Heart valve leaflet anchoring

Abstract

Tissue anchor delivery systems include a shaft, a tissue anchor disposed within the shaft, a sensor configured to detect contact of biological tissue with the distal portion of the shaft, and a trigger release configured to cause deployment of the tissue anchor from the shaft in response to tissue contact detected by the sensor. Deploying a tissue anchor can involve deploying a plurality of secondary tissue anchors into tissue of the target leaflet around a target site, and while holding the target leaflet with the plurality of secondary tissue anchors, deploying the primary tissue anchor through the target site on the leaflet. Further disclosed are tissue anchors including a distal tip portion having a sharp puncture edge and a plurality of teeth projecting from one or more sides of the tissue anchor, the plurality of teeth being arranged in a plurality of axially-offset rows.

Description

HEART VALVE LEAFLET ANCHORINGCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 594,394, filed on October 30, 2023, the entire disclosure which is incorporated by reference for all purposes.BACKGROUND

[0002] Various medical procedures can involve anchoring into / onto a native heart valve leaflet of a patient’s heart. Due to certain pressure, fluid-dynamic, and / or structural / mechanical factors, anchoring to a heart valve leaflet can present certain challenges.SUMMARY

[0003] Described herein are systems, device, and methods that facilitate the anchoring of a tissue anchor or similar device or structure to a heart valve leaflet, such as a leaflet of an atrioventricular heart valve. Some implementations disclosed herein can facilitate leaflet anchoring without the need for sub-leaflet support to provide a counterforce against the puncture / anchoring. For example, implementations of the present disclosure can facilitate leaflet anchoring through sensor- and / or timing -based tissue anchor deployment that correlates with a phase / segment of the cardiac cycle during which the target leaflet portion is in a desired position / contact relative to the anchor delivery system / device. For example, sensor(s) can be implemented to determine when a valve leaflet is pressed / forced into contact with the delivery system / device, wherein anchor deployment is executed at such time to leverage the blood-pressure-based counterforce pressing the leaflet against the delivery system / device to proUde the necessary and / or desirable resistance for leaflet puncture.

[0004] In some implementations of leaflet-anchoring solutions presented herein include the use of leaflet-gripping barbs / spikes for securely holding and / or tightening the target leaflet portion for deployment of a potentially larger tissue anchor into / through the leaflet. Such barbs / spikes can be configured to pull / stretch the leaflet tissue radially outwardly to increase the tautness of the leaflet tissue to facilitate puncture therethrough.

[0005] In some implementations of leaflet-anchoring solutions presented herein include the use of ratcheted tissue anchors configured to permit linear advancement and puncture through the target leaflet, while opposing / resisting removal / withdraw al back out of the target tissue. Such tissue anchors can include linearly- / axially-offset teeth that allow' for incremental and / or iterative embedding / catching of the anchor teeth in the target tissue. As the pressure and contact conditions cyclically force the target leaflet in the direction of thetissue anchor, the anchor can become incrementally further embedded in the tissue w ith subsequent cardiac cycles.

[0006] In some implementations, the present disclosure relates to a tissue anchor delivery system comprising an elongate shaft, a tissue anchor disposed within a distal portion of the elongate shaft, a sensor configured to detect contact of biological tissue with the distal portion of the elongate shaft, and a trigger release configured to cause deployment of the tissue anchor from the distal portion of the elongate shaft in response to tissue contact detected by the sensor.

[0007] In some implementations, the tissue anchor is spring-loaded within the distal portion of the elongate shaft. The trigger release can be configured to actuate a catch feature configured to hold the tissue anchor in a spring-loaded configuration.

[0008] In some implementations, the tissue anchor comprises a distal puncturing tip. In some implementations, the sensor is configured to, in response to the tissue contact, generate an electrical current that indicates the tissue contact. In some implementations, the sensor is a pressure sensor. In some implementations, the sensor comprises one or more optical fibers that run a length of the elongate shaft. In some implementations, the tissue anchor delivery' system further comprises a handle including a manually-engageable input configured to enable the trigger release.

[0009] In some implementations, the present disclosure relates to a method of deploying a tissue anchor. The method comprises advancing a distal portion of an elongate shaft of a delivery system to an atrium of a heart of a patient using a vascular access path, determining a temporal moment associated w ith contact between the distal portion of the elongate shaft and a target leaflet of an atrioventricular valve associated with the atrium, and causing a tissue anchor to be deployed from the distal portion of the elongate shaft at the temporal moment.

[0010] In some implementations, determining the temporal moment comprises detecting the contact between the distal portion of the elongate shaft and the target leaflet, and the temporal moment is a moment when the contact is detected. Detecting the contact can be performed using a sensor disposed at least partially at the distal portion of the elongate shaft.

[0011] In some implementations, the sensor is an electrical sensor. In some implementations, the sensor is a fiber optic sensor. In some implementations, the method further comprises determining one or more parameters associated with a cardiac cycle of the heart of the patient, wherein determining the temporal moment is based on the one or more parameters.

[0012] In some implementations, the method further comprises determining a blood pressure waveform associated with the patient and identifying a portion of the blood pressure waveform that is associated with a ventricular pressure peak, wherein the temporal moment corresponds to the identified portion of the blood pressure waveform.

[0013] In some implementations, the method further comprises determining a pulse of the patient using a pulse oximeter, wherein said determining the temporal moment is based on the pulse. In some implementations, causing the tissue anchor to be deployed comprises ejecting the tissue anchor from a distal opening of the delivery system using a spring. In some implementations, causing the tissue anchor to be deployed comprises actuating a catch arm to disengage from the tissue anchor.

[0014] In some implementations, the method further comprises receiving a signal from a sphygmomanometer indicating a peripheral blood pressure waveform of the patient, and determining the temporal moment as a moment in time that leads a peak of the peripheral blood pressure waveform.

[0015] In some implementations, the method further comprises receiving echocardiogram data representing the heart of the patient, and determining the temporal moment as a moment in time associated with a visual image represented by the echocardiogram data showing the target leaflet at an elevated position.

[0016] In some implementations, the method further comprises receiving ultrasound data representing the heart of the patient and determining the temporal moment as a moment in time associated with a visual image represented by the ultrasound data showing the target leaflet at an elevated position.

[0017] In some implementations, the present disclosure relates to a tissue anchor delivery system comprising an elongate shaft, a tissue anchor disposed within a distal portion of the elongate shaft, a trigger release configured to cause deployment of the tissue anchor from the distal portion of the elongate shaft, and control circuitry configured to actuate the trigger release in synchronization with a high ventricular pressure condition.

[0018] In some implementations, the control circuitry is configured to actuate the trigger release based on a sensor signal from a tissue contact sensor associated with the elongate shaft. The control circuitry can be configured to actuate the trigger release based on at least one of ultrasound data, echocardiogram data, electrocardiogram data, or pressure sensor data.

[0019] In some implementations, the present disclosure relates to a tissue anchor delivery system comprising an elongate shaft, a tissue anchor disposed within a distal portion of the elongate shaft, and a plurality of spikes positioned around the tissue anchor.

[0020] In some implementations, the tissue anchor is disposed in central lumen of elongate shaft. In some implementations, the plurality of spikes are disposed in separate lumens positioned around the central lumen. In some implementations, the separate lumens are formed in a wall of the elongate shaft.

[0021] In some implementations, the plurality of spikes are configured to project distally from the elongate shaft. The plurality of spikes can comprise elongated wires disposed at least partially within the elongate shaft. In some implementations, the plurality of spikes are configured to be deflected radially outwardly relative to an axis of elongate shaft when the plurality of spikes are projected from a distal end of the elongate shaft.

[0022] In some implementations, the plurality of spikes consists of three spikes arrange in a triangle around the tissue anchor. In some implementations, the plurality of spikes comprises four or more spikes arranged in a ring around the tissue anchor.

[0023] In some implementations, the present disclosure relates to a method of deploying a tissue anchor in a heart valve leaflet. The method comprises advancing a distal portion of an elongate shaft of a delivery system to an atrium of a heart of a patient using a vascular access path, the delivery system comprising a primaiy tissue anchor and a plurality of secondary tissue anchors associated with the distal portion of the elongate shaft, approximating the distal portion of the elongate shaft to a target leaflet of an atrioventricular heart valve of the atrium, deploying the plurality of secondaiy tissue anchors into tissue of the target leaflet around a target site on the target leaflet, and while holding the target leaflet with the plurality of secondary tissue anchors, deploying the primary tissue anchor through the target site on the target leaflet.

[0024] In some implementations, the method further comprises retrieving the plurality of secondary’ tissue anchors from the target leaflet while maintaining the primary tissue anchor implanted in the target leaflet.

[0025] In some implementations, the method further comprises, prior to said deploying the primary tissue anchor, tightening the target leaflet in an area of the target site using the plurality of secondary tissue anchors. Tightening the target leaflet can involve deflecting distal ends of the plurality of secondaiy tissue anchors radially outward.

[0026] In some implementations, the present disclosure relates to a tissue anchor comprising a distal tip portion having a sharp puncture edge and a plurality of teeth projecting from one or more sides of the tissue anchor, the plurality of teeth being arranged in a plurality of axially-offset rows.

[0027] In some implementations, the plurality of teeth are angled in a proximal direction. In some implementations, the plurality of teeth comprise an inclined, distally- facing surface and a proximally-facing edge.

[0028] In some implementations, the tissue anchor has a form of a hollow tube with an axial channel running therethrough. In some implementations, the plurality of teeth comprise tabs formed in the hollow tube, and the tabs are coupled to the hollow tube at a base portion thereof w ith free edges thereof deflected radially away from a wall of the hollow tube. Radial deflection of the plurality of tabs can provide openings into the axial channel of the hollow tube.

[0029] In some implementations, the hollow tube includes one or more pairs of opposite-facing apertures. Apertures of the one or more pairs of apertures can be circumferentially offset by 90° from the plurality of teeth. In some implementations, the one or more pairs of apertures comprises a first pair of apertures disposed in a center portion of a length of the tissue anchor. In some implementations, the one or more pairs of apertures further comprises a second pair of apertures disposed in a proximal quartile of the length of the tissue anchor.

[0030] In some implementations, the distal tip portion comprises a pointed tip, a tapered opening extending from the pointed tip to a base of the distal tip portion, and an axially- parallel sidewall extending proximally from the pointed tip to the base of the distal tip portion. The tissue anchor can further comprise a proximal tubular body portion that joins the distal tip portion at the base of the distal tip portion. In some implementations, the plurality of teeth comprises one or more teeth associated with the axially-parallel sidewall of the distal tip portion, and one or more pairs of teeth associated with the proximal tubular body portion.

[0031] In some implementations, each of the one or more pairs of teeth associated w ith the proximal tubular body includes a first tooth on a first circumferential side of the proximal tubular body portion and a second tooth on a second circumferential side of the proximal tubular body portion.

[0032] In some implementations, the present disclosure relates to a method of deploying a tissue anchor in a heart valve leaflet. The method comprises advancing a distal portion of an elongate shaft of a delivery system to an atrium of a heart of a patient using a vascular access path, the delivery system comprising the tissue anchor disposed in the distal portion of the elongate shaft, contacting a distal tip of the tissue anchor to a target leaflet of an atrioventricular heart valve associated with the atrium, during a first cycling of the heart, causing the tissue anchor to advance through the target leaflet such that a first row of one ormore radially-projecting teeth of the tissue anchor passes through the target leaflet, and during a second cycling of the heart, causing the tissue anchor to advance through the target leaflet such that a second row of one or more radially-projecting teeth of the tissue anchor passes through the target leaflet, the second row of one or more radially-projecting teeth being positioned proximal of the first row of one or more radially-projecting teeth.

[0033] In some implementations, the method further comprises causing the tissue anchor to advance entirely through the target leaflet and causing the tissue anchor to rotate to a parallel orientation with respect to the target leaflet on a ventricular side of the target leaflet. In some implementations, the tissue anchor comprises one or more transverse apertures configured to have one or more sutures passed therethrough. In some implementations, causing the tissue anchor to rotate comprises applying tension to a suture coupled to an aperture of the one or more transverse apertures. In some implementations, the method further comprises coupling a suture that is coupled to the tissue anchor to another heart valve leaflet and applying tension to the suture to perform an edge-to-edge procedure.

[0034] In some implementations, the method further comprises proximally withdrawing the tissue anchor by proximally pulling a suture coupled to a proximal end portion of the tissue anchor. The suture can be coupled to the proximal end portion of the tissue anchor via one or more transverse apertures.

