Transcatheter System and Method for Reducing Tricuspid Regurgitation

Abstract

The present invention relates to a system and method for transcatheter therapy for tricuspid regurgitation. A system for transcatheter therapy for tricuspid regurgitation according to one preferred embodiment of the present invention includes a coronary sinus tube inserted into the coronary sinus and a tricuspid valve tube crossing the tricuspid valve, wherein the coronary sinus tube and the tricuspid valve tube communicate with or are adjacent to each other at their upper sides within a predetermined length and are separated from each other at their lower sides, and an obstruction member for obstructing a space caused by incomplete closure of the tricuspid valve is provided at the lower part of the tricuspid valve tube or between the coronary sinus tube and the tricuspid valve tube.

Description

Technical Field

[0001] The present invention relates to a system and method for reducing transcatheter treatment for tricuspid regurgitation, and more particularly, to a system and method for transcatheter treatment for reducing tricuspid regurgitation, the system and method being capable of performing catheter treatment for reducing tricuspid regurgitation, which is a heart disease in which the tricuspid valve fails to close completely, causing blood to flow backward in the heart.

Background Art

[0002] The human heart is divided into four chambers, namely, two atria and two ventricles, and these chambers function as passageways for sending blood by being connected to four blood vessels such as the aorta, vena cava, pulmonary artery, and pulmonary vein. The ventricular septum at the center of the heart divides the heart into two sides, namely, the right atrium and right ventricle on one side and the left atrium and left ventricle on the other side. The tricuspid valve is located between the right atrium and the right ventricle, and the mitral valve is located between the left atrium and the left ventricle.

[0003] The heart functions as a pump by repeating contraction and relaxation, enabling blood to flow along blood vessels. During the systolic phase of the heart, as the blood in the heart flows forward toward the blood vessels, the blood in the right heart is sent from the right ventricle to the pulmonary artery, and the blood in the left heart is sent from the left ventricle to the aorta.

[0004] However, if the valve between the atrium and the ventricle does not function properly, the blood in the ventricle flows backward during the systolic phase of the heart, that is, moves toward the atrium. If the tricuspid valve between the right atrium and the right ventricle does not function properly, the blood in the right ventricle flows backward into the right atrium, which is called "tricuspid regurgitation", and if the mitral valve between the left atrium and the left ventricle does not function properly, the blood in the left ventricle flows backward into the left atrium. This is called "mitral regurgitation".

[0005] In tricuspid regurgitation, the tricuspid valve does not function properly. As a result, when the heart contracts, blood is not pumped into the pulmonary artery, and instead, the blood flows backward into the right ventricle. This is called "tricuspid valve insufficiency." The occurrence of tricuspid regurgitation is caused by the tricuspid valve between the right atrium and the right ventricle of the heart stretching or tearing, or the chordae tendineae that fix the tricuspid valve between the right atrium and the right ventricle breaking, causing the tricuspid valve that should originally close to not close completely.

[0006] As a typical treatment method for tricuspid regurgitation according to the prior art, a method of surgically repairing the disease by opening the patient's chest and incising the heart, that is, the annuloplasty ring method and the De Vega method, have been widely used. However, in these surgical methods, since it is necessary to perform a highly invasive operation, the surgical approach only for the tricuspid valve has not been widely popularized because the importance of the tricuspid valve is relatively low. That is, when a patient with tricuspid regurgitation undergoes mitral valve surgery or an important heart disease surgery such as coronary artery surgery, the above-described surgical treatment for tricuspid regurgitation is performed simultaneously.

[0007] In this regard, the global expectation for research on the treatment of tricuspid regurgitation that can be performed using a catheter or a simple device, rather than the surgical method of opening the chest and incising the heart, has been gradually increasing.

Summary of the Invention

[0008] Cell closure method: In one aspect, the present invention is a method for treating tricuspid regurgitation in a patient. This method uses (i) a cell closure filament and (ii) a sleeve tube. The sleeve tube includes a main segment, a coronary sinus leg, a tricuspid valve leg, and a spacer body attached to the tricuspid valve leg. The method includes the step of forming a vascular entry site into the inlet vein. The inlet vein can be any suitable vein in the patient's body, such as the subclavian vein or the femoral vein. The method further includes the step of inserting the cell closure filament through the vascular entry site and the inlet vein and further into the patient's heart.

