Patent Description:
Heart valve detects, such as, for example, regurgitation, may be caused by a relaxation of the tissue surrounding a heart valve (for example, the mitral valve or the tricuspid valve). This causes the valve opening to enlarge, which prevents the valve from sealing properly. Such heart conditions are commonly treated by a procedure during which an annuloplasty ring is fixed or secured to the annulus of the valve. Cinching or securing the tissue of the annulus to the annuloplasty ring can restore the valve opening to approximately its original size and operating efficiency.

Typically, annuloplasty rings are implanted during open heart surgery so that the annuloplasty ring can be sewn into the valve annulus. However, open heart surgery is a highly invasive procedure that requires connecting a heart and lung machine (to pump the patient's blood and breathe for the patient), stopping the patient's heart, and surgically opening the thoracic cavity and heart organ. Accordingly, the procedure can expose the patient to a high risk of infection and may result in a long and difficult recovery. The recovery may be particularly difficult for patients in less than optimal health due to the effects of suffering from a heart valve defect such as regurgitation.

<CIT> discloses an annuloplasty ring that includes an outer hollow member including a plurality of segments. Adjacent segments cooperate with one another to change the outer hollow member from an elongate insertion geometry to an annular operable geometry.

In an example not forming part of the claimed invention, a system for percutaneous, transcatheter heart valve repair may include a catheter configured to provide percutaneous access into a heart of a patient, an adjustable annuloplasty ring, and a stabilizer. The adjustable annuloplasty ring may include a body member that is transitionable from an elongate insertion geometry to an annular operable geometry. The elongate insertion geometry may be configured to allow percutaneous passage of the annuloplasty ring, via the catheter, into the heart of a patient. The annular operable geometry may have an expanded state to conform to an annulus of a target valve of the heart and a contracted state to reduce a diameter of the annulus of the target valve. The adjustable annuloplasty ring may also include a plurality of anchors deployable in the annular operable geometry to engage the annulus of the target valve. The stabilizer comprising a plurality of prongs configured to engage the annuloplasty ring in the annular operable geometry within the heart to enable percutaneous manipulation of the ring to orient and position the ring in intimate contact with the annulus of the target valve.

The invention concerns a delivery system as defined by claim <NUM>. In an embodiment, a delivery system for percutaneous, transcatheter heart valve repair includes a catheter, a ring shuttle, and a deployment handle. The catheter is configured to provide percutaneous access into a heart of a patient and configured to receive an adjustable annuloplasty ring in an elongate insertion geometry that is transitionable to an annular operable geometry. The ring shuttle is configured to releasably couple to the annuloplasty ring and pass the annuloplasty ring through the catheter into the heart of the patient. The deployment handle is configured to percutaneously manipulate the annuloplasty ring and the ring shuttle to deploy the annuloplasty ring. The deployment handle further comprises: a ring closure knob configured to close the annuloplasty ring, transitioning the annuloplasty ring from the elongate insertion geometry to the annular operable geometry; a ring snap knob configured to snap together a first end and a second end of the annuloplasty ring; an anchor deployment knob configured to deploy anchors of the annuloplasty ring to fasten the annuloplasty ring to an annulus of a target heart valve; and a ring release knob configured to release the annuloplasty ring from the delivery system.

In an example not forming part of the claimed invention, a method for percutaneous, transcatheter heart valve repair may include inserting a distal end of a catheter into a target valve, guiding, via a delivery system, an annuloplasty ring in an elongate geometry from a proximal end of the catheter to the distal end such that the annuloplasty ring transitions to an annular operable geometry upon exiting the distal end of the catheter, and deploying a plurality of anchors from the annuloplasty ring to engage an annulus of the target valve.

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

As used in this document, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one having ordinary skill in the art. Nothing in this disclosure is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term "comprising" means "including, but not limited to.

The following terms shall have, for the purposes of this application, the respective meanings set forth below.

A "heart valve" refers to any valve of a heart. In some embodiments, the heart may be a human heart. In other embodiments, the valve may be a non-human heart. The heart valves include atrioventricular valves (mitral valve and tricuspid valve) and semilunar valves (aortic valve and pulmonary valve). As used herein, the term "valve" is used to denote a heart valve, except where explicitly stated otherwise. Various portions of the heart, including the valves, may contain one or more fibrous rings therearound. Such fibrous rings are commonly known (and used herein) as an "annulus.

A "patient" refers to any human or non-human individual. The patient is generally any patient that has been diagnosed or will be diagnosed with a valve-related disorder, such as, for example, a heart valve-related disorder. In some embodiments, the patient may be an individual that would benefit from the apparatuses, systems, and methods described herein.

As used herein, "percutaneous" refers to a procedure that uses incisions through the skin of the abdomen for access to a surgical site, such as, for example, a patient's heart. Thus, as used herein, percutaneous surgery and laparoscopic surgery are mutually exclusive. In the preferred embodiment, the methods described herein are performed percutaneously, although laparoscopic methods are contemplated. As used herein, a percutaneous procedure may be a minimally invasive procedure or a highly invasive procedure. A percutaneous procedure may also include a trans-septal approach and a trans-apical approach.

The present disclosure generally relates to tools and assemblies that support treating and repairing heart valves, and specifically to apparatuses, systems, and methods for percutaneous trans-catheter repair of valves, particularly heart valves. Disclosed embodiments include delivery systems and features that are used as a catheter and/or through a catheter, such as, for example, a trans-septal approach, a retrograde approach, or a trans-apical approach.

The systems and methods described herein may generally be used to facilitate repair of a heart valve through percutaneous trans-catheter delivery and fixation of an annuloplasty ring to the heart valve. The embodiments of stabilizers and delivery systems can be configured in elongated insertion geometries that can be inserted into a catheter tube and deployed to an operable geometry providing a 3D geometry that corresponds to and attaches to an annuloplasty ring connected to a catheter delivery system.

<FIG> depicts a schematic diagram of a perspective view of an illustrative adjustable annuloplasty ring, generally designated <NUM>, according to an embodiment. As shown in <FIG> , the annuloplasty ring <NUM> may be in an annular (D-shaped) operable geometry in a contracted state. <FIG> depicts a schematic diagram of a perspective view of the adjustable annuloplasty ring <NUM> of <FIG> when in an expanded state. The annuloplasty ring <NUM> may be configured to enable percutaneous, transcatheter annuloplasty to repair a heart valve. The annuloplasty ring <NUM> may be fastened, percutaneously, to the annulus of a target heart valve while in the expanded state and reduced to the contracted state to decrease an A-P distance of the target valve and thereby improve leaflet coaptation of the target valve and reduce regurgitation through the target valve.

Referring collectively to <FIG> , the annuloplasty ring <NUM> may include a body member <NUM> having a plurality of regions 102a, 102b, 102c (collectively <NUM>), biasing elements 103a, 103b (collectively <NUM>), a plurality of anchors <NUM>, a ring closure lock <NUM>, and a pivot <NUM>. In <FIG> , as well as in other embodiments disclosed herein, the body member <NUM>, including the plurality of regions <NUM>, may be arranged in a "D-shape" in the operable geometry. The D-shaped annuloplasty ring <NUM> may have a particular geometrical ratio that is in conformance (or approximate conformance) with the anatomical geometry of the human mitral valve annulus. For example, in certain embodiments, the ratio of the A-P distance to the commissure-commissure (C-C) distance of the annuloplasty ring <NUM> when implanted (for example, in the contracted state) may be about <NUM> to about <NUM>, including about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or any value or range between any two of these values (including endpoints). In a particular embodiment, the implanted ratio of the A-P distance to the C-C distance may be about <NUM>.

Although the illustrated embodiment of an annuloplasty ring <NUM> of <FIG> is a D-shaped operable geometry, those having ordinary skill in the art will recognize that other annular-shaped operable geometries may also be used without departing from the present disclosure. For example, circular or oval operable geometries may be used.

In some embodiments, the body member <NUM> may include a hollow hypotube (or outer hollow member). The hypotube may be cut from, for example, a tube to form the plurality of regions <NUM>. The cuts may define a shape and/or characteristics of the body member <NUM>. For example, laser cuts may define the plurality of regions <NUM> (and define how the plurality of regions interact), anchor windows <NUM>, and/or the biasing elements <NUM>.

In various embodiments, the body member <NUM> may include a shape memory (such as, for example, nitinol) hypotube into which a plurality of cuts and/or segments may be laser cut to define a size, a shape, and/or characteristics of the plurality of regions <NUM>. The shape memory hypotube may be heat set to a "memorized" annular shape (such as, for example, the D-shaped operable geometry). The shape memory hypotube may be superelastic such that applying sufficient stress may place the body member <NUM>, including the plurality of regions <NUM>, into an elongate insertion geometry and releasing the stress allows the body member <NUM>, including the plurality of regions <NUM>, to resume the D-shaped operable geometry. In some embodiments, laser cuts may define a flexibility of the body member <NUM>. For example, the laser cuts may allow the body member <NUM> to be flexible when the annuloplasty ring <NUM> is in an elongate insertion geometry (as described herein) and/or rigid when the annuloplasty ring is in the operable geometry.

In addition to the operable geometry shown in <FIG> , the body member <NUM> may be transitionable from an elongate insertion geometry (see, for example, <FIG>) to the annular operable geometry shown in <FIG>. The elongate insertion geometry may allow the annuloplasty ring <NUM> to be inserted into and passed through a catheter for percutaneous passage into the heart of a patient, as described in greater detail herein. A transition from an elongate insertion geometry to an annular operable geometry is illustrated in <FIG>, and discussed herein with reference to the same.

Once in an annular operable geometry as shown in <FIG> , the annuloplasty ring <NUM> may have a contracted state as shown in <FIG> and an expanded state as shown in <FIG>. The biasing elements <NUM> may be configured to expand to increase the A-P distance of the annuloplasty ring <NUM> to an expanded state. The A-P distance AP1 of the contracted state of <FIG> is enlarged by a distance d such that the A-P distance AP2 of the expanded state <FIG> is larger (AP2 = AP <NUM> + d). Expansion of the biasing elements <NUM> may allow the body member <NUM> to be expanded to an expanded state. In situ in the heart, expansion of the body member <NUM> to the expanded state may enlarge the annuloplasty ring <NUM> to a size conforming, or approximately conforming, to an annulus of a target heart valve to be repaired. Expansion of the body member <NUM> may be accomplished by an expansion tool, such as a balloon, a cage, or another tool such as is shown in <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, and described herein with reference to the same. In the illustrated embodiment of <FIG>, a biasing clement 103a disposed between a first posterior region 102a and an anterior region 102c and a biasing element 103b disposed between a second posterior region 102b and the anterior region 102c may enable a desired expansion from the contracted state shown in <FIG> to the expanded state shown in <FIG>.

