FLEXIBLE VALVE ANCHORS

A tissue anchor comprises a frame comprising at least a first pointed end and a membrane extending across an opening of the frame. The frame is configured to bend such that the first pointed end extends at least partially over the membrane.

BACKGROUND

Field

The present disclosure generally relates to the field of medical procedures and devices.

Description of Related Art

Various medical procedures involve accessing internal anatomy of a patient through biological tissue. Some procedures can involve delivery of deployment devices into a beating heart.

SUMMARY

Described herein are one or more methods and/or devices to facilitate puncture site and/or orientation location and execution.

Some implementations of the present disclosure relate to a tissue anchor comprising a frame comprising at least a first pointed end and a membrane extending across an opening of the frame. The frame is configured to bend such that the first pointed end extends at least partially over the membrane.

In some instances, the frame and membrane are diamond shaped. The frame and membrane may be oval-shaped. In some instances, the frame and membrane are droplet shaped.

The first pointed end may be configured to puncture a valve leaflet of a heart. In some instances, the first pointed end comprises an eyelet configured to receive a tethering suture.

In some instances, the membrane is configured to attach to a tethering suture. The frame may be configured to bend such that the frame assumes a heart-shaped form.

Some implementations of the present disclosure relate to a method comprising delivering a needle carrying two or more tissue anchors situated longitudinally within a lumen of the needle. Each of the two or more tissue anchors comprises a frame having a pointed end and a membrane extending across an opening of the frame. Each of the two or more tissue anchors is tethered to a different suture of two or more sutures. The method further comprises deploying a first tissue anchor of the two or more tissue anchors through a puncture opening in a valve leaflet of a heart and beyond a distal end of the needle, positioning the first tissue anchor such that a first membrane of the first tissue anchor covers the puncture opening, and redirecting a first pointed end of the frame of the first tissue anchor such that the pointed end extends at least partially over the first membrane.

In some instances, the method further comprises puncturing the valve leaflet using a pointed tip of the needle. The pointed tip may extend at least partially over the lumen of the needle to cause the first tissue anchor to exit the lumen at an angle with respect to the needle.

The pointed tip may have rounded edges to cause dilation of the puncture opening. In some instances, the method further comprises deploying a second tissue anchor of the two or more tissue anchors through a second puncture opening in the valve leaflet of the heart and beyond the distal end of the needle.

In some instances, redirecting the first pointed end of the frame causes the first pointed end to extend at least partially over the puncture opening.

Some implementations of the present disclosure relate to a tissue anchoring system comprising a first tissue anchor configured for delivery via a lumen of a delivery shaft to a valve leaflet of a heart. The first tissue anchor comprises a frame comprising at least a first pointed end and a membrane extending across an opening of the frame. The frame is configured to bend such that the first pointed end extends at least partially over the membrane. The anchoring system further comprises a first suture tethered to the first tissue anchor and configured to anchor to a ventricle wall.

In some instances, the frame comprises an eyelet. The first suture may be configured to form a knot through the eyelet.

The first suture may be configured to attach to the membrane. In some instances, the tissue anchoring system further comprises a second tissue anchor configured for delivery via the lumen of the delivery shaft to the valve leaflet of the heart and a second suture tethered to the second tissue anchor and configured to anchor to the ventricle wall.

In some instances, the first tissue anchor is configured to assume a compressed form within the lumen of the delivery shaft and assume an expanded form following removal from the lumen of the delivery shaft. The frame and membrane may have a diamond shape.

DETAILED DESCRIPTION

Although certain preferred examples and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain examples; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular instance. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

Certain reference numbers are re-used across different figures of the figure set of the present disclosure as a matter of convenience for devices, components, systems, features, and/or modules having features that may be similar in one or more respects. However, with respect to any of the examples disclosed herein, re-use of common reference numbers in the drawings does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one having ordinary skill in the art may be informed by context with respect to the degree to which usage of common reference numbers can imply similarity between referenced subject matter. Use of a particular reference number in the context of the description of a particular figure can be understood to relate to the identified device, component, aspect, feature, module, or system in that particular figure, and not necessarily to any devices, components, aspects, features, modules, or systems identified by the same reference number in another figure. Furthermore, aspects of separate figures identified with common reference numbers can be interpreted to share characteristics or to be entirely independent of one another.

Certain standard anatomical terms of location are used herein to refer to certain device components/features and to the anatomy of animals, and namely humans, with respect to the preferred examples. Although certain spatially relative terms, such as “proximal,” “distal,” “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe a spatial relationship of one device/element or anatomical structure to another device/element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s)/structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s)/structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element/structure described as “above” another element/structure may represent a position that is below or beside such other element/structure with respect to alternate orientations of the subject patient or element/structure, and vice-versa.

The present disclosure relates to systems, devices, and methods for deploying one or more anchors and/or attached neo chordae for chordal repair of various cardiac valves (e.g., the mitral and/or tri-cuspid valves) which may have experienced degenerative valve disease. One or more anchors described herein may comprise a stent-like structure configured to be compressed within a deployment device (e.g., a catheter). In some instances, an example anchor can comprise a membrane and/or weave portion configured to promote cellular overgrowth. One or more suture lengths may be configured to attach to an example anchor to allow for adjustment of a repaired valve leaflet. For example, the valve leaflet may be adjusted to reestablish leaflet coaptation and/or to minimize valve regurgitation.

The systems, devices, and methods described herein can allow for placement of multiple anchors and/or chordae utilizing a single delivery device and/or system and/or may eliminate the need to remove and/or reinsert a delivery device for subsequent deployments. As a result, a propensity for tangling of neo chordae may be minimized and/or a risk of damage to the neo chordae and/or native tissue due to chordae tangling may be minimized.

Delivery systems involving single-suture deployment devices can require an average of four to seven chordal replacements to be deployed per patient. This can require that multiple individual deployment devices be inserted into the beating heart, increasing the potential damage to the heart muscle, possible tangling of previously deployed chords with the subsequent chords, and/or a possibility of uneven loading and/or damaging of the neo chordae as a result of tangling and/or interference. The instances described herein can advantageously minimize these risks by allowing for simultaneous and/or single-procedure delivery of multiple tissue anchors and/or neo chordae. For example, example tissue anchors may be configured to be stacked within a single deployment device (e.g., a catheter). The tissue anchors may be advanced using a “ratchet” and/or similar mechanism to advance each anchor and/or suture.