[0009] Once fully inserted, the path taken by the cell curettage filament enters the right atrium, exits the great cardiac vein via the coronary sinus, enters the right ventricle (as used herein, "right ventricle" includes the right ventricular outflow tract), returns into the right atrium through the tricuspid valve, returns to the vascular inlet site through the original inlet vein, and exits therefrom. The entry into the right ventricle can occur by perforating the ventricular septum, particularly the membranous ventricular septum located in the right ventricular outflow tract. This path by the cell curettage filament forms a cell curettage loop. The path of the cell curettage filament can also include entering the septal perforator vein before exiting the septum and entering the right ventricle.

[0010] The method further includes the step of sliding a sleeve tube towards the cell curettage filament. Since the cell curettage filament forms a loop, the cell curettage filament can be considered to have an inlet segment (directed towards the heart) and a return segment (directed away from the heart). In some embodiments, the step of sliding the sleeve tube towards the cell curettage filament includes (i) the step of sliding the coronary sinus leg over one of the inlet segment or the return segment of the cell curettage filament, and (ii) the step of sliding the tricuspid valve leg over the other of the inlet segment or the return segment of the cell curettage filament. For example, the inlet segment of the cell curettage filament can be slid over the coronary sinus leg, and the return segment of the cell curettage filament can be slid over the tricuspid valve leg. This is compatible with the path and direction taken by the cell curettage filament through the heart. However, the reverse configuration can also be envisioned.

[0011] The method further includes advancing a 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 such that the coronary sinus leg enters the patient's coronary sinus of the right atrium and the tricuspid valve leg passes through the patient's tricuspid valve. The sleeve tube or the cell closure 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 while monitoring with an echocardiogram. The purpose of the spacer body is to provide a good surface for improving the leaflet apposition.

[0012] With the cell closure loop created, the method further includes locking the cell closure loop by fastening a portion of the inlet segment of the cell closure filament to the return segment on the opposite side of the cell closure filament. This fastening may be performed at any suitable location within the patient's body at a position outside the right atrium. For example, in a situation where the inlet vein is the femoral vein, this fastening may be performed at a position within the inferior vena cava above one or both of the patient's renal veins. Similarly, in this situation, the proximal end of the sleeve tube may terminate at a position within the inferior vena cava above one or both of the renal veins. The method may further include fixing the cell closure loop to a fixed site within the patient's body. For example, in a situation where the inlet vein is the subclavian vein, this fixing may be performed in a subcutaneous pocket near the subclavian vein inlet site (within 10 cm).

[0013] In some embodiments, the sleeve tube further comprises a stopper located at the distal end of the tricuspid valve leg. 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 against the right ventricular wall through which the cell closure filament pierces. Thus, the stopper prevents the tricuspid valve leg of the sleeve tube from being embedded in the ventricular wall.

[0014] The path of the cell closure filament can be formed using a guide wire. In this embodiment, the method includes inserting a guide wire into the vascular access site and advancing the guide wire into the patient's right atrium. The guide wire can move through the superior vena cava or the inferior vena cava on its way into the right atrium. The distal end of the guide wire is inserted into the coronary sinus. The guide wire is advanced through the heart and its distal end is configured to enter the patient's right ventricle.

[0015] In some embodiments, an introducer sheath is slid onto the guide wire and contrast agent is injected through the sheath to perform coronary venography. This allows identification of the septal perforator vein and advancement of the guide wire into the septal perforator vein. The guide wire follows a path into the right ventricle. This can be done by advancing the guide wire to perforate the ventricular septum, particularly the membranous ventricular septum located in the right ventricular outflow tract. The guide wire is grasped (e.g., by a snare catheter within the right ventricle) and its distal end is withdrawn from the inlet vein.

