CN101184455A - Devices, systems, and methods for reshaping heart valve annulus - Google Patents

Abstract

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

Description

Devices, systems, and methods for reshaping heart valve annulus

technical field

The present invention relates to devices, systems, and methods for improving heart valve function, eg, in the treatment of mitral regurgitation.

Background technique

I. Healthy Heart Anatomy

The heart (see Figure 1) is slightly larger than a clenched fist. The heart is a bilateral (left and right) self-regulating muscle pump with multiple parts working together to push blood to all parts of the body. The right side of the heart receives deoxygenated ("venous") blood from the body through the superior and inferior vena cava and pumps it through the pulmonary artery to the lungs for oxygenation. The left side receives oxygen-rich ("arterial") blood from the lungs through the pulmonary veins and pumps it to the aorta for distribution to the body.

The heart has four chambers, two on each side -- the right and left atria, and the right and left ventricles. The atria are chambers that receive blood, which pumps it into the ventricles. The ventricles are the chambers that drain blood. A wall of fibrous and muscular parts called the septum separates the right and left atria (see Figures 2-4). The fibrous interatrial septum is inherently a somewhat more robust tissue structure in the heart compared to the more brittle musculature in the heart. The anatomical landmark of the interatrial septum is the oval, thumb-sized depression called the fossa ovalis, or fossa ovale (as shown in Figures 4 and 6), which is a remnant of the foramen ovale and was formed in the fetal valve. The fossa ovalis does not have any important structures such as valve structures, blood vessels and conduction pathways. Combined with the inherent fibrous structure of the fossa ovalis and the surrounding fibrous eminence that allows it to be identified by angiographic techniques, the fossa ovalis is an ideal location for transseptal diagnostic and therapeutic procedures from right to left heart. Before birth, oxygenated blood from the placenta passes through the foramen ovale into the left atrium, which closes after birth.

The synchronized pumping action of the left and right sides of the heart makes up the cardiac cycle. The cycle begins with a period of relaxation of the ventricles, called ventricular diastole. The cycle ends with a period of contraction of the ventricles, called ventricular systole.

The heart has four valves (see Figures 2 and 3) that ensure that blood does not flow in the wrong direction during the cardiac cycle; that is, to ensure that blood does not flow back from the ventricles into their corresponding atria, or from the arteries to the corresponding ventricle. 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 at the opening of the pulmonary artery. The aortic valve is at the opening of the aorta.

At the onset of ventricular diastole (ie, ventricular filling) (see Figure 2), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the tricuspid and mitral valves open (as shown in Figure 2) to allow flow from the atria into the corresponding ventricles. Shortly after systole (empty ventricles) begins, the tricuspid and mitral valves close (see Figure 3) to prevent backflow from the ventricles into the corresponding atria, and the aortic and pulmonary valves open to allow blood to flow from The corresponding ventricle drains into the artery.

Heart valves open and close primarily due to pressure differences. For example, the opening and closing of the mitral valve is effected by a pressure difference between the left atrium and left ventricle. During ventricular diastole, when the ventricles relax, venous return blood from the pulmonary veins back into the left atrium causes the pressure in the atria to be greater than the pressure in the ventricles. As a result, the mitral valve opens, allowing blood to enter the ventricles. When the ventricles contract during ventricular systole, the pressure within the ventricles rises greater than the pressure in the atria and pushes the mitral valve closed.

The mitral and tricuspid valves are bounded by rings of collagen fibers (respectively called the annulus) that form part of the fibrous scaffolding of the heart. The ring provides attachment for the two cusps or leaflets of the mitral valve (called the anterior and posterior cusps) and the three cusps or leaflets of the tricuspid valve. The leaflets receive the chordae tendons from more than one papillary muscle. In a healthy heart, these muscles and their chordae support the mitral and tricuspid valves, allowing the leaflets to resist the high pressure generated during contraction (pumping) of the left and right ventricles. Figures 5 and 6 show the tendon and papillary muscles supporting the mitral valve in the left ventricle.

As shown in Figures 2 and 3, the anterior (A) portion of the mitral annulus abuts the noncoronary leaflets of the aortic valve. As also shown in Figures 2 and 3, the mitral annulus is also in the vicinity of other critical cardiac structures, such as the circumflex branch of the left coronary artery (which supplies the left atrium, variable volume left ventricle, and in many people also supply the sinoatrial node) and the atrioventricular node (which together with the sinoatrial node regulate the cardiac cycle).

The coronary sinus and its branches are also near the posterior portion (P) of the mitral annulus. These vessels drain blood from the area of the heart fed by the left coronary artery. The coronary sinus and its branches receive approximately 85% of the coronary venous blood. The coronary sinus empties blood into the posterior portion of the right atrium and anteriorly and inferiorly into the fossa ovalis (see Figure 4). A branch of the coronary sinus is called the great cardiac vein, which runs parallel to and above the posterior mitral annulus at a mean distance of approximately 9.64 +/- 3.15 mm (Yamanouchi, Y, Pacing and Clinical Electrophysiology 21(11):2522-6; 1998).

II. Features and Causes of Mitral Valve Dysfunction

When the left ventricle contracts after being filled with blood from the left atrium, the walls of the ventricle move inward and release some of the tension from the papillary muscles and tendons. Blood pushing upward against the lower surface of the mitral valve leaflets causes the mitral valve leaflets to rise toward the annulus of the mitral valve. As the mitral valve leaflets progress toward the annulus, the leading edges of the anterior and posterior leaflets come together to form a sealed and closed valve. In a healthy heart, the coaptation of the leaflets forms near the plane of the mitral valve annulus. Blood is continuously pressurized in the left ventricle until it ejects into the aorta. The papillary muscles contract while the ventricles contract and serve to keep the healthy valve leaflets tightly closed at the peak systolic pressure exerted by the ventricles.

In a healthy heart (see Figures 7 and 8), the size of the mitral annulus creates anatomical shape and tension so that the leaflets coapt at peak systolic pressure, forming a tight junction. The location where the leaflets meet on opposite medial (CM) and lateral (CL) sides of the annulus is called the commissure.

Valve dysfunction occurs because the chordae (tendons) are stretched and in some cases torn. When the tendon tears, the result is a flail of the valve leaflets. Furthermore, normally configured valves may not function properly due to enlargement or deformation in the valve annulus. This condition is called dilatation of the ring and is usually due to myocardial failure. Also, the valves can be defective at birth or as a result of acquired disease.

Regardless of the cause (see Figure 9), mitral valve dysfunction occurs when the leaflets fail to coapt at peak systolic pressure. As shown in Figure 9, the coaptation line of the two leaflets is not tight during ventricular systole. As a result, blood from the left ventricle backflows undesirably into the left atrium.

Mitral regurgitation is the condition in which the mitral valve allows blood to flow backward from the left ventricle into the left atrium during left ventricular systole. This state has two main consequences.

First, backflow of blood into the atrium results in higher atrial pressure and reduces blood flow from the lungs into the left atrium. When blood backs up into the lung system, fluid leaks into the lungs causing pulmonary edema.

Second, the volume of blood going to the atria reduces the volume of blood advancing into the aorta, reducing cardiac output. Excess blood in the atria overfills the ventricles with each cardiac cycle, overloading the left ventricle with blood volume.

Mitral regurgitation was measured by control ventriculography or by Doppler ultrasonography on a numerical scale ranging from 1+ to 4+. Grade 1+ is trace reflux with little clinical significance. Grade 2+ indicates jet regurgitation midway back into the left ventricle. Reflux grade 3 indicates reflux of left atrial filling up to the pulmonary veins and contrast injection that empties in three or fewer heartbeats. Reflux Class 4 has retrograde flow back into the pulmonary veins and contrast injection that fails to empty from the atrium in three or fewer heartbeats.

Mitral regurgitation is divided 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 during systole. Functional mitral regurgitation due to dilation of the annulus due to primary congestive heart failure other than from causes such as severe irreversible ischemia or primary valvular heart disease in which the primary congestive heart failure Heart failure itself is usually not treatable with surgery.

Organic mitral regurgitation occurs when the free leading edge of the leaflet flails due to tendon or papillary muscle tearing and the seal is compromised; or the valve forms in the atrium if there is excess leaflet tissue The higher height of coaptation droops, and droops further in ventricular systole to open the valve higher in the atrium.

Functional mitral regurgitation results from dilation of the heart and mitral annulus secondary to heart failure, and more often from coronary artery disease or idiopathic dilated cardiomyopathy. Comparing the healthy annulus in Figure 7 with the unhealthy annulus in Figure 9, the unhealthy annulus dilates and in particular increases in distance from anterior to posterior along the minor axis (line P-A). Thus, the shape and tension defined by the ring becomes less oval (see FIG. 7 ) and more circular (see FIG. 9 ). This state is called dilation. The shape and tension that contribute to the coaptation at peak systolic pressure are continually disrupted as the rings expand.

The fibrous mitral annulus is attached to the anterior mitral leaflet in one third of its circumference. The muscular mitral annulus makes up the rest of the mitral annulus and is attached by the posterior mitral leaflets. The anterior fibrous mitral annulus is adjacent to the central fibrous body, whose ends are called the fibrous triangles. Immediately posterior to each fibrous triangle is the two junctions of the anteromedial (CM) and posterolateral (CL). The commissure is where the anterior leaflets meet the posterior leaflets at the annulus.

As noted above, the central fibrous body also abuts the noncoronary leaflets of the aortic valve. The central fibrous body offers some resistance to elongation during mitral annulus dilation. It has been shown that the vast majority of mitral annulus dilatation occurs in the posterior two-thirds of the annulus (ie, the muscular annulus). From this it can be deduced that the percentage associated with the anterior leaflet of the mitral valve decreases when the annulus is dilated.

In functional mitral regurgitation, the dilated annulus separates the leaflets at their commissures during all phases of the cardiac cycle. In organic or functional mitral regurgitation, the onset of mitral regurgitation can be acute, or progressive and chronic.

In dilated cardiomyopathy of ischemic or idiopathic origin, the mitral annulus can dilate to such an extent that functional mitral regurgitation occurs. This problem occurs in approximately 25 percent of patients evaluated for congestive heart failure in the resting state. If during exercise, echocardiography shows that the incidence of functional mitral regurgitation rises to over fifty percent in these patients.

Functional mitral regurgitation is an apparently serious problem in dilated hearts, reflecting increased mortality compared to comparable patients without functional mitral regurgitation. One mechanism by which functional mitral regurgitation aggravates the condition of these patients is through an increase in the volume overload imposed on the ventricle. Directly because of the leak, the heart has increased work to eject blood antegradely through the aortic valve and retrogradely through the mitral valve each cardiac cycle. The latter is referred to as the return fraction of left ventricular ejection volume. The reflux fraction is added to the forward ejection fraction to produce the total ejection fraction. A normal heart has a forward ejection fraction of about 50% to 70%. In functional mitral regurgitation and dilated cardiomyopathy, the total ejection fraction is typically less than 30 percent. If the return fraction was half of the total ejection fraction in the dilated cardiomyopathy group, the forward ejection fraction could be as low as 15 percent.

III. AVAILABLE TREATMENT APPROACHES

In the treatment of mitral regurgitation, diuretics and/or vasodilators may be used to help reduce the amount of blood flowing back into the left atrium. If the condition cannot be stabilized by medication, an intra-aortic balloon counterpulsation device may be used. With chronic or acute mitral regurgitation, surgery is often required to repair or replace the mitral valve.

Today, patient selection criteria for mitral valve surgery are very selective. Patient selection criteria for viable mitral valve surgery included: normal ventricular function, general good health, life expectancy greater than 3 to 5 years, NYHA symptom group III or IV, and at least reflux class 3. If mitral valve repair is required, young patients with mild symptoms are candidates for early surgery. The most common mitral valve surgical repair procedure is for organic mitral regurgitation due to a torn tendon on the mid-basal portion of the posterior valve leaflet.

In conventional annuloplasty ring repair, the posterior mitral annulus is reduced along its circumference by suturing through an annuloplasty sewing ring. The goal of this repair is to advance the posterior mitral leaflet to the anterior leaflet to allow for better coaptation.

Side-to-side surgical coaptation repairs, which can be performed endovascularly, are also performed where mid-valve leaflet-to-mid-valve leaflet suturing or clamping is used to hold these commissures of the leaflets together throughout the cardiac cycle. Other attempts have developed suturing and clamping performed endovascularly to grasp and join the two mitral valve leaflets in the beating heart.

Grade 3+ or 4+ organic mitral regurgitation can be repaired with this edge-to-edge technique. This is because in organic mitral regurgitation the problem is not the annulus but the central valve component.

However, even after side-to-side repair, functional mitral regurgitation can still be maintained at higher grades, especially in the case of higher grades 3+ and 4+ functional mitral regurgitation. After surgery, the repaired valve develops a higher rate of functional mitral regurgitation over time.

In another emerging technique, the coronary sinus is mechanically deformed by an endovascular approach that is applied and included to function only within the coronary sinus.

Twenty-five percent of the six million Americans with congestive heart failure are reported to have some degree of functional mitral regurgitation. This constitutes 1.5 million patients with functional mitral regurgitation. Of these, 600,000 were idiopathic dilated cardiomyopathy. Of the remaining 900,000 people with ischemic disease, roughly half have functional mitral regurgitation due to dilated rings alone.

By interrupting the ongoing cycle of functional mitral regurgitation, patients undergoing surgery have been shown to have improved survival and a substantial increase in forward ejection fraction in most patients. The problem with surgical treatment is the significant toll it inflicts on these long-term patients, who have high morbidity and mortality associated with surgical repair.

For example, in the treatment of organic and functional mitral regurgitation, there remains a need for simple, cost-effective, and less invasive devices, systems and methods for treating heart valve dysfunction.

Contents of the invention

The present invention provides devices, systems, and methods for reshaping a heart valve annulus, and includes the use of an adjustable bridge implant system.

One aspect of the present invention provides an apparatus, system, and method for treating a mitral valve of the heart with a bridge implant system installed. The bridge implant system includes: a bridge member sized and configured to span the left atrium between the great cardiac vein and the interatrial septum; a posterior bridge stop connected to the bridge member and docked on the venous tissue within the great cardiac vein; an anterior bridge stop that connects to the bridge and abuts the interatrial septal tissue in the right atrium; and a bridge adjustment mechanism that shortens and/or lengthens the bridge. At least one of the rear axle stop and the front axle stop includes the bridge adjustment mechanism. The implant system also includes a repositioning ring, wherein the repositioning ring includes at least one radiopaque marker.

The bridging member may comprise, for example, a metallic material or a polymeric material, or a structure in the form of a metal wire or a polymeric wire, or suture material, or equine or porcine or bovine pericardium Membranes or preserved mammalian tissues. The bridge also includes discrete stop beads to allow the bridge to be adjusted in discrete lengths.

The bridge is adjustable by twisting in a first direction to shorten the bridge, and/or twisting in a second direction to lengthen the bridge. The bridge may further comprise a bridge loop, wherein the bridge loop doubles the length of the bridge and provides an adjustment ratio of 1/2 unit to 1 unit.

In one aspect of the invention, the bridge comprises a braided Nitinol wire having a first end and a second end, and including an integral bridge stopper, the braided Nitinol wire having a first end and a second end, the first One end includes a pre-formed portion to form the integral bridge stop when the bridge is implanted.

In another aspect of the invention, the bridge may comprise a toothed or perforated strip or threaded shaft extending through at least part of one of the front and rear axle stops department. A toothed strip portion or a perforated strip portion or a threaded shaft portion may also be connected to the bridge.

Another aspect of the present invention provides devices, systems, and methods for adjusting the tension (i.e., length) of an implant, the implant system comprising: a bridge sized and configured to span the great cardiac vein and the left atrium between the atrial septum; the posterior bridge stop, which is connected to the bridge and butts against the venous tissue within the great cardiac vein; the anterior bridge stop, which is connected to the bridge and butts against the right interatrial septal tissue in the atrium; and a bridge adjustment mechanism that shortens and/or lengthens the bridge. A catheter having a proximal end and a distal end is included, the catheter having an adjustment mechanism at its proximal end. The adjustment mechanism may comprise, for example, a hooked tip. The implant system also includes a repositioning ring coupled to the implant system.

