Patent Description:
Tricuspid valve regurgitation has several causes. Functional tricuspid valve regurgitation (FTR) is characterized by structurally normal tricuspid valve leaflets that are nevertheless unable to properly coapt with one another to close properly due to other structural deformations of surrounding heart structures. Often, the right ventricle is dilated as a result of pulmonary hypertension or an abnormal heart muscle condition (cardiomyopathy).

Other causes of tricuspid valve regurgitation are related to defects of the tricuspid valve leaflets, tricuspid valve annulus, or other tricuspid valve tissues. In some circumstances, tricuspid valve regurgitation is a result of infective endocarditis, blunt chest trauma, rheumatic fever, Marfan syndrome, carcinoid syndrome, or congenital defects to the structure of the heart. Tricuspid valve conditions are also often associated with problems related to the left side of the heart, such as mitral valve regurgitation.

Tricuspid valve regurgitation is often treated by replacing the tricuspid valve with a replacement valve implant or by repairing the valve through an interventional procedure. One method for repairing the tricuspid valve is through annuloplasty. Annuloplasty is accomplished by delivering and implanting a ring or band in the annulus of the tricuspid valve to attempt to return the annulus to a functioning shape. In tricuspid valve repair procedures, a surgeon attempts to reshape or reposition tricuspid valve leaflets so that they can better coapt with one another to sufficiently close the valve and prevent regurgitation.

<CIT> discloses a fixation device for engaging tissue comprising: a stud; a pair of proximal gripping elements operably coupled with the stud, each of the gripping elements having a first end, a free end opposite the first end, and a gripping surface therebetween for gripping the tissue, the first ends being movably coupled together such that the gripping elements are moveable between a first position wherein the free ends are spaced apart with the gripping surfaces generally facing away from each other, and a second position wherein the free ends are separated even further apart; a pair of distal fixation elements operably coupled with the stud, each of the fixation elements having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the first ends being movably coupled together such that the fixation elements are moveable between an open position wherein the free ends are spaced apart and a closed position wherein the free ends are closer together with the engagement surfaces generally facing each other; and means for locking the fixation elements in the open position, the closed position, or positions therebetween, the means for locking having a locked position and an unlocked position whereby the elements are held in a fixed position relative to one another in the locked position and whereby the elements are moveable relative to one another in the unlocked position.

This background is only provided to illustrate one exemplary technology area where some embodiments described herein may be practiced.

In accordance with the present invention, there is provided a heart valve repair device, as defined in claim <NUM>. Certain embodiments described herein are directed to devices and systems for repairing tissue, such as tissue of a malfunctioning cardiac valve, including a regurgitant tricuspid valve. Some examples are directed to methods for repairing tissue by positioning a repair device at a targeted location, wherein the described methods are not part of the claimed invention. In accordance with the claimed device, the heart valve repair device is configured to be delivered to a targeted heart valve and left within heart. The repair device includes a pair of distal arms and a pair of corresponding proximal arms disposed opposite the pair of distal arms, each proximal arm and corresponding opposite distal arm forming an arm pair. The distal arms and proximal arms are moveable between an open configuration in which the arms of an arm pair are moved apart from one another and a closed configuration in which the arms of an arm pair are brought toward one another to enable grasping of leaflet tissue therebetween. The repair device is actuated to grasp leaflet tissue of the targeted valve between the proximal and distal arms. A first arm pair grasps tissue at a first engagement point, and a second arm pair grasps tissue at a second engagement point. Preferably, the first and second engagement points are located respectively on first and second adjacent leaflets of a tricuspid valve.

The leaflet tissue at the second engagement point is sutured. For example, one or more suture lines are passed through the leaflet tissue and are anchored at the second engagement point to prevent the one or more suture lines from detaching or tearing away from the second engagement point. In some embodiments, a suturing catheter is positioned near the second arm pair and engages with the second arm pair to enable deployment of the one or more suture lines at the leaflet tissue grasped by the second arm pair.

