Chordal tuning

Abstract

A method for improving leaflet prolapse and / or valve regurgitation associated with a heart valve is disclosed, the method comprising: introducing a chord capture device into a heart ventricle, the chord capture device comprising a central hub component and a plurality of spokes; extending the plurality of spokes outwardly from the central hub component; rotating the chord capture device in a first direction to cause at least one of the plurality of spokes to physically contact one or more chords disposed in the ventricle; further rotating the chord capture device in the first direction to cause the one or more chords to move inwardly toward the central hub component; and at least partially closing the plurality of spokes over the one or more chords to secure the one or more chords.

Description

Technical Field

[0001] This disclosure generally relates to the field of heart valve correction. Background Technology

[0002] Valve prolapse, caused by the inability of the valvular leaflets to properly assemble, can lead to valvular dysfunction, potentially resulting in regurgitation and other complications. For the atrioventricular valves, the position and / or tension of the chordae tendineae can affect the ability of the valvular leaflets to function normally. Summary of the Invention

[0003] In some embodiments, this disclosure relates to a method for treating heart valves. The method includes: introducing a chordae tendineae capture device into a heart ventricle, the chordae tendineae capture device including a central hub and a plurality of spokes; extending the plurality of spokes outwardly from the central hub; rotating the chordae tendineae capture device in a first direction such that at least one of the plurality of spokes physically contacts one or more chordae tendineae disposed in the ventricle; further rotating the chordae tendineae capture device in the first direction such that the one or more chordae tendineae turn inward toward the central hub; and at least partially closing the plurality of spokes on the one or more chordae tendineae to secure the one or more chordae tendineae. Performing this method can improve at least one of first and second leaflet prolapse of the heart valve and valvular regurgitation.

[0004] In some embodiments, the introduction of the chordae tendineae capture device is performed using a transcatheter procedure. Extending multiple spokes, rotating the chordae tendineae capture device along a first direction, further rotating the chordae tendineae capture device along the first direction, and closing the multiple spokes are performed using a delivery catheter. The method may further include releasing the chordae tendineae capture device from the delivery catheter after closing the multiple spokes.

[0005] The chordae tendon capture device may be disc-shaped. In some embodiments, the center hub component is cylindrical in shape. The plurality of spokes may include a first spoke and a second spoke offset from each other relative to the longitudinal axis of the center hub component. The center hub component may include a spool, wherein the plurality of spokes are configured to be at least partially wound on the spool. In some embodiments, the plurality of spokes comprises two spokes. Alternatively, the plurality of spokes may comprise four spokes. Furthermore, the plurality of spokes may include shape memory metal.

[0006] The method may further include: after rotating the chordae tendineae capturing device along a first direction, rotating the chordae tendineae capturing device along a second direction substantially opposite to the first direction to release one or more tendons from the plurality of spokes. In some embodiments, the method further includes: after further rotating the chordae tendineae capturing device along the first direction, but before closing the plurality of spokes, determining whether the performance of the heart valve is satisfactory. When the performance of the heart valve is determined to be unsatisfactory, the method may further include rotating the chordae tendineae capturing device along a second direction substantially opposite to the first direction. In some embodiments, the method further includes: after further rotating the chordae tendineae capturing device along the first direction, but before closing the plurality of spokes, determining whether the position of the tendons is satisfactory. When the position of the tendons is determined to be unsatisfactory, the method may further include rotating the chordae tendineae capturing device along a second direction substantially opposite to the first direction. In some embodiments, the method further includes: after rotating the chordae tendineae capturing device along the first direction, but before further rotating the chordae tendineae capturing device along the first direction, determining whether a satisfactory number of tendons have been captured on the plurality of spokes.

[0007] In some embodiments, this disclosure relates to a chordae tendineae capture device comprising a hub and a plurality of spokes attached to the hub, the spokes being configured to extend radially outward from the hub and close radially inward on one or more chordae tendineae of the heart, thereby securing one or more chordae tendineae close to the hub.

[0008] In some embodiments, the hub is disc-shaped. Alternatively, the hub component may have a cylindrical shape. The plurality of spokes may include a first spoke and a second spoke offset from each other relative to the longitudinal axis of the hub component. In some embodiments, the hub component includes a spool, wherein the plurality of spokes are configured to be at least partially wound on the spool. The plurality of spokes may include two spokes. The plurality of spokes may include four spokes. The plurality of spokes may include shape memory metal. In some embodiments, the chordae tendineae capture device is configured to be introduced into the ventricle of the heart using a catheter delivery system and to be dissociated from the catheter delivery system in the implanted state.

[0009] In some embodiments, this disclosure relates to a method for treating a heart valve. The method includes introducing a catheter delivery system into a ventricle of the heart; positioning the catheter delivery system at the level of a chordae tendineae disposed in the ventricle, the chordae tendineae connecting papillary muscles to corresponding leaflets of an atrioventricular valve associated with the ventricle; advancing a guidewire from the catheter delivery system around and near the chordae tendineae, thereby trapping at least a portion of the chordae tendineae within the guidewire; advancing a chordae tendineae snare device over the guidewire from the catheter delivery system, the chordae tendineae snare device forming a horseshoe shape around at least a portion of the chordae tendineae, thereby causing the chordae tendineae to converge toward the central flow axis of the atrioventricular valve; and withdrawing the catheter delivery system from the ventricle.

[0010] The method may further include replacing the guidewire with a relatively stiffer guidewire after advancing the guidewire and before advancing the chordal snare device. The method may further include advancing a cannula sheath onto the guidewire after advancing the guidewire and before advancing the chordal snare device.

[0011] In some embodiments, the diameter of the chordal snare device is 1-2 cm. In some embodiments, the diameter of the chordal snare device is 2-4 cm. The chordal snare device may include a flexible catheter and a shape-memory metal support pre-shaped to form a horseshoe shape at body temperature. In some embodiments, advancement of the chordal snare device on the guidewire is performed at least in part by advancing a pusher device from the catheter delivery system.

