Patent Description:
Current methods of tricuspid valve reduction surgery involve open heart surgery. The physician uses pledgets and sutures to plicate the tissue or, alternatively, uses a rigid or semi-rigid C-shaped ring to hold the valve tissue in place.

In a conventional cardiac heart valve replacement surgical procedure, the patient must typically be placed on cardiopulmonary by-pass. During cardio-pulmonary by-pass, the flow of blood into and out of the heart and lungs is interrupted, and the blood flow is routed to a conventional blood pump and oxygenation unit. It is known that complications and side-effects are associated with cardiopulmonary by-pass, and it is generally believed that it is in the best interest of a patient to expedite the cardiac surgical procedure and remove the patent from cardio-pulmonary by-pass as quickly as possible. Complications and side effects associated with cardio-pulmonary surgery typically include the generation of emboli, hemolysis and degradation of the blood's oxygen carrying capacity, and inflammatory response in the blood. Some or all of these complications may be caused contact with the components of the cardiopulmonary bypass equipment. The severity and incidence of potential side effects may be related to the length of the period of time that the patient is being supported on cardiopulmonary by-pass.

Accordingly, there is a need for devices and methods for performing tricuspid regurgitation repair using minimally invasive catheter based procedures to reduce patient recovery time and health risks, as well as preserve the original tricuspid valve shape.

<CIT> discloses systems, devices and methods relating to surgical and percutaneous repair of heart valve regions.

The present invention relates to a heart valve anchor for performing a surgical reduction of a heart valve comprising a body that includes a distal portion, a distal end, a proximal portion, and a proximal end, the distal end and the proximal end defining a longitudinal axis, the body comprising: a first radially expandable portion at the distal portion of the body; a second radially expandable portion at the proximal portion of the body; and a root portion disposed between the first and second radially expandable portions; and the anchor characterized by the body having a first configuration adapted to be housed at least partially within a tissue penetrating device, and a second configuration in which the first and second radially expandable portions are partially or fully expanded such that the anchor engages tissue in a region between the first and second radially expandable portions and wherein the first and second radially expandable portions are configured to compress together annular valve tissue, wherein the first and second radially expandable portions are configured to radially expand when the anchor is compressed along the longitudinal axis.

While, in the following, multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention.

While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

The human body has four heart valves: a pulmonary valve, a tricuspid valve, an aortic valve and a mitral valve. The purpose of the heart valves is to allow blood to flow through the heart and from the heart into the major blood vessels connected to the heart, such as the aorta and pulmonary artery.

<FIG> are illustrations of a heart <NUM> that show a tricuspid valve <NUM>, located between the right atrium <NUM> and right ventricle <NUM>, anchored with an exemplary heart valve anchor <NUM> provided herein. Embodiments of the heart valve anchors <NUM> provided herein can be delivered within a hypodermic needle (e.g., as shown in <FIG>) of needle delivery device. The heart valve anchors <NUM> provided herein can be implanted into a patient by using a transcatheter tricuspid reduction system during a minimally invasive procedure method for performing a tricuspid valve reduction surgery. The anchors <NUM> provided herein can be used in place of pledgets and/or sutures, or in conjunction with, to perform a surgical reduction of a heart valve, e.g., the tricuspid valve.

Various embodiments of the anchors <NUM> provided herein include a first anchoring portion <NUM>, a second anchoring portion <NUM>, and a connecting portion (not shown) therebetween. The first and second anchoring portions <NUM>, <NUM> are expandable portions of the anchor <NUM> configured to compress (anchor) together annular valve tissue to a predetermined length (which will be discussed in greater detail in later sections) when the anchor <NUM> is secured to tissue. The connecting portion is coupled to the first and second anchoring portions <NUM>, <NUM> and maintains the predetermined anchoring length of the anchor <NUM> after the anchor <NUM> has been secured to the annular valve tissue.

Referring to <FIG>, the heart valve anchor <NUM> of <FIG> has a body <NUM> with a distal end <NUM> and a proximal end <NUM>. The anchor <NUM> can transition from a collapsed state (<FIG>) to a diametrically expanded state (<FIG>), respectively. The anchor <NUM> has a rigid body portion that includes a distal coupler <NUM> at the distal end <NUM>, a proximal coupler <NUM> at the proximal end <NUM>, and optionally an inner connector <NUM> coupled to the distal coupler. The anchor <NUM> also contains an expandable portion <NUM> disposed over the inner connector <NUM> and extending from the distal end <NUM> to the proximal end <NUM> of the anchor <NUM>. The expandable portion <NUM> can include a (metallic) stent structure <NUM> formed by a plurality of wires <NUM> orientated in a braided configuration.

The distal and proximal couplers <NUM>, <NUM> are tubular structures each disposed about the distal and proximal portions of the expandable portion <NUM>. The couplers are configured to bind the wires <NUM> of the metallic stent structure <NUM> together such that the stent structure <NUM> does not become unraveled. The couplers provide a benefit of allowing a plurality of wires <NUM> to be coupled together (e.g., welded) at the distal and proximal ends <NUM>, <NUM> of the anchor <NUM> while minimizing potentially damaging the wires <NUM>. For example, in some cases, the coupler can be made of a similar material (e.g., shape memory material such as nitinol) as the wires <NUM>.

