Devices, methods, and systems for reshaping a heart valve annulus

Abstract

Provided herein are anchors for anchoring implants within and / or reshaping body organs. The anchors are configured to be deployed within a patient's body lumen or vasculature and are curved or adaptable to accommodate the patient's anatomy. The present invention provides implant systems having multiple anchors, for example, one or more posterior anchors combined with one or more anterior anchors. Methods for deploying such anchors and the use of multiple anchors or multiple bridging elements are also provided. TIFF2023552438000002.tif82128

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority under 35 U.S.C.§119(e) of U.S. Provisional Patent Application No. 63 / 122,420, filed on December 7, 2020. The disclosure of the prior application is considered part of the disclosure of this application and is incorporated by reference into the disclosure of this application.

[0002] Field of the Invention The present invention generally relates to medical devices and procedures, and more specifically to devices, methods, and systems for anchoring implants within the body and / or reshaping organs within the body.

Background Art

[0003] Background Information A healthy human heart is a muscular, two - sided self - regulating pump that is slightly larger than a clenched fist, as can be seen in FIGS. 2A - 2C. The heart is composed of four chambers including the right atrium (RA) and right ventricle (RV), and the left atrium (LA) and left ventricle (LV). The RA collects deoxygenated blood returning from the lower body via the inferior vena cava (IVC) and from the head and upper body via the superior vena cava (SVC), and delivers the deoxygenated blood to the RV via the tricuspid valve. Then, the RV contracts, which has the effect of closing the tricuspid valve and pushing the blood into the pulmonary artery through the pulmonary valve for circulation to the lungs. The left side of the heart collects oxygenated blood returning from the lungs via the pulmonary veins into the LA. From there, the blood is delivered to the LV. Then, the LV contracts forcefully, which has the effect of closing the mitral valve (MV) and pushing the blood into the aorta through the aortic valve, from where the blood is pushed throughout the body.

[0004] As can be seen in Figure 2C, the atrial septum is a wall composed of fibrous and muscular parts that separates the RA and LA. The fibrous atrial septum is a more materially strong tissue structure within its own area of ​​the heart compared to the more brittle muscular tissue of the heart. The anatomical landmark of the atrial septum, as can be seen in Figure 2C, is an oval, thumbprint-sized depression called the fossa ovalis, which is the remnant of the fetal foramen ovale and its valve. There are no important structures there such as valve structures, blood vessels, or conduction pathways. Along with its inherent fibrous structure and surrounding fibrous elevation, which can be identified by angiography, the fossa ovalis is a preferred site for transseptal diagnostic and therapeutic procedures from the right to the left side of the heart. Before birth, oxygenated blood is directed from the placenta through the foramen ovale into the LA, and after birth, the foramen ovale closes. The heart's four valves primarily function to ensure that blood does not flow in the wrong direction during the cardiac cycle, for example, that there is no regurgitation from the ventricles to the atria, or from the arteries to the corresponding ventricles.

[0005] The synchronous pumping action of the left and right sides of the heart constitutes the cardiac cycle. The cycle begins with a period of ventricular relaxation called ventricular diastole. At the start of ventricular diastole (e.g., ventricular filling), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the tricuspid and mitral valves open to allow blood to flow from the atria into the corresponding ventricles. Immediately after the start of ventricular systole (e.g., ventricular contraction and outflow), the tricuspid and mitral valves close to prevent backflow from the ventricles into the corresponding atria. Next, the aortic and pulmonary valves open to allow blood to be pumped from the corresponding ventricles into the arteries. The opening and closing of the heart valves are primarily the result of pressure differences. For example, the opening and closing of the mitral valve is the result of a pressure difference between the LA and LV. During ventricular diastole, as the LV relaxes, the blood returning from the lungs into the LA creates a pressure in the atria that exceeds the pressure in the LV. As a result, the mitral valve opens, allowing blood to flow from the LA into the LV. Then, during ventricular systole, when the full ventricles contract, the intraventricular pressure becomes higher than the atrium pressure, pushing the mitral valve to close.

[0006] The mitral and tricuspid valves are each defined by a fibrous ring of collagen called the annulus, which forms part of the heart's fibrous skeleton. The annulus provides attachment to the cusps or leaflets of the mitral valve (called the anterior cusp and posterior cusp or anterior leaflet and posterior leaflet) and the three cusps or leaflets of the tricuspid valve. A healthy mitral valve cusp is shown in Figure 2B. Proper closure function is also assisted by the tethering action of the chordae tendineae and one or more papillary muscles. Structurally relevant to this invention and located near the annulus of the mitral valve are its branches, including the coronary sinus and the great cardiac vein (GVC), as can be seen in Figure 2C. The GVC generally runs around the inferior wall of the LA, which is inside the atrial wall rather than outside the atrium. The GVC drains into the RA through the coronary sinus.

[0007] Each of the valves on the agenda is a unidirectional valve, functioning to allow blood to flow only in the correct direction. If any of the valves malfunction, it can affect the efficiency of the heart and lead to serious health problems. For example, mitral valve failure between the LA and LV, which does not completely seal while the LV is contracting, causes some of the blood in the LV to flow backward into the LA. This is commonly called mitral regurgitation and, depending on its severity, can cause a lack of blood flow throughout the body, potentially leading to serious health consequences.

[0008] II. Characteristics and Causes of Mitral Valve Dysfunction When the LV contracts after being filled with blood from the LA, the ventricular wall moves inward, releasing some tension from the papillary muscles and tendons. The blood is pushed upward towards the inferior surface of the mitral valve leaflets, lifting them toward the annular plane of the mitral valve. As the mitral valve leaflets advance toward the annulus, the anterior edges of the anterior and posterior leaflets join together to form a seal and close the valve. In a healthy heart, leaflet junction occurs near the plane of the mitral annulus. Blood remains pressurized in the LV until it is expelled into the aorta. Contraction of the papillary muscles occurs simultaneously with ventricular contraction and plays a role in keeping the healthy leaflets tightly closed by the peak systolic pressure exerted by the ventricle.

[0009] In a healthy heart, the dimensions of the mitral annulus create the anatomical shape and tension that allows the leaflets to join and form a tight junction at peak systolic pressure. As shown in Figure 2B, the points where the leaflets join on the opposite inner and outer sides of the annulus are called the leaflet commissures (CM) and CL. Valve dysfunction can result from stretching, and in some cases, tearing, of the chordae tendineae (tendons). When the tendons are torn, this results in weak leaflets. Also, a normally structured valve may not function properly due to annular dilation or deformation. This condition is called annular dilation and generally results from myocardial failure. In addition, valves can be defective due to congenital or acquired disease. Regardless of the cause, if the leaflets do not join at peak systolic pressure, mitral valve dysfunction can occur. When this occurs, the junction line of the two leaflets is not tight during ventricular systole. As a result, undesirable regurgitation of blood from the LV into the LA may occur.

[0010] Mitral regurgitation, when significant, can lead to several serious health consequences. For example, blood flowing back into the atria can cause high atrial pressure, reducing blood flow from the lungs into the pulmonary artery (LA). If blood flows back into the pulmonary system, fluid can leak into the lungs, causing pulmonary edema. Another health problem arising from mitral valve dysfunction is a reduced cardiac output, or ineffective pumping of blood through the body into the LV. The amount of blood flowing back into the atria reduces the amount of blood flowing into the aorta, resulting in low cardiac output. The excess blood in the atria as a result of mitral regurgitation can also overfill the ventricles during each cardiac cycle, causing volume overload in the LV. Over time, this can lead to dilation of the LV, or in fact, the entire left side of the heart. This can further reduce effective cardiac output due to the dilation of the mitral annulus, potentially worsening the mitral regurgitation problem. Therefore, once a mitral regurgitation problem begins, the resulting cycles can accelerate heart failure. Therefore, addressing the problem not only has an immediate effect in alleviating the aforementioned cardiac output issue, but can also interrupt the downward cycle leading to heart failure.

[0011] III. Current Treatment Methods Various methods have been proposed to treat this serious heart disease. One approach involves removing the natural valve and replacing it with a new one, as described in U.S. Patent No. 6,200,341 by Jones et al. (Patent Document 1) and U.S. Patent No. 7,645,568 by Stone et al. (Patent Document 2), among others. While this approach may be used in some situations, such surgical procedures generally require invasive open-heart surgery and are often contraindicated in critically ill or elderly patients, including many patients suffering from mitral regurgitation.

[0012] Another proposed method, as described in Schroeder et al.'s US2005 / 0075723 (Patent Document 3), involves reshaping the LV by applying tension across it, thereby affecting the functionality of the mitral valve. This approach uses a splint that extends between epicardial pads that cross the ventricle and engage with the outer surface of the heart. This approach is also invasive and potentially problematic because it penetrates the outer surface of the heart.

[0013] Another proposed method, as described in Cohn et al.'s US2002 / 0183841A1 (Patent Document 4), attempts to deflate the LA using a belt-shaped deficiency device that extends medially into the GVC running along the posterior wall of the LA. While this may be partially helpful, in many cases the device cannot adequately alter the shape of the left atrium to completely resolve the malposition of the valve leaflet junction.