[0016] The guide wire is exchanged for the cell closure filament so that the cell closure filament takes a path through the patient's heart. In some embodiments, this guide wire exchange involves inserting an introducer sheath over the guide wire and then withdrawing the guide wire and advancing the cell closure filament through the introducer sheath. In some embodiments, this guide wire exchange involves attaching the distal end of the cell closure filament to the proximal end of the guide wire and withdrawing the guide wire so that the cell closure filament follows the path created by the guide wire.

[0017] In some embodiments, there may be an overpass arch on the cell closure filament, and the method may further include positioning the overpass arch inside the great cardiac vein at a position above the coronary artery. The purpose of the overpass arch is to avoid compressing the coronary artery passing below it. Accordingly, the path taken by the cell closure filament can be arched over the coronary artery when the cell closure filament passes through the great cardiac vein. The aforementioned method of aspects of this invention can be performed using a cardiac cell closure assembly or a cardiac cell closure kit as described below.

[0018] Cardiac cell closure assembly: In other aspects, this invention is a cardiac cell closure assembly comprising (i) a cell closure filament, and (ii) a sleeve tube through which the cell closure filament passes. The cell closure filament may be defined as a wire, rope, cord, string, or a thread such as any other type of very flexible thin filament. The cell closure filament can have any suitable thickness. In some embodiments, the cell closure filament has a thickness in the range of 0.3 to 1.0 mm. An example of the cell closure filament is a nylon-coated braided stainless steel wire. The cell closure filament has various different segments. Among them, the cell closure filament has an inlet segment and a return segment.

[0019] The sleeve tube comprises (a) a main segment, (b) a coronary sinus leg, (c) a tricuspid valve leg, and (d) a spacer body attached to the tricuspid valve leg. 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 segments of the sleeve tube have different lengths. The tricuspid valve leg is longer than the coronary sinus leg. The main segment is longer than the tricuspid valve leg and longer than the coronary sinus leg. A junction is formed at the point on the sleeve tube where the two legs separate from the main segment.

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

[0021] The cardiac cell closure assembly is assembled such that both the inlet segment and the return segment of the cell closure filament move through the main segment of the sleeve tube. Further, one of the inlet segment or the return segment moves through the coronary sinus leg of the sleeve tube. Also, the other of the inlet segment or the return segment moves through the tricuspid valve leg of the sleeve tube. For example, the inlet segment can move through the coronary sinus leg and the return segment can move through the tricuspid valve leg, or vice versa.

[0022] The main segment of the sleeve tube may be of a single barrel type or a double barrel type in which two barrels are combined. In the single barrel type configuration, both the inlet segment and the return segment move through the single barrel of the main segment before separating at the two legs. In the double barrel type configuration, the inlet segment moves through one of the two barrels and the return segment moves through the other of the two barrels. The two barrels are adjacent to each other separately from each of the tricuspid valve leg and the coronary sinus leg.

[0023] The tricuspid valve leaflets may have a telescoping function. In such an embodiment, the tricuspid valve leaflets can be extended and contracted. Accordingly, the tricuspid valve leaflets can have a contracted length and an extended length. To provide this telescoping function, any suitable mechanism can be implemented. For example, the tricuspid valve leaflets can comprise an inner tube and an outer tube that slide relative to each other.

[0024] The sleeve tube further comprises a spacer body that is attached to the tricuspid valve leaflets. The spacer body can have any suitable shape, such as cylindrical, crescent, spherical, oval, ovoid, wing-shaped, 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., like a stent), framework, skeleton, scaffold, occluding device, etc. Optionally, the surface of the spacer body can be provided in any suitable manner, such as with a skin, shell, casing, or membrane. The spacer body can be formed from any suitable material, such as plastic, metal, or a combination thereof.

[0025] The spacer body is formed to have dimensions suitable for providing a bonding surface for the valve tips of the tricuspid valve. In some embodiments, the spacer body has a length in the range of 20 - 60 mm, and in some cases, a length in the range of 30 - 50 mm. As used herein, the "length" of the spacer body means its length measured along the tricuspid valve leaflets of the tube. The spacer body can have a relaxed elongated form. In this situation, the above measurements of the spacer body are made in the relaxed form.

