a cable having a proximal end region slidingly connected to a proximal end region of a first anchoring arm of the one or more anchoring arms, the proximal end region of the first anchoring arm being aligned with the central axis, the cable having a distal end region connected to a distally-extending portion of a selected anchoring arm of the one or more anchoring arms.

In some embodiments of the disclosed device, the device further includes a shaft connecting the flow optimizer and the anchoring mechanism.

In some embodiments of the disclosed device, the shaft is threaded such that rotations of the shaft relative to the anchoring mechanism changes a distance between the flow optimizer and the anchoring mechanism.

In some embodiments of the disclosed device, the shaft is threaded such that rotations of the shaft relative to the anchoring mechanism changes a radial orientation of the flow optimizer relative to the anchoring mechanism.

In some embodiments of the disclosed device, the anchoring mechanism includes a locking collar configured to fix a relative position between the flow optimizer and the anchoring mechanism.

In some embodiments of the disclosed device, the shaft is configured to rotate relative to the anchoring mechanism prior to loading into a catheter, after deployment in the heart via the catheter, or a combination thereof.

In some embodiments of the disclosed device, each of the flow optimizer and the anchoring mechanism has a crimped conformation adapted to be loaded in a catheter and a deployed conformation upon deployment in the heart.

In some embodiments of the disclosed device, the anchoring mechanism includes an anchoring device coupled to the flow optimizer and configured to anchor to a vena cava.

In some embodiments of the disclosed device, the flow optimizer includes an atrial anchor coupled to the flow optimizer and configured to anchor to an atrial wall.

In some embodiments of the disclosed device, the flow optimizer includes a ventricular anchor coupled to the flow optimizer and configured to anchor to a ventricular wall.

There is also hereinafter disclosed an example of an apparatus for implantation, including:.

In some examples of the disclosed apparatus, the distal end region is configured to mate with an annulus of the valve at the commissure.

There is further hereinafter disclosed an example of a method for deploying a device for supporting functions of a valve of a heart, including:.

In some examples of the disclosed method, the anchoring mechanism includes one or more anchoring arms each including a proximal end region joining at a central axis and a distal end region extending from the central axis, wherein the opening includes partially opening the one or more anchoring arms.

In some examples of the disclosed method, after the partially opening the one or more anchoring arms, the method further includes respectively aligning the one or more anchoring arms with commissures of native valve leaflets of the valve.

It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are generally represented by like reference numerals for illustrative purposes throughout the figures. It also should be noted that the figures are only intended to facilitate the description of the preferred embodiments. The figures do not illustrate every aspect of the described embodiments and do not limit the scope of the present disclosure.

The disclosed embodiments relate to catheter-delivered intracardiac implants for supporting and improving the function of the tricuspid valve.

This disclosure captures a novel device with one or more features to address such an anatomically and hemodynamically challenging scenario. During the diastolic phase of the cardiac cycle, a flow optimizer is devised to minimize its cross-sectional area and allows hemodynamic flow around and also through the implant, thus minimizing the potential risk of inducing atrioventricular pressure gradient and thrombogenesis. During the systolic phase, the flow optimizer seals or minimizes the regurgitant orifice and reinstates the efficacy of the tricuspid valve. The device's anchoring system doesn't require traumatic interaction with the tricuspid valve, right atrium and right ventricle, and implantation can be achieved with minimal procedural steps. Furthermore, anchoring mechanism of the device permits intra-procedural adjustments, under standard imaging techniques (e.g. fluoroscopy, echocardiography), of positioning of the flow optimizer within the native tricuspid valve to allow real-time optimization of the hemodynamic flow across the tricuspid valve. The disclosure is devised to increase the efficacy, safety, and procedural success of transcatheter therapy of tricuspid valve regurgitation.

The present disclosure provides tricuspid valve support devices that can be used to reduce or prevent tricuspid regurgitation (TR). The devices are capable of adopting a crimped conformation, so that they can be deployed using a standard intravascular catheter, and a deployed conformation within the body. Generally, the devices have a tricuspid valve flow optimizer that is placed within the lumen of the tricuspid valve. The flow optimizer permits diastolic hemodynamic flow from the right atrium into the right ventricle and, during systole, reduces or prevents blood regurgitation from the right ventricle into the right atrium through the regurgitation orifice present in the tricuspid valve of subjects affected by TR. The flow optimizer is directly connected to an anchoring structure that engages the tricuspid valve annulus at the commissure of the native leaflets and/or the supra-annular walls of the right atrium. In alternative configurations, the flow optimizer is attached to an anchoring element directly or through an articulating link. The articulating link can be configured to adopt and hold a three-dimensional configuration in order to maintain a proper shape and orientation from the anchoring device and within the tricuspid valve lumen. The anchoring element can be an intravascular stent configured to anchor the device by a frictional contact within the SVC or IVC, thereby providing support to the flow optimizer from the atrial side and further comprises an atrial support or anchoring structure. Alternatively, the anchoring element is frictionally engaged with the inner wall of the right ventricle, preferably at the ventricle apex. Optionally, this latter configuration further comprises an atrial anchoring structure.

Although shown and described with reference to a tricuspid valve for purposes of illustration only, the device, the flow optimizer and/or the anchoring mechanism can be applied to any valve of the heart.

In some embodiments, the device can be at least partially oriented such that two opposite end regions of the device are close to and away from the heart, respectively. In those embodiments, "distal" can be a relative term that can refer to the direction or side towards the heart and, more specifically, toward the ventricle apex of the heart. For example, the flow optimizer <NUM> in <FIG> is located at the distal end of the vena cava-anchored device, as described in more detail below. In those embodiments, "proximal" can be a relative term that can refer to the direction or side away from the heart. For example, anchoring stent <NUM> in <FIG> is located at the proximal end of the vena cava-anchored device, as described in more detail below.