Another aspect of the present invention provides devices, systems, and methods for positioning a bridge implant system within a chamber of the heart, the bridge implant system comprising: a bridge sized and configured to span the The left atrium between the great vein and the interatrial septum; the posterior bridge stop, which connects to the bridge and abuts against the venous tissue within the great cardiac vein; the anterior bridge stop, which connects to the bridge and butts interatrial septal tissue in the right atrium; and a bridge adjustment mechanism that shortens and/or lengthens the bridge. At least one of the rear axle stop and the front axle stop may include the bridge adjustment mechanism. The implant system may also include a repositioning ring, wherein the repositioning ring may include at least one radiopaque marker.

In an aspect of the invention, the adjustment mechanism is operated to lengthen or shorten the bridge. This adjustment can be repeated until the desired length of bridge is obtained. Further, the implant system is allowed to stand for a predetermined period of time before repeating the step of operating the adjustment mechanism. A conduit may be connected to the bridge adjustment mechanism, the conduit being used to operate the bridge adjustment mechanism. Optionally, a conduit can also be connected to the bridge, the conduit being used to lengthen or shorten the bridge.

In another embodiment, apparatus, systems, and methods for implanting a bridge implant system into a chamber of the heart further include: providing a catheter comprising a proximal end and a distal end, the catheter having a first end at its proximal end an adjustment mechanism with a second adjustment mechanism at its proximal end; connecting the first adjustment mechanism to one of the rear axle stop and the front axle stop; connecting the second adjustment mechanism to the a bridge; operating the first adjustment mechanism to allow adjustment of the bridge; operating the second adjustment mechanism to lengthen or shorten the bridge; and operating the first adjustment mechanism again to re-secure the bridge .

One aspect of the present invention provides devices, systems, and methods comprising a bridge implant system comprising: a bridge stop housing having a length and a width; an aperture extending through the bridge a length of the stop housing, the aperture being sized and configured to allow the bridge to extend through at least part of the length of the aperture; and an adjustment mechanism connected to the bridge stop housing to allow Adjust the length of the bridge. The adjustment mechanism may include a conduit releasably connected to the bridge stop for actuating the adjustment mechanism. Also, the adjustment mechanism may be disposed within an aperture within the axle stop housing. The adjustment mechanism may allow only lengthening of the bridges or shortening of the bridges only, or lengthening of the bridges and shortening of the bridges. The adjustment mechanism may be sized and configured to allow repeatable adjustment. The bridge stop may also include a repositioning element, and the repositioning element may further include at least one radiopaque marker.

In one embodiment, the bridge stop adjustment mechanism comprises a static, wherein the bridge stop adjustment mechanism constrains the bridge at the static of the adjustment mechanism, thereby requiring positive actuation necessary to allow adjustment of the bridge. power.

In another embodiment, the bridge includes discrete stop beads to allow adjustment of the bridge in discrete lengths. The bridge also includes at least part of a toothed strip portion or a perforated strip portion or a threaded shaft portion extending through an aperture in the axle stop housing.

Another aspect of the present invention provides apparatus, systems, and methods including a bridge implant system having an adjustable bridge stop comprising: a bridge stop housing comprising an inner and an outer , the housing has a length and a width; an aperture extending through the length of the bridge stop housing, the aperture being sized and configured to allow a bridge to extend through the aperture at least a partial length; and an adjustment mechanism connected to the bridge stop housing to allow adjustment of the bridge. The adjustment mechanism may comprise rotating the inner portion or the outer portion. Also, the inner portion may be completely disposed within the outer portion, or the inner portion may partially extend outside the outer portion.

Yet another aspect of the present invention provides apparatus, systems, and methods including a bridge implant system having an adjustable bridge stop, the bridge implant system comprising: a bridge sized and configured to span the left atrium between the great cardiac vein and the interatrial septum; a first bridge stop connected to the bridge; and a second bridge stop connected to the bridge, the second bridge stop comprising: an axle stop housing having a length and a width, an aperture extending through the length of the axle stop housing, the aperture being sized and configured to allow a bridge to extend through the aperture At least part of the length of the bore, and an adjustment mechanism connected to the bridge stop housing to allow adjustment of the bridge. The axle stop housing may further include an inner portion and an outer portion, wherein the adjustment mechanism includes rotating the inner portion or the outer portion, thereby allowing the bridge to be lengthened or shortened.

Yet another aspect of the present invention provides apparatus, systems, and methods for adjusting a bridge stop of an implant system, the bridge stop comprising: a bridge stop housing having a length and a width; an aperture extending through the length of the axle stop housing, the aperture is sized and configured to allow a bridge to extend through at least part of the length of the aperture; and an adjustment mechanism connected to the axle stop the housing to allow adjustment of the length of the bridge. The adjustment mechanism includes a conduit releasably connected to the bridge stop for actuating the adjustment mechanism. Also, the adjustment mechanism may be disposed within an aperture within the axle stop housing. The adjustment mechanism may allow only lengthening of the bridges or shortening of the bridges only, or lengthening of the bridges and shortening of the bridges. The adjustment mechanism is sized and configured to allow repeatable adjustment. The bridge stop may also include a repositioning element, and the repositioning element may further include at least one radiopaque marker.

Yet another aspect of the present invention provides an apparatus, system, and method comprising a bridge for adjusting the length of a bridge implant system within a chamber of the heart, the apparatus, system, and method comprising providing a bridge stop, the Axle stop: A bridge stop housing having a length and a width; an aperture extending through the length of the bridge stop housing, the aperture being sized and configured to allow a bridge to extend through through at least part of the length of the aperture; and an adjustment mechanism connected to the bridge stop housing to allow adjustment of the length of the bridge and subsequent operation of the adjustment mechanism to lengthen or shorten the bridge.

In one aspect of the invention, this adjustment can be repeated until the desired length of bridge is obtained. Further, the implant system is allowed to stand for a predetermined period of time before repeating the step of operating the adjustment mechanism. A conduit may be connected to the bridge stop adjustment mechanism, the conduit being used to operate the adjustment mechanism. Optionally, a conduit can also be connected to the bridge, the conduit being used to lengthen or shorten the bridge.

In another embodiment, an apparatus, system, and method for adjusting the length of a bridge of a bridge implant system within a chamber of the heart further comprises: providing a catheter comprising a proximal end and a distal end, the catheter having a first adjustment mechanism at its proximal end and a second adjustment mechanism at its proximal end; connecting said first adjustment mechanism to one of said rear axle stopper and said front axle stopper; Two adjustment mechanisms are connected to the bridge; operating the first adjustment mechanism allows adjustment of the bridge; operating the second adjustment mechanism lengthens or shortens the bridge; and operates the first adjustment mechanism again to re-fix the bridge.

Other characteristics and advantages of the present invention will be apparent from the accompanying description, drawings and claims.

Description of drawings

Figure 1 is an anatomical anterior view of the human heart with parts removed and shown in cross-section showing the internal heart chambers and adjacent structures.

Figure 2 is an anatomical superimposed view of a 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 the right and left atrium, where during the cardiac cycle During ventricular diastole (ventricular filling) the tricuspid and mitral valves open, while the aortic and pulmonary valves close.

Figure 3 is an anatomical superior view of the cross-section of the human heart shown in Figure 2, with the tricuspid and mitral valves closed and the aortic and pulmonary valves open during the ventricular systole (ventricular emptying) phase of the cardiac cycle.

Figure 4 is an anatomical anterior perspective view of the left and right atria with parts removed and in section showing the interior of the heart chambers and associated structures such as the fossa ovalis, coronary sinus, and great cardiac vein.

Figure 5 is an anatomical lateral view of the human heart with parts removed and in cross section showing the interior of the left ventricle and the structures of the associated muscles and tendons connected to the mitral valve.

Figure 6 is an anatomical lateral view of the human heart with parts removed and in section showing the interior of the left ventricle and left atrium and the structures of the associated muscles and tendons connected to the mitral valve.

Figure 7 is a superior view of a healthy mitral valve with leaflets closed and coapted at peak systolic pressure during ventricular systole.

Figure 8 is an anatomical superposition view of a section of a human heart with the normal mitral valve shown in Figure 7 closed during the ventricular systole (ventricular emptying) phase of the cardiac cycle.

Figure 9 is a superior view of a dysfunctional mitral valve in which the leaflets fail to coapt during ventricular systolic peak systolic pressure, resulting in mitral regurgitation.

Figures 10A and 10B are anatomical anterior perspective views of the left and right atrium, partially removed and shown in section, with an implant system including an interatrial bridge spanning the mitral annulus member having a posterior bridge stop and an anterior bridge stop disposed in the great cardiac vein and comprising a septum member disposed on the interatrial septum with the interatrial bridge in a substantially straight path Extends from the middle region of the annulus to the interatrial septum.

10C is an anatomical anterior perspective view of an alternative embodiment of the implant system shown in FIGS. 10A and 10B showing a repositioning device disposed on the anterior side of the implant with Implant systems are removed or adjusted days, months, or years after the initial procedure or adjustment.

10D is an anatomical anterior perspective view of an alternative embodiment of the implant system shown in FIGS. 10A and 10B showing the anterior bridge stop without the septum member.

FIG. 11A is an anterior perspective view of the left and right atrium, partially removed and shown in section, with an implant system of the type shown in FIGS. 10A and 10B , wherein the anterior region of the implant extends through the Structures, such as septal members, are in the atrial septum and in the superior vena cava.

11B is an anatomical anterior perspective view of the left atrium and right atrium, with parts removed and shown in section, with an implant system of the type shown in FIGS. Structures, such as the septal member, are in the interatrial septum and in the inferior vena cava.

Figure 11C is an anatomical anterior perspective view of the left and right atrium, partially removed and shown in section, with an implant system of the type shown in Figures 10A and 10C present, with the anterior region of the implant positioned over the interatrial septum , and in the superior and inferior vena cava.

12A is a side view of a septum member that may be used as part of an implant system of the type shown in FIGS. 10A and 10B .

12B is a side view of a deployed membrane member of the type shown in FIG. 21A showing the member partially sandwiching the membrane through the existing aperture.

12C is a perspective view of an alternative embodiment of the diaphragm member shown in FIG. 12A showing a grommet or similar protective device disposed at or near the center of the diaphragm member.

13 is an anatomical anterior perspective view of the left and right atrium, partially removed and shown in cross-section, with an implant system including an interatrial bridge spanning the mitral valve annulus, the bridge The member has a posterior region in the great cardiac vein and an anterior region on the interatrial septum, the interatrial bridge extending generally from the outer region of the annulus in a substantially straight path.

14 is an anatomical anterior perspective view of the left and right atrium, partially removed and shown in cross-section, with an implant system including an interatrial bridge spanning the mitral valve annulus, the bridge The member has a posterior region in the great cardiac vein and an anterior region on the interatrial septum, with the interatrial bridge extending generally from the outer region of the annulus in an upwardly curved or arcuate path.

Figure 15 is an anatomical anterior perspective view of the left and right atrium, partially removed and shown in section, with an implant system comprising a bridge across the atrium of the mitral valve annulus, the The bridge has a posterior region in the great cardiac vein and an anterior region over the interatrial septum, the interatrial bridge extending generally from the outer region of the annulus in a downwardly curved path.

Figure 16 is an anatomical anterior perspective view of the left and right atrium, partially removed and shown in section, with an implant system including an interatrial bridge spanning the mitral valve annulus, the bridge The member has a posterior region in the great cardiac vein and an anterior region on the interatrial septum, with the interatrial bridge triangle extending along a curvilinear path while generally curving from the central region of the annulus around the annulus' triangle.

Figure 17 is an anterior perspective view of the left and right atrium, partially removed and shown in cross-section with an implant system including an interatrial bridge spanning the mitral valve annulus, the bridge The piece has a posterior region in the great cardiac vein and an anterior region on the interatrial septum, the interatrial bridge extending along a curvilinear path while curving generally from the middle region of the annulus around the triangular body of the annulus, and along the left The domes of the atria are elevated in a bow shape.

Figure 18 is an anterior perspective view of the left and right atrium, partially removed and shown in section, with an implant system including a bridge across the atrium of the mitral valve annulus, the bridge The member has a posterior region in the great cardiac vein and an anterior region on the interatrial septum, with the interatrial bridging member following a curvilinear path, curving generally from the middle region of the annulus around the triangular body of the annulus, and towards the plane of the valve slope down.

Figure 19 is an anatomical anterior perspective view of the left and right atrium, partially removed and shown in section, with an implant system comprising two interatrial bridges spanning the mitral annulus, so The bridges each have a posterior region in the great cardiac vein and an anterior region on the interatrial septum, the interatrial bridges all extending along generally straight paths from different regions of the annulus.

Figure 20 is an anatomical anterior perspective view of the left and right atrium, partially removed and shown in section, with an implant system comprising two interatrial bridges spanning the mitral annulus, so The bridges each have a posterior region in the great cardiac vein and an anterior region on the interatrial septum, the interatrial bridges each extending along a generally curvilinear path from adjacent regions of the annulus.

Figure 21 is an anatomical anterior perspective view of the left and right atrium, partially removed and shown in section, with an implant system comprising three interatrial bridges spanning the mitral valve annulus, so The bridges each have a posterior region in the great cardiac vein and an anterior region on the interatrial septum, two of the interatrial bridges extend from different regions of the annulus along generally straight paths, and the third The bridges of the individual chambers extend toward the triangular body of the ring along a generally curvilinear path.

22A and 22B are cross-sectional views showing the effect of a bridge stop used in conjunction with the implant shown in FIGS. move.

23-30 are anatomical diagrams depicting representative catheter-based devices and steps for implanting an implant system of the type shown in FIGS. 10A-10C.

Figure 31 is an anatomical cross-sectional view of the left atrium and associated mitral valve structures showing mitral valve dysfunction.

Figure 32 is an anatomical top view of the veins of the human heart showing the presence of an implant system of the type shown in Figures 10A and 10B.

33 is an anatomical sectional view of the implant system taken generally along line 33-33 of FIG. 32 showing the presence of an implant system of the type shown in FIGS. 10A and 10B and showing the mitral Leaflets are properly coapted.

34A-34D are cross-sectional views of a crimp tube used to connect a guide wire to a bridge and illustrate variations in the crimp used.

35A is an anatomical partial view of a patient depicting entry points for implantation of the implant system, also showing a looped guidewire accessible from outside the body at two locations.

35B is an anatomical diagram depicting a representative alternative catheter-based device for implantation of the type of implant system shown in FIGS. Bridges for pipe structures.

36A is an anatomical partial view of a patient showing a bridge stop connected to a bridge poised to be pulled and/or pushed through vasculature and positioned within the great cardiac vein.

36B is an anatomical diagram depicting a representative alternative catheter-based device for implantation of a system of the type shown in FIGS. 10A-10C and showing a bridge stop disposed within the great cardiac vein.

37A is a perspective view of a catheter used to implant an implant system of the type shown in FIGS. 10A-10C.

37B is a partial cross-sectional view showing the magnetic head of the catheter as shown in FIG. 37A.

38 is a perspective view of another catheter that may be used to implant an implant system of the type shown in FIGS. 10A-10C.

Figure 39 is a partial perspective view of the interaction between the magnetic head of the catheter shown in Figure 37A and the magnetic head of the catheter shown in Figure 38, showing the magnetic head extending out of one and into the other. Guide wire with magnetic head.

Figure 40 is an anatomical partial perspective view of the magnetic catheter head shown in Figure 39 with one catheter shown in the left atrium and one catheter shown in the great cardiac vein.

41 is a perspective view of another catheter that may be used in the implantation of an implant system of the type shown in FIGS. 10A-10C.

42A-42C are partial perspective views of a catheter tip that may be used with the catheter shown in FIG. 41 .

