Transcatheter system and method for reducing tricuspid regurgitation

Abstract

To provide a system and method for transcatheter treatment for tricuspid regurgitation.SOLUTION: A system 10 for transcatheter treatment for tricuspid regurgitation according to one preferred embodiment of the present invention includes: a coronary sinus tube 11 inserted into a coronary sinus; and a tricuspid valve tube 12 traversing a tricuspid valve, wherein the coronary sinus tube 11 and the tricuspid valve tube 12 communicate with each other or are adjacent to each other within a range of predetermined length at an upper side and are separate from each other at a lower side, and a blocking member 16 for blocking a space generated by incomplete closing of the tricuspid valve is provided at a lower part of the tricuspid valve tube or between the coronary sinus tube and the tricuspid valve tube.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present invention relates to systems and methods for transcatheter therapy to reduce tricuspid regurgitation, and more particularly to systems and methods for transcatheter therapy to reduce tricuspid regurgitation, which can perform catheter therapy to reduce tricuspid regurgitation, a heart condition in which the tricuspid valve does not close completely, causing blood to flow backward within the heart. [Background technology]

[0002] The human heart is divided into four chambers, two atria and two ventricles, which function as blood passageways by connecting to four blood vessels: the aorta, vena cava, pulmonary artery, and pulmonary vein. The interventricular septum in the center of the heart divides the heart into two sides: the right atrium and right ventricle on one side, and the left atrium and left ventricle on the other. The tricuspid valve is located between the right atrium and right ventricle, and the mitral valve is located between the left atrium and left ventricle.

[0003] The heart acts as a pump by repeatedly contracting and relaxing, allowing blood to flow along the blood vessels. During systole, as the blood from the heart flows forward into the blood vessels, blood from the right heart is pumped from the right ventricle into the pulmonary artery, and blood from the left heart is pumped from the left ventricle into the aorta.

[0004] However, if the valves between the atria and ventricles do not function properly, blood from the ventricles will flow backward, i.e., move toward the atria, during systole. If the tricuspid valve between the right atrium and right ventricle does not function properly, blood from the right ventricle will flow backward into the right atrium, a condition known as "tricuspid regurgitation." If the mitral valve between the left atrium and left ventricle does not function properly, blood from the left ventricle will flow backward into the left atrium, a condition known as "mitral regurgitation."

[0005] In tricuspid regurgitation, the tricuspid valve does not function properly, so blood is not pumped into the pulmonary artery when the heart contracts, causing blood to flow back into the right ventricle. This condition is called "tricuspid regurgitation." Tricuspid regurgitation occurs when the tricuspid valve, located between the right atrium and right ventricle of the heart, is stretched or torn, or when the chordae tendineae that secure the tricuspid valve between the right atrium and right ventricle break, causing the tricuspid valve to not close completely as it should.

[0006] In the prior art, typical treatments for tricuspid regurgitation have been widely used, including surgical repair of the disease by opening the patient's chest and heart, i.e., annuloplasty and Devega procedures. However, because these surgical procedures require highly invasive procedures, surgical approaches for the tricuspid valve alone have not become widespread due to the relatively minor importance of the tricuspid valve. In other words, when patients with tricuspid regurgitation undergo major cardiac surgery, such as mitral valve surgery or coronary artery surgery, the above-mentioned surgical treatment for tricuspid regurgitation is performed at the same time.

[0007] In this regard, there has been a gradual increase in worldwide interest in research into treatments for tricuspid regurgitation that can be performed using catheters or simple devices rather than surgical procedures that involve opening the chest and cutting open the heart. Summary of the Invention

[0008] Cerclage Method: In one aspect, the present invention is a method of treating tricuspid regurgitation in a patient. The method includes (i) using a cerclage filament and (ii) having a sleeve tube. The sleeve tube includes a main segment, a coronary sinus crus, a tricuspid valve crus, and a spacer body attached to the tricuspid valve crus. The method includes creating a vascular entry site to an entry vein. The entry vein can be any suitable vein in the patient's body, such as the subclavian vein or femoral vein. The method further includes inserting a cerclage filament through the vascular entry site and entry vein and into the patient's heart.

[0009] Once fully inserted, the path taken by the cerclage filament is through the right atrium, via the coronary sinus, out the great cardiac vein into the right ventricle (as used herein, "right ventricle" includes the right ventricular outflow tract), back into the right atrium through the tricuspid valve, and back to the original entry vein and exit from there. Entry into the right ventricle can occur by perforating the interventricular septum, particularly the membranous septum located in the right ventricular outflow tract. This path taken by the cerclage filament forms a cerclage loop. The path of the cerclage filament may also include entering a septal perforator vein before exiting the septum and entering the right ventricle.

[0010] The method further includes sliding the sleeve tube toward the cerclage filament. Because the cerclage filament forms a loop, the cerclage filament can be considered to have an inlet segment (directed toward the heart) and a return segment (directed away from the heart). In some embodiments, sliding the sleeve tube toward the cerclage filament includes (i) sliding the coronary sinus crus over one of the inlet or return segments of the cerclage filament, and (ii) sliding the tricuspid valve crus over the other of the inlet or return segments of the cerclage filament. For example, the inlet segment of the cerclage filament can be slid onto the coronary sinus crus, and the return segment of the cerclage filament can be slid onto the tricuspid valve crus. This is consistent with the path and direction taken by the cerclage filament through the heart. However, the reverse configuration is also possible.