The disclosure provides an implantable tricuspid valve support device that can be delivered and implanted using a catheter. The device provides a flow optimizer that is placed within the tricuspid valve to support and improve the hemodynamic function in patients affected by tricuspid regurgitation (TR). The device seals the coaptation gap between the native leaflets during the systolic phase of the cardiac cycle and allows blood flow from the right atrium to the right ventricle during the diastolic phase of the cardiac cycle. In some embodiments, the disclosure provides an anchored device. Anchoring can be achieved from the atrial side such as within the superior vena cava (SVC) or the inferior vena cava (IVC), or anchoring can be achieved by supporting the device from within the right ventricle. In some embodiments, the device is anchored only within the right atrium. In other embodiments, the device is anchored within the right atrium, at the commissures of the tricuspid valve annulus, and/or at the supra-annular region of the right atrium.

<FIG> illustrates a tricuspid valve support device <NUM>, in a deployed conformation, configured to be anchored in the vena cava. The vena cava can include superior vena cava (SVC) and/or inferior vena cava (IVC). <FIG> shows the device <NUM> as including an anchoring stent <NUM> connected to an atrial anchor <NUM> via an articulating Link <NUM>. The atrial anchor <NUM> is attached to a tricuspid valve flow optimizer <NUM> and comprises one or more (e.g., one, two, three, four, or more) atrial support arms <NUM>. <FIG> illustrates an exploded view of these elements in the deployed conformation. <FIG> illustrates the tricuspid valve support device <NUM> in a crimped conformation as the tricuspid valve support device <NUM> can be loaded into an intravascular delivery catheter (not shown). <FIG> illustrates an exploded view of the tricuspid valve support device <NUM> in a crimped conformation. Each of the device elements and the method for deployment is described in more detail below.

The anchoring stent <NUM> is sized and adapted to adopt a crimped conformation, when loaded and housed within an intravascular catheter, and a deployed conformation. The anchoring stent <NUM> can be self-expanding and/or balloon-deployed. The anchoring stent <NUM> can be appropriately sized for the desired anchoring vessel (i.e., the SVC or IVC) and is configured and constructed in accordance with standard techniques and materials used for intravascular stents. For example, the anchoring stent <NUM> can be formed from stainless steel, a memory shape metal such as Nitinol® (NiTi), or any suitable biocompatible polymer. The anchoring stent <NUM> serves to anchor the device within the body by a frictional contact with the inner wall of the blood vessel while maintaining vessel patency. The anchoring stent <NUM> can have a generally cylindrical stent body <NUM>. The stent body <NUM> can be attached at a distal end region thereof to the articulating link <NUM>. In one configuration, the stent body <NUM> can be attached at the distal end region thereof to a proximal end region of the articulating link <NUM> by one or more (e.g., one, two, three, four, or more) Stent Arms <NUM>.

The articulating link <NUM> is adapted to connect the anchoring stent <NUM> to the atrial anchor <NUM> without significantly impeding blood flow. For example, articulating link <NUM> can be configured to reside toward the center and/or midline of the vessel, when deployed. The articulating link <NUM> can be solid or hollow. Articulating link <NUM> further comprises a Receiver <NUM> at its distal end that is adapted to receive and secure the atrial anchor <NUM>. The Receiver <NUM> can comprise a first mating pair member adapted to mate with a second mating pair member located on the atrial anchor <NUM>. The receiver <NUM> can be articulating or non-articulating. For embodiments in which the receiver <NUM> is non-articulating, it is configured to reside entirely within the atrium so that the lack of articulation does not interfere with the proper placement and orientation of the atrial anchor <NUM> and/or the flow optimizer <NUM>.

The articulating link <NUM> is configured to deform and maintain any three-dimensional curvature induced by the catheter delivery system. A variety of gooseneck, interlocking coils, and interlocking links can be used in accordance with the principles set forth herein. <FIG> illustrate two exemplary types of interlocking links that can be used.

The atrial anchor <NUM> comprises a second mating pair member adapted to mate with the first mating pair member located on receiver <NUM>. The atrial anchor <NUM> can include one or more (e.g., one, two, three, four, or more) radially-deploying atrial support arms <NUM>. The atrial anchor <NUM> is adapted to support the flow optimizer <NUM>, on the distal end region of the atrial anchor <NUM> and within the tricuspid valve (e.g., through the receiver <NUM>). Preferably, the arms <NUM> are self-deploying from the crimped conformation to the deployed conformation once released from the delivery catheter. The arms <NUM> can be formed from any suitable material, including memory shape materials such as NiTi. Optionally, the arms <NUM> further comprise a friction enhancing layer on a body-facing surface of the arms <NUM>, in order to enhance adhesion with the atrial wall. Exemplary friction enhancing layer can be made of polymer including, for example, fabric hook and loop fasteners (for example, Velcro® available from Velcro company in United Kingdom) and microbarbs.

Additionally and/or alternatively, the atrial anchor <NUM> further comprises a height adjustment mechanism adapted to adjust the vertical positioning of the arms <NUM> relative to the flow optimizer <NUM>. <FIG> illustrates an exemplary height adjustment mechanism defining a channel <NUM> having a series of notches <NUM> into which an arm <NUM> is fitted. <FIG> provides a close-up view of the vertical positioning system, and <FIG> provides a cross-sectional view of the interior elements. The distal end region of each arm <NUM> terminates in a tab <NUM>. Each arm <NUM> is slidably engaged with a channel <NUM> in the receiver <NUM> such that arm <NUM> can be translocated in the proximal or distal axial direction. Channel <NUM> defines a series of horizontal notches <NUM> sized to accept tab <NUM>.

