Transcatheter device

Abstract

A transcatheter device includes: a main shaft including a proximal portion, an intermediate portion, and a distal portion, and having a first lumen for insertion of a guidewire, a second lumen for insertion of a nickel-titanium alloy wire, and a third lumen for insertion of an injection tube; a distal tail including a distal portion of the spindle; a spacer mounted on an intermediate portion of the main shaft between the distal end portion and the proximal end portion, where the proximal end portion of the main shaft comprises a proximal end section and an intravascular anchor connected to the proximal end section, where the spacer comprises: a mesh structure configured to be contractible or expandable, and expand to have a predetermined configuration without external force from the environment; and a balloon configured to cover the mesh structure body to maintain a closed state and to control a size according to an amount of the salt solution injected into an inner space thereof.

Description

Technical Field

[0001] The present invention relates to a transcatheter device for treating tricuspid valve regurgitation. Background Art

[0002] Heart valve regurgitation (leaking blood from a heart valve) occurs when a heart valve fails to close properly. An example is tricuspid regurgitation, which is usually caused by changes in the geometry of the right ventricle, papillary muscles, and tricuspid valve annulus. These geometric changes lead to incomplete leaflet coaptation during ventricular systole, which produces regurgitation. In the past, repairing heart valves required open-chest surgery and cardiopulmonary bypass. In recent years, various catheter-based valve repair techniques are being introduced. These catheter-based procedures do not require opening the chest or the use of cardiopulmonary bypass. Summary of the invention

[0003] The present invention is directed to providing an improved transcatheter device for treating tricuspid regurgitation.

[0004] Transcatheter Device: On the one hand, the present invention provides a transcatheter device, including a main shaft, a proximal portion, a distal tail, and a spacer body mounted on the main shaft between the proximal portion and the distal tail. The transcatheter device can be used to treat tricuspid regurgitation in the patient's heart. All or part of the transcatheter device is supported by the main shaft. The spacer is mounted on the main shaft passing through the spacer. The proximal portion of the transcatheter device surrounds the proximal segment of the main shaft. In addition, this can be expressed as the proximal segment of the main shaft includes the proximal portion of the transcatheter device. The distal tail of the transcatheter device surrounds the distal segment of the main shaft. In addition, this can be expressed as the distal segment of the main shaft includes the distal tail of the transcatheter device.

[0005] The main shaft includes a lumen and an opening for a guide wire to pass therethrough. The distal tip of the main shaft (at the distal end) can have an opening for the lumen. The proximal opening can also be present at the proximal portion of the transcatheter device. In embodiments where the transcatheter device includes an intravascular anchor, the proximal opening can be located between the spacer and the intravascular anchor. For example, the opening can be located at the proximal end of the main shaft that is connected to the intravascular anchor.

[0006] The total length of the main shaft can range from 50 to 175 centimeters. The main shaft can be constructed in any suitable manner. For example, the main shaft can be made of a wire core (e.g., stainless steel or nickel-titanium (nitinol) alloy) and then covered with a polymer material. For example, the wire core can be covered with a thermoplastic polyurethane braiding or a polytetrafluoroethylene (PTFE) coating. The wire core can extend over the entire length of the main shaft. However, in some embodiments, the wire core terminates before reaching the end of the distal tail (or the distal end of the main shaft). For example, the wire core can terminate within a range of 0.5-4 centimeters from the distal end.

[0007] Distal Tail: The distal tail can be of any suitable length to provide adequate anchoring in the pulmonary artery. In some embodiments, the length of the distal tail is 10-40 cm; in some cases, 15-30 cm. The distal tail can have a pig tail or rounded end to blunt the end and reduce its trauma when entering the pulmonary artery. In some embodiments, the distal tail has one or more bends. The bend has an inner angle in the range of 80-140°. The bend can be located at any suitable position of the distal tail. In some embodiments, there is a bend located 0.25-3.5 cm from the spacer.

[0008] The distal tail may have an inconstant diameter over its length. In some embodiments, the distal tail includes a proximal segment and a distal segment. The proximal segment may account for 10-60% of the total length of the distal tail. The diameter of the distal segment may be less than the diameter of the proximal segment. There may be multiple reasons for this difference, such as the proximal segment having more or thicker sheaths or coatings than the distal segment. The distal segment may be more flexible than the proximal segment of the distal tail. In some embodiments, the distal tail does not include any coil, loop, or stent.

[0009] The distal tail can be designed to have a streamlined shape. In some embodiments, the distal tail is an elongated cylindrical shape (with or without a lumen) without protruding features such as hooks, wires, rings, ridges, etc. This can help prevent thrombus formation or erosion of the distal tail into the wall of the pulmonary artery.

[0010] In some embodiments, the distal segment is more flexible than the proximal segment. In some cases, the proximal segment includes a metal braid and the distal segment does not. The distal segment may include a polymer material that is softer than the proximal segment. The diameter of the distal segment may be smaller than the proximal segment. In some cases, the length of the distal segment is shorter than the proximal segment. The length of the distal segment may be 2-7 centimeters. The length of the proximal segment may be 7-15 centimeters. In some cases, the proximal segment accounts for 35-65% of the total length of the distal tail.