[0035] In some implementations, the tissue anchor has a hollow tubular form including one or more apertures through which one or more sutures are passed.

[0036] In some implementations, the method further comprises, during a third cycling of the heart, causing the tissue anchor to advance through the target leaflet such that a third row of one or more radially-projecting teeth of the tissue anchor passes through the target leaflet, the third row of one or more radially-projecting teeth being disposed proximally of the second row of one or more radially-projecting teeth. For example, the third row of teeth can comprise first and second axially-aligned teeth disposed on opposite circumferential sides of the tissue anchor.

[0037] In some implementations, the present disclosure relates to a tissue anchor delivery system comprising a tissue anchor disposed within a distal portion of an elongate shaft, a sensor configured to detect contact of biological tissue with the distal portion of the elongate shaft, and a trigger release configured to cause deployment of the tissue anchor from the distal portion of the elongate shaft in response to tissue contact detected by the sensor.

[0038] For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular implementation. Thus, the disclosed implementations may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein w ithout necessarily achieving other advantages as may be taught or suggested herein.

[0039] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0040] Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Some implementations are depicted in the accompanying raw ings for illustrative purposes and should in no w ay be interpreted as limiting the scope of the disclosure. In addition, features of different disclosed implementations can be combined to form additional implementations, w hich are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.

[0042] Figure 1 shows cardiac anatomy, including heart valve leaflets, in accordance with one or more implementations.

[0043] Figures 2A and 2B provide a flow7diagram illustrating a process for implementing contact-triggered tissue anchor deployment in accordance with one or more examples.

[0044] Figures 3A, 3B, and 3C provide images of anatomy and devices / components associated with operations of the process of Figures 2A and 2B in accordance wdth one or more implementations.

[0045] Figure 4 is a block diagram of a tissue anchor deployment / delivery system in accordance with one or more implementations.

[0046] Figure 5 is a graph showing cardiac pressure and electrical signals in accordance with one or more implementations.

[0047] Figure 6 is a flow diagram illustrating a process for deploying a tissue anchor using peripheral tissue capturing in accordance with one or more implementations.

[0048] Figures 7A, 7B, and 7C provide images of anatomy and devices / components associated with operations of the process of Figure 6 in accordance with one or more implementations.

[0049] Figures 8A, 8B, and 8C show side and perspective views, respectively, of a ratcheted tissue anchor in accordance with one or more implementations.

[0050] Figures 9A and 9B provide a flow diagram illustrating a process for deploying a ratcheted tissue anchor in accordance with one or more implementations.

[0051] Figures 10A, 10B, 10C, 10D, and 10E provide images of anatomy and devices / components associated with operations of the process of Figures 9A and 9B in accordance with one or more implementations.DETAILED DESCRIPTION

[0052] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claims.

[0053] Although some preferred implementations and examples are disclosed below-, inventive subject matter extends beyond the specifically disclosed implementations to other implementations 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 implementations 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. Some operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding some implementations; 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 some implementations, certain aspects and advantages of these implementations are described. Not necessarily all such aspects or advantages are achieved by any particular implementation. Thus, for example, some implementations 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.

[0054] 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, -withrespect to any of the implementations 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 ordinary7skill in the art may be informed by context with respect to the degree to which usage of common reference numbers can imply7similarity betw een 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.

[0055] Certain standard anatomical terms of location are used herein to refer to the anatomy7of animals, and namely humans, with respect to the preferred implementations. Although certain spatially relative terms, such as “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 betw een element(s) / structures(s), as illustrated in the drawings. It should be understood that spatially7relative 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 may7represent 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.

[0056] The present disclosure relates to tissue anchor deployment in heart valve leaflets and other biological or non-biological tissues / materials. Such tissue anchors may, depending on the particular implementation, be coupled to anchoring / tethering lines / sutures, which may facilitate tissue and anchor manipulation, pulling, tethering, etc. The terms “line” and “suture” are used herein according to its broad and ordinary meaning and may refer to any elongate suture, wire, tether, cord, strip, strand, rope, filament, tie, string, ribbon, strap, or portion thereof, or other type / form of material used in medical procedures to tension, tether, cinch, secure, align, tie, hold, or otherwise control / manipulate implant devices or components (e.g., tissue anchors). Furthermore, in some contexts herein, the terms “tether,” “wire,” “suture,” and “line” may be used substantially7interchangeably. In addition, use of the singular form of any7of the line-related terms listed above, including the terms “tether” and “suture,” may be used to refer to a single line / cord, or to a portion thereof.

[0057] In some aspects, the present disclosure relates to systems, devices, and methods for deploying tissue anchors that have certain pointed, tissue-puncturing features associated therewith, such as barbs, spikes, tips, hooks, arrows, or the like. The term “associated with” is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as being “associated with” a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

[0058] The techniques, methods, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0059] Any of the systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0060] Some implementations are disclosed herein in the context of cardiac tissue anchoring. However, although some principles disclosed herein are particularly applicable to the anatomy of the heart, it should be understood that tissue-anchors in accordance with aspects of the present disclosure may be implanted / deployed in, or configured for implantation / deployment in, any suitable or desirable anatomy.Valvular Heart Disease and Heart Valve Reshaping / Remodeling

[0061] The anatomy of the heart is described below to assist in the understanding of some inventive concepts disclosed herein. In humans and other vertebrate animals, the heart generally comprises a muscular organ having four pumping chambers, wherein the blood flow’ therein 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 andclose in response to pressure gradients present during various stages of the cardiac cycle (e.g., relaxation and contraction) to control the flow of blood to respective regions of the heart and / or to blood vessels {e.g., pulmonary, aorta, etc.). The contraction of the various heart muscles may be prompted by signals generated by the electrical system of the heart.

[0062] Figure 1 illustrates an example representation of a heart 1 and associated anatomy having various features relevant to some implementations of the present inventive disclosure. Generally, the heart 1 includes four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. A wall of muscle 17, referred to as the septum, separates the left 2 and right 5 atria and the left 3 and right 4 ventricles.

[0063] In terms of blood flow, blood generally flows from the right ventricle 4 into the pulmonary artery 11 via the pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during ventricular contraction e.g., systole) so that blood may be pumped toward the lungs and close during ventricular expansion {e.g., diastole)to prevent blood from leaking back into the heart from the pulmonary artery. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs.

[0064] In addition to the pulmonary' valve 9, the heart 1 further includes the tricuspid valve 8, the aortic valve 7, and the mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps / leaflets 28 and generally closes during systole and opens during diastole. The mitral valve 6 generally has two cusps / leaflets 26 and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole so that blood in the left atrium 2 can flow into the left ventricle 3, and, when functioning properly, closes during systole to prevent blood from leaking back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood leaving the left ventricle 3 to enter the aorta 12, and close during diastole to prevent blood from leaking back into the left ventricle 3.

[0065] The heart valves may generally have associated therew ith a relatively dense fibrous / collagenous ring-type structure, referred to herein as the valve annulus, as well as a plurality of leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that when the heart contracts the resulting increased blood pressure produced within the corresponding heart chamber forces the leaflets at least partially open to allow flow from the heart chamber. As the pressure in the heart chamber subsides, the pressure in the subsequent chamber or blood vessel may become dominant and press back against the leaflets. As a result, the leaflets / cusps come in apposition to each other, thereby closing the flow’ passage.[oo66] With respect to heart valves and associated interventions (e.g., leaflet anchoring / manipulation in connection with Alfieri procedures, annuloplasty procedures, etc.), particular reference is made herein to the atrioventricular heart valves, namely the tricuspid 8 and mitral 6 valves. However, it should be understood that any description herein of anatomy and / or devices or procedures associated with the atrioventricular heart valve(s) can apply to the other valves of the heart (e.g., pulmonary’, aortic); references to the tricuspid and / or mitral valve(s) specifically are for conveniences and / or due to particular relevance thereof.

[0067] The atrioventricular (e.g., mitral 6 and tricuspid 8) heart valves may have associated therewith a collection of chordae tendineae 13 and papillary’ muscles 10 for securing the leaflets of the respective valves to promote and / or facilitate proper coaptation of the valve leaflets and prevent prolapse thereof.

[0068] The mitral valve 6 includes a valve annulus 14 that attaches the mitral leaflets 26 and the left atrium 2 to the ostium of the left ventricle 3 and the aortic root. The leaflets 26 of the mitral valve 6 generally include an anterior leaflet 26a and a posterior leaflet 26p. Under normal conditions, the mitral valve 6 undergoes significant dynamic changes in shape and size throughout the cardiac cycle. These changes are primarily due to the dynamic motion of the surrounding mitral valve annulus 14. Throughout the cardiac cycle, the annulus 14 generally undergoes a sphincter motion, narrowing down the orifice area during systole to facilitate coaptation of the leaflets 26 and widening during diastole to allow for relatively easy diastolic filling of the left ventricle 3. This motion can be further enhanced by a pronounced three-dimensional configuration during systole, which may embody a characteristic saddle shape. The shape and form of the annulus 14 throughout the cardiac cycle can affect proper leaflet coaptation and / or tissue stresses. Disfunction of a heart valve and / or associated leaflets (e.g., pulmonary valve disfunction) can result in valve leakage and / or other health complications.

[0069] With respect to the tricuspid valve 8, the normal tricuspid valve comprises three leaflets 28 and three corresponding papillary muscles 10. The leaflets 28 of the tricuspid valve 8 may be referred to as the anterior 28a, posterior 28p, and septal 28s leaflets, respectively. Although tricuspid valves are described herein as comprising three leaflets, it should be understood that tricuspid valves may occur with two or four leaflets in certain patients and / or conditions; the principles relating to leaflet anchoring and remodeling disclosed herein are applicable to atrioventricular valves having any number of leaflets associated therewith.

[0070] The papillary muscles 10 generally comprise finger-like projections from the ventricle walls. The right ventricular papillary muscles to originate in the right ventricle walland attach to the anterior 28a, posterior 28 , and septal 28s leaflets of the tricuspid valve 8, respectively, via the chordae tendineae 13. The papillary muscles 10 of the right ventricle 4 may have variable anatomy; the anterior papillary may generally be the most prominent of the papillary muscles. The papillaiy muscles 10 may serve to secure the leaflets of the tricuspid valve 8 to prevent prolapsing of the leaflets into the right atrium 5 during ventricular systole. Tricuspid regurgitation can be the result of papillary dysfunction or chordae rupture.

[0071] Various problems can disrupt blood flow through the valves of the heart. For example, regurgitation, which is also referred to as valve insufficiency or incompetence, occurs when a valve does not close properly and allows blood to leak backward instead of moving in the proper one-way flow. Regurgitation can cause a decrease in the amount of blood that ultimately travels to the body’s organs. In order to compensate for regurgitation, the heart may work harder, which in time can cause enlargement / dilation of the heart and reduced cardiac output. In some cases, ischemic heart disease can cause valvular regurgitation. For example, mitral regurgitation can be caused by the combination of ischemic dysfunction of the papillary muscles and left ventricular dilation that can present in ischemic heart disease, with the subsequent displacement of the papillary muscles and the dilatation of the mitral valve annulus. Valve problems can be present at birth or caused by infections, heart attacks, or heart disease or damage. Tricuspid regurgitation can present independently or as secondary to left -sided cardiac disease and may result from and / or in correlation with tricuspid annular dilation. Tricuspid regurgitation can present with fatigue, dyspnea, lower extremity edema, abdominal distension, and / or early satiety.Heart Valve Leaflet Anchoring

[0072] Some methods for restoring function to a regurgitant or otherwise dysfunctional valve (e.g., mitral or tricuspid valve) include open-heart, on-pump repair, and / or minimally invasive procedures. For example, in some cases, such as where heart valve regurgitation is a result of abnormal valve morphology, remodeling of the heart valve leaflets and / or annulus can produce positive results in patient health. Some heart valve diseases / dysfunction can be treated through the implementation of an annuloplasty treatment, which can help a deformed valve annulus to regain the physiological form and function of a normal, healthy valve apparatus. For example, annuloplasty treatments can involve the implantation of a prosthetic annuloplasty device (e.g., ring-shaped device, or “annuloplasty ring”), which may be anchored to the native annulus, atrial wall, and / or valve leaflet(s). Annuloplasty treatments can serve to restore / remodel the annular dimensions of a heart valve annulus, w hich can promote proper leaflet coaptation and / or provide a broader surface of coaptation.