Some tissue anchors described herein can comprise a pointed tip to allow the tissue anchors to independently penetrate leaflet tissue prior to deployment of the tissue anchors at one or more leaflets. The tissue anchors may be attached to sutures configured to allow for adjustment of a valve leaflet. In some instances, the deployment device can incorporate a suture management system that allows for free movement of each suture once deployed. Following deployment of one or more tissue anchors, the deployment device(s) may be removed from the patient's heart. Sutures attached to the anchors can be cinched and/or tensioned as a group and/or individually to achieve a desired coaptation of the valve leaflets and/or to minimize and/or eliminate valve regurgitation. Once properly adjusted, the suture ends may be anchored to the exterior wall of the heart and/or trimmed in order to complete valve repair.

Certain examples are disclosed herein in the context of cardiac implants and procedures. However, although certain principles disclosed herein are particularly applicable to the anatomy of the heart, it should be understood that puncture locator devices and puncture/access procedures in accordance with the present disclosure may be implanted in, or configured for implantation in, any suitable or desirable anatomy.

Cardiac Physiology

The following includes a general description of human cardiac anatomy that is relevant to certain inventive features and examples disclosed herein and is included to provide context for certain aspects of the present disclosure. In humans and other vertebrate animals, the heart generally comprises a muscular organ having four pumping chambers, wherein the flow thereof is at least partially controlled by various heart valves, namely, the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves. The valves may be configured to open and close in response to a pressure gradient present during various stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to a respective region of the heart and/or to blood vessels (e.g., pulmonary, aorta, etc.).

FIG.1illustrates an example representation of a heart1having various features relevant to certain aspects of the present inventive disclosure. The heart1includes four chambers, namely the left ventricle3, the left atrium2, the right ventricle4, and the right atrium5. A wall of muscle17, referred to as the septum, separates the left2and right5atria and the left3and right4ventricles. The inferior tip19of the heart1is referred to as the apex and is generally located on the midclavicular line, in the fifth intercostal space. The apex19can be considered part of the greater apical region39.

The left ventricle3is the primary pumping chamber of the heart1. A healthy left ventricle is generally conical or apical in shape in that it is longer (along a longitudinal axis extending in a direction from the aortic valve7to the apex19) than it is wide (along a transverse axis extending between opposing walls25,26at the widest point of the left ventricle) and descends from a base15with a decreasing cross-sectional circumference to the point or apex19. Generally, the apical region39of the heart is a bottom region of the heart that is within the left or right ventricular region but is distal to the mitral6and tricuspid8valves and toward the tip of the heart. More specifically, the apical region39may be considered to be within about 20 cm to the right or to the left of the median axis27of the heart1.

The pumping of blood from the left ventricle is accomplished by a squeezing motion and a twisting or torsional motion. The squeezing motion occurs between the lateral wall18of the left ventricle and the septum17. The twisting motion is a result of heart muscle fibers that extend in a circular or spiral direction around the heart. When these fibers contract, they produce a gradient of angular displacements of the myocardium from the apex19to the base15about the longitudinal axis of the heart. The resultant force vectors extend at angles from about 30-60 degrees to the flow of blood through the aortic valve7. The contraction of the heart is manifested as a counterclockwise rotation of the apex19relative to the base15, when viewed from the apex19. A healthy heart can pump blood from the left ventricle in a very efficient manner due to the spiral contractility of the heart.

The heart1further includes four valves for aiding the circulation of blood therein, including the tricuspid valve8, which separates the right atrium5from the right ventricle4. The tricuspid valve8may generally have three cusps or leaflets and may generally close during ventricular contraction (e.g., systole) and open during ventricular expansion (e.g., diastole). The valves of the heart1further include the pulmonary valve9, which separates the right ventricle4from the pulmonary artery11and may be configured to open during systole so that blood may be pumped toward the lungs, and close during diastole to prevent blood from leaking back into the heart from the pulmonary artery. The pulmonary valve9generally has three cusps/leaflets, wherein each one may have a crescent-type shape. The heart1further includes the mitral valve6, which generally has two cusps/leaflets and separates the left atrium2from the left ventricle3. The mitral valve6may generally be configured to open during diastole so that blood in the left atrium2can flow into the left ventricle3, and advantageously close during diastole to prevent blood from leaking back into the left atrium2. The aortic valve7separates the left ventricle3from the aorta12. The aortic valve7is configured to open during systole to allow blood leaving the left ventricle3to enter the aorta12, and close during diastole to prevent blood from leaking back into the left ventricle3.

The atrioventricular (e.g., mitral and tricuspid) heart valves may comprise a collection of chordae tendineae and papillary muscles for securing the leaflets of the respective valves to promote and/or facilitate proper coaptation of the valve leaflets and prevent prolapse thereof. The papillary muscles, for example, may generally comprise finger-like projections from the ventricle wall. With respect to the tricuspid valve8, the normal tricuspid valve may comprise three leaflets and three corresponding papillary muscles (two shown inFIG.1). The leaflets of the tricuspid valve may be referred to as the anterior, posterior and septal leaflets, respectively. The valve leaflets are connected to the papillary muscles by the chordae tendineae, which are disposed in the right ventricle4along with the papillary muscles.

Surrounding the ventricles (3,4) are a number of arteries (not shown) that supply oxygenated blood to the heart muscle and a number of veins that return the blood from the heart muscle. The coronary sinus (not shown) is a relatively large vein that extends generally around the upper portion of the left ventricle3and provides a return conduit for blood returning to the right atrium5. The coronary sinus terminates at the coronary ostium (not shown) through which the blood enters the right atrium.

With respect to the mitral valve6, a normal mitral valve may comprise two leaflets (anterior and posterior) and two corresponding papillary muscles. The papillary muscles originate in the left ventricle wall and project into the left ventricle3. Generally, the anterior leaflet may cover approximately two-thirds of the valve annulus. Although the anterior leaflet covers a greater portion of the annulus, the posterior leaflet may comprise a larger surface area in certain anatomies.