Some embodiments of the anchors <NUM> provided herein can include the inner connector <NUM>, which is coupled to the distal coupler and couplable to the proximal coupler. In the collapsed state, the inner connector <NUM> is locked to the distal coupler to allow the expandable portion <NUM> of the anchor <NUM> to elongate in a longitudinal direction over the inner connector <NUM>, as desired. In the diametrically expanded state, the inner connector <NUM> can be locked to both the distal coupler and the proximal coupler during the procedure (as will be discussed with a tensioning method in later sections) to set a longitudinal distance between the couplers, as well as the overall anchor length. In the diametrically expanded state, the anchor <NUM> provided herein can maintain a fixed longitudinal length for anchoring tissue in a compressed state.

The expandable portion <NUM> can include a first (distal) anchoring portion (which can be referred to as a first expandable portion) <NUM> and a second (proximal) anchoring portion <NUM> (which can be referred to as a second expandable portion). The first and second anchoring portions <NUM>, <NUM> are adapted to expand to capture tissue in the area between the anchoring portions. The first and second anchoring portions <NUM>, <NUM> can have different, or similar, expanded shapes, when the anchor <NUM> is a diametrically expanded state. In particular, as depicted in <FIG>, the first anchoring portion <NUM> of the anchor <NUM> can expand to a substantially rhombus-shaped shape and the second anchoring portion <NUM> can expand to a substantially bulbous shape. In some cases, both anchoring portions can expand into a substantially rhombus-shaped shape, a substantially bulbous shape, or other shape having a larger, expanded profile.

The anchors <NUM> provided herein are adapted to be delivered within a needle lumen and deployed from a needle tip (as shown in <FIG>). The anchors <NUM> are also adapted to provide a spring-like feature to reduce tissue damage that can occur to the tissue of the pulsating heart. The flexibility of the stent structure <NUM> reduces over-rigidity and tension that might otherwise tear or inflame tissue being anchored together by the anchors <NUM>. In some cases, the individual wires <NUM> of the stent structure <NUM> can be spaced part from one another to create spaced regions that promote tissue ingrowth.

The anchors <NUM> provided herein may, in some cases, further include a fabric material (not shown) disposed over or within the stent structure <NUM>. The fabric material can be composed of a biocompatible material, such as a polymeric material or a biomaterial, adapted to promote tissue growth. In some cases, the fabric material can include a bioabsorbable material. Suitable fabric materials can include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (ePTFE)), a polyolefinic material such as a polyethylene, a polypropylene, or blends thereof, polyester, polyurethane, and combinations thereof.

The anchors <NUM> provided herein can be made of metals, polymers, ceramics, or combinations thereof. In some cases, the anchors <NUM> can include one or more biocompatible alloy materials. In some cases, the anchor <NUM> can include a shape memory material. Suitable materials of the anchor components can include, but are not limited to, nitinol, stainless steel, a titanium alloy, a platinum alloy, and combinations thereof. In some cases, the anchors <NUM> can be made of a biodegradable and/or a bioresorbable material, such as poly(L-lactide) (PLLA), polylactic acid (PLA), polyhydroxybutyrate (PHB), poly(butylene succinate), poly-ε-caprolactone, and combinations thereof.

<FIG> are a side view, a front view, and a transverse cross-sectional view, respectively, of the heart valve anchor <NUM> of <FIG>, but does not show an inner connector (e.g., see inner connector <NUM> in <FIG>). The anchor <NUM> shown in these figures includes the distal coupler <NUM>, the proximal coupler <NUM>, and the expandable portion <NUM> extending therebetween. The depicted anchor <NUM> is shown in a non-stressed state, which is the state in which the anchor <NUM> is not subjected to any tensile or compression forces. The shape of the expandable portion <NUM> of the anchor <NUM> can be set, as desired, by heat setting anchor components (e.g., the stent structure <NUM>), which can be made of a shape memory material (e.g., nitinol). The plurality of wires <NUM> that form the expandable portion <NUM> of the anchor <NUM> are coupled together by the proximal and distal couplers at the proximal and distal ends <NUM>, <NUM>, respectively, of the anchor <NUM>.

Referring <FIG>, the anchor <NUM> includes the first and second anchoring portions <NUM>, <NUM> configured for securing tissue. The anchor <NUM> includes a root portion <NUM>, which is a reduced-diameter region between the first and second anchoring portions <NUM>, <NUM>. In the non-stressed state, the first anchoring portion <NUM> of the anchor <NUM> of FIG. 4A has a substantially rhombus-shaped shape and the second anchoring portion <NUM> has a substantially tear drop shape. Various other shapes can be contemplated for the first and second anchoring portions <NUM>, <NUM> that provide a larger profile adjacent (e.g., proximally adjacent, distally adjacent, or both) to the root portion <NUM> to hold and compress tissue in the area between the first and second anchoring portions <NUM>, <NUM>. In some cases, the anchoring portions <NUM>, <NUM> of the anchor can include any shape adapted for securing tissue between the anchoring portions <NUM>, <NUM>. In some cases, at least a portion of the anchoring portions <NUM>, <NUM> of the anchor can include a flat surface for securing tissue.