After deploying the one or more suture lines at the second engagement point, the second arm pair is pivoted to a third engagement point (e.g., the third tricuspid leaflet) while the first arm pair remains engaged at the first engagement point (e.g., the first tricuspid leaflet). The pivoting motion carries the one or more suture lines deployed at the second engagement point (e.g., the second tricuspid leaflet) to the third engagement point. Tension in the one or more suture lines can then be adjusted to tie together the tissue of the second engagement point and third engagement point to a desired degree. The repair device remains deployed across the first and third engagement points to tie together the tissue of the first and third engagement points. The repair device can be adjusted to tie the grasped tissue together to a desired degree.

In certain embodiments and in accordance with the claimed device, at least a first arm pair of the repair device includes a point element configured to engage against leaflet tissue to function as a pivot point allowing a second arm pair to rotate about the pivot point. In some embodiments and in accordance with the claimed device, at least the second arm pair includes a set of through holes through which one or more suture lines are passable to enable suturing of leaflet tissue grasped by the second arm pair. In accordance with the claimed device, the repair device comprises a lock configured to maintain a length or tension of the one or more suture lines. In some embodiments, the second arm pair is independently adjustable so that the first arm pair can remain in a closed/grasped configuration during pivoting while the second arm pair is in a more open configuration to allow it to rotate around the first engagement point.

In some embodiments, a heart valve repair system includes a repair device and a suturing catheter. The suturing catheter includes an internal lumen through which one or more suture lines are extendable, the suturing catheter being configured to engage with the second arm pair of the repair device to enable passage of the one or more suture lines through the leaflet tissue grasped by the second arm pair.

In certain embodiments, a repair device includes a proximal member with an axial lumen and a plurality or extendable arms which may be extended to an open position transverse to the axial lumen, and a distal member disposed at least partially within the axial lumen of the proximal member so as to be axially translatable relative to the proximal member. The distal member includes an end section extending distally beyond the proximal member. The end section includes a plurality of extendable arms which are extendable to an open position transverse to an axis of the distal member.

At least some of the embodiments described herein are directed to devices and methods for repairing a malfunctioning cardiac valve, such as a regurgitant tricuspid valve. Some embodiments are directed to devices and methods configured to provide repair of a regurgitant tricuspid valve through a "lasso" technique capable of tethering and/or tightening the three leaflets of the tricuspid valve together in a desired configuration to improve valve closure and minimize or eliminate regurgitation at the tricuspid valve.

Although many of the examples illustrated and described herein are directed to tricuspid valve regurgitation, it will be understood that the principles, features, and components described herein may also be applied in other applications, such as repair of other heart valves, or use in other interventional procedures or treatment applications.

<FIG> illustrates a cross-sectional view of a heart <NUM> showing the normal blood flow path. Deoxygenated blood enters the right atrium <NUM> through the superior vena cava <NUM> and superior vena cava <NUM>. During diastole, suction from expansion of the right ventricle <NUM> and contraction of the right atrium <NUM> forces blood from the right atrium <NUM> across the tricuspid valve <NUM> and into the right ventricle <NUM>. During ventricular systole, blood is then forced from the right ventricle <NUM> through the pulmonary valve <NUM> and into the pulmonary arteries for delivery to the lungs. In a normally functioning heart, the tricuspid valve <NUM> closes during systole to prevent backwards movement of blood from the right ventricle <NUM> back into the right atrium <NUM>. When a tricuspid valve is not functioning properly, it may fail to fully close such that some of the blood passes back across the tricuspid valve <NUM> and into the right atrium <NUM>, rather than through the pulmonary valve <NUM>.

Oxygenated blood returning from the lungs enters the left atrium <NUM>, where it is then passed through the mitral valve <NUM> and into the left ventricle <NUM>. During ventricular systole, the blood is then passed from the left ventricle through the aortic valve for delivery throughout the body. Similar to the right side of the heart, failure of the mitral valve <NUM> to fully close during ventricular systole leads to regurgitation of blood from the left ventricle <NUM> back into the left atrium <NUM>. In some circumstances, problems related to mitral valve regurgitation or other issues with the left side of the heart also cause or are associated with structural issues on the right side of the heart, such as tricuspid valve regurgitation.

