Methods for traversing anatomical blood vessel walls

Abstract

Methods are provided for crossing anatomical vascular walls of a subject. The invention allows for the traversal of a wire from one anatomical lumen, such as an artery, vein, esophagus, intestine, or airway, through tissue into another anatomical lumen or cavity, or into a solid mass of tissue. In some embodiments, the invention allows for the traversal of a wire from the great cardiac vein (GCV) into the left atrium without relying on a separate device in the left atrium to facilitate the traversal. TIFF2024500328000002.tif198129

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 122,843, filed on December 8, 2020, under 35 U.S.C. § 119(e). The disclosure of the prior application is considered a part of the disclosure of this application and is incorporated herein by reference.

[0002] Field of the Invention The present invention generally relates to medical treatment, and more specifically, to a method for transecting the anatomical vessel wall of a subject during a surgical procedure, including those for the treatment of heart disease.

Background Art

[0003] Background Information The treatment of mitral valve regurgitation is wide - ranging and diverse, including both replacement valves and many approaches that facilitate valve repair and remodeling by using implants. Many such approaches rely on the endovascular delivery of implants, which often utilize a system of multiple catheters that are frequently repeatedly exchanged, which is often a complex and time - consuming process. To understand the difficulties and challenges associated with the delivery and deployment of implants within the human heart, it is useful to understand the various aspects of the anatomical structure of the heart, as well as the conventional methods of deploying implants for the treatment of mitral valve regurgitation.

[0004] Anatomy of a Healthy Heart As can be seen in Figure 2A, the human heart is a two - sided (left - right) self - regulating pump, the parts of which work in concert to propel blood to all parts of the body. The right side of the heart receives deoxygenated ( "venous") blood from the body via the superior vena cava and the inferior vena cava and pumps it to the lungs via the pulmonary artery to be oxygenated. The left side receives oxygenated ( "arterial") blood from the lungs via the pulmonary veins and pumps it to the aorta for distribution to the body.

[0005] The heart has four chambers: two on each side, the right and left atria, and the right and left ventricles. The atria are the blood-receiving chambers that pump blood into the ventricles. The ventricles are the blood-draining chambers. A wall composed of fibrous and muscular parts called the atrial septum separates the right and left atria (see Figures 2B-2D). The anatomical landmark of the atrial septum is an oval, fingerprint-sized depression called the fossa ovale (FO), shown in Figure 2C. This is the remnant of the fetal foramen uveforme and its valve, and therefore does not contain important structures such as valve structures, blood vessels, and conduction pathways. 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. The cycle ends with a period of ventricular contraction, called ventricular systole. The heart has four valves (see Figures 2B and 2C) that prevent blood from flowing in the wrong direction during the cardiac cycle; that is, to prevent blood from flowing backward from the ventricles to the corresponding atria, or backward from the arteries to the corresponding ventricles. The valve between the left atrium and left ventricle is the mitral valve. The valve between the right atrium and right ventricle is the tricuspid valve. The pulmonary valve is located at the opening of the pulmonary artery. The aortic valve is located at the opening of the aorta.

[0006] At the start of ventricular diastole (ventricular filling), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles.

[0007] Shortly thereafter, as shown in Figure 2B, the tricuspid and mitral valves open, allowing blood to flow from the atria to the corresponding ventricles. Immediately after ventricular contraction (ventricular emptying) begins, as shown in Figure 2C, the tricuspid and mitral valves close to prevent backflow from the ventricles to the corresponding atria, and the aortic and pulmonary valves open, allowing blood to be drained from the corresponding ventricles into the arteries.

[0008] The opening and closing of heart valves primarily occurs as a result of pressure differences. For example, the opening and closing of the mitral valve results from the pressure difference between the left atrium and the left ventricle. During ventricular diastole, as the ventricles relax, venous blood returns from the pulmonary veins to the left atrium, causing the pressure in the atrium to exceed the pressure in the ventricles. As a result, the mitral valve opens, allowing blood to enter the ventricles. During ventricular systole, as the ventricles contract, the intraventricular pressure rises above the atrial pressure, pushing the mitral valve to close.

[0009] As shown in Figures 2B and 2C, the anterior (A) portion of the mitral annulus is in close contact with the non-coronary leaflets of the aortic valve. Notably, the mitral annulus is located near other important cardiac structures such as the circumflex branch of the left coronary artery (supplying the left atrium, variable volume of the left ventricle, and in many people the SA node) and the AV node (which, together with the SA node, regulates the cardiac cycle). Near the posterior (P) mitral annulus are the coronary sinuses and their branches. These vessels drain the region of the heart supplied by the left coronary artery. The coronary sinuses and their branches receive approximately 85% of coronary venous blood. As can be seen from Figure 2C, the coronary sinuses are located posterior to the right atrium, anterior and inferior to the fossa ovale. The branches of the coronary sinuses, called the great cardiac veins, run parallel to most of the posterior mitral annulus and are located only about 9.64 + / - 3.15 millimeters above the posterior mitral annulus.

[0010] Characteristics and causes of mitral valve dysfunction When the left ventricle contracts after being filled with blood from the left atrium, the ventricular walls move inward, releasing some tension from the papillary muscles and cords. Blood is pushed up to the lower surface of the mitral valve leaflets and rises toward the annular plane of the mitral valve. As it progresses toward the ring, the anterior edges of the anterior and posterior leaflets come together to form a seal, closing the valve. In a healthy heart, leaflet junction occurs near the plane of the mitral annulus. The blood remains pressurized in the left ventricle until it is pumped out into the aorta. Contraction of the papillary muscles occurs simultaneously with ventricular contraction and helps to firmly close the leaflets of a healthy valve with the peak systolic pressure exerted by the ventricle.

[0011] In a healthy heart (shown in Figures 2E and 2F), the dimensions of the mitral annulus create an anatomical shape and tension, resulting in the leaflets forming a rigid junction at peak systolic pressure. The point where the leaflets join on the opposite inner (CM) and lateral (CL) sides of the annulus is called the leaflet commissure. Valve malfunction can be caused by stretching, and in some cases tearing, of the chordae tendineae (cords). When the chordae are torn, it results in the leaflets swinging around. Also, normally structured valves 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 may be defective due to birth defects or acquired diseases. Regardless of the cause, if the leaflets do not join at peak systolic pressure, as shown in Figure 2G, mitral valve dysfunction can occur. In such cases, the junction line of the two leaflets is not tight during ventricular systole. As a result, an undesirable backflow of blood from the left ventricle to the left atrium can occur, commonly known as mitral regurgitation. This has two important consequences. First, the blood returning to the atrium can cause high atrial pressure and reduce blood flow from the lungs to the left atrium. As blood returns into the pulmonary system, fluid leaks into the lungs, causing pulmonary edema. Second, the amount of blood heading to the atrium reduces the amount of blood advancing towards the aorta, lowering cardiac output. The excess blood in the atrium overfills the ventricles during each cardiac cycle, causing left ventricular volume overload.