In some cases, the maximum diameter "D1" (i.e., peak) of the first anchoring portion <NUM> can be larger than, or about equivalent to, the maximum diameter "D2" of the second anchoring portion <NUM> in a non-stressed state and/or a diametrically expanded state. In some cases, the maximum diameter (e.g., D1 or D2) of the first or second anchoring portion <NUM>, <NUM> can increase as the length "L" of the overall anchor <NUM> decreases. The maximum diameter (D1 or D2) of the first or second anchoring portion <NUM>, <NUM> can be dependent on the distance between peak locations of the first and second anchoring portions <NUM>, <NUM>, or, more specifically, the compression force being applied to the second anchoring portion <NUM>.

The anchors <NUM> provided herein can be sized (e.g., diameter and length) to any suitable size. For example, in some cases, the anchor <NUM> can have a maximum diameter (e.g., at the first and/or second anchoring portions <NUM>, <NUM>) ranging from about <NUM> (<NUM> inches) to about <NUM> (<NUM> inch). In some cases, the maximum diameter of the anchor <NUM> can range from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, or from about <NUM> to about <NUM>. In some cases, the anchor <NUM> can have a minimum diameter (e.g., at the root portion <NUM>, or the distal or proximal couplers <NUM>, <NUM>) ranging from about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches), e.g., from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, or from about <NUM> to about <NUM>.

In some cases, the anchor <NUM> can have a non-compressed length ranging from about <NUM> (<NUM> inch) to about <NUM> (<NUM> inches), e.g. from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>. In some cases, the compressed length of the anchor can range from about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches), e.g., from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, or from about <NUM> to about <NUM>. In some cases, the different in length between the compressed and non-compressed anchor can range from about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches),. e.g., from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from <NUM> to about <NUM>, or from about <NUM> to about <NUM>.

Referring to <FIG>, another exemplary heart valve anchor <NUM> provided herein that includes a different stent structure as compared to the anchor <NUM> of <FIG>. The anchor <NUM> provided herein includes a distal coupler <NUM>, a proximal coupler <NUM>, and an expandable portion <NUM>. The expandable portion <NUM> of the depicted anchor <NUM> includes a stent structure <NUM> including a plurality of wires <NUM>. As compared to the previous anchor <NUM>, the depicted anchor <NUM> includes a fewer number of wires <NUM> as compared to the number of wires <NUM> of anchor <NUM> of <FIG>. In some cases, the stent structure <NUM> of the anchor <NUM> can include about <NUM> wires to about <NUM> wires (e.g., about <NUM> wires, about <NUM> wires, about <NUM> wires, about <NUM> wires, about <NUM> wires, about <NUM> wires, about <NUM> wires, about <NUM> wires, about <NUM> wires, about <NUM> wires, about <NUM> wires). The number of wires of the stent structure <NUM> can be selected to obtain a desired flexibility and tensile strength in the anchor <NUM>. Increasing the number of wires increases the likelihood of obtaining an adequate welding bond between the wires <NUM> of the expandable portion <NUM> and the couplers.

The wires <NUM> of the stent structure <NUM> can be sized to any suitable dimension that provides the anchor <NUM> with the desired flexibility, structural integrity, and a stent configuration suitable for tissue growth. A suitable wire diameter range can span from about <NUM> millimeters (mm) (. <NUM> inches) to about <NUM> (. <NUM> inches) (e.g., from about <NUM> (. <NUM> inches) to about <NUM> (<NUM> inches), from about <NUM> (. <NUM> inches) to about <NUM> (. <NUM> inches), from about <NUM> (. <NUM> inches) to about <NUM> (. <NUM> inches), from about <NUM> (. <NUM> inches) to about <NUM> (. <NUM> inches), or from about <NUM> (. <NUM> inches) to about <NUM> (. <NUM> inches)). In some cases, a smaller sized wire diameter (e.g., <NUM> (. <NUM> inches) to about <NUM> (. <NUM> inches)) can have greater flexibility and aid in facilitating tissue growth within the expandable portion <NUM> of the anchor <NUM> by allowing a greater number of wires <NUM> to be used in constructing the anchor <NUM>. In some cases, a larger sized wire diameter (e.g., <NUM> (. <NUM> inches) to about <NUM> (. <NUM> inches)) can provide an anchor <NUM> with increased tensile strength.

Referring to <FIG>, another exemplary heart valve anchor <NUM> provided herein includes a body <NUM> with a distal end <NUM> and a proximal end <NUM>. <FIG> provide a side view and a cross-sectional side view of the anchor <NUM>. The anchor <NUM> includes a distal coupler <NUM>, a proximal coupler <NUM>, and an expandable portion <NUM>. Certain components, such as the distal and proximal couplers <NUM>, <NUM>, are similar to the corresponding components <NUM>, <NUM>, <NUM> discussed with the anchor <NUM> of <FIG>, thus the focus of the discussion of the present embodiment will be focused on the expandable portion <NUM> of the anchor <NUM>. The anchor <NUM> can include an inner connector (not shown; see <NUM> of <FIG>) extending from the distal end <NUM> to the proximal end <NUM> and within an annular cavity formed by the expandable portion <NUM>.