[0012] The method may include: determining whether the performance of the heart valve is satisfactory after advancing the chordal snare device but before withdrawing it from the catheter delivery system. When the performance of the heart valve is determined to be unsatisfactory, the method may include withdrawing the chordal snare device at least partially back into the catheter delivery system. In some embodiments, the method includes: determining whether the position of the chordal tendon is satisfactory after advancing the chordal snare device but before withdrawing it from the catheter delivery system. When the position of the chordal tendon is determined to be unsatisfactory, the method may include withdrawing the chordal snare device at least partially back into the catheter delivery system. Attached Figure Description

[0013] For illustrative purposes, various embodiments are depicted in the accompanying drawings and should in no way be construed as limiting the scope of the invention. Furthermore, various features of the different disclosed embodiments may be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numerals may be repeated to indicate correspondences between reference elements.

[0014] Figure 1 Provides a cross-sectional view of the human heart.

[0015] Figure 2 A cross-sectional view of the left ventricle and left atrium of an exemplary heart is provided.

[0016] Figure 3 Provides a cross-sectional view of a heart experiencing mitral regurgitation.

[0017] Figure 4 Illustration Figure 3 A portion of the heart shown.

[0018] Figure 5 A portion of a heart valve having a chordae tendineae capture device implemented therein is shown according to one or more embodiments.

[0019] Figure 6 A flowchart representing a process for capturing chordae tendineae according to one or more embodiments disclosed herein is provided.

[0020] Figure 7 The following are examples illustrating one or more embodiments: Figure 6 Examples of the various stages of the process performed in the heart to capture the chordae tendineae are shown.

[0021] Figure 8 This is a flowchart of a process for adjusting the position of the chordae tendineae according to one or more embodiments.

[0022] Figure 9 This is a perspective view of a chordae tendon capture device according to one or more embodiments.

[0023] Figure 10 A flowchart representing a process for capturing chordae tendineae according to one or more embodiments disclosed herein is provided.

[0024] Figure 11 The following are examples illustrating one or more embodiments: Figure 10 Examples of the various stages of the process performed in the heart to capture the chordae tendineae.

[0025] Figure 12 This is a flowchart of a process for adjusting the position of the chordae tendineae according to one or more embodiments. Detailed Implementation

[0026] The headings provided herein are for convenience only and do not affect the scope or meaning of the claimed invention.

[0027] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents of such alternative embodiments and / or uses. Therefore, the scope of the resulting claims is not limited to any particular embodiment described below. For example, with respect to any method or process disclosed herein, the actions or operations of the method or process can be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as a plurality of discrete operations in a manner conducive to understanding certain embodiments; however, the order of description should not be construed as implying that these operations are order-dependent. Furthermore, the structures, systems, and / or devices / apparatus described herein may be embodied as integrated components or separate components. Certain aspects and advantages of these embodiments are described for the purpose of comparing various embodiments.

[0028] Not all of these aspects or advantages need to be achieved through any particular embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one or a set of advantages as taught herein, without necessarily achieving other aspects or advantages that may also be taught or suggested herein. Similar reference numerals may be used with respect to individual figures and / or embodiments; the use of these similar or identical reference numerals should not be construed as necessarily identifying the same parts and may refer to individual features.

[0029] Overview

[0030] In humans and other vertebrates, the heart typically comprises a muscular organ with four pump chambers, the flow of which is at least partially controlled by various cardiac valves: the aortic valve, the mitral valve (or mitral valve), the tricuspid valve, and the pulmonary valve. Valves can be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., relaxation and contraction) to at least partially control blood flow to corresponding areas of the heart and / or blood vessels (e.g., the lungs, aorta, etc.).

[0031] Figure 1 An exemplary representation of a heart 1 having various features associated with certain embodiments of the invention disclosed herein is shown. The heart 1 includes four chambers: a left atrium 2, a left ventricle 3, a right ventricle 4, and a right atrium 5. A muscular wall 17 (referred to as a diaphragm) separates the left atrium 2 and right atrium 5, and the left ventricle 3 and right ventricle 4. The heart 1 further includes four valves for assisting blood circulation therein, including a tricuspid valve 8 that separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 may typically have three cusps or leaflets and is typically closed during ventricular contraction (i.e., systole) and open during ventricular dilation (i.e., diastole). The valves of the heart 1 further include a pulmonary valve 9 that separates the right ventricle 4 from the pulmonary artery 11, and the pulmonary valve 9 may be configured to open during systole so that blood can be pumped toward the lungs, and to close during diastole to prevent blood from leaking back into the heart from the pulmonary artery. The pulmonary valve 9 typically has three cusps / leaflets, each of which may be crescent-shaped. The heart 1 further includes a mitral valve 6, which typically has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is typically configured to open during diastole to allow blood in the left atrium 2 to flow into the left ventricle 3, and to close advantageously during diastole 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 to leave the left ventricle 3 and enter the aorta 12, and to close during diastole to prevent blood from leaking back into the left ventricle 3.

[0032] Heart valves typically comprise a relatively dense fibrous annulus (referred to herein as the valve annulus) and multiple leaflets or cusps attached to the annulus. Generally, the size and position of the leaflets or cusps are such that, when the heart contracts, the increased blood pressure generated in the corresponding heart chamber forces the leaflet to open at least partially to allow flow out of the heart chamber. As the pressure in the heart chamber decreases, the pressure in subsequent chambers or blood vessels can become dominant and press back against the leaflet. As a result, the leaflets / cusps are positioned juxtaposed, causing them to engage and close the flow passage.

[0033] Atrioventricular (i.e., mitral valve 6 and tricuspid valve 8) heart valves may further include corresponding sets of chordae tendineae (16, 11) and papillary muscles (15, 10) for securing the leaflets of the respective valves to facilitate and / or promote proper engagement of the leaflets and prevent leaflet prolapse. The papillary muscles (15, 10) typically include finger-like projections from the ventricular wall, while the chordae tendineae (16, 10) may include cord-like tendons connecting the papillary muscles to the valve leaflets.