The expanded state of <FIG> may be such that the annuloplasty ring <NUM> is disposed in abutment with, or in intimate contact with, the annulus of the target valve. Disposing the annuloplasty ring <NUM> in intimate contact with the annulus may enhance an anchoring process in which the plurality of anchors <NUM> are deployed to fasten the annuloplasty ring <NUM> to the annulus. Once the annuloplasty ring <NUM> is fastened to the annulus, it may be contracted from the expanded state of <FIG> back to the contracted state of <FIG> to reduce a diameter of the annulus of the target valve.

Contraction of the annuloplasty ring <NUM> from the expanded state to the contracted state may decrease the A-P distance of the annuloplasty ring and, with the plurality of anchors <NUM> securing the annuloplasty ring to the annulus, may also decrease an A-P distance of the target valve to improve leaflet coaptation and reduce regurgitation through the target valve. In the illustrated embodiment of <FIG>, contraction of the annuloplasty ring <NUM> from the expanded state to the contracted state may be accomplished by the biasing elements <NUM>. The biasing elements <NUM> may bias the annuloplasty ring <NUM> toward the contracted state such that expansion of the annuloplasty ring to the expanded state stores potential energy in the biasing elements <NUM>. Releasing the biasing elements <NUM> (such as, for example, releasing or otherwise removing an expansion tool and/or expansion force) may release the stored potential energy, thereby forcing movement of the first posterior region 102a and the second posterior region 102b of the body member <NUM> toward the anterior region 102c of the body member to decrease the A-P distance of the annuloplasty ring <NUM> to the contracted state. In other words, the biasing elements <NUM>, upon release, may actively transition the annuloplasty ring <NUM> from the expanded state to the contracted state.

A typical range for change of the A-P distance d (between the expanded state and the contracted state) may be about <NUM> to about <NUM>, including about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or any value or range between any two of these values (including endpoints). In some embodiments, the range of d may depend on the overall size of the annuloplasty ring <NUM>. For example, for a final geometry of the annuloplasty ring <NUM> that is <NUM>, a change distance d of about <NUM> may be desired. As another example, for a final geometry of the annuloplasty ring <NUM> that is <NUM>, a change distance d of about <NUM> may be desired.

The biasing elements <NUM> of the illustrated annuloplasty ring <NUM> of <FIG> may be a spiral cut or helical portion of the body member <NUM> that is laser cut into the body member. The spiral cut or helical portion, because it is cut into the body member <NUM>, is a biasing element <NUM> that is integral to the body member. The spiral cut portion of the body member <NUM>, as shown in <FIG>, may form or otherwise define a spiral shape configured to expand to allow the anterior region 102c to move away from the first posterior region 102a and from the second posterior region 102b, thereby increasing the A-P distance of the annuloplasty ring <NUM>. Also, the spiral cut or helical portion of the body member <NUM> may be biased toward a relaxed position, or the contracted state as shown in <FIG>, such that expansion of the spiral cut or helical portion stores potential energy and release of an expansion force results in a release of potential energy and contraction toward the contracted state.

In some embodiments, other integral biasing elements <NUM> may be used. For example, a diamond cut pattern cut into the body member <NUM> may allow desired expansion and biasing toward the contracted state. In another embodiment, a corrugated pattern (such as, for example, folds) may be formed in the body member <NUM>. The corrugated pattern may allow desired expansion to increase the A-P distance of the annuloplasty ring <NUM> and may be biased toward the contracted state.

In addition to integral biasing elements <NUM> (formed integrally in the body member <NUM> of the annuloplasty ring <NUM>), other biasing elements <NUM> may be used that are not integral to the body member. For example, <FIG> illustrate an embodiment in which the biasing element <NUM> is a spring and not integral to the body member <NUM>, as described herein. In still other embodiments, the biasing element <NUM> may include a nonintegral biasing component (such as, for example, a spring) to complement or enhance operation of an integrally formed biasing element.

Referring back to <FIG>, the plurality of anchors <NUM>, as noted above, may be configured to secure the annuloplasty ring <NUM> to the annulus of the heart valve. In some embodiments, the anchors <NUM> may be barbs. As used herein, the terms "anchor" and "barb" may be used interchangeably. In certain embodiments, the anchors <NUM> are sufficient such that additional suturing of the annuloplasty ring <NUM> to the valve annulus is not needed. As shown in <FIG>, the anchors <NUM> may be within the body member <NUM> in an insertion geometry. As shown in <FIG>, the anchors <NUM> may be curved in the illustrated deployed configuration. The anchors <NUM> in other embodiments may include other shapes, such as linear or helical deployed configurations. In certain embodiments, the anchors <NUM> may include a shape memory material (such as, for example, nitinol) that is heat set to a deployed configuration (such as, for example, a curved configuration, a linear configuration, or a helical configuration). Those with ordinary skill in the art will recognize that combinations of different deployed anchor configurations may also be used without departing from the scope of the present disclosure.

The anchors <NUM> may be superelastic such that applying sufficient stress places the anchors into an introduction configuration and releasing the stress allows the anchors to resume their respective deployed configurations. In certain embodiments, the anchors <NUM> may lay flat against the body member <NUM> in the introduction configuration during insertion of the annuloplasty ring <NUM> through the catheter. As described in greater detail herein, in other embodiments, the anchors <NUM> may be retracted inside the hollow body member <NUM> of the annuloplasty ring <NUM> in the introduction configuration during insertion of the annuloplasty ring <NUM> through the catheter. In such embodiments, the anchors <NUM> may be selectively deployed at a desired time (such as, for example, after the annuloplasty ring <NUM> is properly positioned against, or in abutment with, the annulus of the heart valve). In certain embodiments, the superelastic property of the anchors <NUM> may be used to self-propel the anchors into the annulus of the heart valve. The anchors <NUM> may be configured to be deployed from within the body member <NUM> through the anchor windows <NUM>.

The ring closure lock <NUM> may be used to secure two open ends of the annuloplasty ring <NUM> to form a closed ring of the operable geometry. In certain embodiments, the ring closure lock <NUM> may include a female snap and a male snap. As discussed in greater detail herein, the annuloplasty ring <NUM> may be "snap locked" using wires or sutures to pull a male snap into a female snap. The ring closure lock <NUM> of the illustrated annuloplasty ring <NUM> of <FIG> may be disposed at a posterior side of the annuloplasty ring. The ring closure lock <NUM> may allow an angled coupling of the two ends, such as, for example, at an apex of a curved side of a D-shaped annular operable geometry.

The pivot <NUM> may be used to automatically rotate the annuloplasty ring <NUM> after it exits the catheter within the heart to align the plane of the annuloplasty ring <NUM> (in the annular operable geometry) with the plane of the heart valve. The annuloplasty ring <NUM> may be pushed from the catheter in a direction that is substantially perpendicular to the plane of the heart valve (such as, for example, parallel to the general direction of blood flow through the valve). Upon exiting the catheter, the annuloplasty ring <NUM> may be rotated at or about the pivot <NUM> to allow proper positioning of the annuloplasty ring <NUM> against the annulus. With the annuloplasty ring <NUM> properly oriented in alignment with the plane of the heart valve, the annuloplasty ring <NUM> may be expanded to the expanded state. For example, an expansion tool may be used to expand the annuloplasty ring <NUM>, as shown in <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> and described in greater detail herein. The annuloplasty ring <NUM> in the expanded state may be pressed against the valve annulus before deploying the anchors <NUM>, and an act of deploying the anchors may drive the anchors into the adjacent tissue. A positioning tool may facilitate expansion and/or proper positioning/orientation of the annuloplasty ring <NUM> against the heart valve annulus. A stabilizer, such as a tri-pod tool or a bi-pod tool, shown for example in <FIG>, <FIG>, and <FIG> and described in greater detail herein, may be used to position the annuloplasty ring <NUM> in abutment against the annulus of the target heart valve, or otherwise in intimate contact with the annulus of the target heart valve. In addition, fluoroscopy, ultrasound, and/or other imaging techniques may be used to assist in proper positioning of the annuloplasty ring <NUM> against the heart valve annulus.

Although not shown in <FIG> , certain ring embodiments may include a selectively adjustable member for changing the size and/or shape of the annuloplasty ring <NUM> postoperatively to compensate for changes in the size of the heart and/or the treated heart valve. An illustrative example of an adjustable member may be a member made of a material that can be adjusted via the application of energy, such as, for example RF energy, light energy, or thermal energy.

<FIG> depicts a schematic diagram of an illustrative cutting pattern, generally designated <NUM>, used for laser processing a hypotube to form a body member <NUM> of an adjustable annuloplasty ring <NUM> according to an embodiment. The pattern <NUM> may enable a hypotube or outer tube (also referred to herein as an "outer hollow member") to be cut for use as a body member <NUM> of an annuloplasty ring <NUM> according to an embodiment. The cutting pattern <NUM> may correspond to the entire body member <NUM> as if the body member were cut along a longitudinal axis and unrolled. The cutting pattern <NUM> may enable cutting the hypotube to form the plurality of regions <NUM> and the integral biasing elements <NUM>. The cutting pattern <NUM> shown in <FIG> may define the configuration of the plurality of regions <NUM> and how the regions <NUM> interact with adjacent regions as the body member <NUM> transitions from the elongate insertion geometry shown to the annular operable geometry.

The cutting pattern <NUM> may also enable cutting the hypotube to form one or more holes <NUM>, <NUM> at each end to allow one or more pins (not shown) to couple male and/or female components of the ring closure lock <NUM> to respective ends of the body member <NUM>. The cutting pattern <NUM> may also enable cutting the hypotube to form anchor windows <NUM> through which the plurality of anchors <NUM> may be deployed.

<FIG> depicts a schematic diagram of a perspective view of an illustrative adjustable annuloplasty ring, generally designated <NUM>, according to an embodiment. The annuloplasty ring <NUM> may be in an annular (D-shaped) operable geometry and a contracted state. <FIG> depicts a schematic diagram of a perspective view of an illustrative adjustable annuloplasty ring <NUM> in an expanded state. The annuloplasty ring <NUM> may be configured to enable percutaneous, transcatheter annuloplasty to repair a heart valve.

Referring collectively to <FIG>, the annuloplasty ring <NUM> may include a body member <NUM> having a plurality of regions 202a, 202b, 202c (collectively <NUM>), biasing elements 203a, 203b (collectively <NUM>), a plurality of anchors <NUM>, a ring closure lock <NUM>, and a pivot <NUM>. The body member <NUM> may be a "D-shape" in the operable geometry, but those having ordinary skill in the art will recognize that other annular-shaped operable geometries may also be used without departing from the scope of the present disclosure. For example, circular or oval operable geometries may be used. Different from the annuloplasty ring <NUM> of <FIG>, the ring closure lock <NUM> may be disposed on the anterior side of the annuloplasty ring <NUM> (rather than the posterior side).