[0012] Mitral regurgitation is classified into two main types: i) organic or structural, and ii) functional. Organic mitral regurgitation results from structurally abnormal valve components that cause the valve leaflets to leak out during systole. Functional mitral regurgitation results from annular dilation due to primary congestive heart failure and is generally not surgically treatable in itself, and is not caused by causes such as severe irreversible ischemia or primary valvular heart disease. Organic mitral regurgitation is seen when a ruptured cord or papillary muscle creates a shell for the leaflet, causing a seal failure at the free anterior edge of the leaflet, or when the leaflet tissue is redundant, the valve may open higher in the atrium during ventricular systole, and the junction may be reduced to a level where it occurs higher into the atrium. Functional mitral regurgitation results from dilation of the heart and mitral annulus secondary to heart failure and, in most cases, results from coronary artery disease or idiopathic dilated cardiomyopathy. Comparing a healthy ring to an unhealthy ring, the unhealthy ring expands, particularly the anterior-posterior distance along the small axis (line PA). As a result, the shape and tension defined by the ring become more rounded rather than elliptical. This condition is called expansion. As a ring expands, the shape and tension favorable for joining at peak contraction pressure gradually deteriorate.

[0013] Pre-treatment modalities Of the 6 million Americans with congestive heart failure, 25 percent are reported to have some degree of functional mitral regurgitation. This accounts for 1.5 million people with functional mitral regurgitation. Treatment for mitral regurgitation can involve the use of diuretics and / or vasodilators to reduce the amount of blood flowing back into the left atrium. Intra-aortic balloon counterpulsation devices are used when the condition does not stabilize with medication. In cases of chronic or acute mitral regurgitation, surgery to repair or replace the mitral valve is often necessary.

[0014] Interrupting the cycle of progressive functional mitral regurgitation has been shown to increase survival rates in surgically treated patients and, in fact, increase anterior pumping rates in many patients. The problem with surgical treatment is that it imposes significant harm on these chronic disease patients, with high morbidity and mortality associated with surgical repair.

[0015] Currently, patient selection criteria for mitral valve surgery are highly selective, and it is usually performed only on patients with normal ventricular function, generally good health, a projected life expectancy of 3–5 years or more, NYHA class III or IV symptoms, and at least grade 3 regurgitation. Patients who do not meet these requirements, typically elderly patients in poor health, are not good candidates for surgical procedures, especially open surgical procedures. Such patients would greatly benefit from short-term, less invasive surgical procedures that improve valve function. However, such patients could also benefit from further improvements in minimally invasive surgical procedures for deploying such valve treatment and repair implants, systems, reducing the complexity of the delivery system, the duration of the procedure, and consistency, reliability, and ease of use.

[0016] Therefore, there is a need for further improvements to reduce the complexity of such delivery systems, as well as for improved delivery methods that shorten the duration of treatment and improve consistency, reliability, and ease of use for clinicians in the deployment of cardiac implants for the treatment of mitral regurgitation. [Overview of the project]

[0017] The present invention provides a method for traversing the anatomical vascular wall of a target. In various embodiments, the present invention enables the traversal of a wire from one anatomical lumen, such as an artery, vein, esophagus, intestine, or airway, through tissue into another anatomical lumen or cavity, or into a solid mass of tissue. In some embodiments, the present invention enables the traversal of a wire from the great cardiac vein (GCV) into the left atrium without relying on another device in the left atrium to facilitate the traversal.

[0018] Accordingly, in one embodiment, the present invention provides a method for traversing a blood vessel wall. The method includes inserting a catheter into a first anatomical lumen having a blood vessel wall and advancing it to a first location, wherein the catheter comprises a lumen extending along the length of the catheter, a distally located opening, and a stabilizing element; stabilizing the catheter in the first lumen at the first location via the stabilizing element; advancing a penetrating guidewire along the lumen of the catheter to the first location toward the distally located opening, wherein the penetrating guidewire comprises a tip having shape memory and configured to form a trapping structure when traversing a blood vessel wall; and advancing the penetrating guidewire out of the distally located opening to penetrate the blood vessel wall, traverse the blood vessel wall and enter a second anatomical lumen or tissue, thereby traversing the blood vessel wall.