[0011] The method further includes advancing the sleeve tube toward the patient's right atrium. The sleeve tube may pass through the superior vena cava or the inferior vena cava on its way into the right atrium. The sleeve tube is advanced so that the coronary sinus crura enters the coronary sinus of the patient's right atrium and the tricuspid valve crura passes through the patient's tricuspid valve. The sleeve tube or the cerclage filament is manipulated to position the spacer body between the leaflets of the patient's tricuspid valve. This step of positioning the spacer body may be performed under echocardiographic monitoring. The purpose of the spacer body is to provide a good surface for improving leaflet coaptation.

[0012] Once the cerclage loop has been created, the method may further include locking the cerclage loop by fastening a portion of the entry segment of the cerclage filament to the opposite return segment of the cerclage filament. This fastening may be performed at any suitable location within the patient's body at a location outside the right atrium. For example, in situations where the entry vein is a femoral vein, this fastening may be performed at a location within the patient's inferior vena cava above one or both of the renal veins. Similarly, in this situation, the proximal end of the sleeve tube may terminate at a location within the inferior vena cava above one or both of the renal veins. The method may further include securing the cerclage loop to an anchoring site within the patient's body. For example, in situations where the entry vein is a subclavian vein, this fastening may be performed in a subcutaneous pocket near (within 10 cm of) the subclavian vein entry site.

[0013] In some embodiments, the sleeve tube further includes a stopper located at the distal end of the tricuspid valve crust. In this situation, the method further includes positioning the stopper against the wall of the patient's right ventricle. The purpose of the stopper is to abut the right ventricular wall through which the cerclage filament penetrates. Thus, the stopper prevents the tricuspid valve crust of the sleeve tube from becoming embedded in the ventricular wall.

[0014] The path of the cerclage filament may be formed using a guidewire. In this embodiment, the method includes inserting the guidewire through a vascular entry site and advancing the guidewire into the patient's right atrium. The guidewire may travel through the superior vena cava or inferior vena cava on its way into the right atrium. The distal end of the guidewire is inserted into the coronary sinus. The guidewire is advanced through the heart, and its distal end is formed to enter the patient's right ventricle.

[0015] In some embodiments, an introducer sheath is slid over the guidewire, and contrast is injected through the sheath to perform a coronary venogram. This allows the septal perforator veins to be identified and the guidewire advanced into them. The guidewire follows a path into the right ventricle. This can be done by advancing the guidewire to penetrate the interventricular septum, particularly the membranous septum located in the right ventricular outflow tract. The guidewire is grasped (e.g., with a snare catheter in the right ventricle) and its distal end is withdrawn from the entry vein.

[0016] A guidewire is exchanged for the cerclage filament so that the cerclage filament follows a path through the patient's heart. In some embodiments, this guidewire exchange involves inserting an introducer sheath over the guidewire and then withdrawing the guidewire to advance the cerclage filament through the introducer sheath. In some embodiments, this guidewire exchange involves attaching the distal end of the cerclage filament to the proximal end of the guidewire and withdrawing the guidewire so that the cerclage filament follows the path created by the guidewire.

[0017] In some embodiments, there may be an overpass arch on the cerclage filament, and the method further includes positioning the overpass arch inside the great cardiac vein at a location above the coronary arteries. The purpose of the overpass arch is to avoid compressing the coronary arteries passing underneath. Thus, the path taken by the cerclage filament may arch over the coronary arteries as it passes through the great cardiac vein. The foregoing methods of this aspect of the invention may be performed using a cardiac cerclage assembly or a cardiac cerclage kit as described below.

[0018] Cardiac Cerclage Assembly: In another aspect, the present invention is a cardiac cerclage assembly comprising (i) a cerclage filament and (ii) a sleeve tube through which the cerclage filament passes. The cerclage filament may be defined as a wire, rope, cord, string, or any other type of highly flexible, thin, thread-like line. The cerclage filament may be of any suitable thickness. In some embodiments, the cerclage filament has a thickness ranging from 0.3 to 1.0 mm. An example of a cerclage filament is a nylon-coated braided stainless steel wire. The cerclage filament has a variety of different segments. Among them, the cerclage filament has an entrance segment and a return segment.

[0019] The sleeve tube includes (a) a main segment, (b) a coronary sinus crus, (c) a tricuspid valve crus, and (d) a spacer body that attaches to the tricuspid valve crus. The sleeve tube may be formed from any suitable material or combination of materials, such as a metal or plastic material. The various components of the sleeve tube may be formed from the same material or different materials. The sleeve tube segments have different lengths. The tricuspid valve crus is longer than the coronary sinus crus. The main segment is longer than both the tricuspid valve crus and the coronary sinus crus. A junction is formed on the sleeve tube at a point where the two crus separate from the main segment.

[0020] In some embodiments, the main segment of the sleeve tube has a length ranging from 25 to 65 cm, optionally ranging from 30 to 55 cm, and optionally approximately 45 cm. This may be useful in positioning the cerclage assembly as described above in situations where the entry vein is the subclavian vein. In some embodiments, the main segment of the sleeve tube has a length ranging from 6 to 20 cm, optionally ranging from 8 to 18 cm. This may be useful in positioning the cerclage assembly as described above in situations where the entry vein is the femoral vein. In some embodiments, the tricuspid valve crus has a length ranging from 4.0 to 11 cm, optionally ranging from 5.5 to 9.0 cm. In some embodiments, the coronary sinus crus has a length ranging from 2.2 to 5.0 cm, and optionally approximately 3.0 cm.

[0021] The cardiac cerclage assembly is assembled so that both the inlet and return segments of the cerclage filament travel through the main segment of the sleeve tube. Furthermore, one of the inlet or return segments travels through the coronary sinus crus of the sleeve tube. The other of the inlet or return segment travels through the tricuspid valve crus of the sleeve tube. For example, the inlet segment can travel through the coronary sinus crus and the return segment can travel through the tricuspid valve crus, or vice versa.