In addition to the operable geometry shown in <FIG>, the body member <NUM> may be transitionable from an elongate insertion geometry (see, for example, <FIG>) to the annular operable geometry shown in <FIG>. The elongate insertion geometry may allow the annuloplasty ring <NUM> to be inserted into and passed through a catheter for percutaneous passage of the annuloplasty ring into the heart of a patient. A transition from an elongate insertion geometry to an annular operable geometry is illustrated in <FIG>, and discussed herein with reference to the same.

Once in an annular operable geometry, the annuloplasty ring <NUM> may have a contracted state as shown in <FIG> and an expanded state as shown in <FIG>. The biasing elements <NUM> may be configured to allow expansion of the body member <NUM> to increase the A-P distance of the annuloplasty ring <NUM> to an expanded state. In situ within the heart, expansion of the body member <NUM> to the expanded state may enlarge the annuloplasty ring <NUM> to a size conforming, or approximately conforming, to an annulus of a target heart valve to be repaired. Expansion of the body member <NUM> may be accomplished by an expansion tool, such as a balloon, a cage, or another expansion tool, such as is shown in <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, and described in greater detail herein. In the illustrated embodiment of <FIG>, a biasing element 203a disposed between a first anterior region 202a and a posterior region 202c and a biasing element 203b disposed between a second anterior region 202b and the posterior region 202c may enable a desired expansion from the contracted state shown in <FIG> to the expanded state shown in <FIG>.

The expanded state of <FIG> may be such that the annuloplasty ring <NUM> is disposed in abutment with, or in intimate contact with, the annulus of the target valve. Disposing the annuloplasty ring <NUM> in intimate contact with the annulus may enhance an anchoring process in which the plurality of anchors <NUM> is deployed to fasten the annuloplasty ring <NUM> to the annulus.

Once the annuloplasty ring <NUM> is fastened to the annulus, it may be contracted from the expanded state of <FIG> back to the contracted state of <FIG> to reduce a diameter of the annulus of the target valve. Contraction of the annuloplasty ring <NUM> may include the first and second anterior regions 202a, 202b of the body member <NUM> moving in a telescopic manner into the posterior region 202c as the biasing members <NUM> force movement of the first and second anterior regions of the body member toward the posterior region. Contraction of the annuloplasty ring <NUM> from the expanded state to the contracted state may decrease the A-P distance of the annuloplasty ring and, with the plurality of anchors <NUM> securing the annuloplasty ring to the annulus, may also decrease the A-P distance of the target valve to improve leaflet coaptation and reduce regurgitation through the target valve.

In the illustrated embodiment of <FIG>, contraction of the annuloplasty ring <NUM> from the expanded state to the contracted state may be accomplished by the biasing elements <NUM>. The biasing elements <NUM> may bias the annuloplasty ring <NUM> toward the contracted state such that expansion of the annuloplasty ring <NUM> to the expanded state stores potential energy in the biasing elements. Releasing the biasing elements <NUM> (for example, releasing or otherwise removing an expansion tool and/or expansion force) releases the stored potential energy and thereby forces movement of the first anterior region 202a and the second anterior region 202b of the body member <NUM> toward the anterior region 202c of the body member to decrease the A-P distance of the annuloplasty ring <NUM> to the contracted state. In other words, the biasing elements <NUM>, upon release, may actively transition the annuloplasty ring <NUM> from an expanded state to the contracted state.

The biasing elements <NUM> of the illustrated annuloplasty ring <NUM> of <FIG> may include springs or another similar element that is nonintegral to the body member. The springs of the biasing elements <NUM> may allow the anterior regions 202a, 202b to move away from the first posterior region 202c, thereby increasing the A-P distance of the annuloplasty ring <NUM>.

The A-P distance AP1 of the contracted state of <FIG> may be enlarged a distance d upon expansion of the annuloplasty ring <NUM> such that the A-P distance AP2 of the expanded state <FIG> is larger (AP2 = AP <NUM> + d). The springs of the biasing elements <NUM> may be biased toward a relaxed position, or the contracted state as shown in <FIG>, such that expansion of the springs stores potential energy and release of the springs results in a release of potential energy and contraction toward the contracted state.

In various embodiments, the plurality of anchors <NUM> may be configured to secure the annuloplasty ring <NUM> to the annulus of the heart valve. In <FIG>, the anchors <NUM> may be curved in the illustrated deployed configuration. The anchors <NUM> in other embodiments may include other shapes, such as, for example, linear or helical deployed configurations. In certain embodiments, the anchors <NUM> may include a shape memory material (such as, for example, nitinol) that is heat set to a deployed configuration (for example, curved configuration, linear configuration, or helical configuration). Those with ordinary skill in the art will recognize that combinations of different deployed anchor configurations may also be used without departing from the scope of the present disclosure.

The anchors <NUM> may be superelastic such that applying sufficient stress places the anchors into an introduction configuration and releasing the stress allows the anchors to resume their respective deployed configurations. In certain embodiments, the anchors <NUM> may lay flat against the body member <NUM> in the introduction configuration during insertion of the annuloplasty ring <NUM> through the catheter. As discussed below, in other embodiments, the anchors <NUM> may retract inside a hollow body member <NUM> of the annuloplasty ring <NUM> in the introduction configuration during insertion of the annuloplasty ring through the catheter. In such embodiments, the anchors <NUM> may be selectively deployed at a desired time (for example, after the annuloplasty ring <NUM> is properly positioned against, or in abutment with, the annulus of the heart valve). In certain embodiments, the superelastic property of the anchors <NUM> may be used to self-propel the anchors into the annulus of the heart valve.

The ring closure lock <NUM> may be used to secure two open ends of the annuloplasty ring <NUM> to form a closed ring of the operable geometry. Different from the annuloplasty ring <NUM> of <FIG>, the ring closure lock <NUM> may be disposed on the anterior side of the annuloplasty ring <NUM> (rather than the posterior side). In certain embodiments, the ring closure lock <NUM> may include a female snap and a male snap. The annuloplasty ring <NUM> may be "snap locked" using wires or sutures to pull a male snap into a female snap.

The pivot <NUM> may facilitate rotation of the annuloplasty ring <NUM> after it exits the catheter within the heart to align the plane of the annuloplasty ring (in the annular operable geometry) with the plane of the heart valve, as previously described herein.

<FIG> depicts a schematic diagram of a perspective view of an illustrative adjustable annuloplasty ring <NUM> according to another embodiment. The annuloplasty ring <NUM> may be in an annular (D-shaped) operable geometry and an expanded state. <FIG> depicts a schematic diagram of a perspective view of the adjustable annuloplasty ring <NUM> of <FIG> in a contracted state. The annuloplasty ring <NUM> may be configured to enable percutaneous, transcatheter annuloplasty to repair a heart valve.

Referring collectively to <FIG>, the annuloplasty ring <NUM> may include a body member <NUM> having a plurality of regions 302a, 302b, 302c (collectively <NUM>), a plurality of anchors <NUM>, a ring closure lock <NUM>, and a pivot <NUM>, similar to previously described embodiments. The annuloplasty ring <NUM> may be transitionable from an elongate insertion geometry (see, for example, <FIG>) to the annular operable geometry shown in <FIG>. The elongate insertion geometry may allow the annuloplasty ring <NUM> to be inserted into and passed through a catheter for percutaneous passage of the annuloplasty ring into the heart of a patient, as illustrated in <FIG> and discussed in greater detail herein.

The plurality of regions <NUM> of the illustrated annuloplasty ring <NUM> of <FIG> may be separate, individual segments. The segments <NUM> may be coupled together by stopped connectors 330a, 330b (collectively <NUM>) in the annular operable geometry. The stepped connectors <NUM> may be configured to enable the body member <NUM> to be adjustable to decrease the A-P distance of the annuloplasty ring <NUM> from an expanded state as shown in <FIG> to a contracted state as shown in <FIG>. The stepped connectors <NUM> may initially couple the posterior segment 302c to each of a first anterior segment 302a and a second anterior segment 302b in the expanded state of <FIG>, conforming, or approximately conforming, to an annulus of a target heart valve to be repaired. The expanded state of <FIG> may be such that the annuloplasty ring <NUM> is disposed in abutment with, or in intimate contact with, the annulus of the target valve, thereby enhancing an anchoring process in which the plurality of anchors <NUM> are deployed to fasten the annuloplasty ring to the annulus.

Once the annuloplasty ring <NUM> is fastened to the annulus, it may be contracted from the expanded state of <FIG> to the contracted state of <FIG> to reduce a diameter of the annulus of the target valve. Contraction of the annuloplasty ring <NUM> may include the stepped connectors <NUM> moving in a telescopic manner into the posterior region 302c as the first and second anterior regions 302a, 302b of the body member <NUM> move toward the posterior region. Contraction of the annuloplasty ring <NUM> from the expanded state to the contracted state may decrease the A-P distance of the annuloplasty ring and, with the plurality of anchors <NUM> securing the annuloplasty ring <NUM> to the annulus, may also decrease an A-P distance of the target valve to improve leaflet coaptation and reduce regurgitation through the target valve. The stepped connectors <NUM> may allow for multiple degrees of adjustment. For example a stepped connector having two engagement steps (sec engagement steps <NUM> in <FIG>) may allow two degrees of adjustment, as discussed in greater detail herein.

In the illustrated embodiment of <FIG>, contraction of the annuloplasty ring <NUM> from the expanded state to the contracted state may be accomplished percutaneously through use of sutures or wires to force the posterior segment 302c toward the first and second anterior segments 302a, 302b and vice versa.

In certain embodiments, a biasing element (not shown in <FIG>) may bias the annuloplasty ring <NUM> toward the contracted state and aid in contraction of the annuloplasty ring <NUM> from the expanded state to the contracted state. In other embodiments, a biasing element may enable expansion from an initial state to an expanded state, and a stepped connector <NUM> may operate to ensure expansion from the contracted state is restricted.

Different from the embodiments of <FIG> and <FIG>, the annuloplasty ring <NUM> of <FIG> may initially be in an expanded state upon transition to the annular operable geometry. In other words, the initial A-P distance AP1 of the annuloplasty ring <NUM> may be sufficient to conform or substantially conform to the A-P distance of a target valve. The A-P distance AP1 of the expanded state of <FIG> may be decreased a distance d upon contraction of the annuloplasty ring <NUM> such that the A-P distance AP2 of the contracted state <FIG> is smaller (AP2 = AP1 - d). The decrease of the A-P distance, with the anchors fastening the annuloplasty ring <NUM> to the annulus of the valve, may decrease the A-P distance of the target valve to improve leaflet coaptation of the target valve and reduce regurgitation through the target valve.