Various disease processes can impair the proper functioning of one or more of the valves of the heart. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic deficiency), inflammatory processes (e.g., rheumatic heart disease) and infectious processes (e.g., endocarditis). Additionally, damage to the ventricle from prior heart attacks (e.g., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can distort the valve's geometry causing it to dysfunction. However, the vast majority of patients undergoing valve surgery, such as mitral valve surgery, suffer from a degenerative disease that causes a malfunction in one or more leaflets of the valve which results in prolapse and regurgitation.

The mitral valve6and tricuspid valve8can be divided into three parts: an annulus, leaflets, and a sub-valvular apparatus. The sub-valvular apparatus can be considered to include the papillary muscles and the chordae tendineae, which can elongate and/or rupture. If a valve is functioning properly, when closed, the free margins or edges of the leaflets come together and form a tight junction, the arc of which, in the mitral valve, is known as the line, plane or area of coaptation. Normal mitral and tricuspid valves open when the ventricles relax allowing blood from the atrium to fill the decompressed ventricle. When the ventricle contracts, the chordae tendineae advantageously properly tether or position the valve leaflets such that the increase in pressure within the ventricle causes the valve to close, thereby preventing blood from leaking into the atrium and assuring that substantially all of the blood leaving the ventricle is ejected through the aortic valve7or pulmonic valve9and into the arteries of the body. Accordingly, proper function of the valves depends on a complex interplay between the annulus, leaflets, and sub-valvular apparatus. Lesions in any of these components can cause the valve to dysfunction and thereby lead to valve regurgitation.

Generally, there are three mechanisms by which a heart valve becomes regurgitant or incompetent; they include Carpentier's type I, type II and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (e.g., do not coapt properly). Included in a type I mechanism malfunction are perforations of the valve leaflets, as in endocarditis. A Carpentier's type II malfunction involves prolapse of one or both leaflets above the plane of coaptation. This is the most common cause of mitral regurgitation and is often caused by the stretching or rupturing of chordae tendineae normally connected to the leaflet. A Carpentier's type III malfunction involves restriction of the motion of one or more leaflets such that the leaflets are abnormally constrained below the level of the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (IIIa) or dilation of the ventricle (IIIb).

One or more chambers in the heart1may be accessed in accordance with certain heart valve-repair procedures and/or other interventions. Access into a chamber in the heart may be made at any suitable site of entry. In some implementations, access is made to a chamber of the heart, such as a target ventricle (e.g., left ventricle) associated with a diseased heart valve, through the apical region39. For example, access into the left ventricle3(e.g., to perform a mitral valve repair) may be gained by making a relatively small incision at the apical region39, close to (or slightly skewed toward the left of) the median axis27of the heart. Access into the right ventricle4(e.g., to perform a tricuspid valve repair) may be gained by making a small incision into the apical region39, close to or slightly skewed toward the right of the median axis27of the heart. Accordingly, the ventricle can be accessed directly via the apex, or via an off-apex location that is in the apical region39but slightly removed from the tip/apex, such as via lateral ventricular wall, a region between the apex and the base of a papillary muscle, or even directly at the base of a papillary muscle. In some implementations, the incision made to access the appropriate ventricle of the heart is no longer than about 1 mm to about 5 cm, from 2.5 mm to about 2.5 cm, or from about 5 mm to about 1 cm in length. When a percutaneous approach is sought, no incision into the apex region of the heart may be made, but rather access into the apical region39may be gained by direct needle puncture, for instance by an 18-gauge needle, through which an appropriate repair instrument can be advanced.

Heart Valve Leaflet Tethering

Certain inventive features disclosed herein relate to certain heart valve repair systems and devices, and/or systems, process, and devices for repairing any other type of target organ tissue. In some implementations, a tissue anchor delivery device may be employed in repairing a mitral valve in patients suffering from degenerative mitral regurgitation or other condition. In some implementations, a transapical, off-pump repair procedure is implemented in which at least part (e.g., a shaft portion/assembly) of a valve repair system is inserted in the left ventricle and advanced to the surface of the diseased portion of a target mitral valve leaflet and used to deploy/implant a tissue anchor in the target leaflet. The tissue anchor may advantageously be integrated or coupled with one or more artificial/synthetic cords serving a function similar to that of chordae tendineae. Such artificial cord(s) may comprise suture(s) and/or suture tail portions associated with a knot-type tissue anchor and may comprise any suitable or desirable material, such as expanded polytetrafluoroethylene (ePTFE) or the like. The term “suture” is used herein according to its broad and ordinary meaning and may refer to any elongate cord, strip, strand, line, tie, string, ribbon, strap, or portion thereof, or other type of material used in medical procedures. One having ordinary skill in the art will understand that a wire or other similar material may be used in place of a suture. Furthermore, in some contexts herein, the terms “cord,” “chord,” “chordae,” and “suture” may be used substantially interchangeably. In addition, use of the singular form of any of the suture-related terms listed above, including the terms “suture” and “cord,” may be used to refer to a single suture/cord, or to a portion thereof, or to a plurality of suture/cords, such as a pair of suture/cord tails emanating from a single anchor, knot, form, device, or other structure or assembly. Where a suture knot or anchor is deployed on a distal side of a tissue portion, and where two suture portions extend from the knot/anchor on a proximal side of the tissue, either or both of the suture portions may be referred to as a “suture” or a “cord,” regardless of whether both portions are part of a unitary suture or cord or are separate.

Processes for repairing a target organ tissue, such as repair of mitral valve leaflets to address mitral valve regurgitation, can include inserting a tissue anchor delivery device, such as a delivery device as described in PCT Application No. PCT/US2012/043761, (published as WO 2013/003228, and referred to herein as “the '761 PCT Application”) and/or in PCT Application No. PCT/US2016/055170 (published as WO 2017/059426 and referred to herein as “the '170 PCT Application”), the entire disclosures of which are incorporated herein by reference for all purposes, into a body and extending a distal end of the delivery device to a proximal side of the target tissue (e.g., leaflet).

The '761 PCT Application and the '170 PCT Application describe in detail methods and devices for performing non-invasive procedures to repair a cardiac valve, such as a mitral valve. Such procedures include procedures to repair regurgitation that occurs when the leaflets of the mitral valve do not coapt properly at peak contraction pressures, resulting in an undesired backflow of blood from the ventricle into the atrium. As described in the '761 PCT Application and the '170 PCT Application, after the malfunctioning cardiac valve has been assessed and the source of the malfunction verified, a corrective procedure can be performed. Various procedures can be performed in accordance with the methods described therein to effectuate a cardiac valve repair, which may depend on the specific abnormality and the tissues involved.