[0014] Another method that has proven particularly useful is to employ a system that applies tension directly across the width of the LA and across the short axis of the mitral valve annulus, as shown in Figure 3. System 1 utilizes a bridging element 2 extending between an anterior anchor 3 and a posterior anchor 4. The anterior anchor 3 is generally positioned on the wall between the LA and RA, for example, on the fossa ovale on the septal wall, and is attached to the bridging element 2 extending across the LA. The posterior anchor 4 is positioned to cross the atrium posterior to the anterior anchor and may be positioned outside the atrial cavity within the GVC. The bridging element is fixed to the posterior anchor and provides a bridge across the LA between the septa. The GVC is tensioned so as to directly affect the shape of the LA, particularly the mitral valve annulus. By adjusting the tension of the bridging element, the shape of the LA, particularly the mitral valve annulus, can be adjusted to achieve optimal mitral valve closure during cardiac function. An example of this approach is described in detail in Chang et al., U.S. Patent No. 8,979,925B2 (Patent Document 5), the entire contents of which are incorporated herein by reference for all purposes.

[0015] This approach offers many advantages over conventional approaches, including avoiding invasive procedures such as open-heart surgery or cardiopulmonary bypass. However, several challenges still need to be addressed. While anterior anchors provide relatively robust and reliable anchoring in the fossa ovalis, anchoring within human blood vessels such as the GCV presents more challenges. The fossa ovalis is defined by a prominent depression, which helps in medial placement of the anchor, whereas the GCV lacks a prominent anatomical feature and is defined by blood vessels with relatively smooth walls along the outer wall of the left atrium. In addition, the heart is a highly dynamic organ, and consequently, any implant placed within it is subjected to highly variable forces and movement due to myocardial strain during the heart's pumping cycle. These aspects make anchoring within the GCV particularly difficult. Therefore, there is a need for devices, systems, and methods that enable robust and reliable anchoring within blood vessels such as the GCV. Further, there is a need for such anchoring devices that can withstand considerable forces over the lifespan of the device. There is a greater need for such anchoring devices that can assist in the reshaping of organs such as the heart. [Prior art documents] [Patent Documents]

[0016] [Patent Document 1] U.S. Patent No. 6,200,341 [Patent Document 2] U.S. Patent No. 7,645,568 [Patent Document 3] US2005 / 0075723 issue [Patent Document 4] US2002 / 0183841A1 [Patent Document 5] U.S. Patent No. 8,979,925B2 [Overview of the project]

[0017] The present invention provides a system, method, and related devices for the delivery and deployment of cardiac implants for reshaping the cardiac annulus for the treatment of cardiac diseases such as mitral regurgitation.

[0018] Accordingly, in one embodiment, the present invention provides an anchor system comprising an augmentation device and an anchor. In some embodiments, the augmentation device has an elongated cylindrical body defined by a substantially cylindrical wall. The lumen is configured to receive the anchor, and the cylindrical wall includes slots arranged along the length of the cylindrical body for engaging with a bridging element of the anchor. The system further includes an anchor having a substantially cylindrical body sized to pass through the elongated cylindrical body of the augmentation device, and a bridging element coupled to the intermediate portion of the anchor.

[0019] In another embodiment, the augmentation device has an elongated shaft body, the shaft body having a first elongated configuration and a second bent configuration. The second bent configuration has a reduced length compared to the first elongated configuration. The system further includes an anchor having a substantially cylindrical body having a length shorter than the length of the augmentation device, and a bridging element coupled to the middle portion of the anchor. The system is configured such that when the augmentation device and the anchor are coupled and deployed into a human body lumen, the force acting on the wall of the human body lumen from the anchor is transferred to the augmentation device to deform the wall.

[0020] In various embodiments, the present invention provides an anchoring system comprising a front anchor and a rear anchor. In some embodiments, the anchoring system includes a front anchor having an anchor portion operable to fix the front anchor into tissue, a through-hole extending through an anchoring member, and an elongated tube having a lumen having the same width as the through-hole, wherein the elongated tube is made of a semi-rigid or rigid material that resists bending; and a rear anchor coupled to a first end of a bridging element, wherein a second end of the bridging element is configured to traverse the lumen of the elongated tube of the front anchor.

[0021] In another aspect, the anchor system includes a front anchor having an anchor portion operable to fix the front anchor within tissue, a through-hole extending through the anchor member, and an adjustable arm extending from the anchor portion, and a rear anchor coupled to a first end of the bridging element, wherein a second end of the bridging element is configured to traverse the through-hole of the front anchor, and the adjustable arm is operable to adjust the positioning of the bridging element when the front anchor and the rear anchor are coupled via the bridging element during deployment within a human blood vessel.

[0022] In yet another embodiment, the present invention provides an anchor system including a front implant and a rear anchor. In some aspects, the front implant has a first front anchor, a second front anchor, a connection rail extending between the first and second front anchors, and a bridging element connector disposed on the connection rail. The system further includes a rear anchor coupled to a first end of the bridging element, wherein a second end of the bridging element is configured to engage the bridging element connector and traverse a through-hole of the first front anchor or a through-hole of the second front anchor when the front implant and the rear anchor are coupled via the bridging element during deployment within a human blood vessel. In some aspects, the bridging element connector is configured as a slidable lock slidably disposed on the connection rail to enable adjustment of the positioning of the bridging element along the connection rail.

[0023] In another embodiment, the present invention provides a method of reshaping a heart cavity within a subject. The method includes implanting the anchor system of the present invention into the heart cavity, thereby reshaping the heart cavity of the subject.

[0024] In yet another embodiment, the present invention provides a method of treating mitral regurgitation in a subject by reshaping the left atrial cavity of the subject. The method includes implanting the anchoring system of the present invention into the left atrial cavity, thereby treating mitral regurgitation in the subject. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] [Figure 1] FIG. 1A illustrates a cardiac implant system including an interatrial bridging element spanning the mitral valve annulus between a front anchor disposed within the fossa ovalis and a rear anchor positioned within the GVC, according to an aspect of the present invention. FIG. 1B illustrates a cardiac implant system including an interatrial bridging element spanning the mitral valve annulus between a front anchor disposed within the fossa ovalis and a rear anchor positioned within the GVC, according to an aspect of the present invention. [Figure 2A] An anatomical top view of a section of the human heart showing the tricuspid valve in the right atrium, the mitral valve in the LA, and the aortic valve therebetween, with the tricuspid and mitral valves open and the aortic and pulmonary valves closed during ventricular diastole (ventricular filling) of the cardiac cycle. [Figure 2B] Illustrates a healthy mitral valve demonstrating complete junction between the valve leaflets along the entire main axis of the valve. [Figure 2C] An anatomical front perspective view of the left and right atria, partially cut away and sectioned, showing the interior of the cardiac cavity and associated structures, such as the fossa ovalis, coronary sinus, and GVC. [Figure 3] Shows a conventional implant system having a bridge across the left atrium between a front anchor disposed within the fossa ovalis and a curved rear anchor disposed within the GCV. [Figure 4A] Illustrates the tendency of a conventional curved rear anchor to invert or reverse when a tension force is applied. [Figure 4B] Illustrates the tendency of a conventional curved rear anchor to invert or reverse when a tension force is applied. [Figure 5] Illustrates a rear anchor having a jacket attached to a tensioning member, according to some embodiments. [Figure 6] Several embodiments illustrate a rear anchor having a jacket attached to a tensioning member. [Figure 7A] Several embodiments illustrating a rear anchor attached to a tensioning member having an anti-reversal feature are described below. [Figure 7B] Several embodiments illustrating a rear anchor attached to a tensioning member having an anti-reversal feature are described below. [Figure 8] Several embodiments illustrate rear anchors attached to tensioning members having different anti-reversal features. [Figure 9A] We illustrate a rear anchor, which includes a support element positioned distal to a compressible cylinder so as to deform the cylinder when tensioned, according to several embodiments. [Figure 9B] The rear anchor shown in Figure 9A, arranged within the GCV, is illustrated in several embodiments, both before and after modification. [Figure 9C] The rear anchor shown in Figure 9A, arranged within the GCV, is illustrated in several embodiments, both before and after modification. [Figure 10A] We illustrate cardiac implant systems according to several embodiments, each having an anterior anchor and multiple bridge elements, each extending to a separate posterior anchor within the GCV. [Figure 10B] We illustrate several embodiments of cardiac implant systems having an anterior anchor extending to a single posterior anchor within the GCV and multiple bridge elements. [Figure 10C] We illustrate a cardiac implant system for reshaping a tricuspid valve according to several embodiments, wherein the system has two bridge elements extending from anchors in the superior and inferior vena cava to a posterior anchor located in the right ventricle. [Figure 11A] Several embodiments illustrate a rear anchor that is bendable or adaptable when adjusting a tensioning member by the use of one or more tethers. [Figure 11B] Several embodiments illustrate a rear anchor that is bendable or adaptable when adjusting a tensioning member by the use of one or more tethers. [Figure 11C] Several embodiments illustrate a rear anchor that is bendable or adaptable when adjusting a tensioning member by the use of one or more tethers. [Figure 11D] Several embodiments illustrate a rear anchor that is bendable or adaptable when adjusting a tensioning member by the use of one or more tethers. [Figure 11E] Several embodiments illustrate a rear anchor that is bendable or adaptable when adjusting a tensioning member by the use of one or more tethers. [Figure 11F] Several embodiments illustrate a rear anchor that is bendable or adaptable when adjusting a tensioning member by the use of one or more tethers. [Figure 11G] Several embodiments illustrate a rear anchor that is bendable or adaptable when adjusting a tensioning member by the use of one or more tethers. [Figure 12A] We illustrate a rear anchor defined by an expandable structure that can be laterally compressed during tensioning of the support backbone, according to several embodiments. [Figure 12B] We illustrate a rear anchor defined by an expandable structure that can be laterally compressed during tensioning of the support backbone, according to several embodiments. [Figure 12C] We illustrate a rear anchor defined by an expandable structure that can be laterally compressed during tensioning of the support backbone, according to several embodiments. [Figure 13A] We illustrate alternative rear anchors defined by an expandable structure having a folding zone that facilitates lateral compression during tensioning of the support backbone, according to several embodiments. [Figure 13B]We illustrate alternative rear anchors defined by an expandable structure having a folding zone that facilitates lateral compression during tensioning of the support backbone, according to several embodiments. [Figure 14] The anchor system of the present invention is illustrated by several embodiments, defined by an augmentation device having a slot for enabling engagement with a bridging element of the rear anchor of the present invention. [Figure 15] The anchor system of the present invention is illustrated by several embodiments defined by an augmentation device configured to change shape during deployment and to operate in a manner that allows it to connect to the rear anchor of the present invention. [Figure 16] The anchor system of the present invention, including a forward anchor having a hypotube, is illustrated by several embodiments. [Figure 17] The forward anchor of the present invention is illustrated by several embodiments. [Figure 18] The implantation of the anchor system of the present invention is illustrated by several embodiments. [Figure 19] The forward anchor of the present invention is illustrated by several embodiments. [Figure 20] The operation of the forward anchor, as depicted in Figure 19, is illustrated by several embodiments. [Figure 21] Some embodiments illustrate a portion of the forward anchor depicted in Figure 19. [Figure 22] The anchor system of the present invention, including the anterior implant and posterior anchor of the present invention according to several embodiments, is illustrated below. [Figure 23] Several embodiments of the anchor system depicted in Figure 22 are illustrated below. [Figure 24] Several embodiments of the anchor system depicted in Figure 22 are illustrated below. [Figure 25] Several embodiments of the anchor system depicted in Figure 22 are illustrated below. [Figure 26]Several embodiments of the anchor system depicted in Figure 22 are illustrated below. [Figure 27] Several embodiments of the anchor system depicted in Figure 22 are illustrated below. [Figure 28] Several embodiments of the anchor system depicted in Figure 22 are illustrated below. [Figure 29] The anchor system of the present invention, including the forward anchor and the rear anchor of the present invention according to several embodiments, is illustrated below. [Figure 30] Several embodiments of the anchor system depicted in Figure 29 are illustrated below. [Figure 31] Several embodiments of the anchor system depicted in Figure 29 are illustrated below. [Modes for carrying out the invention]