<FIG> depict a perspective view and a cross-sectional view, respectively, of a male component <NUM> of a stepped connector <NUM> of an adjustable annuloplasty ring <NUM> according to an embodiment. A corresponding female component (not shown) may be configured to receive the male component <NUM> to form the stepped connector <NUM>. The stepped connector <NUM> may include two engagement steps 402a, 402b (collectively <NUM>) to allow two degrees of adjustment and/or gradual adjustment. As shown in <FIG>, a cable <NUM> or suture may couple to the male component <NUM> of the stopped connector <NUM>. The cable <NUM> or suture may enable a force to move the male component <NUM> in a telescopic manner into a female component of the stopped connector <NUM>. Contraction of the annuloplasty ring <NUM> until engagement of a first engagement step 402a within the female component may secure the annuloplasty ring in a partial contracted state. Further contraction of the annuloplasty ring <NUM> to engagement of a second engagement step 402b within the female component may secure the annuloplasty ring in the contracted state. In this manner, the stepped connector <NUM> may enable two degrees of adjustment (and for gradual adjustment) of the A-P distance of the annuloplasty ring.

<FIG> depicts a schematic diagram illustrating a side view of an illustrative internal anchor ribbon <NUM> including the curved anchors <NUM> shown in <FIG> according to an embodiment. In certain embodiments, deployment of the anchors <NUM> may be accomplished using an internal anchor member, such as anchor ribbon <NUM>, that is selectively movable within a hollow tube of the body member <NUM> (<FIG>). The curved anchors <NUM> may be affixed (for example, laser welded) to the internal anchor ribbon <NUM> or directly cut into the internal anchor ribbon. Like the anchors <NUM>, the internal anchor ribbon <NUM> may include a superelastic shape memory material (such as, for example, nitinol). The shape memory of the anchor ribbon <NUM> may be heat set to the same memorized annular shape as the plurality of regions <NUM> of the body member <NUM> in the contracted state of the annular operable geometry, as shown in <FIG>.

The internal anchor ribbon <NUM> may be slidable (for example, using wires or sutures accessible through the catheter) in the hollow body member <NUM> of the annuloplasty ring <NUM>. To reduce friction between the internal anchor ribbon <NUM> and the body member <NUM>, certain ring embodiments may include an internal glide ribbon <NUM>. The internal glide ribbon <NUM> may include a low-friction material (for example, as a coating or covering) such as polytetrafluoroethylene (PTFE) or other polymer. In addition, or in other embodiments, the internal glide ribbon <NUM> may include a superelastic shape memory material (such as, for example, nitinol) that is heat set to the same memorized annular shape as the body member <NUM>. Thus, in particular embodiments, three D-shaped superelastic members (the outer tube of the body member <NUM>, the internal anchor ribbon <NUM>. and the internal glide ribbon <NUM>) may be included, which may cooperate to increase the rigidity of the annuloplasty ring <NUM>.

In various embodiments, as shown in <FIG>, the internal anchor ribbon may be a tube-like polymeric element <NUM> having a curved wall <NUM> and an opening <NUM> therethrough. In some embodiments, the polymeric element <NUM> may be located inside the ring <NUM> (<FIG>) such that the anchors <NUM> (<FIG>) slide inside the ring. The general shape and/or pattern of the polymeric element <NUM> is not limited by this disclosure, and may generally be any pattern that allows for movement of the anchors <NUM> (<FIG>) inside the ring <NUM> (<FIG>), as described herein. For example, <FIG> depict a top view, a first side view, and a second side view, respectively, of an illustrative pattern for a polymeric element <NUM>. The polymeric material <NUM> may generally be made of any material now known or later developed to reduce friction and facilitate sliding of the anchors <NUM> (<FIG>) within the ring. Illustrative materials may include, but are not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyether block amide (PEBA), and/or the like. In addition, the polymeric element <NUM> may be constructed by any method now known or later developed, including, but not limited to, an extrusion method, an injection molding method, a machining method, and/or the like.

<FIG> depicts a schematic diagram of a top view of the anchors <NUM> cut into the internal anchor ribbon <NUM> shown in <FIG> in the elongate insertion geometry according to an embodiment. In some embodiments, a laser may be used to cut the anchors <NUM> along a first side <NUM>, a second side <NUM> (for example, in a pointed or tip shape), and a third side <NUM>, while leaving a fourth side <NUM> of the anchor <NUM> uncut and attached to the internal anchor ribbon <NUM>. After cutting, the anchors <NUM> may be heat set to the desired memorized shape for the deployed configuration. For example, <FIG> depicts a schematic diagram of a side view of the internal anchor ribbon <NUM> in the elongate insertion geometry and the anchors <NUM> in a curled or curved deployed configuration according to an embodiment. The amount of curvature in the deployed configuration of the anchors <NUM> may depend on the particular application. In the example shown in <FIG>, the anchors <NUM> may fold back on themselves such that the prong or tip <NUM> points parallel to or away from the internal anchor ribbon <NUM>. <FIG> depicts a schematic diagram of a top view of the internal glide ribbon <NUM>, and <FIG> depicts a schematic diagram of a side view of the internal glide ribbon <NUM>, in the elongate insertion geometry according to an embodiment.

<FIG> depict schematics of cross-sectional side views of an annuloplasty ring <NUM> before (<FIG>) and after (<FIG>) deployment of the anchors <NUM> shown in <FIG> according to an embodiment. For illustrative purposes, the annuloplasty ring <NUM> in <FIG> is shown in an elongate insertion geometry. Those having ordinary skill in the art will recognize, however, that the anchors <NUM> may generally be deployed when the annuloplasty ring <NUM> is in the annular operable geometry without departing from the scope of the present disclosure.

The illustrated annuloplasty ring <NUM> may include an outer tube <NUM> (for example, formed by the body member <NUM> shown in <FIG>) including a plurality of anchor deployment windows <NUM>. During the manufacturing of the annuloplasty ring <NUM>, and before the annuloplasty ring is loaded into the catheter, the internal anchor ribbon <NUM> and the internal glide ribbon <NUM> may be inserted into the outer tube <NUM> in a position where the anchors <NUM> are prevented from exiting through the windows <NUM>. As shown in <FIG>, inserting the internal anchor ribbon <NUM> into the outer tube <NUM> may prevent the anchors from assuming their fully curved deployed configuration.

For deploying the anchors <NUM>, the internal anchor ribbon <NUM> may include (or may be attached to) a hook or loop <NUM> for engaging a wire or suture <NUM> that may be pulled by a user through the catheter (for example, in the direction of arrow <NUM> in <FIG>) to move the tip of each anchor <NUM> to a corresponding window <NUM>. In particular embodiments, the anchors <NUM> and windows <NUM> may be arranged such that the tip of each anchor <NUM> reaches its respective window <NUM> at substantially the same time as the other anchor/window pairs. As shown in <FIG>, once the tips of the anchors <NUM> reach the respective windows <NUM>, the superelasticity of the anchors may propel the internal anchor ribbon <NUM> in the opposite direction (as indicated by arrow <NUM>) as the anchors spring out the windows (as indicated by arrow <NUM>) to resume their curved configurations. As the anchors <NUM> drive through the windows <NUM> the anchors may drive into surrounding tissue (for example, the heart valve annulus). The superelasticity of the anchors <NUM> may allow the anchors to be self-propelled into the tissue adjacent or proximate to the annuloplasty ring <NUM>.

In some embodiments, as shown in <FIG>, the anchors <NUM> may be divided into a plurality of segments 650a, 650b, 650c. While <FIG> depicts <NUM> segments, those having ordinary skill in the art will recognize that any number of segments may be used without departing from the scope of the present disclosure. For example, the anchors <NUM> may be divided into <NUM> segments, <NUM> segments, <NUM> segments. <NUM> segments, <NUM> segments, or more. Dividing the anchors <NUM> into a plurality of segments 650a, 650b, 650c may allow for actuation of one or more of the segments at a time such that the actuated segment deploys its respective anchor(s) <NUM> while the remaining anchors remain non-deployed. In some embodiments, various segments 650a, 650b, 650c may be actuated sequentially. In other embodiments, various segments 650a, 650b, 650c may be actuated simultaneously. In some embodiments, various segments 650a, 650b, 650c may be actuated based upon which anchors <NUM> an operator desires to deploy, which may be based upon positioning and location of the annuloplasty ring. In some embodiments, the segments <NUM>, 650b, 650c may be arranged in a plurality of zones. For example, a posterior side may be a first zone having a first plurality of segments and an anterior side may be a second zone having a second plurality of segments. Thus, the anterior zone may be deployed separately from the posterior zone, or at substantially the same time.

<FIG> depicts a simplified schematic diagram of a side view of an illustrative internal anchor member (or members) <NUM> including linear anchors <NUM> according to an embodiment. The linear anchors <NUM> may be affixed (for example, laser welded) to the internal anchor member <NUM>. In the embodiment shown in <FIG>, however, the internal anchor member <NUM> and linear anchors <NUM> may be cut from a single superelastic shape memory (such as, for example, nitinol) hypotube. <FIG>, for example, shows remaining tubular portions <NUM> after the hypotube is cut to form prongs <NUM> of the linear anchors <NUM>. The remaining tubular portions <NUM> may facilitate sliding (for example, using wires or sutures accessible through the catheter) the internal anchor member <NUM> coaxially within the hollow tube of the annuloplasty ring (for example, within the annuloplasty ring <NUM> shown in <FIG>).

The internal anchor member <NUM> may be heat set to the same memorized annular shape as the annuloplasty ring <NUM>. The anchor prongs <NUM> may be heat set to protrude outward through windows cut in the annuloplasty ring <NUM>. Barbs <NUM> may be laser welded to the prongs <NUM> to form the linear anchors <NUM>. The linear anchors <NUM> may be retracted/deployed by sliding the internal anchor member <NUM> within the annuloplasty ring <NUM>.

As described herein, the annuloplasty ring may be configured for percutaneous transcatheter delivery and fixation to heart valves. The annuloplasty ring may be delivered through a catheter to the mitral valve, for example, using a trans-septal approach, a retrograde approach, or a trans-apical approach. For example, <FIG> depicts a schematic diagram of an illustrative trans-septal approach for endovascular delivery of an annuloplasty ring (not shown) to the mitral valve <NUM> of a heart <NUM> according to an embodiment. For illustrative purposes, a partial cross-section of the heart <NUM> is illustrated to show the right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV. For clarity, certain features (for example, papillary muscles and chordae tendineae) are not shown. In the trans-septal approach shown in <FIG>, the left atrium LA may be approached by advancement of a catheter <NUM> through the inferior vena cava <NUM>, into the right atrium RA, across the interatrial septum <NUM>, and into the left atrium LA. The annuloplasty ring may be delivered through the catheter <NUM> into the atrium and anchored to the annulus of the mitral valve <NUM>.