[0022] The main segment of the sleeve tube may be a single-barrel or a double-barrel configuration. In the single-barrel configuration, both the inlet and return segments travel through the single barrel of the main segment before separating into two legs. In the double-barrel configuration, the inlet segment travels through one of the two barrels, and the return segment travels through the other of the two barrels. The two barrels are adjacent to the tricuspid valve leg and the coronary sinus leg, respectively.

[0023] The tricuspid valve legs may have telescoping functionality. In such embodiments, the tricuspid valve legs can be extended and retracted. Thus, the tricuspid valve legs can have a retracted length and an extended length. Any suitable mechanism can be implemented to provide this telescoping functionality. For example, the tricuspid valve legs can include inner and outer tubes that slide relative to each other.

[0024] The sleeve tube further comprises a spacer body that is attached to the tricuspid valve crust. The spacer body can have any suitable shape, such as a cylindrical, crescent, spherical, elliptical, oval, wing, etc. In some embodiments, the spacer body has a curved croissant shape. The spacer body can have any suitable structure, such as a balloon (e.g., foam or air-filled), basket, mesh, strut (e.g., stent-like), framework, skeleton, scaffold, occlusion device, etc. If desired, the surface of the spacer body may be provided in any suitable manner, such as a skin, shell, casing, or membrane. The spacer body may be formed from any suitable material, such as plastic, metal, or a combination thereof.

[0025] The spacer body is formed with dimensions suitable for providing a coaptation surface for the leaflets of the tricuspid valve. In some embodiments, the spacer body has a length ranging from 20 to 60 mm, and in some cases, a length ranging from 30 to 50 mm. As used herein, "length" of a spacer body refers to its length measured along the tricuspid valve limb of the tube. The spacer body can have a relaxed, elongated configuration. In this context, the above measurements of the spacer body are taken in the relaxed configuration.

[0026] The width of the spacer body can be measured in a cross section perpendicular to the longitudinal axis. On this cross section, there is a width axis along which the spacer body has its widest width and a cross axis perpendicular to the width axis. In some embodiments, the width of the spacer body on the width axis is in the range of 7 to 30 mm, and in some cases, in the range of 10 to 25 mm. In some embodiments, the width of the spacer body on the cross axis is in the range of 7 to 30 mm, and in some cases, in the range of 10 to 25 mm. In some embodiments, the width of the spacer body on the width axis is greater than the width of the spacer body on the cross axis (i.e., a non-circular cross section). The spacer body can have a relaxed elongated configuration. In this situation, the above measurements of the spacer body are taken in the relaxed configuration.

[0027] In some embodiments, the cerclage assembly further comprises an overpass arch attached to the cerclage filament. The overpass arch is a curved, thin tube through which the cerclage filament passes. The overpass arch can be formed from any suitable rigid material, such as stainless steel or a nitinol alloy. The overpass arch can have any dimensions suitable for retaining the cerclage filament and providing passage through the coronary artery. For example, the overpass arch can have a height from arch to base of 2 to 6 mm and a length of 6 to 17 mm. In some embodiments, the sleeve tube further comprises a stopper located at the distal end of the tricuspid valve crust. The stopper is wider or has a larger diameter than the distal end of the tricuspid valve crust. Furthermore, the stopper has a width or diameter in the range of 2 to 6 mm.

[0028] In some embodiments, the cerclage assembly further comprises a lock that fastens the entrance segment of the cerclage filament to the opposing return segment. This lock may be located at the proximal end of the main segment of the sleeve tube. The cardiac cerclage assembly of this aspect of the invention may be assembled from a cardiac cerclage kit as described below.

[0029] Cardiac Cerclage Kit: In another aspect, the present invention is a cardiac cerclage kit for treating tricuspid regurgitation in a patient. This cardiac cerclage kit can be used to form the cardiac cerclage assembly described above. The cardiac cerclage kit includes (i) a cerclage filament and (ii) a sleeve tube. The sleeve tube includes (a) a main segment, (b) a coronary sinus crunch, (c) a tricuspid valve crunch, and (d) a spacer body positioned over the tricuspid valve crunch.

[0030] The kit may further include a guidewire used to provide a path for the cerclage filament. The kit may further include an introducer sheath that slides over the guidewire, or exchanges the guidewire for the cerclage filament, or provides a channel path for introducing a sleeve tube. The kit may further include a torque application tool for applying a rotational torque to the guidewire, which may be particularly useful for twisting the guidewire to puncture the septal wall. The kit may further include a lock for fastening opposite segments of the cerclage filament to form a cerclage loop.

[0031] Further Embodiments: The descriptions and examples provided herein are intended to merely illustrate the invention and are not intended to be limiting. Each of the disclosed aspects and embodiments of the invention may be considered individually or in combination with other aspects, embodiments, and variations of the invention. Furthermore, unless otherwise specified, the steps of the methods of the invention are not limited to any particular order of performance. Modifications of the disclosed embodiments that incorporate the spirit and essence of the invention may occur to those skilled in the art, and such modifications are within the scope of the invention.

[0032] The use of the word "or" herein is intended to be inclusive and is equivalent to the term "and / or," unless the context clearly dictates otherwise. Thus, for example, the term "A or B" means A, or B, or both A and B. Similarly, for example, the term "A, B, or C" means A, or B, or C, or any combination thereof.