43A is a perspective view of a symmetrically shaped T-bridge stop or member that may be used with an implant system of the type shown in FIGS. 10A-10C.

43B is a perspective view of an alternative embodiment of the T-shaped bridge stop shown in FIG. 43A, showing the bridge stop being asymmetrical and having one leg shorter than the other.

44A is a cross-sectional view of a bridge stop that may be used with an implant system of the type shown in FIGS. 10A-10D showing the adjustment characteristics of the bridge in the closed position.

44B is a cross-sectional view of a bridge stop of the type shown in FIG. 44A showing the adjustment characteristics of the bridge in the open position.

45A is an anatomical partial perspective view of an alternative magnetic catheter head with one catheter shown in the left atrium and one catheter shown in the great cardiac vein, and showing a side-to-end configuration.

45B is a partial cross-sectional view of an alternative magnetic catheter head of the type shown in FIG. 45A showing the guidewire piercing the wall of the great cardiac vein and the left atrium and extending into the receiving catheter.

Figure 45C is a partial perspective view of an alternative magnetic head of the type shown in Figure 45B.

46 is an anatomical partial perspective view of another alternative embodiment of a magnetic catheter head of the type shown in FIG. 45A, showing a side-to-side configuration.

47 is a perspective view depicting an alternative embodiment of an implant system of the type shown in FIGS. 10A-10D showing the use of a bridge stop having a bridge adjustment feature and further including a repositioning ring.

Figure 48 is a perspective view depicting an alternative embodiment of a bridge stop having a bridge adjustment feature and showing the bridge adjustment feature in an open position.

Fig. 49 is a perspective view of the bridge stop shown in Fig. 48 and showing the bridge adjustment feature in the closed position.

50-52 are perspective views depicting alternative embodiments of a bridge stop having a bridge adjustment feature.

Figure 53 is a cross-sectional view of a bridge stop of the type shown in Figure 52 showing the bridge adjustment feature in the closed position and showing the adjustment conduit prior to connection to the bridge stop for adjusting the bridge top.

54 is a cross-sectional view of a bridge stop of the type shown in FIG. 52 showing the bridge adjustment feature in the open position and showing the adjustment guide tip connected to the bridge stop for adjusting the bridge.

55 is a top view depicting an alternative embodiment of a bridge stop with a bridge adjustment feature.

Figure 56 is a front view of the axle stop shown in Figure 55 showing the retaining tabs within the axle stop.

57A is a cross-sectional view of an alternative embodiment of a bridge lock with a bridge adjustment feature, showing the bridge in the closed position.

Figure 57B is a perspective view looking into the bridge lock shown in Figure 57A showing the bridge in a closed position.

57C is a top view of the bridge lock shown in FIG. 57A showing the bridges in the closed position.

58A is a cross-sectional view of the bridge lock shown in FIG. 57A showing the bridge in an unclosed position.

Figure 58B is a perspective view looking into the bridge lock shown in Figure 57A showing the bridge in an unclosed position.

58C is a top view of the bridge lock shown in FIG. 57A showing the bridges in an unclosed position.

Figures 59A to 60C are views of an alternative embodiment of the bridge lock shown in Figures 57A to 58C and illustrate alternative bridge locks with revolving doors to provide a convenient mechanism to reset the bridge lock for adjustment .

61 is a perspective view of an alternative embodiment of a bridge lock having a bridge adjustment feature and showing the bridge adjustment feature in an open position.

Figure 62 is a perspective view of the groove part of the bridge lock shown in Figure 61 without the bridge.

63 is a cross-sectional view of the groove member of the bridge lock shown in FIG. 62 taken generally along line 63-63 of FIG. 62. FIG.

FIG. 64 is a perspective view of the snap-in components of the bridge lock shown in FIG. 61. FIG.

Figure 65 is a front view of the bridge lock shown in Figure 61 and showing the bridge adjustment feature in the unlocked position.

Figure 66 is a front view of the bridge lock shown in Figure 61 and showing the bridge adjustment feature in the locked position.

Figure 67 is a perspective view of the bridge lock shown in Figure 61 and shows the adjustment guide tube with a pair of cooperating guide tube tips, the inner torque device tip is disposed on the toothed bridge and the outer torque device tip is disposed on the bridge lock it.

68 is a perspective view of an alternative embodiment of the bridge lock shown in FIG. 61 having internal threads to allow adjustment of the threaded bridge.

FIG. 69 is a perspective view of the threaded components of the bridge lock shown in FIG. 68. FIG.

70 is a cross-sectional view of a threaded component of the bridge lock shown in FIG. 69 taken generally along line 70-70 of FIG. 69 .

FIG. 71 is a perspective view of the hub component of the bridge lock shown in FIG. 68. FIG.

Figure 72 is an anatomical anterior perspective view of the left atrium and part of the right atrium, partially removed and shown in section, with an alternative implant system of the type shown in Figures 10A-10D present, the alternative implant system The implant system includes a multi-element bridge spanning the mitral valve annulus, and a repositioning ring for removing or adjusting the implant system.

Figure 73 is an anatomical anterior perspective view of the left atrium and part of the right atrium, partially removed and shown in section, with an alternative implant system of the type shown in Figures 10A-10D present, the alternative implant system The implant system includes a toothed strap bridge spanning the mitral valve annulus, and a repositioning ring for removing or adjusting the implant system.

74 and 75 are perspective views of alternative embodiments of a T-bridge stop or member of the type shown in FIGS. 10A-10D showing a T-bridge stop with a bridge adjustment feature.

76 and 77 are perspective views of alternative embodiments of a T-bridge stop or member of the type shown in FIGS. 10A-10D showing a T-bridge stop with only a bridge tensioning feature. .

78 is a perspective view depicting an alternative embodiment of an implant system of the type shown in FIGS. 10A-10D showing the use of strap bridges.

79 is a perspective view depicting an alternative embodiment of an implant system of the type shown in FIGS. 10A-10D showing the use of an annular bridge.

80A is a perspective view depicting an alternative embodiment of an implant system of the type shown in FIGS. 10A-10D showing the use of a braided bridge comprising curved ends on the anterior side and forming Bridge stop.

80B is a side view of the bent end of the braided bridge of FIG. 80A showing the bent end in one state of curvature.

80C is a side view of the bent end of the braided bridge of FIG. 80A showing the bent end in another state of curvature.

Detailed ways

While the disclosure of the invention is detailed and specific to enable those skilled in the art to practice the invention, the specific embodiments disclosed herein are merely examples of the invention embodied in other specific structures. While a preferred embodiment of the invention has been described, modifications of detail may be made without departing from the invention as defined by the claims.

I. Transseptal implants for direct shortening of the short axis of the heart valve annulus

A. Implant structure

10A-10D illustrate an embodiment of an implant 10 sized and configured to extend through the left atrium in a generally anterior-to-posterior direction, thereby spanning the mitral valve annulus. The implant 10 includes a spanning region or bridge 12 having a rear axle stop region 14 and an anterior axle stop region 16 .

Posterior bridge stop area 14 is sized and configured to allow bridge 12 to be positioned in a region of atrial tissue above the posterior mitral annulus. This area is preferred because it will generally give more tissue mass for obtaining control of the posterior bridge stop area 14 than in tissue areas located at or near the posterior mitral annulus. Engagement of tissue at a location above the ring also reduces the risk of injury to the circumflex coronary arteries. To a lesser extent, the circumflex coronary artery passes above and medial to the great cardiac vein on the left atrial aspect of the great cardiac vein, thereby lying between the great cardiac vein and the endocardium of the left atrium. However, since the forces in the region of the posterior bridge stop are oriented upward and inward relative to the left atrium and not in a compressive manner along the long axis of the great cardiac vein, other techniques in the art that compress the tissue of the great cardiac vein use The possibility of circumflex arterial compression is reduced. However, should coronary angiography be able to reveal circumflex artery stenosis, the symmetrically shaped posterior bridge stop may be replaced by an asymmetrically shaped bridge stop, eg where one leg of the T-member is shorter than the other, thereby avoiding circumflex Compression of arterial junctions. The form of this asymmetry can first be selected on the basis of the angiogram.

There are also other reasons why an asymmetrical rear axle stop can be used. When a patient is found to have a severely stenotic distal great cardiac vein, the asymmetrical posterior bridge stopper is chosen, where the asymmetrical bridge stopper is better for avoiding occlusion of the vessel. Moreover, an asymmetric bridge stop is chosen because it is used to select forces that act differently and preferably at different points along the posterior mitral annulus to optimize treatment, for example in the case of a malformed or asymmetric mitral valve. .

The anterior bridge stop area 16 is sized and configured to allow the bridge 12 to be positioned proximate to tissue in or near the right atrium as it passes through the septum into the right atrium. For example, as shown in FIGS. 10A-10C , the anterior bridge stop region 16 is adjacent to or abuts an area of fibrous tissue in the interatrial septum. As shown, the bridge stop site 16 is desirably higher than the height of the anterior mitral annulus at the same height as or higher than the posterior bridge stop region 14 . In the illustrated embodiment, the anterior bridge stop area 16 is near or near the lower edge of the fossa ovalis. Optionally, the anterior axle stop area 16 may be located at a more superior location in the septum, such as at or near the upper edge of the fossa ovalis. The anterior bridge stop area 16 can also be located further up or down in the septum, away from the fossa ovale, if the bridge stop site does not cause damage to the tissue area.

Optionally, as shown in FIGS. 11A and 11B , the anterior bridge stop region 16 may be located in the superior vena cava (SVC) or inferior vena cava (IVC) or in the superior vena cava or In the inferior vena cava, rather than set at the diaphragm itself.

In use, the spanning region or bridge 12 may be placed under tension between the two bridge stop regions 14 and 16 . Thus, the implant 10 serves to direct mechanical forces through the left atrium generally in a posterior-to-anterior direction. The direct mechanical force can be used to shorten the minor axis of the ring (line P-A in Figure 7). To this end, implant 10 may also reactively reshape the annulus along its long axis (line CM-CL in FIG. 7 ) and/or reactively reshape other surrounding anatomical structures. It should be understood, however, that the presence of implant 10 may serve to stabilize tissue adjacent to the annulus of the heart valve without affecting the length of the minor or major axes.

It should also be understood that when the axes are in other valve structures, the affected axes may also be other than the major and minor axes due to the anatomy of the surrounding tissue. Moreover, for therapeutic purposes, when the mitral valve leaks most of the time, the implant 10 is only needed during a portion of the cardiac cycle, such as late diastole and systole when the heart fills with blood at the onset of ventricular systole. In the early stage, the ring is shaped. For example, the implant 10 may be sized to limit the outward displacement of the ring during the late diastolic phase of ventricular diastole as the ring expands.

The mechanical force exerted by the implant 10 across the left atrium can restore the heart valve annulus and leaflets to a more normal anatomical shape and tension. A more normal anatomical shape and tension facilitate leaflet coaptation in late ventricular diastole and early ventricular systole, thereby reducing mitral regurgitation.

In its most basic form, the implant 10 is constructed of a biocompatible metallic or polymeric material, or a metallic or polymeric material adapted to be coated, infiltrated, or otherwise treated with a material that is biocompatible. , or a combination of these materials. The material is also desirably radiopaque or incorporates radiopaque properties to facilitate fluoroscopy.

The implant 10 is formed by bending, shaping, joining, machining, molding, or extruding metallic or polymeric linear structures, which may have flexible or rigid, or inelastic or elastic mechanical properties, or its combination. Alternatively, implant 10 may be formed from a metallic or polymeric thread-like or suture material. Materials from which implant 10 may be formed include, but are not limited to, stainless steel, Nitinol, titanium, silicone, plated metals, Elgiloy ^™ , NP55, and NP57.

Implant 10 may take a variety of shapes and have a variety of cross-sectional geometries. Implant 10 may have, for example, a generally curvilinear (ie, circular or oval) cross-section, or a generally rectilinear cross-section (ie, square or rectangular), or combinations thereof. Shapes that promote laminar flow and thus reduce hemolysis are all contemplated, with shapes such as smoother surfaces and longer and narrower leading and trailing edges in the direction of blood flow.

B. Rear axle stop area

The posterior bridge stop region 14 is sized and configured to be positioned in or at the left atrium in a supraannular position, ie, in or near the left atrium above the posterior mitral annulus.

In the illustrated embodiment, the posterior bridge stop region 14 is shown positioned generally at the level of the great cardiac vein, which runs proximate to and parallel to most of the posterior mitral annulus. Branches of the coronary sinus can provide strong and reliable fluorescent labeling when a radiopaque device is placed within or a contrast agent is injected into the branch. As previously stated, securing the bridge 12 in position above the annulus also reduces the risk of encroachment on the circumflex coronary artery and the risk of injury thereto compared to procedures that act directly on the mitral annulus. Furthermore, the position above the ring ensures that the valve leaflets are not contacted, thereby allowing coaptation and reducing the risk of mechanical damage.

The great cardiac vein also provides a site where the relatively thin, non-fibrous atrial tissue tends to enlarge and reinforce. In order to enhance the retention and control of the posterior axle stop region 14 in which mainly non-fibrous cardiac tissue is present, and to improve the distribution of forces exerted by the implant 10, the posterior axle stop region 14 may include a posterior axle stop 18, which The rear axle stopper 18 is disposed within the great cardiac vein and abuts the vein tissue. The posterior bridge stop region 14 can thus be fixed in the non-fibrous part of the heart in a manner that still maintains significant hold and control of the tissue for a period of time without dehiscence (expressed in a clinically relevant time frame).

C. Front axle stop area

The anterior bridge stop area 16 is sized and configured to allow the bridge 12 to stay securely in place near or near fibrous tissue and surrounding tissue in the right atrium side of the atrial septum. The fibrous tissue in this region may provide superior mechanical strength and integrity compared to muscle, and may better resist passing equipment. The septum is some of the most fibrotic tissue structures in the heart. After surgery, the septum is often the only heart tissue into which the suture can be placed, and it may be desirable for the suture to remain in the heart tissue without the use of gauze or deeply anchored into the muscle tissue.

As shown in FIGS. 10A-10D , the anterior bridge stop region 16 passes through the septal wall at a supraannular position above the plane of the anterior mitral valve annulus. The distance above the ring on the front side is generally at or above the distance above the ring on the rear side. As previously noted, the anterior bridge stop area 16 is shown in FIGS. 10A to 10D as being at or near the lower edge of the fossa ovalis, although within the fossa ovalis in view of the need to prevent damage to and surrounding septal tissue. Or other more lower or upper points can be used on the outside.

By positioning the bridge 12 at a height above the annulus in the right atrium, said bridge 12 is completely outside the left atrium and positioned just above the anterior mitral annulus, the implant 10 avoids the anterior mitral annulus or intravascular attachment near the anterior mitral annulus where there is a very thin margin of annulus tissue bounded anteriorly by the anterior leaflets, inferiorly by the aortic outflow tract, and medially by the The conduction system is defined by the atrioventricular node. The anterior mitral annulus is where the noncoronary leaflets of the aortic valve attach to the mitral annulus through the central fibrous body. The anterior position of the implant 10 at the level above the annulus in the right atrium avoids the risk of encroachment on and injury to the aortic valve and the atrioventricular node.

Control of the axel stop region 16 in the fibrous septum tissue is desirably enhanced by the diaphragm member 30 or the axel stop 20 , or a combination thereof. 10A to 10C illustrate the front axle stop area including the diaphragm member 30 . Figure 10D shows the front axle stop area without a diaphragm member. The septum member 30 may be an expandable device and may also be a commercially available device such as a septum occluder, such as the Amplatzer(R) PFO occluder (see FIGS. 12A and 12B ). The diaphragm member 30 preferably mechanically enhances the retention or containment of the front axle stop area 16 in the fibrous tissue site. The septum member 30 also desirably increases, at least in part, reliance on the anatomy adjacent the septum to securely position the implant 10 . Furthermore, the septum member 30 is also used to insert or occlude a small hole formed in the fossa ovale or surrounding area during the implantation procedure.