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

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

[0028] In some embodiments, the cell closure assembly further comprises a lock that fastens the inlet segment of the cell closure filament to the return segment on the opposite side. This lock can be located at the proximal end of the main segment of the sleeve tube. The heart cell closure assembly of this aspect of the invention may be assembled from a heart cell closure kit as described below.

[0029] Cardiac Cell Crimping Kit: In other aspects, the present invention is a cardiac cell crimping kit for treating tricuspid regurgitation in a patient. This cardiac cell crimping kit can be used to form the aforementioned cardiac cell crimping assembly. The cardiac cell crimping kit comprises (i) a cell crimping filament, and (ii) a sleeve tube. The sleeve tube comprises (a) a main segment, (b) a coronary sinus leg, (c) a tricuspid valve leg, and (d) a spacer body located on the tricuspid valve leg.

[0030] The kit can further comprise a guide wire used to provide a path for the cell crimping filament. The kit can further comprise an introducer sheath that slides on the guide wire, or exchanges the guide wire with the cell crimping filament, or provides a channel path for introducing the sleeve tube. The kit can further comprise a torque application tool for applying rotational torque to the guide wire. This can be particularly useful for screwing the guide wire to drill a hole in the septum. The kit can further comprise a lock for fastening segments on both sides of the cell crimping filament so that a cell crimping loop is formed.

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

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

[0033] The features and advantages of the subject matter recited in the claims will be apparent from the following description of embodiments that correspond thereto, which description should be considered in conjunction with the accompanying drawings.

Brief Description of the Drawings

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Mode for Carrying Out the Invention

[0035] To facilitate understanding of the present invention, specific embodiments in which the present invention can be implemented are shown by way of example with reference to the accompanying drawings. The drawings in this specification are not necessarily drawn to scale or in actual proportions. For example, the length and width of components can be adjusted according to the page size.

[0036] The transcatheter system 10 on the cell closure filament 18 for treating retrograde flow in the tricuspid valve of the heart may include a first catheter tube 12 having an outer peripheral surface and a distal end and 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 provided proximate to the distal end of the first catheter tube 12 protruding from the outer peripheral surface. The spacer body 16 may be sized to intersect the space within the tricuspid valve created by an incomplete closure of the tricuspid valve.

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

[0038] The trans-catheter system 10 may further include a stopper 15 defined on a first catheter tube 12 configured such that a distal end thereof does not penetrate the intraventricular septum of the heart.

[0039] One embodiment of the trans-catheter system 10 on a cell closure filament 18 for treating retrograde flow in the tricuspid valve of the heart may include a first catheter tube 12 having a first outer peripheral surface and a distal end defining an axis. The first catheter tube 12 may be dimensioned to extend through the tricuspid valve. The trans-catheter system 10 may further include a spacer body 16 provided proximate to the distal end of the first catheter tube 12 protruding from the outer peripheral surface, and the spacer body 16 is dimensioned to intersect a space within the tricuspid valve generated by an incomplete closure of the tricuspid valve.

[0040] The trans-catheter system 10 may further include a second catheter tube 11 having a second outer peripheral surface that contacts the first outer peripheral surface over a selected distance and branches from the first outer peripheral surface at a selected position spaced from the distal end of the first catheter tube 12.

[0041] The spacer body 16 may be configured to intersect a space within the tricuspid valve caused by an incomplete closure of the tricuspid valve at an angle oblique 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 trans-catheter system 10 may further include a stopper 15 defined on a first catheter tube 12 configured such that a distal end thereof does not penetrate the intraventricular septum of the heart. The trans-catheter 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 straddle a coronary artery of the heart.

[0043] FIG. 1A shows one embodiment of a trans-catheter system 10. The trans-catheter system 10 may include a main segment 13, a stopper 15, and a spacer body 16. The main segment 13 may be separated into a coronary sinus leg 11 and a tricuspid valve leg 12. A junction 14 may be defined as the location where the main segment 13 separates into the coronary sinus leg 11 and the tricuspid valve leg 12.