[0033] Features and advantages of the claimed subject matter will become apparent from the following description of the corresponding embodiments, which description should be considered in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0034] [Figure 1A] FIG. 1 illustrates one embodiment of a transcatheter system including a longitudinal stem consistent with the present disclosure. [Figure 1B] FIG. 10 illustrates a transcatheter system inserted over a cerclage filament consistent with the present disclosure. [Figure 1C] 1A-1C illustrate a transcatheter system when the tricuspid valve crura and coronary sinus crura are dilated, consistent with the present disclosure. [Figure 2] FIG. 1 illustrates a transcatheter system including a hinge ring consistent with the present disclosure. [Figure 3] FIG. 1 illustrates a stemless transcatheter system consistent with the present disclosure. [Figure 4] FIG. 1 illustrates a stemless transcatheter system including a hinge ring consistent with the present disclosure. [Figure 5] FIG. 1 illustrates a one-tube stem transcatheter system consistent with the present disclosure. [Figure 6] FIG. 1 illustrates a one-tube stem transcatheter system with a hinge ring consistent with the present disclosure. [Figure 7] FIG. 1 illustrates a one-tube stemless transcatheter system consistent with the present disclosure. [Figure 8A]FIG. 1 illustrates a transcatheter system including an anchoring ring consistent with the present disclosure. [Figure 8B] FIG. 1 illustrates an anchor ring including a ring body and an anchor, consistent with the present disclosure. [Figure 9A] FIG. 1 illustrates a diseased tricuspid valve consistent with the present disclosure. [Figure 9B] 10A-10C illustrate a spacer body positioned through a diseased tricuspid valve consistent with the present disclosure. [Figure 10A] FIG. 10 is a side view of a spacer body during expansion, consistent with the present disclosure. [Figure 10B] FIG. 10 is a cross-sectional view of a spacer body consistent with the present disclosure. [Figure 10C] FIG. 10 is a side view of a spacer body during deflation, consistent with the present disclosure. [Figure 11A] FIG. 10 is a side view of a spacer body during expansion, consistent with the present disclosure. [Figure 11B] FIG. 10 is a cross-sectional view of a spacer body consistent with the present disclosure. [Figure 11C] FIG. 10 is a side view of a spacer body during deflation, consistent with the present disclosure. [Figure 12A] FIG. 10 is a perspective view of a spacer body during expansion consistent with the present disclosure. [Figure 12B] FIG. 10 is a perspective view of a spacer body during deflation consistent with the present disclosure. [Figure 13A] FIG. 10 is a side view of a spacer body during expansion, consistent with the present disclosure. [Figure 13B] FIG. 10 is a cross-sectional view of a spacer body consistent with the present disclosure. [Figure 13C] FIG. 10 is a side view of a spacer body during deflation, consistent with the present disclosure. [Figure 13D] FIG. 1 is a perspective view of one embodiment of a spacer body consistent with the present disclosure. [Figure 14A] FIG. 1 is a perspective view of one embodiment of a spacer body consistent with the present disclosure. [Figure 14B] FIG. 10 is a side view of an embodiment of a spacer body consistent with the present disclosure. [Figure 14C]1 is a cross-sectional view of an embodiment of a spacer body consistent with the present disclosure. [Figure 15A] 10A-10C illustrate an embodiment of a spacer body when the tricuspid valve legs are expanded, consistent with the present disclosure. [Figure 15B] 10A-10C illustrate an embodiment of a spacer body when the tricuspid valve legs are contracted, consistent with the present disclosure. [Figure 16A] FIG. 1 illustrates an embodiment of a tricuspid valve leg including a balloon consistent with the present disclosure. [Figure 16B] 1A-1C illustrate embodiments of the tricuspid valve legs during balloon expansion consistent with the present disclosure. [Figure 17A] FIG. 1 is a perspective view of one embodiment of a balloon spacer body during deflation consistent with the present disclosure. [Figure 17B] FIG. 1 is a perspective view of one embodiment of a balloon spacer body during expansion consistent with the present disclosure. [Figure 18A] FIG. 1 is a perspective view of one embodiment of a balloon spacer body with a stent consistent with the present disclosure. [Figure 18B] FIG. 10 is a perspective view of one embodiment of a spacer body including a membrane partially covering a stent consistent with the present disclosure. [Figure 19A] FIG. 1 is a perspective view of an embodiment of a transcatheter system including only the tricuspid valve legs consistent with the present disclosure. [Figure 19B] FIG. 1 is a perspective view of one embodiment of a transcatheter system including a separate coronary sinus limb consistent with the present disclosure. [Figure 20] FIG. 1 illustrates a transcatheter system positioned within the heart consistent with the present disclosure. [Figure 21] 1A-1C are perspective views of a transcatheter system positioned within the heart, consistent with the present disclosure, from different angles. [Figure 22] 1A-1C are perspective views of a transcatheter system positioned within the heart, consistent with the present disclosure, from different angles. [Figure 23] 1A-1C are perspective views of a transcatheter system positioned within the heart, consistent with the present disclosure, from different angles. [Figure 24]1A-1C are perspective views of a transcatheter system positioned within the heart, consistent with the present disclosure, from different angles. [Figure 25A] FIG. 1 is a side view of a cerclage filament consistent with the present disclosure. [Figure 25B] FIG. 1 is a cross-sectional view of a cerclage filament consistent with the present disclosure. [Figure 26A] FIG. 1 shows an example of a cerclage assembly of the present invention. [Figure 26B] FIG. 1 shows an example of a cerclage assembly of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0035] To facilitate an understanding of the present invention, reference is made to the accompanying drawings, which show, by way of illustration, specific embodiments in which the invention may be practiced. The drawings herein are not necessarily drawn to scale or to actual proportions. For example, the length and width of components may be adjusted to fit the page size.