With further reference toFIG.1,FIG.1shows an example deployed leaflet/tissue anchor190deployed in a heart valve leaflet (e.g., a posterior leaflet154and/or anterior leaflet156) and tethered to a heart/ventricle wall18via one or more sutures/suture tails195coupled to and/or associated with the anchor190. The suture tails195coupled to the anchor190may be secured at the desired tension using a pledget71or other suture-fixing/locking device or mechanism on the outside of the heart wall18through which the suture tails195may run. A knot or other suture fixation mechanism or device may be implemented to hold the sutures at the desired tension and to the pledget71. With the suture tail(s)195fixed to the ventricle wall18, a portion of the suture tail(s)195disposed within the ventricle3may advantageously function as replacement leaflet cords (e.g., chordae tendineae) that are configured to tether the target leaflet154in a desired manner.

FIG.2is a perspective view of a tissue anchor delivery device in accordance with one or more examples. The tissue anchor delivery system100may be used to repair a heart valve, such as a mitral valve, and improve functionality thereof. For example, the tissue anchor delivery system100may be used to reduce the degree of mitral regurgitation in patients suffering from mitral regurgitation caused by, for example, midsegment prolapse of valve leaflets as a result of degenerative mitral valve disease. In order to repair such a valve, the tissue anchor delivery system100may be utilized to deliver and anchor tissue anchors, such as malleable tissue anchors, in a prolapsed valve leaflet. As described in detail below, such procedure may be implemented on a beating heart.

The delivery system100includes a rigid elongate tube110forming at least one internal working lumen. Although described in certain examples and/or contexts as comprising a rigid elongate tube, it should be understood that tubes, shafts, lumens, conduits, and the like disclosed herein may be either rigid, at least partially rigid, at least flexible, and/or at least partially flexible. Therefore, any such component described herein, whether or not referred to as rigid herein should be interpreted as possibly being at least partially flexible. In accordance with the present disclosure, the rigid elongate tube110may be referred to as a shaft for simplicity. Implementation of a valve-repair procedure utilizing the delivery system100can be performed in conjunction with certain imaging technology designed to provide visibility of the shaft110of the delivery system100according to a certain imaging modality, such as echo imaging. Generally, when performing a valve-repair procedure utilizing the tissue anchor delivery system100, the operating physician may advantageously work in concert with an imaging technician, who may coordinate with the physician to facilitate successful execution of the valve-repair procedure.

In addition to the delivery shaft110, the delivery system100may include a plunger feature140. The tissue anchor delivery system100may further include a plunger lock mechanism145, which may serve as a safety lock that locks the valve delivery system until ready for use or deployment of a leaflet anchor as described herein. The plunger140may have associated therewith a suture-release mechanism, which may be configured to lock in relative position a pair of suture tails195associated with a pre-formed knot anchor (not shown) to be deployed. For example, the suture portions195may be ePTFE sutures. The system100may further comprise a flush port150, which may be used to de-air the lumen of the shaft110. For example, heparinized saline flush, or the like, may be connected to the flush port150using a female Luer fitting to de-air the valve repair system100. The term “lumen” is used herein according to its broad and ordinary meaning, and may refer to a physical structure forming a cavity, void, pathway, or other channel, such as an at least partially rigid elongate tubular structure, or may refer to a cavity, void, pathway, or other channel, itself, that occupies a space within an elongate structure (e.g., a tubular structure). Therefore, with respect to an elongate tubular structure, such as a shaft, tube, or the like, the term “lumen” may refer to the elongate tubular structure and/or to the channel or space within the elongate tubular structure.

The lumen of the shaft110may house a needle (not shown) configured to deploy one or more anchors, as described in detail herein. In some examples, the shaft110presents a relatively low profile. For example, the shaft110may have a diameter of approximately 3 mm or less (e.g., about 9 Fr). The shaft110is associated with an atraumatic tip114feature. The atraumatic tip114can be an echogenic leaflet-positioner component, which may be used for deployment and/or positioning of the suture-type tissue anchor. The atraumatic tip114, disposed at the distal end of the shaft110, may be configured to have deployed therefrom one or more valve anchors, as described herein.

The atraumatic tip114may be referred to as an “end effector.” In addition to one or more valve anchors and associated needle, the shaft110may house an elongated knot pusher tube (not shown; also referred to herein as a “pusher”), which may be actuated using the plunger140in some examples. As described in further detail below, the tip114provides a surface against which the target valve leaflet may be held in connection with deployment of a leaflet anchor.

The delivery system100may be used to deliver any of the various tissue anchors described in greater detail below. For example, the delivery system100may be utilized to deliver a tissue anchor on a distal side of a mitral valve leaflet. The tip114(e.g., end effector), can be placed in contact with the ventricular side of a leaflet of a mitral valve. The tip114can be coupled to the distal end portion of the shaft110, wherein the proximal end portion of the shaft110may be coupled to a handle portion120of the delivery system100, as shown. Generally, the elongate pusher (not shown) may be movably disposed within a lumen of the shaft110and coupled to a pusher hub (not shown) that is movably disposed within the handle120and releasably coupled to the plunger140. A needle and/or catheter carrying one or more tissue anchors can be movably disposed within a lumen of the pusher and coupled to a needle hub (not shown) that is also coupled to the plunger140. In some instances, the needle and/or catheter may comprise a pointed tip to facilitate puncturing a valve leaflet. However, in some instances, one or more tissue anchors may have pointed tips and/or the needle and/or catheter may not comprise a pointed tip. The plunger140can be used to actuate or move the needle and/or the pusher during deployment of a distal anchor (see, e.g.,FIG.10) and is movably disposed at least partially within the handle120. For example, the handle120may define a lumen in which the plunger140can be moved. During operation, the pusher may also move within the lumen of the handle120. The plunger lock145can be used to prevent the plunger140from moving within the handle120during storage and prior to performing a procedure to deploy a tissue anchor.

The needle and/or catheter may have the one or more tissue anchors disposed at a distal portion thereof while maintained in the shaft110. For example, one or more tissue anchors may be arranged generally longitudinally while within a lumen of the needle and/or catheter. In some instances, one or more suture tails may extend from each of the one or more tissue anchors. The suture tails195may extend through the lumen of the needle and/or through a passageway of the plunger140and may exit the plunger140at a proximal end portion thereof.