[0026] Detailed description of the invention The present invention relates to devices, systems, and methods for intravascular anchoring of implants within the body and / or reshaping organs within the body by using anchors deployed within human body lumens or human body blood vessels. The implants and associated anchors described herein are intended to improve the function of a heart valve by reshaping the mitral annulus for the treatment of mitral regurgitation. It is understood that any cardiac implant system may utilize a posterior anchor having any of the features described herein, or any combination thereof. Furthermore, the following embodiments describe a posterior anchor for use in a cardiac implant system having a bridging element extending across the left atrium between an anterior anchor and a posterior anchor deployed within a GCV, but it is understood that the features described herein may relate to an implant system for the treatment of any heart valve or to any anchor deployed within a human body lumen and may be used in various other implant systems in other human locations according to the concepts described herein.

[0027] One important feature of the cardiac valve treatment system for the treatment of mitral regurgitation presented herein is the posterior anchor. As shown in the implant system 100 in Figures 1A-1B, the posterior anchor 10, once placed, is generally positioned within the GVC. It is important that the posterior anchor distributes the tensioning force from the bridging element as widely as possible along the length of the GVC to avoid tearing the GVC / LA wall or pulling the posterior anchor through the tissue of the GVC / LA wall, thereby reducing or eliminating tension on the bridging element. Furthermore, the tensioning on the bridging element, which pulls a large portion of the LV wall within the annular area forward toward the septum, also helps in the treatment to restore the shape of the LA and the anatomical distance of the LA from the septum and the mitral valve annulus. If the tension is instead concentrated at a point on the LA wall, this may tend to pull only a limited point area forward and not significantly move the entire LA wall. The organization can either pull the entire wall of LA forward, or it can fold inward.

[0028] Unlike previous GCV device concepts in which the device is placed alone within the GCV to reshape the left atrium, these systems rely on additional lateral forces applied to the LA wall, which are supplied by an anchor on a substantially thicker and more robust septal wall and maintained at a preferred septal-lateral spacing that is attached to and controlled by the operator. GCV-only devices attempt to reshape the GCV pathway medially, but their ability to move surrounding tissue, including part of the ventricle, is significantly limited, and all applied forces must be resolved or balanced within the GCV itself. An anchor for the GCV is needed to distribute these substantially larger forces so as to uniformly move the lateral wall, join the leaflets without trauma or erosion, and ideally maintain the natural shape, contour, and function of the GCV, as well as the septal-lateral spacing with the septum, as much as possible.

[0029] Among the challenges associated with such implant systems, stably and reliably engaging the posterior anchor along the posterior wall of the left atrium while it is positioned within the GCV is particularly difficult. Firstly, because the inner wall of the GCV along the left atrium is generally smooth with no prominent anatomical features, the posterior anchor tends to slide or move, which can lead to variability in the septal-lateral spacing provided by the implant system, allowing some level of mitral regurgitation to still occur. Furthermore, because the heart is subjected to a considerable amount of periodic movement during the cardiac cycle, this sliding movement of the posterior anchor over time can lead to tissue erosion or expansion of the penetration where bridging elements persist, resulting in tearing of the LA wall along the GCV. Secondly, in such systems with a curved or flexible posterior anchor, the curvature of the anchor often does not match the natural curvature of the atrial wall, and as a result, the posterior anchor cannot consistently engage with a sufficiently large portion of the posterior wall of the left atrium to ensure that the desired reshaping of the annulus is maintained throughout the cardiac cycle. To address these challenges, presented herein are anchors having improved design features that provide enhanced anchoring stability and consistency, as well as improved engagement with adjacent tissues, particularly when deployed within human blood vessels. In one embodiment, the anchor has an elongated body sized and dimensioned for delivery and deployment within the patient's vascular system. In the case of cardiac implant systems, such an anchor may have a length dimension of 1 cm to 10 cm, typically 2 cm to 8 cm, to distribute the laterally applied anchoring force and engage with a substantial portion of the heart wall. The anchor may have a width dimension of 0.5 cm to 5 cm, typically 1 cm to 3 cm. The anchor may be contoured or curved along its length and width dimensions to more closely conform to the anatomical structure of the human lumen or adjacent organ. In some embodiments, the anchor is specifically shaped to engage with at least a portion of one side of the deployed blood vessel, while simultaneously leaving the remaining vessel open to facilitate blood flow through it.Examples of such shapes include D-shapes, C-shapes, and egg shapes, all of which increase the contact area of ​​the posterior anchor along one side of the human blood vessel while maintaining vascular patency.

[0030] Figures 1A-1B illustrate an exemplary cardiac valve treatment system 100 that includes a bridging element 12 extending into the left atrium, between an anterior anchor 14 fixed in the fossa ovalis and a posterior anchor 10 deployed within the GCV. In this embodiment, the posterior anchor 10 is a cylindrical structure, such as that detailed in Figure 13A, and is laterally collapsible to provide an increased contact surface area along the inner wall of the GCV along the wall of the LA when deployed. As can be seen in Figure 1B, the posterior anchor 10 is also curved along its length to more closely conform to the anatomical structure of the lateral curvature of the LA along which the GCV extends. The posterior anchor 10 may further include anti-reversal features 11 to prevent reversal or inversion along its length due to movement and forces imparted by the structure of the heart during the cardiac cycle. While specific designs of rear anchors are shown in Figures 1A-1B, it is understood that system 100 may utilize any suitable rear anchor, including any of the preferred anchor features described herein or any preferred anchor features according to the concepts described herein.

[0031] In some embodiments, the intravascular anchor is defined as an elongated member having a central rigid portion along the location where the tensioning member is attached, and a flexible outer end. The central rigid portion may include stress-relieving features, such as attachment points, that are flexible, movable, or pivotable to accommodate sudden movements of the tensioning member, in order to maintain engagement of the anchor with adjacent tissue during the cardiac cycle. The flexible outer end may be provided by modifying the central rigid portion (e.g., a notch, a calf) or by an additional component such as a polymer jacket or cover that fits over the rigid portion.