[0073] In some cases, heart valve dysfunction can be treated through direct remodeling of the heart valve leaflets. For example, some methods involve edge-to-edge repair techniques (e.g., an Alfieri stitch) to create a permanent area of coaptation between two or more leaflets. Edge-to-edge stitching / clipping of mitral leaflets, for example, can form a double orifice; similar orifice reconfiguration can be produced by tricuspid edge-to-edge stitching / clipping. Annulus and leaflet remodeling can be implemented at least in part through anchoring to heart valve leaflets, using tissue anchor devices, and manipulating such anchors and / or anchored tissue to produce the desired leaflet and / or annulus remodeling. Implementations of the present disclosure provide solutions for deploying tissue anchors in target heart valve leaflets for such purposes.

[0074] In some implementations, leaflet anchoring solutions in accordance with the present disclosure can be implemented using transcatheter and / or other minimally invasive access and / or devices / systems, which may advantageously be associated w ith reduced risk to patient health and / or simplified procedural complexity. For example, open-heart and on- pump heart valve repair procedures can require arresting the patient’s heart and maintaining life support with a heart-lung machine, which can present risks to patient health. Moreover, in some cases, operating surgeons perform such procedures rarely (e.g., a few times per year) and may lack the necessary experience to become proficient in valve repair, which may lead to poor outcomes. Transcatheter leaflet-anchor deployment in accordance w ith aspects of the present disclosure can be performed on a beating heart through a percutaneous, vascular access to the chamber(s) of the heart.

[0075] Figure 1 shows catheters 111 that may be used to implant tissue anchors for heart valve repair / treatment in accordance with aspects of the present disclosure. The catheters 111 can advantageously be steerable and relatively small in cross-sectional profile to allow for traversal of the various blood vessels and chambers through which they may be advanced en route to, for example, the right atrium 5, left atrium 2, or other anatomy or chamber. Catheter access to the right atrium 5, coronary or left atrium 2 in accordance with certain transcatheter solutions may be made via the inferior vena cava 16 (as shown by the catheter 111a) or the superior vena cava 19 (as shown by the catheter 111b). Further access to the left atrium may involve crossing the atrial septum (e.g., in the area at or near the fossa ovalis).

[0076] In some implementations, the catheter(s) 111 can include a steerable guide catheter, as well as a flexible tube configured to be advanced through the guide catheter in order to facilitate delivery of a leaflet tissue anchor therefrom. During the delivery, at least a portion of a steerable distal end / portion of such flexible tube can be deployed from the distal end of the guide catheter for advancement to the target valve (e.g., mitral valve 6, tricuspid valve 8). In some implementations, the steerable distal end portion of the catheter 111 can besteered such that it is positioned in a desired spatial orientation within the target atrium. The steering of the catheter in can be performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and / or echocardiography.

[0077] In some implementations, access to the right atrium 5 may be made using any suitable or desirable access path, such as through the femoral vein and / or through arterial access. It should be understood that any suitable point of origin may be utilized with implementations of this disclosure. For instance, access may be made by introduction into the femoral vein of the patient, through the inferior vena cava 19, into the right atrium 5, and possibly further into the left atrium 2 trans-septally (e.p., through the fossa ovalis). In some implementations, access may be made through the basilic vein, the subclavian vein, the superior vena cava 16, and into the right atrium 5. In some implementations, access may be made via the jugular vein, the subclavian vein, the superior vena cava 16, and into the right atrium 5 and / or the left atrium 2.

[0078] In some implementations, a guidewire may be advanced to the target position within the left or right atrium through the selected access path. For instance, the delivery catheter 111 can be advanced over the guidewire into the target atrium. The delivery catheter 111 can be placed over the portion of the target leaflet to provide a suitable attack position for deployment of a leaflet tissue anchor as described herein. In some implementations, verification of the anchoring location can be obtained using imaging.

[0079] With respect to atrioventricular valve leaflet anchoring, anchor deployment from the atrial side of the target leaflet can be preferable to deployment from the ventricular side in some cases. For example, as shown in Figure 1, access to the right atrium can be relatively direct through venous access. In addition, the sub-valvular apparatus within the ventricle presents potentially challenging anatomy to navigate around without entanglement or damaging the local anatomy. Therefore, implementations of the present disclosure can be beneficial as providing solutions for heart valve leaflet anchoring from the atrial side of a target leaflet.

[0080] Driving a tissue anchor through a leaflet of the tricuspid or mitral valve from the atrial side of the target leaflet can be challenging in the absence of a counterforce from the ventricle side, as described above. For example, some leaflet anchoring solutions can involve catching the target leaflet from the ventricular side to apply a counterforce thereto against which puncturing or other anchoring force may be exerted from the atrial side of the valve / leaflet. Providing such ventricular counterforce can require the use of a delivery tool or component to be placed against the ventricular side of the target leaflet to provide the desired force, thereby requiring positioning / access from within the ventricle. However, implementing a ventricular approach / access when deploying leaflet anchors can addundesirable complexity to the relevant procedure and / or increase the risks of anatomical damage / injury associated therewith.

[0081] Leaflet tissue anchoring solutions of the present disclosure can be used in connection w ith any type of valve-remodeling procedure. For example, leaflet anchoring can be implemented to perform an edge-to-edge Alfieri procedure, wherein leaflet anchoring can be used to capture the leaflets and bind them together in some manner along the line of coaptation. In some implementations, leaflet puncturing / anchoring in accordance with aspects of the present disclosure can be used with double-sided, sandwich anchors, grommet-type anchors, harpoon-type anchors, or other types of anchors. In some implementations, tissue anchors in accordance with the present disclosure can be used to hold / secure a valve spacer device, which may be placed in a target valve orifice to improve valve closure. Leaflet anchoring as disclosed herein can be implemented to implant anchors in the area of the target valve annulus, wherein tensioning of coupling line(s) between tissue anchors can remodel the annulus to improve valve function.

[0082] With further reference to Figure 1, the mitral valve 6 typically is a bi-leaflet valve with chordae tendineae connecting the leaflets to two ventricular papillary muscles 10. With respect to the leaflets 26 of the mitral valve 6, the anterior 26a and posterior 26b leaflets are divided by two commissure structures / areas. In some implementations, the posterior leaflet 26p can further be considered to be divided into Pi, P2, and P3 scallop regions by clefts in the leaflet 26p. Any of such scallop regions can be used as a target tissue anchoring site in connection with examples disclosed herein. In some implementations, the anterior leaflet 26a can be considered to be subdivided into At, A2, and A3 regions that oppose the scallops Pt, P2, and P3, respectively, of the posterior leaflet 26p. Any of the Al, A2, or A3 regions can be used as a target tissue anchoring site in connection with examples disclosed herein.

[0083] The tricuspid valve 8 has an asymmetrical annulus 15 in the shape of a saddle- shaped ellipsoid that is dynamic in nature, allowing it to change with varying loading conditions. The leaflets 28 are usually semicircular or triangular in shape and are attached basally to the fibrous annulus 15. Typically, the distal quarter to third of the leaflets 28 is coupled to chordae tendineae; these regions can serve as tissue anchoring targets in connection with procedures and devices disclosed herein. The anterior (or superior) leaflet 28a is usually the largest and most mobile, abutting the outflow of the right ventricle 4. The posterior 28p and septal 28s leaflets are generally more variable in size and mobility, with the septal leaflet 28s typically being the least mobile. Any of the leaflets 28, or areas thereof, may serve as tissue anchor targets in connection with implementations disclosed herein.Contact-Triggered / Synchronized Tissue Anchor Deployment

[0084] In some implementations, the present disclosure provides a contact-triggered driver mechanism configured to sense and / or determine when a target leaflet, or portion thereof, is pressed against the distal end of a tissue anchor delivery system and / or an associated driver, wherein the anchor driver is configured to responsively deploy / drive the tissue anchor through the target leaflet when triggered by leaflet detected or determined contact. As described in detail herein, ventricular pressure during systole can exert force on the ventricular side of atrioventricular heart valve leaflets, wherein such force on the leaflets can provide sufficient counterforce to the leaflet to obviate the need for an opposing component / device being implemented on the ventricular side of the leaflet. That is, when pressure in the ventricle is sufficiently high to close the heart valve leaflets by forcing the leaflets towards the respective atrium, the pressure force on the ventricle side of the leaflets can supply the desired opposing force to resist against the deployment force of the tissue anchor through / into the target leaflet.

[0085] Figures 2A and 2B provide a flow diagram illustrating a process 200 for implementing contact-triggered tissue anchor deployment in accordance with one or more implementations disclosed herein. Figures 3A, 3B, and 3C provide images of certain anatomy and devices / components corresponding to operations of the process 200 of Figures 2A and 2B in accordance w ith one or more implementations.

[0086] At block 202, the process 200 involves accessing an atrium associated with a target heart valve of a patient with a delivery system 30. Such atrium access may advantageously be made through a transcatheter access path, as described in detail herein. In some implementations, access may be made to the right atrium 5 through the superior or inferior venae cavae, wherein the delivery system 30 may approach the tricuspid valve 8 from the right atrium 5, or traverse the interatrial septum to access the left atrium and mitral valve. Although the tricuspid valve 8 is shown and described below, it should be understood that the concepts disclosed are applicable to the mitral valve or other valves.

[0087] At block 204, the process 200 involves advancing the delivery system 30 into a position in the area of the target valve ostium, such that the distal end 31 of the delivery system 30 is positioned in an area / volume into which the target leaflet 28a cyclically moves in response to increased ventricular pressure. Figure 3A shows an implementation of the tissue anchor delivery system 30 approaching the leaflet 28a of the target valve 8, which may be a tricuspid or mitral valve, or other valve or anatomy, on the atrial side of the valve 8. For example, although the catheter / shaft 30 is shown in the right atrium 5 in Figure 3A, it should be understood that the process 200 may involve accessing the left atrium.[oo88] As the patient’s heart cycles in response to cardiac electrical signals propagating through the heart muscle, the valve leaflets 28 may be pressed / brought-up towards the atrium 5 in synchronization with the systolic phase of the cardiac cycle. For example, at a point between isovolumic contraction and isovolumic relaxation, the ventricular pressure may peak (see Figure 5), wherein the peak pressure in the ventricle 4 may cause the leaflets 28 to be pressed up towards the atrium 5 to a maximum degree permitted by the tethering chordae (not shown for visual clarity), w herein such leaflet positioning and ventricular pressure levels provide the desired counterforce for anchor deployment. At such point / phase, with the distal end 31 of the delivery system positioned in the area of the valve orifice, the target leaflet(s) 28 may be brought into contact with the distal end 31 of the delivery system 30, wherein such contact may be detected by the delivery' system 30 and / or predicted based on the determined cardiac cycle phase and / or frequency parameters.

[0089] At block 206, the process 200 involves detecting cyclical leaflet tissue contact, or otherwise determining a temporal moment of contact or expected contact between the leaflet 28a and the distal tip 31 of the delivery system 30. In some implementations, the delivery catheter / system 30 can be used to transport a spring-loaded, barbed tissue anchor, or other tissue anchor configured to be relatively quickly deployed from the delivery? system 30. Figure 3B show s a tissue anchor 32 disposed within a distal portion 38 of the delivery? system 30, w herein the tip 31 of the delivery? system 30 has come into contact with the target leaflet 28a in response to deflection of the leaflet 28a towards the atrium 5 caused by increased ventricular pressure. In some implementations, as referenced above, the distal end / tip 31 of the delivery? system 30 can include a sensor 39 configured to detect contact with the leaflet 28a.

[0090] At block 208, the process 200 involves deploying the spring-loaded or otherwise primed tissue anchor 32 in response to the detected leaflet contact and / or other timing indication indicating a temporal moment associated with an expected leaflet contact or high ventricular pressure condition sufficient to provide counterforce for leaflet puncture. Figure 3C shows deployment of the tissue anchor 32 through the target leaflet 28a. In some implementations, once leaflet contact is detected, or contact is predicted based on cardiac cycle (e.t / ., pressure-based, electrical-signal-based, imaging-based) analysis, the anchor 32 can be released distally from an axial opening of the delivery system 30, as show?n.