As shown in <FIG>, the catheter <NUM> may be delivered percutaneously into the heart <NUM>. A guiding sheath (not shown) may be placed in the vasculature system of the patient and used to guide the catheter <NUM> and its distal end <NUM> to a desired deployment site. In some embodiments, a guide wire (not shown) may be used to gain access through the superior or inferior vena cava <NUM>, for example, through groin access for delivery through the inferior vena cava <NUM>. The guiding sheath may be advanced over the guide wire and into the inferior vena cava <NUM> shown in <FIG>. The catheter <NUM> may be passed through the right atrium RA and toward the interatrial septum <NUM>. Once the distal end <NUM> of the catheter <NUM> is positioned proximate to the interatrial septum <NUM>, a needle or piercing member (not shown) is advanced through the catheter <NUM> and used to puncture the fossa ovalis or other portion of the interatrial septum <NUM>. In some embodiments, the catheter <NUM> may be dimensioned and sized to pass through the fossa ovalis without requiring a puncturing device. That is, the catheter <NUM> may pass through the natural anatomical structure of the fossa ovalis into the left atrium LA.

Similarly, any chamber (LV, RV, LA, RA) of the heart <NUM> may be approached through the inferior vena cava <NUM>. For example, the right ventricle RV may be approached through the interior vena cava <NUM>, into the right atrium RA, and through the tricuspid valve <NUM>. A variety of other endovascular approaches may also be used.

<FIG> depicts a schematic diagram of an illustrative retrograde approach of an annuloplasty ring (not shown) to the mitral valve <NUM> of a heart <NUM> according to another embodiment. In <FIG>, a femoral approach is shown wherein the delivery catheter <NUM> may be advanced through the aorta <NUM> and the aortic valve <NUM>. Typically, the catheter <NUM> may be advanced through a sheath positioned within the femoral artery (not shown). Under fluoroscopy or other methods of guidance, the distal end of the catheter <NUM> may be guided within the left ventricle LV and turned (for example, as shown with a "U-turn" <NUM>) within the left ventricle LV so as to pass through the leaflets of the mitral valve <NUM> and into the left atrium LA. After verification of the appropriate positioning of the catheter <NUM>, a guide wire (not shown) may be inserted through the catheter <NUM> into the left atrium LA, which may be used to guide one or more other catheters into the left atrium LA for delivering and anchoring the annuloplasty ring to the annulus of the mitral valve <NUM>.

<FIG> depicts a schematic diagram of an illustrative trans-apical approach of an annuloplasty ring (not shown) to the mitral valve <NUM> of a heart <NUM> according to another embodiment. As shown in <FIG>, the catheter <NUM> may pass through the apex <NUM> of the heart <NUM>, through the left ventricle LV, through the leaflets of the mitral valve <NUM>, and into the left atrium LA. The annuloplasty ring may be delivered through the catheter <NUM> into the left atrium LA and anchored to the annulus of the mitral valve <NUM>. In an embodiment, a needle or trocar may be used to puncture through the apex <NUM> to create a small opening through which a guide wire (not shown) can be inserted through the left ventricle LV into the left atrium LA. The guide wire may be used to guide successively larger and stiffer catheters so as to gradually increase the size of the opening in the apex <NUM> of the heart <NUM>.

<FIG> depicts a flow diagram of a first illustrative method of placing an annuloplasty ring at a target valve according to an embodiment. The method may include inserting <NUM> a distal end of a catheter into a target tissue, such as the heart. The method of insertion <NUM> is not limited by this disclosure and may be any method, particularly methods described herein with respect to <FIG>. The annuloplasty ring may be inserted <NUM> in the proximal end of the catheter and advanced <NUM> through the catheter and out of the distal end such that it is placed at the location of the target tissue. In some embodiments, advancing <NUM> may include guiding the annuloplasty via the delivery system described herein. When the annuloplasty ring is inserted <NUM> and advanced <NUM>, it may be in an elongate insertion geometry, as described in greater detail herein. As the ring advances <NUM> out of the catheter, it may be allowed <NUM> to transition to an annular operable geometry, as described in greater detail herein. Advancing <NUM> and/or allowing <NUM> the annuloplasty ring includes manipulating a ring closure knob located on a deployment handle, as described in greater detail herein.

The ends of the annuloplasty ring may be drawn <NUM> together, such as, for example, by pulling a first suture connected to the annuloplasty ring through the catheter. The ends are drawn <NUM> together via manipulating a ring closure knob located on a deployment handle, as described in greater detail herein. In some embodiments, a ring closure lock may lock the two ends of the ring together once they have been sufficiently drawn <NUM> together. Drawing <NUM> the ends together includes manipulating a ring snap knob on a deployment handle to cause the ends to snap together, as described in greater detail herein.

In various embodiments, a determination <NUM> may be made as to whether the ring is sufficiently oriented. In some embodiments, orientation of the ring may be based on the positioning and/or location of the catheter, the location and/or positioning of the target tissue, the shape of the ring, and/or the like. If orientation of the ring is necessary, the ring may be oriented <NUM>. Orienting <NUM> may include, for example, rotating the ring, the catheter, and/or various other components described herein. In some embodiments, orienting <NUM> may include automatically rotating the ring to change a plane of the ring from a first orientation that is parallel to the catheter to a second orientation that is parallel to a plane of the annulus. In some embodiments, orienting <NUM> the annuloplasty ring may be completed via the stabilizer portion, such as by manipulating a stabilizer knob on a deployment handle, as described in greater detail herein.

In various embodiments, a determination <NUM> may be made as to whether the ring is sufficiently expanded. In some embodiments, expansion of the ring may be based on the construction of the ring, as described in greater detail herein. Thus, in some embodiments, expansion may not occur, particularly in embodiments where the ring is not expandable, as described in greater detail herein. If expansion of the ring is necessary, the ring may be expanded <NUM>. Expansion of the ring may be completed by manipulating one or more sutures, as described in greater detail herein. In some embodiments, expanding <NUM> the ring may be completed via an expansion tool, such as, for example, by manipulating an expansion tool knob on a deployment handle, as described in greater detail herein. In some embodiments, a percutaneously, transcatheter-operated expansion tool may be actuated to expand <NUM> the annuloplasty ring in the annular operable geometry to an expanded state to thereby increase an A-P distance of the annuloplasty ring. Expansion of the annuloplasty ring may include expanding a biasing element of the annuloplasty ring.

In various embodiments, a determination <NUM> may be made as to whether the ring is contacting the annulus. The determination <NUM> may be necessary, for example, to ensure proper placement of the ring adjacent to the annulus. In some embodiments, the ring may be pressed <NUM> against the annulus. Pressing <NUM> may include positioning the annuloplasty ring in abutment or similar relatively intimate contact with an annulus of a target valve to enhance a process of fastening the annuloplasty ring to the annulus. The method may include manipulating a stabilizer, such as via a stabilizer knob, as described in greater detail herein. The method may also include pulling a second suture connected to the annuloplasty ring through the catheter to deploy <NUM> a plurality of tissue anchors from the annuloplasty ring. Deployment <NUM> of the anchors is completed via manipulation of an anchor deployment knob, as described in greater detail herein. With the anchors deployed <NUM> and the annuloplasty ring fastened to the tissue of the target valve, the expansion tool may be released <NUM>. The annuloplasty ring may be contracted <NUM> to transition the annuloplasty ring in the operable geometry to a contracted state to decrease the A-P distance, thereby decreasing the A-P distance of the target heart valve to improve coaptation and reduce regurgitation through the target heart valve. In some embodiments, contraction <NUM> of the annuloplasty ring may be completed by biasing elements that have stored potential energy during expansion of the annuloplasty ring.

In various embodiments, the annuloplasty ring may be detached <NUM> from the catheter and the first and second sutures, and the catheter may be removed <NUM> from the heart. The ring is detached <NUM> via manipulation of a ring release knob on a deployment handle, as described in greater detail herein.

<FIG> depicts a flow diagram of a second illustrative method of placing an annuloplasty ring at a target valve according to an embodiment. The method may include inserting <NUM> a distal end of a catheter into a target tissue, such as the heart. The method of insertion <NUM> is not limited by this disclosure and may be any method, particularly methods described herein with respect to <FIG>. The annuloplasty ring may be inserted <NUM> in the proximal end of the catheter and advanced <NUM> through the catheter and out of the distal end such that it is placed at the location of the target tissue. In some embodiments, advancing <NUM> may include guiding the annuloplasty via the delivery system described herein. When the annuloplasty ring is inserted <NUM> and advanced <NUM>, it may be in an elongate insertion geometry, as described in greater detail herein. In some embodiments, the annuloplasty ring may be attached to a catheter. As the ring advances <NUM> out of the catheter, it may be allowed <NUM> to transition to an annular operable geometry, as described in greater detail herein. Advancing <NUM> and/or allowing <NUM> the annuloplasty ring includes manipulating a ring closure knob located on a deployment handle, as described in greater detail herein.

The annuloplasty ring may be contacted <NUM> with a posterior side of the valve. Such contacting <NUM> may generally be completed via the delivery system, as described in greater detail herein. Use of the delivery system may include manipulating at the stabilizer, as described in greater detail herein. A first portion of the anchors may be deployed <NUM>, such as, for example, the posterior zone anchors (as described herein). Thus, in some embodiments, anchors located in two posterior zones may be deployed sequentially. Alternatively, anchors located in two posterior zones may be deployed simultaneously. Deployment <NUM> may effect engagement of the one or more posterior zones of the annuloplasty ring (or a portion thereof) to the posterior side of the valve. As previously described herein, deployment <NUM> is completed via manipulation of an anchor deployment knob.

The valve tissue may be dragged <NUM>, via the delivery system, such that the annuloplasty ring may be contacted <NUM> to the anterior side of the valve. Use of the delivery system may include manipulating at least the stabilizer, as described in greater detail herein. A second portion of the anchors may be deployed <NUM>, such as, for example, the anterior zone anchors (as described herein). Thus, in some embodiments, anchors located in two anterior zones may be deployed sequentially. Alternatively, anchors located in two anterior zones may be deployed simultaneously. Deployment <NUM> may effect engagement of the anterior zone of the annuloplasty ring (or a portion thereof) to the anterior side of the valve.