[0032] In some embodiments, the intravascular anchor is contoured or molded to fit at least a portion of one side of the vessel in which it is deployed. In some embodiments, the intravascular anchor has a fixed shape, while in other embodiments, the shape of the anchor is flexible or adaptable. In some embodiments, the intravascular anchor can take on multiple configurations of various sizes and shapes to facilitate delivery and deployment. In any of the embodiments described herein, the anchor may be defined with a hollow lumen through which it passes to facilitate intravascular delivery via a guidewire or catheter.

[0033] These and other embodiments of the improved anchor can be further understood by referring to the embodiments depicted in Figures 5-13B. While these embodiments describe a posterior anchor for use in tensioned cardiac implants, it is understood that these anchor features may be applicable to various other types of anchors for implants in various other human locations. For example, any of the features described may be used in implants to provide improved anchoring, which may include improved fit to the anchored tissue, improved force distribution, and improved tissue engagement to facilitate the reshaping of human organs.

[0034] Figure 5 illustrates a posterior anchor defined as a T-bar 110 covered with a jacket to provide strain relief and a non-traumatic end configuration. In some embodiments, a thin or thick-walled polymer jacket 160 may fit over a conventional rigid T-bar anchor to provide a non-traumatic surface. The T-bar 110 is coupled to a bridge element 105, which may be a suture, tether, or any element suitable for crossing the left atrium and maintaining sufficient tension to reshape the atrium. The jacket 160 is sized and dimensioned so that the end portion of the jacket extends beyond the end of the rigid T-bar 110. The jacket 160 may be formed of PTFE, high-silicone soft block urethane, silicone, or any preferred material, and may further include a thin fabric outer cover such as polyester. In some embodiments, the jacket is preferably formed of a material that promotes internal tissue growth. The jacket may be held in place by adhesive, or it may be shrunk over the T-bar, or both. In this embodiment, the jacket 160 is defined as two end pieces that abut against an internally mounted central bridge attachment; however, the jacket may be defined as a single piece jacket attached along the entire length of the T-bar, as in the following embodiments described below. The end extensions are shaped to reduce tissue strain and may be curved or meandered, for example, to enhance stability and aid in delivery (not shown). This approach allows conventional T-bar anchors to be improved to change the size and / or shape of the anchor, to provide improved or variable flexibility along its length, or to provide a variety of other advantageous properties.

[0035] Figure 6 illustrates another posterior anchor configured as a rigid T-bar backbone 110 covered by a molded jacket 162. The molded jacket 162 may be a polymer semi-rigid or corresponding “surfboard” that fits over the rigid T-bar 110. Such a configuration is advantageous because it allows the conventional rigid T-bar anchor to be modified to bear any shape, contour, or flexibility desired for a particular application. In this embodiment configured for use in the cardiac implant system described above, the molded jacket 162 is molded to be planar or flat on one side to increase the tissue contact area with the inner wall of the GVC toward the LA and to further distribute the anchoring contact force. The planar portion may be flat or curved to correspond to the shape of the vessel. In this embodiment, the planar portion is contained on a central portion having a wider width than either end portion and includes an opening near the center of the planar central portion, thereby facilitating engagement with the vessel wall of the planar central portion. This increased width dimension and planar portion provide improved resistance to inversion. The molded jacket 162 may be formed thin along its posterior / anterior dimensions so as to lie flat relative to the GCV wall, thus maximizing blood flow within the GCV. This configuration also helped stabilize the posterior anchor and resist inversion. As with other embodiments, the surface may be coated or constructed with a material that induces internal tissue growth. The molded jacket may be formed from a variety of polymer materials, including PTFE, high-silicone soft block urethane, silicone, and other implant-grade elastomers. An optional thin fabric, such as polyester, may be used to cover the polymer jacket to promote tissue growth or inhibit sliding. The size of the device may, of course, vary depending on the surgeon's requirements and the patient's specific requirements, e.g., larger male patients versus pediatric patients, but one favorable size for a typical adult patient would be, for example, a 12F round or oval T-bar. Such links may be combined as a "backbone" to stabilize and reinforce other jacket or wire-shaped structures discussed above.The wire form can be metal, plastic, or any other material that would allow a rigid backbone to compress the form, as described above.

[0036] A straight version of the molded jacket 162 is shown in Figure 6, but it is understood that the molded jacket 162 may be formed with a predetermined curved shape along its length to match the curvature of the mitral annulus or GCV or both. Having a width close to the width of the GCV and obtaining more grip on the sidewalls will prevent the curvature from reversing or becoming straight. In some embodiments, the delivery catheter used to deliver the anchor may include mounting features that allow axial rotation to enable proper positioning of the anchor so that its curvature aligns with the GCV. Such features may include lumens or guides or arbitrary boundary features to enable manipulation of the anchor's orientation during deployment. The molded jacket may be composed of a semi-rigid material to allow its shape to be somewhat straightened to allow it to travel on a guidewire, and to allow for more significant bending when the guidewire is removed and the device is released. One or more radiopaque features may be added to the anchor to allow the clinician to visualize its position and orientation during delivery and deployment. In these embodiments, the bridge element 105 is described as a suture wrapped around the middle portion of the T-bar 110, but it is understood that various other bridging elements and suitable means of attachment (e.g., adhesive, welding, joining) may be used.

[0037] Some conventional systems utilize curved posterior anchors, but such anchors tend to invert (in the case of rigid structures) or reverse (in the case of more flexible structures). This action can be further understood by referring to a conventional cardiac valve treatment system 1 shown in Figure 3, which includes a bridging element 2 extending from an anterior anchor 3 to the midpoint of a conventional posterior anchor 4 defined as a rigid curved tubular member. When a thin, curved posterior anchor, particularly a rigid curved anchor, is placed within a GVC and tension is applied to the internal curvature of the arc, especially near the apex, the force will tend to invert the curved anchor within the GVC, presenting the outer edge of the curve in the passage between the GVC and the atrium.

[0038] Figures 4A-4B illustrate this inversion tendency. Inversion of the anchor leads to more stable energy conditions, and therefore this is the configuration that the anchor tends to seek. When considering this inversion in the configuration, it is important to remember that the distal anchor, in a given position within the GVC, is far from a stationary curved structure lying relative to a statically curved vein. It is in a given position within a blood-filled vessel embedded within the wall of the heart, which generally beats about 75 times per minute. When the posterior anchor is tossed about and drawn into the flowing blood, the anchor quickly seeks the most stable orientation in relation to the tensioning force from the bridging element, resulting in an inversion to an orientation where the apex of the curve faces the direction of the tensioning element, and the apex is drawn into the hole in the GVC / LA wall being pulled by the bridging element unless some mechanism is provided to prevent the inversion from occurring, e.g., one of the mechanisms described herein. When inverted or reversed, the anchor structure tends to concentrate the tensioning force applied by the bridging element on the GVC / LA wall at a single point, which is the puncture point between the LA / GVC walls. This increases the likelihood of tearing the wall and potentially pulling the posterior anchor into the atrium, completely releasing the tension, or pulling it partway into the atrium, releasing tension to the point where treatment is severely compromised.

[0039] The reversing movement described above may also be considerably less effective in pulling the LA wall toward the septum to affect the reshaping of the valve annulus, and therefore less effective in providing treatment. With only a single contact point between the curved posterior anchor and the GVC medial wall, the posterior anchor may be more likely to slide longitudinally within the GVC, in which case the suture forming the bridging element may slice through the tissue forming the GVC / LA wall, expanding the puncture hole and further increasing the likelihood that the posterior anchor may be pulled into the LA. Thus, the anti-reversal configuration and features can simultaneously provide an anti-slide mechanism, which can be doubly advantageous.

[0040] One such anti-reversal anchor configuration is shown in Figures 7A–7B. This anchor employs a short, rigid link 151 attached by a hinge 150, or a similar flexible attachment mechanism extending from the inward curvature of the anchor body 152. The link 151 is of a relatively rigid length, which can rotate to lie nearly flat against the inward curvature of the anchor body 152 as it is delivered via a guidewire GW, as shown in Figure 7A, and opens to be generally perpendicular to the anchor when deployed by pulling a bridging element through a penetration in the wall of the LA, as shown in Figure 7B. Typically, in the deployed configuration, the distal end of the link 151 protrudes slightly into the LA in its stationary position. In some embodiments, the link 151 is hollow so that a flexible bridging element 105 is attached to the curved rear anchor body 152 via the hollow link 151. In other embodiments, the bridging element 105 is attached to an end that extends away from the anchor body 152. Link 151 is long enough to cause coaxial alignment with the tensioned bridging element 105 and prevent the anchor from reversing. Link 151 may be made of a material such as plastic or smooth metal and may have a diameter large enough that the possibility of cutting the tissue of the GVC wall through which the penetration between the atrium and GV occurs is lower than that of a bare bridging element, such as a suture. Thus, the link serves a dual purpose: to prevent reversal and to protect the GVC wall. The link is folded flat and directed toward the puncture site during delivery, and is set to open vertically once the suture is tensioned at that site.