[0091] The tissue anchor 32 may be any type of tissue anchor configured to puncture through and / or embed in leaflet tissue. In some implementations, the tissue-anchor 32 is configured to be quickly ejected from the delivery system 30 to facilitate timing synchronization of leaflet puncture. Furthermore, by implementing the anchor 32 with spring-loading or other fast-ejection mechanism, the delivery' system 30 can facilitatepenetration of the leaflet tissue without requiring a relatively high degree of counterforce, such that systolic ventricular pressure is sufficient to provide the counterforce against the anchor deployment. The relatively quick response and action of the spring-loaded anchor deployment can allow the anchor 32 to puncture the leaflet tissue while the leaflet 28a is still under systolic pressure that acts as a counterforce against the ventricular side of the leaflet.

[0092] In some implementations, as shown in Figure 3B, prior to deployment, the tissue anchor 32 may be spring-loaded using a coiled spring 33, which stores elastic energy used to deploy the anchor 32 when the spring energy is released. In some implementations, the anchor 32 may be held in-place by a trap and / or catch configured to hold / lock the spring 33 under tension, wherein release of the kinetic energy from the spring 33 is transferred to the proximal portion of the anchor 32 to translate the anchor 32 in the distal direction. In some implementations, a latching lever, sear, and / or catch arm 34 may be configured to hold a corresponding catch feature 35 of the anchor, wherein disengagement of the sear / catch arm 34 with the interference / catch surface 35 can allow the spring 33 to axially expand in accordance with a relaxed shape memory configuration thereof, thereby pushing the tissue anchor 32 distally. In some implementations, pneumatic energy? or other ejection actuators, may? be used to eject the tissue anchor 32. In some implementations, when the sear / catch arm 34 reaches the point of release of the catch 35, the trigger break occurs and a sudden loss of resistance against the anchor 32 and spring 33 occurs. The sear / catch arm 34 can have any desirable trigger weight.

[0093] In some implementations, the anchor 32 can have a distal puncturing tip 36 that is pointed and configured to provide a puncturing lead for the anchor 32. In some implementations, the anchor 32 includes a proximally-facing point or surface 37 (e.q., base stopper) configured to provide interference for the head of the anchor 32 to prevent backing- out of the anchor once the proximal point / surface 37 has cleared or become embedded in the tissue 28a. In some implementations, the anchor head may? be tapered between the puncturing tip 36 and the proximal point / surface 37 to gradually? expand / cut the tissue from the narrower point 36 to the proximal point / surface 37. The anchor 32 can be repositionable and / or retrievable prior to full deployment.

[0094] In some implementations, the delivery system 30 can be configured with certain safety features, such as a manually-operable actuator / trigger. The manually-operable actuator / trigger can be configured such that engagement (e.p., manually holding down) of the trigger does not cause immediate tissue anchor deployment, but rather causes the tissue anchor delivery apparatus to be primed. In a primed state, the sensor-triggering of the anchor release / deployment is enabled, and subsequent leaflet tissue contact automatically triggers tissue anchor ejection from the delivery system 30. That is, in someimplementations, tissue-contact-sensing can trigger tissue anchor deployment while / when the trigger or other similar anchor-release-enablement input trigger is activated / primed. In such implementations, the user input / actuator can operate as a ‘fire-when-ready’ input / signal actuator. In some implementations, the manually-operable actuator / trigger, can be associated with a handle or other component of the delivery system 30,

[0095] In some implementations, the tissue-contact sensor 39 can advantageously provide an accurate timing trigger for tissue anchor deployment. The sensor 39 can be any type of sensor configured to generate a signal and / or otherwise provide information indicating tissue contact or proximity w ith the distal end 31 of the delivery system 30. In some implementations, the sensor 39 can be an electrical signal configured to generate an electrical current in response to and / or indicating tissue contact with the sensor 39 and / or delivery system 30. In some implementations, the sensor 39 comprises a capacitive electrical contact configured to provide an electrical response, such as a change in capacitance and / or electrical current, to pressure and / or contact with a plate or other component thereof. For example, tissue contact with the sensor 39 may effectively close or open an electrical circuit, such that electrical current change in the circuit can be used to determine tissue contact. In some implementations, piezoelectric sensor(s) (e.g., piezoresistive, piezocapacitive) may be implemented.

[0096] In some implementations, contact with the sensor 39 and / or end 31 of the delivery system 30 can produce an electrical, pneumatic, hydraulic, mechanical, pressure, etc. signal representative of tissue contact. In some implementations, the sensor 39 comprises one or more fiber optic cables / lines providing optical feedback of tissue position in contact with, or in the area of, an end / interface thereof. For example, tissue contact or proximity to an interface (e.g., axial end) of the fiber(s) can block light transmitted through the fiber(s), thereby indicating tissue contact.

[0097] Figure 4 is a block diagram of a tissue anchor deployment / delivery system 40 in accordance with one or more examples. The tissue anchor delivery system 40 may represent some configurations of any of the example tissue anchor delivery systems disclosed herein. In some implementations, the delivery system 40 includes an elongate shaft portion 30 which may have the form of a catheter, sheath, or other tubular device comprising one or more lumens configured for transporting a tissue anchor to a target implantation site through a transcatheter vascular access. For example, the shaft 30 may be sufficiently long and / or narrow to pass through a patient’s arterial and / or venous blood vessel(s) into a target chamber of the heart of a patient.

[0098] In some implementations, the delivery system 40 comprises a handle 62 or other manually operable / manipulable proximal component / portion 62, which may be used by theoperator to maneuver / steer the distal end 38 of the deliver}7system and / or control actuation of some delivery' system components. In some implementations, the handle 62 comprises an anchor-release enablement input / actuator 63, such as a button, trigger, knob, or other electrical, digital, and / or mechanical input / actuator. Engaging the input 63 can activate / enable a synchronized tissue anchor deployment / release 68, wherein, when enabled, the anchor release 68 can be configured to eject / deploy a tissue anchor 32 from the distal end portion 38 of the shaft 30 based on detected physical contact signaled by a contact sensor 39 or through other synchronization means. That is, the anchor-release enablement input 63 may operate as a ‘fire-when-ready’ actuator, as described above.

[0099] In some implementations, during operation, the tissue anchor 32, anchor release assembly / mechanism 68 and / or contact sensor(s) 39 may be disposed at least partially with i n the distal portion 38 of the shaft 30, as described in detail above. In some implementations, the anchor release 68 and / or contact sensor 39 may be electrically coupled to the control circuitry’ 64 disposed at least in part within the handle 62 and / or outside of the handle 62. For example, the system 40 may' include one or more electrical connectors 67, such as wires or the like, that run the length of the shaft 30 between the distal portion 38 and the control circuitry' 64 (or portion thereof). In some implementations, the distal portion 38 of the delivery' system shaft 30 may' have one or more pressure sensors configured to provide pressure signals indicative of atrial and / or ventricular pressure when the distal portion 38 is disposed within a chamber of the patient’s heart.

[0100] In some implementations, the control circuitry 64 may communicate with the shaft 30, handle 62, and / or component! s) thereof through wired and / or wireless data and / or power transmission. The term “control circuitry ” is used herein according to its broad and ordinary meaning, and may refer to any collection of processors, processing circuitry, processing modules / units, chips, dies (e.g., semiconductor dies including come or more active and / or passive devices and / or connectivity circuitry), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuitry, analog circuitry', digital circuitry, and / or any device that manipulates signals (analog and / or digital) based on hard coding of the circuitry’ and / or operational instructions. Control circuitry referenced herein may further comprise one or more, storage devices, w'hich may be embodied in a single memory' device, a plurality of memory devices, and / or embedded circuitry of a device. Such data storage may comprise read-only memory', random access memory', volatile memory', non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. It should be noted that in examples in which controlcircuitry comprises a hardware and / or software state machine, analog circuitry, digital circuitry, and / or logic circuitry', data storage device(s) / register(s) storing any associated operational instructions may be embedded within, or external to, the circuitry’ comprising the state machine, analog circuitry’, digital circuitry, and / or logic circuitry’.

[0101] In some implementations, the sensor device 39 may be a pressure sensor according to any of the examples disclosed herein. In some examples, the sensor 39 comprises a transducer, such as a MEMS pressure transducer. Using the sensor 39, in some implementations, the anchor release 68 acts as a contact-triggered anchor driver that can sense when the leaflet is been pressed against the end of the shaft / driver 30 due to electrical contact or pressure sensing. The delivery sy stem 40 may responsively drive / fire the tissue anchor 32, which may be a toggle anchor or other type of anchor, through the target leaflet.

[0102] In some implementations, the sensor 39 can comprise a force-collector-type pressure sensor. In some examples, the sensor 39 comprises a diaphragm, piston, bourdon tube, bellows, or other strain- or deflection-measuring component(s) to measure strain or deflection applied over an area / surface thereof. In some implementations, the sensor 39 can comprise a piezoresistive MEMS pressure sensor, which may be configured to use bonded or formed conductors to detect strain due to applied pressure, wherein resistance increases as pressure deforms the component / material. In some implementations, the sensor 39 can comprise a capacitive pressure sensor. The sensor transducer may incorporate any type of material, including but not limited to silicon (e.g., monocrystalline), polysilicon thin film, bonded metal foil, thick film, silicon-on-sapphire, sputtered thin film, and / or the like. In some implementations, the sensor 39 comprises an electromagnetic pressure sensor, which can be configured to measure the displacement of a diaphragm by means of changes in capacitance, linear variable displacement transducer (LVDT) functionality, Hall Effect, or eddy current sensing. In some implementations, the sensor 39 can comprise a piezoelectric strain sensor. For example, such a sensor may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in some materials, such as quartz. In some implementations, the sensor 39 can comprise a strain gauge. For example, a strain gauge example may comprise a pressure sensitive element on or associated with an exposed surface of the sensor 39. In some implementations, the sensor 39 may comprise any other type of sensor or pressure sensor, such as optical, potentiometric, resonant, thermal, ionization, or other types of strain or pressure sensors. In some implementations, the sensor 39 comprises one or more optical fibers, which can run the length of the shaft 30 and can be configured to detect / indicate changes in pressure in response to changes in light, pressure, and / or strain conditions.

[0103] In some implementations, the anchor release 68 can be configured to cause a spring or other energy-storing device / component to advance (e.g., shoot) the tissue anchor 32 forward, such as through a deflecting, twisting, pulling, etc., mechanical actuator / element. In some implementations, the anchor release can be tied to the contact sensor signal 39, which can automatically trigger the anchor release in real-time to eject the tissue anchor 32. Additionally or alternatively, in some implementations, the control circuitry 64, which may be embodied in component(s) of the delivery system 40 (e.g., shaft 30, handle 62, etc.), can be configured to determine and / or implement anchor release in connection with predicted leaflet contact and / or positioning based at least in part on cardiac cycle data. For example, the tissue anchor deliveiy system 40 may be configured to trigger the anchor release 68 in synchronization with a closed position of a target heart valve, wherein determination of the timing of such synchronized release / deployment may be based on any suitable or desirable type of sensor signal or other physiological data. For example, as described in detail above, anchor release may be triggered by a signal from the contact sense r(s) 39. Additionally or alternatively, the control circuitry 64 may be configured to trigger the anchor release 68 at a determined point in a cardiac cycle of the heart that correlates with the desired position of the target leaflet(s). For example, the control circuitry764 may be configured to trigger the anchor release based on some physiological data derived using one or more sensor and / or imaging devices 66. In some implementations, anchor triggering can be based on an electrocardiogram, wherein the patient’s cardiac electrical signal may be derived in any suitable or desirable manner, such as by using EKG sensor(s) or other physiological sensor(s) 66 that may be used to derive the phase and frequency of the cardiac cycle of the patient.

[0104] Figure 5 is a graph 500 showing cardiac pressure and electrical signals that can be used to determine anchor release timing / synchronization in accordance with any example disclosed herein. The cardiac cycle generally can be considered to include four major stages of activity, namely isovolumic relaxation 510, inflow7, isovolumic contraction 509, and ejection. In some implementations where the control circuitry764 is utilized to synchronize tissue anchor release / deployment with pressure and / or electrical signals from one or more physiological sensors 66, the control circuitry 64 may advantageously7be configured to trigger tissue anchor release / deployment after isovolumic contraction 509 and prior to isovolumic relaxation 510. For example, tissue anchor release may be triggered in the ejection stage, which generally occurs between isovolumic contraction and isovolumic relaxation . Isovolumic relaxation, in combination with the resulting inflow- into the ventricles, comprise the ventricular diastole period, including atrial systole, during which blood returning to the heart flows through the atria into the relaxed ventricles. Isovolumic contraction, combined with the resulting blood ejection, represent the ventricular systoleperiod, which involves the simultaneous pumping of separate blood supplies from the two ventricles, one to the pulmonary’ artery and one to the aorta. In some implementations, examples of the present disclosure can provide for tissue anchor deployment from an atrial side of a target leaflet by timing such deployment with the ejection stage of the cardiac cycle, during which the atrioventricular heart valves are generally closed, thereby’ providing the desired counterforce for atrium-to-ventricle deployment.