[0034] Regarding the mitral valve 6, a normal mitral valve comprises two leaflets (anterior and posterior) and chordae tendineae 16 connecting the leaflets to two corresponding papillary muscles 15. The papillary muscles 15 originate from the left ventricular wall and protrude into the left ventricle 3. The chordae tendineae 16, which connect the valve leaflets to the papillary muscles 15, act as tendons, preventing the leaflets of the mitral valve 6 from prolapse into the left atrium 2. The relatively inelastic chordae tendineae 16 are attached at one end to the papillary muscles 15 and at the other end to the valve leaflets; each papillary muscle 15's chordae tendineae are attached to the corresponding leaflet of the mitral valve 6. Therefore, when the left ventricle 3 contracts, the intraventricular pressure can force the valve to close, while the chordae tendineae 16 keep the leaflets engaged and prevent the valve from opening in the wrong direction, thus preventing blood from flowing back into the left atrium 2. The various types of tendineae can have different thicknesses, with relatively thinner tendineae attached to the free leaflet margin, while relatively thicker tendineae (e.g., strut tendineae) are attached further away from the free margin.

[0035] Regarding the tricuspid valve, a normal tricuspid valve may consist of three leaflets. Figure 1 Two) and three corresponding nipple muscles are shown in the figure. Figure 1(Two are shown in the diagram). The leaflets of the tricuspid valve 8 may be referred to as the anterior leaflet, posterior leaflet, and septal leaflet, respectively. The leaflets are connected to the papillary muscles via chordae tendineae 11, which, together with the papillary muscles 10, are positioned in the right ventricle 4. Although the tricuspid valve is described herein as comprising three leaflets, it should be understood that in some patients and / or conditions, the tricuspid valve may have two or four leaflets; the principles disclosed herein relating to papillary muscle attachment and / or adjustment apply to atrioventricular valves or their associated papillary muscles with any number of leaflets and / or chordae tendineae. The right ventricular papillary muscles 10 originate from the right ventricular wall and are attached to the anterior, posterior, and septal leaflets of the tricuspid valve via chordae tendineae 11, respectively. The papillary muscles 10 can be used to fix the leaflets of the tricuspid valve 8 to prevent leaflets from prolapse into the right atrium 5 during ventricular systole. Tricuspid regurgitation may be a result of papillary dysfunction or chordae tendineae rupture.

[0036] Figure 2 A cross-sectional view of the left ventricle 3 and left atrium 2 of an exemplary heart 1 is provided. Figure 2 The diagram illustrates the mitral valve 6, wherein the arrangement of the valve 6, papillary muscle 15, and / or chordae tendineae 16 can be interpreted as providing proper engagement of the valve leaflets 65 to advantageously prevent, at least partially, regurgitation and / or unwanted flow from the left ventricle 3 into the left atrium, and vice versa. Although the mitral valve 6 is shown in... Figure 2 The principles of chordae tendineae capture and / or adjustment disclosed herein have been described in the various other accompanying drawings provided herein and in the context of certain embodiments of this disclosure. However, it should be understood that the principles of chordae tendineae capture and / or adjustment disclosed herein can be applied to any atrioventricular valve, such as the tricuspid valve, and associated anatomical structures (e.g., chordae tendineae, papillary muscles, ventricular walls, etc.).

[0037] As described above, regarding Figure 2 The healthy heart valve shown has leaflets 65 that extend inward from the valve annulus and converge in the flow orifice to allow flow in the outflow direction (e.g., Figure 2 The flow is directed downwards and prevented from flowing in the inflow direction (e.g., Figure 2The backflow or regurgitation (in the upward direction) of blood. For example, during atrial systole, blood flows down a pressure gradient from atrium 2 to ventricle 3, causing chordae tendineae 16 to relax as atrioventricular valve 6 is forced to open. When ventricle 3 contracts during ventricular systole, the increased blood pressure in both chambers can push valve 6 to close, preventing blood from flowing back into atrium 2. Because the blood pressure in the atrium is lower than in the ventricle, the valve leaflets may tend to be drawn towards the atrium. Chordae tendineae 16 can be used to tighten the leaflets and hold them in a closed position when the chordae tendineae become taut during ventricular systole. Papillary muscles 15 provide structures in the ventricle for securing chordae tendineae 16, thus allowing chordae tendineae 16 to hold leaflets 65 in a closed position. Papillary muscles 15 may include anterolateral papillary muscles and posteromedial papillary muscles; for example, the anterolateral papillary muscles may be tightened on the posterior leaflet, and the posteromedial papillary muscles may be tightened on the anterior leaflet. Figure 2 The state of the heart 1 shown, with proper engagement of the valve leaflets (which may be partly due to the proper position and / or tension of the chordae tendineae 16), can advantageously make mitral valve operation substantially leak-free.

[0038] Heart valve disease refers to a condition in which one or more valves of the heart fail to function properly. Diseased heart valves can be classified as stenotic heart valves and / or insufficiency heart valves. In stenotic heart valves, the valve cannot open sufficiently to allow blood to flow forward adequately through the valve. In insufficiency heart valves, the valve does not close completely, causing excessive backflow of blood through the valve when it is closed. In some cases, if not adequately treated, valvular disease can lead to severe heart failure or even death. Regarding insufficiency heart valves, over time and / or due to various physiological conditions, the position and / or tension of the chordae tendineae and / or papillary muscles may change, pulling the valve leaflets to at least partially open, which can lead to valvular regurgitation. For example, functional mitral regurgitation can occur when the left ventricle of the heart is deformed or dilated, causing displacement of the papillary muscles supporting the mitral valve leaflets and the chordae tendineae attached to them. For example, the valve leaflets may no longer come together to close the valve annulus, causing blood to flow back into the atria. If left untreated, functional mitral regurgitation can overload the heart and cause or accelerate heart failure. Moving or pulling the chordae tendineae closer to the flow axis of the valve annulus, based on their natural and healthy position, can potentially reduce the occurrence of valvular regurgitation.