<FIG> illustrate superior views of a tricuspid valve <NUM> in various states and positions. <FIG> illustrates a properly functioning tricuspid valve <NUM> in a closed position. A properly functioning tricuspid valve <NUM> takes this form during ventricular systole in order to block backflow of blood. As shown, when in the closed position, the three leaflets of the tricuspid valve <NUM> coapt to fully close the valve. <FIG> illustrates a properly functioning tricuspid valve <NUM> in an open position. When open, the leaflets of the tricuspid valve <NUM> extend downward into the right ventricle so that passage of blood through the tricuspid valve <NUM> is provided.

<FIG> illustrates a defective tricuspid valve <NUM> during ventricular systole. In contrast to the properly closed tricuspid valve of <FIG>, the leaflets of the defective tricuspid valve are unable to fully coapt, leaving a passage through which regurgitant blood may pass. The inability to fully close may be due to defects to the leaflets themselves, or to defects to other structures of the heart which deform the tricuspid valve annulus or stretch the chordae tendineae, for example.

<FIG> illustrates a cross-sectional view of an embodiment of a repair device <NUM> that may be utilized to reduce or eliminate regurgitation in a defective valve. The illustrated embodiment includes a proximal member <NUM> and a distal member <NUM> disposed within the proximal member <NUM> and configured to be axially translatable relative to the proximal member <NUM>. Each of the distal member <NUM> and the proximal member <NUM> include arms extending transversely from respective longitudinal axes. In the illustrated embodiment, for example, the distal member <NUM> and proximal member <NUM> are configured with T shaped cross sections. As indicated by arrows <NUM>, the distal member <NUM> is translatable relative to the proximal member <NUM> such that the space between the arms of the distal member <NUM> and the proximal member <NUM> may be selectively expanded or reduced.

As explained in more detail below, the repair device <NUM> may be utilized to grasp tissue between the respective arms of the distal member <NUM> and proximal member <NUM> by positioning the distal member <NUM> on a first side of the targeted tissue, with the proximal member <NUM> positioned on the opposite side of the targeted tissue, and translating the distal member <NUM> relative to the proximal member <NUM> to reduce the space between the arms of the distal member <NUM> and proximal member <NUM> to grasp the targeted tissue therebetween.

<FIG> depict another embodiment of a repair device and an exemplary method for deploying a repair device to grasp tricuspid valve tissue for repair of a regurgitant tricuspid valve. <FIG> illustrates a repair device including a distal member <NUM> positioned within a proximal member <NUM> and extending out of and distally beyond a distal end of the proximal member <NUM>. In the illustrated embodiment, the distal member <NUM> is translatable relative to the proximal member <NUM> such that the distal member <NUM> may be selectively extended distally or retrieved proximally relative to the proximal member <NUM>.

In some embodiments, the repair device is delivered to the targeted tricuspid valve <NUM> by positioning the repair device in the right atrium, superior to the tricuspid valve <NUM>, and extending the distal member <NUM> through the tricuspid valve <NUM> into the right ventricle. For example, the repair device may be delivered via a transfemoral approach so that the device passes through the inferior vena cava into the right atrium. Alternatively, the device may be delivered through a transjugular approach, transapical approach, or other approach.

Although the example depicted in <FIG> is related to an approach in which the device is delivered to the right atrium and positioned superior to the tricuspid valve prior to deployment (e.g., through a transfemoral approach), it will be understood that the described principles and features may be applied to other approaches. For example, in a transapical approach, the repair device may be inserted into the right ventricle and be positioned inferior to the tricuspid valve. In the illustrated example, the repair device is deployed by extending the distal member <NUM> from the right atrium through the tricuspid valve <NUM> and into the right ventricle. It will be understood that from an inferior approach, the repair device may be deployed by extending the distal member <NUM> from the right ventricle through the tricuspid valve and into the right atrium.