[0105] In some implementations, blood pressure data may be used to determine when the control circuitry 64 triggers the release / deployment of the tissue anchor 32. For example, a pressure cuff, pressure sensor, or similar device may be used to provide a signal representing arterial and / or venous blood pressure of the patient, wherein a peak in the blood pressure waveform may’ be identified to determine a desired position of the target heart valve leaflets for tissue anchor deployment. In some implementations, a peak in a pressure waveform, such as a peak 504 in a waveform 502 representing ventricular pressure (e.<7. , right-ventricular and / or left-ventricular pressure) can correspond to a periodic temporal moment / point where tissue anchor release is triggered. Such ventricular pressure waveform 502 can be generated using a sensor associated with the distal portion 38 of the shaft 30 or other pressure sensor / implant.

[0106] In some implementations in which the analyzed blood pressure waveform is representative of radial or peripheral blood pressure, as represented by the waveform 503, a temporal moment / point 506 associated with the blood pressure waveform 503 that leads the peak 505 can be used as the trigger point for releasing the tissue anchor 32 due to the peripheral pressure peak 505 potentially lagging the ventricular pressure peak 504 by some period of time, which may be more closely aligned with the optimal leaflet position for tissue anchor deployment. The temporal moment / point 506 may be considered to ‘lead’ the peak 505 in that it is associated with an increasing slope of the pressure waveform immediately preceding the peak 505.

[0107] As referenced above, the radial / peripheral pressure waveform 503 can be generated using a sphygmomanometer (e.g., pressure cuff). For example, the sensor(s) 36 may comprise an inflatable cuff that is attachable to the patient’s arm, finger, or other appendage or member, wherein the cuff can be operable to inflate and deflate in a controlled manner and determine a pulse response; a mercury or aneroid manometer can be utilized to measure the pressure. In some implementations, tissue anchor deployment triggering is based on a pulse signal generated using a pulse oximeter or other device.

[0108] In some implementations, cardiac electrical signals can provide a basis for anchor release triggering. For example, such electrical signals may be generated using electrocardiogram (EKG) sensor(s) applied to the patient. Figure 5 shows an EKG waveform501 that may be used to trigger tissue anchor release in accordance -with any of the examples presented herein.

[0109] The electrical signal 501 comprises various components or features, which may be associated with different conditions or factors related to the electrical impulse of the heart. For example, as denoted in the diagram of Figure 5, the signal 501 includes a P wave, which represents the depolarization of the atria. For example, atrial depolarization generally spreads from the sinoatrial (SA) node towards the atrioventricular (AV) node, and generally from the right atrium to the left atrium. The electrical signal 501 further indicates a PR interval, which may generally be measured from the beginning of the P wave to the beginning of what is referred to as the QRS interval. The PR interval may generally reflect the time an electrical pulse takes to travel from the SA node through the AV node; the PR interval represents the portion of the signal 501 after the P wave and before the QRS interval.

[0110] The QRS interval may represent a relatively rapid depolarization of the right and left ventricles, which may be associated with the discharging of blood from the ventricles as the muscle mass of the ventricles contracts. The signal 501 further illustrates an ST segment (STseg), which connects the QRS complex to another wave, referred to as the T wave. The ST segment may generally represent the period when the ventricles are depolarized. The T wave represents the repolarization of the ventricles. The QT interval may be measured from the beginning of the QRS complex to the end of the T wave.

[0111] In some implementations, the EKG signal can be utilized as input to identify a point / moment in the cycle of the electrical signal that corresponds to the point where the target leaflet is at the highest point and / or pressurized to a degree that provide sufficient counterforce for tissue puncture from the atrial side of the leaflet, as disclosed in detail herein. In some implementations, the trigger point 507 may be at a point 511 during / within the T wave, such as at or near the advent / onset 508 of the T wave e.g., within 5-10% of the T wave onset 508 with respect to the full cardiac period). In some implementations, the control circuitry 64 detects the onset 508 of the T wave based on the electrical signal 501 and drives / initiates tissue anchor deployment in response thereto, such as at the point / moment 508, the point / moment 511, so some point therebetween. In some implementations, the control circuitry may be configured to derive the frequency and phase of the trigger point 507 and implement a synchronized triggering of the anchor release based on the derived electrical signal timing parameters. In some implementations, the triggering point 507 can be a point during / within the ST segment (STseg), or any point within the ST interval (ST).

[0112] In some implementations, imaging solutions may be used to derive cardiac cycling information, wherein the cardiac cycling information can be utilized by the control circuitry 64 to trigger tissue anchor release in the manner described herein. For example,ultrasound imaging may be used to derive timing with respect to target leaflet position for tissue anchor deployment. Imaging can be analyzed to determine a temporal moment / point corresponding to an image where the target leaflet is at a desired elevated position towards the atrium. Other imaging modalities that may be utilized include fluoroscopy, echocardiography, computed tomography (CT), or the like. For example, echocardiogram data, CT data, fluoroscopy data, or other similar data may be received by system control circuitry and analyzed to determine tissue anchor triggering sy nchronization in accordance with any example disclosed herein.Peripheral Tissue Capture for Tissue Anchor Deployment

[0113] As described above, cyclical ventricular pressure increases can provide ventricular counterforce against tissue of a target leaflet of a heart valve to facilitate puncture of a tissue anchor through the target leaflet. While relatively high ventricular pressure can provide counterforce against tissue anchor deployment, some implementations of the present disclosure can additionally and / or alternatively oppose tissue anchor deployment forces using anchoring of the target heart valve leaflet tissue using one or more secondary tissue anchor features deployed from the atrium. In some implementations, secondary’ anchors can be smaller, lighter, and / or less forceful with respect to engagement thereof with the target leaflet compared to the primary anchor intended for permanent or semi-permanent implantation. In some implementations, the supporting counterforce anchor(s) may be temporarily anchored in the target leaflet for the period during which the primary anchor is deployed, and removed / retracted while maintaining the primary anchor in the target leaflet tissue.

[0114] Figure 6 provides a flow diagram illustrating a process 600 for deploying a tissue anchor 72 using peripheral tissue capturing in accordance with one or more implementations of the present disclosure. Figures 7A, 7B, and 7C provide images of certain anatomy and devices / components associated with operations of the process 600 of Figure 6 in accordance with one or more examples.

[0115] At block 602, the process 600 involves accessing an atrium (e.g., left or right atrium) associated with a target atrioventricular valve with a delivery system including one or more secondary anchors used to tighten the target leaflet tissue in the area where a primary tissue anchor is intended to be deployed. Figure 7A shows the delivery’ system 70, which is configured to implement peripheral tissue capture to provide counterforce for secure anchoring of a primary tissue anchor 72 in accordance with aspects of the present disclosure. In some implementations, the delivery’ system 70 may advantageously comprise one or more lumens or channels 73 through which one or more secondary anchors 74 can be transported and deployed. In some implementations, the secondary anchor(s) 74 maycomprise relatively shallow spikes or barbs configured to puncture and / or grip leaflet tissue 26 in an area 703 around a primary target site 701. For instance, the secondary anchors 74 can be configured to hold and / or pull the target tissue around the primary site 701 radially outwardly in some manner as to make / retain the tissue 26 in a taut configuration for a period of time during which the larger primary7tissue anchor 72 may be driven into / through the tissue 26 at the target site 701.

[0116] In some implementations, the secondary tissue anchors 74 and / or associated channels / lumens 73 can be arranged in a ring configuration around the tissue anchor 74. Although four tissue anchor spikes 74 are shown, it should be understood that any number of secondary tissue anchors may be implemented in connection w ith examples disclosed herein. Due to the relatively smaller diameter / size of the secondary7anchors 74, the anchors 74 may require relatively less counterforce to embed in the target tissue from the atrial side of the valve 6.

[0117] At block 604, the process 600 involves contacting or bringing the distal tip 71 of the delivery system 70 into relatively close proximity to a target position 701 of the target leaflet 26, such that the distal tip 71 of the delivery system approximates the leaflet within sufficiently close proximity to the leaflet tissue 26 to enable directed deployment of one or more secondary anchors 74 from the delivery system into the leaflet tissue 26 around the target point 701. Approximating the leaflet 26 for secondary tissue anchor deployment may advantageously be within 1 cm, or 2 cm of contact with the leaflet 26, and may involve physically contacting the leaflet 26 -with the delivery7system 70 in some cases.

[0118] At block 606, the process 600 involves deploying and / or anchoring the secondary anchors {e.g., spikes) 74 around the target anchoring site / position 701. Figure 7B shows example anchoring positions 702a, 702b, 702c, 7O2d for the secondary anchors 74 around the primary anchoring target site 701 on the leaflet tissue 26. The anchors 74 may be deployed generally in positions along a circular radius 703 around the primary target 701, such as in a circular, triangular, rectangular, or other constellation / configuration about the primary target 701. In some implementations, three secondary anchors / spikes 74 are deployed / arranged in a triangle around the primary anchoring site 701. In some implementations, more than three secondary anchors / spikes 74 may be arranged in a ring around primary site. Furthermore, although solutions are described herein including multiple secondary7anchors for tissue stabilization / counterforce, it should be understood that any of the examples disclosed herein can be implemented using a single secondary tissue anchor. In addition, although a mitral valve 6 is shown and described, it should be understood that the process 600 may be implemented with respect to a tricuspid valve or other heart valve or tissue.

[0119] At block 608, the process 600 involves holding the area 27 of tissue immediately around the target anchoring site 701 taut and / or against the delivery system 70 using the secondary anchors 74. For example, the process 600 may involve deflecting and / or pulling the secondary anchors 74 away from the center / axis A of the delivery system 70 and / or the primary7anchoring position 701 in order to tighten / tauten the leaflet tissue 27 in the area of the target. Deflection of the secondary anchors 74 may be performed in a suitable or desirable manner, such as by deploying the anchors / spikes 74 from the delivery system 70, wherein shape-memory and / or configuration of the spikes 74 causes the distal ends thereof to deflect radially outwardly at a deflected angle. Alternatively or additionally, a mechanism may be utilized to bend or force the distal portions / tips 77 of the spikes 74 radially outwardly to some degree. For example, the tips 77 of the secondary anchors 74 may be deflected such that they project radially outside of the diameter of the catheter / sheath of the delivery system 70, as shown in Figure 7C.

[0120] In some implementations, the secondary anchors 74 can comprise relatively shallow spikes (e.g., compared to the length and / or other dimension(s) of the primary anchor 72) that are configured to grip the leaflet tissue 26 around the primary anchoring site 701. The relatively smaller secondary anchors may advantageously be sufficiently strong w ith respect to tissue-gripping features thereof to hold the leaflet tissue 27 and allow for manipulation thereof to tighten the tissue 27 to provide force against which the primary' anchor 74 can be pressed to facilitate puncture of the target tissue 701. By utilizing a higher number of secondary' anchors 74, the individual gripping force / strength of a given second anchor may not necessarily be as great, or be required to be as great, to hold the tissue 27. That is, the total oppositional force provided by the secondary' anchors 74 may be distributed among the plurality of secondary' anchors 74, wherein collectively, the secondary anchors 74 provide sufficient resistance against the puncture of the primary anchor 72 as the primary anchor 72 is driven into / through the tissue 27 between the secondary' anchors 74.

[0121] At block 610, the process 600 involves driving the primary anchor 72 through the target anchoring point 701 inside the border 703 defined by the secondary anchors 74. Figure 7C shows the leaflet 26 held against and / or in proximity to the distal end 71 of the delivery system by the secondary anchors / spikes 74. As shown in the figure, the anchors 74 are angled radially outward to tighten the tissue 27, w ith the primary anchor 72 punctured through the primary' target site 701 on the leaflet 26 within the boundaries 703 of the secondary anchors 74. In some implementations, the use of the secondary anchors 74 can reduce or prevent tenting effects in the tissue 27 when deploying the primary' anchor 72.