The expandable portion <NUM> of the anchor <NUM> includes first and second anchoring portions <NUM>, <NUM> and a v-shaped root portion <NUM> therebetween. Each anchoring portion has a concave design that includes an outer profile having a frustoconical portion <NUM>, <NUM> and a cylindrical portion <NUM>, <NUM>. Each anchoring portion has one end that folds in on itself to create a concave region <NUM>, <NUM> that forms a depressed feature that faces away from tissue when the anchor <NUM> is implanted. The first anchoring portion <NUM> includes a distal concave region <NUM> that faces the distal coupler <NUM>. The second anchoring portion <NUM> includes a proximal concave region <NUM> that faces the proximal coupler <NUM>. The concave regions <NUM>, <NUM> of anchor <NUM> help to maintain tissue contact between the first and second anchoring portions <NUM>, <NUM> of the anchor <NUM> while the heart pulsates, and its overlapping fold increases the area for potential cell growth on the expandable portion <NUM>.

Referring to <FIG>, another exemplary heart valve anchor <NUM> provided herein includes a body <NUM> with a distal end <NUM> and a proximal end <NUM>. <FIG>, and 6C provide a side view and a cross-sectional side view of the anchor <NUM>. The anchor <NUM> includes a distal coupler <NUM>, a proximal coupler <NUM>, and an expandable portion <NUM>. Certain components, such as the distal and proximal couplers are similar to the components of the anchor <NUM> of <FIG>, thus the focus of the discussion of the present embodiment will be focused on the expandable portion <NUM> of the anchor <NUM>. In some cases, the anchor <NUM> optionally includes an inner member disposed within an annular cavity formed by the expandable portion <NUM>.

The expandable portion <NUM> of the anchor <NUM> includes first and second anchoring portions <NUM>, <NUM> and a root portion <NUM> between. Each anchoring portion includes an outer profile with a frustoconical portion <NUM>, <NUM> and a cylindrical portion <NUM>, <NUM>. Each anchoring portion has a one end that folds in on itself to create a reverse-concave region <NUM>, <NUM> with a depressed feature that faces toward tissue when the anchor <NUM> is implanted. The first anchoring portion <NUM> includes a distal reverse-concave region <NUM> that faces the second anchoring portion <NUM>. The second anchoring portion <NUM> includes a proximal reverse-concave region <NUM> that faces the first anchoring portion <NUM>. The root portion <NUM> includes a portion of the expandable portion <NUM> disposed about the inner connector (not shown; see, e.g., <NUM> of <FIG>). As such, the root portion <NUM> is substantially cylindrical in shape and has a diameter that ranges from about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches). The reverse-concave regions <NUM>, <NUM> of anchor <NUM> help to maintain tissue contact between the first and second anchoring portions <NUM>, <NUM> of the anchor <NUM> while the heart pulsates, and its overlapping fold increases the area for potential cell growth on the expandable portion <NUM>. The anchor <NUM> can include an inner connector (not shown; see inner connector <NUM> of <FIG>) disposed within an annular cavity formed by the expandable portion <NUM>, wherein the inner connector facilitates locking of the expandable portion <NUM> when the anchor is implanted in the patient's body.

Referring to <FIG>, another exemplary heart valve anchor <NUM> provided herein includes a body <NUM> with a distal end <NUM> and a proximal end <NUM>. <FIG> provide a side view and a cross-sectional side view of the anchor <NUM>. The anchor <NUM> includes a distal coupler <NUM>, a proximal coupler <NUM>, and an expandable portion <NUM>. Certain components, such as the distal and proximal couplers are similar to the components of the anchor <NUM> of <FIG>, thus the focus of the discussion of the present embodiment will focus on the expandable portion <NUM> of the anchor <NUM>. In various embodiments, the anchor <NUM> can locked by a locking mechanism, which will be discussed with <FIG>, in later sections. In certain cases, the anchor <NUM> can include an inner connector (e.g., inner connector <NUM> of <FIG>) disposed within an annular cavity formed by the expandable portion <NUM>, wherein the inner connector facilitates locking of the expandable portion <NUM> when anchored in the patient's body.

The expandable portion <NUM> of the anchor <NUM> includes first and second anchoring portions <NUM>, <NUM> and a v-shaped root portion <NUM> therebetween. Each anchoring portion has an outer profile with a frustoconical portion <NUM>, <NUM>, a cylindrical portion <NUM>, <NUM>, and bulbous portion <NUM>, <NUM>. Each anchoring portion has one end that folds in on itself to create a concave region <NUM>, <NUM> between the cylindrical and the bulbous portions <NUM>, <NUM>. For example, the first anchoring portion <NUM> can include a distal concave region that faces the distal coupler. The second anchoring portion <NUM> can include a proximal concave region that faces the proximal coupler. The concave regions <NUM>, <NUM> and bulbous portions <NUM>, <NUM> of anchor <NUM> increase the area for potential cell growth on the expandable portion <NUM> of the anchor <NUM>.