With the anchors deployed <NUM>, <NUM> and the annuloplasty ring fastened to the tissue of the target valve, the stabilizer may be released <NUM>. The annuloplasty ring may be contracted <NUM> to transition the annuloplasty ring in the operable geometry to a contracted state to decrease the A-P distance, thereby decreasing the A-P distance of the target heart valve to improve coaptation and reduce regurgitation through the target heart valve. In some embodiments, contraction <NUM> of the annuloplasty ring may be completed by biasing elements that have stored potential energy during expansion of the annuloplasty ring.

<FIG>, <FIG>, <FIG>, and <FIG> depict schematic diagrams illustrating transcatheter delivery of an annuloplasty ring <NUM> from a delivery system <NUM> according to various embodiments. <FIG> depicts a perspective view of a distal end <NUM> of the delivery system <NUM>. As shown in <FIG>, the annuloplasty ring <NUM> may be in the elongate insertion geometry and partially deployed from the distal end <NUM> of a delivery catheter <NUM> in a first deployment stage. In the first stage, the annuloplasty ring <NUM> may be still substantially in the elongate insertion geometry. As shown in <FIG>, a first suture <NUM> for snapping together the ends of the annuloplasty ring <NUM> may pass through a male snap <NUM> of a ring closure lock <NUM> (shown in <FIG>).

<FIG> is a perspective view of the annuloplasty ring <NUM> in a second stage of partial deployment from the delivery catheter <NUM>. In the second stage, the portion of the annuloplasty ring <NUM> that has exited the delivery catheter <NUM> has begun to transition (due to the shape memory materials used in the annuloplasty ring) from the elongate insertion geometry to the annular operable geometry.

<FIG> is a perspective view of the annuloplasty ring <NUM> in a third stage of deployment in which a ring shuttle <NUM> of the delivery system <NUM> has substantially pushed the annuloplasty ring out of the delivery catheter <NUM>, but the plane of the annuloplasty ring is still aligned with (for example, parallel to) the longitudinal axis of the delivery catheter. In <FIG>, the annuloplasty ring <NUM> may be in a configuration, for example, immediately before a ring deployment wire <NUM> cooperates with the pivot <NUM> to rotate the annuloplasty ring <NUM> (see <FIG>). In the configuration shown in <FIG>, the distal end of the ring deployment wire <NUM> may include a bend or hook <NUM> as it passes through a hole in the pivot <NUM>. The ring deployment wire <NUM> includes a superelastic shape memory material (such as, for example, nitinol), and bending the distal end of the ring deployment wire <NUM> into the hook <NUM> shape may spring load the annuloplasty ring <NUM> within the outer jacket delivery catheter <NUM> such that the annuloplasty ring <NUM> automatically rotates about the pivot <NUM> upon exiting the outer jacket delivery catheter <NUM>. At this third stage of deployment, the hook <NUM> shape formed in the superelastic ring deployment wire <NUM> is ready to unload (return to a heat-set memorized straight configuration) as soon as the delivery catheter <NUM> no longer prevents it from doing so. The suture <NUM> may be used to draw together the male components <NUM> and female components <NUM> of a ring closure lock <NUM>.

<FIG> depicts a perspective view of the annuloplasty ring <NUM> in a fourth stage of deployment in which the plane of the annuloplasty ring (in its annular operable geometry) has been changed to be perpendicular to the longitudinal axis of the delivery catheter <NUM>. As shown in <FIG>, the superelastic ring deployment wire <NUM> has returned to its heat set (memorized) straight configuration. At this fourth stage of deployment, the plane of the annuloplasty ring <NUM> may be configured to be parallel to the plane of the heart valve annulus. In situ within the heart, a longitudinal axis of the delivery catheter <NUM> may be oriented parallel to the direction of blood through the valve and approximately perpendicular to the plane of the heart valve. The annuloplasty ring <NUM>, when oriented such that the plane of the annuloplasty ring is transverse to (and perpendicular or approximately perpendicular to) the longitudinal axis of the delivery catheter <NUM>, may be oriented such that the plane of the annuloplasty ring is parallel or approximately parallel to the plane of the heart valve.

In further stages of deployment, the annuloplasty ring <NUM> may be expanded and/or pressed against the heart valve annulus before deploying the anchors (such as the curved anchors <NUM> shown in <FIG>). As discussed herein, certain anchors may propel themselves into the tissue of the heart valve annulus upon being deployed. In other embodiments, the anchors (such as the linear anchors <NUM> shown in <FIG>) may be deployed before pressing the annuloplasty ring <NUM> against the annulus. After the annuloplasty ring <NUM> is anchored to the heart valve annulus and transitioned to the contracted state, the ring deployment wire <NUM> may be pulled from the hole in the pivot <NUM> to release the annuloplasty ring <NUM> from the ring shuttle <NUM>. Any remaining sutures, such as the first suture <NUM>, may also be cut and/or pulled from the annuloplasty ring <NUM> before the delivery catheter <NUM> is removed from the heart. In some embodiments, removal of the ring deployment wire <NUM> and/or any remaining sutures may be completed via one or more of the knobs, as described in greater detail herein.

<FIG> depicts a schematic diagram of a perspective, partial cross-sectional view of a heart <NUM> during the expansion of an adjustable annuloplasty ring <NUM> using an expansion tool <NUM>, preparatory to affixation to the annulus of the mitral valve <NUM> according to an embodiment. As shown in <FIG>, a delivery catheter <NUM> may extend from the left ventricle into the left atrium through the leaflets of the mitral valve <NUM>. Thus, this illustrated embodiment may correspond to, for example, a trans-apical approach or a retrograde approach, as discussed herein. Those with ordinary skill in the art will recognize from the present disclosure that similar principles as those illustrated may be used for trans-septal approaches.

In <FIG>, an expansion tool <NUM> may be used to expand the annuloplasty ring <NUM>. The annuloplasty ring <NUM> may be positioned on or next to the annulus of the mitral valve <NUM>. The expansion tool <NUM> may be disposed within the annuloplasty ring <NUM> (and within the target valve <NUM>) to expand the annuloplasty ring <NUM> to transition it from a contracted state to an expanded state. The expansion tool <NUM> of the illustrated embodiment of <FIG> is a balloon expansion tool <NUM>. The balloon expansion tool <NUM> may be inflated to expand the annuloplasty ring <NUM> to an expanded state. In some embodiments, the balloon expansion tool <NUM> may include a plurality of sections and may be considered a "multichamber" balloon with a plurality of chambers. In particular embodiments, the balloon expansion tool <NUM> may have two chambers. In other embodiments, a balloon expansion tool <NUM> may have a single chamber.

In the embodiment shown in <FIG>, the inflated balloon expansion tool <NUM> may reduce or prevent the flow of blood through the mitral valve during at least part of the implantation procedure. In such embodiments, inflation of the balloon expansion tool <NUM> may last <NUM> seconds or less to prevent adverse consequences of occluding the mitral valve <NUM>. In other embodiments, such as the embodiment of an expansion tool shown in <FIG>, <FIG>, <FIG>, and <FIG>, blood may be allowed to flow through the target valve <NUM> during the entire procedure.

<FIG> depicts a schematic diagram of a perspective, partial cross-sectional view of a heart <NUM> during the expansion of an adjustable annuloplasty ring <NUM> using a cage or basket tool <NUM> as an expansion tool, preparatory to affixation to the annulus of the mitral valve <NUM> according to another embodiment.

The basket expansion tool <NUM> may include a plurality of flexible members <NUM> that lay flat against a central rod <NUM> during insertion of the basket expansion tool through the delivery catheter (see <FIG>) and may be forced into an expanded configuration (shown in <FIG>) when the central rod is pushed into an end cap <NUM>. In another embodiment, each of the plurality of flexible members <NUM> may include a superelastic material so as to spring from a delivery catheter into the expanded configuration shown in <FIG>.

<FIG> and <FIG> depict schematic diagrams of perspective views of an illustrative stabilizer, generally designated <NUM>, that may be used in lieu of the expansion tool according to an embodiment. <FIG> depicts a perspective view of the stabilizer <NUM> separated from other components of the percutaneous annuloplasty system. <FIG> depicts the stabilizer <NUM> disposed through a delivery catheter <NUM> and engaging an annuloplasty ring <NUM>.

In order to achieve sufficient intimate contact between an annuloplasty ring <NUM> (shown in <FIG>) and the tissue of the target heart valve (for example, the annulus of the heart valve), the stabilizer <NUM> may be used to position, orient, and otherwise manipulate the annuloplasty ring <NUM> in the annular operable geometry, prior to affixation to tissue of the valve. The stabilizer <NUM> may have a metallic rib structure having a plurality of arms 1202a, 1202b, 1202c (collectively <NUM>) or prongs configured to extend outward at an angle from a central column <NUM>. While only three arms <NUM> are shown in the present embodiment, those having ordinary skill in the art will recognize any number of arms may be suitable without departing from the scope of the present disclosure. For example, the stabilizer <NUM> may have <NUM>. <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more arms <NUM>. The rib structure, specifically the arms <NUM> and central column <NUM>, may be laser cut from a shape memory material, such as nitinol. The stabilizer <NUM> may be cut from a hollow tube such that the central column <NUM> has a hollow cylindrical shape. The arms <NUM> may be heat set to extend at an angle from the central column <NUM>.

The illustrated stabilizer <NUM> of <FIG> and <FIG> may include three arms <NUM> arranged, for example, as a tripod. The plurality of arms <NUM> of the stabilizer <NUM> may be loaded into a delivery catheter <NUM> together with the annuloplasty ring <NUM> (for example, configured in the elongate insertion geometry). As the arms <NUM> emerge from a distal end of the delivery catheter <NUM>, they may automatically expand outward. The stabilizer <NUM>, and specifically the plurality of arms <NUM>. may be configured to align with and engage the annuloplasty ring <NUM> as shown in <FIG>. When aligned and engaged with the annuloplasty ring <NUM>, the stabilizer <NUM> may be used to push/pull the annuloplasty ring <NUM> toward the tissue of an annulus of a heart valve.

The illustrated stabilizer of <FIG> and <FIG> may be configured to engage a top surface of the annuloplasty ring <NUM>, through the annuloplasty ring, to pull the annuloplasty ring downward. For example, the plurality of arms <NUM> may include a curved, angled, or hooked portion at a distal end to facilitate engagement with the annuloplasty ring <NUM>. The stabilizer <NUM> may be used to pull the annuloplasty ring <NUM> toward the heart valve to facilitate intimate contact of the annuloplasty ring with the annulus. Intimate contact, or close abutment, of the annuloplasty ring <NUM> with the annulus of the valve may enhance an anchor deployment process to fasten the annuloplasty ring <NUM> to the annulus.