[0044] As shown in FIGS. 1A and 20-24, the coronary sinus leg 11 may be configured to wrap around or surround the mitral valve (MV) via the coronary sinus (CS), and the tricuspid valve leg 12 may be configured to extend across or through the orifice of the tricuspid valve leaflets. The stopper 15 may be disposed at the distal end of the tricuspid valve leg 11, whereby the stopper 15 prevents the distal end from further advancing into the interventricular septum (IVS) as shown in FIGS. 20-24. The junction 14 may be disposed at or near the orifice of the coronary sinus. The tricuspid valve leg 11 may be configured to be freely suspended in an inverted "C" shape through the orifice of the tricuspid valve leaflets. The tricuspid valve leg 12 may have sufficient rigidity to resist bending when tension is applied to the cell closure filament 18 or the cell closure filament 19. The spacer body 16 may be attached to the tricuspid valve leg 12 between the junction 14 and the stopper 15.

[0045] As shown in FIGS. 1B and 1C, when the cell closure filament 18 is disposed at a predetermined position, the trans-catheter system 10 can be inserted over the cell closure filament 18, whereby it can be positioned within the heart. The cell closure filament 18 may include an arch portion 18a. The arch portion 18a may be configured to straddle the coronary artery when tension is applied.

[0046] According to one aspect shown in FIG. 2, the trans-catheter system 10 may also include a hinge ring 17 around the junction 14. The hinge ring 17 may be configured to reinforce the junction 14 so that it is not separated by tension.

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

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

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

[0050] Figures 8A - 8B show a transcatheter system 10 with at least one ring - shaped anchor 20 disposed on the coronary sinus leg 11. The ring - shaped anchor 20 can include a ring body 20a and at least one anchor 21b. The anchor 20 can be configured to stabilize the transcatheter system 10 and maintain the junction 14 in place throughout the cardiac contraction.

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

[0052] Figures 10A-10C show one embodiment of a spacer body 16 that can include a stent 16a and at least one membrane 16b. The stent 16a may be expandable. The membrane 16a may be configured to completely or partially cover the stent 16a. The stent 16a may be configured to be covered by the membrane 16b either inside or outside or both. The membrane 16b may be flexible and may be made of a flexible material such that the membrane 16b expands or contracts in accordance with the movement of the stent 16a.

[0053] As shown in FIG. 10A, the spacer body 16 may be configured to be coaxially attached along the longitudinal axis of the tricuspid valve leaflet 12. Both ends of the spacer body 16 may have a tapered shape. As will be appreciated by those skilled in the art, the spacer body 16 may 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 may be configured to slide as it expands or contracts with the proximal portion fixed, or vice versa. Both ends of the spacer body 16 may also be configured to slide as the spacer body 16 expands and contracts.

[0054] According to one aspect, FIGS. 11A-11B show a croissant-shaped 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, the tricuspid valve leaflet 12, and the cell closure filament 18. The spacer body 16 may be configured such that it can continue to maintain its croissant shape or crescent shape when the tricuspid valve leaflet is bent or curved in an inverted C shape. As will be appreciated by those skilled in the art, the spacer body 16 may have a shape other than a croissant or crescent shape. For example, the spacer body 16 can form an oval or a ball. FIG. 11C shows the spacer body 16 in its contracted state.

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

[0056] According to one aspect, Figures 13A - 13D show another embodiment of the two - tube spacer body 16 connected to two parts of the tricuspid valve leg 12. The tricuspid valve leg 12 can include a proximal tricuspid valve tube part 12b and a distal tricuspid valve tube part 12a as shown. The proximal end of the spacer body may be configured to be attached to the proximal tricuspid valve tube part 12b, and the distal end of the spacer body 16 may be configured to be attached to the distal tricuspid valve tube part 12a. In this configuration, the cell closure filament 18 can be configured to exit through the stopper 15 after passing through the proximal tricuspid valve tube part 12b and the distal tricuspid valve tube part 12a.

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

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

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

[0060] According to one aspect, the tricuspid valve leg 12 of FIGS. 16A - 16B can comprise a groove and a balloon. FIG. 16B shows the balloon 12e expanded as a balloon spacer body.