[0011] The proximal segment may be different in size from the distal segment. In some cases, the distal segment has a smaller diameter than the proximal segment. In some cases, the diameter of the distal segment is 45-85% of the diameter of the proximal segment. For example, the diameter of the distal segment may be 2-5 mm, while the diameter of the proximal segment may be 3-6 mm.

[0012] In some cases, the distal tail also includes an intermediate section between the proximal section and the distal section. The intermediate section is more flexible than the proximal section, but harder than the distal section. In some cases, the length of the intermediate section is shorter than the proximal section. For example, the length of the intermediate section can be 2-7 cm.

[0013] Spacer Body: The spacer body is mounted on the main shaft. The size or shape of the spacer body is suitable for providing a coaptation surface for the leaflets of the tricuspid valve. For example, the shape of the spacer body can have a specific design. In some embodiments, the spacer body has a linear shape (e.g., an ovoid with tapered or conical ends, a cylindrical shape, etc.). In some embodiments, the spacer body has a non-linear shape (e.g., a curved or boot-shaped shape). In a non-linear shaped spacer body, the spacer body can include a bend, and the internal angle of the bend ranges from 80-140°.

[0014] Another design parameter is the length of the spacer. For example, the length of the spacer can be 4-13 cm; in some cases, 5-9 cm. In the case where the spacer has a non-linear shape, this length is represented by the travel distance along the longitudinal axis of the spacer. The width of the spacer can be measured in a cross-sectional plane perpendicular to the longitudinal axis. In some embodiments, the widest width of the spacer in this cross-sectional plane is in the range of 0.5-3.5 cm; in some cases, in the range of 0.5-2.5 cm. The spacer can have a relaxed contracted configuration and an elongated configuration. In this case, the measurements of the above spacers are performed in a relaxed configuration. In some embodiments, the width of the spacer on the widest axis is greater than the width on the transverse axis in the cross section (i.e., a non-circular or asymmetric cross section).

[0015] The spacer can have any suitable structure, such as a balloon (e.g., liquid, foam or air filled), a basket, a net, a strut (e.g., like a stent), a framework, a skeleton, a scaffolding, etc. If desired, the surface of the spacer can be provided in any suitable manner, such as a skin, a shell, a casing or a membrane. The spacer can be made of any suitable material, such as plastic, metal or a combination thereof. The spacer can have one or more openings to allow blood to flow through. There can be a gap between the spacer (at one end thereof) and the main shaft to allow blood to flow through. These openings or gaps allow blood to flow easily through the spacer, which can help prevent thrombosis.

[0016] In some embodiments, the spacer includes one or more side appendages. These can be located on the lateral sides of the spacer. The side appendages can be any type of thin, flexible structure to enhance the spacer's function as a barrier to blood flow through the tricuspid valve leaflet gap. Examples of side appendages include wings, flaps, shrouds, drapes, skirts, free edges, tags, and the like. Side appendages have widened structures (for ventricular systole) and narrowed structures (for ventricular diastole).

[0017] The widening structure of the side appendage is induced by the blood flow direction and can be performed in any suitable manner, such as spreading out, extending out, enlarging, distending, folding out, opening, etc. The narrowing structure of the side appendage is induced by another blood flow direction and can be performed in any suitable manner, such as folding in, retracting, collapsing, shrinking, closing, etc.

[0018] The side attachments should be wide enough to reduce the gap between the tricuspid valve leaflets or help stabilize the spacer across the tricuspid valve. In some embodiments, the side attachments are 0.3-5.0 centimeters wide; in some cases, 0.5-3.5 centimeters wide. The width is the maximum distance of the side attachment measured from the spacer in a direction perpendicular to the transverse axis of the spacer.

[0019] The length of the side attachment can be shorter than the length of the spacer. In some embodiments, the length of the side attachment is 2-9 cm; in some cases, 4-7 cm. The length is the longest length measured along the longitudinal axis of the spacer.

[0020] The side attachment should be thin enough to flexibly respond to blood flowing through the tricuspid valve. In some embodiments, the side attachment has a thickness of 0.2-10 mm; in some cases, 0.3-6 mm. The thickness is measured along a transverse axis perpendicular to the longitudinal axis of the side attachment and the spacer.

[0021] The side attachments can have any suitable shape. In some embodiments, the side attachments have a non-flat shape with a three-dimensional curvature, so that the side attachments have an inner side (concave surface) and an outer side (convex surface). Having such a non-flat shape can help improve the response to blood flowing through the tricuspid valve.

[0022] Proximal Portion: The proximal portion of the transcatheter device includes the proximal segment of the main shaft. The proximal segment can be a proximal continuation of the main shaft. The proximal portion of the transcatheter device can have any suitable length to provide intravascular access or provide adequate anchoring within the inferior vena cava. In some embodiments, the total length of the proximal portion is in the range of 10-60 centimeters. In embodiments where the proximal portion includes an intravascular anchor, the measurement of this length includes the length of the intravascular anchor. In cases where the intravascular anchor does not have a linear shape (e.g., a coil), this refers to the length measured along the longitudinal axis.

[0023] In some embodiments, the proximal section of the main shaft has one or more bends. The inner angle of the bend can be in the range of 80-140 °. The bend can be located at any suitable position of the proximal section of the main shaft. In some embodiments, there is a bend located at a distance of 0.25-5.5 cm from the spacer. The proximal section can also have a curved portion (curved portion) (wider than the above-mentioned bend). In some embodiments, the proximal section has two separate bends and a curved portion between the two bends. The length of the proximal section can be in the range of 3-15 cm.