[0041] Figure 8 illustrates another anchor embodiment that includes an anti-reversal or anti-reversal feature defined as an inwardly curved portion 153 along the location where the bridging element 105 is attached to the anchor body 152. When used in a left atrial implant for the treatment of MVR, the inwardly curved intermediate portion generally protrudes into the plane of the curved anchor in a GCV shape, and the bridge 105 is attached to the intermediate portion of the anti-reversal curved portion 153. This allows for simpler attachment to the anchor and avoids the complexity factors of the linkage mechanism in both its structure and delivery.

[0042] In another embodiment, the posterior anchor may consist of a delivery configuration and an expandable configuration in which the anchor is eccentrically positioned along one side of the vessel wall. Such a configuration is non-circular and expandable and compressible to form an eccentric shape having a larger surface area on one side that engages with the wall of a human body lumen or vessel. An example of such a configuration is illustrated in the following embodiments.

[0043] Figures 9A–9C illustrate a rear anchor defined as a collapsible cylinder 103, in which a more rigid support member 101, such as a T-bar support, is mounted or embedded within the cylinder. While a cylinder is described in this embodiment, it is understood that such anchors can consist of a variety of elongated shapes, including but not limited to partial cylinders, crescent shapes, oval shapes, or various irregular shapes. The collapsible cylinder may be formed of any suitable collapsible material, such as foam material or structure. Typically, the rigid support member 101 is mounted or embedded in the outer rear diameter furthest from where the bridging element 105 extends, as shown in Figure 9A, to facilitate further collapsion of the cylinder when the bridging element is tensioned. The rigid support member 101 may be substantially linear as shown, or may be curved to generally follow the curvature of the inner wall of the GVC, thus allowing for uniform distribution of tensile forces against the tissue wall.

[0044] Figures 9B and 9C illustrate cross-sections of the rear anchor of Figure 9A positioned within the GVC before and after deployment, respectively. When delivered into the GVC and connected to the bridging element 105, the collapsible cylinder 103 is adjacent to the walls of the GVC and LA through which the bridging element 105 extends, while the rigid support element 101 is positioned on the side furthest from the LA, as shown in Figure 9B. When tension is applied to the bridging element relative to the T-bar 101, the collapsible material is crushed into an eccentric shape 103a with a reduced cross-section that is less likely to obstruct blood flow within the GVC. The crushed cylinder also adheres more closely to the inner shape of the GVC, thereby adopting a shape that increases the contact surface area compared to the uncrushed cylinder. When crushed, the material is also somewhat more compressed and generally harder than the uncrushed material, which also helps to distribute the force applied by the bridging element across the surface area of ​​the GVC wall.

[0045] The embodiments shown in Figures 9A-9C are represented as relatively short, elongated crushable members and T-bars, but it is understood that the T-bars or spines can be significantly longer to distribute tensile forces and can be formed with a curve to more commonly distribute forces within a curved GVC.

[0046] In some embodiments, the materially crushable is a material that promotes internal growth and / or scarring of tissue to create a tissue-anchor matrix. This internal growth further helps ensure that the posterior anchor is not pulled through the GVC wall or inverted within the GVC. This crushable material is constrained by the delivery catheter in its crushed form, reducing its delivery profile and thus aiding delivery, and when released, is further reshaped to its final dimensions by bridging elements.

[0047] Figures 10A–10B illustrate alternative implant systems that can utilize a posterior anchor as described herein. Figure 10A illustrates a cardiac implant system 200 having an anterior anchor and a plurality of bridge elements 105 extending to a plurality of posterior anchors 10 within a GCV. In this embodiment, the posterior anchor 10 is a crushable cylindrical structure as described in Figure 13A. Figure 10B illustrates a cardiac implant system 300 having an anterior anchor and a plurality of bridge elements 105 extending to a single posterior anchor 10 deployed within a GCV. In this embodiment, the posterior anchor 10 is a segmented tube as described in Figure 11G. It is understood that each of the depicted posterior anchors can utilize any one or a combination thereof of anchor features in any of the embodiments described herein. Figure 10C illustrates a cardiac implant system 400 for reshaping a tricuspid valve according to several embodiments, the system having two bridge elements extending from anchors 40 in the superior and inferior vena cava to a posterior anchor 10 located in the right ventricle. In this embodiment, the posterior anchor 10 is a crushable cylindrical structure as described in Figure 13A.

[0048] In another embodiment, a curved rear anchor is provided that can be transformed from a substantially linear configuration to a curved configuration. In some embodiments, the curvature of the anchor can be adjusted during deployment. Some such rear anchors include a series of boundary or interconnecting components that articulate into a curved shape when tensioned by either a bridging element or one or more tethers extending through it. These anchors may be configured for use with a system having a single bridging element per anchor, as shown, for example, in Figure 10A, or for use in a system having multiple bridging elements, as shown, for example, in Figure 10B. In some embodiments, the curveable rear anchor is defined within a single tube having a series of notches or kerfs that allow for controlled articulation or curvature of the anchor body by a tensioned bridge. Adjustment of such anchors may include multiple schemes and anchor configurations. Examples of such configurations are described in further detail below.

[0049] Figures 11A–11D illustrate a posterior anchor configured to curve inward toward a bridging element when deployed. Such configurations may be designed to match the curvature of a blood vessel or adjacent tissue or organ wall, and the tensioned bridging element can maintain the curvature, thus further resisting inversion. Typically, the posterior anchor is defined to match the curvature of the GVC, and to distribute the anchoring force provided by the attachment via a tensioned bridging element relative to the anterior anchor more evenly and reliably.

[0050] Embodiments in Figures 11A–11D may be segmented tubes formed from a single tube. One way this can be achieved is to cut a hollow metal or polymer tube 130 of a suitable length (e.g., a length matching the mitral valve ring along the GVC) into a series of segments 131, 132, 133 by a series of cuts called kerfs 140, 141, 142, as shown in Figure 11A. The kerfs may be, for example, 1 / 2 to 3 / 4 of the diameter of the tube and may be angled to promote a tighter radius of curvature. These areas are open, meaning that some material is cut from the tube to define the series of segments, allowing the tube to bend preferentially in the direction of the kerf when a force is applied to both ends 130a, 130b.

[0051] One or more tethers can be used to pull the segments inward and curve the anchor. In some embodiments, internal tethers 105a, 105b are fixed inside the respective ends 130a, 130b of the tube, respectively, and can exit along the central portion of the anchor through one or two of the calves 138, 139 (for example, as shown in Figures 11A-11B), to which the bridging element is attached to the exposed tether. By tensioning the bridging element against the GCV wall, the short axis of the mitral valve is shortened at the same time, and the anchor bends into the desired shape. Such a configuration curves the tube 130 when the bridging element 105 is tensioned. The more tension applied, the greater the curvature toward the bridging element until the calf opening closes or the engaged tissue exerts an equal counterforce on the tubular body 130. This is particularly advantageous for use in dynamic environments such as the heart, as the aforementioned inversion typically occurs when the bridging element is subjected to increased tension.

[0052] Figure 11C illustrates a similar embodiment having internal tethers 105a, 105b that are coupled to ends 130a, 130b and exit through a central opening 144 to connect with bridging element 105. Alternatively, the tethers 105a, 105b are each independently fixed to ends 130a, 130b to allow independent bending of each end and to exit from the center of the anchor. This approach may provide configurations that offer anchors with multiple segments and custom shapes.

[0053] Figure 11D illustrates an alternative embodiment in which the bridging element 105 is a loop extending through the tubular body 130 of the anchor, thereby shortening the internal tether portion 105c when the loop is tensioned, and the force of the tensioned tether portions 105a and 105b shortens the inward ends 130a and 130b, thereby curving the anchor body. The length of the loop can be shortened by pulling one or more free ends of the loop and attaching them to the front anchor, thereby allowing the user to adjust the tension of the bridging element.

[0054] Alternatively, the bending may be independent of the bridging element. Figure 11E illustrates an example of such a bending scheme, in which a catheter is used within a GCV to pull an internal tether 106, which is internally fixed to the distal end of an anchor through the lumen of the catheter. This causes the proximal end of the anchor to engage with the catheter tip and bend. The bent anchor can be secured in the desired curved position using a fastener 107 such as a clip, knot, or any preferred mechanism, and the excess tether is cut off.

[0055] It is understood that the curved configuration and force required to bend the tube, as well as the stiffness of the curved tube, can be varied as desired by adjusting the number, width, spacing, and depth of the kerfs. The kerfs can be of various lengths along the length of the anchor, combining wider and narrower sections to make each section relatively stiffer or softer. The curvature of the anchor can be achieved with a single shared bridge or a double independent bridge element, the latter allowing for a more relaxed curve at one end.

[0056] In another similar approach, the anchors are defined by individual, unconnected hollow links of similar or coordinated length. The links are formed to have the desired stiffness and shape for their resting places when deployed. The links may be formed using any of the structures detailed herein. Such embodiments may utilize a delivery scheme having a single bridge, where the anchors or anchor links are mounted in their resting places after the deployment of the first bridge ends, followed by the deployment of the second bridge. The ends of the anchors or outer links may have grommets or other means to protect the tissue from any abrasion from the bridging elements.