In one embodiment, the arms <NUM> can be positioned in the deployed conformation, prior to loading the device <NUM> into the deliver catheter. The selection of the height positioning can be determined using imaging and/or other data obtained from the patient.

Additionally and/or alternatively, the arms <NUM> can be positioned proximally or distally relative to the flow optimizer <NUM> after deployment of the device <NUM> within the atrium. For example, the arms <NUM> can be translocated relative to the flow optimizer <NUM> using an internal operator-controlled wire that is affixed to the distal end of the arms <NUM> and adapted to pull the distal end regions of the arms <NUM> inward towards the central axis of lumen of the device <NUM>, thereby releasing the tabs <NUM> from the notches <NUM>. The arms <NUM> can be translocated in the axial direction and the spring/memory shape property of the distal ends returns the tabs <NUM> into the notches <NUM> when tension from the catheter is released.

Additionally and/or alternatively, the tabs <NUM> are reversibly engaged with a wire or tube internal to the catheter lumen in a manner that maintains the tabs <NUM> disengaged from the notches <NUM>. After deployment of the device, the operator may translocate the arms <NUM> using that internal wire or tube until the arms <NUM> are properly positioned within the atrium (e.g., frictionally engaged with the atrial wall), and them disengage the tabs <NUM> from the internal wire or tube such that the tabs <NUM> become engaged with the notches <NUM>.

<FIG> shows the tricuspid valve flow optimizer <NUM> as being in conical in shape. However, the tricuspid valve flow optimizer <NUM> can be formed in any desirable shape, preferably to match the tricuspid valve anatomy to ensure the atraumatic coaptation during systole of the native tricuspid valve leaflets on the flow optimizer. Specifically, during the systolic phase of the cardiac cycle, the flow optimizer <NUM> is devised to coapt with the tricuspid valve leaflets and fill the regurgitation orifice in the tricuspid valve. During the diastolic phase of the cardiac cycle, the flow optimizer <NUM> permits hemodynamic flow from the right atrium into the right ventricle. Exemplary flow optimizer <NUM> can include a frame <NUM>. An exemplary frame <NUM> can be formed from a memory-shape material. For example, the frame <NUM> can include a wire/ribbon frame made from a memory shape material, such as NiTi. The exemplary flow optimizer <NUM> can include a covering formed from one or more (e.g., two, three, four, five, or more) layers of the leaflets <NUM> (shown in <FIG>).

As shown in <FIG>, the flow optimizer frame can comprise two or more (e.g., two, three, four, five, or more) arms <NUM> that support the covering material and impart the desired three-dimensional shape to the leaflets <NUM>. The leaflets <NUM> can be made of a material that is impermeable to blood cells and, preferably, impermeable to blood fluids (e.g., aqueous solutions). The leaflets <NUM> can be formed from any suitable biocompatible material including, for example, woven or nonwoven polymer fabrics or sheets, and/or biological tissue harvested from animals (e.g., bovine, porcine, and equine) or humans. Suitable biological tissue includes, for example, tissue obtained from the pericardial sac of the donor animal and/or human. The leaflets <NUM> are sutured or attached with other standard fastening methods (e.g. adhesives) on the arms <NUM> of the frame <NUM>. Additionally and/or alternatively, the leaflets <NUM> can be molded in the desired three dimensional shape as a single sub-assembly mountable on the frame <NUM> as shown in <FIG> and <FIG>.

As shown in <FIG>, the tricuspid valve flow optimizer <NUM> can be configured to allow the leaflets <NUM> to collapse towards the center axis of frame <NUM> during diastole (or during a diastole phase of the cardiac cycle). The leaflets <NUM> of the tricuspid valve flow optimizer <NUM> are made from a pliable but impermeable material that forms a collapsible dome and/or other three-dimensional structures. During diastole, when blood flows from the right atrium into the right ventricle through the tricuspid valve under atrial contraction, the atrioventricular hemodynamic pressure gradient opens the tricuspid valve leaflets (not shown). The atrioventricular hemodynamic pressure gradient collapses the leaflets <NUM> of flow optimizer <NUM> towards the center axis of the frame <NUM>, such that the three-dimensional volume and cross sectional area of the flow optimizer <NUM> can be reduced as shown in <FIG>, thereby allowing blood to flow unrestricted into the ventricle around the flow optimizer <NUM>. The cross sectional area of the tricuspid valve flow optimizer <NUM> can include a size of the tricuspid valve flow optimizer <NUM> when the tricuspid valve flow optimizer <NUM> is viewed from the right atrium.

As shown in <FIG>, the tricuspid valve flow optimizer <NUM> can be configured to inflate towards the arms <NUM> to fill the lumen of the regurgitation orifice (not shown) and thereby prevents regurgitation during systole. As shown in <FIG>, during systole (i.e., ventricular contraction), when the tricuspid valve leaflets coapt around the flow optimizer <NUM>, the ventricular hemodynamic pressure inflates the leaflets <NUM> to their full three-dimensional volume which is sufficient to close the tricuspid valve regurgitant orifice and reduce or prevent blood flow into the right atrium.