[0036] A transcatheter system 10 over a cerclage filament 18 for treating regurgitation in the tricuspid valve of a heart may include a first catheter tube 12 having an outer circumferential surface and a distal end defining an axis. The first catheter tube 12 may be sized to extend through the tricuspid valve. The transcatheter system 10 may further include a spacer body 16 disposed proximate the distal end of the first catheter tube 12 protruding from the outer circumferential surface. The spacer body 16 may be sized to intersect a space within the tricuspid valve created by incomplete closure of the tricuspid valve.

[0037] The spacer body 16 may be configured to intersect the space within the tricuspid valve created by incomplete closure of the tricuspid valve at an oblique angle relative to the axis. The spacer body 16 may include an expandable stent and a membrane portion defined between the outer periphery and the outer surface of the first catheter tube 12. At least one of the size or shape of the spacer body 16 may be adjustable in volume.

[0038] The transcatheter system 10 may further include a stopper 15 defined on the first catheter tube 12 configured to prevent the distal end from penetrating the interventricular septum of the heart.

[0039] One embodiment of a transcatheter system 10 over a cerclage filament 18 for treating regurgitation in a cardiac tricuspid valve within the heart may include a first catheter tube 12 having a first outer circumferential surface and a distal end defining an axis. The first catheter tube 12 may be sized to extend through the tricuspid valve. The transcatheter system 10 may further include a spacer body 16 disposed proximate the distal end of the first catheter tube 12 protruding from the outer circumferential surface, the spacer body 16 being sized to intersect a space within the tricuspid valve created by incomplete closure of the tricuspid valve.

[0040] The transcatheter system 10 may further include a second catheter tube 11 having a second outer circumferential surface that contacts the first outer circumferential surface over a selected distance and diverges from the first outer circumferential surface at a selected location spaced from the distal end of the first catheter tube 12.

[0041] The spacer body 16 may be configured to intersect the space within the tricuspid valve caused by incomplete closure of the tricuspid valve at an oblique angle relative to the axis. The second catheter tube 11 may be configured to enter the coronary sinus of the heart. At least one of the size, shape, or position of the spacer body 16 may be adjustable.

[0042] The transcatheter system 10 may further include a stopper 15 defined on the first catheter tube 12 configured to prevent the distal end from penetrating the interventricular septum of the heart. The transcatheter system 10 may further include an overpass arch 18a defined intermediate the distal end of the first catheter tube 12 and the distal end of the second catheter tube 11 configured to overcome a coronary artery of the heart.

[0043] 1A illustrates one embodiment of a transcatheter system 10. The transcatheter system 10 may include a main segment 13, a stopper 15, and a spacer body 16. The main segment 13 may separate into a coronary sinus crus 11 and a tricuspid valve crus 12. A junction 14 may be defined as where the main segment 13 separates into the coronary sinus crus 11 and the tricuspid valve crus 12.

[0044] As shown in FIGS. 1A and 20-24, the coronary sinus crus 11 may be configured to wrap or surround the mitral valve (MV) through the coronary sinus (CS), and the tricuspid valve crus 12 may be configured to extend across or through the orifice of the tricuspid valve leaflet. A stopper 15 may be positioned at the distal end of the tricuspid valve crus 11, thereby preventing the distal end from advancing further into the interventricular septum (IVS), as shown in FIGS. 20-24. The coaptation crus 14 may be positioned at or near the orifice of the coronary sinus. The tricuspid valve crus 11 may be configured to hang freely in an inverted "C" shape through the orifice of the tricuspid valve leaflet. The tricuspid valve crus 12 may be sufficiently rigid to resist bending when tension is applied to the cerclage filaments 18 or 19. A spacer body 16 may be attached to the tricuspid valve crus 12 between the commissure 14 and the stopper 15 .

[0045] 1B and 1C, once the cerclage filament 18 is in place, the transcatheter system 10 can be inserted over the cerclage filament 18 and positioned within the heart. The cerclage filament 18 may include an arched portion 18a. The arched portion 18a may be configured to overcome the coronary artery when tension is applied.

[0046] According to one embodiment shown in Figure 2, the transcatheter system 10 may also include a hinge ring 17 around the joint 14. The hinge ring 17 may be configured to reinforce the joint 14 from separating under tension.

[0047] Figure 3 shows an embodiment of a stemless transcatheter system 10 configured without a stem portion 13. Figure 4 shows a stemless transcatheter system 10 with the addition of a hinge ring 17 for reinforcement.

[0048] Figure 5 shows an embodiment of a one-tube stem transcatheter system 10 in which the stem portion 13 can be configured as one main tube. The transcatheter system 10 can then be separated into two tubes, the coronary sinus crus 11 and the tricuspid valve crus 12, at a hinge portion 14. Figure 6 shows an embodiment of a one-tube stem transcatheter system 10 with a hinge ring 17 at the hinge portion 14.

[0049] 7 illustrates one embodiment of a one-tube stemless transcatheter system 10 that may separate into a coronary sinus crus 11 and a tricuspid valve crus 12 at a junction 14. The one-tube stemless transcatheter system 10 may also include at least one fixation ring 20 disposed on the coronary sinus crus 11 and / or the tricuspid valve crus 12. Fixation ring(s) may be added to any embodiment of the transcatheter system 10.