[0019] In another embodiment, the present invention provides a method for treating mitral regurgitation in a subject by reshaping the cardiac chambers of the subject. The method involves inserting a catheter through a vascular access site and advancing the catheter along a first anatomical lumen having a vascular wall to a first location close to the heart of the subject, wherein the catheter comprises a lumen extending along the length of the catheter, a distally located opening, and a stabilizing element; stabilizing the catheter in the first lumen at the first location via the stabilizing element; advancing a penetrating guidewire along the lumen of the catheter to the first location toward the distally located opening; and advancing the penetrating guidewire out of the distally located opening to penetrate the vascular wall, traverse the vascular wall, and enter the cardiac chamber, wherein the penetrating guidewire comprises a tip having shape memory and forming a trapping structure when traversing the vascular wall. The procedure is configured to advance a first anchor through the lumen of a catheter to a first location, the first anchor being coupled to the first anchor at a first end of a bridge element; advance a second end of a bridge element through a penetrated vessel wall at a first location; advance a second anchor along the bridge element and deploy a second anchor at a second location within or near the heart, the bridge element spanning a cardiac chamber; and reshape the cardiac chamber by shortening the length of the bridge element, and while the cardiac chamber is being reshaped, the second end of the bridge element being coupled to the deployed second anchor so that the cardiac chamber remains reshaped, thereby treating the mitral regurgitation of the target. [Invention 1001] The method involves inserting a catheter into a first anatomical lumen having a blood vessel wall and advancing it to a first location, wherein the catheter comprises a lumen extending along the length of the catheter, a distally positioned opening, and a stabilizing element. The catheter in the first lumen is stabilized at the first location via the stabilizing element, The process involves advancing a penetrating guidewire along the lumen of the catheter to the first location toward the distally positioned opening, wherein the penetrating guidewire is provided with a tip, the tip having shape memory, and is configured to form a trapping structure when traversing the blood vessel wall. By advancing the through guidewire out of the distally located opening, it penetrates the blood vessel wall, crosses the blood vessel wall, and enters a second anatomical lumen or tissue, thereby traversing the blood vessel wall. A method for traversing the blood vessel wall, including [specific method / technique]. [Invention 1002] The method of the present invention 1001, wherein the stabilizing element includes an expandable balloon or stent. [Invention 1003] The method of the present invention 1001, wherein the capture structure includes a hook or loop structure, and optionally the hoop or loop comprises a bent section having an angle greater than approximately 90 degrees, greater than 100 degrees, greater than 110 degrees, greater than 120 degrees, greater than 130 degrees, greater than 140 degrees, greater than 150 degrees, greater than 160 degrees, greater than 170 degrees, greater than 180 degrees, or greater than 190 degrees. [Invention 1004] The method of the present invention 1003 further comprises advancing the first anchor through the lumen of the catheter to a first location. [Invention 1005] The method of the present invention 1004, wherein the first anchor includes a bridge element, and the bridge element is coupled to the anchor at a first end of the bridge element. [Invention 1006] The method of the present invention 1005 further comprises advancing the second end of the bridge element through the penetrated vessel wall at the first location. [Invention 1007] The method of the present invention 1006, further comprising advancing a second anchor to a second location in or adjacent to a second lumen, and deploying the second anchor at the second location, wherein the first anchor is coupled to the first end of the bridge element and the second anchor is coupled to the second end of the bridge element. [Invention 1008] The method of the present invention 1007, further comprising applying tension to the bridge element. [Invention 1009] The method of the present invention 1008, wherein the first location is in close proximity to a cardiac chamber. [Invention 1010] The method of the present invention 1009, wherein the second location is located within or adjacent to the cardiac chamber. [Invention 1011] The method of the present invention 1010, wherein the cardiac chamber is the left atrium and the first location is within the great cardiac vein. [Invention 1012] Ten methods for reshaping the heart chambers, wherein the bridge element spans the heart chambers and tension is applied to the bridge element. [Invention 1013] The method of the present invention 1002, further comprising coupling a guide wire to the capture structure. [Invention 1014] The method of the present invention 1004, wherein the first anchor is advanced to the first location via a guide wire. [Invention 1015] The method of the present invention 1014 further comprises releasing the first anchor from the guidewire by retracting the guidewire along the lumen of the catheter. [Invention 1016] The method of the present invention 1001, further comprising determining the insertion depth of the catheter into the first lumen in order to determine the first position. [Invention 1017] The method involves inserting a catheter through a vascular access site and advancing the catheter along a first anatomical lumen having a vascular wall to a first location close to the target heart, wherein the catheter comprises a lumen extending along the length of the catheter, a distally positioned opening, and a stabilizing element. The catheter in the first lumen is stabilized at the first location via the stabilizing element, The penetrating guidewire is advanced along the lumen of the catheter to the first location toward the distal opening, The method involves advancing the through-guide wire out of the distally positioned opening to penetrate the blood vessel wall, traverse the blood vessel wall, and enter the cardiac chamber, wherein the through-guide wire is provided with a tip, the tip having shape memory, and is configured to form a trapping structure when traversing the blood vessel wall. The method involves advancing the first anchor through the lumen of the catheter to the first location, wherein the first anchor is coupled to the first end of the bridge element. The second end of the bridge element is advanced at the first location through the penetrated blood vessel wall, The procedure involves advancing a second anchor along the bridge element and deploying the second anchor at a second location within or near the heart, wherein the bridge element spans the cardiac chambers. The length of the bridge element is shortened to reshape the cavity of the heart, and while the cavity of the heart is being reshaped so that the cavity of the heart remains reshaped, the second end of the bridge element is connected to the deployed second anchor, thereby treating the mitral valve regurgitation in the target. A method for treating mitral valve regurgitation in the subject, including the treatment of mitral valve regurgitation in the subject. [Invention 1018] The method of the present invention 1017, wherein the stabilizing element includes an expandable balloon or stent. [Invention 1019] The method of the present invention 1017, wherein the capture structure includes a hook or loop structure, and optionally the hoop or loop comprises a bent section having an angle greater than about 90 degrees, greater than 100 degrees, greater than 110 degrees, greater than 120 degrees, greater than 130 degrees, greater than 140 degrees, greater than 150 degrees, greater than 160 degrees, greater than 170 degrees, greater than 180 degrees, or greater than 190 degrees. [Invention 1020] The method of the present invention 1017, wherein the cardiac chamber is the left atrium and the first location is within the great cardiac vein. [Invention 1021] The method of the present invention 1017, wherein the first anchor is advanced to the first location via a guide wire. [Invention 1022] The method of the present invention 1021 further comprises releasing the first anchor from the guide wire by retracting the guide wire along the lumen of the catheter. [Invention 1023] The method of the present invention 1017, further comprising determining the insertion depth of the catheter into the first lumen in order to determine the first position. [Brief explanation of the drawing]