It is contemplated that with minimal pulling forces acting on the diaphragm from the anterior bridge stop region 16, the forces acting on the diaphragm member 30 will be distributed over the appropriate area without impacting the valves, vessels or conducting tissue. Shortening of the minor axis is achieved as tension or tension is transmitted down the ring. A flexible, stiff septum member is preferred because it tends to cause less constriction of the lesion in the direction of the left atrium tensioning the bridge as the tension applied to the bridge increases. The septum member 30 should also have a low profile configuration and a surface that is very wash resistant to reduce thrombosis of the device employed in the heart. The membrane member may also have a folded configuration as well as an unfolded configuration. Diaphragm member 30 also includes a socket 31 (see FIGS. 12A and 12B ) to allow attachment of axle stop 20 . The diaphragm member 30 also includes a grommet or similar protective device 32 disposed at or near the middle of the diaphragm member to allow unrestricted movement of the bridge 12 through the diaphragm member, for example, during adjustment of the bridge 12 (see FIG. 12C). Hub 31 can also provide this feature.

A diaphragm tie rod may be used in conjunction with the diaphragm member 30 and front axle stop 20 to distribute force evenly along the diaphragm (see FIG. 11C ). Alternatively, devices in the IVC or SVC can be used as bridge stop sites (see Figure 1 IA and Figure 1 IB), without limitation to the septum.

Positioning of the radiopaque bridge-lock and fluorescently labeled posterior bridge-stop region 14 and anterior bridge-stop region 16, respectively, for better differentiation of tissue sites above the annulus is described, not only does not address critically important structures, Such as damage or localized effects on the circumflex arteries, the AV node, and the left coronary and noncoronary cusps of the aortic valve, and the sites of concentration above the annulus do not depend on penetration in tissue and direct tension loads /Piercing/maintaining control between tissue attachment bodies. Instead, physical structures and force distribution mechanisms such as brackets, T-shaped members, and diaphragm members can be used that can better provide attachment or docking of mechanical levers and bridge locks, and potentially Tissue tearing force can be better distributed. Further, the bridge stop sites 14, 16 do not require the operator to use complex imaging.

Freedom from these constraints also facilitates adjustment of the implant position during or after implantation. The bridge stop sites 14, 16 allow for complete intra-atrial retrieval of the implant 10 by capturing and subsequently shearing the bridge 12 on either side of the left atrium wall from which the implant 10 emerges. As shown in FIG. 10C , a repositioning device such as a hook or loop 24 is provided to facilitate re-entry of the bridge stop sites 14 , 16 to allow for future adjustments or to allow for implant removal. The repositioning device allows adjustment or removal of the implant days, months, or even years after the initial procedure or after adjustment.

D. Orientation of bridge pieces

In the embodiment shown in FIGS. 10A to 10D , the implant 10 is shown spanning the left atrium, starting at a point posterior to the lesion approximately midpoint above the mitral valve annulus, and extending along a path directly into the septum. The generally straight path of the region of the anterior lesion runs in an anterior direction. As shown in FIGS. 10A-10D , the spanning region or bridge 12 of the implant 10 may be pre-shaped or configured to extend in said generally straight path above the plane of the valve, with a height towards the plane of the annulus or away from it. The plane of the ring does not deviate significantly, except as indicated by the difference in height between the positioned rear and front regions.

Lateral or medial deviations and/or upward or downward deviations in the trajectory may be imparted to affect the nature and direction of the force vector or force vectors acting on the implant 10, if desired. It should be appreciated that the spanning regions or bridges 12 may be pre-shaped or configured with various medial/lateral and/or downward/downward deviations to achieve the desired annulus and/or to take into account the needs of a particular treatment and the different morphologies of the patient. or structural remodeling of the atrium. Furthermore, deviations in the trajectory of the bridges may also be given to avoid high flow vessels in chambers of the heart such as the left atrium.

For example, as shown in Figure 13, the implant 10 is shown spanning the left atrium, starting in the posterior region proximal to the lateral triangular edge of the annulus (ie, away from the septum). Optionally, the posterior region may also be located near the inner triangular edge of the ring (ie, near the septum). From either of these posterior regions, the implant 10 can extend in an anterior direction in a straight path directly to the anterior region in the septum. As shown in Figure 13, similar to Figure 10A, the spanning region or bridge 12 of the implant 10 can be pre-shaped or configured to extend in a generally straight path above the plane of the valve without being significantly higher in height towards the annulus. Plane or deviation from the plane of the ring, except as indicated by a height difference, if any, between the rear and front regions.

Regardless of the particular location of the posterior region (see FIG. 14 ), the spanning region or bridge 12 of the implant 10 may be preshaped or configured to bow upwardly in the plane of the valve toward the dome of the left atrium. Alternatively (see FIG. 15 ), the spanning region or bridge 12 of the implant 10 can be pre-shaped or configured to slope downward toward the plane of the valve annulus, extending close to the plane of the valve, but avoiding the gap between the valve leaflets. interaction between. Or, still alternatively (see FIG. 16 ), the spanning region or bridge 12 of the implant 10 can be pre-shaped or configured to follow a curved trajectory towards the triangular edge of the ring ( inside or outside).

Of course, various combinations of lateral/medial and upward/downward deviations of the spanning regions of the implant 10 or bridges 12 are possible. For example, as shown in Fig. 17, the spanning region or bridge 12 may follow a curvilinear trajectory that curves around the three edges (inside or outside) of the ring, and lifts in an arcuate away from the valve plane. Alternatively, as shown in Figure 18, the spanning region or bridge 12 may follow a curved trajectory that curves around the three edges (inside or outside) of the ring and slopes downward toward the valve plane.

Regardless of orientation, more than one implant 10 may be installed to form implant system 22 . For example, FIG. 19 shows a system 22 including a lateral implant 10L and a medial implant 10M of the same type as the implant 10 described. FIG. 19 shows the implants 10L and 10M positioned in the common anterior axle stop area 16 . It should be understood that the implants 10L and 10M also include spaced apart anterior bridge stop regions.

One or both of the implants 10L and 10M may be straight (as in FIG. 13 ), or curved upwards (as in FIG. 14 ), or curved downwards (as in FIG. 15 ). A given system 10 may include lateral or medial implants 10L and 10M of different configurations. Furthermore, a given system 10 may also include more than two implants 10 .

FIG. 20 shows a system 22 comprising two curvilinear implants 10L and 10M of the type shown in FIG. 16 . In FIG. 20, curvilinear implants 10L and 10M are shown in a common posterior region, but implant 10 may also be from a spaced apart posterior region. One or both of the implants 10L and 10M may be parallel to the plane of the valve (as in FIG. 16 ), or arched upwards (as in FIG. 17 ), or curved downwards (as in FIG. 18 ). A given system 22 may include curvilinear implants 10L and 10M in different configurations.

Figure 21 shows a straight medial implant 10D, a medial curvilinear implant 10M, and a straight lateral implant 10L. One, two or all implants 10 may be parallel to the valve, or arched upward, or curved downward, as described above.

E. Rear axle stop and front axle stop

It should be understood that an axle stop including a rear axle stop and a front axle stop as described herein describes a device that releasably retains the bridge 12 in a tensioned state. As shown in FIGS. 22A and 22B , bridge stops 20 and 18 , respectively, are shown releasably secured to bridge member 12 to allow fore-and-aft movement of the bridge stop structure during portions of the cardiac cycle when tension is reduced or zero. , independent of the atrial septum and the inner wall of the great cardiac vein. Alternative embodiments are also described, all of which provide this functionality. It should also be understood that the general description of rear and front is not limited to the axle stop function, ie a rear axle stop could be used at the front and a front axle stop could be used at the rear.

When the bridge stop is interfaced with the diaphragm member or the T-member, for example, the bridge stop allows the bridge to move freely within or around the diaphragm member, ie the bridge is not connected to the diaphragm member or the T-member. In this configuration, the bridges are held in tension by bridge stops, for which a diaphragm member or T-shaped member is used to distribute the forces acting by the bridges across a larger surface area. Alternatively, the bridge stop may be mechanically connected to the diaphragm member or the T-shaped member, for example when the bridge stop is disposed over or secured to the diaphragm member hub. In this configuration, the bridge is fixed in position relative to the diaphragm member and is not free to move around the diaphragm member.

II. General approach to transseptal implantation

The implant 10 or implant system 22 as previously described implants itself in the heart valve annulus in a number of ways. Implant 10 or implant system 22 may be implanted, for example, during an open heart surgical procedure. Alternatively, implant 10 or implant system 22 may be implanted using catheter-based techniques via a peripheral venous access site, which may be in the femoral or jugular vein under image guidance (via IVC or SVC), or the same image-guided transcatheter arterial retrograde approach from the femoral artery through the aorta to the left atrium.

Alternatively, implant 10 or implant system 22 is implanted through the chest cavity using a thoracoscopic approach, or by other surgical access methods through the right atrium, also under image guidance. Image guidance includes, but is not limited to, fluorescence, ultrasound, magnetic resonance, computed tomography, or combinations thereof.

Implant 10 or implant system 22 includes separate components that fit within the body to form the implant, or alternatively include separate components that fit outside the body and are implanted as a whole.

Figures 23-30 illustrate a representative embodiment of an implant 10 of the type shown in Figures 10A-10D using a percutaneous, catheter-based procedure under image guidance.

Percutaneous vascular access is achieved by conventional methods of accessing the femoral and jugular veins, or a combination of both. As shown in Figures 23 and 24, under image guidance, a first or great cardiac vein catheter 40, and a second or left atrial catheter 60 are steered through the vasculature into the right atrium. The function of the great cardiac vein (GCV) catheter 40 and the left atrial (LA) catheter 60 is to form the posterior bridge stop region. Catheters to the right and left atrium can be routed through the femoral vein to the IVC or SVC (in the latter state, for the vena cava pull rod) or the upper extremity or jugular vein to the IVC or SVC (in the latter state). In one state, it is used for the vena cava pull rod). In the state of the SVC, the easiest access is from the upper extremity venous or jugular venous system; however, the IVC can also be accessed by crossing the SVC and right atrium. Likewise, the easiest access to the IVC is via the femoral vein; however, the SVC can also be accessed by passing through the IVC and right atrium. Figures 23, 24, 27, 28 and 29 illustrate entry via the SVC route and the IVC route for purposes of illustration.

The implantation of implant 10 and implant system 22 is firstly described here in four general steps. Each step, and the various tools used are then described in additional detail below in subsection III. Furthermore, alternative implantation procedures can be used and are described in Section IV. Another alternative embodiment of the bridge stop is described in subsection V, another alternative embodiment of the T-shaped tool or bridge stop is described in subsection VI, and another alternative embodiment of the bridge Embodiments are described in Section VII.

The first insertion step can generally be described as forming the rear axle stop area 14 . As shown in Figure 24, the GCV catheter 40 is maneuvered through the vasculature into the right atrium. The GCV catheter 40 is then navigated through the coronary sinus and into the great cardiac vein. A second catheter or LA catheter 60 is also passed through the vasculature and into the right atrium. The LA catheter 60 is then passed through the septal wall at or near the fossa ovale and into the left atrium. Mullins ^™ catheter 26 is configured to assist in guiding LA catheter 60 into the left atrium. The GCV and LA catheters 40, 60 function to construct the posterior bridge stop region 14 when the GCV and LA catheters 40 and LA catheters 60 are in their respective locations in the great cardiac vein and left atrium, respectively.

The second step can generally be described as forming the transit bridge 12 . Deployment catheter 24 via LA catheter 60 is used to position posterior bridge stop 18 and bridge 12, preferably pre-attached and of predetermined length, within the great cardiac vein (see FIG. 27 ). A bridge 12 of predetermined length (eg, two meters) extends from the rear axle stop 18 through the left atrium, through the fossa ovale, through the vasculature, and preferably remains accessible outside the body. A predetermined length of the bridge is cut or separated in a later step, leaving a portion extending from the rear axle stop 18 to the front axle stop 20 . Optionally, the bridge 20 cannot be cut or separated at the front axle stop 20, but the bridge 20 can be allowed to extend into the IVC for possible subsequent recovery.

The third step can generally be described as forming the front axle stop area 16 (see FIG. 29 ). The bridge 12 first pivots through the diaphragm member 30 . The septum member 30 is then advanced through the Mullins catheter 26 in a collapsed state past the bridge 12 and deployed and deployed at or near the fossa ovale within the right atrium. Advancement stop 20 is attached to bridge 12 and advanced through septum member 30, or alternatively bridge stop 20 may be advanced to the right atrial side of septum member 30 after septum member deployment or deployment.

The fourth step can generally be described as adjusting the bridge 12 to obtain the proper therapeutic effect. When the rear axle stop area 14 , the bridge 12 , and the front axle stop area 16 are constructed as described above, tension acts on the bridge 12 . The implant 10 and associated area are allowed to rest for a predetermined period of time, such as five seconds or longer. The mitral valve and mitral regurgitation are observed for desired treatment effects. The tension on the bridge 12 is adjusted or readjusted until the desired result is obtained. The bridge stop 20 then allows the bridge 12 to be immobilized when the desired tension or measured length or degree of mitral regurgitation reduction is achieved.

III. Detailed Methods and Implantation Devices

The four generally described implantation steps will now be described in more detail, including the various tools and devices used in the implantation of implant 10 or implant system 22 . The exemplary embodiments will describe methods and tools for implanting implant 10 . The same or similar methods and tools may be used to implant implant system 22 .

A. Form the rear axle stop area

1. Implantation tool

A variety of tools may be used to form the rear axle stop area 14 . For example, a great cardiac vein (GCV) catheter 40, a left atrial (LA) catheter 60, and a cutting catheter 80 may be used.

Figure 37A shows one embodiment of a GCV catheter 40 according to the present invention. GCV catheter 40 preferably includes a magnetic or ferromagnetic head 42 disposed at the distal end of catheter shaft 45 and a hub 46 disposed at the proximal end. Catheter shaft 45 includes a first portion 48 and a second portion 50 . The first portion 48 is generally rigid to allow rotation of the shaft 45 and is a solid or braided structure. First portion 48 includes a predetermined length (eg, fifty centimeters) to position shaft 45 within the vasculature. The second portion 50 is generally flexible to be steerable within the vasculature, such as into the coronary sinus. The second portion 50 includes a predetermined length (eg, ten centimeters). The inner diameter or lumen 52 of the catheter shaft 45 is preferably sized to pass the GCV guidewire 54, and additionally the LA guidewire 74 (see Figures 39 and 40). The GCV guidewire and LA guidewire 74 are pre-curved and both are steerable. GCV catheter 40 preferably includes radiopaque markers 56 to facilitate image-guided adjustment of catheter alignment with LA catheter 60 .

The magnetic or ferromagnetic head 42 is preferably polarized to magnetically attract or connect the distal end of the LA catheter 60 (see FIGS. 37B and 25 ). The head 42 includes a side hole 58 formed therein to allow passage of the LA guide wire 74 . As shown in FIG. 40, the left atrium side 43 of the head 42 has an attractive magnetic force, and the outside of the heart side 44 of the head 42 has a repulsive magnetic force. It should be understood that these magnetic forces can be reversed when the magnetic forces in the respective catheters are consistent with appropriate magnetic attraction. The magnetic head 42 preferably includes a bullet or tapered tip 55 to allow the catheter to track along the vasculature. In the tip 55 is a port hole 59 configured to allow passage of the GCV guide wire 54 .

One embodiment of an LA catheter 60 is shown in FIG. 38 . Like GCV catheter 40, LA catheter 60 preferably includes a magnetic or ferromagnetic head 62 disposed at the distal end of catheter shaft 65, and a hub 66 disposed at the proximal end. Catheter shaft 65 includes a first portion 68 and a second portion 70 . The first portion 68 is generally rigid to allow rotation of the shaft 45 and is of solid or braided construction. First portion 68 includes a predetermined length (eg, ninety centimeters) to allow shaft 65 to be positioned within the structure of the vasculature. The second portion 70 is generally flexible and anatomically shaped to allow steerability through the fossa ovalis and into the left atrium. The second portion 70 includes a predetermined length, eg, ten centimeters. The inner diameter or lumen 72 of the catheter shaft 65 is preferably sized to allow passage of the LA guide wire 74 and additionally receive the guide wire 54 passing from the GCV. LA catheter 60 includes radiopaque markers 76 to facilitate image-guided adjustment of catheter 60 alignment with GCV catheter 40 .