In some embodiments, the stabilizer <NUM>, particularly the arms <NUM>, may also be configured to function as an expansion tool to engage the annuloplasty ring <NUM> and effectuate and/or facilitate transition of the annuloplasty ring from a contracted state to an expanded state. For example, a superelastic property and memorized shape of the plurality of arms <NUM> may effectuate expansion of the annuloplasty ring <NUM>. The superelastic arms <NUM> may engage an inner surface of the annuloplasty ring <NUM> and exert outward force to expand the annuloplasty ring. In other embodiments, a suture or other elongate member may enable percutaneous manipulation of one or more of the plurality of arms to effectuate expansion of the annuloplasty ring <NUM>.

<FIG> and <FIG> depict a stabilizer <NUM> that includes a balloon <NUM>. The balloon <NUM> may pass through the central column <NUM> of the stabilizer <NUM>. When the balloon <NUM> is inflated, it may cause the arms <NUM> of the stabilizer <NUM> to expand. By expanding the stabilizer <NUM>, the ring <NUM> (<FIG>) may be expanded to its expanded configuration. In some embodiments, the ring <NUM> (<FIG>) may also be contracted when the balloon <NUM> is deflated and the tool <NUM> is retracted.

<FIG> depicts a schematic diagram that demonstrates how various holes <NUM> may be used to guide one or more sutures <NUM> that exit the ring <NUM>, as described in greater detail herein. The sutures <NUM> may be used for deployment or recapturing of the anchors held within the ring <NUM>. In some embodiments, the sutures <NUM> may extend through the windows in the ring and/or dedicated holes in the laser cut pattern of the ring, as described herein. The holes in the tool <NUM> may allow the sutures <NUM> to be gathered together and guided through the hollow central column <NUM> and the catheter <NUM> via the handle at the proximal end of the catheter, as described in greater detail herein.

In various embodiments, the expansion tool and/or the stabilizer may be configured to complete one or more additional tasks. Illustrative additional tasks are not limited by this disclosure, and may include, for example, navigating the annuloplasty ring within a chamber of a heart, creating an intimate contact between the annuloplasty ring and the target tissue (such as a valve annulus), expanding the annuloplasty ring, and stabilizing the annuloplasty ring during various deployment and anchoring processes, as described in greater detail herein.

<FIG> and <FIG> depict schematic diagrams of perspective views of an illustrative stabilizer <NUM> to be used as an expansion tool of a percutaneous annuloplasty system according to an embodiment. The illustrated stabilizer <NUM> may include one or more arms or prongs <NUM>, such as, for example, two arms 1302a, 1302b. <FIG> depicts a perspective view of the stabilizer <NUM> separated from other components of the percutaneous annuloplasty system. <FIG> depicts the stabilizer <NUM> disposed through a delivery catheter <NUM> and engaging an annuloplasty ring <NUM>. The stabilizer <NUM> may be used to position, orient, and otherwise manipulate the annuloplasty ring <NUM> to achieve intimate contact in abutment with tissue of the annulus of a target heart valve.

Referring generally and collectively to <FIG>, the arms <NUM> of the stabilizer <NUM> may be configured to extend outward at an angle from a central column <NUM>, thereby forming a rib structure. The rib structure, particularly the arms <NUM> and central column <NUM>, may be laser cut from a shape memory material, such as, for example, nitinol. The stabilizer <NUM> may be cut from a hollow tube such that the central column <NUM> has a hollow cylindrical shape. The arms <NUM> may be heat set to extend at an angle from the central column <NUM>.

The illustrated stabilizer <NUM> of <FIG> and <FIG> may include two arms 1302a, 1302b arranged, for example as a bipod. The two arms 1302a, 1302b in cooperation with a ring shuttle <NUM> of a delivery system. of the percutaneous annuloplasty system form a tripod structure engaging the annuloplasty ring <NUM> at three points. The plurality of arms <NUM> may be loaded into a delivery catheter <NUM> together with the annuloplasty ring <NUM> (for example, configured in the elongate insertion geometry). As the arms <NUM> extend from a distal end of the delivery catheter <NUM>, they may automatically expand outward and may be configured to align with and engage the annuloplasty ring <NUM> as shown in <FIG>. When aligned and engaged with the annuloplasty ring <NUM>, the stabilizer <NUM> may be used to push/pull the annuloplasty ring toward the tissue of the annulus of a valve.

The illustrated stabilizer of <FIG> and <FIG> may be configured to engage a top surface of the annuloplasty ring <NUM> to pull the annuloplasty ring. For example, the plurality of arms <NUM> may include a curved, angled, or hooked portion at a distal end to facilitate engagement with the annuloplasty ring <NUM>. The stabilizer <NUM> may be used to pull the annuloplasty ring <NUM> toward the heart valve to facilitate intimate contact of the annuloplasty ring with the annulus to enhance an anchor deployment process to fasten the annuloplasty ring to the annulus.

The stabilizer <NUM>, particularly the arms <NUM>. may also be configured to function as an expansion tool to engage the annuloplasty ring <NUM> and effectuate and/or facilitate transition of the annuloplasty ring from a contracted state to an expanded state. For example, a superelastic property and memorized shape of the plurality of arms <NUM> may enable the arms to engage an inner surface of the annuloplasty ring <NUM> and via its inherent material properties, exert outward force to expand the annuloplasty ring. In other embodiments, a suture or other elongate member may enable percutaneous manipulation of one or more of the plurality of arms <NUM> to effectuate expansion of the annuloplasty ring <NUM>.

In some embodiments, the arms <NUM> of the stabilizer <NUM> may also include a feature that locks the stabilizer against the annuloplasty ring <NUM>, thereby preventing each arm from moving relative to another, such as, for example, after the deployment and during creation of intimate contact between the ring and the tissue. For example, the arms <NUM> of the stabilizer <NUM> may each have at least one strat 1303a, 1303b (collectively <NUM>). Each strat <NUM> may prevent its respective arm <NUM> from sliding on the annuloplasty ring <NUM> and may allow and/or facilitate engagement on a particular position of the ring. In some embodiments, a particular position of engagement on the annuloplasty ring <NUM> may ensure a proper ring size, shape, and/or orientation. After aligning the stabilizer <NUM> relative to the annuloplasty ring <NUM>, the stabilizer may be fixed in relation to the ring by the strats <NUM>. By manipulating the tool <NUM>, the operator may be able to manipulate the position and orientation of the annuloplasty ring <NUM>.

In various embodiments, as shown in <FIG>, the annuloplasty ring <NUM> may also have at least one strat 1355a, 1355b (collectively <NUM>). Each strat <NUM> may prevent the annuloplasty ring <NUM> from sliding when attached to the arms <NUM>. In some embodiments, each strat <NUM> may allow and/or facilitate engagement of a particular portion of the annuloplasty ring <NUM> with a particular arm <NUM>. In some embodiments, a particular position of engagement of the strats <NUM> on the annuloplasty ring <NUM> may ensure a proper ring size, shape, and orientation. After aligning the stabilizer <NUM> (<FIG>) relative to the annuloplasty ring <NUM>, the stabilizer may be fixed in relation to the ring by the strats <NUM>. In some embodiments, the strats <NUM> on the annuloplasty ring <NUM> may be used in conjunction with the strats <NUM> on the arms <NUM> of the stabilizer. In other embodiments, the strats <NUM> on the annuloplasty ring <NUM> may be used in lieu of the strats <NUM> on the arms <NUM> of the stabilizer.

<FIG> and <FIG> depict diagrams illustrating perspective views of a stabilizer <NUM> of a percutaneous annuloplasty system according to an embodiment. The stabilizer <NUM> may be configured to push and/or press an annuloplasty ring <NUM> (from above) into intimate contact with, or abutment against, an annulus of a target heart valve. The illustrated stabilizer <NUM> may include a plurality of arms or prongs <NUM>, such as, for example two arms 1402a, 1402b. <FIG> depicts a perspective view of the stabilizer <NUM> separated from other components of the percutaneous annuloplasty system. <FIG> depicts the stabilizer <NUM> disposed through a delivery catheter <NUM> and engaging an annuloplasty ring <NUM> from above. The stabilizer <NUM> may be used to position, orient, and/or otherwise manipulate the annuloplasty ring <NUM> to achieve intimate contact with or abutment against tissue of the annulus of a target heart valve.

The arms <NUM> of the stabilizer <NUM> may be configured to extend outward at an angle from a central column <NUM>, thereby forming a rib structure. The rib structure, particularly the arms <NUM> and central column <NUM>, may be laser cut from a shape memory material, such as nitinol. The stabilizer <NUM> may be cut from a hollow tube such that the central column <NUM> has a hollow cylindrical shape. The arms <NUM> may be heat set to extend at an angle from the central column <NUM>.

The illustrated stabilizer <NUM> of <FIG> and <FIG> may include two arms 1402a, 1402b arranged, for example, in the shape of a bipod. The two arms 1402a, 1402b, in cooperation with a ring shuttle <NUM> of the percutaneous annuloplasty system, may form a tripod structure engaging the annuloplasty ring <NUM> at three points. The plurality of arms <NUM> may be loaded into a delivery catheter <NUM> together with the annuloplasty ring <NUM> (for example, configured in the elongate insertion geometry). As the arms <NUM> emerge from a distal end of the delivery catheter <NUM>, they may automatically expand outward and may be configured to align with and engage the annuloplasty ring <NUM>, as shown in <FIG>. When aligned and engaged with the annuloplasty ring <NUM>, the stabilizer <NUM> may be used to push/pull the annuloplasty ring toward the tissue of an annulus of a heart valve.

The illustrated stabilizer of <FIG> and <FIG> may be configured to engage a top surface of the annuloplasty ring <NUM> from above to push the annuloplasty ring. For example, the plurality of arms <NUM> may include a curved, angled, and/or hooked portion at a distal end to facilitate engagement with the annuloplasty ring <NUM>. The stabilizer <NUM> may be used to push the annuloplasty ring <NUM> from above in a downward direction toward the heart valve to facilitate intimate contact of the annuloplasty ring with the annulus to enhance an anchor deployment process and/or to aid in the fastening of the annuloplasty ring to the annulus.

The stabilizer <NUM>, particularly the arms <NUM>, may also be configured to function as an expansion tool to engage the annuloplasty ring <NUM>, effectuate, and/or facilitate transition of the annuloplasty ring from a contracted state to an expanded state. For example, a superelastic property and shape memory property of the plurality of arms <NUM> may enable the arms to engage an inner surface of the annuloplasty ring <NUM> and exert an outward force to expand the annuloplasty ring. The stabilizer <NUM> may be manipulated to expand the annuloplasty ring <NUM> within the annulus of the target valve, or otherwise press the annuloplasty ring against the valve and thereby effectuating expansion of the annuloplasty ring to the expanded state. In other embodiments, a suture or other elongated member may enable percutaneous manipulation of one or more of the plurality of arms <NUM> to effectuate expansion of the annuloplasty ring <NUM>.