The delivery device/system100can further include a suture/tether catch mechanism (not shown) coupled to the plunger140at a proximal end of the delivery system100, which may be configured to releasably hold or secure a suture195extending through the delivery system100during delivery of a tissue anchor as described herein. The suture catch can be used to hold the suture195with a friction fit or with a clamping force and can have a lock that can be released.

As described herein, the anchor delivery system100can be used in beating heart mitral valve repair procedures. In some instances, the shaft110of the delivery system100can be configured to extend and contract with the beating of the heart. During systolic contraction, the median axis of the heart generally shortens. For example, with reference toFIG.1, the distance from the apex19of the heart to the valve leaflets154,154can vary by about 1 cm to about 2 cm with each heartbeat in some patients. In some instances, the length of the shaft110that protrudes from the handle120can change with the length of the median axis of the heart. That is, distal end of the shaft110can be configured to be floating such that the shaft can extend and retract with the beat of the heart so as to maintain contact with the target mitral valve leaflet.

Advancement of the delivery system100may be performed in conjunction with echo imaging, direct visualization (e.g., direct transblood visualization), and/or any other suitable remote visualization technique/modality. With respect to cardiac procedures, for example, the delivery system100may be advanced in conjunction with transesophageal (TEE) guidance and/or intracardiac echocardiography (ICE) guidance to facilitate and to direct the movement and proper positioning of the device for contacting the appropriate target cardiac region and/or target cardiac tissue (e.g., a valve leaflet, a valve annulus, or any other suitable cardiac tissue). Typical procedures that can be implemented using echo guidance are set forth in Suematsu, Y., J.Thorac. Cardiovasc. Surg.2005; 130:1348-56 (“Suematsu”), the entire disclosure of which is incorporated herein by reference.

FIG.3illustrates an example tissue anchor300configured to anchor one or more sutures and/or artificial chordae at one or more valve leaflets of a heart. In some environments, the anchor300may have a diamond and/or rectangular shape and/or may comprise one or more corners and/or points, including a first point311across from a second point312and/or a third point313across from a fourth point314. One or more of the points may be pointed ends and/or may represent a change in direction of an outer frame302. The anchor300may comprise an outer frame302at least partially enclosing an at least partially flexible and/or porous membrane304. For example, the outer frame302may at least partially surround a space having a shape similar to a shape of the outer frame302. In the example shown inFIG.3, the outer frame302may be diamond-shaped and/or may enclose a space that is similarly diamond-shaped. The membrane304may be configured to extend at least partially across an interior space and/or opening of the frame302. In some instances, the frame302and/or membrane304may be at least partially composed of any of a variety of generally flexible materials. For example, the frame302may be at least partially composed of one or more shape memory alloys (e.g., nitinol) and/or the membrane may comprise a network of interwoven fibers and/or cords. In some instances, the frame302may be configured to bend such that at least the first point311extends at least partially over the membrane304. The first point311and/or other points may have relatively sharp tips such that the first point311and/or other points may be configured to puncture a valve leaflet. However, the first point311and/or other points may additionally or alternatively have rounded and/or blunt tips and/or may not be configured to puncture a valve leaflet.

In some instances, the anchor300may have a stent-like structure and/or may be movable between a compressed and/or expanded form. For example, the anchor300may be configured to assume a compressed form while within a catheter and/or other delivery device. In the compressed form, the anchor300may assume an at least partially modified form from the default and/or expanded form shown inFIG.3. For example, compression of the anchor may involve a decrease of a width316of the anchor300and/or an increase of a length318of the anchor300as the frame302bends in response to outside forces. Upon removal from the delivery device, the anchor300may be configured to naturally expand and/or to be expanded using wires and/or other manual means. Expansion of the anchor may involve an increase in the width316and/or a decrease in the length318. The width316may represent a distance between the third point313and the fourth point314. The length318may represent a distance between the first point311and the second point312.

The membrane304may comprise a network of weaved and/or interwoven materials, which can include various cords and/or fibers. In some instances, the membrane304may be configured to promote cellular overgrowth following deployment at a valve leaflet and/or other target area. For example, the membrane304may have a generally porous structure and/or may be configured to allow tissue growth through openings and/or gaps of the membrane304. The anchor300may be configured to lay generally flatly along a surface of a valve leaflet such that the membrane304may extend over a surface area of the valve leaflet.

In some instances, one or more sutures and/or similar devices may be configured to couple, attach, and/or extend from the anchor300. For example, a suture may be configured to couple to the anchor300to allow for adjustment of a valve leaflet which the anchor300may be anchored to. Adjustment of the valve leaflet may be configured to cause and/or reestablish leaflet coaptation and/or to minimize valve regurgitation. The one or more sutures may be configured to anchor and/or attach to any portion of the anchor300. For example, a suture may be configured to attach to a central portion of the membrane304of the anchor300. In this way, the suture may be configured to apply force across a wide area of the membrane304and/or frame302.

The membrane304may be composed of any of a variety of suitable materials. For example, the membrane304may be at least partially composed of electro spun fabric. The membrane304may be configured to lay flatly against a tissue surface and/or to at least partially cover a delivery puncture through the tissue. The membrane304may comprise a closed-cell network of materials. In some instances, the membrane304may be configured to allow tissue growth through the membrane304. For example the membrane304may have a porous structure including gaps between fibers forming the membrane304.

The frame302may have a generally rigid and/or flexible structure. In some instances, the frame302may be configured to bend during deployment and/or following deployment. Bending of the frame302may allow for adjustments to the shape of the anchor300. While the anchor300(e.g., the frame302and/or membrane304) is shown having a diamond shape inFIG.3, the anchor300may have any suitable shape. The anchor300is shown inFIG.3from an overhead view. For example, the anchor300(e.g., the frame302and/or membrane304) may be configured to lay flatly against a tissue valve leaflet with at least a portion of the frame302and/or membrane304contacting and/or covering the tissue. Following deployment at the valve leaflet, the anchor300may be configured to cover a diamond-shaped area of the valve leaflet. However, the anchor300may be adjusted to change a coverage area of the anchor300. For example, the first point311may be redirected to extend at least partially over the membrane304and/or over a puncture opening through the valve leaflet. Following adjustment of the anchor300, the anchor may be configured to have a heart shape and/or to cover a heart-shaped area of the valve leaflet.