The magnetic or ferromagnetic head 62 of the LA catheter 60 is polarized to magnetically attract or connect the distal end of the GCV catheter 40 . As shown in FIG. 40, the end side 64 of the head 62 is polarized to attract the head 42 of the GCV catheter. When the attracting magnetic poles in LA catheter 60 and GCV catheter 40 are aligned, the magnetic force in head 62 can be reversed. Magnetic head 42 preferably includes a generally planar tip 75 and includes a central opening 78 sized to allow passage of cutting catheter 80 and LA guide wire 74 (see FIG. 38 ).

FIG. 41 shows a cutting catheter 80 that is preferably sized to fit within the inner diameter or lumen 72 of the LA catheter 60 . Optionally, cutting catheter 80 is placed over LA guidewire 74 when LA catheter 60 is removed.

The cutting catheter 80 preferably includes a hollow cutting tip 82 disposed at the distal end of the catheter shaft 85 and a hub 86 disposed at the proximal end. Catheter shaft 85 includes a first portion 88 and a second portion 90 . The first portion 88 is generally rigid to allow rotation of the shaft 85 and is a solid or braided construction. The first portion 88 includes a predetermined length (eg, ninety centimeters) to position the shaft 85 within the structures of the vasculature and the LA catheter. The second portion 90 is generally flexible to allow steerable passage through the fossa ovalis and into the left atrium. The second portion 90 also includes a predetermined length, eg, twenty centimeters. The inner diameter 92 of the catheter shaft 85 is preferably sized to allow passage of the LA guide wire 74 . The cutting catheter 80 preferably includes a radiopaque marker 96 disposed on the shaft 85 to mark the depth of cut relative to the radiopaque magnetic tip 62 or marker 76 of the LA catheter 60 .

The hollow cutting or piercing tip 82 includes a sharpened distal end 98 and is preferably sized to fit through the LA catheter 60 and magnetic head 62 (see FIG. 42A ). Alternatively, cutting or piercing tips 100 and 105 may be used instead of, or in conjunction with, hollow cutting tip 82, as shown in FIGS. 42B and 42C. The three-blade 100 of Figure 42B includes a sharpened distal tip 101 and three cutting blades 102, although any number of blades may be used. The three blades 100 can be used to avoid the creation of cored tissue, whereas the hollow cutting tip 82 would produce cored tissue. Elimination of core tissue helps minimize thrombotic complications. A sharp tip guide wire 105 as shown in Fig. 42C may also be used. A sharp tip 106 is provided at the end of the guidewire to pierce the walls of the left atrium and great cardiac vein.

2. Implantation method

Access to the vasculature is typically provided through the use of introducers known in the art. A 16F or less hemostatic introducer sheath (not shown) is first placed in the superior vena cava (SVC) to set the access GCV catheter 40 . Optionally, the introducer can also be placed in the subclavian vein. A second 16F or less hemostatic introducer sheath (not shown) is then placed in the right femoral vein to provide access to the LA catheter 60 . Access to the SVC and right femoral vein, for example, also allows for implantation methods utilizing loop guide wires. For example, in the procedure described hereafter, the loop guidewire is created by advancing the LA guidewire 74 through the vasculature until the loop guidewire emerges from the body and extends outside the body of the superior vena cava sheath and the femoral sheath. LA guidewire 74 may follow an intravascular path extending at least through the interatrial septum from the superior vena cava sheath into the left atrium, through atrial tissue and from the left atrium into the femoral sheath through the great cardiac vein. The loop guidewire enables the physician to both push and pull the device into the vasculature during the implantation procedure (see Figures 35A and 36A).

An optional step includes placing a catheter or catheters within the vasculature to provide a baseline measurement. An AcuNav ^™ intracardiac echocardiography (ICE) catheter (not shown), or similar device, is placed via the right femoral artery or vein to provide, by way of non-limiting example, distance measurements such as baseline lateral septal (SL) separation, atrial wall separation , and measurement methods such as mitral valve regurgitation methods. Furthermore, ICE catheters are used to evaluate access to the aortic valve, tricuspid valve, pulmonary valve, IVC, SVC, pulmonary vein, and left atrium.

The GVC catheter is then deployed in the great cardiac vein close to the posterior mitral annulus. Under image guidance, a 0.035 inch GCV guide wire 54 from the SVC is advanced, for example, into the coronary sinus and to the great cardiac vein. Optionally, a contrast injection with an angiographic catheter can be injected into the left aorta from the aorta and images of the left coronary system are taken to assess the location of important coronary structures. Also, a contrast injection was performed into the great cardiac vein to provide images and methods of measurement. If the great cardiac vein is too small, the great cardiac vein is dilated with a 5 to 12 mm balloon, eg, to the middle of the posterior leaflet. GCV catheter 40 is then advanced through GCV guidewire 54 to a location in the great cardiac vein, for example, near the posterior valve leaflet or posterior mitral annulus (see FIG. 23 ). The desired location for the GCV catheter 40 is also seen to be approximately 2 to 6 centimeters from the anterior ventricular vein. When the GCV catheter 40 is in place, an injection is performed to confirm adequate blood flow around the GCV catheter 40 . If blood flow is low or absent, the GCV catheter 40 is pulled back into the coronary sinus until the GCV catheter is needed.

LA catheter 60 is then deployed in the left atrium. A 0.035 inch LA guidewire 74 from the femoral vein was advanced into the right atrium under image guidance. A 7F Mullins ^™ dilator with a needle was deployed into the right atrium (not shown). Injections were performed in the right atrium to seat the fossa ovale on the septal wall. The septal wall at the fossa ovalis is then pierced by the needle and guide wire 74 advanced into the left atrium. The needle is then removed and the dilator advanced into the left atrium. Injections were performed to confirm location relative to the left ventricle. The 7F Mullins system is removed and subsequently replaced with a 12F or other appropriately sized Mullins system 26 . The 12F Mullins system 26 is placed in the right atrium and extends a short distance into the left atrium.

Next, LA catheter 60 is advanced through LA guide wire 74 and positioned within the left atrium, as shown in FIG. 24 . If the GCV catheter 40 is returned to allow blood flow, the GCV catheter 40 is now returned in place. GCV catheter 40 is then generally rotated to magnetically align with LA catheter 60 . Referring now to FIG. 25 , preferably under image guidance, LA catheter 60 is advanced and rotated as necessary until magnetically induced head 62 of LA catheter 60 is magnetically attracted to magnetically induced head 42 of GCV catheter 40 . The wall of the left atrium and the venous tissue of the great cardiac vein separate the LA catheter 60 and the GCV catheter 40 . Magnetic attachment is preferably confirmed via images from multiple viewing angles, if necessary.

Next, an access lumen 115 is formed in the great cardiac vein (see FIG. 26 ). Cutting catheter 80 is first placed over LA guide wire 74 within LA catheter 60 . Cutting catheter 80 and LA guidewire 74 are advanced until resistance is felt against the wall of the left atrium. LA guidewire 74 is retracted slightly, and cutting catheter 80 is rotated and/or pushed as forward pressure is applied to cutting catheter 80 . Under image guidance, penetration of the cutting catheter 80 into the great cardiac vein is confirmed. The LA guide wire 74 is then advanced into the great cardiac vein and further into the GCV catheter 40 towards the coronary sinus and exits the body at the sheath in the neck. LA catheter 60 and GCV catheter 40 can now be removed. The LA guidewire 74 and GCV guidewire 54 are now in place for the next step of forming the transit bridge 12 .

B. Form a transit bridge

Now that the rear axle stop area 14 has been formed, the transom bridge 12 is arranged to extend from the rear axle stop area 14 through the left atrium in a rear-to-front direction to the front axle stop area 16 .

In the exemplary embodiment of the method of implantation, the transseptal bridge 12 is implanted via the left atrium to GCV approach. In this approach, the GCV guidewire 54 is not used and can be removed. Optionally, the GCV to left atrium pathway is also described. An alternative GCV-to-LA approach for forming the transseptal bridge 12 is described in detail in Section IV.

Bridge 12 is constructed of suture material or suture equivalents known in the art. Typical examples include, but are not limited to, 1-0, 2-0, and 3-0 polyester sutures, stainless steel braids (eg, 0.022 inch diameter), and NiTi wire (eg, 0.008 inch diameter). Alternatively, bridge 12 may be constructed of biological tissue such as bovine, equine or porcine pericardium, or preserved mammalian tissue, preferably in a glutaraldehyde-fixed state. Optionally, the bridge is surrounded by pericardium, or polyester fabric or equivalent. Other optional bridges are described in Section VII.

A bridge stop such as a T-shaped bridge stop 120 is preferably connected to a predetermined length of bridge 12 . The bridge member 12 is fixed to the T-shaped bridge stop 120 (see FIG. 44 ) by using a bridge stop 150, or connected to the T-shaped bridge stop 121 by a fixing device 121 such as tying, welding, or gluing, or any combination thereof. Shaped bridge stop 120. As shown in Figures 43A and 43B, the T-bridge stop 120 may be symmetrical or asymmetrical in shape, may be curved or straight, and preferably includes a flexible tube 122 having a predetermined Length, such as three to eight centimeters, and its inner diameter 124 forms a certain size to at least allow the guide wire to pass through. Tube 122 is preferably braided and solid, and is also covered with a polymeric material. Each end 126 of the tube 122 preferably includes a radiopaque marker 128 to aid in positioning and positioning the T-bridge stop 120 . Tube 122 also preferably includes an atraumatic end 130 to protect the tube wall. The T-bridge stopper 120 is flexibly curved or pre-shaped to generally conform to the curved shape of the great cardiac vein or interatrial septum with less trauma to the surrounding tissue. The overall shape of the T-shaped bridge stop 120 is predetermined and based on a number of factors including, but not limited to, the length of the bridge stop, the material composition of the bridge stop, and the loads to be applied to the bridge stop.

The reinforced base tube 132 also includes a T-bridge stop 120 . Reinforcement tube 132 may be disposed above flexible tube 122 as shown, or alternatively, reinforcement tube 132 may be disposed within flexible tube 122 . Reinforcement tube 132 is preferably solid, but may also be braided, and is one centimeter shorter in length than flexible tube 122 . Reinforced center tube 132 adds stiffness to T-bridge stop 120 and helps prevent T-shaped member 120 from exiting through cored or pierced lumen 115 in the great cardiac vein and left atrium wall.

Alternative T-shaped members or bridge locks and means for connecting bridge 12 to the T-shaped bridge lock are described in subsection VI.

As shown in FIG. 27 , a T-bridge stop 120 (attached to the forward end of the bridge 12 ) is first placed on or over the LA guide wire 74 . Deployment catheter 24 is then placed over LA guidewire 74 (which remains in place and extends into the great cardiac vein) and is used to push T-bridge stop 120 through Mullins catheter 26 and into the right atrium and from The right atrium passes through the interatrial septum into the left atrium, and from the left atrium through atrial tissue into the region of the great cardiac vein near the posterior mitral annulus. LA guidewire 74 is then withdrawn proximal to the tip of deployment catheter 24 . Deployment catheter 24 and guide wire 74 are then withdrawn to the left atrial wall. The T-bridge stop 120 and attached bridge 12 stay within the great cardiac vein. The length of the bridge 12 extends from the posterior T-bridge stop 120 through the left atrium, through the fossa ovale, through the vasculature, and preferably remains distally accessible to the body. Preferably under the guidance of the image, the tail end of the bridge piece 12 is slowly pulled to separate the T-shaped bridge stopper 120 from the deployment catheter 24 . When separation is confirmed, the bridge 12 is gently pulled again to position the T-bridge stop 120 relative to the vein tissue in the region of the great cardiac vein and centered over the great cardiac vein entry lumen 115 . The deployment catheter 24 and guide 74 can then be removed (see FIG. 28 ).

Transit bridge 12 is now in place and extends from posterior axle stop area 14 through the left atrium to anterior axle stop area 16 in a posterior to anterior direction. The bridge 12 preferably extends through the structure of the vasculature and outside the body.

C. Formation of front axle stop area

Now that the transit bridge 12 is in place, the front axle stop area 16 will next be formed.

In one embodiment, the proximal or trailing end of the bridge 12 extends outside the body, and is then rotated through or around a front axle stop, such as the diaphragm member 30 . Preferably, the bridge 12 passes through the outer body septum member 30 closest to its centre, and when the latter is deployed over the fossa ovale, the bridge 12 transmits its force to the central point on the septum member 30, whereby Twisting or rocking of the diaphragm member is reduced. The septal member is advanced in a folded configuration through the Mullins catheter 26 over the bridge 12 and positioned within the right atrium, unfolding at the fossa ovale and abutting the interatrial septal tissue. The bridge 12 is then held in tension by the bridge stop 20 (see Figures 29 and 30). The front axle stop 20 is attached to or disposed over the bridge 12 and advances with the diaphragm member 30, or alternatively, the axle stop 20 advances over the bridge 12 to the diaphragm after the diaphragm member is deployed or deployed. The right atrium side of member 30. Optionally, bridge stop 20 may also be positioned over LA guide wire 74 and pushed by deployment catheter 24 into the right atrium. When in the right atrium, the bridge stop 20 is then attached to or placed over the bridge 12, and the LA guidewire 74 and deployment catheter 24 are then completely removed from the body.

FIG. 44A shows a cross-sectional view of bridge stop 170 . The bridge stop 170 is shown connected to a guide tube 172 having a bridge lock adjustment screw 174 at the tip of the guide tube. In one embodiment, the axle lock adjustment bolt 174 remains connected to the axle stop 170 after the adjustment is complete. In an alternative embodiment, the axle lock adjustment bolt 174 remains attached to the axle stop 170 for removal after adjustment is complete. Axle stop 170 includes a housing 176 having a lumen 178 extending axially therethrough. Disposed within the lumen 178 is a bridge and closure spring 182 for retaining and adjusting, such as a clamp or jaw 180 . As shown, clamp member 180 is in a closed position. The clamp tips 184 are pressed together by the force acting on the clamp 180 through the closing spring 182 . In the closed position, the closing spring 182 exerts a predetermined force on the clamp tip 184, thereby exerting a clamping force on the bridge member 12 to maintain the position of the bridge member. Discontinuous stops 158 provide another barrier to maintain bridge 12 in place and allow adjustment of bridge 12 to fit the predetermined spacing of the stops.

Optionally, conduit 172 is used to reduce the length of bridge 12 (increase the tension) when clamp 180 is closed. A catheter with a hooked tip 146 is used to hook the exposed loop 156 . Adjustment bolt 174 is then threaded partially into bridge stop 170 to connect conduit 172 to bridge stop 170 . When conduit 172 is held stationary, bridge 12 is pulled to apply a force sufficient to bridge 12 and associated discrete stop 158 to overcome the retaining force of clamp 180, thereby allowing bridge 12 and stop 158 to through the clamp tip 184 .

As described here for the bridge stop 170 and for the optional bridge stop described below, a repositioning/readjustment device (i.e., repositioning ring 156) may be included to provide for days, weeks of stability to the implant. , or functions that can be repositioned and/or reconditioned after several years. Repositioning/readjustment of the implant can be performed after the initial implantation procedure or after previous adjustments.

44B is a cross-sectional view of the bridge stop 170 shown in FIG. 44A showing the adjustment characteristics of the bridge in the open position. As shown, the adjustment bolt 174 is shown threaded into the lumen 178 of the bridge lock housing 176 . When the adjustment bolt 174 is threaded into the axle stop 170 , the top end 186 of the adjustment bolt 174 exerts sufficient force on the clamp 180 to overcome the force of the closing spring 182 . Clamp tip 184 opens to allow shortening and elongation of bridge 12 .