[0050] 8A-8B show the transcatheter system 10 with at least one ring-shaped anchor 20 positioned on the coronary sinus crura 11. The ring-shaped anchor 20 may include a ring body 20a and at least one anchor 21b. The anchor 20 may be configured to stabilize the transcatheter system 10 and maintain the junction 14 in place throughout the contractions of the heart.

[0051] Figure 9A shows a diseased tricuspid valve with an orifice formed due to incomplete closure by its three leaflets, resulting in tricuspid regurgitation. Figure 9B shows a spacer body 16 positioned through the orifice of the diseased tricuspid valve to induce coaptation of the tricuspid valve leaflets onto the spacer body 16, thereby reducing the incomplete closure and regurgitation.

[0052] 10A-10C illustrate one embodiment of a spacer body 16 that can include a stent 16a and at least one membrane 16b. The stent 16a can be expandable. The membrane 16a can be configured to completely or partially cover the stent 16a. The stent 16a can be configured to be covered on either the inside or outside or both sides by the membrane 16b. The membrane 16b can be flexible and made of a flexible material so that the membrane 16b can be configured to expand or contract according to the movement of the stent 16a.

[0053] As shown in FIG. 10A , the spacer body 16 can be configured to be coaxially mounted along the longitudinal axis of the tricuspid valve leg 12. Both ends of the spacer body 16 can have a tapered shape. As will be appreciated by those skilled in the art, the spacer body 16 can have a shape other than a tapered shape. FIG. 10B shows a cross-sectional view of the spacer body 16. FIG. 10C shows the spacer body 16 in its contracted state. The distal portion of the spacer body 16 can be configured to slide as it is expanded or contracted while the proximal portion remains fixed, or vice versa. Both ends of the spacer body 16 can also be configured to slide as the spacer body 16 expands or contracts.

[0054] According to one embodiment, FIGS. 11A-11B show a croissant- or crescent-shaped spacer body 16, in which the upper portion of the spacer body 16 can expand more than the lower portion. FIG. 11B shows a cross-sectional view of the expanded spacer body 16, tricuspid valve leaflet 12, and cerclage filament 18. The spacer body 16 can be configured to maintain its croissant or crescent shape when the tricuspid valve leaflet flexes or curves into an inverted C-shape. As will be appreciated by those skilled in the art, the spacer body 16 can have shapes other than a croissant or crescent shape. For example, the spacer body 16 can be oval or ball-shaped. FIG. 11C shows the spacer body 16 in its contracted state.

[0055] 12A-12B are perspective views of a croissant- or crescent-shaped spacer body 16 in its expanded and contracted states. The tricuspid valve legs 12 may be configured to form curves as shown. The size, shape, and volume of the spacer body 16 may vary according to different sizes and shapes of the heart and tricuspid valve.

[0056] 13A-13D illustrate another embodiment of a two-tube spacer body 16 connected to two components of a tricuspid valve leg 12. The tricuspid valve leg 12 can include a proximal tricuspid valve tube component 12b and a distal tricuspid valve tube component 12a, as shown. The proximal end of the spacer body can be configured to attach to the proximal tricuspid valve tube component 12b, and the distal end of the spacer body 16 can be configured to attach to the distal tricuspid valve tube component 12a. In this configuration, the cerclage filament 18 can be configured to exit through a stopper 15 after passing through the proximal tricuspid valve tube component 12b and the distal tricuspid valve tube component 12a.

[0057] Figure 13C shows the two-tube spacer body 16 in a contracted state with the proximal tricuspid tube component 12b and the distal tricuspid tube component 12a, and Figure 13D shows a perspective view of the two-tube spacer body 16 in an expanded state with the proximal tricuspid tube component 12b and the distal tricuspid tube component 12a.

[0058] According to one aspect, the spacer body 16 can be configured to attach to a defined distal surface of the tricuspid valve leg 12, as shown in Figures 14A-14C. Figure 14A shows a perspective view of this embodiment, Figure 14B shows a side view of this embodiment, and Figure 14C shows a cross-sectional view of the spacer body 16.

[0059] According to one embodiment, the spacer body of FIGS. 15A-15B can be configured to be positioned on two separate tubes of the tricuspid valve leg 12. As shown, the tricuspid valve leg 12 can include a distal component 12a and a proximal component 12b. The distal component 12a can include a stopper 15 disposed at its end. The stent 16a of the spacer body 16 can be positioned over the two components of the tricuspid valve leg 12. For example, as shown, the proximal end of the stent 16a can be configured to be rigidly attached to the proximal component 12b, and the distal end of the stent 16a can be configured to be rigidly attached to the distal component 12a. Thus, the spacer body 16 can be configured to expand or contract with the movement of the two components of the tricuspid valve leg 12.

[0060] According to one embodiment, the tricuspid valve crust 12 of Figures 16A-16B can comprise a groove and a balloon. Figure 16B shows the balloon 12e expanded as a balloon spacer body.

[0061] 17A-17B may include a distal end stopper 15, a distal hole 12c, a proximal hole 12d, and a balloon 12e disposed thereon. The distal hole 12c may be configured to connect to the proximal hole 12d such that the balloon 12e expands when air is supplied through the proximal hole 12d.

[0062] FIG. 18A shows a perspective view of another embodiment that may include a balloon 12e and a stent 16a within the balloon 12e.

[0063] According to one aspect, another embodiment of the spacer body 16 of FIG. 18B may include a membrane 16b that may partially cover the stent 16a so that the proximal and distal ends of the stent 16a may be exposed.

[0064] 19A can include tricuspid valve legs 12, a stopper 15, a spacer body 16, and a hinge ring 17. Cerclage filaments 18 can be configured to pass through the hinge ring 17, the tricuspid valve legs 12, the spacer body 16, and the stopper 15.