FIG.4illustrates another example tissue anchor400comprising a pointed tip406which may be configured to facilitate delivery of the anchor400through one or more valve leaflets. As shown inFIG.4, one or more corners of the anchor400may be extended to form the pointed tip406, which may be configured to penetrate a tissue wall and/or in valve leaflet. For example, the anchor400may comprise a frame402forming a first point411(e.g., corner) across from a second point412and/or a third point413across from a fourth point414. The first point411may extend into the pointed tip406and/or may comprise an eyelet408(e.g., aperture) configured to receive one or more sutures and/or similar devices.

In some instances, the pointed tip406of the anchor400may be configured to facilitate delivery of the anchor400. After the anchor400is extended through a valve leaflet, the anchor400may be deployed from a catheter and/or other delivery systems. In some instances, the anchor400may comprise one or more eyelets408configured to receive one or more sutures which may be tethered to the anchor400. The eyelet408may comprise a generally circular opening in the first point411configured to allow one or more sutures to extend through the first point411.

After the anchor400and/or the pointed tip406punctures through a valve leaflet, the anchor400may be configured to twist and/or adjust such that the pointed tip406extends along the valve leaflet such that the membrane404of the anchor lays flatly along the valve leaflet. For example, the anchor400may be configured to cover a diamond-shaped area of the valve leaflet. However, the anchor400may be adjusted to change a coverage area of the anchor400. For example, the first point411may be redirected to extend at least the pointed tip406at least partially over the membrane404and/or over a puncture opening through the valve leaflet. Following adjustment of the anchor400, the anchor may be configured to have a heart shape and/or to cover a heart-shaped area of the valve leaflet.

FIG.5illustrates a generally oval-shaped tissue anchor500having a pointed tip506to facilitate delivery of the anchor500at one or more valve leaflets, in accordance with one or more instances. The anchor500may comprise a generally oval-shaped frame502at least partially enclosing a generally oval-shaped membrane504. The frame502may comprise one or more points and/or corners, which may include a first point511situated generally across from a second point512. The first point511may extend into the pointed tip506and/or may comprise an eyelet508configured to receive one or more sutures and/or similar devices.

FIG.6illustrates a droplet-shaped anchor600configured for delivery and/or anchoring at one or more valve leaflets, in accordance with one or more instances. The anchor600may comprise a generally oval-shaped frame602at least partially enclosing a generally oval-shaped membrane604. The frame602may comprise one or more points and/or corners, which may include a first point611. The first point611may comprise an eyelet608configured to receive one or more sutures and/or similar devices.

FIG.7illustrates an example anchor700following delivery at one or more valve leaflets, in accordance with one or more instances. The anchor700may comprise a frame702at least partially enclosing a membrane704. In some instances, the frame702may comprise one or more points and/or anchors, which can include a first point711and/or a second point712. The first point711may extend into a pointed tip706and/or may comprise an eyelet708. The anchor700may be configured to assume the form shown inFIG.7following delivery at a valve leaflet. For example, the anchor700may comprise a diamond and/or oval form (see, e.g.,FIGS.4and5) during delivery of the anchor700through and/or against the valve leaflet. Following delivery of the anchor700, the frame702of the anchor700may be configured to bend such that a pointed tip706of the frame702is redirected and/or extends towards the second point712and/or at least partially over the membrane704. In some instances, the frame702may be configured to bend such that an eyelet708at the first point711may be situated approximately over a central portion of the membrane704.

Redirecting the pointed tip706may cause a change of shape and/or form of the anchor700. For example, a diamond and/or oval anchor700may assume a heart-shaped and/or similar form, as shown inFIG.7. By extending the pointed tip706at least partially over the membrane704, risk of damage from the pointed tip706to the surrounding tissue may be reduced.

As the frame702bends to allow redirection of the first point711, the membrane704may be configured to bend, collapse, and/or fold in response to the movement of the frame702. At least some portions of the membrane704may be configured to overlap with each other and/or a coverage area of the membrane704may be decrease as a result of bending of the frame702.

FIG.8illustrates an example anchor800following delivery at one or more valve leaflets, in accordance with one or more instances. The anchor800may comprise a frame802at least partially enclosing a membrane804. In some instances, the frame802may comprise one or more points and/or anchors, which can include a first point811. The first point811may comprise an eyelet808. The eyelet808may be configured to receive one or more sutures configured to tether the anchor800to a second anchoring point within the point (e.g., a ventricle wall). For example, a suture may be configured to be knotted through the eyelet808to establish a secure attachment between the suture and the anchor800.

The anchor800may be configured to assume the form shown inFIG.8following delivery at a valve leaflet. For example, the anchor800may comprise a droplet form (see, e.g.,FIG.6) during delivery of the anchor800through and/or against the valve leaflet. Following delivery of the anchor800, the frame802of the anchor800may be configured to bend such that a first point811of the frame802is redirected and/or extends at least partially over the membrane804. In some instances, the frame802may be configured to bend such that an eyelet808at the first point811may be situated approximately over a central portion of the membrane804.

FIGS.9(9-1,9-2, and9-3) provides a flow diagram illustrating a process900for implanting a leaflet anchor in accordance with one or more examples.FIGS.10(10-1,10-2,10-3,10-4, and10-5) provide images of cardiac anatomy and certain devices/systems corresponding to operations of the process ofFIG.9in accordance with one or more examples.

The process900may be implemented when a minimally invasive approach is determined to be advisable. Although not shown specifically in the flow diagram ofFIG.9, the process900may initially involve making one or more incisions proximate to the thoracic cavity to provide a surgical field of access. The total number and length of the incisions to be made depend on the number and types of the instruments to be used as well as the procedure(s) to be performed. The incision(s) may advantageously be made in such a manner as to be minimally invasive. As referred to herein, the term “minimally invasive” means in a manner by which an interior organ or tissue may be accessed with relatively little damage being done to the anatomical structure through which entry is sought. For example, a minimally invasive procedure may involve accessing a body cavity by a small incision of, for example, approximately 5 cm or less made in the skin of the body. The incision may be vertical, horizontal, or slightly curved. If the incision is located along one or more ribs, it may advantageously follow the outline of the rib. The opening may advantageously extend deep enough to allow access to the thoracic cavity between the ribs or under the sternum and is preferably set close to the rib cage and/or diaphragm, dependent on the entry point chosen.