As shown in <FIG>, the proximal member <NUM> includes extendable arms <NUM> and <NUM>, and the distal member <NUM> includes extendable arms <NUM> and <NUM>. <FIG> illustrates the arms <NUM>, <NUM>, <NUM>, and <NUM> in a retracted or collapsed position, providing the device with a low profile for delivery to the targeted tricuspid valve <NUM>. In the illustrated embodiment, the extendable arms <NUM>, <NUM>, <NUM>, and <NUM> are coupled to the axial bodies of the proximal member <NUM> and distal member <NUM>, respectively, through a hinged attachment to enable actuation from the retracted position to an extended position. Alternatively, or additionally, one or more arms may be provided with the ability to selectively extend and retract through use of spring biasing and/or tension wire controls (e.g., one or more tension wires extending from a respective arm to a proximal handle/control element).

In some embodiments, the distal member <NUM> and/or proximal member <NUM> may be delivered in a sheathed configuration such that the corresponding arms, which are biased toward an expanded position, are held in a collapsed position by the sheath. The arms may then be selectively opened to the expanded position by retracting the corresponding sheath and/or pushing the respective member out from the sheath. The arms may be retracted to a collapsed position by repositioning the corresponding sheath over the arms to force them back into the retracted position.

As shown in <FIG>, the distal member <NUM> may be positioned so as to pass through the plane of the tricuspid valve <NUM> and be positioned on a ventricular side of the valve, while the proximal member <NUM> remains on the atrial side of the valve. As shown in <FIG>, the extendable arms <NUM>, <NUM>, <NUM>, and <NUM> may then be opened to the extended position so that arms <NUM> and <NUM> of the proximal member <NUM> remain on the atrial side of the valve <NUM> and arms <NUM> and <NUM> remain on the ventricular side of the valve <NUM>. As shown in <FIG>, the distal member <NUM> may then be proximally retracted and/or the proximal member <NUM> may then be distally extended so as to bring the proximal (atrial side) arms <NUM> and <NUM> closer to the distal (ventricular side) arms <NUM> and <NUM> so as to grasp the tricuspid valve tissue <NUM> therebetween, as indicated by the arrows <NUM>. In some embodiments, one or more of the arms <NUM>, <NUM>, <NUM>, and <NUM> may include tines, hooks, protrusions, or other structures to enhance tissue grasping.

As shown, the proximal arms <NUM> and <NUM> are each substantially aligned with a corresponding distal side arm <NUM> and <NUM> to form an arm pair. In the illustrated embodiment, the proximal arm <NUM> and the distal arm <NUM> form a first arm pair, and the proximal arm <NUM> and distal arm <NUM> form a second arm pair. Additional examples of repair devices are provided in <CIT>. One or more of the clip device components and/or features described therein may be utilized for grasping tricuspid valve leaflet tissue as part of a tricuspid valve repair procedure described herein.

<FIG> illustrate superior views of the tricuspid valve <NUM> showing deployment of any of the repair devices described herein in order to affix the tricuspid valve leaflets so as to reduce or prevent regurgitation through the tricuspid valve <NUM>. Referring to <FIG>, a first leaflet and a second leaflet of the tricuspid valve <NUM> may be grasped according to the procedure illustrated by <FIG> or through another grasping process. From the superior view of <FIG>, the proximal arms <NUM> and <NUM> of the proximal member are shown extending across the first and second leaflets so that a first end of the proximal member is located on the first leaflet at a first engagement point <NUM>, and a second end of the proximal member is located on the second leaflet at a second engagement point <NUM> (i.e., so that the first arm pair is located at the first engagement point <NUM> and the second arm pair is located at the second engagement point <NUM>).

From this position, one or more suture lines are passed from the first engagement point <NUM> to the second engagement point <NUM>, or vice versa, to tie the first and second leaflets together. For example, one or more suture lines may be tied or otherwise attached (e.g., using buttons, anchors, pledgets, etc.) at the first engagement point <NUM>, and passed to the second engagement point <NUM> where they may be likewise attached. Alternatively, one or more suture lines may be anchored at or tied to the second engagement point <NUM>, but not passed to or from the first engagement point <NUM>.

In some embodiments, one or more suture loops are attached at the first and/or second engagement points. For example, one or more suture lines may be passed from the first engagement point <NUM> to the second engagement point <NUM> where they are passed through a suture loop attached at the second engagement point <NUM>. The one or more sutures may then be further routed to other areas of the tricuspid valve <NUM>, as described in more detail below.