[0057] In another embodiment, a hybrid concept of a bendable GVC anchor with two end bridges is provided. An example of such an embodiment includes a bendable anchor, similar to a series of segments or boundary elements, extending between bridge elements and attached to each end. In some embodiments, the bridging elements are permanently fixed to each end of the anchor. The first bridge is preferably deployed furthest from the coronary sinus, followed by a second bridge with a puncture-to-puncture interval equal to the length of the anchor, which is then preferably positioned centered on the larger central voile leaflet of the mitral valve. The anchor is then deployed by pulling both the bridge and the anchor through a protective sheath. In some embodiments, the ends of the individual segments are angled such that when the entire series of segments is pulled tightly and the ends are in contact, the length of the series of segments forms a curved structure. The curved structure can be pre-selected depending on the angle of the segments and does not need to be a constant curve. For example, such an anchor may include a relatively straight section at the center of the anchor and sections that are more sharply curved at each end. Alternatively, the anchor may include a straight segment and a more sharply curved segment on the other end of the anchor, which may be a useful configuration in some applications.

[0058] Figures 11F and 11G illustrate examples of alternative approaches described above for achieving a curved rear anchor by using individual links. The links may be unconnected to the interface between them, or they may be interconnected in a manner that allows relative movement between adjacent links to enable the curvature of the anchor. In these depicted embodiments, the tube 131 is formed by several individual segments 181, 182, which may be formed with a mating surface 183 that is either straight or angled as desired. In the embodiment of Figure 11F, the ends of the anchor tube may be protected by grommets 145 connected to bridging elements 105a, 105b. In some embodiments, the grommet 145 is configured as a fixed stop for securing a bridging element or tether extending through it to a predetermined length so as to provide the anchor with a predetermined curvature. In the embodiment of Figure 11G, the anchor link is suspended on a single bridging element or tether, which is free to move along the bridge, thereby engaging with both ends of the anchor so that shortening of the bridging element or tether causes the anchor to curve. Such a configuration allows links to be added or configured to vary in length or stiffness along the anchor. In any embodiment, two bridging elements 105a, 105b may be attached at the same location on the anterior anchor. By applying tension to these bridging elements, the tube 131 curves inward. When such an anchor is incorporated into a cardiac implant system, the curved tube 131 pulls the entire wall of the LA toward the septum, advantageously forming a mitral annulus that can be biased in length toward one side or the other, while visualizing regurgitation in real time using ultrasound. Although the link or segment is shown here as a hollow tubular segment, it is understood that the link may be formed in a variety of sizes and shapes, including shapes contoured to match the curvature of the vessel or the patient's anatomical structure. In some embodiments, the link is defined as a series of boundary elements such that, by shortening bridging elements or tethers, the link articulates along the anchor in a curved arrangement.The boundary elements can be of any suitable structure (e.g., solid, hollow) and can be formed in any desired shape.

[0059] Similar to these examples, each of the series of rear anchors will be mounted separately, as shown in Figure 10A, in that the configuration requires the attachment of multiple bridging elements to the front anchor. Such a configuration allows for separate, individual mountings that can apply tension at various angles to optimally deform the LA wall and mitral annulus, thereby reducing mitral regurgitation. Each rear anchor may adopt any of the shapes and features of the rear anchors described above. Each may be mounted in the same location on the front anchor, or in slightly different locations on the front anchor or in yet another separate front anchor to optimize the tension angle for maximum effect.

[0060] In another embodiment, the posterior anchor may include an expandable structure that can be crushed to form a reduced profile that allows it to engage with at least a portion of one side of the vessel through which it is deployed and to improve blood flow through it. Examples of such embodiments include a scaffold or wire-shaped structure configured to expand in the vessel after delivery and then be laterally crushed by tensioning of a bridging element. Such embodiments may include a wire-shaped structure having a weakened portion extending longitudinally on the opposite side of the wire-shaped structure to facilitate lateral crushing. The structure may be self-expanding or balloon-deployable. In some embodiments, the crushable wire-shaped structure includes one or more support ribs extending longitudinally to reinforce the crushed structure to improve anchoring and attachment of the structure along the length of the human vessel. Such reinforcing ribs may be straightened or curved as needed for the particular anatomical structure.

[0061] Figures 12A–12C and 13A–13B illustrate an example of the crushable wire-shaped cylindrical structure 120 described above. Typically, the wire-shaped structure is a cylindrical mesh structure that is delivered in a low profile and can be expanded to a desired diameter by either self-expansion or balloon expansion. The cylindrical mesh structure may include a rear backbone 122 that forms a T-bar and attaches to the bridging element 105.

[0062] As shown in Figure 12A, after the cylindrical mesh structure 120 is deployed within a blood vessel such as a GCV, the bridging element 105 extends from where the bridging element 105 extends through the GCV / LA wall to a support backbone 122 located on the opposite side of the cylindrical mesh structure 120. When tension is applied to the backbone by the bridging element 105, the support collapses the cylindrical mesh structure wall on its own, creating a flattened ribbon against the LA / GCV wall. Such a configuration is advantageous because it forms a rigid, relatively flat surface that effectively distributes the tensioning force against the wall to prevent the posterior anchor from being pulled through the GVC wall. Furthermore, the folded design doubles the wall thickness and therefore its strength, increasing its grip on the GCV wall to 1.5 times its uncollapsed diameter. Such a configuration allows for improved ease of deployment and enables the anchor to be embedded within the GVC wall during deployment. Moreover, the mesh structure of the scaffold further promotes internal tissue growth.

[0063] Figures 13A–13B illustrate another embodiment of the crushable scaffold structure 120, which includes folding zones or softer sections 123 to ensure preferential folding along predetermined lines. These folding zones extend longitudinally along most or all of the length of the cylindrical structure and are defined by scores, weakened sections, or deformed areas to facilitate folding of the cylindrical mesh structure along these areas when unfolded. Also, as with embodiments of the crushable foam, the material or coating of the wire morphological structure, and the surface structure of the crushable wire morphological structure, may be such as to promote internal tissue growth over time to form a tissue-anchor matrix. In any embodiment, the support backbone may be substantially linear or, preferably, generally curved to mimic the curvature of the inner wall of the GVC. The scaffold may be a mesh structure that can be defined to promote internal tissue growth.

[0064] Figure 14 illustrates an augmentation device 500 that can be used with the posterior anchor of the present invention to enable a variable loading effect on the atrial wall by the posterior anchor. As discussed herein, in various embodiments, the present invention provides a posterior anchor defined as a T-bar anchor 510 in which a bridging element 515 is mounted at the center of a T-bar backbone. In some embodiments, the augmentation device 500 is used with the T-bar anchor 510 of the present invention and includes a slot feature 505 that allows the loading effect on the atrial wall by the T-bar anchor 510 to be changed in situ.

[0065] Accordingly, the present invention provides an anchor system comprising the augmentation device 500 and the anchor of the present invention. In some embodiments, the augmentation device 500 has an elongated cylindrical body defined by an elongated lumen having a substantially cylindrical wall. In some embodiments, as shown in Figure 14, the lumen is configured to receive a T-bar anchor 510, and the cylindrical wall of the augmentation device includes a slot 505 disposed along the length of the cylindrical body of the device for engaging with a bridging element 515 of the anchor 510. In some embodiments, the anchor 510 has a substantially cylindrical body sized to pass through the elongated cylindrical body of the augmentation device 500 and a bridging element 515 coupled to the middle portion of the anchor 510. It will be understood that the anchor for use with the augmentation device 500 may be any T-bar device disclosed herein or any other anchor device of similar shape.

[0066] In practice, once the T-bar anchor is delivered to the GCV, the augmentation device is delivered to the GCV to engage and augment the T-bar anchor of the present invention. As shown in Figure 14, the augmentation device 500 is delivered in an orientation parallel to the T-bar anchor 510, and then rotated so that the augmentation device 500 is sandwiched between the inner wall of the GCV and the T-bar anchor 510, with the bridging element 515 passing through one of a plurality of slots 505 on the augmentation device 500. The augmentation device allows the compressive force of the T-bar anchor to be distributed more uniformly on the GCV wall. Furthermore, this force distribution can be varied and optimized by having different slots along the length of the augmentation device that the physician can choose to engage with the bridging element.

[0067] It will be understood that the augmentation device 500 allows for greater flexibility for physicians to adjust the outcome of the procedure within the procedure. Additionally, because the augmentation device provides a relatively larger contact area with the GCV wall (compared to that of a T-bar anchor), a T-bar anchor of reduced length can be used, facilitating delivery and deployment.

[0068] Furthermore, it will be understood that there are certain limitations to using T-bar anchors with a larger contact area in order to distribute the contact force and reduce the possibility of tissue cutting and erosion. For example, delivering a wide or large T-bar anchor on the same catheter is typically difficult, and at the same time, a penetrating guidewire is used to penetrate and traverse the atrial wall during the procedure. The augmentation device 500 allows the surgical step of traversing the atrial wall to be separated from the surgical step of deploying a relatively large T-bar anchor. In addition, multiple slots 505 on the augmentation device 500 that engage with the bridging element 515 allow the effective attachment point of the bridging element 515 to the T-bar anchor 510 to be varied during the procedure.