In one example method, the heart may be accessed through one or more openings made by one or more small incision in a portion of the body proximal to the thoracic cavity, such as between one or more of the ribs of the rib cage of a patient, proximate to the xyphoid appendage, or via the abdomen and diaphragm. Access to the thoracic cavity may be sought to allow the insertion and use of one or more thorascopic instruments, while access to the abdomen may be sought to allow the insertion and use of one or more laparoscopic instruments. Insertion of one or more visualizing instruments may then be followed by transdiaphragmatic access to the heart. Additionally, access to the heart may be gained by direct puncture (e.g., via an appropriately sized needle, for instance an 18-gauge needle) of the heart from the xyphoid region. Accordingly, the one or more incisions should be made in such a manner as to provide an appropriate surgical field and access site to the heart in the least invasive manner possible. Access may also be achieved using percutaneous methods, further reducing the invasiveness of the procedure. See, e.g., “Full-Spectrum Cardiac Surgery Through a Minimal Incision Mini-Sternotomy (Lower Half) Technique,” Doty et al.,Annals of Thoracic Surgery1998; 65(2): 573-7 and “Transxiphoid Approach Without Median Sternotomy for the Repair of Atrial Septal Defects,” Barbero-Marcial et al.,Annals of Thoracic Surgery1998; 65 (3): 771-4, the entire disclosures of each of which are incorporated herein by reference.

At block902, the process900involves contacting a target leaflet154with an end effector114of a delivery system, as shown in image1002ofFIG.10. Image1002shows the shaft110of the tissue anchor delivery system100positioned on the target valve leaflet154(e.g., mitral valve leaflet). For example, the target site of the valve leaflet154may be slowly approached from the ventricle side thereof by advancing the distal end of the shaft110along or near to the posterior wall of the ventricle3(e.g., left ventricle), without contacting the ventricle wall.

Once the tip114is positioned in the desired position, the distal end of the shaft110and the tip114may be used to drape, or “tent,” the leaflet154to better secure the tip114in the desired position, as shown in image1002. Draping/tenting may advantageously facilitate contact of the tip114with the leaflet154throughout one or more cardiac cycles, to thereby provide more secure or proper deployment of leaflet anchor(s). The target location may advantageously be located relatively close to the free edge of the target leaflet154to minimize the likelihood of undesirable intra-atrial wall deployment of the anchor. Navigation of the tip114to the desired location on the underside of the target valve leaflet154may be assisted using echo imaging, as described in detail herein. Echo imaging may be relied upon to confirm correct positioning of the tip114prior to anchor/knot deployment.

At block904, the process900involves puncturing the valve leaflet154using one or more anchors1001and/or catheters1026(including needles and/or other tipped delivery systems). For example, as shown in image1004a, a first anchor1001amay comprise a pointed tip1016at a first point1011of the first anchor1001a. The pointed tip1016may be configured to extend at least partially beyond the needle1026to contact and/or puncture a proximal surface of the valve leaflet154. The pointed tip1016of the first anchor1001amay advantageously allow for delivery of one or more anchors1001without requiring delivery systems comprising a needle tip. While only the first anchor1001ais shown comprising a pointed tip1016, a second anchor1001band/or any additional anchors1001may also comprise pointed tips1016for puncturing other areas of the valve leaflet154.

As shown in images1004aand1004b, the needle1026may be configured to carry multiple anchors1001in a stacked configuration to allow for deployment of multiple anchors1001via the needle1026. While the anchors1001are shown situated in an end-to-end manner, the anchors1001may be situated in any suitable manner within the needle1026. In some instances, one or more pushers and/or ratchet mechanisms may be used to deploy the anchors1001from the needle1026one at a time.

In some instances, the needle1026may comprise a needle tip1027, as shown in image1004b. The needle tip1027may be radiused and/or may extend over a midpoint and/or lumen of the needle1026such that the needle tip1027may be configured to puncture a portion of the valve leaflet154that is situated over a midpoint and/or lumen of the needle1026. Edges of the needle1026along the beveled and/or pointed end of the needle1026may be rounded and/or may be configured to cause dilation of the valve leaflet154rather than cutting of the valve leaflet154. For example, a width of the needle tip1027may increase from the pointed end to the length of the shaft110. Thus, as the needle1026is extended further into and/or through the leaflet154, the needle tip1027may gradually increase a width and/or size of a puncture opening through the leaflet154. In some instances, the beveled needle tip1027of the needle1026may be configured to deploy the one or more anchors1001at an angle1030(e.g., at an approximately 45-degree angle) from the inner lumen of the needle1026. By deploying the one or more anchors1001at an angle1030, each anchor1001may advantageously be deployed out of the way of any subsequent anchors1001. For example, the needle1026may be twisted to adjust a deployment position of the anchors. Where the needle1026comprises a needle tip1027, the one or more anchors1001may not comprise pointed tips1016.

Each of the one or more anchors1001may have one or more sutures1021attached to and/or extending from the anchor1001. In some instances, one or more anchors1001(e.g., the first anchor1001a) may comprise an eyelet configured to receive one or more sutures1021. For example, a first suture1021amay be configured to extend through an eyelet of the first anchor1001aand/or to form a knot1019at or near the eyelet to secure the first suture1021ato the first anchor1001a. For anchors1001that do not comprise an eyelet, one or more sutures1021may be configured to attach to a membrane of the anchors (see, e.g., the second suture1021battaching to the second anchor1001b). Each of the anchors1001may be coupled and/or tethered to a different suture1021. The sutures1021may each extend from the anchors1001through the lumen of the shaft and/or may be configured to be anchored to a pledget and/or otherwise at a tissue wall to provide tension to the anchors1001.