In alternative implementations, one or more suture lines may be anchored to one of the engagement points but not passed between the first and second engagement points <NUM> and <NUM>. For example, one or more suturing lines may be attached (e.g., using buttons, anchors, pledgets, or other anchoring structures) at the second engagement point <NUM>. The first and second leaflets are not sutured together, but the one or more suture lines anchored to the second leaflet at the second engagement point <NUM> are subsequently passed to the third leaflet to tie the second leaflet to the third leaflet. The one or more suture lines may be passed to the third leaflet in this manner by a pivoting motion of the repair device, as shown in <FIG>.

As shown in <FIG>, the repair device is then pivoted so that the second arm pair is pivoted about a pivot point to position the second end at the third leaflet. For example, as indicated by arrow <NUM> in the illustrated embodiment, the first engagement point <NUM> is used as a pivot point, and the second arm pair is pivoted so that the second arm pair is located on the third leaflet at a third engagement point <NUM>. In some embodiments, one or more suture lines may be passed from the second engagement point <NUM> to the third engagement point <NUM> to tie the second leaflet to the third leaflet. Additionally, in some implementations, one or more suture lines may be passed from the third engagement point <NUM> to the first engagement point <NUM> to tie the third leaflet to the first leaflet.

In some embodiments, one or more suture lines are anchored at or threaded through the leaflet tissue through at least two of the various engagement points <NUM>, <NUM>, and <NUM> to form a suture lasso. Additionally, or alternatively, one or more suture lines are passed through one or more suture loops positioned at the engagement points <NUM>, <NUM>, and/or <NUM>. In some embodiments, one or more sutures are tied to the first leaflet at the first engagement point <NUM> then passed through suture loop(s) at engagement point <NUM> (and in some embodiments passed additionally through engagement point <NUM>), or are tied/anchored to the second leaflet at the second engagement point <NUM> then passed through suture loop(s) at engagement point <NUM>. The one or more suture lines are then tightened to bring the leaflets of the tricuspid valve <NUM> closer together to reduce or eliminate regurgitation through the valve. In some embodiments, one or more sutures are tied at the first engagement point <NUM>, then passed to both the second engagement point <NUM> and third engagement point <NUM> before being passed back to the first engagement point <NUM> to tie all three leaflets together.

The various engagement points <NUM>, <NUM>, and <NUM> may be positioned relative to one another so as to provide a desired degree of tightening and/or a desired amount of valve closure when the leaflets are cinched closer together with a suture lasso. Further, the suture lasso may be tightened so as to provide a desired degree of closure to the leaflets. For example, in a procedure where a targeted tricuspid valve has a relatively greater degree of structural deformity, a suture lasso may be tightened to a greater degree and/or one or more engagement points may be positioned relatively further from the valve annulus and relatively closer to a respective leaflet margin. In contrast, in a procedure where a targeted tricuspid valve has a relatively lower amount of structural deformity, the suture lasso may be tightened to a lesser degree and/or one or more engagement points may be positioned relatively closer to the valve annulus and further from a respective leaflet margin.

<FIG> illustrate an exemplary embodiment of a repair device in accordance with the claimed device, configured as a clip device <NUM>, which may be utilized to grasp tricuspid valve leaflet tissue and to aid in suturing at least two adjacent leaflets to one another. The illustrated clip device <NUM> includes a pair of proximal arms <NUM> and <NUM>, and a corresponding pair of opposing distal arms <NUM> and <NUM>. The arms <NUM>, <NUM>, <NUM>, and <NUM> are pivotally connected to the shaft <NUM> so as to be adjustable between a more open configuration (as shown in <FIG> where the arms are relatively more aligned to the axis of the shaft <NUM> and the device has a lower profile) and a more closed position (as shown in <FIG> where the proximal and distal arms are brought toward one another to grasp tissue therebetween). Proximal arms <NUM> and <NUM> can also include point elements <NUM> that can engage or penetrate into the valve tissue when proximal arms <NUM> and <NUM> are positioned against the tricuspid valve <NUM>.