[0020] [Figure 1] This paper outlines a conventional catheter system for intravascular delivery of cardiac implants for the treatment of mitral valve regurgitation. [Figure 2A] This is an anatomical front view of the human heart, with parts separated and cross-sections showing the internal chambers and adjacent structures. [Figure 2B] This is an anatomical top view of a cross-section of the human heart, showing the tricuspid valve in the right atrium, the mitral valve in the left atrium, and the aortic valve between them, with the tricuspid and mitral valves open and the aortic and pulmonary valves closed during ventricular dilation (ventricular filling) of the cardiac cycle. [Figure 2C] Figure 2B is an anatomical top view of a cross-section of the human heart, where the tricuspid and mitral valves are closed, and the aortic and pulmonary valves are open during ventricular contraction (ventricular ejection) of the cardiac cycle. [Figure 2D] This is an anatomical anterior oblique view of the left and right atria, with the parts separated and showing cross-sections of the internal chambers and related structures (e.g., fossa ovale, coronary sinus, and great cardiac vein). [Figure 2E] This is a top view of a healthy mitral valve, where the valve leaflets close during ventricular contraction and coagulate at the peak contractile pressure. [Figure 2F] Figure 2E is an anatomical top view of a cross-section of a human heart, showing a normal mitral valve closed during ventricular contraction (ventricular ejection) of the cardiac cycle. [Figure 2G]This is a top view of a dysfunctional mitral valve, a condition in which the valve leaflets do not close during the peak systolic pressure of ventricular contraction, leading to mitral valve regurgitation. [Figure 3] One aspect of the present invention demonstrates penetration of a blood vessel wall and deployment of an anchor using a single catheter via the method of the present invention. [Figure 4] One aspect of the present invention demonstrates penetration of a blood vessel wall and deployment of an anchor using a single catheter via the method of the present invention. [Figure 5] This describes anchor deployment via a method of the present invention using a single catheter, according to one aspect of the present invention. [Figure 6A] The image shows an anatomical anterior oblique view of the left and right atria, with a section separated and showing the presence of an implant system comprising an interatrial bridge element spanning the mitral annulus between a posterior anchor located in the great cardiac vein and an anterior anchor within the atrial septum, which is suitable for delivery using the method of the present invention. [Figure 6B] The image shows an anatomical anterior oblique view of the left and right atria, with a section separated and showing the presence of an implant system comprising an interatrial bridge element spanning the mitral annulus between a posterior anchor located in the great cardiac vein and an anterior anchor within the atrial septum, which is suitable for delivery using the method of the present invention. [Figure 7A] This is a detailed diagram showing the anterior anchor deployed within the fossa ovale of the atrial septum and the posterior anchor deployed within the great cardiac vein. [Figure 7B] This is a detailed diagram showing the anterior anchor deployed within the fossa ovale of the atrial septum and the posterior anchor deployed within the great cardiac vein. [Figure 8A] A detailed diagram of an exemplary anterior anchor implant suitable for fixation within the patent fossa ovalis of the atrial septum is shown. [Figure 8B] A detailed diagram of an exemplary anterior anchor implant suitable for fixation within the patent fossa ovalis of the atrial septum is shown. [Figure 9]Figure 9A shows an exemplary locking bridge stop for locking a bridge element to an anterior anchor of an implant. Figure 9B shows an exemplary locking bridge stop for locking a bridge element to an anterior anchor of an implant. [Figure 10] Figure 10A shows an alternative cardiac implant suitable for intravascular delivery according to an aspect of the present invention. Figure 10B shows an alternative cardiac implant suitable for intravascular delivery according to an aspect of the present invention. [Figure 11] Figure 11A shows an alternative example of a posterior anchor attached to a bridge element for an implant suitable for intravascular delivery, according to an aspect of the present invention. Figure 11B shows an alternative example of a posterior anchor attached to a bridge element for an implant suitable for intravascular delivery, according to an aspect of the present invention. [Figure 12] Figure 12A shows an alternative example of a posterior anchor for a cardiac implant suitable for intravascular delivery, according to an aspect of the present invention. Figure 12B shows an alternative example of a posterior anchor for a cardiac implant suitable for intravascular delivery, according to an aspect of the present invention. [Figure 13] One aspect of the present invention demonstrates penetration of a blood vessel wall via the method of the present invention, through the deployment of a penetrating guidewire (e.g., a transverse wire), using a catheter having a distally positioned stabilizing element (e.g., an expandable balloon) and a radiopaque marker. [Modes for carrying out the invention]

[0021] Detailed description of the invention As discussed herein, the present invention provides a method for traversing the anatomical vascular wall of a subject. While this disclosure demonstrates traversing the cardiovascular wall, such as a GCV, into the left atrium, it will be understood that the methodology of the present invention may be used in procedures involving any anatomical vessel to achieve wire traversal, such as entering from one anatomical lumen, such as an artery, vein, esophagus, intestine, or airway, through tissue into another anatomical lumen or cavity, or into a solid mass of tissue.

[0022] To achieve transverse vascular wall access, conventional techniques require the physical engagement of a catheter in one lumen with another catheter in an adjacent cavity, typically by magnetic attraction. The wire then enters the other catheter through the tissue wall from one catheter and advances forward.

[0023] Figure 1 shows an example of a conventional catheter-based delivery system used to reshape the cardiac chambers in the treatment of mitral regurgitation. The delivery system utilizes a pair of magnetic catheters that advance from separate vascular access points and are magnetically coupled across the tissue within the heart. The pair of catheters includes a vena cava (GCV) anchor delivery catheter 50, which is introduced from the jugular vein and advances along the superior vena cava (SVC) approach to the GCV, and a left atrial (LA) catheter 60, which is introduced from the femoral vein and advances along the inferior vena cava (IVC) approach, crossing the interatrial septum and into the left atrium. Each catheter includes a magnetic head along its distal portion (magnetic head 52 of catheter 50 and magnetic head 62 of catheter 60), and as a result, when magnetically coupled, the catheters provide a stable area to facilitate penetration of the tissue wall between the LA and GCV, and subsequent advancement of a puncture guidewire 54 through the GCV catheter 50 to the LA catheter 60. The posterior end of the puncture guidewire 54 is attached (e.g., by suturing) to one end of the bridge element 12, and the other end is attached to a posterior anchor 18 located on the distal portion of the GCV catheter 50. This configuration allows the bridge element 12 to advance across the left atrium by advancing the puncture guidewire 54 through the LA catheter 60 and out of the femoral vein, while the magnetic heads remain magnetically coupled to each other.

[0024] Unlike conventional catheter systems and procedures, the present invention requires only one catheter to achieve transverse vessel wall traverse. Using a single catheter to achieve transverse vessel wall traverse not only reduces the costs associated with materials and components but also simplifies the surgical procedure.

[0025] Accordingly, in one embodiment, the present invention provides a method for traversing an anatomical vascular wall. The method includes inserting a catheter into a first anatomical lumen having a vascular wall and advancing it to a first location. Once the catheter is in the anatomical lumen and has advanced to the desired position, the catheter is stabilized within the lumen using a stabilizing element.

[0026] Therefore, in various embodiments, the catheter 100 includes a lumen extending along the length of the catheter, a distally located opening 105, and a stabilizing element 110, as shown in Figure 3. In some embodiments, the stabilizing element 110 is positioned distally along the length of the catheter so that when the stabilizing element is deployed, the stabilizing element 110 is positioned adjacent to the distal catheter opening 105.

[0027] Figure 3 shows a catheter 100 positioned within a GCV and adjacent to the left atrium. The catheter 100 includes a stabilizing element 110 configured as an inflatable balloon. As the catheter opening moves to a desired position within the GCV, the balloon's inflation stabilizes the balloon's position within the GCV to prevent the catheter 100 from moving while the vessel wall is punctured and one or more anchors 120 are deployed. In one embodiment, the stabilizing element 110 is an inflatable balloon. In another embodiment, the stabilizing element 110 is an inflatable stent. In some embodiments, the stent is constructed of braid or mesh so as not to obstruct blood flow through the vessel when the stent is deployed to stabilize the catheter.

[0028] Once the stabilizing element 110 is deployed, the penetrating guidewire 115 advances along the lumen of the catheter toward the distally located opening 105. As shown in Figure 3, the penetrating guidewire 115, also called the transverse wire, is advanced beyond the distally located opening 105 and across the vessel wall to reach adjacent anatomical lumens such as the left atrium.