[0069] Figure 15 illustrates another configuration of the augmentation device 600 which may be used with the rear anchor of the present invention. As discussed herein, the augmentation device 600 is configured to add an additional force vector to the mechanism that shortens the A / P dimension of the mitral valve by allowing asymmetric loading of the rear anchor as needed.

[0070] Furthermore, the device 600 allows physicians to more specifically tailor treatment to the patient's anatomical structure by providing variations of supplemental implants having different shapes, sizes, or strengths. Accordingly, in one embodiment, the present invention provides an anchor system comprising the augmentation device 600 and the anchor of the present invention, wherein the augmentation device is at least 1.5, 2, 3, 4, 5, 6, 7, or 8 times the length of the anchor device.

[0071] Figure 15 shows an anchor system including an augmentation device 600 having an elongated shaft body 605 made of a shape memory material configured to deform from a first elongated configuration to a second bent configuration. The second bent configuration (shown in Figure 15) has a reduced length compared to the first elongated configuration. The shaft body 605 is configured to conform to the patient's anatomical structure in the second configuration when deployed. The system further includes an anchor 610 having a substantially cylindrical body shorter in length than the augmentation device 600, and a bridging element 615 coupled to the middle portion of the anchor 610. In some embodiments, the system is configured such that when the augmentation device 600 and the anchor 610 are coupled during deployment in a human body lumen, forces acting on the wall of the human body lumen are transferred from the anchor 610 to the augmentation device 600, causing the wall to deform.

[0072] As discussed herein, in certain embodiments, a short T-bar anchor is used as an anchoring mechanism within the GCV to assist in delivery. Once the short T-bar anchor is positioned within the GCV, the augmentation device is positioned adjacent to the T-bar anchor and coupled to it. In some embodiments, the augmentation device is composed of a shape memory material, such as a nitinol wire, which allows the device to change from a first configuration to a second configuration. In other embodiments, the augmentation device changes from a first configuration to a second configuration by a mechanical process, such as an adjustable linkage between parts of the device. The augmentation device is coupled to the T-bar anchor when deployed and applies a force to the rear wall that is different from that applied to the anchor alone, thereby reshaping the valve ring.

[0073] The present invention further provides devices and methods that enable variable adjustment of bridging elements for reshaping human body lumens, such as cardiac chambers, by connecting one or more posterior anchors to one or more anterior anchors. As discussed herein, in certain embodiments, the methods and devices are used to reshape the left atrium for the treatment of heart diseases such as mitral regurgitation. In various embodiments, the devices and methods of the present invention provide means by which the left atrium can be reshaped so as to reduce or inhibit regurgitation through the mitral valve. It will be understood that this requires specific positioning of the anchors and tensioning between them.

[0074] Referring to Figure 16, it is desirable to direct the force applied to the left atrial wall from the posterior anchor to a location closer to the A2 position in the atrium. This can be achieved in several ways, as described herein. For example, in one embodiment, the present invention provides an anterior anchor 650 modified to include a tube 660 extending from the anchor into the atrial cavity to direct the force acting between the posterior and anterior anchor toward the A2 position, as shown in Figure 16. In this configuration, the tube 660 extends from the anchor 650 into the atrial cavity toward A2 so that a bridge element 670 connected to the posterior anchor 680 applies force with a more correct AP orientation. During implantation, the anterior anchor 650 is delivered in a linear configuration using a core pin that retracts as the tube 660 enters the left atrium. The anterior anchor 650 is then rotated to position the tube 660 toward the A2 annulus, and the anterior anchor is deployed and optionally includes an anti-rotation function.

[0075] Figure 17 illustrates an anterior anchor 700 configured to position a bridging element closer to the A2 location where the left atrium is located. The anchor 700 provides a means of reducing the AP dimension of the mitral valve using the anterior anchor 700, which has a semi-rigid, pre-formed hollow tube 710, e.g., a "hypotube", passing through the anterior anchor 700, which repositions the bridging element closer to A2. The anchor 700 allows for more efficient AP diameter reduction by redirecting the bridging element to a trajectory that crosses the A2 / P2 location of the mitral valve. The tube 710 extending from the body 705 of the anchor is used to bring the suture closer to A2. Figure 18 shows the anchor 700 of Figure 17 in an unfolded configuration, coupled to a posterior anchor 720 positioned at P2.

[0076] To achieve similar results, the present invention further provides an anterior anchor 750 having a movable arm 760 coupled to the anchor body 755, as shown in Figure 19. The adjustable arm mechanism is used to change the trajectory of the bridging element to provide the physician with a controlled, movable linkage system. In practice, the anchor 750 is delivered into the left atrium via a transverse wire, and the anterior anchor 750 is deployed as usual. In some embodiments, the physician can adjust the angle and length / extension of the arm 760, as shown in Figure 20, to determine the best clinical outcome. The arm angle and extension length of the arm are then locked in place.

[0077] In relation to the embodiments of the present invention depicted in Figures 17, 19, and 20, the anchor is delivered in a flattened linear configuration. The anchor is loaded onto a transverse wire / bridging element and deployed into the left atrium.

[0078] In some embodiments, the anchor 700 shown in Figure 17 has a pre-formed tubular rigid member that is used to keep the tube straight for insertion and is then removed during deployment to allow the tube 710 to take its thermoformed form, thereby bringing the anterior position of the suture bridge closer to A2. In some embodiments, the proximal portion of the pre-formed tubing is shaped to move the suture lock position nearly in line with the trajectory of the bridging element that crosses the mitral valve. This helps to balance the moment generated on the anchor by moving the transverse bridge away from the center of the posterior anchor device, as shown in Figure 18.

[0079] In embodiments of the present invention depicted in Figures 19 and 20, once the anchor 750 is deployed, two mandrels, actuated by a physician at the proximal end of the deployment catheter, are used to adjust the rotation angle and the length of extension of the arm 760. The angle is changed by pulling tension on the arm of the implant via a rotating hinge 765, as shown in Figure 21. In some embodiments, arm extension is performed by using an additional mandrel to push the arm 760 along a track between the extension arm and the rotating arm, as shown in Figure 20. Once the desired position is determined, both control devices can be locked in place by locking the mandrels in place relative to the proximal side of the anchor. The mandrels are then released proximal to the locking feature, and the anchor 750 is permanently deployed.

[0080] Figure 22 illustrates an additional aspect of the present invention that provides a means for reducing the AP dimension of the mitral valve using a posterior implant in the GCV and an anterior implant (including two connected anterior anchors 800 and 810) extending from the left atrial appendage (LAA) to the fossa ovalis (FO). As shown in Figure 22, the present invention provides an implant system having a connecting rail 820 with a slide lock 830 between the anterior anchors 800 and 810 in the LAA and FO, the connecting rail 820 being coupled to the posterior anchor 815 via a suture bridge 840. This slide lock can be positioned across the span from the LAA to the FO to achieve the most effective reduction of mitral regurgitation based on anatomical structure and disease state.

[0081] An aspect of the present invention shown in Figure 22, as discussed herein, allows a physician to pull a posterior anchor, such as a T-bar anchor, from a location close to A2. This enables more efficient AP shortening. It also allows the physician to tailor treatment to the specific location where a regurgitation jet over the valve is present. Figure 23 illustrates the difference between an implant system with three anchors, as opposed to one with two.

[0082] Referring to Figures 22-28, the implantation procedure actually proceeds normally until the wire has crossed the atrial wall and the left atrial appendage catheter has been removed from the sheath. At this point, as shown in Figure 24, the posterior anchor positioned within the GCV, including the coupled bridging element, crosses the atrial wall and enters the catheter (light blue), exiting to the proximal end of the device.

[0083] Next, the anterior implant is loaded onto the transverse wire / bridging element. The anterior implant includes a first distal anterior anchor (shown as a nitinol wire vascular plug in the diagram), a connecting rail (shown as a nitinol hypotube), a bridging element connector (shown as a slide lock), and a second distal anterior anchor. The first and second distal anterior anchors are connected by the connecting rail. The proximal end of the transverse wire is reverse-loaded into the slide lock and passed through the distal implant grommet, allowing the implant to advance through the sheath into the left atrium.

[0084] A first distal anterior anchor, such as an LAA anchor, is advanced into the LAA and deployed therein. In one embodiment of the present invention, the sheath is maneuverable to allow wire transposition at P2 and to facilitate deployment within the LAA. A second distal anterior anchor, such as a septal anchor, is then advanced and deployed within the septum. The anterior implant is envisioned to be delivered as a single implant (LAA anchor, slide lock, rail, and septal anchor) or as a series of discreetly delivered components. In some embodiments, the LAA anchor is a nitinol mesh that expands into the LAA, or an anchor-type device that deploys into cardiac tissue or the fibrous skeleton of the heart, such as the left fibrous triangle. In some embodiments, it will be understood that the delivery catheter is maneuverable to allow the first distal anterior anchor and the second distal anterior anchor to be delivered within the same catheter.

[0085] In some embodiments, the septal implant is then deployed into the septum, and the bridging element passes through the septal anchor, for example, a second anterior anchor. The physician then begins applying the treatment using an Echoppler to assess the effectiveness of the synchronization. The present invention provides two controls: 1) the physician can apply tension to the suture bridge to reduce the ap dimension, and / or 2) the physician can adjust the position of the slide lock to change the angle at which the posterior anchor is pulled.