Typically, as shown in <FIG>, the clip device <NUM> is positioned with distal arms <NUM> and <NUM> disposed on the distal side of the tricuspid valve <NUM> (e.g., the ventricular side when a transfemoral approach is used) with the proximal arms <NUM> and <NUM> remaining on the proximal side of the valve (e.g., atrial side). The distal arms <NUM> and <NUM> are then positioned against the leaflet tissue of the valve <NUM> and the proximal arms <NUM> and <NUM> are then brought down to engage the leaflet tissue as shown in <FIG>. After grasping, the arms <NUM>, <NUM>, <NUM>, and <NUM> can be adjusted to move the clip device <NUM> into a closed position to bring grasped tissue closer together (see <FIG>). The clip device may then be detached from the shaft <NUM> at detachment point <NUM> and left within the heart valve as an implant.

The clip device <NUM> may include one or more control lines, actuator rods, and/or other control mechanisms operably coupled to a handle to enable adjustments to the clip arms, detachment of the device, etc. The clip device <NUM> is preferably delivered using a transfemoral approach, although a tranjugular approach, transapical approach, or other suitable approach method may also be utilized.

The illustrated clip device <NUM> is also configured to enable suturing of grasped leaflet tissue. As shown, the distal arms <NUM> and <NUM> include through holes <NUM> and <NUM> for receiving suturing components. The proximal arms <NUM> and <NUM> also include corresponding through holes <NUM> and <NUM> (best seen in the superior view of <FIG>). The corresponding through holes are formed so as to align when opposing arms are closed against tissue. As explained in more detail below, this allows suturing components to pass through a proximal through hole, through leaflet tissue, and into a distal through hole, in order to provide passage and/or positioning of one or more suture lines.

<FIG> illustrates a superior view of the clip device <NUM> that has grasped a first leaflet <NUM> and second leaflet <NUM> of the tricuspid valve <NUM>. From this view, the proximal arms <NUM> and <NUM> are visible, as well as associated through holes <NUM> and <NUM> which provide passage through the proximal arms <NUM> and <NUM> to the underlying leaflet tissue. After leaflet tissue has been grasped in this manner, a suturing procedure can be carried out using the repair device <NUM> to tie two or more of the leaflets together.

<FIG> illustrates, in side view, the same grasping position shown in <FIG>. While the first and second leaflets <NUM> and <NUM> are grasped by the clip device <NUM>, a suturing catheter <NUM> is routed to the vicinity of the tricuspid valve. The suturing catheter <NUM> may be routed through a tranjugular approach or transfemoral approach (e.g., using the femur opposite from the one used for transfemoral delivery of the clip device <NUM>). The illustrated embodiments show a transjugular approach where the suturing catheter <NUM> is positioned on the proximal side of the clip device <NUM> (e.g., on the atrial side) and passing one or more suture lines through leaflet tissue from the proximal side to the distal side, but it will be understood that the same components and principles of operation may be utilized by positioning the suturing catheter <NUM> on the distal side of the clip device <NUM> and passing one or more suture lines through from the distal side to the proximal side.

As shown in <FIG>, a first suture deployment catheter <NUM> is extended from the suturing catheter <NUM>, and is extended to the proximal arm <NUM>. The first suture deployment catheter <NUM> is positioned through the proximal through hole <NUM>, the second leaflet <NUM>, and into the corresponding distal through hole <NUM>. A first suture line <NUM> (or optionally two or more suture lines) is associated with the first suture deployment catheter <NUM> so that as the first suture deployment catheter <NUM> is passed from one side of the leaflet <NUM> to the other, the first suture line <NUM> is also passed through the leaflet <NUM>. In some implementations, a guide wire can first be passed out of the suturing catheter <NUM>, through the proximal through hole <NUM>, through the leaflet <NUM>, and into the distal through hole <NUM> prior to moving the first suture deployment catheter <NUM>, in order to establish a guided path for the first suture deployment catheter <NUM>.