[0122] The spreading / deflecting apart of the tissue anchors 74 can stretch the leaflet tissue 27 by pulling laterally away from the center 701. In some implementations, thesecondary anchors 74 can advantageously comprise straight spike features, w ithout requiring proximally-facing barb / grabbing features, which can facilitate smooth movement through relatively small channels 73 in the delivery system 70. The need for barb / gripping features can be reduced due to the outward deflection of the spikes 74, which can produce frictional force to hold the anchors 74 in the target tissue. Furthermore, as the stretching action of the anchors 74 comes primarily from contact with / against the sides of the anchors 74, additional barb features may not be necessary’ to effect the stretching of the tissue 27. The secondary anchors 74 can comprise elongated wires / spikes that are not fully deployed from the delivery system 70, but rather can be extended from the delivery’ system 70 and retracted by translating a more-proximal portion of the elongated wire / spike.

[0123] The use of secondary’ tissue-holding anchors as described herein for primary tissue anchor puncturing can be particularly suitable for leaflet puncture and / or other types of biological tissue that naturally provide relatively little pushback and / or opposing force from one or more directions (e.g., limited opposing force of heart valve leaflets towards the atrium associated therewith). The use of secondary anchors can advantageously facilitate primary? tissue anchor puncturing w ithout the need of additional components and / or tools to be placed on the opposite / ventricular side of the tissue to provide a reference / opposing force that, in some solutions, may be required due to the absence of such force potentially causing the target tissue to simply move away from the direction of the anchor puncturing force / deployment against it. While holding the tissue relatively tight / taut, the target tissue 27 may be more readily? pierced by the primary? anchor 72. After deployment of the primary? anchor 72, the secondary? anchors 74 may be retrieved and / or w?ithdraw?n into the delivery sy stem and / or otherwise removed from the patient anatomy.Ratcheted Tissue Anchors

[0124] Tissue anchors are disclosed herein that may be utilized for anchoring to, and / or attaching repair devices to, heart valve leaflets and / or other similar biological tissue. In some implementations, harpoon-type tissue anchors (see, e.g., Figure 3B) are disclosed that may be deployed using various delivery? system solutions described herein. With respect to tissue anchor deployment from an atrium side of a target heart valve leaflet, tissue anchors disclosed herein may have features that render the anchors particularly suitable for anchor deployment without a counterforce delivery system component positioned in the ventricle. In some implementations, ratchet-type tissue anchors may be implemented for leaflet anchoring without the need for a sub-leaflet support for leaflet puncture. Although some implementations are disclosed herein as being deployable w ithout a sub-leaflet / ventricular counterforce support, it should be understood that the some examples of the presentdisclosure may be implemented in combination w ith any type of counterforce device disposed in on the ventricle side of a target leaflet.

[0125] Solutions disclosed herein that are implemented without a sub-leaflet counterforce component can provide relatively simplified procedures and / or reduce risks related to sub-leaflet / valvular anatomy entanglements. For example, the sub-valvular apparatus, comprising some papillary muscles, chordae tendineae, trabeculae carneae, and / or other anatomy disposed within the ventricle can be damaged and / or become entangled with devices disposed or manipulated within the ventricle. Therefore, solutions that obviate the need for such devices can provide reduced risk of anatomical damage.

[0126] Figures 8A, 8B, and 8C show side and perspective views, respectively, of a ratcheted tissue anchor 80 in accordance with one or more examples of the present disclosure. The tissue anchor 80 may be considered a barbed toggle anchor, which is configured for gradual advancement in discrete steps through a target leaflet or other tissue. Aspects of the tissue anchor 80 are further described in connection with Figures 9 and 10 below.

[0127] The ratcheted tissue anchor 80 can be used to attach a suture or other device to a target valve leaflet or other biological tissue. The anchor 80 includes a distal tip portion 802 and a proximal body portion 803. The tip portion 802 includes a sharp puncturing tip 83, and a tapered portion 81 and an axially parallel side wall portion 804 that extend from the tip 83 to a base 901 of the distal tip portion 802. In examples in which the anchor 80 can comprise and / or be formed from a hollow tube structure, the tapered tip portion / surface 81 can form a distal opening of a channel 88 of the tube. The distal tip portion 802 of the tissue anchor 80 joins the proximal body / tubular portion 803 at the base 901 of the tapered surface 81.[o 128] The sharp tip / edge 83 may be positioned against a target leaflet and pressed against the leaflet to cause puncturing of the leaflet. For example, the point / edge 83 of the anchor 80 may be positioned on the atrial side of the target leaflet, wherein the delivery system used for deployment of the anchor may be positioned in the atrium without necessarily passing through the valve ostium into the ventricle. During high systolic ventricular pressure phases, the heart valve leaflets (e.g., mitral leaflets or tricuspid leaflets) may be drawn upward towards the atrium. Therefore, with the tissue anchor 80 positioned with the tip 83 in the area of the ostium of the target heart valve, the movement of the leaflets towards the atrium in a cyclical manner can press the leaflets periodically against the pointed tip / edge 83 and / or other part(s) of the anchor 80 (e.g., tapered cutting edge / surface 81), thereby lacerating / puncturing the leaflet against the sharpened point / edge 83.

[0129] The anchor 80 advantageously includes a plurality of teeth, flaps, tabs, barbs, or the like 82a, 82b, 8201, 8202, 82di, 82d2, 82ei, 82e2 (collectively and / or individually referred to herein by reference number ‘82’ for convenience and clarity, and described herein as ‘teeth’) for tissue engagement. In some implementations, the teeth 82 may be angled proximally, such as at an angle 6 as shown, such that the proximal edges / surfaces 86 thereof can prevent backing-out of the anchor 80 once a given tooth 82 is advanced through (or into) the target leaflet past the axial position of the proximal edge / surface 86 of the tooth 82. The angle () may advantageously be between 30-60°, such as approximately 45°.

[0130] The teeth 82 are configured to engage the target leaflet tissue. In some implementations, the teeth 82 can advantageously be axially asymmetrical, w ith each tooth 82 having a moderate slope on an inclined radially-outer edge / surface 89, wherein the proximal contact / surface 86 presents a relatively steeper slope to prevent passage of the tissue back over the primal edge 86. When the teeth 82 are advanced in the distal, less- restricted direction, the leaflet tissue can relatively easily slide up and over the gently sloped surfaces 89 of the teeth 82, with the natural elasticity and shape of the leaflet causing the leaflet to pass into the space 801 between axially-offset rows of teeth 82. The leaflet tissue may nest in the area 801 between tooth rows as the tip 86 of each tooth 82 is passed over by the leaflet tissue. When the teeth 82 are moved / forced in the proximal direction relative to the leaflet tissue, the leaflet can catch against the jutting-out edge 86 of the tooth 82 that is first encountered by the leaflet tissue, thereby locking the leaflet against the tooth edge 86 and preventing further motion in the proximal direction. The teeth 82 may advantageously be blunt on the proximal edges 86 thereof to prevent or reduce damage to the leaflet tissue when the edges 86 come into contact w ith the leaflet.

[0131] In some implementations, the anchor 80 can be solid, or the anchor can be hollow, as shown in Figures 8A-8C. For example, the anchor 80 can be formed from a metal or plastic tube or similar structure. In hollow implementations, the teeth 82 can be formed by cutting and deflecting tabs from the wall of the anchor tube. By deflecting the cut-out tabs outward from the tube wall, the tabs can provide access openings 805 to the inner channel 88 of the tube structure. Deflection of the tabs 82 can be implemented by bending the tabs at a base 806 thereof that is integrated with the tubular structure, w ith the free edges / ends 86 deflected outward.

[0132] In some implementations, the teeth 82 may be configured to be held within the delivery system sheath / tube with the teeth 82 oriented generally parallel with the walls of the anchor tube, wherein the teeth 82 may deflect outwardly, either automatically or in response to force by a delivery system component, thereby forming the tooth configuration shown. In some implementations, the teeth / tabs 82 can be laser-cut from the anchor tube toallow for the outward deflection of the teeth. Use of hollow’ ratcheted tissue anchors can be beneficial as providing a lower-weight structure compared to solid anchors. Furthermore, by implementing the anchor 80 as an axially-hollo ’ anchor, the axial channel 88 through the anchor 80 can provide internal access to the teeth / tabs 82 to allow for pushing of the teeth 82 radially outward and / or to allow for sutures / wires to run through the anchor 80.

[0133] In some implementations, each row of teeth 82 in the distal tip portion 802 may consist of a single tooth on the straight sidewall 804, whereas rows of teeth 82 in the body portion 803 of the anchor 80 may have pairs of teeth projecting from opposite circumferential sides St, S2of the anchor 80, as shown. In some examples, the teeth 82 can include one or more teeth (e.g., teeth 82a, 82b) associated with the axially-parallel sidewall 804 of the distal tip portion 802. In some implementations, the teeth 82 can additionally or alternatively include one or more pairs of teeth associated with the proximal tubular body portion 803. For example, the anchor 80 can include a first row / pair of teeth 82CI, 8202 on opposite circumferential sides Si, S2, respectively, of the proximal tubular body portion 803. In some implementations, the anchor 80 can comprise a second row / pair of teeth 82dt, 82d2 on opposite circumferential sides , S2, respectively, of the proximal tubular body portion 803. In some implementations, the anchor 80 can comprise a third row / pair of teeth 82ei, 82e2 on opposite circumferential sides S , S2, respectively, of the proximal tubular body portion 803.

[0134] In some implementations, the anchor 80 may include one or more apertures, such as apertures 84 that are transverse with respect to the axis Arof the anchor 80, as shown. The transverse aperture(s) 84 may be utilized for attachment of sutures, wires, or the like, which may be utilized for delivery and / or valve repair. In some implementations, the anchor 80 includes a first aperture 84a (or pair of opposite-facing, axially-aligned apertures for example anchors that are hollow, as shown) may be used for retrieval during implantation. For example, the suture / wire associated with the anchor 80 may pass through the proximal aperture(s) 84a to allow for pulling on the proximal portion of the anchor 80 to retrieve / retract the anchor forcefully. In some implementations, the proximal aperture(s) 84a can advantageously be positioned in a proximal-most quartile of the length of the anchor. The apertures 84, as shown, can be rotationally / circumferentially-offset from the teeth 82 by 90° to reduce interference between such features.

[0135] In some implementations, the anchor may include a central aperture 84b (or pair of apertures), which may be disposed in a central half of the length of the anchor 80. The central aperture(s) 84b can have a suture / wire passed therethrough to allow for a force moment on the central area / portion of the anchor. For example, with the suture passing out of the central aperture(s) 84b, pulling on the suture / wire can produce transverse force(relative to the axis ) on the anchor 80, which may be desirable in implementations in which the anchor 80 is rotated to an orientation generally parallel with the target valve leaflet to provide greater contact surface / area for leaflet manipulation / anchoring (see Figure 10E). Furthermore, hollow anchor examples in accordance w ith Figures 8A-8C can allow for coupled sutures / wires to pass through the axial channel 88, which may be desirable for some suture / wire configurations. In some implementations, the aperture(s) 84b maybe considered axially- or lengthwise-central with respect to a position thereof when the aperture(s) 84b is / are positioned within a central 50% of the length of the anchor 80.

[0136] Figures 9A and 9B (collectively referred to as Figure 9 in some contexts) provide a flow diagram illustrating a process 900 for deploying a ratcheted tissue anchor in a target heart valve leaflet in accordance w ith one or more examples of the present disclosure. Figures 10A, 10B, 10C, 10D, and 10E (collectively referred to as Figure 10 in some contexts) provide images of certain anatomy and devices / components corresponding to operations of the process 900 of Figures 9A and 9B in accordance with one or more implementations. The tissue anchor 80 of Figures 8A-8B represents an example implementation of the tissue anchor described in the process 900, and common reference identifiers are used below for convenience. It should be understood that other tissue anchors can be used in the process 900, wherein such anchors may or may not have any of the features disclosed above and / or additional features not described in connection w ith Figures 8A-8C.