[0024] Intravascular Anchor: In some embodiments, the proximal portion includes an intravascular anchor. Examples of intravascular anchors include helical coils and expandable stents. In some embodiments, the intravascular anchor is a helical coil. The helical coil may have at least two helices. The intravascular anchor may have any width suitable for anchoring in the vena cava. In some embodiments, the widest width of the intravascular anchor is in the range of 2-7 centimeters. The length of the intravascular anchor may be in the range of 4-11 centimeters (measured straight along its longitudinal axis). In the case where the intravascular anchor does not have a linear shape (e.g., a coil), this refers to the length measured along the longitudinal axis. In the case where the intravascular anchor has a flexible structure (e.g., a helical coil), this length is measured in its natural coil configuration. In another embodiment of the present invention, the transcatheter device includes an intravascular anchor or a distal tail, but not both.

[0025] Radiopaque Markers: The transcatheter device may have one or more radiopaque markers visible under X-ray imaging (e.g., X-ray fluoroscopy). In some embodiments of the transcatheter device, there is a first radiopaque marker located at the proximal segment of the main shaft (close to the spacer), and a second radiopaque marker located at the distal tail (away from the spacer). The first radiopaque marker may be located within 2 centimeters of the proximal end of the spacer. The second radiopaque marker may be located within 2 centimeters of the distal end of the spacer.

[0026] Coaptation Assembly: On the other hand, the present invention provides a coaptation assembly for treating tricuspid regurgitation. The assembly includes a transcatheter device of the present invention. The assembly also includes a guidewire passing through the lumen of the main shaft. In some embodiments, the assembly also includes a removable delivery sheath, which can cover the spacer or intravascular anchor. The sheath can be advanced to cover the spacer or intravascular anchor. Alternatively, the spacer can be retracted to uncover the spacer or intravascular anchor. In some embodiments, the assembly also includes a deployment catheter. The deployment catheter is long enough to deploy the transcatheter device in the patient's heart. For example, the length of the deployment catheter can be 50-150 cm.

[0027] Coaptation Kit: In another aspect, the present invention provides a coaptation kit for treating tricuspid regurgitation. The kit includes a transcatheter device of the present invention, a deployment catheter, a delivery sheath, and a guidewire. These components can be assembled or used as described herein.

[0028] Method of Treatment: In another aspect, the present invention provides a method of treating a defective tricuspid valve in a patient using a transcatheter device of the present invention. When the transcatheter device is implanted, the distal tail is in the pulmonary artery and the spacer spans the tricuspid valve. The transcatheter device is inserted into an entry vein, such as the femoral, subclavian, or jugular vein. The transcatheter device is further advanced into the vena cava (either the inferior vena cava or the superior vena cava). The transcatheter device passes through the right atrium of the heart, across the tricuspid valve, and into the right ventricle of the heart. The transcatheter device is further advanced into the pulmonary artery. The distal tail is advanced into the pulmonary artery. This can be the left or right pulmonary artery.

[0029] The distal tail helps anchor the transcatheter device. Thus, the distal tail can extend into the pulmonary artery a sufficient distance to perform this function. In some embodiments, the distal tail extends a distance of at least 10 centimeters in the pulmonary artery; in some cases, at least 15 centimeters. In some embodiments, the distal tail is advanced after the first branching point of the pulmonary artery; in some cases, after the second branching point of the pulmonary artery; in some cases, after the third branching point of the pulmonary artery. The correct position of the distal tail can be confirmed by radiopaque markings and X-ray imaging. In some embodiments, the distal tail is not embedded in cardiac tissue.

[0030] The spacer should be correctly positioned between the leaflets of the tricuspid valve. This correct positioning can be confirmed by external imaging such as X-ray or echocardiogram. In some embodiments, the spacer is positioned against the supraventricular crest of the heart. This position against the supraventricular crest can occur at a position within the distal half of the spacer. The tricuspid valve has a tricuspid annulus, and an annular plane is defined for the tricuspid annulus. This annular plane is along the x-axis of the tricuspid annulus and is perpendicular to the y-axis of the tricuspid annulus. In some embodiments, the spacer is positioned at an oblique angle (<90°) relative to the annular plane. This oblique angle can be in the range of 15-75°.

[0031] In embodiments where the spacer comprises a side appendage, the method may further comprise widening the side appendage during ventricular systole and narrowing the side appendage during ventricular diastole. In the widened configuration, the side appendage may be located between the tricuspid valve leaflets and block the gap present therein. In the case where the side appendage has a non-planar shape, the inner side (concave surface) faces the right ventricle.

[0032] In the embodiment where the spacer is equipped with a balloon, after the spacer is correctly positioned between the tricuspid valve leaflets, saline solution or air can be injected into the spacer to expand and maintain the balloon. In this case, the amount of saline solution or air injected can be adjusted so that the spacer has a predetermined size and volume to accommodate the size of the tricuspid valve regurgitation space.