With the shaft110positioned against the target leaflet154, a plunger of the tissue anchor delivery device can be actuated to move the needle1026and a pusher disposed within the shaft110. As the plunger140is actuated, a distal piercing portion of the anchor1001and/or needle1026punctures the leaflet154and forms an opening in the leaflet. In some instances, the anchor1001and/or needle1026is projected a distance of between about 0.2-0.3 inches (e.g., between about 5-8 mm), or less, distally beyond the distal end of the shaft110(e.g., beyond the tip114). In some instances, the anchor1001and/or needle1026is projected a distance of between about 0.15-0.4 inches (e.g., between about 3-10 mm). In some instances, the anchor1001and/or needle1026is projected a distance of about 1 inch (e.g., about 2.5 cm), or greater. In some instances, the needle1026extends until the anchor1001and/or needle1026extend through the leaflet154. While the anchor1001and/or needle1026are projected into the atrial side of the leaflet154, the shaft110and tip114advantageously remain entirely on the ventricular side of the leaflet154.

As the pusher (not shown) within the tissue anchor delivery device shaft110is moved distally, a distal end of the pusher advantageously moves or pushes the first anchor1001aover the distal end of the needle1026and further within the atrium of the heart on a distal side of the leaflet154, such that the first anchor1001aextends distally beyond a distal end of the needle1026.

At block906, the process900involves deploying at least a first anchor1001abeyond a distal end of the needle1026, through the puncture opening of the valve leaflet154, and/or beyond a distal surface of the valve leaflet154, as shown in images1006aand1006bofFIG.10. In some instances, the anchors1001may be deployed one at a time and/or a single anchor1001may be deployed at each puncture site. Following deployment of the first anchor1001abeyond the distal surface of the valve leaflet154, the needle1026may be moved to allow for deployment of the second anchor1001bat a different portion of the valve leaflet154.

In some instances, the first anchor1001aand/or second anchor1001bmay be configured to assume a compressed form while within the lumen of the needle1026and/or shaft110. For example, the walls of the needle1026may press against the sides of the first anchor1001aand/or second anchor1001b. The first anchor1001aand/or second anchor1001bmay be configured to compress laterally and/or extend longitudinally (e.g., along the needle1026) in response to pressure from the walls of the needle1026. Following removal from the lumen of the needle1026, the first anchor1001aand/or second anchor1001bmay be configured to assume an expanded in form, in which the first anchor1001aand/or second anchor1001bmay expand laterally and/or compress longitudinally. The first anchor1001aand the second anchor1001bmay be configured to be situated end-to-end longitudinally within the needle1026.

At block908, the process900involves positioning the first anchor1001aon the valve leaflet154, as shown in image1008ofFIG.10. Following removal of the first anchor1001afrom the needle1026, the first anchor1001amay be configured to twist and/or to be twisted such the first anchor1001aextend generally perpendicularly from the delivery needle1026and/or along a surface of the valve leaflet154. For example, the first anchor1001amay be twisted such that the membrane1014of the first anchor1001aextends along and/or contacts the distal surface of the valve leaflet154. The first anchor1001amay be configured to cover a generally diamond-shaped and/or other shaped portion of the valve leaflet154. The membrane1014may be configured to at least partially cover the puncture1032and/or puncture opening through the valve leaflet154. The first suture1021amay extend through the puncture1032while the first anchor1001aremains situated at the distal surface of the valve leaflet154.

At block910, the process900involves redirecting a first point1011and/or pointed tip1016of the first anchor1001ato prevent damage to the valve leaflet154, as shown in image1010ofFIG.10. The first point1011and/or pointed tip1016may be redirected toward a second point1022of the frame1012and/or at least partially along the membrane1014. Following redirection of the first point1011and/or pointed tip1016, the pointed tip1016and/or eyelet may be situated at least partially over the puncture1032and/or membrane1014.

Steps of the process900may be repeated for other anchors1001delivered via the shaft110. For example, as the first anchor1001ais deployed beyond the distal end of the shaft110, the second anchor1001bmay take the place of the first anchor1001aand/or may be pushed toward the distal end of the shaft110. Following deployment of the first anchor1001a, the shaft110and/or needle1026may be repositioned and/or placed below a different portion of the leaflet154. The needle1026and/or second anchor1001bmay then be used to create a second puncture opening in the leaflet154. The second anchor1001bmay be extended beyond the distal end of the needle1026and/or may otherwise be deployed at a distal side of the leaflet154. The second anchor1001bmay be adjusted such that a membrane of the second anchor1001bat least partially covers the second puncture opening. In some instances, the second anchor1001bmay be at least partially flexible to allow adjusting the second anchor1001bsuch that at least a first point of the second anchor1001bextends at least partially along the membrane of the second anchor1001band/or at least partially over the second puncture opening.

FIG.11illustrates an example delivery system for delivering the one or more anchors described herein, in accordance with one or more instances. In some instances, a shaft1106and/or catheter1115may comprise one or more receptors1113and/or suture channels configured to receive one or more sutures extending from one or more anchors. For example, one or more anchors may be configured to be carried and/or deployed via the shaft1106and/or catheter1115. Sutures attached to the anchors may be configured to each extend into one of multiple receptors1113of the delivery system to prevent tangling of the sutures. While three receptors1113are shown inFIG.11, the delivery systems may comprise any number of receptors1113. The delivery systems may also comprise an atraumatic tip for facilitating delivery of the one or more anchors and/or sutures.

In some implementations, echo imaging, such as involving TEE (two-dimensional (2D) and/or three-dimensional (3D)), transthoracic echocardiography (TTE), ICE, and/or cardio-optic direct visualization (e.g., via infrared vision from the tip of a 7.5 F catheter), or other imaging modality, may be performed to assess the heart, heart valves, and/or tissue anchor delivery device component(s) in connection with any of the steps of the processes described herein. For example, echo imaging can be used to guide positioning of tissue anchor(s) onto a target valve leaflet. Although the procedures described herein are with reference to repairing a cardiac mitral valve or tricuspid valve by the implantation of one or more leaflet anchors and associated cord(s), the methods presented are readily adaptable for various types of tissue, leaflet, and annular repair procedures. The methods described herein, for example, can be performed to selectively approximate two or more portions of tissue to limit a gap between the portions. That is, in general, the methods herein are described with reference to a mitral valve but should not be understood to be limited to procedures involving the mitral valve.

ADDITIONAL EXAMPLES

Depending on the instance, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain examples, not all described acts or events are necessary for the practice of the processes.

Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain examples include, while other examples do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular instance. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require at least one of X, at least one of Y and at least one of Z to each be present.

It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.

Unless otherwise expressly stated, comparative and/or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”