Additionally and/or alternatively, as shown in <FIG>, the covering of flow optimizer <NUM> can be formed from an overlapping cascade of two or more (e.g., two, three, four, or more) circumferential leaflet layers of the leaflets <NUM> to achieve, during the diastolic phase, an efficient reduction of the three-dimensional volume, and to leave open gaps between the leaflet layers of the leaflets <NUM>, allowing a blood flow path throughout the flow optimizer <NUM>. The gaps further minimize the cross-section area of the flow optimizer <NUM> that can restrict the hemodynamic flow, thus reducing the potential of creating a pressure gradient across the native tricuspid valve. The gaps also improve blood washout within the flow optimizer, minimizing blood stagnation and thus risk of thrombogenesis. The circumferential leaflets are aligned such that the distal (bottom, or the ventricle-side) edge of the upper leaflet layer (closest to the atrium) 150a overlaps on the inside of the proximal (upper, or the atrium-side) edge of the lower leaflet layer (closest to the ventricle) 150b.

As shown in <FIG>, during systole, the ventricular pressure closes the leaflets of the tricuspid valve, making the leaflets of the tricuspid valve coapt around the flow optimizer <NUM>, and expands the leaflets layers 150a, 150b to a full three-dimensional shape, pressing the leaflets layers 150a, 150b together to seal gaps <NUM> (shown in <FIG>), and preventing blood flowing into the ventricle to pass through and around the flow optimizer <NUM>.

During diastole, depending upon the construction and choice of materials and shapes, the leaflets layers 150a, 150b of the flow optimizer <NUM> partially and/or completely collapse, allowing blood flow from the atrium into the ventricle around the flow optimizer <NUM> and also through the gaps <NUM> open between the leaflets layers 150a and 150b as shown in <FIG>. A similar pattern of overlapping three, four or more leaflet layers can be used for each leaflet <NUM>.

In one embodiment shown in <FIG>, six flaps 250a, 250b, arranged over two levels, allow hemodynamic flow through gaps <NUM> of the flow optimizer <NUM> during the diastolic phase of the cardiac cycle. As shown in <FIG>, the flaps 250a and 250b close the gaps <NUM> during the systolic phase of the cardiac cycle and thus prevent regurgitation through the native tricuspid valve. The flaps 250a, 250b are semi-rigid in order to retain a shape when opening or closing. Three flaps 250a are arranged on the upper layer of the frame <NUM>, and three flaps 250b are arranged on the lower layer of the frame. The flaps 250a and 250b are connected to the frame <NUM> of flow optimizer <NUM> with connection strips 252a, 252b, which are patches of soft tissue or other pliable impermeable material preventing blood passage through the boundaries of flaps 250a and 250b. The patches are connected to the frame <NUM> with hinges 251a, 251b. <FIG> show flow optimizer <NUM> during the diastolic phase of the cardiac cycle, when the atrioventricular pressure gradient rotates the flaps 250a and 250b about hinges 251a and 251b in the direction of the hemodynamic flow. In this conformation, blood can pass through the open gaps <NUM> between the flaps 250a and 250b, providing a washing action to prevent risk of blood stagnation and thrombogenesis within the flow optimizer.

<FIG> shows the flow optimizer <NUM> during the systolic phase of the cardiac cycle, when the atrioventricular pressure gradient rotates the flaps 250a and 250b towards the atrium. In this conformation, the distal (closer to the ventricle) edges of the flaps 250b overlap with the proximal (closer to the atrium) edges of the flaps 250a, thus sealing gaps <NUM> and preventing blood passage through.

Device <NUM> can be anchored in the SVC and/or the IVC, depending upon which vessel is accessed. Deployment through the SVC is shown herein. The same principles and techniques can apply to the deployment of device <NUM> through the IVC.

<FIG> illustrate the deployment sequence of device <NUM> into the heart <NUM> of a subject (for example, a patient). <FIG> illustrates that the device is inserted into the right atrium <NUM> via the SVC <NUM>. Device <NUM> is housed within an intravascular delivery catheter (not shown) which holds device <NUM> in the crimped conformation. As illustrated in <FIG>, device <NUM> is deflected toward tricuspid valve <NUM> using the catheter steering mechanism. When aligned with tricuspid valve <NUM>, device <NUM> can be pushed through into such that the distal end region of device <NUM> (and catheter) is located within the right ventricle <NUM>. The flow optimizer <NUM> can be deployed as shown in <FIG> and device <NUM> is positioned such that flow optimizer <NUM> is disposed within tricuspid valve <NUM>. The flow optimizer <NUM> can be deployed by a partial retraction of the catheter. As shown <FIG>, the arms <NUM> can be deployed such that the distal end regions of the arms <NUM> are seated on the top of tricuspid valve <NUM> and/or against the wall of atrium <NUM> so as to suspend flow optimizer <NUM> within the tricuspid valve <NUM>. Optionally, arms <NUM> can be height-adjusted as described herein. <FIG> provides a perspective view of a fully deployed device <NUM>. <FIG> provides a wire drawing illustrating a fully deployed device <NUM> within the heart <NUM>.

<FIG> illustrates a tricuspid valve support device <NUM>, in a deployed conformation, configured to be anchored in the right ventricle and in the right atrium. <FIG> shows the device <NUM> as including a ventricular anchor <NUM>, which can include one or more (e.g., one, two, three, four, or more) support arms <NUM>, connected to an articulating link <NUM> which is attached to tricuspid valve flow optimizer <NUM>. Additionally and/or alternatively, device <NUM> can further comprise an atrial anchor <NUM> that can have one or more (e.g., one, two, three, four, or more) arms <NUM>. The arms <NUM> can be radially disposed from a central axis of device <NUM> and can be single ribbons or rods, or regular geometric or random shapes, as illustrated. <FIG> illustrates an exploded view of the tricuspid valve support device <NUM> in the deployed conformation. <FIG> illustrates the tricuspid valve support device <NUM> in a crimped conformation as the tricuspid valve support device <NUM> can be loaded into an intravascular delivery catheter (not shown). <FIG> illustrates an exploded view of the tricuspid valve support device <NUM>, in a crimped conformation. Each of the device elements of the tricuspid valve support device <NUM> and the method for deployment is described in more detail below.