[0033] In an embodiment where the transcatheter device also includes an intravascular anchor at its proximal portion, this intravascular anchor is fixed in the vena cava (inferior vena cava or superior vena cava). The transcatheter device can be implanted using a guidewire. The guidewire is inserted into an entry vein, such as the femoral vein, and further advanced into the vena cava (inferior vena cava or superior vena cava). The guidewire passes through the right atrium of the heart, across the tricuspid valve, and into the right ventricle of the heart. The guidewire is further advanced to the pulmonary artery. The guidewire is inserted into the guidewire lumen of the transcatheter device, and the transcatheter device is advanced along this guidewire.

[0034] Deployment: The transcatheter device can be deployed using a delivery sheath and a deployment catheter. During insertion, the delivery sheath can move to cover the spacer and, for related embodiments, the intravascular anchor. During deployment, the delivery sheath is retracted rearward. Retracting the delivery sheath and unsheathing the components of the transcatheter device can be part of the implantation process. In embodiments where the spacer is self-expanding, this unsheathing can allow the spacer to self-expand outward to provide a wider engagement surface. In embodiments where the transcatheter device includes an intravascular anchor having an expandable configuration, the unsheathing allows the anchor to expand outward to be secured in the vena cava.

[0035] In some embodiments, the deployment assembly is not removed immediately after the procedure is completed. The clinician may wish to implement a brief trial period to confirm the effectiveness of the device. During this brief trial period, one or more components of the delivery assembly (deployment catheter, delivery sheath, or guidewire) may remain in the patient's body, along with the transcatheter device. During the brief trial period, tricuspid valve function is monitored (e.g., by echocardiography). If the transcatheter device appears effective during the trial period, the delivery assembly is removed, but the transcatheter device remains in place (still-in-place). If the trial period shows an invalid result, keeping the delivery assembly in place allows the transcatheter device to be easily removed. The trial period can be any suitable short duration. For example, the trial period can be in the range of 12-48 hours post-insertion.

[0036] Retrieval: After implantation, the transcatheter device can be removed if necessary. This can be done by grasping the intravascular anchor (e.g., the helical coil at its proximal end) and pulling the transcatheter device out to remove it from the patient. For example, this can be performed by inserting a snare catheter into the access vein, advancing the snare catheter to the helical coil, grasping the helical coil, withdrawing the snare catheter, and pulling the transcatheter device out of the access vein.

[0037] In embodiments where the spacer comprises a balloon, it may be necessary to deflate the spacer by withdrawing saline or air from the spacer prior to performing retrieval. In this case, a needle with a sharp tip may be wrapped in a delivery sheath, close to the outside of the spacer, and then the needle may be exposed from the delivery sheath, a hole may be made in the balloon of the spacer, and the saline solution may be allowed to drain from the spacer through the hole.

[0038] As described above, the present invention can be effectively applied to the catheter treatment of tricuspid regurgitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1A is a diagram illustrating an embodiment of a transcatheter device for treating tricuspid regurgitation.

[0040] Figure 1B It is shown Figure 1A Mid-view of the main axis and distal tail of the transcatheter device.

[0041] Figure 1C is along Figure 1A The cross-sectional view taken along EE' in FIG. 1 shows a cross-sectional view of the main axis of the transcatheter device.

[0042] Figure 1D yes Figure 1C Cross-sectional views of various parts of the mid-distal tail, wherein (a) is a cross-sectional view taken along II', (b) is a cross-sectional view taken along II-II', and (c) is a cross-sectional view taken along III-III'.

[0043] Figure 1E is a view showing another example of a transcatheter device for treating tricuspid regurgitation.

[0044] Figure 1F It is shown Figure 1E Mid-view of the main axis and distal tail of the transcatheter device.

[0045] Figure 2A is a view showing a spacer having a balloon covered with a mesh structure.

[0046] Figure 2B is a view showing a spacer covering the e-PTFE layer of the balloon.

[0047] Figure 2C is along Figure 2B A cross-sectional view taken along line AA' in (b).

[0048] Figure 3A is a view showing an example of a transcatheter device in which an injection valve is installed in a spacer.

[0049] Figure 3B yes Figure 3A Enlarged view of the injection valve installation section.

[0050] Figure 3C is along Figure 3B The cross-sectional view taken along DD' in FIG. 1 shows the opening and closing states of the injection valve.

[0051] Figure 3D is along Figure 3C The cross-sectional view taken along BB' in FIG. 1 shows the opening and closing states of the injection valve.

[0052] Figure 4A is a view showing an embodiment of a transcatheter device in which an injection valve is mounted on a proximal end portion of a main shaft.

[0053] Figure 4B yes Figure 4A An enlarged view of the injection valve mounting portion showing the open and closed states of the injection valve.

[0054] Figure 5A is a view showing another embodiment of a transcatheter device in which an injection valve is mounted on a proximal end portion of a main shaft.

[0055] Figure 5B yes Figure 5A An enlarged view of the injection valve mounting portion showing the open and closed states of the injection valve.

[0056] Figure 5C is along Figure 5B The cross-sectional view taken along CC' in FIG. 1 shows the opening and closing states of the injection valve.

[0057] Figure 6 is a view showing deployment of a transcatheter device within the heart. DETAILED DESCRIPTION

[0058] To help understand the present invention, specific embodiments in which the present invention may be implemented are exemplarily shown with reference to the accompanying drawings. The drawings herein are not necessarily drawn to scale or actual proportion. For example, the length and width of the components may be adjusted to accommodate the page size. Hereinafter, the terms "distal end" and "proximal end" are used to refer to a position far from an operator as the "distal end" and a position near an operator as the "proximal end".