[0029] As discussed herein, the method of the present invention may further include advancing an anchor 120, shown as a T-bar anchor in Figure 3, via a catheter 100 to a site where the vessel wall is penetrated. As discussed herein, the anchor 120 may be part of an implant structure used to alter the shape of a cardiac chamber, for example, the left atrium, via a bridge element 130, as shown in Figure 5. In one embodiment, the bridge element 130 is connected to the anchor 120 via a first end and extends across the cardiac chamber to a second anchor deployed within the cardiac chamber or in close proximity to the cardiac chamber at a second location, as further discussed herein.

[0030] As shown in Figure 4, the penetrating guidewire 115 may include a tip 122 made of shape-memory material that, when the tip 122 traverses the blood vessel wall, forms a capture structure 125 such as a loop or hook. This allows the guidewire 115 to be captured via a second guidewire or catheter, etc., and allows the placement and / or deployment of one or more additional anchors of an implant. As shown in Figure 4, the tip curls back over the guidewire 115 to form a capture structure 125, which can then be hooked into the lumen of a catheter or advanced. Figure 4 shows a catheter 127 having a flared or funnel-shaped distal end that allows the capture structure 125 to be guided into the lumen of the catheter 127.

[0031] As discussed herein, the through guidewire includes a tip made of shape memory material. This allows the tip of the guidewire to advance along the GCV, traversing the container wall in a first generally straight configuration, and then transition to a second bent configuration that forms a capture structure. In some embodiments, the tip forms a hook or V-shape in the second configuration. In some embodiments, the tip forms a loop shape in the second configuration. In various embodiments, the capture structure includes a curved or arc-shaped section that forms an angle of at least about 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, or 190 degrees, or an angle greater than about 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, or 190 degrees, allowing the capture structure to catch and be drawn into a vascular cavity or into the lumen of a second catheter. In various embodiments, the shape memory material is composed of a shape memory metal, alloy, or plastic. In some embodiments, the shape memory material is composed of nickel-titanium (NiTi) or a copper-aluminum-nickel alloy.

[0032] As discussed herein, the methods and devices described herein are particularly useful for treating mitral regurgitation by reshaping the cardiac chambers, for example, by reshaping the left atrium. Accordingly, the present invention also provides a method for treating mitral regurgitation in a target by reshaping the cardiac chambers in a target. The method involves inserting a catheter through a vascular access site and advancing the catheter along a first anatomical lumen having a vascular wall to a first location close to the heart in a target, wherein the catheter comprises a lumen extending along the length of the catheter, a distally located opening, and a stabilizing element; stabilizing the catheter in the first lumen at the first location via the stabilizing element; advancing a penetrating guidewire along the lumen of the catheter to the first location toward the distally located opening; advancing the penetrating guidewire out of the distally located opening to penetrate the vascular wall, traverse the vascular wall and enter the cardiac chamber; and inserting a first anchor through the lumen of the catheter. The procedure includes: advancing the bridge element to a first location, wherein the first anchor is coupled to the first anchor at the first end of the bridge element; advancing the second end of the bridge element through the penetrated vessel wall at the first location; advancing the second anchor along the bridge element and deploying the second anchor at a second location within or near the heart, wherein the bridge element spans the cardiac chambers; and reshaping the cardiac chambers by shortening the length of the bridge element, wherein the cardiac chambers remain reshaped, and while the cardiac chambers are being reshaped, the second end of the bridge element is coupled to the deployed second anchor, thereby treating the mitral regurgitation of the target.

[0033] Figure 5 shows the deployment of an anchor within the GCV. As shown, the bridge element 130 of anchor 120 traverses the tissue wall through a hole formed by a penetrating guidewire deployed from the catheter while the stabilizing element is deployed. In some embodiments, the retraction of the guidewire 115 detaches anchor 120 from the guidewire 115, leaving the guidewire 115 in the GCV so that it can be coupled to one or more additional anchors located in or near another cardiac chamber via the bridge element 130.

[0034] Figure 13 illustrates penetration of a blood vessel wall by the method of the present invention via the deployment of a penetrating guidewire 115, using a catheter 100 having a distally positioned stabilizing element 110 and a radiopaque marker 116 in one embodiment of the present invention. In various embodiments, the catheter 100 includes a pre-curved shaft that mimics the curvature of the cardiac surface or anatomical blood vessels such as the coronary sinus, GCV, etc. In various embodiments, the radiopaque marker 116 has a unique shape that indicates to the user a specific orientation and position of the stabilizing element 110 for proper positioning during the procedure and while the penetrating guidewire 115 is traversing the blood vessel wall.

[0035] Cardiac implants for the treatment / repair of the heart valve annulus Exemplary implant structure for use in conjunction with the present invention Figures 6A and 6B show embodiments of an implant 10 that spans the mitral annulus and is sized and configured to extend across the left atrium in a generally anterior-posterior direction. The implant 10 comprises a spanning region or bridge element 12 having a posterior anchor region 14 and an anterior anchor region 16.

[0036] The posterior anchor region 14 is sized and configured to allow the bridge element 12 to be positioned in the region of atrial tissue above the posterior mitral annulus. This region is preferred because, generally, there is more tissue mass available to acquire the posterior anchor region 14 than in the tissue region located at or adjacent to the posterior mitral annulus. Tissue engagement in this annular position can also reduce the risk of injury to the circumflex coronary artery. In a small number of cases, the circumflex coronary artery may pass through and medial to the great atrial vein on the left atrium lateral to the left great cardiac vein, and lie between the great cardiac vein and the endocardium of the left atrium. However, because the forces within the posterior anchor region are upward and inward relative to the left atrium and not in a contractile manner along the long axis of the great cardiac vein, the likelihood of circumflex artery compression is lower compared to other techniques in this field, and it does not constrict the tissue of the great cardiac vein. Nevertheless, if coronary angiography reveals circumflex artery stenosis, a symmetrical posterior anchor may be replaced with an asymmetrical anchor, such as one limb of the T-shaped member being shorter than the other, thus avoiding compression of the transverse point of the circumflex artery. The asymmetrical morphology may also be initially selected based on pre-placement angiography.

[0037] Asymmetrical posterior anchors may also be used for other reasons. They may be selected when a patient is found to have severe stenosis of the distal great cardiac vein and the asymmetrical anchor is better suited to avoiding occlusion of that vessel. In addition, asymmetrical anchors may be chosen to optimize treatment, for example, in cases of malformed or asymmetrical mitral valves, by selectively and preferentially applying force to different points along the posterior mitral annulus.