The ventricular anchor <NUM> is configured and adapted to support device <NUM> by resting against the inner wall of the right ventricle at and/or near the ventricle apex. In some embodiments, the ventricular anchor <NUM> contains a plurality of arms <NUM> on the distal side. The arms <NUM> can be formed from a memory shape material as described herein such that the arms <NUM> are self-expanding when released from the intravascular delivery catheter. The arms <NUM> can be formed from any suitable material, including memory shape materials such as NiTi. Additionally and/or alternatively, the arms <NUM> can comprise a friction enhancing layer (e.g., polymer) including, for example, Velcro® and micro-barbs, in order to enhance adhesion with the ventricular wall. Additionally and/or alternatively, the arms <NUM> can partially penetrate the ventricular wall in order to facilitate anchoring. The ventricular anchor <NUM> is attached to articulating link <NUM> on a distal end region of the articulating link <NUM>.

The articulating link <NUM> can have similar or the same construction as the articulating link <NUM>, as described above in the context of device <NUM>. A tricuspid valve flow optimizer <NUM> can be attached at a proximal end region of the articulating link <NUM>.

The tricuspid valve flow optimizer <NUM> can have the same or similar construction as the tricuspid valve flow optimizer <NUM>, as described above in the context of device <NUM>. The tricuspid valve flow optimizer <NUM> can be supported from the ventricle at the ventricle apex by the articulating link <NUM> and from the atrium by the atrial anchor <NUM>.

Additionally and/or alternatively, the flow optimizer <NUM> and the articulating link <NUM> can have a height adjustment mechanism to allow for more precise positioning of the flow optimizer <NUM> within the tricuspid valve. In one embodiment, illustrated in <FIG> and <FIG>, the articulating link <NUM> can have a centrally-disposed non-articulating attachment member <NUM> defining a plurality of notches <NUM>. The flow optimizer <NUM> comprises a frame <NUM> having a centrally-disposed sleeve <NUM> which one or more detents <NUM> configured to mate with notches <NUM>. The flow optimizer <NUM> positioning can be adjusted by sliding the frame <NUM> longitudinally along attachment member <NUM> such that the detents <NUM> disengage and re-engage with the notches <NUM>. In one embodiment, the detents <NUM> are configured to allow sliding in only one direction. For example, unidirectional detents <NUM> are configured to allow translocation in the proximal direction (i.e., toward the ventricle apex). In another embodiment, the frame <NUM> and the attachment member <NUM> have a threaded engagement such that the operator can rotate the frame <NUM> to cause a translocation in either direction.

Additionally and/or alternatively, the device <NUM> can comprises an atrial anchor <NUM> which extends proximally from the tricuspid valve flow optimizer <NUM> into the right atrium. When deployed, atrial anchor <NUM> rests on the inner wall of the right atrium above and/or adjacent to the annulus of the tricuspid valve, to provide additional support and stabilization to the tricuspid valve flow optimizer <NUM>. The atrial anchor <NUM> can comprise one or more (e.g., one, two, three, four, or more) support arms <NUM>. The arms <NUM> can be linear and/or contoured to conform to the atrial wall in and/or adjacent to the supra-annular region of the tricuspid valve. Alternatively, the arms <NUM> can each include a wire that defines a closed shape. Preferably, the atrial anchor <NUM> and/or the arms <NUM> are formed from a memory shape material (e.g., NiTi) such that they are self-expanding when released from the delivery catheter. Additionally and/or alternatively, the arms <NUM> can comprise, on the body-facing surface thereof, a friction enhancing layer (e.g., polymer) including, for example, Velcro® and micro-barbs, in order to enhance adhesion with the atrial wall.

In one embodiment, the atrial anchor <NUM> can be locked in the desired position relative to the articulating link <NUM> prior to loading the device <NUM> into the deliver catheter. The selection of the height positioning can be determined using imaging and/or other data obtained from the patient.

Additionally and/or alternatively, the atrial anchor <NUM> can be positioned proximally or distally relative to the articulating link <NUM> after deployment of the ventricular anchor <NUM> within the ventricle. For example, the atrial anchor <NUM> can be translocated relatively to the articulating link <NUM> via an internal operator-controlled lumen that is affixed to the central sleeves <NUM> of the flow optimizer <NUM>. A secondary operator-controlled lumen connected to the proximal end of the articulating link <NUM> and covering the notches <NUM> can prevent the notches <NUM> from engaging with the detents <NUM> of the sleeves <NUM>. Once the flow optimizer <NUM> is translocated to the desired position on the articulating link <NUM>, the secondary operator-controlled lumen can be retrieved to expose the notches <NUM> thus allowing the detents <NUM> to engage with the notches <NUM> and lock the position of the flow optimizer <NUM> on the articulating link <NUM>.