<FIG> is a perspective view of a distal portion of an exemplary heart valve anchor assembly <NUM> provided herein that includes a heart valve anchor <NUM>, a detachable pull rod <NUM> (or hypotube), and a push rod <NUM>. The push rod <NUM> can include a tubular body that has a distal end and a proximal end, the body defining a lumen configured to receive the pull rod. The push rod can be slidably disposed over the inner rod. The push rod can be sized such that distal end of the push rod mates with the proximal end <NUM> of the anchor <NUM>, in particular, the proximal coupler <NUM>. The push rod can be adapted to apply compressional force to the anchor <NUM> during the deployment of the anchor <NUM> when used in conjunction with the inner connector.

<FIG> shows an optional inner component, e.g., the inner connector <NUM>, which can be disposed within the anchor <NUM> provided herein, and coupled to the pull rod <NUM>. The inner connector <NUM> include a distal portion <NUM>, a proximal portion <NUM>, and a locking portion <NUM> configured to lock the anchor <NUM> in a diametrically expanded state when the locking portion <NUM> is positioned proximal to the proximal coupler. The conical shape of the locking portion <NUM> allows the locking portion <NUM> to slide within a lumen of the proximal coupler, but its barbed end prevents the locking portion <NUM> from reinserting into a proximal coupler (e.g., the proximal coupler of <FIG>) once pulled from a lumen of the proximal coupler. The pull rod <NUM> can be used in conjunction with the push rod <NUM> to longitudinally compress the anchor <NUM> during anchor deployment. For example, the pull rod <NUM> may be pulled in a proximal direction while the position of the push rod is either maintained or advanced in a distal (opposite) direction to expand the anchor <NUM>. In some cases, the anchor <NUM> and the detachable inner rod are one integral component. In some cases, the anchor <NUM> and the inner rod are bonded together by a bonding process, such as soldering, adhesive bonding, or laser welding.

The inner connector <NUM> may be detachably coupled to the pull rod <NUM> of the heart valve anchor assembly <NUM>. In particular, a proximal portion <NUM> of the inner connector <NUM> of the anchor <NUM> provided herein can be decoupled from the pull rod <NUM> in a necked region <NUM> of the anchor <NUM>. In some cases, the anchor assembly <NUM> can be configured to release inner connector <NUM> of the anchor <NUM> from the pull rod <NUM> when a threshold tensile force is applied to the anchor assembly <NUM>. As shown in <FIG>, the anchor assembly <NUM> can include the necked region <NUM> proximate to the proximal portion <NUM> of the anchor <NUM>. The anchor <NUM> can be decoupled from the pull rod <NUM> in the necked region <NUM> when the anchor assembly <NUM> is subjected to a threshold tensile force. In some cases, the threshold tensile force is about <NUM> Newtons (N), <NUM> pounds force (lbf). In some cases, the threshold tensile force can range from about <NUM> N (<NUM> lbf) to <NUM> N (<NUM> lbf) (e.g., from about <NUM> N (<NUM> lbf) to about <NUM> N (<NUM> lbf), from about <NUM> N (<NUM> lbf) to about <NUM> N (<NUM> lbf), from about <NUM> N (<NUM> lbf) to about <NUM> N (<NUM> lbf), or from about <NUM> N (<NUM> lbf) to about <NUM> N (<NUM> lbf)).

Certain embodiments of the anchor assembly <NUM> can include other means for decoupling the inner connector <NUM> of the anchor <NUM> from the pull rod <NUM>. For example, in some cases, the anchor assembly <NUM> can include mating threaded portions on the proximal portion <NUM> of the inner connector <NUM> and the distal end of the pull rod <NUM>. The threaded portions can be adapted to decouple the inner connector <NUM> from the pull rod <NUM> when the pull rod <NUM> is rotated (e.g., clockwise) relative to the inner connector <NUM>. In some cases, the anchor assembly <NUM> includes a heating element configured to decouple the inner connector <NUM> of the anchor <NUM> from the pull rod <NUM> by application of heat, generated by an electrical, thermal, or radio-frequency source, that melts at least a portion of the anchor assembly <NUM>. In some cases, the inner connector <NUM> and the pull rod <NUM> have mating components (e.g., a socket and mating ball) configured to release when subjected to a threshold axial load.

<FIG> provide various embodiments of alternative locking features of the anchor assembly that connects the proximal end of the anchor to a push wire. The locking features shown in <FIG> can be optionally applied to an inner connector that extends from the distal end to the proximal end of an anchor, as shown in <FIG>. Alternatively, the locking features can be included in an inner portion (a proximal inner portion, or a distal inner portion).

In some cases, the locking feature can include expandable barbs (<FIG>), a hypotube clasp (<FIG>), an expandable stent (<FIG>), a collapsible pull wire (<FIG>), a flexible insert (<FIG>), or a one-directional clasp (e.g., locking portion <NUM> of <FIG>), configured to lock the expandable portion at the proximal coupler. For example, the expandable barbs, which are in a collapsed state when within a lumen of the proximal coupler, expand in a radially outward direction when the locking feature of the inner portion, or the inner connector, is pulled out of the proximal coupler lumen.

<FIG> is a perspective view of another exemplary heart valve anchor assembly <NUM> provided herein, shown with an anchor <NUM> partially deployed from a needle. The depicted anchor <NUM> can include a first (distal) anchoring element <NUM>, a proximal anchoring element <NUM>, and a connector element <NUM> therebetween.