[0065] 19B shows a perspective view of another embodiment of a transcatheter system 10 that may include a tricuspid valve crus 12 having a spacer body 16a, a stopper 15, and a coronary sinus crus 11. The coronary sinus crus 11 has holes 11a on its surface. A cerclage filament 18 may be configured to pass through the holes 11a in the coronary sinus crus 11, tricuspid valve crus 12, spacer body 16, and stopper 15 and return to the coronary sinus crus 11, as shown.

[0066] FIG. 20 illustrates a transcatheter system 10 positioned within the heart. As shown, the coaptation portion 14 or hinge ring 17 of the transcatheter system 10 can be configured to be located near or at the orifice of the coronary sinus. The coronary sinus crus 11 can be configured to extend through the coronary sinus and wrap around the mitral valve (MV). The tricuspid valve crus 12, with the spacer body 16 as shown, can be configured to extend through or traverse the leaflets of the tricuspid valve (TV), and the distal end of the tricuspid valve crus 12 can be stopped by a stopper 15 against the interventricular septum (IVS). The portion of the tricuspid valve crus 12, which can be defined from the coaptation portion or hinge ring to the stopper 15, can be configured to maintain a bent shape when the cerclage filaments 18 have appropriate tension. Thus, the spacer body 16 attached to the tricuspid valve crus 12 can be configured to prevent regurgitation of a diseased tricuspid valve, as shown in FIG. 9B.

[0067] As shown in FIG. 20, the cerclage filament 18 can be configured to be positioned within the stem portion 13, tricuspid valve crus 12, stopper 15, and coronary sinus crus 11 so that the cerclage filament 18 can form a loop through the coronary sinus, across the interventricular septum (IVS), coronary arteries, and tricuspid valve under echocardiographic guidance, as also shown in FIGS. 23-24.

[0068] 21-24 show perspective views from different angles of the transcatheter system 10 positioned within the heart. The proximal portion of the spacer body 16 may be located on the atrial side of the tricuspid valve (TV), while the distal portion of the spacer body 16 may be located on the ventricular side of the tricuspid valve. The position, size, and volume of the spacer body 16 may vary depending on the patient's condition. FIG. 23 shows a perspective view from the ventral side. FIG. 24 shows a perspective view from the atrial side.

[0069] According to one embodiment, the transcatheter system 10 can completely replace both the cerclage filament 18 and the overpass portion 18a with a cerclage rope 19, as shown in FIG. 25A. The cerclage rope 19 can include a stainless steel metal wire 19b therein and a coating 19c made of biocompatible nylon covering the wire. The cerclage rope 19 can further include an arched coronary artery protector 19e. The cerclage rope 19 can further include a coating 19d that partially covers the coronary artery protector 19d, thereby incorporating the arched coronary artery protector 19e. FIG. 25B is a cross-sectional view of the cerclage rope 19 showing the stainless steel metal wire 19b and the coating 19c.

[0070] Figures 26A and 26B illustrate an example of a cerclage assembly of the present invention. Figure 26A shows a cerclage assembly 30 that includes a sleeve tube 46. The sleeve tube 46 includes a main segment 32. At a junction 38, the sleeve tube 34 divides into a tricuspid valve crus 34 and a coronary sinus crus 36. A curved, croissant-shaped spacer body 40 is attached to the tricuspid valve crus 34. The tricuspid valve crus 34 includes a stopper 42 at its distal end. The coronary sinus crus 34 also includes a non-slip ring 44 to improve fixation within the coronary sinus.

[0071] FIG. 26A also shows an example of how the length and width of the spacer body 40 are measured. Here, the croissant-shaped spacer body 40 is in a relaxed configuration, and its length is measured as distance L1 along the tricuspid valve leg 34. L1 also represents the longitudinal axis of the spacer body 40. For measurement purposes, there is also a plane X1 where the spacer body 40 has its widest width in the relaxed configuration. Plane X1 is perpendicular to the longitudinal axis of the tricuspid valve leg 34. FIG. 26B shows a cross-section of the spacer body 40 along plane X1 to illustrate how the width is measured. Width W1 is located along line 47 of the widest part of the spacer body 40. Width W2 is also located along line 48, which is perpendicular to the line at which width W1 is located. As can be seen, width W1 is greater than width W2.

[0072] According to another aspect, the present disclosure features a method of introducing a transcatheter system 10 to a cardiac valve, the method including the steps of passing a primary sheath through a left subclavian vein or a right jugular vein or a femoral vein; passing a guidewire through the right atrium, the coronary sinus, septal traversal (with or without septal vein), and the RVOT septum; capturing the wire exiting the RVOT and re-entering the captured wire into the right atrium; pulling the guidewire toward the right atrium; exchanging the guidewire for a cerclage filament 18; and The method includes the steps of withdrawing both ends of the cerclage filament from the main sheath, inserting or pushing the transcatheter system 10 over the cerclage filament 18, positioning the transcatheter system 10 within the heart, adjusting the tension on the cerclage filament 18 to suit the transcatheter system 10 and adjusting the position of the transcatheter system 10 while monitoring with an echocardiogram, and locking the cerclage filament 18 when the transcatheter system 10 is positioned as intended.

[0073] The descriptions and examples set forth herein are intended merely to illustrate the present invention and are not intended to be limiting. Each of the disclosed aspects and embodiments of the present invention may be considered individually or in combination with other aspects, embodiments, and variations of the present invention. Furthermore, unless otherwise specified, the steps of the methods of the present invention are not limited to a particular order of performance. Modifications of the disclosed embodiments that incorporate the spirit and essence of the present invention may occur to those skilled in the art, and such modifications are within the scope of the present invention.