[0137] At block 902, the process 900 involves contacting a target leaflet 28 w ith a pointed tip or edge 83 of a ratcheted tissue anchor 80 as disclosed herein. For example, the tissue anchor 80 may be similar to the tissue anchor shown in Figures 8A-8C. In some implementations, contacting the target leaflet 28 may advantageously be performed from an atrium 5 of the patient’s heart using a delivery system 90 advanced into the atrium 5 through a transcatheter access as described in detail herein. In some implementations, the implantation of the tissue anchor 80 may be effected by advancing / deploying the tissue anchor 80 from the delivery system catheter / sheath 90 such that a point / edge 83 thereof contacts a target position / site on the target leaflet as the leaflet cyclically rises towards the atrium 5 as ventricular pressures increase.

[0138] Figure 10A shows the delivery system 90 with the tissue anchor 80 at least partially deployed from a distal opening thereof, with the point 83 of the tissue anchor 80 in position to be contacted by the target leaflet 28. In some implementations, a pusher or other device (not shown for visual clarity) may be included as a component of the delivery system 90 to facilitate pushing of the anchor 80 out of the delivery system 90 and towards the leaflet 28. In some implementations, the anchor 80 may be coupled to the deliveiy system 90 and / or any other anchoring component by the suture / wire 93, which may be engaged withone or both of the axially-offset apertures / features 84. For example, the suture 93 may pass on an outside of the tissue anchor 80 and / or within an axial channel of the tissue anchor (e.g., for implementations in w hich the anchor is formed of a hollow tube or other hollow7structure), and through one or both of the apertures 84a, 84b. In some implementations, engagement of the suture 93 with the proximal-most suture-engagement features 84a can facilitate pulling in an axial direction proximally on the tissue anchor 80 in the event that withdrawal / retrieval of the anchor 80 is desired, such as for removal of the anchor 80 and / or repositioning at any point during the process 900.

[0139] At block 904, the process 900 involves gradually advancing rows / levels of one or more barbs / teeth 82 of the tissue anchor 80 through the leaflet 28. For example, the barbs / teeth 82 may be positioned along the length of the anchor 80 to allow the anchor 80 to be gradually worked through the leaflet 28 over several heartbeat cycles. In some implementations, the anchor 80 may gradually enter the leaflet 28, a row at a time every7one or more heartbeats, thereby causing the leaflet 28 to jump from level-to-level of the teeth 82 in discrete, ratcheted incremental steps.

[0140] Figures 10B, 10C, and 10D show the anchor 80 being progressively advanced such that the leaflet 28 is positioned at progressively more-proximally positioned levels between ratchet teeth / barbs 82. For example, Figure 10B shows a first-level tooth / teeth 82a advanced through the leaflet 28, whereas Figure 10C shows a second-level tooth / teeth 82b advanced through the leaflet 28 such that leaflet 28 is positioned proximal of the first tw o levels (82a, 82b) of teeth 82. In some implementations, due to the tapered surface 81 of the leading tip 802 of the anchor 80, the barbs / teeth 82 associated with one or more of the most-distal levels of teeth 82 may be on one circumferential side of the anchor 80, w hereas proximal to the base 901 of the taper, levels / rows of teeth 82 may include multiple axially- aligned teeth / barbs on more than one circumferential side of the anchor 80 (e.g., on more than one circumferential position of the anchor).

[0141] In some instances, each systolic phase of the cardiac cycle, or certain successive or subsequent systolic phases, whether sequential or having gaps therebetween, can cause pressure increase that pushes the leaflet 28 progressively farther over the anchor 80. However, due to the proximal edge / surface 86 of the deflected / angled teeth 82, the leaflet 28 may resist back-tracking over the teeth / barbs 82 that have advanced through the leaflet during diastole, thereby permitting one-directional movement of the anchor 80 relative to the tissue 28. Over several cardiac cycles, the toggle anchor 80 can eventually work its way entirely through the leaflet 28.

[0142] In some implementations, the traction / holding force of the teeth 82 once they have passed through the leaflet 28, combined with the pressure effects on the leaflet 28 ofthe high systolic ventricular pressure, can obviate the need for a supporting structure on the opposite side of the leaflet in the ventricle 4. By not requiring a reference / opposing force on the ventricle side of the leaflet 28, obstruction and / or entanglement with the sub- valvular apparatus, including chordae tendineae, papillary muscles, and / or other anatomy , can be avoided.

[0143] At block 906, the process 900 involves configuring the anchor 80 for permanent, or semi-permanent, anchoring. For example, such configuring may be implemented once the anchor has entirely (or mostly) passed through the leaflet 28 to the ventricular side of the leaflet, and may involve rotating, or allowing the rotation of, the anchor 80 to align in a more parallel orientation w ith the leaflet 28. That is, in the rotated configuration of the anchor 80, the axis Arof the anchor may be angled, such as mostly transverse / parallel relative to the angle / orientation of puncture through the leaflet. Figure 10E shows the re- configured / oriented anchor 80 on the ventricular side of the leaflet 28. The axisrmay advantageously be more closely aligned with the surface of the leaflet 28 in the area of puncture than to the angle / orientation of puncture through the leaflet 28.

[0144] With the anchor turned sideways as in Figure 10E, the anchor 80 may provide increased surface area for engagement ■with the ventricular side of the leaflet 28, which may increase the efficacy of the anchoring of the anchor 80 and coupled suture 93. The attachment of the suture 93 to the central aperture or other tissue-coupling feature 84b may permit the anchor 80 to rotate as shown, wherein the suture 93, through coupling with the feature 84b, can pull on the anchor in a transverse direction relative to the axis Ar.

[0145] The process 900 may further involve coupling the suture 93 that is coupled to the tissue anchor 80 to another heart valve leaflet 29 in some manner, such as by suturing, anchoring (e.g., with an anchor similar to the tissue anchor 80), or otherwise coupling the suture 93 to the other heart valve leaflet 29. With the suture 93 coupled / anchored to both leaflets, the process 900 may further involve applying tension to the suture 93 to perform an edge-to-edge procedure, such as an Alfieri procedure, w hich may bring the leaflet edges together to reduce regurgitant flow and / or produce desirable remodeling of the native valve annulus.Additional Implementations

[0146] Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any example described above may be implemented in any of the numbered examples provided below.

[0147] Example 1: A tissue anchor delivery system comprising an elongate shaft, a tissue anchor disposed within a distal portion of the elongate shaft, a sensor configured to detectcontact of biological tissue w ith the distal portion of the elongate shaft, and a trigger release configured to cause deployment of the tissue anchor from the distal portion of the elongate shaft in response to tissue contact detected by the sensor.

[0148] Example 2: The tissue anchor delivery system of any example herein, in particular example 1, wherein the tissue anchor is spring-loaded w ith in the distal portion of the elongate shaft.

[0149] Example 3: The tissue anchor delivery system of any example herein, in particular example 2, wherein the trigger release is configured to actuate a catch feature configured to hold the tissue anchor in a spring-loaded configuration.[o 150] Example 4 : The tissue anchor delivery system of any example herein, in particular any of examples 1-3, wherein the tissue anchor comprises a distal puncturing tip.

[0151] Example 5: The tissue anchor delivery system of any example herein, in particular any of examples 1-4, wherein the sensor is configured to, in response to the tissue contact, generate an electrical current that indicates the tissue contact.

[0152] Example 6: The tissue anchor delivery system of any example herein, in particular any of examples 1-5, wherein the sensor is a pressure sensor.

[0153] Example 7: The tissue anchor delivery system of any example herein, in particular any of examples 1-6, wherein the sensor comprises one or more optical fibers that run a length of the elongate shaft.

[0154] Example 8: The tissue anchor delivery system of any example herein, in particular any of examples 1-7, further comprising a handle including a manually-engageable input configured to enable the trigger release.[o 155] Example 9 : A method of deploying a tissue anchor, the method comprising advancing a distal portion of an elongate shaft of a delivery system to an atrium of a heart of a patient using a vascular access path, determining a temporal moment associated with contact between the distal portion of the elongate shaft and a target leaflet of an atrioventricular valve associated with the atrium, and causing a tissue anchor to be deployed from the distal portion of the elongate shaft at the temporal moment.

[0156] Example to: The method of any example herein, in particular example 9, wherein said determining the temporal moment comprises detecting the contact between the distal portion of the elongate shaft and the target leaflet, and the temporal moment is a moment when the contact is detected.

[0157] Example 11: The method of any example herein, in particular example 10, wherein said detecting the contact is performed using a sensor disposed at least partially at the distal portion of the elongate shaft.

[0158] Example 12: The method of any example herein, in particular example 11, wherein the sensor is an electrical sensor.

[0159] Example 13: The method of any example herein, in particular example 11, wherein the sensor is a fiber optic sensor.

[0160] Example 14: The method of any of any example herein, in particular any of examples 9-13, further comprising determining one or more parameters associated with a cardiac cycle of the heart of the patient, wherein said determining the temporal moment is based on the one or more parameters.

[0161] Example 15: The method of any example herein, in particular any of examples 9-14, further comprising determining a blood pressure waveform associated with the patient, and identifying a portion of the blood pressure waveform that is associated with a ventricular pressure peak, wherein the temporal moment corresponds to the identified portion of the blood pressure waveform.

[0162] Example 16: The method of any example herein, in particular any of examples 9-15, further comprising determining a pulse of the patient using a pulse oximeter, wherein said determining the temporal moment is based on the pulse.

[0163] Example 17: The method of any example herein, in particular any of examples 9-16, wherein said causing the tissue anchor to be deployed involves ejecting the tissue anchor from a distal opening of the delivery system using a spring.

[0164] Example 18: The method of any example herein, in particular any of examples 9-17, wherein said causing the tissue anchor to be deployed involves actuating a catch arm to disengage from the tissue anchor.

[0165] Example 19: The method of any example herein, in particular any of examples 9-18, further comprising receiving a signal from a sphygmomanometer indicating a peripheral blood pressure waveform of the patient, and determining the temporal moment as a moment in time that leads a peak of the peripheral blood pressure waveform.

[0166] Example 20: The method of any example herein, in particular any of examples 9-19, further comprising receiving echocardiogram data representing the heart of the patient, and determining the temporal moment as a moment in time associated with a visual image represented by the echocardiogram data showing the target leaflet at an elevated position.

[0167] Example 21: The method of any example herein, in particular any of examples 9- 20, further comprising receiving ultrasound data representing the heart of the patient, and determining the temporal moment as a moment in time associated w ith a visual image represented by the ultrasound data showing the target leaflet at an elevated position.

[0168] Example 22: A tissue anchor delivery system comprising an elongate shaft, a tissue anchor disposed within a distal portion of the elongate shaft, a trigger release configured to cause deployment of the tissue anchor from the distal portion of the elongate shaft, and control circuitry configured to trigger the trigger release in synchronization with a high ventricular pressure condition.

[0169] Example 23: The tissue anchor delivery system of any example herein, in particular example 22, wherein the control circuitry7is configured to trigger the trigger release based on a sensor signal from a tissue contact sensor associated with the elongate shaft.

[0170] Example 24: The tissue anchor delivery system of any example herein, in particular example 22 or example 23, wherein the control circuitry is configured to trigger the trigger release based on at least one of ultrasound data, echocardiogram data, electrocardiogram data, or pressure sensor data.

[0171] Example 25: A tissue anchor delivery system comprising an elongate shaft, a tissue anchor disposed within a distal portion of the elongate shaft, and a plurality of spikes positioned around the tissue anchor.

[0172] Example 26: The tissue anchor delivery system of any example herein, in particular example 25, wherein the tissue anchor is disposed in central lumen of elongate shaft.

[0173] Example 27: The tissue anchor deliveiy system of any example herein, in particular example 26, wherein the plurality of spikes are disposed in separate lumens positioned around the central lumen.

[0174] Example 28: The tissue anchor delivery^ system of any example herein, in particular example 27, wherein the separate lumens are formed in a w all of the elongate shaft.

[0175] Example 29: The tissue anchor delivery system of any example herein, in particular any of examples 25-28, wherein the plurality of spikes are configured to project distally from the elongate shaft.

[0176] Example 30: The tissue anchor deliveiy system of any example herein, in particular example 29, wherein the plurality of spikes comprise elongated wires disposed at least partially with in the elongate shaft.

[0177] Example 31: The tissue anchor delivery system of any example herein, in particular example 30, wherein the plurality of spikes are configured to be deflected radially outwardly relative to axis of elongate shaft when the plurality of spikes are projected from a distal end of the elongate shaft.

[0178] Example 32: The tissue anchor delivery system of any example herein, in particular any of examples 25-31, wherein the plurality of spikes consists of three spikes arrange in a triangle around the tissue anchor.