The distal and proximal anchoring elements can each include two, three, or more than three collapsible prongs <NUM> (e.g., two, three, four, five, ten, twenty, thirty, fifty, a hundred, or more than a hundred prongs). Each prong has a first end coupled to the connector element and a free second end. In some cases, each prong is configured to align with a longitudinal axis defined by the connector element such that the anchor <NUM> can be inserted into a tissue-penetrating device, such as a needle lumen. In a diametrically expanded configuration, each prong can angulate a predetermined angle relative to the connector element. Each prong <NUM> can be biased toward angulation by the application of various methods, such as shape-setting a shape memory material into a desired angled configuration, or incorporating a spring, or a spring-like component (e.g., elastic polymer tubing) into the prong <NUM>. In some cases, each prong can angulate about <NUM> degrees relative to the connector element when the anchor <NUM> is in a diametrically expanded configuration. In some cases, each prong can angulate from about <NUM> degrees to <NUM> degrees (e.g., from about <NUM> degrees to about <NUM> degrees, from about <NUM> degrees to about <NUM> degrees, from about <NUM> degrees to about <NUM> degrees, from about <NUM> degrees to about <NUM> degrees).

<FIG> is a perspective view of another exemplary heart valve anchor <NUM> provided herein, shown in a fully deployed state. The depicted anchor <NUM> can have a body that includes a distal anchoring element, a proximal anchoring element, and a connector element therebetween. In some cases, the distal and proximal anchoring elements can include a nitinol rod. In some cases, the connector element can include a spring.

The distal and proximal anchoring element each include one collapsible T-bar prong. Similar to the anchor <NUM> of <FIG>, the center point of each prong is coupled to the connector element. In a collapsed configuration, each prong can be aligned with a longitudinal axis defined by the connector element such that the anchor body can be inserted into a tissue-penetrating device, such as a needle lumen. In a diametrically expanded configuration, each prong can articulate to a predetermined angle relative to the connector element.

The connector element can be configured to provide an elastic connection between the distal and proximal anchoring elements. For example, in some cases, the connector element includes a coiled spring or an elastic polymer segment. The connector element can have a varying length that is dependent on axial forces being applied to the connector element. For example, when the connector element is subjected to a tensile force or compression force, the connector element can expand or reduce a length of the overall anchor from about <NUM>% to about <NUM>% (e.g., from about <NUM>% to about <NUM>%, from about <NUM>% to about <NUM>%, from about <NUM>% to about <NUM>%, from about <NUM>% to about <NUM>%, from about <NUM>% to about <NUM>%, or from about <NUM>% to about <NUM>%). In some cases, the connector element can elongate the anchor about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, or more than <NUM>% relative to the anchor original (non-stressed) length.

<FIG> are side views of various exemplary heart valve anchors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> provided herein. As shown, each of the various heart valve anchors can include a single expandable portion that can anchor against a targeted tissue surface. In some cases, the single expandable portion is a radially expandable portion that includes one of concave (<FIG>), a reverse-concave (<FIG>), a dual-concave (<FIG>), a floating (<FIG>), or a fixed anchor shape (<FIG>). The heart valve anchor can be anchored in place, in some embodiments, against the tissue surface by fixing the anchor in place, for example, by suturing the anchor to the tissue or using a coupler (e.g., clip) to hold the anchor in position. Accordingly, various embodiments of the anchors provided herein include suture attachable anchors that can be used in open heart surgery, or minimally invasive heart surgery.

Referring to <FIG>, a heart valve anchor <NUM> provided herein that includes a body having a distal portion, a distal end, a proximal portion, and a proximal end. The body can define a lumen therethrough, extending from the distal end to the proximal end. The body can include a radially expandable portion at the distal portion of the body. As shown, the anchor of <FIG> includes a single concave expandable portion <NUM>. In some cases, the body defines a lumen therethrough and includes a radially expandable portion comprising a spirally-wound wire, and a tissue-securing means coupled to the distal portion of the body.

A suture or wire can be coupled to the distal end of the body, and extended through the lumen and the proximal end of the body. The suture or wire may be extended from the proximal end of the anchor body and anchored to tissue to hold the tissue anchor in position. The anchor pulling the anchor against the tissue and tying a knot in the suture to secure the anchor tightly against the tissue. In some cases, the knot in the suture can be pushed into place with a knot pushing element (e.g., rod).

The distal end of the body can optionally include a tissue piercing tip. The tissue piercing tip may be made from a portion of the suture or wire coupled to the distal end of the body that extends distally therefrom. The tissue piercing tip can allow the anchor to partially or fully penetrate tissue during anchor deployment. In one example, when a needle catheter device has already penetrated tissue, the anchor may be advanced out of the needle catheter device and further penetrate the tissue until it has emerged from a tissue surface. In another example, the anchor with a tissue piercing tip may be used to penetrate tissue fully by piercing a tissue surface and penetrating through the entire tissue area.

The anchor may optionally include a locking feature described herein at the proximal portion of the body. The anchor may optionally include a locking feature including one of expandable barbs, a hypotube clasp, an expandable stent, a collapsible pull wire, a flexible insert, and a one-directional clasp.