Claims

1. 1. A method of treating tricuspid regurgitation in a patient's heart, comprising: having a cerclage filament; a step of providing a sleeve tube, the sleeve tube comprising: (a) a main segment; (b) the coronary sinus crura; (c) the tricuspid valve crus; (d) a spacer body attached to the tricuspid valve leg; Equipped with the tricuspid valve crus is longer than the coronary sinus crus; a step, the main segment being longer than the tricuspid valve crus and longer than the coronary sinus crus; creating a vascular entry site into an entry vein; inserting the cerclage filament through the vascular entry site and the entry vein and further into the patient's heart so that it follows a path to the right atrium, through the coronary sinus, into the great cardiac vein, into the right ventricle, through the tricuspid valve, back into the right atrium, and back out through the entry vein to the vascular entry site; sliding the sleeve tube over the cerclage filament; advancing the sleeve tube toward the patient's right atrium; positioning the spacer body between the leaflets of the patient's tricuspid valve; forming a locked cerclage loop by fastening an entrance segment of the cerclage filament to an opposing return segment of the cerclage filament, the fastening occurring at a location outside the right atrium; A method comprising:

2. The method of claim 1 , wherein the path of the cerclage filament also includes the patient's septal perforator veins.

3. inserting a guidewire through the vascular entry site and advancing the guidewire into the right atrium of the patient; inserting a distal end of the guidewire into the coronary sinus of the patient; advancing the guidewire until the distal end of the guidewire emerges into the patient's right ventricle; grasping the guidewire and withdrawing the distal end of the guidewire from the entor vein; exchanging the guidewire for the cerclage filament such that the cerclage filament follows the path through the patient's heart; The method of claim 1 further comprising:

4. 4. The method of claim 3, wherein the step of exchanging the guidewire for the cerclage filament comprises attaching a distal end of the cerclage filament to a proximal end of the guidewire and withdrawing the guidewire so that the cerclage filament follows the path created by the guidewire.

5. 10. The method of claim 1, wherein the entry vein is a femoral vein and the cerclage filament passes through the patient's inferior vena cava.

6. 6. The method of claim 5, wherein the fastening is performed at a location in the inferior vena cava superior to the patient's renal veins.

7. The method of claim 5 , wherein the proximal end of the sleeve tube terminates at a location in the inferior vena cava that is superior to the patient's renal veins.

8. sliding the coronary sinus limb over one of the entrance segment or the return segment of the cerclage filament; sliding the tricuspid valve limb over the other of the inlet segment or the return segment of the cerclage filament; The method of claim 1 further comprising:

9. The method of claim 1 , wherein the step of positioning the spacer body is performed under echocardiographic monitoring.

10. The method of claim 1 , further comprising the step of anchoring the cerclage loop to an anchoring site within the patient's body.

11. 2. The method of claim 1, wherein the step of advancing the sleeve tube includes inserting the coronary sinus limb into the patient's coronary sinus in the right atrium and inserting the tricuspid valve limb through the patient's tricuspid valve.

12. 10. The method of claim 1, wherein the cerclage filament further comprises an overpass arch, the method further comprising positioning the overpass arch inside the great cardiac vein at a location above a coronary artery.

13. The method of claim 1 , wherein the spacer body provides a coaptation surface for the leaflets of the tricuspid valve.

14. 2. The method of claim 1, wherein the sleeve tube further comprises a stopper located at a distal end of the tricuspid valve crus, the method further comprising positioning the stopper against a wall of the right ventricle of the patient.

15. a cerclage filament having an entrance segment and a return segment; A sleeve tube, (a) a main segment; (b) the coronary sinus crura; (c) the tricuspid valve crus; (d) a spacer body attached to the tricuspid valve leg; (e) a stopper located at the distal end of the tricuspid valve leg; Equipped with the tricuspid valve crus is longer than the coronary sinus crus; the main segment is longer than the tricuspid valve crus and longer than the coronary sinus crus; the stopper is wider than the distal ends of the tricuspid valve legs or has a larger diameter than the distal ends of the tricuspid valve legs, the stopper having a width or diameter in the range of 2 to 6 mm; the sleeve tube; Equipped with both the inlet segment and the return segment travel through the main segment of the sleeve tube; one of the inlet segment or the return segment travels through the coronary sinus limb of the sleeve tube; the other of the inlet segment or the return segment travels through the tricuspid valve leg of the sleeve tube. Cardiac cerclage assembly.

16. 16. The cardiac cerclage assembly of claim 15, wherein the spacer body has a curved croissant shape with a length in the range of 20 to 60 mm.

17. 16. The cardiac cerclage assembly of claim 15, wherein the tricuspid valve crura have a length in the range of 4.0 to 11 cm.

18. 16. The cardiac cerclage assembly of claim 15, wherein the coronary sinus limb has a length in the range of 2.2 to 5.0 cm.

19. 16. The cardiac cerclage assembly of claim 15, further comprising a lock fastening the entrance segment of the cerclage filament to an opposing return segment.

20. 1. A cardiac cerclage kit for treating tricuspid regurgitation, comprising: Cerclage filaments, A sleeve tube, (a) a main segment; (b) the coronary sinus crura; (c) the tricuspid valve crus; (d) a spacer body attached to the tricuspid valve leg; Equipped with the tricuspid valve crus is longer than the coronary sinus crus; the main segment is longer than the tricuspid valve crus and longer than the coronary sinus crus; the sleeve tube; A cardiac cerclage kit comprising:

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