[0086] Once the treatment is applied, a locking system similar to that used for suture locks is employed to lock the slide lock in place on the slide rail. The suture will be locked on the right atrial side of the distal implant, for example, on the second anterior anchor. The procedure then continues so that the suture lock is deployed and the suture is cut.

[0087] Figures 29-31 illustrate an anterior anchor 900 in another aspect of the present invention, configured to position the bridging element 950 closer to the A2 location where the left atrium is located. To alter the direction of tensioning between the septal puncture site and the GCV puncture site, the anterior anchor 900 includes a left-side anchor member 910 and a right-side anchor member 920, which are mounted independently of each other. This alters the angle and orientation of the bridging element 950 coupled to the posterior anchor, providing a more controlled treatment for the patient.

[0088] Unlike conventional front anchors with coaxial through-holes, the anchor 900 shown in Figures 29-31 provides a double front anchor with a left anchor member 910 and a right anchor member 920 positioned separately. The through-holes of each member are connected by a tubular lumen 930. As shown in the figures, the through-holes are not aligned coaxially, thereby orienting the bridging element 950, for example, a suture bridge, to apply the most effective tensioning treatment.

[0089] The above is to be considered merely illustrative of the principles of the present invention. The embodiments disclosed herein are merely illustrative of the present invention, which may be embodied in other specific structures. Preferred embodiments are described, but details may be modified without departing from the present invention. Furthermore, much of the present invention is shown in simple forms to illustrate basic functions and features, which may be combined into final embodiments using another element combined into a single device. Also, the embodiments described may be combined, without limitation, by examples having a constrained backbone of a collapsible foam, or a configuration having multiple curved anchors with anti-reversal features, or multiple attachments to a forward anchor. Furthermore, since numerous modifications and changes will be readily conceivable to those skilled in the art, the present invention is not limited to the structures and operations illustrated and described in the preferred embodiments, except for the limitations of the claims.

[0090] Although the present invention has been described with reference to the above examples, it will be understood that modifications and variations are included within the spirit and scope of the invention. Accordingly, the present invention is limited only by the following claims.

Claims

1. a) an augmentation device having an elongated cylindrical body, the augmentation device having an elongated lumen defined by a substantially cylindrical wall, the lumen configured to receive an anchor, the cylindrical wall including one or more slots disposed along the length of the cylindrical body for engaging a bridging element of the anchor; b) an anchor having a substantially cylindrical body sized to pass through the elongated cylindrical body of the augmentation device and a bridging element coupled to an intermediate portion of the anchor; An anchor system comprising:

2. The anchor system of claim 1 , wherein the anchor further comprises a substantially rigid backbone extending longitudinally along at least a portion of the cylindrical body of the anchor.

3. The anchor system of claim 2 , wherein the substantially rigid backbone is disposed on or within the cylindrical body of the anchor.

4. The anchor system of claim 1 , wherein the augmentation device and the anchor are longitudinally curved to conform to a patient's anatomy.

5. 10. The anchor system of claim 1, wherein the augmentation device comprises at least 2, 3, 4, 5, 6, 7, 8, 9, 10, or more slots disposed along the length of the augmentation device.

6. a) an augmentation device having an elongate shaft body, the shaft body having a first elongate configuration and a second bent configuration, the second bent configuration having a reduced length compared to the first elongate configuration; b) an anchor having a substantially cylindrical body having a length shorter than the length of the augmentation device and a bridging element coupled to an intermediate portion of the anchor, wherein the system is configured such that when the augmentation device and anchor are coupled and deployed in a body lumen, a force applied to a wall of the body lumen from the anchor is transferred to the augmentation device to deform the wall; and An anchor system comprising:

7. 7. The anchor system of claim 6, wherein the shaft body is constructed from a shape memory material and is configured to transition to the second configuration when the shaft body is in a relaxed state.

8. The anchor system of claim 6 , wherein the shaft body is configured to transition to the second configuration by mechanical manipulation by a user.

9. The anchor system of claim 6 , wherein the shaft body is configured to conform to a patient's anatomy in the second configuration.

10. The anchor system of claim 6 , wherein in the second configuration, the augmentation device forms an arcuate shape.

11. The anchor system of claim 6 , wherein in the second configuration, the augmentation device forms a shape having at least one deflection point.

12. 12. The anchor system of claim 11, wherein in the second configuration, the augmentation device is defined by a shape having at least two straight portions with a deflection point sandwiched therebetween.

13. 13. The anchor system of claim 12, wherein in the second configuration, the augmentation device is defined by a shape having two, three, four, five, six, seven, eight, nine, ten, or more linear portions with a deflection point sandwiched between each of the linear portions.

14. a) an anterior anchor having an anchor portion operable to secure the anterior anchor in tissue, a throughbore extending through the anchor member, and an elongate tube having a lumen coextensive with the throughbore, the elongate tube being constructed from a semi-rigid or rigid material that resists bending; b) a posterior anchor coupled to a first end of a bridging element, the second end of the bridging element being configured to traverse the lumen of the elongate tube of the anterior anchor; and An anchor system comprising:

15. 15. The anchor system of claim 14, wherein the elongate tube is formed of a shape memory material having a first linear configuration and a second non-linear configuration, the elongate tube being configured to transition to the second configuration when the tube is in a relaxed state.

16. The anchor system of claim 14 , wherein the elongate tube extends from a single side of the anchor member.

17. 15. The anchor system of claim 14, wherein the elongate tube extends through the through hole and away from the anchor member on either side of the anchor member.

18. 15. The anchor system of claim 14, wherein the anchor portion comprises a first anchor member and a second anchor member, the first and second anchor members configured to couple to one another on opposite sides of tissue.

19. 20. The anchor system of claim 18, wherein the through holes traversing the first and second anchor members are offset when the members are joined together.

20. a) an anterior anchor having an anchor portion operable to secure the anterior anchor in tissue, a throughbore extending through the anchor member, and an adjustable arm extending from the anchor portion; b) a posterior anchor coupled to a first end of the bridging element, the second end of the bridging element being configured to traverse the through-hole of the anterior anchor, the adjustable arm operable to adjust the positioning of the bridging element when the anterior anchor and the posterior anchor are coupled via the bridging element during deployment in a body vessel; and An anchor system comprising:

21. 21. The anchor system of claim 20, wherein the adjustable arm is rotatable about the circumference of the anterior anchor.

22. 21. The anchor system of claim 20, wherein the adjustable arm has an extendable portion operable to lengthen the arm.

23. 22. The anchor system of claim 21, wherein the adjustable arm is connected to the anchor portion by a rotatable hinge.

24. 21. The anchor system of claim 20, wherein the adjustable arm includes a locking element operable to lock the positioning of the arm relative to the anchor portion.

25. 25. The anchor system of claim 24, wherein the locking element is a mandrel that engages with an extendable portion of the adjustable arm.

26. a) an anterior implant having a first anterior anchor, a second anterior anchor, a connecting rail extending between the first and second anterior anchors, and a bridging element connector disposed on the connecting rail; b) a posterior anchor coupled to a first end of a bridging element, the second end of the bridging element configured to engage with the bridging element connector and traverse the through-hole of the first anterior anchor or the through-hole of the second anterior anchor when the anterior implant and the posterior anchor are coupled via the bridging element upon deployment in a body vessel; An anchor system comprising:

27. 27. The anchor system of claim 26, wherein the bridging element connector is configured as a slide lock slidably disposed on the connecting rail.

28. 27. The anchor system of claim 26, wherein the first anterior anchor is configured to anchor the first anterior anchor proximate a left atrial appendage and the second anterior anchor is configured to anchor the second anterior anchor proximate a fossa ovalis.

29. 27. The anchor system of claim 26, wherein the anterior anchor implant is configured to be delivered as a single implant.

30. 27. The anchor system of claim 26, wherein the anterior anchor implant is configured to be delivered as separate components that are delivered in series.

31. 27. The anchor system of claim 26, wherein the first anterior anchor is constructed of nitinol mesh and configured to anchor the first anterior anchor proximate the left atrial appendage.

32. 27. The anchor system of claim 26, wherein the first anterior anchor is configured to anchor the first anterior anchor within fibrous cardiac tissue and / or within a fibrous skeleton of the heart.

33. 27. The anchor system of claim 26, wherein the first anterior anchor is configured to anchor the first anterior anchor in a left fibrous trigon.

34. 34. A method of reshaping a heart chamber in a subject, the method comprising implanting an anchor system according to any one of claims 1 to 33 within the heart chamber, thereby reshaping the heart chamber of the subject.

35. 35. The method of claim 34, wherein the heart chamber is the left atrium.

36. 35. The method of claim 34, wherein the anchor system is implanted using a magnetic catheter system.

37. 34. A method of treating mitral valve regurgitation in a subject by reshaping a left atrial heart chamber in the subject, the method comprising implanting an anchor system of any one of claims 1-33 within the left atrial heart chamber, thereby treating mitral valve regurgitation in the subject.

38. 38. The method of claim 37, wherein the anchor system is implanted using a magnetic catheter system.

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