The bridge stop 170 and the optional embodiments described thereafter have a predetermined size, such as eight millimeters by eight millimeters, such that the bridge stop is positioned close to, for example, a diaphragm member or a T-shaped member. The bridge lock is also preferably made of stainless steel or other biocompatible metal or polymer material suitable for implantation.

Another alternative bridge stop implementation is described in subsection V.

D. Adjustment of the bridge

The front axle stopper 20 is preferably arranged to interface with the diaphragm member 30 , or optionally arranged above the diaphragm member hub 31 . Bridge stop 20 is used to adjustably stop or hold bridge 12 in a tensioned state for proper therapeutic effect.

When the rear axle stop area 14, the bridge 12, and the front axle stop area 16 are constructed as described above, tension is applied to the bridge 12, either externally or internally to the proximal body of the bridge 12, Included within vasculature and cardiac structures. After first applying tension to bridge 12, implant 10 and its associated regions may be allowed to set for a predetermined time, such as five seconds. The mitral valve and its associated mitral regurgitation are subsequently observed for the desired therapeutic effect. The tension on the bridge 12 is adjusted as these steps are repeated (as described for each bridge stop embodiment) until the desired result is obtained. The bridge stop 20 then fixes the desired tension of the bridge 12 . The bridge 12 is then cut or separated at a predetermined distance from the bridge stop 20 (eg, zero to three centimeters into the right atrium). The remaining length of bridge 12 is then removed from the vasculature. Optionally, the bridge 12 includes repositioning devices such as hooks or loops or other structures to allow re-entry into the bridge stop sites 14, 16 for future adjustments to the implant system 10, recovery, or remove.

Optionally, the bridge 12 is allowed to extend into the IVC and into the femoral vein, or eventually to the femoral vein access point. Allowing the bridge to extend into the IVC and into the femoral vein will allow for later retrieval of the bridge if adjustment to the bridge is necessary or desired.

A bridge adjustment procedure as just described, including the steps of setting tension, waiting, observing, and readjusting if necessary, is preferred over a procedure that includes adjustment while simultaneously or in real time observing and Procedures for adjustments, such as when the doctor applies tension while simultaneously observing the real-time ultrasound image and continuing to make adjustments based on the real-time ultrasound image. The waiting step is advantageous because it allows the heart and implant to pass through a period of rest. This period of rest allows the heart and implant to settle and allows the tension and equipment in the rear and anterior axle stop regions to begin to reach equilibrium. Desired results may be better maintained when the heart and implant are allowed to seat before the tension is fixed than when the mitral valve is seen and the tension is adjusted in real time without providing time for deployment before the tension is fixed.

Figure 31 shows an anatomical view of mitral valve dysfunction prior to implant 10 implantation. As can be seen, the two leaflets do not coapt and thus an undesired backflow of blood from the left ventricle to the left atrium occurs. After the implant 10 has been implanted as just described, the implant 10 serves to shorten the minor axis of the annulus, thereby allowing the two leaflets to coapt and reducing undesired mitral valve regurgitation (see FIGS. 32 and 33 ). As shown, implant 10 is disposed in the heart, said implant 10 comprising: bridge 12, which spans the mitral valve annulus; anterior bridge stopper 20 and septum member 30, which rests on the fossa ovale or in the vicinity of the fossa ovalis; and the posterior axle stop 18, which is within the great cardiac vein.

IV. Optional Implantation Steps

The implantation procedure as described above varies for various reasons such as the age, health, and size of the patient, and the desired therapeutic effect. In an alternative embodiment, the posterior T-bridge stopper 120 (or an alternative embodiment) is implanted via the GCV approach rather than the left atrial approach as described above. In another alternative embodiment, the sampling procedure of the left atrium wall is replaced by a puncture procedure from the great cardiac vein to the left atrium.

A. GCV pathway

As described above, penetration of the cutting catheter 60 into the great cardiac vein was confirmed under image guidance (see FIG. 26 ). When penetration is confirmed, LA guidewire 74 is advanced into the great cardiac vein and into GCV catheter 40 . LA guide wire 74 is advanced further through GCV catheter 40 until its end exits the body (preferably at the superior vena cava sheath). Now the LA catheter 60 and GCV catheter 40 are removed. Both the LA guidewire 74 and the GCV guidewire 54 are in place for the next step of forming the transit bridge 12 (see FIG. 35A ). At this point, the optional exchange catheter 28 is advanced over the LA guidewire 74, starting at either end of the guidewire 74 and entering the body at either the femoral sheath or the superior vena cava sheath, and advancing the exchange catheter 28 until said exchange catheter 28 Lead out the body at the other end of the guide wire 74 . The purpose of the present exchange catheter is to facilitate the passage of the LA guidewire 74 and bridge 12 during the procedures described below without having to cut or cause damage to the vessels and cardiac tissue. In a preferred embodiment, the exchange conduit 28 has an ID of about 0.040 to 0.060 inches, an OD of about 0.070 to 0.090 inches, a length of about 150 cm; a smooth inner diameter surface; and a trauma-resistant soft tip on at least one end, The exchange catheter 28 is thereby advanced through the vasculature without causing damage to the tissue. It should be understood that ID, OD, and length vary depending on the particular procedure being performed.

In the GCV approach, the transseptal bridge 12 is implanted via the GCV to left atrium approach. A predetermined length (eg, two meters) of bridge 12 (with leading and trailing ends) is connected at the leading end to the tip of LA guide wire 74 before exiting the body in the superior vena cava sheath and femoral sheath. In the described embodiment, the LA guide wire 74 acts as a loop guide wire, allowing the bridge to be gently pulled or retracted into or through at least part of the vasculature and into the heart chamber. The vascular path of the bridge extends from the superior vena cava sheath through the coronary sinus into the region of the great cardiac vein near the posterior mitral annulus, from the great cardiac vein through atrial tissue into the left atrium, and from the left atrium Extends across the interatrial septum into the right atrium, and from the right atrium to the femoral sheath.

As shown in FIGS. 34A to 34D , a crimp tube or connector 800 is used to connect the bridge 12 to at least one end of the LA guidewire 74 . FIG. 34A shows a crimp tube 800 preferably having an outer protective shell 802 and an inner tube 04 . The outer protective shell 802 is preferably made of a polymer material to provide softness that prevents damage to the crimp tube, although other crimpable materials may also be used. Inner tube 804 is made of a ductile or malleable material, such as a soft metal, to allow crimps to hold bridge 12 and guide wire 74 in place. The end 806 of the crimp tube is slightly bent inward to aid movement of the crimp tube 800 as it moves through the vasculature. It should be understood that the crimp tube may simply comprise a single tube made of ductile or malleable material.

The bridge piece 12 is partially disposed within the crimping tube 800 . Force is applied via pliers or similar crimping tool to create a first crimp 808 (see FIG. 34B ). The ends of the bridge include a knot such as a single overhand knot to aid in retention of the bridge 12 within the crimp tube. Next, the LA guide wire 74 is partially disposed within the crimp tube 800 of the opposing bridge 12 . The force is applied again with pliers or similar crimping tool to create a second crimp 810 (see FIG. 34C ). Optionally, the bridge 12 and guide wire 74 are placed at opposite ends within the crimp tube 800 and a single crimp 812 is used to secure the bridge 12 and guide wire 74 within the crimp tube (see FIG. 34D ). It should be appreciated that the crimp tube 800 may be attached to the bridge 12 or guide wire prior to the implant procedure to eliminate the step of crimping the bridge 12 within the crimp tube 800 during the implant procedure. The guide wire 74 is easy to be retracted slowly. It should also be understood that arrangements using adhesives or optionally snap-together pre-attachment mechanisms may also be used to attach the bridge to the guidewire.

As shown in Figure 35B, the LA guide wire 74 is slowly retracted, allowing the bridge 12 to follow through the vasculature. If an optional exchange catheter 28 is used (as shown in FIGS. 35A and 35B ), the LA guidewire 74 is retracted through the lumen of the exchange catheter 28 without causing tissue damage. The LA guide wire 74 is completely removed from the outside of the body at the femoral sheath, leaving the bridge 12 to extend from the outside of the body, preferably at the femoral sheath, through the vasculature, and out again at the superior vena cava sheath. The LA guidewire 74 is then removed from the bridge 12 by cutting or separating the bridge 12 at or near the crimp tube 800 .

A rear axle stop such as T-shaped axle stop 120 is preferably connected to the trailing end of bridge 12 extending from the superior vena cava sheath. The T-bridge stop 120 is then positioned on or over the GCV guideline 54 . Deployment catheter 24 is then positioned on or over GCV guide wire 54 and used to advance or push T-bridge stop 120 and bridge 12 through the right atrium, through the coronary sinus, and into the great cardiac vein. If the optional exchange catheter 28 is used, the exchange catheter is gently retracted with or slightly in front of the bridge 12 (see Figures 36A and 36B). Optionally, bridge 12, either alone or in combination with deployment catheter 24, is pulled out of the femoral vein region to advance T-bridge stop 120 and bridge 12 into position in the great cardiac vein. The GCV guidewire 54 is then retracted disengaging the T-bridge stop 120 from the GCV guidewire 54 and deployment catheter 24 . Preferably under image guidance, and when separation is confirmed, the bridge 12 is slowly pulled to place the T-bridge stop 120 in abutment with the venous tissue within the great cardiac vein and centered over the GCV entry lumen 115 . Deployment catheter 24 and optional exchange catheter 28 are then removed.

The T-bridge stop 120 and attached bridge 12 stay within the great cardiac vein. The length of bridge 12 extends from posterior T-bridge stop 120 through the left atrium, through the fossa ovale, through the vasculature, and preferably remains accessible from the outside of the body. The bridge 12 is now ready for the next step of forming the front axle stop area 16, as described above and as shown in FIGS. 28 to 30 .

B. Piercing Procedure

In the alternative embodiment, the procedure for coring the lumen from the left atrium into the great cardiac vein is replaced by a procedure in which a sharp-tip guidewire within the great cardiac vein is used to create to the channel in the left atrium. An alternative embodiment of the magnetic head of both the GCV catheter 40 and the LA catheter 60 is preferably used for the procedure.

45A and 45B illustrate an embodiment of end-to-side polarity for the GCV catheter magnetic head 200 and the LA catheter magnetic head 210 . Alternatively, side-to-side polarity can also be used. The GCV catheter magnetic head 200 can maintain the same configuration for end-to-side polarity and end-to-end polarity, while the LA catheter magnetic head 215 is shown substantially rotated for the side-to-side polarity embodiment Ninety degrees (see Figure 46).

As shown in Figure 45B, the GCV catheter magnetic head 200 includes a dual lumen configuration. Navigation guidewire lumen 202 allows GCV catheter 54 to extend through tapered or bullet-shaped end 204 of head 200 to steer GCV catheter 400 into proper position. The second radially curved side hole lumen 206 allows the sharp tip guidewire 105 (or tri-blade 100 ) to extend through the head 200 and guide the sharp tip guidewire 105 into the LA catheter magnetic head 210 . The LA catheter magnetic head 210 includes a funnel-shaped end 212 and a guidewire lumen 214 (see FIG. 45C ). The funnel-shaped end 212 guides the sharpened tip guidewire 105 into the lumen 214 and into the LA catheter shaft 65 .

Figure 46 shows an alternative embodiment of the LA catheter magnetic head 215 using a side-to-side polarized embodiment. Head 215 has the same construction as GCV catheter magnetic head 42 shown in FIGS. 39 and 40 and described in Section III. The head 215 includes a navigation guidewire lumen 216 at a tapered or bullet-shaped end 218 , and a side hole 220 . Side hole 220 funnels sharp tip guidewire 105 (or tri-blade 100 ) from GCV catheter 40 to LA catheter 60 and guides guidewire 105 into LA catheter shaft 65 .

In use, both GCV catheter 40 and LA catheter 60 are advanced into the great cardiac vein and left atrium as described above. GCV catheter 40 and LA catheter 60 each include an optional magnetically induced tip as described. As shown in Figures 45A and 45B, the sharp-tipped guide wire 105 is advanced through the GCV catheter 40 to the inner wall of the great cardiac vein. The sharp-tipped guidewire 105 is advanced further until the guidewire 105 punctures or pierces the walls of the great cardiac vein and left atrium, and enters the funnel-shaped end 212 within the LA catheter head 210 . The sharp-tipped guidewire 105 is advanced further until the guidewire 105 emerges from the proximal end of the LA catheter 60 . Both the GCV catheter 40 and the LA catheter 60 are now removed, leaving the GCV guidewire 54 and the sharp-tipped guidewire 105 in place. The posterior T-bridge stopper 120 is implanted via the GCV approach, as described above and shown in Figures 35A-36B.

V. Alternative Bridge Stop Implementations

Alternative embodiments of bridge stops may be used and are described herein. Axle stops are used to secure the bridge 12 at the rear axle stop area 14 or the front axle stop area 16 or both. It should be understood that alternative embodiments of the axle stop may include a single element, or may include multiple elements. Also, an alternative embodiment of the bridge stop features adjustments to the bridge to only tension, or only release, or tension and release.

FIG. 47 shows a perspective view of an alternative embodiment of an implant system 10 of the type shown in FIGS. 10A-10D . The implant system 10 of FIG. 47 illustrates the use of an exposed ring 156 to allow adjustment or removal of the implant system. As shown, a catheter with a hooked tip 146 can be used to hook the exposed loop 156 . A radiopaque marker 160 may be used to facilitate grasping or hooking the exposed loop 156 . Bridge 12 is also shown to include the use of discrete stops 158 in conjunction with front axle stops 170 .

Figure 48 is a perspective view of an alternative embodiment of a bridge stop 390 in accordance with the present invention. Optional axle stop 390 preferably includes a toothed belt 392 and an axle stop housing 394 . The toothed belt 392 includes all or part of the bridges 12 and includes at least one row of spaced teeth 396 disposed along at least one edge of the belt. The housing includes a locking collar 398 at one end. The locking ring 398 includes a rectangular opening 400 to allow free movement of the toothed strap 392 when the locking ring is in the open position (see FIG. 48 ); and to engage the teeth 398 when the locking ring is in the locked position (see FIG. 48 ). 49). Another bridge or suture-type material 402 may be attached to the toothed belt 492, allowing the housing 494 and locking collar 398 to be disposed on the toothed belt.

In use, the bridge stop 390 allows adjustment of the length of the bridge comprising the toothed strap 392 by rotating the locking collar 398 to the open position (see Figure 48). A conduit (not shown) is desirably used to grasp the locking collar 398 and to provide the function of rotation. When the locking collar is in the open position, the strap 392 is free to move, thereby adjusting the length of the bridge 12 . When the desired tension is established, the catheter is again used to rotate the locking collar 398 ninety degrees to engage the teeth 396 and hold the strap 392 in place (see FIG. 49 ).

Figure 50 is a perspective view of an alternative embodiment of a bridge stop 410 in accordance with the present invention. The optional bridge stop 410 preferably includes an adjustment collar or nut 414 , a locking collar or nut 416 , and a threaded shaft 412 that includes all or part of the bridge 12 . As shown, adjustment nut 414 and lock nut 416 include features to facilitate rotation. Adjustment nut 414 is shown having a rod or rods 418 extending radially from the nut. Locking nut 416 is shown with one or more notches 420 on the periphery of the nut. These rotational characteristics allow the catheter to be placed over the threaded shaft and over the adjusting nut 414 and locking nut 416 to loosen the locking nut 416, adjust the position of the adjusting nut 414, thereby adjusting the tension on the bridge 12, and subsequently re-secur lock nut 416 . Another bridge or suture material 402 can be attached to the threaded shaft 412 to allow adjustment of a nut 414 and a lock nut 416 to set on the threaded shaft.

Alternatively, a single nut 422 with self-locking threads, such as nylon thread, may be used (see FIG. 51 ). A single nut has the advantage of reducing the number of steps required to adjust the bridge 12 .