[0059] Figure 1A 1 is a view showing an embodiment of a transcatheter device 100. In this embodiment, the transcatheter device 100 has a distal tail 122, a spacer 150, a proximal segment 140 of a main shaft 120, and an intravascular anchor 148. In addition, a link 510 is provided between the proximal segment 140 of the main shaft 120 and the intravascular anchor 148 to connect the transcatheter device 100 to a deployment catheter (not shown). The intravascular anchor 148 is composed of a spiral coil wound on a metal wire.

[0060] like Figure 6 As shown, the transcatheter device 100 has a distal tail 122 anchored to the pulmonary artery (PA), an intravascular anchor 148 anchored to the inferior vena cava (IVC), and a spacer 150 arranged across the tricuspid annulus (TVA), more specifically, between the leaflets of the tricuspid valve (TV).

[0061] like Figure 1A and Figure 1B As shown, the distal tail 122 has at least three segments with different flexibility. The three segments are the distal segment 124, the middle segment 126 and the proximal segment 128. The three segments are the distal segment 124, the middle segment 126 and the proximal segment 128. The distal segment 124 has a curved shape with a constant anchoring curvature R0. The anchoring curvature R0 is about 110 mm.

[0062] In addition, the distal segment 124 of the distal tail 122 is softer than the middle segment 126 and the proximal segment 128. The proximal segment 128 of the distal tail 122 is harder than the middle segment 126 and the distal segment 124. The flexibility of the distal tail 122 increases toward the distal side along the length direction of the curved shape of the distal tail 122, so that when the distal tail 122 is inserted into the pulmonary artery (PA), the distal tail 122 can be easily bent according to the configuration of the pulmonary artery (PA), which causes less trauma to the pulmonary artery (PA).

[0063] Specifically, refer to Figure 1D, the middle section 126 and the distal section 124 of the distal tail 122 have a jacket 160, wherein the inside of the jacket 160 is formed with a first lumen 162 for guiding the guide wire. In addition, the nickel-titanium alloy core wire 164 is not inside the jacket 160 of the middle section 126 of the distal tail 122 and the jacket 160 of the distal section 124. The jacket 160 of the middle section 126 of the distal tail 122 is made of Pellethane 55D (Shore D hardness grade 55), and the jacket 160 of the distal section 124 of the distal tail 122 is made of Pellethane 90A (Shore A hardness grade 90). The material of Pellethane 55D is harder than the material of Pellethane 90A. The diameters of the middle section 126 and the distal section 124 of the distal tail 122 are smaller than the diameter of the proximal section 128 of the distal tail 122. The outer cover 160 of the intermediate section 126 of the distal tail 122 and the outer cover 160 of the distal section 124 are surrounded by an e-PTFE layer 161. Pellethane is a brand name for a thermoplastic polyurethane elastomer that is often used in medical devices.

[0064] The proximal section 128 of the distal tail 122 is composed of a first proximal section 128a and a second proximal section 128b. The first proximal section 128a and the second proximal section 128b both have a jacket 160 made of pellethane (thermoplastic polyurethane elastomer) and an e-PTFE layer 161 surrounding the jacket 160. Inside the jacket 160, a first cavity 162 is formed to guide the guide wire, and a second cavity 163 is formed to insert a nickel-titanium alloy core wire 164. The jacket 160 of the first proximal section 128a is made of Pellethane 55D (Shore D hardness grade 55), and the jacket 160 of the second proximal section 128b is made of Pellethane 75D (Shore D hardness grade 75). Pellethane 75D is harder than Pellethane 55D. The diameter of the proximal section 128 is about 3 mm.

[0065] As described above, the distal tail 122 has the following structure: the flexibility increases toward the distal side along the length direction of the curved shape, that is, the second proximal segment 128b (nickel-titanium alloy wire + Pellethane 75D jacket)> the first proximal segment 128a (nickel-titanium alloy wire + Pellethane 55D jacket)> the middle segment 126 (Pellethane 55D jacket)> the distal segment 124 (Pellethane 90A jacket).

[0066] The total length of the distal tail 122 is about 15 cm. The length of the distal segment 124 is about 2.5 cm. The length of the middle segment 126 is about 2.5 cm. The lengths of the first proximal segment 128a and the second proximal segment 128b of the proximal segment 128 are respectively about 5 cm.

[0067] The main shaft 120 of the transcatheter device 100 refers to a structure in which the nickel-titanium alloy wire 164 is inserted to support the transcatheter device 100, and for convenience of description, is sometimes described as having a proximal portion, a middle portion, and a distal portion.

[0068] Figure 1A and Figure 1B As shown in , the main shaft 120 corresponds to the portion of the proximal section 140 to the proximal section 128 of the distal tail 122. The proximal portion of the main shaft 120 may be the portion corresponding to the proximal section 140, the middle portion of the main shaft 120 may be the portion between the proximal section and the distal section, the spacer 150 is installed in the middle portion, and the distal portion of the main shaft 120 may be the portion corresponding to the proximal section 128 of the distal tail 122. In addition, the intravascular anchor 148 is connected to the proximal portion of the main shaft 120.