[0038] The anterior anchor region 16 is sized and configured to allow the bridge element 12 to be positioned in or near adjacent tissue within the right atrium as it enters the right atrium through the septum. For example, as shown in Figures 6A and 6B, the anterior anchor region 16 may be adjacent to or abut against a region of fibrous tissue within the atrial septum. As shown, the anchor site 16 is preferably located above the anterior mitral annulus at approximately the same elevation as or higher than that of the posterior anchor region 14. In the illustrated embodiment, the anterior anchor region 16 is adjacent to or near the inferior edge of the fossa ovale. Alternatively, the anterior anchor region 16 may be located in a higher position within the septum, for example, at or near the superior edge of the fossa ovale. The anterior anchor region 16 may also be located in a higher or lower position within the septum, away from the fossa ovale, provided that the anchor site does not harm the tissue within the region.

[0039] Alternatively, the anterior anchor region 16, upon entering the right atrium through the septum, may be located within one or more additional anchors situated in the surrounding tissue or region, for example, within the superior vena cava (SVC) or inferior vena cava (IVC), or otherwise extend.

[0040] During use, the spanning region or bridge element 12 may be positioned under tension between the two anchor regions 14 and 16. This allows the implant 10 to act as a generally direct mechanical force, traversing the left atrium from posterior to anterior. This direct mechanical force can help shorten the short axis of the annulus (along the line PA in Figure 2E). In doing so, the implant 10 can also reactively reshape the annulus along its long axis (the line CM-CL in Figure 2E) and / or reactively reshape other surrounding anatomical structures. However, it should be understood that the presence of the implant 10 can help stabilize tissues adjacent to the cardiac valve annulus without affecting the length of the short or long axis.

[0041] Furthermore, it should be understood that when located within other valve structures, the affected axis may not be the "long axis" or "short axis" due to the surrounding anatomical structure. In addition, for therapeutic purposes, the implant 10 only needs to reshape the ring during a portion of the cardiac cycle, for example, during late diastole and early systole when most mitral leakage occurs, when the heart is most filled with blood at the onset of ventricular contraction. For example, the implant 10 can be sized to limit the outward displacement of the ring during late diastole relaxation as the ring expands.

[0042] The mechanical force applied by implant 10 across the left atrium can restore a more normal anatomical shape and tension to the valve annulus and leaflets. This more normal anatomical shape and tension promotes leaflet fusion during late ventricular diastole and early ventricular systole, thereby reducing mitral regurgitation.

[0043] In its most basic form, the implant 10 is made from a biocompatible metal or polymer material, or a metal or polymer material that has been appropriately coated, impregnated, or otherwise treated with a material to impart biocompatibility, or a combination of such materials. The material is also preferably radiopaque, or incorporates radiopaque properties to facilitate visualization on X-ray fluoroscopy.

[0044] In some embodiments, the implant 10, or at least a portion thereof, may be formed by bending, molding, joining, machining, shaping, or extruding a metal or polymer wireform structure that may have flexible or rigid, inelastic or elastic mechanical properties, or a combination thereof. In other embodiments, the implant 10, or at least a portion thereof, may be formed from a metal or polymer thread-like or suture material. Materials that can form the implant 10 include, but are not limited to, stainless steel, nitinol, titanium, silicone, plated metals, Elgiloy®, NP55, and NP57.

[0045] In any of the implants described herein, the bridge member may be formed from a substantially inelastic material, such as a threaded or sutured material.

[0046] Rear anchor area The posterior anchor region 14 is sized and configured to be located within the left atrium or in the annular position of the left atrium, for example, within the left atrial wall above the posterior mitral annulus or near the left atrial wall.

[0047] In the illustrated embodiment, the posterior anchor region 14 is generally positioned at the level of the great cardiac vein, adjacent to and parallel to a large portion of the posterior mitral annulus. This extension of the coronary sinus can provide a strong and reliable fluoroscopic landmark when placing radiopaque devices within the coronary sinus or when injecting contrast agents into the coronary sinus. As previously stated, fixing the bridge element 12 in this annular position also reduces the risk of intrusion and damage to the circumflex coronary artery compared to procedures applied directly to the mitral annulus. Furthermore, the annular position does not ensure contact with the valve leaflets, thus allowing for bonding and reducing the risk of mechanical damage.

[0048] Furthermore, the great cardiac vein provides a site where relatively thin non-fibrous atrial tissue can be easily reinforced and strengthened. To enhance the retention or acquisition of the posterior anchor region 14, which is essentially non-fibrous cardiac tissue, and to improve the distribution of forces applied by the implant 10, the posterior anchor region 14 may include a posterior anchor 18 positioned within the great cardiac vein and the abutting venous tissue. This makes it possible to fix the posterior anchor region 14 to the non-fibrous portion of the heart, and nevertheless maintain considerable retention or acquisition on its tissue for a considerable period without rupture, expressed within a clinically appropriate timeframe.

[0049] Front anchor area The anterior anchor region is sized and configured to allow the bridge element 12 to remain firmly in place adjacent to or near the fibrous tissue and surrounding tissue on the right atrial side of the interatrial septum. The fibrous tissue in this region provides superior mechanical strength and integrity compared to muscle, allowing it to withstand device withdrawal with confidence. The septum is the most fibrous tissue structure within its own range in the heart.

[0050] Surgically treated cardiac tissue is usually one of the only cardiac tissues to which sutures can actually be placed, and it can be expected that it can be held without cotton suturing, or, if necessary, without deeply grasping the muscle tissue.

[0051] As shown in Figures 6A and 6B, the anterior anchor region 16 passes through the septal wall at the aforementioned annular position above the plane of the anterior mitral valve annulus. The anterior annular distance may generally be greater than or equal to the posterior annular distance. The anterior anchor region 16 may be located in or near the lower edge of the fossa ovale, although other lower or higher locations may be used both inside and outside the fossa ovale, considering the need to prevent damage to the septal tissue and surrounding structures.

[0052] By positioning the bridge element 12 at this aforementioned annular level within the right atrium, so that it is entirely outside the left atrium and sufficiently spaced above the anterior mitral annulus, the implant 10 avoids the impracticality of intravascular connection to the anterior mitral annulus, which has a very thin margin of ring tissue connected anteriorly by the anterior leaflets, inferiorly by the aortic outflow tract, and medially by the atrioventricular node of the conduction system. The anterior mitral annulus is the site where the non-coronary leaflets of the aortic valve attach to the mitral annulus via the central fibrous body. The anterior location of implant 10 within the aforementioned annular level within the right atrium (either intraseptally or intravenously) avoids the risk of harm and damage to both the aortic valve and the atrioventricular node.