Similarly to the deployment of device <NUM>, device <NUM> can be deployed using an intravascular catheter (not shown) and delivered through either the SVC or IVC. The catheter is pushed through the tricuspid valve from the right atrium into the right ventricle, with the catheter lumen positioned near the ventricle apex. The catheter's outer lumen can be partially retracted to deploy the ventricular anchor <NUM> and/or the arms <NUM>. Using a catheter with steerable distal-end functionality, the positioning of device <NUM> can be adjusted to seat the ventricular anchor <NUM> at the ventricle apex. The catheter's outer lumen can be further retracted, exposing articulating link <NUM> and the flow optimizer <NUM>. The articulating link <NUM> can be manipulated using the catheter's steerable distal end to seat the flow optimizer <NUM> at the desired location within the tricuspid valve. The catheter's outer lumen can be fully retracted, deploying the atrial anchor <NUM>. <FIG> is a wireframe drawing showing device <NUM> fully deployed in the right atrium. <FIG> is an enlargement illustrating the positioning of the ventricular anchor <NUM> at the ventricle apex of the right ventricle. <FIG> is an illustration of a deployed device <NUM> viewed from the atrial side.

<FIG> illustrates a tricuspid valve support device <NUM>, in a deployed conformation, configured to be anchored in the right atrium. <FIG> shows the device <NUM> as including an Atrial Anchor <NUM>. The atrial anchor <NUM> can include one or more (e.g., one, two, three, four, or more) support arms <NUM>, attached to tricuspid valve flow optimizer <NUM>. The arms <NUM> can be radially disposed from the central axis of device <NUM> and can be single ribbons or rods, or regular geometric or random shapes, as illustrated. <FIG> illustrates the tricuspid valve support device <NUM> in a crimped conformation as the tricuspid valve support device <NUM> can be loaded into an intravascular delivery catheter. <FIG> illustrates the tricuspid valve support device <NUM> including an optional vertical height adjustment mechanism to vary the relative distance between the flow optimizer <NUM> and the atrial anchor <NUM>. Each of the device elements and the method for deployment is described in more detail below.

The tricuspid valve flow optimizer <NUM> can have the same or similar construction as the tricuspid valve flow optimizer <NUM>, as described above in the context of device <NUM>. The tricuspid valve flow optimizer <NUM> can be supported from a proximal direction by the atrial anchor <NUM>.

Device <NUM> further comprises an atrial anchor <NUM> which extends proximally from the tricuspid valve flow optimizer <NUM> into the right atrium. When deployed, the atrial anchor <NUM> rests on the inner wall of the right atrium above and/or adjacent to the annulus of the tricuspid valve to provide support and stabilization to the tricuspid valve flow optimizer <NUM>. The atrial anchor <NUM> can comprise one or more (e.g., one, two, three, four, or more) support arms <NUM>. The arms <NUM> can be linear and/or contoured to conform to the atrial wall in and/or adjacent to the supra-annular region of the tricuspid valve, and they can have individual shapes and/or length. Alternatively, the arms <NUM> can include a wire that defines a closed shape, for example a looped shape. Preferably, the atrial anchor <NUM> and/or the arms <NUM> are formed from a memory shape material (e.g., NiTi) such that the atrial anchor <NUM> and/or the arms <NUM> are self-expanding when released from the delivery catheter. Optionally, the arms <NUM> further comprise on the body-facing surface a friction enhancing layer (e.g., polymer) including, for example, Velcro® and micro-barbs, in order to enhance adhesion with the atrial wall.

Optionally, the flow optimizer <NUM> and the atrial anchor <NUM> can be coupled with a height adjustment mechanism to allow for more precise positioning of the flow optimizer <NUM> within the tricuspid valve. In one embodiment, illustrated in <FIG> and <FIG>, the atrial anchor <NUM> has a centrally-disposed articulating or non-articulating attachment member <NUM> defining a plurality of notches <NUM>. The flow optimizer <NUM> comprises a Frame <NUM> having a centrally-disposed sleeve <NUM> which one or more detents <NUM> configured to mate with notches <NUM>. The flow optimizer <NUM> positioning can be adjusted by sliding the frame <NUM> longitudinally along attachment member <NUM> such that the detents <NUM> disengage and re-engage with the notches <NUM> as shown in <FIG>. In one embodiment, the notches <NUM> are configured to allow sliding in both distal and proximal directions. Optionally, unidirectional the notches <NUM> are configured to allow translocation in one direction, either distal (e.g., towards the ventricle) or proximal (e.g. towards the atrium). In another embodiment, the frame <NUM> and attachment member <NUM> have a threaded engagement such that the operator can rotate the frame <NUM> to allow a translocation in either direction.

In one embodiment, the atrial anchor <NUM> can be positioned in the desired position relative to the flow optimizer <NUM> prior to loading the device <NUM> into the deliver catheter. The selection of the height positioning can be determined using imaging and/or other data obtained from the patient.

Additionally and/or alternatively, the atrial anchor <NUM> can be positioned proximally or distally relative to the flow optimizer <NUM> after deployment of the device <NUM> within the atrium. For example, the atrial anchor <NUM> can be translocated relatively to the flow optimizer <NUM> via an internal operator-controlled lumen that is affixed to the proximal end of the flow optimizer <NUM>. A secondary operator-controlled lumen connected to the distal end of anchoring mechanism <NUM> and covering the notches <NUM> can prevent the notches <NUM> from engaging with the detents <NUM>. Once achieved the desired positioning of the flow optimizer <NUM> on the anchoring mechanism <NUM>, the secondary operator-controlled lumen is retrieved to expose the notches <NUM> thus allowing the detents <NUM> to engage the notches <NUM> and lock the position of the flow optimizer <NUM> on the anchoring mechanism <NUM>.

Similarly to the deployment of device <NUM>, the device <NUM> can be deployed using an intravascular catheter and delivered through either the SVC or IVC. For example, the catheter is pushed through the tricuspid valve from the right atrium into the right ventricle, with the catheter lumen positioned near the ventricle apex. The catheter can be partially retracted, exposing the flow optimizer <NUM> and the atrial anchor <NUM>. The catheter can be further retracted to deploy the shortest of the atrial anchor arms <NUM>. The catheter can be fully retracted deploying all remaining atrial arms <NUM>. <FIG> is a wireframe drawing showing device <NUM> fully deployed in the right atrium. <FIG> is an illustration of a deployed device <NUM> viewed from the atrial side.