[0069] The first lumen 162 for inserting the guide wire, the second lumen 163 for inserting the nickel-titanium alloy core wire 164, and the third lumen 165 for inserting the injection tube 132 are formed to extend along the length direction inside the main shaft 120. However, the third lumen 165 for inserting the injection tube 132 is formed only from the proximal end section 140 to the point where the injection valve 129 described below is located.

[0070] like Figure 6 As shown in FIG. 1 , the proximal end section 140 of the main shaft 120 is connected to the upper end of the intravascular anchor 148 at a point biased toward one side of the right atrium (RA) rather than the center of the inferior vena cava (IVC). In addition, the proximal end section 140 of the main shaft 120 includes an insertion portion 141, a first curved portion 142, a connection portion 143, and a second curved portion 144, as shown in FIG. Figure 1A and Figure 1B shown.

[0071] Specifically, the insertion portion 141 has a straight shape that is vertically inserted into the inferior vena cava (IVC), and its lower end is connected to the intravascular anchor 148. The insertion portion 141 can be configured to contact the inner surface of the right atrium (RA) side of the inferior vena cava (IVC). The first curved portion 142 extends curvedly with a first curvature R1 from the upper end of the insertion portion 141 to the tricuspid valve (TV) side. The second curved portion 144 extends curvedly with a second curvature R2 from the middle portion of the main axis 120 to the inferior vena cava (IVC) side. The connecting portion 143 connects the first curved portion 142 and the second curved portion 144, and extends along the inferior vena cava tricuspid valve annulus (CTI) between the inferior vena cava (IVC) and the tricuspid valve annulus (TVA).

[0072] The connecting portion 143 has a shape that mimics the shape of the isthmus (CTI) between the inferior vena cava (IVC) and the tricuspid valve annulus (TVA). Figure 6 Specifically, Figure 1A and Figure 1B As shown, the connecting portion 141 may have an upward slope from the first curved portion 142 to the second curved portion 144. The transcatheter device 100 having the connecting portion 143 with an upward slope may be preferably applied to the following heart: wherein the inferior vena cava tricuspid annular isthmus (CTI) has an upward slope because of the lower position of the inferior vena cava (IVC) and the higher position of the tricuspid annulus (TVA). In addition, the inner angle α of the first curved portion 142 ranges from 80° to 120°. In addition, the inner angle β of the second curved portion 144 ranges from 80° to 120°.

[0073] The main shaft 120 having the proximal end section 140 can be elastically deformed around the second curved portion 144 , and can also be elastically deformed with the first curved portion 142 of the proximal end section 140 as the center.

[0074] Meanwhile, the position of the installed transcatheter device 100 may change due to the movement of the heart during diastole and systole. In particular, when the right ventricle (RV) contracts, the middle portion and the distal portion may experience a movement that pushes toward the right ventricle (RV). This may cause the middle portion and the distal portion to move along the second curved portion 144 as the center. Figure 6 The deformation is in the direction of the arrow A in FIG. 1 and the ... Figure 6 Deformation in the direction of arrow A.

[0075] As described above, since the middle portion and the distal portion of the transcatheter device 100 can be elastically deformed around the second curved portion 144 of the proximal segment 140, and can also be elastically deformed around the first curved portion 142 of the proximal segment 140, even in this case, a restoring force is generated that pushes the middle portion and the distal portion in the direction of arrow B opposite to the direction of arrow A described above. Therefore, the distal tail 122 including the distal portion can be in close contact with the inside of the pulmonary artery (PA), and further, the point where the distal portion and the middle portion intersect can be in close contact with the supraventricular crest (SUV) (see Figure 6 ). Thus, the transcatheter device 100 and the spacer 120 can be stably maintained in a desired position relative to the movement of the heart, particularly during systole.

[0076] In addition, the first curvature R1 of the first curved portion 142 and the second curvature R2 of the second curved portion 144 are respectively determined by the structure of the heart in the corresponding parts and can be the same or different. However, when the first curvature R1 of the first curved portion 142 and the second curvature R2 of the second curved portion 144 are the same, it is easier to manufacture.

[0077] Meanwhile, the horizontal length L1 of the proximal section 140 of the main shaft 120, i.e., the length L1 between the first curved portion 142 and the second curved portion 144, preferably has a range covering the isthmus of the tricuspid ring of the inferior vena cava (CTI). In this embodiment, the horizontal length L1 of the proximal section 140 ranges from 30 to 70 mm. In addition, the extension length L2 in the length direction of the connecting portion 143 located between the first curved portion 142 and the second curved portion 144 ranges from 30 to 50 mm.

[0078] Figure 1C is along Figure 1A The cross-sectional view taken along E-E' in FIG. 1 illustrates a cross-sectional view of the main axis of the transcatheter device. Figure 1C As shown, the proximal end section 140 of the main shaft 120 has a jacket 160 made of Pellethane 90A (Shore A hardness grade 90) and an e-PTFE layer 161 surrounding the jacket 160, wherein a first lumen 162 is formed inside the jacket 160 to guide a guide wire. The diameter D1 of the proximal end section 140 of the main shaft 120 is about 3 mm.