Figure 52 is a perspective view of an alternative embodiment of a bridge stop 430 in accordance with the present invention. Optional bridge stop 430 preferably includes a perforated strap 432 and a bridge stop housing 434 . The perforated strap 432 includes all or part of the bridge 12 and includes at least one row of spaced perforations 436 along the length of the strap. Another bridge or suture material 402 may be attached to the perforated strip 432 allowing the bridge stop housing 434 to be disposed on the perforated strip.

Referring to FIGS. 53 and 54 , the housing includes a latch spring 438 disposed within a notch 440 . The housing 434 also includes a protrusion or protrusions 442 allowing a conduit 444 to be connected or adjusted. As shown, conduit 444 includes a connecting arm or arms 446 to connect to housing protrusion 442 (see FIG. 54 ). This connection between the housing and the adjustment conduit maintains the position of the bridge stop housing 434, allowing adjustment of the perforated strap 432 to increase or decrease the length of the bridge.

Figure 53 shows the bridge stop 430 in a locked configuration. Lockout spring 438 is shown extending into perforation 436 in strap 432 . To adjust the bridge, conduit 444 is first connected to bridge stop housing protrusion 442 by engaging conduit connection arm 446 . As shown in FIG. 54 , adjustment conduit 444 is connected to bridge stop 430 . In the adjusted configuration, the perforated strap 432 can be pulled or pushed, causing the lock spring 438 to temporarily bend out of the perforation 436 and into the empty notch 440 . Perforation 436 has rounded edges to facilitate bending of lock spring 438 out of perforation 436 when strap 432 is adjusted. The strap is adjusted to the point where the lock spring 438 bends again into the perforation 436 to maintain the position of the bridge 12 .

Figures 55 and 56 show an alternative embodiment of a bridge stop 450 according to the invention. The optional axle stop 450 preferably includes a unidirectional toothed belt 452 and an axle stop housing 454 having a lumen 456 extending radially through the housing. The unidirectional toothed belt 452 includes all or part of the bridges 12 and includes at least one row of spaced apart teeth 458 along at least one edge of the belt. In one embodiment, the teeth 458 are angled to allow one-way adjustment of the strap 452 (see FIG. 55). Within the lumen 456 of the housing are provided means for holding the unidirectional toothed belt 452 in place. As shown in Figures 55 and 56, a protrusion 460 or the like is provided within the lumen 456 of the housing to engage the angled teeth 458 and allow passage of the teeth in one direction, but not both. In one embodiment, the angled teeth 458 are generally flexible, while the protrusions 460 are generally rigid, allowing the housing to push over the teeth 458 in one direction while resisting movement of the housing in the opposite direction. In an alternative embodiment, the angled teeth 458 are generally rigid, while the protrusions 460 are generally flexible. It should be understood that bridge stop 450 may be modified to include generally flexible teeth 458 and protrusions 460 to allow bidirectional movement of toothed belt 452 .

57A-58C illustrate another alternative embodiment of a bridge stop 470 in accordance with the present invention. Figures 57A to 57C illustrate a bridge stop 470 including a bridge 12 in a restrained configuration. 58A to 58C illustrate bridge stop 470 including bridge 12 in an unconstrained configuration. The optional bridge stop 470 preferably includes a housing 472 which, although not required, may be tubular; the housing includes a top side 474, a bottom side 476, an inner surface 478, and an outer surface 480 . Disposed within the housing is an inclined wall or ramp 482 extending from or near top side 474 to inner surface 478 at or near bottom side 476 . A groove or slot 484 is provided in ramp 482 that extends to offset circular opening 486 . A slot 484 is disposed at or near the top side 474 and extends to a circular opening 486 disposed at or near the bottom side 476 .

57A-57C show the bridge 12 and associated discontinuous stop 158 in a restrained position. As shown, the slot 484 is sized to only allow movement of the bridge 12 within the slot. Tension force applied to bridge 12 in an upward direction (toward housing top side 474 ) allows ramp 482 to facilitate movement of stop 158 and bridge 12 into slot 484 and to the restrained position, as shown. The stop 158 prevents movement of the bridge 12 in a substantially upward direction.

58A to 58C show the bridge 12 and associated discrete stop 158 in an unconstrained position. In this configuration, the length (tension) of the bridge 12 can be adjusted. As shown, the circular opening 486 is sized and configured to allow passage of the bridge 12 including the discontinuous stop 158 through the opening 486 . It should be understood that the opening may take any shape related to the shape of the stop 158 . (Towards housing bottom side 476) tension on bridge 12 allows ramp 482 to facilitate movement of stop 158 and bridge 12 down ramp 482 (i.e., out of slot 484 and into opening 486) and to the unrestricted position, as shown. The stop 158 (and the bridge 12 ) can freely pass through the circular opening 486 . It should be understood that the bridge 12 and discrete stop 158 may comprise a single element, or may comprise a single stop connected to the bridge.

An alternative embodiment of a bridge stop 970 is shown in FIGS. 59A-60C . The optional bridge stop 970 preferably includes the addition of a turnstile 988 . The revolving door 988 provides a convenient mechanism to allow resetting of the bridge 12 and discrete stops 158, thereby allowing adjustments to be made during the procedure. Figures 59A-59C show a bridge stop 970 including the bridge 12 in a constrained configuration, while Figures 60A-60C show a bridge stop 970 including the bridge 12 in an unconstrained configuration.

Optional bridge stop 970 preferably includes a housing 972 which, though not required, may be tubular; said housing includes a top side 974, a bottom side 976, an inner surface 978, and an outer surface 980 . Disposed within the housing are sloped walls and ramps 982 extending from or near top side 974 to interior surface 978 generally at or near bottom side 976 . A groove or slot 984 is provided in ramp 982 that extends to offset circular opening 986 . A slot 984 is disposed at or near top side 974 and extends to a circular opening 986 disposed at or near bottom side 976 .

A swing door 988 disposed within the housing 972 includes a slot 989 sized and configured to match the length and width of the slot 984 disposed within the ramp 982 . Swivel door 988 is hingedly or rotationally connected to housing 972 or ramp 982 . As shown, swing door 988 includes a pin or protrusion 990 disposed within aperture 991 to allow door 988 to pivot or rotate about protrusion 990 . An aperture 991 is provided in housing 972 to allow swing door 988 to pivot or rotate at or near where slot 984 in ramp 982 engages offset circular opening 986 . The revolving door 988 can be held in a constrained position by a spring 994 (as shown in FIGS. 59A to 59C ), or the door can be allowed to move freely, depending on the tension of the bridge 12 and discrete stop 158 . Attached to the outer edge 992 of the revolving door 988 is a reset ring 993 with radiopaque markers 160 .

59A-59C show the bridge 12 and associated discontinuous stop 158 in a restrained position. As shown, the slots 984 in the ramp 982 and the slots 989 in the door 988 are sized to only allow movement of the bridge 12 within the respective slots. Tension force acting on bridge 12 in an upward direction (toward housing top side 974) allows door 988 to facilitate movement of stop 158 and bridge 12 into slot 988 (and slot 984) and to a restrained position, such as shown. The stop 158 prevents movement of the bridge 12 in a substantially upward direction.

60A-60C illustrate the bridge 12 and associated discontinuous stop 158 in an unconstrained position. In this configuration, the length (tension) of the bridge 12 can be adjusted. As shown, the circular opening 986 is sized and configured to allow passage of the bridge 12 including the discontinuous stop 158 through the opening 986 . It should be understood that the opening may take any shape related to the shape of the stop 158 . With the aid of a conduit (not shown), the reset ring 993 is pulled in a downward direction (toward the housing bottom side 976) to drive the bridge 12 and discrete stop 158 down the swing door 988 ( That is, out of the slot 989) and into the offset circular opening 986 and to the unrestricted position for adjustment, as shown. The stop 158 (and the bridge 12 ) can freely pass through the circular opening 986 . It should be understood that the bridge 12 and discrete stop 158 may comprise a single element, or may comprise a single stop connected to, for example, a bridge.

Figure 61 is a perspective view of another alternative embodiment of a bridge stop 500 in accordance with the present invention. The optional slidable axle stop 500 preferably includes a toothed belt 502 and an axle stop slider member 504 . The toothed belt 502 includes all or part of the bridges 12 and includes at least one row of spaced teeth 506 disposed along at least one edge of the belt. As shown, toothed belt 502 includes a row of teeth 506 spaced on each side of the belt. Teeth 506 are shown arranged in a zigzag pattern that is not staggered. In one embodiment, toothed belt 502 has a height H1 of approximately 0.060 inches, however height H1 may vary. The slider member 504 includes a groove member 508 and a snap member 510 .

Figures 62 and 63 illustrate the groove member 508 (Figure 63 shows the groove member in cross-section). As shown, the groove member may be generally tubular and include a lumen 512 extending therethrough. A groove or channel 520 is disposed generally on the outer surface 518 intermediate the first end 514 and the second end 516 , the groove or channel 520 extending around the outer surface 518 . A dimple or depression 522 is disposed within channel 520 . It is desired that the channel 520 includes four dimples 522 arranged ninety degrees apart from each other. The groove member 508 may also include a twist pin or a plurality of twist pins 524 extending radially from the outer surface 518 .

An axisymmetric groove 526 is disposed in the lumen 512 of the groove member 508 (see FIG. 63 for details). The groove 526 does not extend completely around the inner diameter of the lumen 512 . At least one bridge channel 528 , and desirably two parallel channels, extend the length of the groove member 508 .

FIG. 64 shows the snap-in member 510 rotatably disposed partially over and through the groove member 508 . The snapping member 510 includes: a base 530 ; at least one finger 532 extending from the base 530 ; and a base extension 534 . The base 530 and base extension include a channel 536 extending therethrough. The at least one finger desirably includes four fingers 532 , one finger for each dimple 522 on groove member 508 . At the tip of each finger 532 there may be provided a protrusion 538 which cooperates with the dimple 522 to act as a stop, limiting rotational movement of the snap member 510 about the groove member 508 .

In use, the snap-in member 510 is disposed over the groove member 508, as shown in FIG. 61 . When the channel 528 in the groove member 508 aligns with the channel 536 in the snap member, adjustment (lengthening or shortening of the bridge) of the toothed strap 502 is allowed. In this adjustment configuration (see FIG. 65 ), the spaced teeth 506 on the toothed strap 502 are not bounded by the grooves 526 provided in the groove member 508 and the strap 502 is within the bridge stop 500. Swipe freely. The detent feature (dimple 522 and protrusion 538 ) provides predetermined adjustment and limit positions, thereby making transitioning the axle stop 500 between the adjustment and limit configurations easier.

When the desired tension on the bridge 12 is achieved, a catheter (see FIG. 67 ) having a twisting tool 540 at its distal end is used to rotate the groove member 508 either clockwise or counterclockwise, while maintaining the toothed belt The strip (and snapping member 510) is positioned so as to engage the spaced apart teeth 306 within mating grooves 526 of the groove member 508, thereby constraining the toothed belt strip 502 (see FIG. 66). Also, the detent feature (dimple 522 and protrusion 538 ) provides a predetermined restraint position, thereby maintaining the axle stop 500 in the restraint configuration after the twisting tool 540 is removed.

As shown in FIG. 67 , the twisting tool 540 includes an outer torque device 542 and an inner torque device 544 . The external twist tool 542 includes at least one notch 546 at its distal end 548 to engage the twist pin or pins 524 on the groove member 508 . The inner torque device 544 (disposed within the outer torque device 542 ) includes a channel 550 sized and configured to allow the toothed belt to extend within the inner torque device 544 .

In an alternative embodiment of the slidable bridge stop 500 , a helically threaded bridge stop 560 (see FIG. 68 ) preferably includes a toothed strap 562 and a bridge stop helical thread member 564 . The toothed belt 562 includes all or part of the bridges 12 and includes at least one row of spaced teeth 566 disposed along at least one edge of the belt. As shown, the toothed belt 562 includes a row of spaced apart teeth 566 on each side of the belt. Teeth 566 are shown arranged in a staggered sawtooth pattern. In one embodiment, the toothed belt 562 has a height H2 of approximately 0.060 inches, however the height H2 can vary. The helical threaded member 564 includes a threaded member 568 and a base member 570 .

69 and 70 illustrate the threaded member 568 (Fig. 70 shows the threaded member in cross-section). As shown, the threaded member is generally tubular and includes a lumen 572 extending therethrough. A groove or channel 580 is disposed generally on the outer surface 578 intermediate the first end 574 and the second end 576 , the groove and channel 580 extending around the outer surface 578 . Threaded member 568 may also include a pin or a plurality of pins 584 extending radially from outer surface 578 .

A helical (threaded) groove 586 is provided within the lumen 572 of the threaded member 578 (shown in particular in FIG. 70 ). The groove 586 extends completely around the inner diameter of the lumen 572 .

FIG. 71 shows a base member 570 rotatably disposed partially over and through threaded member 568 . Base member 570 includes a base or hub 590 and a base extension 594 . Hub 590 and base extension 594 include a channel 596 extending therethrough. One or more holes 598 are disposed within hub 590 and are sized and configured to restrain pin 600 . Two holes 598 are shown in FIG. 71 . After the threaded member 568 is connected to the base member 570 , the pin 600 is inserted into the hole 598 . Aperture 598 is configured to allow an inserted pin 600 to be disposed within channel 580 on threaded member 568 . Pin 600 retains base member 570 on threaded member 568 while allowing threaded member 568 to rotate relative to base member 570 .

In use, the base member 570 is disposed over the groove member 568 as shown in FIG. 68 . A catheter (shown in FIG. 67 and described above) having a twisting tool 540 at its distal end is used to rotate the threaded member 568 either clockwise or counterclockwise when bridge 12 is adjusted. The helical groove 586 of the threaded member 568 engages the teeth 566 of the toothed belt 562, causing the toothed belt to helically pass through the bridge stop 560, which in turn lengthens or shortens the toothed belt 562 (the bridge). When the desired bridge tension is achieved, the twisting tool 540 is removed. It should be understood that embodiments of the bridge stop may be configured with a bridge-fixed configuration when static to require the positive actuation force necessary to allow free movement of the bridge within or around the bridge stop. When the desired tension is achieved in the bridge, the actuation force can be removed, thereby returning the bridge stop to its static state and securing the bridge stop to the bridge. Optionally, the bridge stop is also configured to allow free movement of the bridge 12 in a static state, thereby requiring a positive securing force on the bridge stop required to secure the bridge within the bridge stop.

Preferably, the bridge fixation properties are evident via tactile or fluorescent feedback. The fastening function can preferably be locked and unlocked several times, thus allowing readjustment of the bridge. The material of the bridge stop is still desirably radiopaque or combines radiopaque properties to enable the provision of the bridge stop with fluorescence.

As noted above, bridge 12 may comprise a single element, or may comprise multiple elements. In various of the above-described embodiments, the bridge comprises a plurality of elements. FIG. 72 shows an example where the toothed belt 502 of the bridge stop 500 comprises part of the bridge 12 . As shown, toothed strap 502 , for example, extends through bridge stop 500 and through diaphragm member 30 , and then connects to a segment of bridge 12 . Toothed strap 502 may be attached to bridge 12 by tying, gluing, crimping, welding, or machining a single piece of material, as shown by non-limiting example.

In an alternative embodiment, the toothed belt 502, for example, may include integral bridges, as shown in FIG. 73 . As shown, the toothed strap 502 extends through the bridge stop 500 and through the diaphragm member 30, and continues through the left atrium to the rear axle stop region 14, where the toothed strap 502 is connected to the rear axle stop. Device 18.

Segments of bridge 12 may extend into the right atrium to allow retrieval of the implant or adjustment of the bridge, as shown in FIG. 72 . As shown, a segment of the bridge including the exposed loop 156 extends from the toothed belt 502 . A radiopaque marker 160 is used to facilitate grasping or hooking the exposed loop 156 .