[0179] Example 33: The tissue anchor delivery’ sy stem of any example herein, in particular any of examples 25-32, wherein the plurality of spikes comprises four or more spikes arranged in a ring around the tissue anchor.

[0180] Example 34: A method of deploying a tissue anchor in a heart valve leaflet, the method comprising advancing a distal portion of an elongate shaft of a delivery system to an atrium of a heart of a patient using a vascular access path, the delivery system comprising a primary tissue anchor and a plurality of secondary tissue anchors associated w ith the distal portion of the elongate shaft, approximating the distal portion of the elongate shaft to a target leaflet of an atrioventricular heart valve of the atrium with the distal portion of the elongate shaft, deployi ng the plurality of secondary tissue anchors into tissue of the target leaflet around a target site on the target leaflet, and, while holding the target leaflet with the plurality of secondary tissue anchors, deploying the primary tissue anchor through the target site on the leaflet between the plurality' of secondary' tissue anchors.

[0181] Example 35: The method of any example herein, in particular example 34, further comprising retrieving the plurality of secondary' tissue anchors from the target leaflet while maintaining the primary' tissue anchor implanted in the target leaflet.

[0182] Example 36: The method of any example herein, in particular example 34 or example 35, further comprising, prior to said deploying the plurality of secondary tissue anchors, tightening the target leaflet in an area of the target site using the plurality of secondary tissue anchors.

[0183] Example 37: The method of any example herein, in particular example 36, wherein said tightening the target leaflet involves deflecting distal ends of the plurality' of secondary' tissue anchors radially outward.

[0184] Example 38: A tissue anchor comprising a distal tip portion having a sharp puncture edge, and a plurality of teeth projecting from one or more sides of the tissue anchor, the plurality of teeth being arranged in a plurality of axially-offset rows.

[0185] Example 39: The tissue anchor of any example herein, in particular example 38, wherein the plurality of teeth are angled in a proximal direction.

[0186] Example 40: The tissue anchor of any example herein, in particular example 39, wherein the plurality of teeth comprise an inclined, distally-facing surface, and a proximally- facing edge.

[0187] Example 41: The tissue anchor of any example herein, in particular any of examples 38-40, wherein the tissue anchor has a form of a hollow tube w ith an axial channel running therethrough.

[0188] Example 42: The tissue anchor of any example herein, in particular example 41, wherein the plurality of teeth comprise tabs formed in the hollow tube, and the tabs are coupled to the hollow tube at a base portion thereof w ith free edges thereof deflected radially away from a wall of the hollow- tube.

[0189] Example 43: The tissue anchor of any example herein, in particular example 42, wherein radial deflection of the plurality of tabs provides openings into the axial channel of the hollow tube.

[0190] Example 44: The tissue anchor of any example herein, in particular any of examples 41-43, wherein the hollow- tube includes one or more pairs of opposite-facing apertures.

[0191] Example 45: The tissue anchor of any example herein, in particular example 44, w-herein apertures of the one or more pairs of apertures are circumferentially offset by 90° from the plurality of teeth.

[0192] Example 46: The tissue anchor of any example herein, in particular example 44 or example 45, wherein the one or more pairs of apertures comprises a first pair of apertures disposed in a center portion of a length of the tissue anchor.

[0193] Example 47: The tissue anchor of any example herein, in particular example 46, wherein the one or more pairs of apertures further comprises a second pair of apertures disposed in a proximal quartile of the length of the tissue anchor.

[0194] Example 48: The tissue anchor of any example herein, in particular any of examples 38-47, w herein the distal tip portion comprises a pointed tip, a tapered opening extending from the pointed tip to a base of the distal tip portion, and an axially-parallel sidew all extending proximally from the pointed tip to the base of the distal tip portion.

[0195] Example 49: The tissue anchor of any example herein, in particular example 48, further comprising a proximal tubular body portion that joins the distal tip portion at the base of the distal tip portion.

[0196] Example 50: The tissue anchor of any example herein, in particular example 49, wherein the plurality of teeth comprises one or more teeth associated w ith the axially- parallel sidewall of the distal tip portion, and one or more pairs of teeth associated w ith the proximal tubular body portion.

[0197] Example 51: The tissue anchor of any example herein, in particular example 50, wherein each of the one or more pairs of teeth includes a first tooth on a first circumferential side of the proximal tubular body portion and a second tooth on a second circumferential side of the proximal tubular body portion.

[0198] Example 52: A method of deploying a tissue anchor in a heart valve leaflet, the method comprising advancing a distal portion of an elongate shaft of a delivery’ system to an atrium of a heart of a patient using a vascular access path, the delivery system comprising a ratcheted tissue anchor disposed in the distal portion of the elongate shaft, contacting a distal tip of the ratcheted tissue anchor to a target leaflet of an atrioventricular heart valve associated with the atrium, during a first cycling of the heart, causing the tissue anchor to advance through the target leaflet such that a first row of one or more radially-projecting teeth of the tissue anchor passes through the target leaflet, and during a second cycling of the heart, causing the tissue anchor to advance through the target leaflet such that a second row of one or more radially-projecting teeth of the tissue anchor passes through the target leaflet, the second row of one or more radially-projecting teeth being positioned proximal of the first row- of one or more radially-projecting teeth.

[0199] Example 53: The method of any example herein, in particular example 52, further comprising causing the tissue anchor to advance entirely through the target leaflet, and causing the tissue anchor to rotate to a parallel orientation with respect to the target leaflet on a ventricular side of the target leaflet.

[0200] Example 54: The method of any example herein, in particular example 53, w-herein the tissue anchor comprises one or more transverse apertures configured to have one or more sutures passed therethrough.

[0201] Example 55: The method of any example herein, in particular example 54, wherein said causing the tissue anchor to rotate comprises applying tension to a suture coupled to an axially-central aperture of the one or more transverse apertures.

[0202] Example 56: The method of any example herein, in particular any of examples 53-55, further comprising coupling a suture that is coupled to the tissue anchor to another heart valve leaflet, and applying tension to the suture to perform an edge-to-edge procedure.

[0203] Example 57: The method of any example herein, in particular any of examples 52-56, further comprising proximally withdrawing the tissue anchor by proximally pulling on a suture coupled to a proximal end portion of the tissue anchor.

[0204] Example 58: The method of any example herein, in particular any of examples 52-example 57, wherein the suture is coupled to the proximal end portion of the tissue anchor via one or more transverse apertures.

[0205] Example 59: The method of any example herein, in particular any of examples 52-example 58, wherein the tissue anchor has a hollow tubular form including one or more apertures through which one or more sutures are passed.

[0206] Example 60 : The method of any example herein, in particular any of examples 52-59, further comprising, during a third cycling of the heart, causing the tissue anchor to advance through the target leaflet such that a third row of one or more radially-projecting teeth of the tissue anchor passes through the target leaflet, the third row of one or more radially-projecting teeth being disposed proximally of the second row of one or more radially-projecting teeth.

[0207] Example 61: The method of any example herein, in particular example 60, wherein the third row of teeth comprises first and second axially-aligned teeth disposed on opposite circumferential sides of the tissue anchor.

[0208] Depending on the implementation, some 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 some implementations, not all described acts or events are necessary7for the practice of the processes.

[0209] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically7stated otherwise, or otherwise understood within the context as used, is intended in its ordinary7sense and is generally7intended to convey that some implementations include, while other implementations do not include, some features, elements and / or steps. Thus, such conditional language is not generally7intended to imply7that features, elements and / or steps are in any way7required for one or more implementations or that one or more implementations 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 implementation. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in theirordinary 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 some implementations require at least one of X, at least one of Y and at least one of Z to each be present.

[0210] It should be appreciated that in the above description of implementations, features are sometimes grouped together in a single implementation, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and / or described in a particular implementation herein can be applied to or used with any other implementation(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each implementation. Thus, it is intended that the scope of the implementations herein disclosed and claimed below should not be limited by the particular implementations described above, but should be determined by a fair reading of the claims that follow7.

[0211] It should be understood that some 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.

[0212] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example implementations belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that isconsistent w ith their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0213] 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 raw ings. 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 “below7” 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.

[0214] 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.”

Claims

WHAT IS CLAIMED IS:

1. A tissue anchor delivery system comprising: an elongate shaft; a tissue anchor disposed with in a distal portion of the elongate shaft; a sensor configured to detect contact of biological tissue w ith the distal portion of the elongate shaft; and a trigger release configured to cause deployment of the tissue anchor from the distal portion of the elongate shaft in response to tissue contact detected by the sensor.

2. The tissue anchor delivery system of claim 1, wherein the tissue anchor is spring-loaded within the distal portion of the elongate shaft.

3. The tissue anchor delivery system of claim 2, wherein the trigger release is configured to actuate a catch feature configured to hold the tissue anchor in a spring-loaded configuration.

4. The tissue anchor delivery system of claim 1, wherein the tissue anchor comprises a distal puncturing tip.

5. The tissue anchor delivery system of any of claims 1-4, wherein the sensor is configured to, in response to the tissue contact, generate an electrical current that indicates the tissue contact.

6. The tissue anchor delivery system of any of claims 1-4, wherein the sensor is a pressure sensor.

7. The tissue anchor delivery system of any of claims 1-4, wherein the sensor comprises one or more optical fibers that run a length of the elongate shaft.

8. The tissue anchor delivery system of any of claims 1-4, further comprising a handle including a manually-engageable input configured to enable the trigger release.

9. A method of deploying a tissue anchor in a heart valve leaflet, the method comprising: advancing a distal portion of an elongate shaft of a delivery system to an atrium of a heart of a patient using a vascular access path, the delivery system comprising a primary tissue anchor and a plurality of secondary tissue anchors associated with the distal portion of the elongate shaft; approximating the distal portion of the elongate shaft to a target leaflet of an atrioventricular heart valve of the atrium; deploying the plurality of secondary tissue anchors into tissue of the target leaflet around a target site on the target leaflet; andwhile holding the target leaflet w ith the plurality of secondary tissue anchors, deploying the primary7tissue anchor through the target site on the target leaflet. to. The method of claim 9, further comprising retrieving the plurality of secondary tissue anchors from the target leaflet while maintaining the primary tissue anchor implanted in the target leaflet.

11. The method of claim 9 or claim 10, further comprising, prior to said deploying the primary tissue anchor, tightening the target leaflet in an area of the target site using the plurality of secondary tissue anchors.

12. The method of claim 11, wherein said tightening the target leaflet involves deflecting distal ends of the plurality of secondary' tissue anchors radially outward.

13. A tissue anchor comprising: a distal tip portion having a sharp puncture edge; and a plurality of teeth projecting from one or more sides of the tissue anchor, the plurality of teeth being arranged in a plurality of axially-offset rows.

14. The tissue anchor of claim 13, wherein the plurality of teeth are angled in a proximal direction.

15. The tissue anchor of claim 14, wherein the plurality of teeth comprise: an inclined, distally-facing surface; and a proximally-facing edge.

16. The tissue anchor of any of claims 13-15, wherein the tissue anchor has a form of a hollow tube with an axial channel running therethrough.

17. The tissue anchor of claim 16, wherein: the plurality of teeth comprise tabs formed in the hollow tube; and the tabs are coupled to the hollow tube at a base portion thereof with free edges thereof deflected radially away from a wall of the hollow tube.

18. The tissue anchor of claim 17, wherein radial deflection of the tabs provides openings into the axial channel of the hollow tube.

19. The tissue anchor of claims 16, wherein the hollow tube includes one or more pairs of opposite-facing apertures.

20. The tissue anchor of claim 19, wherein apertures of the one or more pairs of apertures are circumferentially offset by 90° from the plurality of teeth.

21. The tissue anchor of claim 19, wherein the one or more pairs of apertures comprises: a first pair of apertures disposed in a center portion of a length of the tissue anchor; and a second pair of apertures disposed in a proximal quartile of the length of the tissue anchor.

22. The tissue anchor of any of claims 13-15, wherein the distal tip portion comprises: a pointed tip; a tapered opening extending from the pointed tip to a base of the distal tip portion; and an axially-parallel sidewall extending proximally from the pointed tip to the base of the distal tip portion.

23. The tissue anchor of claim 22, further comprising a proximal tubular body portion that joins the distal tip portion at the base of the distal tip portion, wherein the plurality of teeth comprises: one or more teeth associated with the axially-parallel sidewall of the distal tip portion; and one or more teeth associated with the proximal tubular body portion.

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