[0039] Figure 3The illustration shows a cross-sectional view of a heart 1 undergoing functional mitral regurgitation flow 21, which can be at least partially caused by left ventricular dilation. Left ventricular dilation can cause a change in the position of the papillary muscles 15, thereby allowing flow 21 to return from ventricle 3 to atrium 2. Left ventricular dilation can be caused by a number of conditions such as focal myocardial infarction, global ischemia of myocardial tissue, or idiopathic dilated cardiomyopathy, resulting in alterations in the geometry between the papillary muscles and other components associated with the valve(s)(s) that can cause regurgitation. Functional regurgitation may be present even if the valvular components are pathologically normal, but may fail to function properly due to changes in the surrounding environment. Examples of such changes include geometrical alterations of one or more cardiac chambers and / or reduced myocardial contractility. In any case, the potential volumetric overload due to valvular insufficiency can increase chamber wall stress, ultimately leading to a drag effect that causes changes in the papillary muscles and / or chordae tendineae, resulting in valvular dysfunction and reduced cardiac efficiency.

[0040] When the chordae tendineae 16 is pulled away from the flow axis of valve 6, the attached valve leaflets 65 no longer sufficiently converge to close the valve annulus and prevent blood from flowing back into the atrium 2. The solution proposed in this paper provides a device and method for bringing the chordae tendineae 16 closer to its previous position, which can advantageously reduce the occurrence of mitral regurgitation. Figure 3 As shown, the failure of the leaflet 65 of the mitral valve (or tricuspid valve) to engage results in an opening between the leaflets 65 during the systolic phase of the cardiac cycle, which allows the leakage flow 21 of fluid to return upward into the atrium 2. This is in addition to the outflow direction (e.g., Figure 3 Undesirable flow 21 in the upward direction (in the middle), the valve leaflets 65 failed to properly engage, resulting in flow towards the inflow direction (e.g., Figure 3 (downward direction in the middle) and in some cases, unwanted backflow or reflux.

[0041] Various techniques with certain drawbacks (including surgical repair or replacement of the diseased valve or patient management) can be implemented to treat mitral valve dysfunction. These techniques may be appropriate / effective primarily in the early stages of valve dysfunction where the level of regurgitation may be relatively low. For example, such management often focuses on volume reduction, such as diuretics or afterload-reducing agents (such as vasodilators). Valve replacement procedures can also be used to treat regurgitation caused by valvular dysfunction. However, such procedures may lead to ventricular dysfunction or postoperative failure. Further limitations on valve replacement protocols may include the potential need for prolonged or lifelong treatment using potent anticoagulants to mitigate the possibility of thromboembolism in the prosthetic valve implant. Furthermore, in the case of bio-derived devices, such as those used for mitral valve replacement, long-term durability is limited. Another commonly used repair technique involves using annulusop annuloplasty rings to improve mitral valve function. Annulusop annuloplasty rings can be placed within the valve annulus, and tissue of the annulus can be sutured to or otherwise secured to the ring. Valve annuloplasty rings can reduce the annular periphery and / or increase the leaflet junction area. However, annuloplasty rings may flatten the saddle-shaped shape of the valve and / or impede the natural contraction of the valve annulus. Additionally, various surgical techniques can be used to treat valvular dysfunction. However, these techniques may be limited by various factors, such as the need to open the heart to directly access the valve and valve annulus. Therefore, cardiopulmonary shunts may be required, which can increase morbidity and mortality during surgical procedures. Furthermore, assessing the effectiveness of the repair before the completion of the procedure is difficult or impossible for surgical procedures.

[0042] This document discloses various solutions for reducing regurgitation while maintaining substantially normal lobular anatomy. These solutions relate to devices and methods for treating valvular dysfunction without cardiopulmonary bypass and without significant remodeling of the dysfunctional valve. Such devices and methods include using passive techniques to capture and adjust some or all of the chordae tendineae to alter the degree and / or orientation of the tension of one or more chordae tendineae on the corresponding lobule of the associated heart valve. Furthermore, the various embodiments disclosed herein provide treatment for valvular dysfunction that can be performed on a beating heart, thereby allowing the ability to assess the efficacy of papillary muscle repositioning therapy and potentially enabling modifications thereto without the need for bypass support.

[0043] Certain embodiments disclosed herein provide solutions for heart valves with closure insufficiency, involving the use of an implanted capture device to capture one or more chordaes tendinos in order to adjust (one or more) the chordaes(s) and pull (one or more) of the chordaes(s) in an inward direction relative to the flow axis of the valve. The term "chordae" is used herein according to its broad and general meaning, and in the context of chordaes tendinos, can be understood to refer to one or more or all individual strings, tendons, chordae, or a group of identical chordaes / chordae that collectively comprise the chordae tendinos or its valvular leaflets associated with the heart valve. The solutions proposed herein can be used to at least partially alter the position of one or more chordaes tendinos to reduce the occurrence and / or severity of regurgitation, such as mitral regurgitation.

[0044] chordae tendineae capture / adjustment

[0045] As described above, certain embodiments disclosed herein provide systems, apparatus, and methods for capturing and / or adjusting the position of chordae tendineae (CTs) in the left and / or right ventricles of the heart to improve valve engagement during ventricular systole. For example, a CT capture / adjustment device is disclosed that can be independently implanted into one ventricle of the heart. This device can be introduced into the patient's system surgically or advantageously via minimally invasive means.

[0046] Figure 4 Illustration Figure 3 This is a part of the heart 1 shown and described above. Specifically, Figure 4 The diagram shows valve leaflets 65a and 65b in a closed state, where undesired tension and / or outward pulling force applied to the leaflets by the corresponding chordae tendineae creates an opening 23 through which fluid can flow in the regurgitation direction. As shown, CTs 16a and 16b can hold leaflets 65a and 65b in a position such that the leaflet edges do not properly engage during ventricular systole. Regurgitation may be present when CTs 16a and 16b are in a position where they pull leaflets 65a and 65b outward to prevent proper engagement.