[0053] The acquisition of the anterior anchor region 16 in fibrous septal tissue is preferably enhanced by a septal member 30, an anterior anchor 20, or a combination of both. Figures 8A and 8B show the anterior anchor region including the septal member 30. The septal member 30 may be an expandable device or a commercially available device such as a septal occluder, e.g., an Amplatzer® PFO occluder. The septal member 30 preferably mechanically amplifies the retention or acquisition of the anterior anchor region 16 in the fibrous tissue site. The septal member 30 also preferably at least partially increases the septum's reliance on adjacent anatomical structures to ensure the position of the implant 10. In addition, the septal member 30 may also help to close or occlude any small openings created in the fossa ovalis or surrounding region during the implantation procedure.

[0054] Anticipating that a pinpoint tensile force will be applied to the septum by the anterior anchor region 16, the force acting on the septum member 30 should spread over a moderate area without causing collision with valves, blood vessels, or conduction tissue. Shortening of the short axis is achieved by transmitting the tensile force or tension to the loop. A flexibly rigid septum member is preferred because, as the tension of the bridge element increases, the focal point in the tension direction of the bridge element in the left atrium tends not to narrow. The septum member 30 should also have a low-profile configuration and a highly washable surface to reduce thrombus formation of the device deployed in the heart. The septum member may also have a folded configuration and an deployed configuration. The septum member 30 may also include a hub 31 (see Figures 8A and 8B) to allow attachment of the anchor 20. The septum brace can also be used in conjunction with the septum member 30 and the anterior anchor 20 to uniformly distribute the force along the septum. Alternatively, a device in the IVC or SVC can be used as the anchor site instead of being limited to the septum.

[0055] The positions of the posterior and anterior anchor regions 14 and 16, respectively, which have radiopaque bridge locks and well-defined fluoroscopic landmarks in the aforementioned annular tissue region, not only provide freedom from major critical structural damage or local impact to the left coronary and non-coronary processes of the aortic valve, for example, the rotational artery, the atrioventricular node, and the aortic valve, but also the annular focusing region does not rely on the acquisition of a tissue-to-tissue penetration / occlusion / retaining tissue attachment mechanism. Instead, physical structures and force distribution mechanisms such as stents, T-shaped members, and septal members can be used, which can better accommodate the attachment or contact of the mechanical lever and bridge lock and better distribute potential tissue tearing forces. Furthermore, anchor regions 14 and 16 do not require the operator to use complex imaging. Adjustment of the implantation position after or during implantation is also easier without these constraints. Anchor regions 14 and 16 also allow for complete intraatrial retrieval of the implant 10 by intravascular snareing on both sides of the left atrial wall from which the implant 10 emerges, and then cutting the bridge element 12.

[0056] Orientation of bridge elements In the embodiments shown in Figures 6A and 6B, the implant 10 is shown to span the left atrium, beginning at a posterior focal point above the approximate midpoint of the mitral annulus and extending forward in a generally linear path directly into the anterior focal region of the septum. The spanning region or bridge element 12 of the implant 10 may be preformed or otherwise configured to extend along this essentially linear path on the plane of the valve without significant elevation deviation toward or away from the plane of the annulus, except as determined by the elevation difference between the posterior and anterior regions of the arrangement. It is understood that such an implant may include bridge members having lateral or medial deviations and / or upward or downward deviations, and may include bridge members that are rigid or semi-rigid and / or substantially fixed in length.

[0057] Rear and front anchors It should be understood that anchors as described herein, including posterior or anterior anchors, describe devices capable of releasably holding the bridge element 12 under tension. As can be seen in Figures 7A and 7B, anchors 20 and 18 are shown releasably fixed to the bridge element 12, and the anchor structure can move anteriorly and posteriorly independently of the inner wall of the atrial septum and the great cardiac vein during a portion of the cardiac cycle when the tension may decrease or become zero.

[0058] Alternative embodiments are also described, all of which may provide this functionality. Furthermore, it should be understood that the general descriptions of rear and front anchors are not limited to anchoring functions; for example, rear anchors may be used forward, and front anchors may be used rearward.

[0059] When a bridge element is in contact with a bulkhead member (e.g., a front anchor) or a T-shaped member (e.g., a rear anchor), the anchor, for example, allows the bridge element to move freely within or around the bulkhead member or T-shaped member, and allows the bridge element not to be connected to the bulkhead member or T-shaped member. In this configuration, the bridge element is held by tension by a lock bridge stop, thereby the bulkhead member or T-shaped member plays a role in distributing the force applied by the bridge element over a larger surface area. Alternatively, the anchor can be mechanically connected to the bulkhead member or T-shaped member, for example, when the bridge stop is positioned on and fixed to the bulkhead member hub. In this configuration, the bridge element is fixed to the position of the bulkhead member and cannot move freely around the bulkhead member.

[0060] Figures 9A and 9B show perspective views of exemplary lock bridge stops 20 according to the present invention. Each bridge stop 20 preferably includes a fixed upper body 302 and a movable lower body 304. Alternatively, the upper body 302 may be movable and the lower body 304 may be fixed. The upper body 302 and the lower body 304 are positioned adjacent to a tubular rivet 306. The upper body 302 and the lower body 304 are preferably held in place by a rivet head 308 and a base plate 310. The rivet 306 and the base plate 310 include a predetermined inner diameter 312 of a size that allows the bridge stop 300 to be installed on a guide wire. A spring, such as a spring washer 314, or a spring also known in the mechanical art as a Belleville spring, is positioned adjacent to the rivet 306 and between the rivet head 308 and the upper body 302, applying an upward force to the lower body 304. The lower body 304 is movable between the bridge unlock position (see Figure 9A) and the bridge locked position (see Figure 9B). In the bridge unlock position, the lower body 304 and the upper body 302 are not in contact, so a groove 320 is formed between the upper body 302 and the lower body 304. In the bridge locked position, the axial force of the spring washer 314 biases the lower body 304 to be in contact with or near contact with the upper body 302, thereby locking the bridge element 12, which is positioned in the groove 320, into place as the axial force of the lower body 304 is applied to the upper body 302. During use, the bridge element 12 is positioned in the groove 320 while the lower body 304 is maintained in the bridge unlock position 316. The bridge stop 300 is positioned relative to the partition member 30, and the bridge element 12 is adjusted to the appropriate tension. Next, the lower body 304 is allowed to move toward the upper body 302, thereby fixing the position of the bridge stop 300 on the bridge element 12. While this embodiment illustrates a specific lock bridge stop design, it will be understood that any suitable lock can be used, including any of the types described in U.S. Patent Application Publication No. 2017 / 0055969.