<FIG> and <FIG> illustrate a tricuspid valve support device <NUM>, in a deployed conformation, configured to be anchored at the annulus of the tricuspid valve in correspondence of commissures of the native leaflets of the tricuspid valve. Generally, the device <NUM> comprises an anchoring mechanism <NUM>, which can contain one or more (e.g., one, two, three, four, or more) support arms <NUM>, and its connected via a threaded shaft <NUM> to the tricuspid valve flow optimizer <NUM>. The arms <NUM> can be radially disposed from the central axis of the device <NUM> and can be single ribbons or rods defining geometric, regular and/or random shapes, as illustrated. Alternatively, the arms <NUM> can be formed by a wire defining a closed shape. The end region (or distal end region) <NUM> of the arms 415a-415c is contoured to mate with the tissue wall of the tricuspid valve annulus at the commissures of the native leaflets. The intermediate portion <NUM> of the arm <NUM> is shaped to conform to the inner supra-annular wall of the right atrium to provide further support and/or stabilization. <FIG> illustrates the tricuspid valve support device <NUM> in a crimped conformation as it can be loaded into an intravascular delivery catheter. Each of the device elements and the method for deployment is described in more details below.

Tricuspid valve flow optimizer <NUM> can have similar or the same construction as the tricuspid valve flow optimizer <NUM>, as described above in the context of device <NUM>. The tricuspid valve flow optimizer <NUM> can be connected to the threaded shaft <NUM>. The tricuspid valve flow optimizer <NUM> can be supported in the proximal direction by commissures/atrial wall anchoring mechanism <NUM> via the threaded shaft <NUM>.

Although <FIG> shows the shaft <NUM> as being threaded, the shaft <NUM> can be threaded and/or non-threaded, without limitation. The anchoring mechanism <NUM> can be connected to the shaft <NUM> via any mechanism that is same as and/or different from threading.

As shown in <FIG>, the Device <NUM> further comprises commissures anchoring mechanism <NUM> which extends proximally from tricuspid valve flow optimizer <NUM> into the right atrium (not shown). The commissures anchoring mechanism <NUM> comprises one or more (e.g., one, two, three, four, or more) anchoring arms <NUM>. The anchoring arms <NUM> can have identical or individual shapes and/or length (shown in <FIG>). As shown in <FIG>, when deployed, the end regions (or the distal end regions) <NUM> of the arms 415a-415c mate with the tissue wall of the tricuspid valve annulus at the commissures of the leaflets, and the intermediate portion <NUM> rests against the inner supra-annular wall of the right atrium to provide further retention and stabilization to the tricuspid valve flow optimizer <NUM>. Preferably, the arms 415a-415c are formed from a memory shape material (e.g., NiTi) such that they are self-expanding when released from the delivery catheter. As an example, <FIG> show an exemplary range of expansion of the shape of the arm 415a from the center axis of the device. The arm 415a can expand into either of the shapes shown in <FIG> and/or any intermediate shapes between the shapes shown in <FIG>, allowing placement and/or fitting of commissures anchoring mechanism <NUM> in tricuspid valve annuli of variable shape and size. Similar range of displacement applies to the arms 415a-415c. Optionally, the arms 415a-415c can comprise, on the tissue-facing surface, a friction enhancing layer (e.g., polymer) including, for example, Velcro® and micro-barbs, in order to enhance adhesion with the tissue at the commissures and at the inner supra-annular wall. The inner core <NUM>, threaded shaft <NUM>, locking collar <NUM> as shown in <FIG> can be machined from standard metallic alloys or polymers.

As shown in <FIG>, the arm 415a protrudes proximally in a cylindrical shape. Stated somewhat differently, the arm 415a includes a proximal end region that includes a cylindrical protrusion. The inner core <NUM> can sit within the cylindrical shape protruding from the arm 415a. As shown in <FIG>, snap-fit edge <NUM> on the inner core <NUM> is devised to mate with notch <NUM> of the arm 415a, axially interlocking the components while still allowing limited rotation of inner core <NUM> within the arm 415a. As shown in <FIG> and <FIG>, the arm 415b is mated to the inner core <NUM> within matching groove <NUM> defined on the inner core <NUM>, allowing combined rotation of the arm 415b with inner core <NUM>. As shown in <FIG>, the arm 415c protrudes proximally in a cylindrically-shaped central portion. The central portion of the arm 415c can be inserted on the inner core <NUM> by mating in a groove <NUM> defined on the inner core <NUM>, allowing the arm 415a to be rotated independently from inner core <NUM>. Clockwise (CW) and/or counterclockwise (CCW) rotations of arm 415b can be limited by the edges of groove <NUM> on the inner core <NUM> within which the central portion of the arm 415c is mated.

As shown in <FIG>, the arm 415c can be radially displaced by rotating CW or CCW a proximal end region of the arm 415c. The proximal end region of the arm 415c protrudes through the locking collar <NUM>. Similarly, as shown in <FIG>, the arm 415b can be radially displaced by rotating clockwise or counterclockwise the proximal end region of the inner core <NUM> protruding along the threaded shaft <NUM>. As shown in the atrial views in <FIG>, by rotating the proximal end regions of the inner core <NUM> and/or of the arm 415c, an operator can individually position arms 415a-415c at different relative angles, matching angles across the commissures of the leaflets of the patients' native tricuspid valves. The rotating arms 415a-415c can be performed pre-procedurally (for example, prior to loading of the device <NUM> into the delivery catheter), and/or intra-procedurally (for example, prior to loading of the device <NUM> into the delivery catheter) via the device's delivery system controls.