Referring to <FIG>, the expandable portion of the heart valve anchors <NUM>, <NUM>, <NUM>, <NUM> provided herein can include one of various shapes. For example, the anchor of <FIG> has a reverse-concave expandable portion <NUM> that includes a depressed feature adapted to face towards tissue. The anchor of <FIG> has dual-concave design <NUM> that includes an expanded bulb portion insides of a depressed feature configured to face away from tissue. The anchor of <FIG> has a floating expandable portion <NUM>. The floating expandable portion <NUM> can form a peak (maximum diameter) at its center when the anchor is not subjected to any axial forces, however, the peak of the floating expandable portion <NUM> may form distal or proximal to the center when an axial force is exerted on the expandable portion. The anchor of <FIG> includes a single-fixed expandable portion <NUM>. The single-fixed expandable portion <NUM> includes a disk-shaped expandable portion <NUM>, in which a first set of inner wires is fixed to a second set of outer wires. The single-fixed expandable portion <NUM> has a flat transverse region that can be shaped in one of various cross-sectional shapes (e.g., circular, square, rectangular) to provide a pledget surface during a heart valve surgical procedure.

<FIG> is a flowchart providing a series of steps along with illustrations demonstrating a non-claimed method of using a heart valve tissue anchor provided herein. The steps of use can include delivering and attaching tissue anchors during a minimally invasive catheter based procedure, for example, a procedure for performing a heart valve reduction surgery.

The illustrations of <FIG>, labeled (a) - (c), show an images of a tricuspid regurgitation device system extending from the superior vena cave to the inferior vena cave within a patient's heart. The system includes an introducer, a visualization catheter, and a tissue penetrating and anchoring (TPA) device. Certain components of the system (e.g., introducer) are inserted into the jugular vein using an over-the-wire method following a JAG and snare wire introduction into the anatomy. The introducer allows other components of the system, such as the visualization catheter, to be introduced and fed into the heart through the jugular vein. The visualization catheter can be advanced to the right atrium from the superior vena cava and positioned in the right atrium. The visualization catheter can include a visualization balloon in which saline is inputted into the balloon through an exterior port attached at a proximal end of the visualization catheter. A visualization catheter can be steerable such that the visualization balloon can be positioned within the atrium to establish visualization of the coronary sinus (CS).

Once the introducer has been positioned within the heart, a hypodermic needle device, pre-loaded with anchors provided herein and connected to a deployment fixture (discussed in greater detail with <FIG>), can be fed through the opening in a femoral vein. The needle device can be advanced through the inferior vena cava over a guide wire until the needle device reaches the entrance of the heart's right atrium. While the balloon of the visualization catheter is deployed at the coronary sinus location, the needle device can be advanced from the introducer through the coronary sinus at a <NUM> degree angle by using an actuator (e.g., a hand-operated or automated micrometer or dial).

Referring to illustration (a), the needle device can be tunneled through the tricuspid annular tissue, and around the posterior leaflet of the tricuspid valve while a camera within visualization balloon is steered to follow the needle and guide the physician. The needle can be advanced until a distal end of the needle exits the edge of the posterior leaflet. The needle device can be slowly retracted until the needle tip exits the edge of the posterior leaflet. A stylet at the proximal end of the anchor can be advanced to push against the anchor to expose deploy a distal portion of the first anchor head from the needle tip.

Referring to illustration (b), the needle can continue to be retracted back through the tunneled tissue so the needle is fully retracted from the tissue and the remaining (proximal) portion of the anchor is exposed. The proximal portion of the anchor can be deployed and diametrically expanded such that the tunneled tissue is disposed between the distal and proximal portions of the anchor. The anchor can be compressed, squeezing the tissue between the anchors, and locked into place. The needle device can be retracted completely back into the catheter; leaving the anchor behind in the heart valve tissue.

Referring to illustration (c), the locked anchor can be applied to placate the annular tissue of the posterior leaflet and reduce the tricuspid valve. The delivery device system components can be removed from the patient's body once the anchor has been locked into place. The needle device can be removed from the body through the femoral vein, and the catheter and introducer can be removed from the body through the jugular vein.

<FIG> provide a series of illustrations of a system <NUM> showing the various stages of the anchor <NUM> of <FIG> being deployed from a needle device <NUM> and locked into a final state. In particular, the illustrations show the distal portion of the system <NUM> (which includes a distal portion of the needle device and the anchor), and a corresponding proximal portion of the system <NUM> (which includes a deployment fixture <NUM> coupled at the proximal end of the needle device <NUM>).

Referring to <FIG>, the distal portion of the system <NUM> shown includes a needle device <NUM> that contains within its lumen a collapsed anchor <NUM>. The proximal portion of the system is a deployment fixture (handle) <NUM> that includes a multi-component coupler, and three (block) actuators slidably disposed along one or more drive shafts. The multi-component coupler includes a first coupler configured to couple to a needle shaft of the needle device, a second coupler configured to couple to a push rod, and a third coupler configured to couple to a pull wire. The three actuators include a first actuator <NUM> adapted for translating distally or proximally the needle device, a second actuator <NUM> for translating distally or proximally the push rod, and a third actuator <NUM> for translating distally or proximally the pull wire. As shown in <FIG>, once the system components have been attached to the deployment fixture <NUM>, all three actuators <NUM>, <NUM>, <NUM> may be distally translated (as depicted by the arrows) to advance the needle device and the components contained therein (e.g., anchor, pull wire, and push rod) into targeted tissue. The needle device <NUM> may be optionally disposed within a sheath during delivery through an introducer and unsheathed before advanced into tissue.