In the illustrated embodiment, the first suture line <NUM> includes at a distal end a first suture anchor <NUM>. The first suture anchor <NUM> can be a pledget, button, bight or bundle or suture, or other structure capable of holding position against the leaflet <NUM> to prevent movement or tearing through the leaflet <NUM> when tightening tension is applied to the first suture line <NUM>. In some embodiment, the first suture anchor <NUM> is flexible enough to bend and/or fold to a lower profile shape when passed through the leaflet <NUM>, and is capable of expanding and/or folding into a larger profile shape once passed to the distal side of the leaflet <NUM>.

After deploying the first suture line <NUM>, the first suture deployment catheter <NUM> is retracted, leaving the first suture line <NUM> deployed in the leaflet <NUM>, as shown in <FIG>. From this position, the clip device <NUM> can be selectively actuated to allow one end of the clip device <NUM> to be moved to another leaflet, while the other end of the clip device <NUM> remains anchored in place, thereby allowing another leaflet to be sutured and tied to the already sutured leaflet <NUM>.

As shown in <FIG>, the proximal arm <NUM> is lifted from the leaflet <NUM>. The first suture line <NUM> is still deployed/anchored to the leaflet <NUM> and still passes through the proximal arm <NUM>. The opposite proximal arm <NUM> is held in a closed position against leaflet <NUM> so that the point element <NUM> of the proximal arm <NUM> can act as a pivot point for moving, via a pivoting motion, the clip device <NUM> from the previous position (in which the proximal arm <NUM> and distal arm <NUM> were positioned on either side of leaflet <NUM>) to a new position in which the proximal arm <NUM> and distal arm <NUM> are positioned on either side of adjacent leaflet <NUM>. In some implementations, the distal arm <NUM> may be additionally moved away from the leaflet <NUM>. However, in a typical application, inherent fluctuations in leaflet position will allow the leaflet <NUM> to be freed simply by lifting the proximal arm <NUM>.

<FIG> illustrates a superior view of the tricuspid valve <NUM> showing the clip device <NUM> after the pivoting motion. As shown, the proximal arm <NUM> remains grasped against the first leaflet <NUM>, while proximal arm <NUM> has been swung from the second leaflet <NUM> to the third leaflet <NUM>. At this position, the proximal arm <NUM> and/or corresponding distal arm <NUM> is/are adjusted to grasp the third leaflet <NUM>. As shown, the first suture line <NUM> now extends from the second leaflet <NUM>, where it is anchored at engagement point <NUM>, to the third leaflet <NUM>, where it is held in place by the proximal arm <NUM>. The free end of the first suture line <NUM> passes up through the through hole <NUM> and into the suturing catheter <NUM> (not shown in this view).

As shown in <FIG>, the first suture line <NUM> can be tensioned (by pulling upward as indicated by arrow <NUM>) to pull the second leaflet <NUM> and third leaflet <NUM> toward one another to a desired degree, as indicated by arrows <NUM>. As shown by <FIG>, a lock <NUM> may then be applied to maintain the length and/or tension of the first suture line <NUM> between the engagement point <NUM> and the proximal through hole <NUM>.

The lock <NUM> may be a cinch, clamp, grommet, stop, or other fastening device capable of engaging against the suture line <NUM> to hold it in place and prevent it from slipping past the lock <NUM>. In some embodiments, the lock <NUM> may be applied using the suturing catheter <NUM>. In other embodiments, the lock <NUM> may form part of the clip device <NUM> and may be selectively actuated to engage against the suture line <NUM>. In some embodiments, the suture line <NUM> may be slipped through a bight or otherwise knotted, in addition to or as an alternative to the lock <NUM>, in order to hold the position of the suture line <NUM>. Excess suture material may be cut from the device <NUM> prior to finishing the repair procedure.

After tensioning the first suture line <NUM> to tie the second leaflet <NUM> and third leaflet <NUM> together, the clip device <NUM> may also be kept in the position shown to tie the third leaflet <NUM> and first leaflet <NUM> together. The clip device <NUM> may be adjusted toward a more closed position, as shown in <FIG> and as indicated by arrows, to effectively bring and hold together grasped tissue from the leaflets <NUM> and <NUM>.