<FIG> depicts a diagram of a perspective view of an illustrative proximal end handle, generally designated <NUM>, of a percutaneous annuloplasty system according to an embodiment. <FIG> depicts a diagram of a perspective cross-sectional view of the proximal end handle <NUM> of <FIG>. In various embodiments, the proximal end handle <NUM> may enable percutaneous transcatheter deployment of an annuloplasty ring. More particularly, the proximal end handle <NUM> may enable percutaneous manipulation of an annuloplasty system. configured to deliver, configure, and/or orient an annuloplasty ring and to fasten the annuloplasty ring to the annulus of a target valve.

In various embodiments, the proximal end handle <NUM> include rotating knobs that are configured to perform or enable functions. In some embodiments, one rotatable knob may be used for each function to be performed. In other embodiments, one rotatable knob may be used for a plurality of functions. A ring closure knob <NUM> enables closure of the annuloplasty ring to transition from an elongated insertion geometry to an annular operable geometry, as described in greater detail herein. A ring snap knob <NUM> enables snapping together of first and second ends (for example, distal and proximal ends) of the annuloplasty ring or other manipulation of a ring closure lock, as described herein. An anchor deployment knob <NUM> enables deployment of anchors of an annuloplasty ring to fasten the annuloplasty ring to the annulus of the target heart valve, as described herein. An A-P adjustment knob <NUM> may enable contraction of the annuloplasty ring from an expanded state to a contracted state, as described herein. In other embodiments, the A-P adjustment knob <NUM> may also enable manipulation of a stabilizer to facilitate expansion of the annuloplasty ring to an expanded state (for example, prior to deployment of the anchors). A ring release knob <NUM> enables release of the annuloplasty ring from a delivery system and/or delivery shuttle of a percutaneous annuloplasty system. Additional or fewer knobs may be possible, depending on the functions to be performed. Furthermore, the positioning of each knob relative to other knobs as shown in <FIG> is merely illustrative. Accordingly, those having ordinary skill in the art will recognize other positions of each knob relative to other knobs as being included within the scope of this disclosure.

In various embodiments, each of the knobs <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be coupled to an independent system of cables and/or sutures. Manipulation of a respective cable and/or suture may be achieved by rotating the respective knob <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. As shown in <FIG>, each of the knobs <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be mechanically coupled to a respective translation gear mechanism. The gear mechanism may be connected to a respective cable or suture that is configured to perform a given function.

<FIG> and <FIG> depict diagrams of perspective views of an illustrative delivery system, generally designated <NUM>, of a percutaneous annuloplasty system, according to an embodiment. In some embodiments, the delivery system <NUM> may include a plurality of sections, such as, for example, a distal end section <NUM>, a catheter section <NUM>, and/or a proximal handle section <NUM>. The delivery system <NUM> may be configured to enable percutaneous transcatheter deployment of an annuloplasty ring, as described herein. More particularly, the delivery system <NUM> may enable percutaneous manipulation of an annuloplasty system configured to deliver, configure, and/or orient an annuloplasty ring. Further, the delivery system <NUM> may be configured to fasten the annuloplasty ring to the annulus of a target heart valve, as described in greater detail herein.

<FIG> and <FIG> depict illustrative examples of a full assembly of a ring <NUM>, a stabilizer <NUM>, and a distal end of the catheter <NUM> as configured in a target site after deployment of the ring from the catheter. <FIG> and <FIG> further depict an illustrative example of an attachment mechanism between the ring <NUM> and the stabilizer <NUM>. As described in greater detail herein, the connection may be accomplished between a pivot point <NUM> on the ring <NUM> and the ring shuttle <NUM> on the stabilizer <NUM> via a wire <NUM> that may be configured to pass through the catheter <NUM> to the proximal end of the delivery system.

Also shown in <FIG> and <FIG> is an illustrative example of a delivery system <NUM> showing, at the distal end, a solid piece <NUM>. The solid piece <NUM> may be manufactured from any material, such as, for example, stainless steel. The solid piece <NUM> may be configured for one or more functions. Illustrative functions may include, but are not limited to, holding the ring shuttle <NUM> in a particular position, locating the stabilizer <NUM> in relation to the ring shuttle and/or the ring <NUM> at the target site, and guiding the sutures from the ring through the holes <NUM> towards the proximal end of the delivery system <NUM>.

<FIG> depict a longitudinal cross-sectional view of an illustrative catheter. generally designated <NUM>, connecting the distal end of the delivery system. <NUM> (<FIG> and <FIG>) to the proximal end of the delivery system <NUM> (<FIG> and <FIG>). The catheter <NUM> may include one or more lumens <NUM> containing, but not limited to, a hollow outer sleeve <NUM> that is attached to the proximal end of the delivery system <NUM>.

In various embodiments, an inner hollow shaft <NUM> may be located within the hollow outer sleeve <NUM>. Referring also to <FIG>, the inner hollow shaft <NUM> may be connected to a moving member <NUM> that is configured to transfer movement of a rotating knob <NUM> to the inner hollow shaft <NUM> and to the solid piece <NUM> (<FIG> and <FIG>) at the distal end of the delivery system <NUM> (<FIG> and <FIG>).

In some embodiments, a stabilizer shaft <NUM> may be located within the inner hollow shaft <NUM>. The stabilizer shaft <NUM> may connect the stabilizer <NUM> to the proximal end of the delivery system <NUM> (<FIG> and <FIG>). In some embodiments, the stabilizer shaft <NUM> may be configured to allow distal control of the stabilizer <NUM> from the proximal end <NUM> (<FIG>). In some embodiments, a guidewire or pig-tail catheter <NUM> may be passed through the center of the stabilizer shaft <NUM>. The guidewire or pig-tail catheter <NUM> may generally be one of a commonly used tool in the cardiovascular field to function as a guide in the heart chambers and/or to function as a conduit for injection of contrast media for fluoroscopy.

<FIG>, <FIG>, and <FIG> depict an illustrative embodiment for the proximal side of the delivery system <NUM>, which may function as a handle. The system <NUM> may include one or more functional mechanisms. Illustrative functional mechanisms may include, but are not limited to, a ring deployment mechanism <NUM>, a ring closure or snapping mechanism <NUM>, a barb or anchor deployment mechanism <NUM>, and control channel mechanism for the ring release wire <NUM> (<FIG> and <FIG>). The ring deployment mechanism <NUM> may include a rotating knob <NUM> and/or a moving member <NUM> that may be attached to the inner hollow shaft <NUM>. In some embodiments, the knob <NUM> may be configured to be rotated such that the ring <NUM> (<FIG> and <FIG>) is pushed distally and away through the outer sleeve <NUM>, thereby deploying from the catheter. The end of the suture <NUM> from the ring <NUM> (<FIG> and <FIG>) may be fixed at the proximal end <NUM> such that when the ring deploys, the suture may be placed under a constant tension.

<FIG> depicts an illustrative suture <NUM> attached to the ring <NUM> at the distal end <NUM>. The suture may pass through the proximal end of the ring <NUM>, the ring shuttle <NUM>, the solid piece <NUM> and the outer sleeve <NUM> to the proximal end of the delivery system <NUM> (<FIG>). The total length of the suture <NUM> may be the length of a first portion a plus the length of a second portion b (a + b).

<FIG> depicts an illustrative ring <NUM> after deployment from the outer sleeve <NUM>. As shown in <FIG>, the suture <NUM> may remain the same length as it is attached at the same points of the ring <NUM> relative to the delivery system. Accordingly, the suture <NUM> may be placed under tension.

Referring again to <FIG>, a channel <NUM> may be provided for one or more barb deployment elongated members (such as, for example, sutures) to be held and pulled once barbs and/or anchors are deployed, as described in greater detail herein. Any number of barb deployment members may be placed via the channel <NUM>. In some embodiments, the number of barb deployment members may correspond to a number of windows, as described herein. For example, <NUM> barb deployment member, <NUM> barb deployment members, <NUM> barb deployment members, <NUM> barb deployment members, <NUM> barb deployment members, <NUM> barb deployment members, <NUM> barb deployment members, <NUM> barb deployment members, <NUM> barb deployment members, <NUM> barb deployment members or more may be placed via the channel <NUM>.

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

The present disclosure is not to be limited in terms of the particular embodiments described in this application, which are intended as illustrations of various aspects. Many modifications and variations can be made without departing from the scope of the appended claims, as will be apparent to those skilled in the art. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as "open" terms (for example, the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," et cetera). While various compositions, methods, and devices arc described in terms of "comprising" various components or steps (interpreted as meaning "including, but not limited to"), the compositions, methods, and devices can also "consist essentially of" or "consist of" the various components and steps, and such terminology should be interpreted as defining essentially closed-member groups. It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (for example, "a" and/or "an" should be interpreted to mean "at least one" or "one or more" ), the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (for example, the bare recitation of "two recitations. " without other modifiers, means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to "at least one of A, B, and C, et cetera" is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, " a system having at least one of A, B, and C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, et cetera). In those instances where a convention analogous to "at least one of A, B, or C, ct cetera" is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, " a system having at least one of A, B, or C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, ct cetera). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms.

Claim 1:
A delivery system (<NUM>, <NUM>, <NUM>) for percutaneous, transcatheter heart valve repair, the delivery system (<NUM>, <NUM>) comprising:
a catheter (<NUM>, <NUM>) configured to provide percutaneous access into a heart of a patient and to receive an adjustable annuloplasty ring in an elongate insertion geometry that is transitionable to an annular operable geometry;
a ring shuttle (<NUM>, <NUM>, <NUM>, <NUM>) configured to releasably couple to the annuloplasty ring and pass the annuloplasty ring through the catheter into the heart of the patient; and
a deployment handle configured to percutaneously manipulate the annuloplasty ring and the ring shuttle (<NUM>, <NUM>, <NUM>, <NUM>) to deploy the annuloplasty ring, the deployment handle further comprising:
a ring closure knob (<NUM>) configured to close the annuloplasty ring, transitioning the annuloplasty ring from the elongate insertion geometry to the annular operable geometry;
a ring snap knob (<NUM>) configured to snap together a first end and a second end of the annuloplasty ring;
an anchor deployment knob (<NUM>) configured to deploy anchors of the annuloplasty ring to fasten the annuloplasty ring to an annulus of a target heart valve; and
a ring release knob (<NUM>) configured to release the annuloplasty ring from the delivery system (<NUM>, <NUM>, <NUM>).