The threaded shaft <NUM> supports the flow optimizer <NUM> and is threaded through the inner core <NUM> as shown in <FIG> and <FIG>. As shown in <FIG>, CW and/or CCW rotations of the distal end region of the threaded shaft <NUM> can axially displace the distally-connected flow optimizer <NUM> in the distal and proximal longitudinal directions, allowing shortening or extending the relative distance between the flow optimizer <NUM> and commissures anchoring mechanism <NUM>, and/or to change the radial orientation of the flow optimizer <NUM> relatively to the anchoring arms 415a-415c.

The locking collar <NUM> is shown as sitting on the proximal end of the anchoring mechanism <NUM>, over the inner core <NUM> and the arm 415c as shown in <FIG>. As shown in <FIG>, the proximal surface <NUM> of the locking collar <NUM> can be displaced distally until being mated with a proximal cylindrical surface <NUM> of the arm 415a. The proximal surface <NUM> of the locking collar <NUM> can engage a snap-fit edge <NUM> of the inner core <NUM>. In this position, the locking collar <NUM> compresses the arm 415a over the inner core <NUM>, while radially constraining the arm 415c and the proximal ends of the inner core <NUM> over the threaded shaft <NUM>, thus locking simultaneously the relative radial and axial positions of the inner core <NUM>, the arms 415a-b-c and the threaded shaft <NUM>.

Optionally, the commissures anchoring mechanism <NUM> can be coupled with a height adjustment mechanism to allow discrete individual control of the expansion or contraction of each arm <NUM>. In one embodiment, illustrated in <FIG>, the end regions (or distal end regions) and/or the intermediate portions of the anchoring arms 415a-415c can be connected to cables <NUM>. The proximal ends of the cable <NUM> are connected to sliders <NUM>. The longitudinal cross-sectional profile of the sliders <NUM> is configured to mate with that of notches <NUM> cut along the cylindrical protrusion of the arm 415a. Expansion or contraction of the arms 415a-415c relative to the center axis of the anchoring mechanism can be individually controlled by longitudinally displacing distally or proximally the slider <NUM> along the arm 415a such that detents <NUM> disengage and re-engage with the sliders <NUM> as shown in <FIG>. In one embodiment, the detents <NUM> are configured to allow sliding in both distal and proximal directions. Optionally, unidirectional detents <NUM> are configured to allow translocation in either the distal direction (e.g. towards the ventricle) or the proximal direction (e.g. towards the atrium).

Similarly to the deployment of the device <NUM>, device <NUM> can be loaded within an intravascular catheter <NUM> as shown in <FIG>, and delivered to the right atrium and into the tricuspid valve either via transfemoral access through the IVC, or via right internal jugular vein access of the IVC. Once positioned within the tricuspid valve, the distal end of outer lumen <NUM> can be partially retracted to allow the expansion of the flow optimizer <NUM> and partial opening of the anchoring arms <NUM> (shown in <FIG>). Under standard visualization techniques (e.g., angiography, fluoroscopy, echocardiography), the radial position of the arm 415c can be modified by rotating CW or CCW the delivery system mid lumen <NUM> (shown in <FIG>). The mid lumen <NUM> is connected via the slider <NUM> (shown in <FIG>) to the proximal end of the Arm 415c.

As shown in <FIG>, a slider <NUM> on an inner lumen <NUM> can be advanced to engage mating notch <NUM> at the distal end region of the inner core <NUM>. As shown in <FIG>, the radial position of the arm 415b can be modified rotating CW or CCW the delivery system inner lumen <NUM>.

Once the anchoring arms <NUM> have been aligned with commissures of leaflets of the native valve, the slider <NUM> on the inner lumen <NUM> can be retracted by the operator, thus disengaging the rotation control of Arm 415b, and then the height and orientation of the flow optimizer <NUM> can be modified by rotating CW or CCW the inner lumen <NUM>. As shown in <FIG>, locking the positions of the anchoring arms and of flow optimizer <NUM> can be achieved by sliding distally the slider <NUM> and advancing the locking collar <NUM> until is mated with the arm 415a.

The outer lumen <NUM> can be further retrieved to allow the anchoring arms <NUM> to fully reach the annulus of the tricuspid valve at the commissures of the leaflets and/or at the supra-annular wall of the right atrium. As shown in <FIG>, the catheter operator can rotate (for example, CCW) the inner lumen <NUM> to disengage the threaded shaft <NUM>, allowing release of the device and retrieval of the delivery system catheter. Optionally, an additional outer lumen (not shown) with three separate sliders (not shown) can be added to the delivery system to allow the operator to modify the position of the sliders <NUM> (shown in <FIG>), and thus controlling the expansion and/or contraction of each individual anchoring arm <NUM>.

Claim 1:
A device (<NUM>) for assisting a valve of a heart, comprising:
a flow optimizer (<NUM>/<NUM>) configured to be located at a position within the valve and having a cross sectional area that reduces a regurgitation orifice of the valve during systole; and
an anchoring mechanism (<NUM>) coupled to said flow optimizer (<NUM>/<NUM>) and configured to fix the position of said flow optimizer (<NUM>/<NUM>) relative to the valve, wherein said anchoring mechanism (<NUM>) has a central axis and includes one or more anchoring arms (<NUM>) each including a proximal end region and a distal end region, distal end regions of the anchoring arms (<NUM>) extending away from the central axis and being configured to be located at commissures of native valve leaflets.