[0079] In addition, a second lumen 163 is formed inside the proximal section 140 of the main shaft 120, into which a nickel-titanium alloy core wire 164 is inserted to structurally support the main shaft 120 over the entire length of the main shaft 120. This nickel-titanium alloy core wire 164 extends to the proximal section 128 of the distal tail 122 and imparts a preformed curved shape to the distal tail 122. In addition, a third lumen 165 is formed in the main shaft 120, into which an injection tube 132 described below is inserted.

[0080] In addition, from Figure 1C and Figure 1D As can be seen from (c), the proximal section 140 of the main shaft 120 has a similar structure and a similar material composition as the proximal section 128 of the distal tail 122, except that a cavity 165 of the injection tube is formed. Therefore, the proximal section 128 of the distal tail 122 and the proximal section 140 of the main shaft 120 have similar strengths.

[0081] The transcatheter device 100 has a series of radiopaque markings. The proximal section 140 of the main shaft has a radiopaque strip (not shown). The distal tail 122 has a series of radiopaque bands. In addition, the distal tail 122 is provided with a radiopaque band at its end.

[0082] Figure 1E is a schematic illustration of another example of a transcatheter device for treating tricuspid regurgitation, Figure 1F yes Figure 1E Schematic view of the main shaft and distal tail of a mid-stage transcatheter device. Figure 1E and Figure 1F The transcatheter device 100 ′ shown in FIG. Figures 1A to 1D The transcatheter device 100 shown in FIG. 1 is different only in the configuration of the connecting portion 143 ′ composed of the proximal end section 140 of the main shaft 120 , and the remaining portions are the same.

[0083] Specifically, Figures 1A to 1D The connecting portion 143 of the transcatheter device 100 shown in FIG. Figure 1E and Figure 1F The connecting portion 143' of the transcatheter device 100' shown in the figure is different: the former has an upward slope from the first curved portion 142 to the second curved portion 144, while the latter has a downward slope from the first curved portion 142 to the second curved portion 144. The transcatheter device 100 having the connecting portion 143' with a downward slope can be preferably applied to the following heart: due to the higher position of the inferior vena cava (IVC) and the lower position of the tricuspid annulus (TVA), the tricuspid isthmus (CTI) of the inferior vena cava has a downward slope. In addition, the inner angle α of the first curved portion 142 ranges from 80° to 120°, and the inner angle β of the second curved portion 144 ranges from 80° to 120°. In addition, the extension length L2 of the connecting portion 143' located between the first curved portion 142 and the second curved portion 144 in the length direction ranges from 30 to 50 mm.

[0084] At the same time, the main shaft 120, the distal tail 122 and the intravascular anchor 148 are all surrounded by a constant thickness e-PTFE layer 161, which is made of e-PTFE. Figure 1A , Figure 1B , Figure 1E and Figure 1FAs shown, the e-PTFE layer 161 extends a certain distance from the end of the distal tail 122 to form a circular wrapped end 125. That is, since the end 124 protrudes more than the end of the distal segment 124 of the distal tail 122, is composed only of the e-PTFE layer, and is wrapped in a circular shape, when inserted into the pulmonary artery (PA), the end 125 will not cause trauma to the pulmonary artery (PA) even if it contacts the pulmonary artery (PA).

[0085] Figure 2A and Figure 2C 1 is a view illustrating an embodiment of the spacer 150 in detail. In addition, Figure 2A (a) and (b) respectively show a state where the spacer 150 is not filled with saline solution and a state where the spacer 150 is filled with saline solution. The spacer 150 has a distal end 151a and a proximal end 151b, and a mesh structure 151 formed of wires. The main shaft 120 passes through the spacer 150. One side of the distal end 151a and the proximal end 151b of the main shaft 120 is fixedly mounted to the main shaft 120, and the other side is not fixedly mounted to the main shaft 120 and can move axially relative to the main shaft 120. In this embodiment, the proximal end 151b of the spacer 150 is fixed, and the distal end 151b is movable.

[0086] The mesh structure 151 is made of a shape memory alloy or the like, and maintains a predetermined configuration of expansion without external force. In addition, when an external force is applied, the mesh structure 151 can shrink, in which case the other side not fixed to the main shaft 120 can move along the main shaft 120. The mesh structure 151 can shrink or expand during deployment.

[0087] like Figure 2A As shown, the spacer 150 has a balloon 152 having a distal end 152a and a proximal end 152b. The distal end 152a and the proximal end 152b of the balloon 152 are fixedly mounted to the main shaft 120. The balloon 152 is formed into a closed structure covering the mesh structure 151. The closed internal space of the balloon 152 can be filled with a saline solution S.

[0088] like Figure 2A As shown in (a), even if the internal space of the balloon 152 is not filled with the saline solution S, the balloon 152 can maintain its shape to a certain extent by the mesh structure 151 located inside the balloon 152. Figure 2A As shown in (b), when the inner space of the balloon 152 is filled with the saline solution S, the balloon 152 expands and the mesh structure 151 also expands accordingly.

[0089] The balloon 152 is formed to adjust its shape according to the patient's heart (specifically, the size of the regurgitation space where tricuspid regurgitation occurs). In this embodiment, the balloon 152 is shaped such that, in the expanded state, the right ventricle (RV) side is larger than the right atrium (RA) side relative to the main axis 120.