A distal portion of the anchor <NUM> can be exposed from the distal tip of the needle device <NUM> once the needle has fully tunneled through the targeted tissue. The distal portion of the anchor <NUM> can be exposed such that the proximal portion of the anchor <NUM> remains collapsed in the needle lumen. The anchor <NUM> can be exposed by distally translating the second and third actuators <NUM>, <NUM> of the deployment fixture <NUM> at about equal rates and distances.

The distal portion of the anchor <NUM> can be diametrically expanded by translating the pull wire proximally, while leaving the push rod stationary. The pull wire can be proximally translated by sliding the third actuator <NUM> in a proximal direction.

Referring to <FIG>, the system <NUM> can be proximally translated to compress the tissue abutting the proximal surface of the distal portion of the anchor <NUM> by proximally translating all three actuators <NUM>, <NUM>, <NUM> in a proximal direction. In this step, the tissue is compressed by the distal portion of the anchor <NUM> to reduce the size of the posterior leaflet.

Referring to <FIG>, the needle <NUM> can be retracted to expose the proximal portion of the anchor <NUM>. In this step, the first actuator <NUM> is proximally translated to retract the needle <NUM>, while the second and third actuators <NUM>, <NUM> are held in place.

Referring to <FIG>, the proximal portion of the anchor <NUM> is diametrically expanded to secure the tissue between the distal and proximal portions of the anchor <NUM>. The proximal portion of the anchor <NUM> can be diametrically expanded by distally translating the push rod, thus, applying compressional force on the anchor <NUM>. The push rod can be distally translated by slidably moving the second actuator <NUM> in a proximal direction while holding the first and third actuators <NUM>, <NUM> stationary.

Referring to <FIG>, the anchor <NUM> is locked into its final position by releasing the anchor <NUM> from the pull wire. In some cases, the anchor <NUM> can be released retracting the pull wire with a predetermined tensile force. For example, the pull wire may be detached from the anchor <NUM> if a tensile force of about <NUM> N (<NUM> lbf) or greater is applied to the anchor assembly (which includes the pull wire and anchor). To apply a tensile force on the anchor assembly the third actuator <NUM> can be proximally translated while holding the first and second actuators <NUM>, <NUM> stationary in the deployment fixture <NUM>.

Referring to <FIG>, the anchor <NUM> can be released from the system (e.g., the needle and push rod) <NUM> such that the system <NUM> can be removed from the patient's body. In some cases, the push rod includes a c-shaped clasp connector that couples the push rod to the anchor <NUM> during a device delivery procedure. The clasp connector can be disconnected by retracting the needle and exposing the clasp connector distal to the needle tip. Needle retraction is accomplished by proximally translating the first actuator <NUM> while holding the second and third actuators stationary <NUM>, <NUM>. Since the pull wire has been detached from the anchor, the clasp connector automatically unlatches from the anchor, once exposed from the needle lumen, releasing the anchor <NUM> in the tissue. The system <NUM> can be withdrawn from the patient's body, as desired.

Claim 1:
A heart valve anchor (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) for performing a surgical reduction of a heart valve comprising:
a body (<NUM>, <NUM>, <NUM>, <NUM>) that includes a distal portion, a distal end (<NUM>, <NUM>, <NUM>), a proximal portion, and a proximal end (<NUM>, <NUM>, <NUM>), the distal end and the proximal end defining a longitudinal axis, the body (<NUM>, <NUM>, <NUM>, <NUM>) comprising:
a first radially expandable portion (<NUM>, <NUM>, <NUM>, <NUM>) at the distal portion of the body (<NUM>, <NUM>, <NUM>, <NUM>);
a second radially expandable portion (<NUM>, <NUM>, <NUM>, <NUM>) at the proximal portion of the body (<NUM>, <NUM>, <NUM>, <NUM>); and
a root portion (<NUM>, <NUM>, <NUM>, <NUM>) disposed between the first and second radially expandable portions (<NUM>, <NUM>, <NUM>, <NUM>; <NUM>, <NUM>, <NUM>, <NUM>); and
wherein the body (<NUM>, <NUM>, <NUM>, <NUM>) has a first configuration adapted to be housed at least partially within a tissue penetrating device, and a second configuration in which the first and second radially expandable portions (<NUM>, <NUM>, <NUM>, <NUM>; <NUM>, <NUM>, <NUM>, <NUM>) are partially or fully expanded such that the anchor (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) engages tissue in a region between the first and second radially expandable portions (<NUM>, <NUM>, <NUM>, <NUM>; <NUM>, <NUM>, <NUM>, <NUM>) and wherein the first and second radially expandable portions (<NUM>, <NUM>, <NUM>, <NUM>; <NUM>, <NUM>, <NUM>, <NUM>) are configured to compress together annular valve tissue, and characterised in that the first and second radially expandable portions (<NUM>, <NUM>, <NUM>, <NUM>; <NUM>, <NUM>, <NUM>, <NUM>) are configured to radially expand when the anchor (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is compressed along the longitudinal axis.