<FIG> illustrate an embodiment in which a second suture line <NUM> is also deployed to tie targeted leaflet tissue together. <FIG> shows a side view of the repair device <NUM> after it has been pivoted to the position shown in <FIG>. In this position, the first suture line <NUM> extends from the second leaflet <NUM> (not shown in this view) to the proximal arm <NUM>, where it passes up through the through hole <NUM> and into the suturing catheter <NUM>. As shown, a second suture deployment catheter <NUM> is extended from the suturing catheter <NUM>. The second suture deployment catheter <NUM> deploys a second suture line <NUM> in a manner similar to that of the first suture deployment catheter <NUM> and first suture line <NUM>, by passing through the through hole <NUM>, through the third leaflet <NUM>, and into the through hole <NUM>. A second suture anchor <NUM> functions to hold the second suture line <NUM> in a manner similar to that of the first suture anchor <NUM> holding the first suture line <NUM>.

As shown in <FIG>, the second suture deployment catheter <NUM> is then retracted, leaving the first and second suture lines <NUM> and <NUM> in position extending through the proximal arm <NUM> and into the suturing catheter <NUM>. <FIG> shows a superior view of the repair device <NUM> in this position. From this position, tension may be selectively applied to the first and/or second suture lines <NUM>, <NUM> to cinch and bring the second leaflet <NUM> and third leaflet <NUM> closer to one another. As shown in <FIG>, a lock <NUM> may be deployed to maintain the positions of the first and second suture lines <NUM>, <NUM>. Excess suture material may be cut from the device <NUM>. As described above, the clip device <NUM> may also be kept in place across the third leaflet <NUM> and first leaflet <NUM>, and may be moved to a closed position as shown in <FIG> to effectively bring and hold together tissue from the grasped leaflets <NUM> and <NUM>.

The combination of suturing a pair of adjacent leaflets and deploying the clip device <NUM> across another pair of adjacent leaflets beneficially provides effective repair of the tricuspid valve and effective reduction or elimination of regurgitant flow through the valve. In some embodiments, even further closing of a targeted tricuspid valve is achieved by adding a suture to the first leaflet <NUM> (e.g., by passing a suture deployment catheter through the proximal through hole <NUM> of the proximal arm <NUM> in a manner similar to that described above) and connecting that suture to the engagement point <NUM> of the second leaflet <NUM> to thereby stitch all three leaflets together.

The terms "approximately," "about," and "substantially" as used herein represent an amount or condition close to the stated amount or condition that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," and "substantially" may refer to an amount or condition that deviates by less than <NUM>%, or by less than <NUM>%, or by less than <NUM>%, or by less than <NUM>%, or by less than <NUM>% from a stated amount or condition.

Claim 1:
A heart valve repair device (<NUM>) configured to be delivered to a targeted heart valve and left within the heart valve as an implant, the heart valve repair device comprising:
a pair of distal arms (<NUM>, <NUM>); and
a pair of corresponding proximal arms (<NUM>, <NUM>) disposed opposite the pair of distal arms, each proximal arm and corresponding opposite distal arm forming an arm pair (<NUM>/<NUM>, <NUM>/<NUM>),
wherein the distal arms and proximal arms are moveable between an open configuration in which the arms of an arm pair (<NUM>/<NUM>, <NUM>/<NUM>) are moved apart from one another and a closed configuration in which the arms of an arm pair (<NUM>/<NUM>, <NUM>/<NUM>) are brought toward one another to enable grasping of leaflet tissue therebetween,
wherein at least a first arm pair (<NUM>/<NUM>) includes a point element (<NUM>) configured to engage against leaflet tissue to function as a pivot point allowing a second arm pair (<NUM>/<NUM>) to rotate about the pivot point, at least the second arm pair including a set of through holes (<NUM>, <NUM>) through which one or more suture lines (<NUM>, <NUM>) are passable to enable suturing of leaflet tissue grasped by the second arm pair (<NUM>/<NUM>); and
a lock (<NUM>) configured to maintain a length or tension of the one or more suture lines (<NUM>, <NUM>).