[0047] The chordae tendon capture methods and / or devices disclosed herein may include structures for corralling and / or retracting one or more tendons to provide advantageous repositioning for CT. Reference Figure 5 This allows for the understanding of various solutions for capturing and / or repositioning the chordae tendineae to allow proper closure of the associated valves during ventricular systole. Figure 5A heart valve 500 is illustrated, comprising leaflets 65a, 65b coupled to corresponding chordae tendineae (CTs) 16a, 16b, wherein the CTs are at least partially captured by a CT capture device 20. The device 20 can be implemented to treat, for example, mitral regurgitation. In some embodiments, implantation of the device 20 provides valve (e.g., mitral valve) remodeling by influencing the convergence of one or more chordae tendineae 16a, 16b toward the central axis or midline point of the ventricle. Thus, the leaflets 65a, 65b can be pulled more tightly together, which can advantageously improve function and / or reduce regurgitation through improved leaflet engagement.

[0048] Device 20 may include any suitable or desired form, shape, or configuration, and may include any number of components or parts. For example, embodiments of device 20 disclosed herein include one or more hubs, spokes, belts, lines, shapes, or the like. Procedures and methods for implanting CT capture devices according to this disclosure may involve transcatheter delivery such as transfemoral, transseptal, transapical, or other types of transcatheter procedures.

[0049] Figure 6 A flowchart is provided representing the process of capturing chordae tendineae (CT) using a CT capture device 30 according to one or more embodiments disclosed herein. Figure 7 As shown Figure 6 Examples of the various stages of the process for capturing chordae tendineae are shown below.

[0050] At box 602, process 600 involves introducing a CT capture device 30 into a cardiac ventricle, approaching the chordae tendineae of the ventricle. For example, stage 702 shows a top view of the CT capture device 30, which is positioned to approach a plurality of chordae tendineae 76 in the relevant ventricle. Although a certain number and configuration of chordae tendineae and a specific positioning of the CT capture device 30 are illustrated, it should be understood that process 600 can be implemented using any number or configuration of chordae tendineae and / or any positioning of the CT capture device within the proximity range, within which one or more chordae tendineae can be effectively captured by the CT capture device.

[0051] In some embodiments, prior to full deployment, the device 30 may take the form of a relatively small disc or hub component 32 having one or more spokes 35 or extensions configured to radiate or extend outward from a central hub, such as by rotation or other activation of the hub 32 and / or the spokes 35. When initially positioned to approach the cable 76, the spokes 35 may be in a retracted state, such as being at least partially wound around the central hub 32. The hub may be disc-shaped, cylindrical, spherical, elliptical, or other shapes. Furthermore, the hub 32 may include a reel or other form or component around which the spokes 35 may be at least partially wound. In some embodiments, the shape of the CT capture device 30 may, in some respects, at least partially resemble the shape of a spiral galaxy such as the Milky Way.

[0052] In some embodiments, spokes 35 may comprise wires such as shape memory metal wires (e.g., nitinol). Spokes 35 may be designed to close concentrically around themselves and wind around a central hub at least partially during deployment. Device 30 may be configured to collapse at least partially into, for example, a cylindrical shape. In the collapsed / retracted state, device 30 may be adapted for introduction via a guide catheter and / or cannula sheath.

[0053] At block 604, process 600 involves extending the spokes / extensions 35 and rotating the device 30 by a certain amount, such that one or more of the spokes / extensions 35 contact and / or capture or hold one or more of the tendineae 76, as shown in stage 704. It should be understood that although four spokes 35 are shown for illustrative purposes, the CT capture device according to embodiments of this disclosure can have any suitable or desired number of spokes or extensions, and the CT capture device can be configured to capture any number of tendineae. Once extended, process 600 may involve capturing or contacting one or more tendineae 76 using one or more spokes 35 by rotating the device 30 in a first direction (e.g., clockwise relative to the top view, as shown) or in the opposite direction (e.g., counterclockwise).

[0054] As shown in stage 704, one or more spokes 35 may initially contact or capture one or more cables 76 at or near the distal portion of the spoke. As shown, the spokes 35 may have a shape that is at least partially curved, such that rotation of the device 30 in the concave direction of the spokes(one or more) 35 can be used to drag the captured cable 76 in an inward direction toward the central hub 32. Although Figure 7 The diagram illustrates each spoke of device 30 as capturing or catching a cable, but it should be understood that process 600 may involve capturing / catching more than one cable or not capturing / catching a cable with any given spoke of device 30.

[0055] At frame 606, process 600 involves further rotating the device 30 to bring the captured cord inward, thereby advantageously pulling the associated valvular leaflets closer together to reduce regurgitation or otherwise improve valvular function. As described above, the concave surface or one or more other features of the spokes 35 may cause the captured cord 76 to be pulled inward toward the central hub 32.

[0056] At frame 608, process 600 may involve ratcheting or otherwise collapsing the spokes 35 at least partially about the central hub 32 to secure the captured cable 76 in a desired position. In some embodiments, the central hub 32 of the CT capture device 30 may serve as an anchor point for the spokes and may further include a ratcheting mechanism for ratcheting the spokes, as shown. The device 30 may further include tools or mechanisms for attaching to and / or separating from a delivery system for delivering the device 30 to... Figure 7 The positions shown are one or more. For example, a ratchet mechanism can be used to constrain the spokes 35 in their fully open configuration (e.g., a spiral configuration) before final deployment. With embodiments including shape-memory wire spokes, the spokes can be in a tensioned state in an extended position; when the ratchet mechanism is activated, the spokes can return (e.g., gradually return) to their pre-formed shape-memory position. For example, the shape-memory position of the spokes can be a position similar to that shown in stage 702, where the spokes 35 are wound around the hub 32 in a wound spiral configuration.