[0061] According to one aspect, another embodiment of the tricuspid valve leg 12 of FIGS. 17A - 17B can include a stopper 15 at the distal end, a distal hole 12c, a proximal hole 12d, and a balloon 12e disposed on its surface. The distal hole 12c may be configured to be connected 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 have 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 can partially cover the stent 16a such that the proximal and distal ends of the stent 16a can be exposed.

[0064] According to one aspect, another embodiment of the trans-catheter system 10 of FIG. 19A can include the tricuspid valve leaflet 12, the stopper 15, the spacer body 16, and the hinge ring 17. The cell closure filament 18 can be configured to pass through the hinge ring 17, the tricuspid valve leaflet 12, the spacer body 16, and the stopper 15.

[0065] FIG. 19B shows a perspective view of another embodiment of the trans-catheter system 10 that can include the tricuspid valve leaflet 12 having the spacer body 16a, the stopper 15, and the coronary sinus leaflet 11. The coronary sinus leaflet 11 has holes 11a on its surface. The cell closure filament 18 can be configured to pass through the holes 11a of the coronary sinus leaflet 11, the tricuspid valve leaflet 12, the spacer body 16, the stopper 15 and return to the coronary sinus leaflet 11 as shown.

[0066] FIG. 20 shows the trans-catheter system 10 disposed within the heart. As shown, the junction 14 or the hinge ring 17 of the trans-catheter system 10 can be configured to be located near or at the orifice of the coronary sinus. The coronary sinus leaflet 11 can be configured to extend through the coronary sinus and wrap around the mitral valve (MV). The tricuspid valve leaflet 12 having the spacer body 16 as shown can be configured to extend through or traverse the valve tip of the tricuspid valve (TV), and the distal end of the tricuspid valve leaflet 12 can be stopped by the stopper 15 against the interventricular septum (IVS). The portion of the tricuspid valve leaflet that can be defined from the junction or the hinge ring to the stopper 15 can be configured to maintain a bent shape when the cell closure filament 18 has appropriate tension. Thus, the spacer body 16 attached to the tricuspid valve leaflet 12 can be configured to prevent the backflow of the diseased tricuspid valve as shown in FIG. 9B.

[0067] As shown in FIG. 20, the cell closure filament 18 can be configured to be disposed inside the stem portion 13, the tricuspid valve leg 12, the stopper 15, and the coronary sinus leg 11 such that, as also shown in FIGS. 23-24, the cell closure filament 18 can form a loop passing through the coronary sinus across the interventricular septum (IVS), the coronary artery, and the tricuspid valve under the guidance of an intracardiac echocardiogram.

[0068] FIGS. 21-24 show perspective views of the transcatheter system 10 disposed within the heart, viewed from different angles. 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 can vary according to the patient's condition. FIG. 23 shows a perspective view seen from the ventral side. FIG. 24 shows a perspective view seen from the atrial side.

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

[0070] Figures 26A and 26B show an example of the cell closure assembly of the present invention. Figure 26A shows a cell closure assembly 30 including a sleeve tube 46. The sleeve tube 46 includes a main segment 32. At the junction 38, the sleeve tube 34 branches into a tricuspid valve leg 34 and a coronary sinus leg 36. A curved croissant-shaped spacer body 40 is attached to the tricuspid valve leg 34. There is a stopper 42 at the distal end of the tricuspid valve leg 34. Also, there is an anti-slip ring 44 on the coronary sinus leg 34 to improve fixation within the coronary sinus.

[0071] Figure 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 form, and its length is measured as the distance L1 along the tricuspid valve leg 34. Also, L1 represents the longitudinal axis of the spacer body 40. For measurement purposes, there is also a plane X1 in which the spacer body 40 has its maximum width in the relaxed form. The plane X1 is orthogonal to the longitudinal axis of the tricuspid valve leg 34. Figure 26B shows a cross-section of the spacer body 40 along the plane X1 to show how the width is measured. There is a width W1 along the line 47 of the maximum width of the spacer body 40. There is also a width W2 along the line 48 orthogonal to the line at the width W1. As can be seen here, the width W1 is larger than the width W2.