In an alternative embodiment, the toothed strap 502 includes integral hooks or loops 303 to allow retrieval of the implant or adjustment of the bridge, as shown in FIG. 72 . A radiopaque marker 160 may be used to facilitate grasping or hooking the exposed loop 303 .

VI Optional T-bridge stopper implementation

Alternative embodiments of T-bridge stops may be used and are described herein. T-shaped axle stops may be used to secure the bridge 12 (or alternative bridge embodiments) at the front axle stop area 16 or the rear axle stop area 14 or both. It should be understood that alternative embodiments of the T-bridge stop may include a single element, or may also include multiple elements, as shown and described in FIGS. 43A and 43B . It should also be understood that alternative embodiments of the T-bridge stop may be symmetrical, or may also be asymmetrical in shape. Also, alternative embodiments of the T-bridge stop have the ability to adjust the bridge to only tighten, or to loosen and tighten.

Figure 74 is a perspective view of an alternative embodiment of a T-bridge stop 680 in accordance with the present invention. The optional T-bridge stop 680 preferably includes an outer threaded male member 682 partially nested within an inner threaded female member 684 . The male member 682 includes a tubular portion 686 that extends from an end 688 disposed within the female member to approximately the middle of the male member 682, although the tubular portion 686 extends through the middle of the male member, including extending the entirety of the male member 682. length, or may not extend to the middle of the male member. An aperture 690 is provided in the male member 682 and extends from the outer surface 692 of the male member to the tubular portion 686 .

In use, the T-bridge stop 680 allows the length of the bridge 12 to be adjusted by rotating the female member either clockwise or counterclockwise. As shown in FIG. 74, a conduit 694 is adapted to connect to an end 696 of the female member 684 to provide for rotation of the female member. The bridge 12 is secured at 698 within the female member 684 such that rotation of the female member 684 causes the entire length of the T-bridge stop 680 to extend or contract, thereby adjusting the length of the bridge 12 . T-bridge stop 680 is shown disposed within the lumen of blood vessel 700 . From the fixation point 698 the bridge 12 extends through the tubular portion 686 of the male member, then through the aperture 690 , and through the vessel wall at 702 . Penetration of bridge 12 through the vessel wall at 702 and through aperture 690 stops male member 682 from rotating, thereby allowing female member 684 to rotate to adjust the length of bridge 12 . T-bridge stop 680 is shown disposed within the lumen of vessel 700 . The bridge 12 extends from the fixed point 698 through the tubular portion 686 of the male member, then through the aperture 690 , and through the catheter wall at 702 . Passage of bridge 12 through the conduit wall at pair 702 and aperture 690 stops male member 682 from rotating, thereby allowing female member 684 to rotate to adjust the length of bridge 12 . Figure 75 is a perspective view of an alternative embodiment of a T-bridge stop 710 in accordance with the present invention. The optional T-bridge stop 710 preferably includes: a ratchet mechanism 712 having a first member 720 and a second member 722 (e.g., a ballpoint pen type mechanism); and a compression spring 714 that operates with the ratchet mechanism 712; Both the ratchet mechanism 712 and the compression spring 714 are disposed within the tubular member 716 . Provided generally in the middle of the tubular member 716 (although other locations along the length of the bridge stop are possible) is an aperture 718 that allows the bridge 12 to pass through the wall of the tubular member 716 and connect to the ratchet mechanism 712 .

In use, the T-bridge stop 710 allows the length of the bridge 12 to be adjusted by operation of the ratchet mechanism 712 . As shown in FIG. 75 , the conduit 694 is adapted to connect to the first member 720 of the ratchet mechanism 712 to provide an axial force to the ratchet mechanism and thereby rotate the second member 722 of the ratchet mechanism. When the first end 720 is pushed through the conduit 694 , discrete segments of the bridge 12 are allowed to be presented or retracted through the aperture 718 . The catheter 694 can also release and reset any tension on the bridge 12 by rotating the ratchet mechanism 712 . Rotation of the second member 722 causes the bridge 12 to wrap around the second member 722 , thereby adjusting the length of the bridge 12 . As shown in Figure 74, a T-bridge stopper 710 is positioned within a blood vessel or against an organ wall. Penetration of the bridge 12 through the vessel wall and penetration of the aperture 718 stops the tubular member 716 from rotating, thereby allowing the second member 722 to rotate to adjust the length of the bridge 12 .

Figure 76 is a perspective view of an alternative embodiment of a T-bridge stop 730 in accordance with the present invention. Optional T-bridge stop 730 preferably includes: a tubular member 732 having an aperture 734 ; and a clamp 736 disposed within tubular member 732 . The aperture 734 is disposed generally in the middle of the tubular member 732 (although other locations along the length of the bridge stop are possible), and the clamp 736 is disposed generally near the first end 738 of the tubular member. Within the tubular member 732 , generally near the second end 740 , the bridge is connected to the tubular member at a fixed point 742 .

In use, the T-bridge stop 730 allows the length of the bridge 12 to be shortened (increased tension) by pulling on the exposed loop 744 of the bridge 12 by a catheter having an adjustment device such as a hooked tip 746 . It should be understood that another means of attachment to the exposed ends of the bridge 12, such as clips, rings, or magnetic elements, is also contemplated. As shown in FIG. 76 , a catheter 746 is used to hook and then pull the exposed loop 744 . One leg of bridge 12 is pulled through clamp 736 by pulling on the exposed loop. The pulling force must be greater than the clamping force of the clamp 736 to maintain the position of the bridge within the clamp when the exposed loop 744 is released. Clamp 736 includes serrated jaws 748, thereby improving the performance of clamp 736 to allow pulling bridge 12 through serrated jaws 748 to increase tension, but not to allow tension on bridge 12 to pull bridge 12 back through the clamp 736 (this will cause a reduction in tension).

Figure 77 is a perspective view of an alternative embodiment of a T-bridge stop 750 in accordance with the present invention. Optional T-bridge stop 750 preferably includes a tubular member 752 that includes a slit 754 . The slot 754 is disposed generally in the middle of the tubular member 752, although other locations along the length of the bridge stop are possible.

In use, the T-bridge stop 750 allows the length of the bridge 12 to be shortened (increased tension) by pulling on the exposed loop 756 of the bridge 12 by an adjustment guide having such a hooked tip 146 . As shown in FIG. 77 , in the described embodiment, the bridge member 12 includes a discontinuous bead or stop 158 . Conduit 146 is used to hook and then pull exposed loop 156 . By pulling the exposed loop, the bridge 12 including the discontinuous stop 158 is pulled through the slit 754 . The slit 754 allows the bead to be pulled into the tubular member 752 but not pulled out of the tubular member 752 . The slit 754 includes a flap 760 (as in a duckbill valve) to help maintain the tension on the bridge 12 and prevent the discontinuous stop 158 from dislodging from the tubular member through the tension on the bridge 12. 752 pulled out. The discrete stops 158 are positioned spaced apart from each other by a predetermined length (eg, about 2 mm to about 5 mm) to allow shortening of the bridge by the predetermined length.

VII. Alternative Bridge Implementations

Alternative bridge implementations may be used and described herein. Bridges are used to secure the front axle stop area 16 to the rear axle stop area 14 . It should be understood that alternative embodiments of the bridge may comprise a single element, or may also comprise a plurality of elements.

Figure 78 is a perspective view of an alternative embodiment of an implant system 10 having a bridge 770 in accordance with the present invention. A bridge 770 having a first end 772 and a second end 774 is shown extending through the diaphragm member 30 and connected to the rear axle stop 18 . The bridge is also connected to the diaphragm member 30 . Bridge 770 desirably comprises a strip of malleable (ie, capable of being shaped, bent, or pulled) material, such as stainless steel. By twisting the bridge 770, which can be done in the rear axle stop area 14 and/or the front axle stop area 16, the bridge shortens or lengthens, and because of the bending of the bridge, the bridge remains at the desired length. The torsional force required to adjust bridge 770 is greater than the tension applied to the bridge. Twisting can be accomplished by adjusting the catheter (not shown).

Figure 79 is a perspective view of another alternative embodiment of an implant system 10 having a bridge 780 in accordance with the present invention. Bridge 780 is shown extending through diaphragm member 30 and connecting to rear axle stop 18 . The bridge may also be connected to the diaphragm member 30 . Bridge 780 desirably includes at least one ring of bridges. A first end 782 of bridge 780 may be connected to diaphragm member 30 , or alternatively to front axle stop 20 , or alternatively to grommet 32 . From the first end 782 , the bridge wraps around a hook or retainer 784 that connects to the rear axle stop 18 and then extends back through the diaphragm member 30 . The annular bridge 780 doubles the length of the bridge, which allows finer adjustment of the implant system 10 due to the increased 1/2 unit to 1 unit pull ratio.

80A is a perspective view of another alternative embodiment of an implant system 10 having a bridge 790 in accordance with the present invention. A bridge 790 having a first end 792 and a second end 794 is shown with integral front axle stop 26 and connected to rear axle stop 18 . It should be understood that bridge 790 may have an integral rear axle stop, or may have front and rear axle stops. The bridge 790 desirably includes a braided nitinol wire having a predetermined length. The braided Nitinol wire desirably remains straight for a predetermined extent (eg, about 8 cm to about 10 cm). A predetermined portion (eg, about 1 cm to about 3 cm) of the braided Nitinol wire is pre-shaped to crimp into the anterior bridge stop 796 when released from the delivery catheter in the right atrium. 80B and 80C illustrate the changing configuration of first end 792 (ie, front axle stop 796 ) as tension on bridge 790 increases (see FIG. 80B ) or decreases (see FIG. 80C ).

The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, the invention is not necessarily limited to the exact construction and operation shown and described. While preferred embodiments have been described, changes may be made in detail without departing from the invention as defined in the claims.

Claims (42)

1. An implant system comprising: a bridging member sized and configured to span the left atrium between the great cardiac vein and the atrial septum, a rear axle stop connected to said bridge and abutting venous tissue within said great cardiac vein, an anterior bridge stop that connects to the bridge and abuts the interatrial septal tissue in the right atrium, and A bridge adjustment mechanism that shortens and/or lengthens the bridges. 2. The implant system according to claim 1, Wherein, the bridging element is twisted in a first direction to shorten the bridging element, and/or the bridging element is twisted in a second direction to lengthen the bridging element. 3. The implant system according to claim 2, Wherein, the bridging member comprises ductile material. 4. The implant system of claim 1, Wherein, the bridging piece further includes a ring of the bridging piece, the loop of the bridging piece doubles the length of the connecting piece and provides an adjustment ratio of 1/2 unit to 1 unit. 5. The implant system of claim 1, Wherein, the bridging member comprises a braided nitinol wire having a first end and a second end, the first end including a preformed portion, and including an integral bridge stop, wherein when The bridge, when implanted, forms the integral bridge stop. 6. The implant system according to claim 5, Wherein, the preformed portion comprises a range of about one centimeter to about three centimeters. 7. The implant system of claim 1, Wherein, at least one of the rear axle stopper and the front axle stopper includes the bridge adjusting mechanism. 8. The implant system of claim 1, Wherein the bridge includes discrete stop beads to allow the bridge to be adjusted in discrete lengths. 9. The bridge stop of claim 1, Wherein the bridge comprises a toothed strip portion or a perforated strip portion or a threaded shaft portion extending through at least part of one of the front and rear axle stops. 10. The bridge stop of claim 1, Wherein, the bridge comprises a toothed strip portion or a perforated strip portion or a threaded shaft portion connected to the bridge, the toothed strip portion or the perforated strip portion or the threaded shaft portion extending passing through at least part of one of the front axle stop and the rear axle stop. 11. The bridge stop of claim 1, Wherein, the bridging member further includes a first edge and a second edge. 12. The bridge stop of claim 11, Wherein, at least one of the first edge and the second edge includes a toothed pattern. 13. The bridge stop of claim 11, Wherein the first edge includes a toothed pattern and the second edge includes a toothed pattern that deviates from the toothed pattern on the first edge. 14. The bridge stop of claim 1, Wherein, the bridge comprises at least one radiopaque marker. 15. The bridge stop of claim 1, Wherein, the bridging member includes a repositioning ring. 16. The bridge stop of claim 15, Wherein, the repositioning ring includes at least one radiopaque marker. 17. The bridge stop of claim 1, Wherein, the bridging member comprises a metal material or a polymer material, or a structure in the form of a metal wire or a polymer wire, or a suture material, or horse pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue. 18. A system for adjusting the tension of an implant comprising: an implant system, as defined in claim 1, and A catheter having a proximal end and a distal end, the catheter having an adjustment mechanism at its proximal end. 19. The system of claim 18, A repositioning ring is further included, the repositioning ring coupled to the implant system. 20. The system of claim 18, Wherein, the catheter adjustment mechanism includes a hooked tip. 21. The system of claim 19, Wherein, the repositioning ring includes at least one radiopaque marker. 22. A bridge stop device comprising: an axle stop housing having a length and a width; an aperture extending through the length of the axle stop housing, the aperture being sized and configured to allow a bridge to extend through at least part of the length of the aperture, and an adjustment mechanism connected to the bridge stop housing to allow adjustment of the length of the bridge. 23. The bridge stop of claim 22, Wherein the adjustment mechanism includes a conduit releasably connected to the bridge stop for actuating the adjustment mechanism. 24. The bridge stop of claim 22, Wherein, the adjusting mechanism is arranged in the small hole in the housing of the axle stopper. 25. The bridge stop of claim 22, Wherein, the adjustment mechanism includes a locking ring. 26. The bridge stop of claim 22, Therein, the adjustment mechanism allows only lengthening of the bridges or shortening of the bridges only. 27. The bridge stop of claim 22, Wherein, the adjustment mechanism allows lengthening and shortening of the bridge. 28. The bridge stop of claim 22, Therein, the adjustment mechanism is sized and configured to allow repeatable adjustment. 29. The bridge stop of claim 22, wherein the bridge stop adjustment mechanism comprises a static, and The bridge stop adjustment mechanism constrains the bridge at the static of the adjustment mechanism, thereby requiring the positive actuation force necessary to allow adjustment of the bridge. 30. The bridge stop of claim 22, Wherein the bridge includes discrete stop beads to allow the bridge to be adjusted in discrete lengths. 31. The bridge stop of claim 22, Wherein the bridge comprises a toothed strip portion or a perforated strip portion or a threaded shaft portion extending through at least part of the aperture in the axle stop housing. 32. The bridge stop of claim 22, Wherein, the length of the axle stop housing is greater than the width of the axle stop housing. 33. The bridge stop of claim 22, Wherein, the axle stop housing further comprises at least one radiopaque marker. 34. The bridge stop of claim 22, Wherein the bridge stop comprises a repositioning element. 35. The bridge stop of claim 33, Wherein, the repositioning element further comprises at least one radiopaque marker. 36. A bridge stop device comprising: an axle stop housing comprising an interior and an exterior, the housing having a length and a width; an aperture extending through the length of the axle stop housing, the aperture being sized and configured to allow a bridge to extend through at least part of the length of the aperture, and an adjustment mechanism connected to the bridge stop housing to allow adjustment of the bridge. 37. The bridge stop of claim 36, Wherein said adjustment mechanism comprises rotation of said inner or said outer. 38. The bridge stop of claim 36, Wherein the interior is completely disposed within the exterior. 39. The bridge stop of claim 36, Wherein the inner part extends outside the outer part. 40. An implant system comprising: a bridge sized and configured to span the left atrium between the great cardiac vein and the atrial septum; a first bridge stop connected to the bridge; a second axle stop connected to the bridge, the second axle stop comprising: an axle stop housing having a length and a width, an aperture extending through the length of the axle stop housing, the aperture being sized and configured to allow a bridge to extend through at least part of the length of the aperture, and an adjustment mechanism connected to the bridge stop housing to allow adjustment of the bridge. 41. The implant system of claim 40, Wherein, the axle stop housing further includes an interior and an exterior. 42. The implant system of claim 40, Wherein said adjustment mechanism comprises a rotation of said inner or said outer, thereby enabling lengthening or shortening of said bridge.

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