[0057] In some embodiments, in Figure 7 As shown in and combined Figure 6 The capture of the cable 76 described in process 600 may be at least partially reversible. For example, the configuration of process 600 and / or device 30 and / or the associated delivery system may allow spokes 35 to open and close, thereby allowing device 30 to be repositioned and / or removed before final deployment, or even restored and / or repositioned after final deployment.

[0058] Phase 708 shows the CT capture device 30 in its final deployed state, wherein the capture cable 76 is constrained by folded or retracted spokes 35. The degree to which the spokes rotate or tighten around the captured CT can be determined by the resulting movement of the CT and / or the reduction of associated valvular regurgitation. In the fully deployed state, the device 30 can remain in place indefinitely within the ventricle (e.g., the left ventricle) to provide continuous improvement in valvular function. In some embodiments, the deployed device 30 and / or its central hub 32 may have a shape or form that is at least partially similar to a button or similar design.

[0059] Figure 8 This is a flowchart of a process for adjusting the position of the chordae tendineae according to one or more embodiments. At block 802, process 800 involves introducing a chordae tendineae (CT) capture device into the ventricle of the heart and positioning the CT capture device near one or more chordae tendineae disposed in the ventricle and attached to its atrioventricular valves. The CT capture device can be introduced into the ventricle using a transcatheter procedure such as transfemoral, transapical, transseptal, or other transcatheter procedures. In some embodiments, process 800 may involve introducing the CT capture device into the ventricle during open-heart surgery / open-heart surgery, or using a hybrid surgical / transcatheter approach. The CT capture device can be introduced into the desired location using a cannula containing the device, wherein the cannula can be advanced, for example, into the left ventricle.

[0060] In some embodiments, the CT capture device is positioned below the associated atrioventricular valve (e.g., the mitral valve) and at least partially above the papillary muscle, at or near the level of the chordae tendineae attached to the valve. The sheath may be retracted, or the CT capture device may be otherwise exposed. In some embodiments, the CT capture device may include one or more spokes or extensions, such as spiral spokes or the like.

[0061] At frame 804, process 800 involves extending one or more spokes or extensions of the CT capture device. For example, the spokes may be deployed in a plane parallel or substantially parallel to the valve annulus. A delivery system for positioning the CT capture device may be positioned in a location substantially parallel to the CT and perpendicular to the deployment plane of the spokes.

[0062] As further illustrated in block 804, process 800 involves rotating the CT capture device in a first direction to contact and / or capture one or more cables of the CT. Rotation of the device can cause one or more spokes to contact one or more cables, wherein the shape or configuration of the spokes(s) can facilitate cable capture upon contact and further rotation. For example, the spokes can utilize a concave shape that, when the CT capture device rotates in a concave direction, causes the cable in contact with the spokes(s) to be dragged inward.

[0063] At decision box 805, process 800 may involve determining whether the previously performed steps have achieved the desired CT capture. For example, it may be determined whether the desired line or number of lines has been captured, and / or whether the desired spoke(s) ...

[0064] If it is determined that the desired CT capture has not been achieved, process 800 may involve rotating the CT capture device in a second direction at block 806, which may be in the opposite direction to the first direction. Rotation in the second direction may at least partially release one or more spokes from the captured CT to allow adjustment / repositioning of the CT capture device, as shown in block 808. In some embodiments, rotation in the second direction may release all captured CT. In some embodiments, if it is determined at block 805 that a satisfactory result has not been achieved, the CT capture device may be completely retrieved at this stage by withdrawing it into the cannula sheath. If repositioning of the CT device is desired at block 808, the device may be repositioned, and the CT capture process may be repeated starting from block 804.

[0065] If the desired capture is achieved at frame 805, process 800 can proceed to frame 810, where the CT capture device can be further rotated in the first direction so that the captured CT is in an inward orientation. In some embodiments, as rotation continues, the spiral / concave spokes of the CT capture device operate to force the captured cable to move closer to the central hub or central portion of the device, which in turn can attach the CT to the corresponding valve leaflet, pulling the valve leaflet closer together.

[0066] At decision box 811, process 800 involves determining whether previous steps have resulted in the desired repositioning of the CT. For example, the CT apparatus and CT may be assessed to determine whether they are in the desired position and / or whether the resulting function of the heart valves is satisfactory. The assessment at box 811 may be performed using echocardiography or other means. Whether the results assessed at box 811 are satisfactory can be determined by the movement produced by the CT and / or a reduction in valvular regurgitation. For example, valvular function may be assessed to determine whether acceptable valvular closure has been achieved. If not, process 800 may proceed to box 812, where the CT capture device may be further rotated in a first direction to further tighten or bring the captured CT inward, or alternatively, the CT capture device may be rotated in a second direction opposite to the first direction to release or relax the CT. The purpose of the steps at box 812 is to achieve the desired CT capture, and therefore the modification steps(s) performed at box 812 may be guided by the desired specific modification / repositioning. Boxes 811 and 812 can provide loops to adaptively produce the desired result through evaluation and subsequent adjustments until the desired result is achieved.

[0067] The results of the CT capture device configuration / adjustment can be observed continuously or at selected intervals to determine when the CT has been adequately repositioned to provide the desired improvement in valve closure during the cardiac cycle phase associated with the closure of the relevant valve (e.g., during systole in the case of the mitral valve). Therefore, the process 800 and / or other processes, devices, and systems disclosed herein can advantageously provide a tunable CT adjustment system that can be tuned, for example, by using echo or other visual guidance, while monitoring system effectiveness. In some embodiments, if a satisfactory result is not achieved at block 811, process 800 may involve complete retrieval of the CT capture device by withdrawing it into the cannula sheath.

[0068] At box 814, if a satisfactory result has been achieved as shown at box 811, process 800 involves rotating or closing the spokes of the CT capture device like a ratchet to at least partially hold the captured CT in the desired position. For example, the CT capture device and / or its associated delivery system may include a ratchet system configured such that the spokes of the CT capture device are at least partially wound around the central hub or central portion of the device, thereby keeping the captured CT close to the central hub or central portion. It should be understood that in some embodiments, any step of process 800 is reversible.