[0061] Figures 10A and 10B show alternative cardiac implants suitable for delivery by the method described herein. Figure 10A shows an implant 10' having a T-shaped posterior anchor 18 and a T-shaped anterior anchor 70 in the great cardiac vein. The anterior T-shaped bridge stop 75 may be any of the embodiments of the T-shaped bridge stop described. The T-shaped member 75 includes a lumen 75 extending through the T-shaped member 75 perpendicular to the length of the T-shaped member. The bridge element 12 may be fixed by a free-floating bridge stop as described above. Figure 10B shows an implant 10' having a T-shaped posterior anchor 18 and a lattice-type anterior anchor 76 in the great cardiac vein. The lattice 77 is positioned in the fossa ovalis or near the fossa ovalis on the septum. Optionally, the lattice 77 may include reinforcing struts 78 for distributing the tension of the bridge element 12 over a larger area on the septum. The anterior lattice-type bridge stop 76 may be packed into a deployment catheter through which the bridge element 12 passes. The grid 77 is preferably self-expanding and can be deployed by a plunger. The bridge element 12 can be fixed by a free-floating bridge stop as described above. It is understood that various other such implants can be devised that utilize the same concepts as the implants described above for delivery and deployment by the method described herein.

[0062] Figures 11A and 11B illustrate alternative methods for connecting the bridge element 12 to the rear anchor of the T-shape. Figure 11A shows a T-shaped member 18, in which the bridge element 12 is wrapped around the central portion of the T-shaped member. The bridge element 12 may be secured, for example, by adhesive 712, knots, or fastening bands placed on top of the bridge element 12. Alternatively, the bridge element 12 may first be screwed through a lumen 714 extending through the rear anchor 18 of the T-shape, with the length of the T-shaped member perpendicular to it. The bridge element 12 may then be wrapped around the T-shaped member and secured, for example, by adhesive 712, fastening bands, or knots. Figure 11B shows a T-shaped member 18 in which the bridge element 12 is welded or forged to a plate 716. The plate 716 may then be embedded within the T-shaped member 710, or alternatively, it may be secured to the T-shaped member 710, for example, by adhesive or welding. It is understood that various other connections can be used to secure the bridge element 12 and the rear anchor 18, and that delivery can be facilitated by the method described herein.

[0063] Figures 12A and 12B show alternative anchors suitable for use as posterior anchors in cardiac implants according to the present invention. Figure 12A is a perspective view of a T-shaped anchor 18' including an intravascular stent 80 and optionally a reinforcing strut 81. The stent 80 may be a balloon-expandable or self-expandable stent. As described above, the T-shaped anchor 18' is preferably connected to a predetermined length of the bridge element 12. The bridge element 12 may be held inside, on or around the T-shaped bridge stop 80 by using one of the bridge locks described above, or it may be connected to the T-shaped anchor 18 by, for example, tying, welding, or bonding, or by any combination thereof. Figure 12B shows a T-shaped anchor 18” including a flexible tube 90 having a predetermined length, for example, 3 to 8 centimeters, and an inner diameter 91 of a size that allows at least a guidewire to pass through. The tube 90 is preferably braided, but may also be solid and may also be coated with a polymer material. Each end of the tube 90 preferably includes a radiopaque marker 92 to assist in positioning and locating the T-shaped anchor. The tube 90 also preferably includes a non-traumatic end to protect the vascular wall. The tube generally conforms to the curved shape of the great cardiac vein or atrial septum and the surrounding area. The anchors may be curved or pre-formed to minimize trauma to the tissues. A reinforcing center tube 93 may also be included to add rigidity to the anchor and help prevent the anchor from exiting the great cardiovein and left atrial wall. The bridge element 12 extends through a central hole 94 inside the reinforcing center tube 93. Each of the described anchors may be linear, curved, or flexible in shape to correspond to the anatomical structure. It is understood that various other types of anchors may be used with a posterior anchor 18 attached to the bridge element 12 for delivery and deployment as described herein.

[0064] General methods of delivery and transplantation The implant system 10 described herein can be implanted in the cardiac annulus in various ways. In some embodiments, the implant 10 is implanted using catheter-based techniques via a peripheral venous access site such as the femoral vein or jugular vein (via the IVC or SVC) under image guidance, or via an intra-arterial retrograde approach from the femoral artery through the aorta to the left atrium, even under image guidance. As previously stated, the implant 10 comprises independent components that are assembled in the body to form the implant and delivered and assembled in the body from outside the body via the interaction of one or more catheters. However, penetration into cardiac tissue is performed via interaction with a single catheter.

[0065] Although the present invention has been described with reference to the above embodiments, it should 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 first catheter comprising a lumen extending along the length of the first catheter, an opening located distally, and a stabilizing element configured to stabilize the first catheter within a first anatomical blood vessel, A penetrating guidewire configured to advance along the lumen of the first catheter toward the distally located opening, wherein the penetrating guidewire has a tip, the tip having shape memory and being configured to form a trapping structure, A second catheter comprising an expandable flared distal end configured to guide the capture structure into the lumen of the second catheter, and An implant system including, The penetrating guidewire is further configured to advance out of the distally located opening and to cross the wall of the first anatomical vessel and enter the second anatomical vessel. Implant system.

2. The implant system according to claim 1, wherein the stabilizing element includes an expandable balloon.

3. The implant system according to claim 1, wherein the stabilizing element includes an expandable stent.

4. The implant system according to any one of claims 1 to 3, wherein the capture structure includes a hook or loop structure.

5. The implant system according to claim 4, wherein the hook or loop comprises a bent section having an angle of more than 90 degrees, more than 100 degrees, more than 110 degrees, more than 120 degrees, more than 130 degrees, more than 140 degrees, more than 150 degrees, more than 160 degrees, more than 170 degrees, more than 180 degrees, or more than 190 degrees.

6. The implant system according to any one of claims 1 to 5, further comprising a first anchor configured to advance through the lumen of the first catheter.

7. The implant system according to claim 6, wherein the first anchor includes a bridge element, and the bridge element is coupled to the first anchor at a first end of the bridge element.

8. The implant system according to claim 7, wherein the second end of the bridge element is configured to advance through the wall of the first anatomical blood vessel.

9. The implant system according to claim 8, further comprising a second anchor coupled to the second end of the bridge element.

10. The implant system according to claim 9, wherein the first anchor is configured to deploy at a first location, and the second anchor is configured to deploy at a second location different from the first location.

11. The implant system according to any one of claims 7 to 10, wherein the bridge element is configured to be subjected to tension.

12. The implant system according to any one of claims 7 to 10, wherein the bridge element is configured to be shortened.

13. The implant system according to any one of claims 7 to 12, further comprising a guide wire coupled to the capture structure.

14. The implant system according to claim 13, wherein the first anchor is configured to advance via the guide wire.

15. The implant system according to claim 13, wherein the first anchor is configured to be released from the guidewire when the guidewire is retracted along the lumen of the first catheter.

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