[0072] According to another aspect, the present disclosure features a method of introducing the transcatheter system 10 to a heart valve, the method including steps of inserting a main sheath into the left subclavian vein or the right jugular vein or the femoral vein; passing a guide wire through the right atrium, the coronary sinus, the septal traversal (with or without the septal vein), and the RVOT septum; capturing the wire exiting the RVOT and re-entering the captured wire into the right atrium; pulling the guide wire toward the right atrium; exchanging the cell closure filament 18 with the guide wire; pulling both ends of the cell closure filament out of the main sheath; inserting or pushing the transcatheter system 10 over the cell closure filament 18; placing the transcatheter system 10 into the heart; adjusting the tension suitable for the transcatheter system 10 acting on the cell closure filament 18 and adjusting the position of the transcatheter system 10 while monitoring with an echocardiogram; and locking the cell closure 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 invention and are not intended to limit it. Each of the disclosed aspects and embodiments of the invention may be considered separately or in combination with other aspects, embodiments, and variations of the invention. Further, unless otherwise specified, the steps of the methods of the invention are not limited to a particular order of implementation. Modifications of the disclosed embodiments incorporating the spirit and gist of the invention can be conceived by those skilled in the art, and such modifications are within the scope of the invention.

Claims

1. a cell closure filament having an inlet segment and a return segment, a sleeve tube, (a) a main segment, (b) a coronary sinus leg, (c) a tricuspid valve leg, (d) a spacer body attached to the tricuspid valve leg, (e) a stopper located at the distal end of the tricuspid valve leg, comprising, the tricuspid valve leg being longer than the coronary sinus leg, the main segment being longer than the tricuspid valve leg and longer than the coronary sinus leg, the stopper having a width wider than the distal end of the tricuspid valve leg or a diameter larger than the distal end of the tricuspid valve leg, the stopper having a width or diameter in the range of 2 to 6 mm, the sleeve tube, comprising, both the inlet segment and the return segment move through the main segment of the sleeve tube, one of the inlet segment or the return segment moves through the coronary sinus leg of the sleeve tube, the other of the inlet segment or the return segment moves through the tricuspid valve leg of the sleeve tube, the spacer body is configured to be expandable and contractible, and when expanded from the contracted state, expands in a first direction perpendicular to the longitudinal axis of the tricuspid valve leg, the spacer body, in the expanded state, extends from the tricuspid valve leg along the first direction and spreads in a second direction perpendicular to the first direction and the longitudinal axis of the tricuspid valve leg, a cardiac cell closure assembly.

2. The cardiac cell closure assembly according to claim 1, wherein the spacer body has a curved croissant shape with a length in the range of 20 to 60 mm.

3. The cardiac cell closure assembly according to claim 1, wherein the tricuspid valve leg has a length in the range of 4.0 to 11 cm.

4. The cardiac cell closure assembly according to claim 1, wherein the coronary sinus leg has a length in the range of 2.2 to 5.0 cm.

5. The cardiac cell closure assembly according to claim 1, further comprising a lock for fastening the inlet segment of the cell closure filament to the opposite return segment.

6. A cardiac cell closure kit for treating tricuspid regurgitation, a cell closure filament, a sleeve tube, (a) a main segment, (b) a coronary sinus leg, (c) a tricuspid valve leg, (d) a spacer body attached to the tricuspid valve leaflet; comprising: the tricuspid valve leaflet being longer than the coronary sinus leaflet; the main segment being longer than the tricuspid valve leaflet and longer than the coronary sinus leaflet; the sleeve tube; comprising: the spacer body is configured to be expandable and contractible, and when expanded from the contracted state, it expands in a first direction orthogonal to the longitudinal axis of the tricuspid valve leaflet; the spacer body, in the expanded state, extends from the tricuspid valve leaflet along the first direction and spreads in a second direction perpendicular to the first direction and the longitudinal axis of the tricuspid valve leaflet, a cardiac cell repair kit.

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