[0069] At box 815, process 800 may involve separating or otherwise decoupling the CT capture device from the delivery system to leave the final implant, such as one configured in the ventricle of the heart.

[0070] Figure 9 A perspective view of a chordae tendineae (CT) capture device 930 according to one or more embodiments is provided. Device 930 includes a central hub portion 932, which may be generally cylindrical, as shown. Device 930 may include a plurality of spokes or extensions 91-94, which in some embodiments may be vertically staggered. For example, one or more spokes (e.g., spokes 91, spokes 93) may be vertically offset along the longitudinal axis y of the cylindrical hub 932 of device 930. In some embodiments, two or more spokes may be positioned in a first vertical position, while two or more other spokes are positioned in a second vertical position offset from the first vertical position. The vertical staggering / offset of the spokes may allow device 930 to be more easily loaded into relatively small-sized intubation devices or catheters. Device 930 may be implanted into the ventricle of the heart according to any of the procedures or operations disclosed herein.

[0071] Tendon looper

[0072] The apparatus and methods for capturing and / or adjusting chordae tendineae (CTs) according to this disclosure can use devices of any suitable or desired form. Certain embodiments disclosed herein provide CT capture using a snare or similar device. In some embodiments, the snare may be at least partially wrapped around the CT in the ventricle to force or push the CT toward a center point to improve mitral valve leaflet engagement. For example, the center point may be aligned with or near the flow axis of a heart valve associated with the wrapped CT.

[0073] Figure 10 A flowchart representing a process 1000 for capturing chordae tendineae according to one or more embodiments disclosed herein is provided. Figure 11 As shown Figure 10 Examples of the various stages of the process 1000 for capturing chordae tendineae are shown.

[0074] At box 1002, procedure 1000 may involve inserting catheter 40 into the ventricle using a transcatheter procedure. Catheter 40 may be inserted as part of a delivery system for a CT snare device, wherein the catheter is capable of holding the CT snare device and / or a guide catheter. The system may be introduced via a transapical, transseptal, or possibly transfemoral approach. In some embodiments, the delivery system may be advanced into the left ventricle via the apex. The distal end of catheter 40 may provide the working end of the delivery system and may be close to the CT 16, such as at or just below the CT level.

[0075] At frame 1004, process 1004 involves advancing guidewire 53 from catheter 40 and further advancing CT snare device 50 from catheter 40 to form a partial loop around CT 16. For example, a particularly curved catheter and guidewire 53 may be pushed out from the delivery system. Wire 53 and catheter may be shaped to allow wire 53 and catheter to curve around the inner wall of the ventricle. Wire 53 may be bent around CT 16 in a plane generally parallel to the valve annulus (not shown) of valve 13 and / or at the level of CT 16. Catheter and wire may be further advanced and manipulated around the curve until they complete a near-circular loop around the ventricular wall, forming at least a partial loop and terminating near the delivery system. Several strands of CT 16 may advantageously be captured within the loop.

[0076] The end of wire 53 can be grasped and pulled out of the system, resulting in a straight wire looped around the outside of several cables, with both ends of the wire outside the delivery system and close to the operator. In some embodiments, wire 53 can be replaced with a stiffer wire, such as by using an exchange catheter, to facilitate the advancement of one or more components on wire 53. For example, an intubator sheath can be advanced coaxially with the delivery system on the wire until it passes through the CT. In some embodiments, the wire can be further replaced with a softer wire.

[0077] Once the guidewire 53 has been looped around the CT 16, the snare device 50 can be advanced from the catheter 40 (such as from another lumen of the delivery system) into the ventricle. The device 50 can take the form of a relatively short horseshoe-shaped or hoop-shaped tube. In some embodiments, the snare device 50 can be approximately 1-2 cm in diameter, or approximately 2-4 cm in diameter. The snare device 50 can comprise a material that is rigid enough to restrain the CT 16 within the loop, but flexible enough to be advanced in a relatively straight configuration over the guidewire 53. In some embodiments, the snare device 50 can be manufactured using a combination of flexible catheter materials, reinforced with shape-memory metal (e.g., nitinol) struts that have been pre-shaped to form a horseshoe or hoop configuration when heated to body temperature.

[0078] The snare device 50 can be introduced onto the guidewire 53 within the guiding catheter, followed by a pusher component (such as a relatively rigid, straight catheter). The pusher component (not shown) can be advanced until the device 50 is at the level of the CT 16 and, once deployed, positioned to form a relatively taut loop around the CT 16. The snare device 50 can be exposed when the pusher component and / or the internal guiding catheter / cannula is withdrawn. After withdrawal of the guiding catheter, the snare device 50 can form its final hoop shape and operate, for example, in a direction toward an imaginary center point to restrain the CT 16. In some embodiments, process 1000 may involve evaluating the performance, position, and / or function of the snare device 50 relative to the valve 13 (e.g., the mitral valve).

[0079] At frame 1006, process 1000 involves forming a ring using a CT snare device. The ring can be advantageously tensioned relative to each other to constrain the CT 16 in a position that allows the valve leaflet 65 to enter the engagement position. Using, as... Figure 11As shown in stage 1106, the snare device 50 can be positioned so that the CT 16 can be captured from the outside, rather than from the inside as in some other embodiments. If the resulting position and / or valve performance is satisfactory, the CT capture device 50 can be fully deployed, at least partially, by removing the guidewire 53. If device retrieval is recommended or desired prior to deployment, this retrieval can be achieved, at least partially, by re-sheathing the device 50 within the guiding catheter and withdrawing the device 50. In some embodiments, retrieval can be performed at virtually any point prior to guidewire removal.

[0080] Adjustable chordae tendineae

[0081] Figure 12 This is a flowchart of a process 1200 for adjusting the position of the chordae tendineae (CT) according to one or more embodiments. At block 1202, process 1200 involves inserting a CT capture device (such as a hub and spoke device or snare device as described in more detail herein) into the ventricle using a transcatheter procedure. Although Figure 12 Transcatheter procedures are described, but in some embodiments, surgical means may be used, such as during open-heart surgery, to introduce a CT capture device into the ventricle.

[0082] At box 1204, process 1200 involves using a CT capture device to capture multiple cables of a CT associated with a heart valve. For example, capturing a cable may involve dragging the cable in a certain way to allow the valve leaflet to enter the proper engagement, as described in detail herein. At box 1206, process 1200 involves tightening, winding, or otherwise adjusting the CT capture device to change the position of the captured CT.

[0083] The degree of adjustment of the CT capture device at box 1206 can be determined by the movement produced by the CT and / or the resulting reduction in regurgitation. At box 1208, process 1200 involves evaluating the CT position and / or valvular regurgitation caused by the CT capture / adjustment, such as by determining whether the evaluation position and / or regurgitation performance of the evaluated / observed CT is satisfactory or desirable, to determine the effectiveness of the CT capture device.

[0084] At decision box 1210, process 1200 involves determining whether the CT position and / or regurgitation performance evaluated / observed at box 1208 is satisfactory or desirable. If not, process 1200 returns to box 1206, where the CT capture device can be further adjusted by tightening, loosening, and / or repositioning, thereby further altering the device's effect on CT. In some embodiments, the operator may use echocardiography or any other suitable means to observe the movement of the valve leaflets, such as observing the movement of the valve leaflets in real time. The results of the CT capture device positioning / configuration can be observed continuously or at selected intervals to determine when the CT has been sufficiently repositioned to provide the desired improvement in valve closure during the cardiac cycle phase associated with the closure of the relevant valve (e.g., during systole in the case of the mitral valve). Therefore, the process 1200 and / or other processes, devices, and systems disclosed herein can advantageously provide an adjustable device that can be tuned, for example, by using echocardiography or other visual guidance, when monitoring the effectiveness of the device.

[0085] If the desired result is determined to be achieved at box 1210, process 1200 continues to box 1212, where the CT capture device can be fixed and / or locked in the desired position and / or released from the delivery system to allow the CT capture device to provide continuous CT positioning on a sustained basis to improve cardiac valve function.

[0086] Additional Examples

[0087] According to embodiments, certain actions, events, or functions of any process or algorithm described herein may be performed in a different order, and may be added, combined, or omitted entirely. Therefore, in some embodiments, not all described actions or events are necessary for the practice of the process. Furthermore, in some embodiments, actions or events may be performed concurrently, for example, through multithreaded processing, interrupt handling, or via multiple processors or processor cores, rather than sequentially.

[0088] The conditional language used herein, such as, in particular, “can,” “able to,” “may,” “may,” “e.g.,” etc., unless expressly stated otherwise or otherwise understood in the context in which they are used, is intended to mean “in the general sense” and is generally intended to express that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Therefore, this conditional language is not generally intended to imply that one or more embodiments require features, elements, and / or steps in any way, or that one or more embodiments must include logic for determining whether or not such features, elements, and / or steps are included or will be performed in any particular embodiment, with or without author input or prompting. The terms “comprising,” “including,” “having,” etc., are synonymous, used in their general sense, and used in an open-ended manner, encompassing without excluding other elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive sense (rather than in its exclusive sense), and thus, when used, for example, to connect a list of elements, the term “or” indicates one, some, or all of the elements in the list. Unless otherwise specifically stated, connective language such as the phrase "at least one of X, Y, and Z" should be understood as generally used in contexts indicating that an item, term, element, etc., can be any one of X, Y, or Z. Therefore, such connective language is not generally intended to imply that certain embodiments require the presence of each of at least one X, at least one Y, and at least one Z.

[0089] It should be understood that in the above description of the embodiments, various features are sometimes grouped together in a single embodiment, drawing, or description thereof in order to simplify this disclosure and aid in understanding one or more of the various aspects of the invention. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than those expressly recited in that claim. Furthermore, any component, feature, or step shown and / or described in the specific embodiments herein can be applied to or used with any one or more other embodiments. Moreover, not every embodiment, component, feature, step, or group of components, features, or steps is necessary or essential. Therefore, the scope of the invention disclosed and claimed herein should not be limited to the specific embodiments described above, but should be determined solely by a fair reading of the appended claims.

Claims

1. A chordae tendineae capture device, comprising: Hub components; Multiple spokes are attached to the hub assembly, and the spokes are configured as follows: It has an extended position in which the spokes extend radially outward from the hub component; It has a closed position in which the spokes close radially inward on one or more tendons of the heart, thereby securing the one or more tendons close to the hub component; and Having at least a partially curved shape, such that rotation of the tendon cable capturing device in the concave direction of the spokes drags the captured cable toward the hub component in an inward direction; as well as A ratchet mechanism is configured to constrain the plurality of spokes to their fully open configuration before final deployment of the tendon ligament capture device; and when the ratchet mechanism is activated, the plurality of spokes return to their pre-formed memory positions, such that the plurality of spokes are wound around the hub component in a spiral configuration.

2. The tendon chordae capture device according to claim 1, wherein the hub component is disc-shaped.

3. The tendon chord capture device according to claim 1, wherein the hub component has a cylindrical shape.

4. The tendon ligament capture device of claim 3, wherein the plurality of spokes includes a first spoke and a second spoke, the first spoke and the second spoke being offset from each other relative to the longitudinal axis of the hub component.

5. The tendon ligament capturing device of claim 1, wherein the hub component comprises a spool, and wherein the plurality of spokes are configured to be at least partially wound around the spool.

6. The tendon chord capture device according to claim 1, wherein the plurality of spokes comprises two spokes.

7. The tendon chordae capture device according to claim 1, wherein the plurality of spokes comprises four spokes.

8. The chordae tendineae capture device of claim 1, wherein the chordae tendineae capture device is configured to be introduced into the ventricle of the heart using a catheter delivery system and to be detached from the catheter delivery system in the implanted state.

9. The tendon chordae capture device of claim 1, wherein the plurality of spokes comprise shape memory metal.

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