[0090] The volume of the spacer 150 can be adjusted according to the amount of saline solution S injected into the balloon 152. Therefore, the size of the spacer 150 can be adjusted to fit the size of the regurgitation space where tricuspid regurgitation occurs, etc. Therefore, when the spacer 150 does not fit the size of the regurgitation space, the operator can simply adjust the amount of the injected saline solution S without taking it back. In addition, the inside of the balloon 152 can be filled with air instead of the saline solution S.

[0091] Figure 2B is a view showing another embodiment of the spacer 150, wherein Figure 2B (a) and (b) respectively show a state where the spacer 150 is not filled with saline solution and a state where the spacer 150 is filled with saline solution. Figure 2B The spacer 150 shown in FIG. Figure 2A The spacer 150 shown in FIG. 1 further includes an e-PTFE layer 153 formed to cover the balloon 152. The e-PTFE layer 153 is formed to expand together with the balloon 152 when the balloon 152 is expanded by supplying a saline solution. The e-PTFE layer 153 is formed to adjust the shape of the balloon 152 according to the patient's heart (specifically, the size of the regurgitation space where tricuspid regurgitation occurs) like the balloon 152.

[0092] Figure 2C is along Figure 2B When the spacer 150 is expanded in the tricuspid valve, the balloon 152 and the e-PTFE layer 153 are formed to cover the expanded mesh structure 151 .

[0093] Figure 3A and Figure 3B is a schematic diagram of the injection valve 129 and the injection tube 132, wherein Figure 3B yes Figure 3A An enlarged view of the injection valve 129, Figure 3C is along Figure 3B A cross-sectional view of the injection valve 129 taken along line DD' in FIG. Figure 3D is along Figure 3C A cross-sectional view of the injection valve 129 taken along line BB' in FIG. Figure 3C (a) and Figure 3D (a) shows a state where the injection tube 132 is inserted and the injection valve 129 is opened. Figure 3C (b) and Figure 3D(b) in FIG. 1 shows a state where the injection tube 132 is removed and the injection valve 129 is closed.

[0094] The injection valve 129 is formed of a silicone band 129 a having elasticity. The silicone band 129 a surrounds the outer side surface of the main shaft 120. The injection tube 132 may be inserted between the silicone band 129 a and the main shaft 120.

[0095] The main shaft 120 has an injection hole 131 formed therein, the injection hole 131 communicating with the third cavity 165 and the inner space of the spacer 150. The silicone tape 129a covers the injection hole 131. The injection tube 132 may pass through the injection hole 131.

[0096] The third lumen 165 extends from the proximal end section 140 of the main shaft 120 to the injection hole 131, and the injection tube 132 advances along the third lumen 165 and is exposed to the inner space of the spacer 150 through the injection hole 131 (see Figure 3B and Figure 3C (a)).

[0097] When the distal end of the injection tube 132 is exposed to the inner space of the spacer 150, the silicone tape 129a extends in the radial direction due to the injection tube 132, causing the injection valve 129 to be in an open state (see FIG. Figure 3C (a) and Figure 3D (a)). When a saline solution S is injected into the inner space of the spacer 150 through the injection tube 132 in this open state, the balloon 152 expands. As the balloon 152 expands, the e-PTFE layer 153 also expands.

[0098] When the injection of the saline solution S is completed through the injection tube 132 and the injection tube 132 is withdrawn to the outside and retrieved, the silicone band 129a shrinks and comes into close contact with the outer surface of the main shaft 120. Therefore, the injection hole 131 is blocked by the silicone band 129a, so that the third chamber 165 is closed when the injection valve 129 is closed (see FIG. Figure 3C (d) and Figure 3D (d) in the figure.

[0099] In the closed state of the injection valve 129, the spacer 150 is filled with a saline solution S having a predetermined pressure, so the silicone band 129a can be more firmly in close contact with the outer surface of the main shaft 120 due to the pressure. This more safely prevents the saline solution S filled in the spacer 150 from escaping through the third cavity 165.

[0100] Next, Figure 4A is a schematic diagram showing an embodiment of a transcatheter device in which an injection valve is mounted on a proximal portion of a main shaft, Figure 4B yes Figure 4A An enlarged view of the injection valve installation portion, showing the injection valve in the open state ( Figure 4B(a)) and the closed state ( Figure 4B (b)).

[0101] Reference Figure 4A and Figure 4B The injection valve 129 is formed of a silicone band 129b having elasticity and is wrapped around a point on the proximal portion of the main shaft 120. The main shaft 120 has an injection hole 131 formed therein, which communicates with the third cavity 165 and the inner space of the spacer 150. That is, the third cavity 165 of the main shaft 120 extends from the proximal portion of the main shaft 120 to the injection hole 131.

[0102] In addition, the proximal end portion of the main shaft 120 is provided with a closing portion 133, which closes a section of the third cavity 165. Communication holes 134a and 134b are formed at both ends of the closing portion 133, and the communication holes 134a and 134b communicate with the third cavity 165 and the outside of the main shaft 120, and the injection tube 132 is inserted therethrough.

[0103] The silicone tape 129b constituting the injection valve 129 has a size in the length direction to cover the closing portion 133 and the communication holes 134a and 134b, and is capable of closing the communication holes 134a and 134b when contracted.

[0104] like Figure 4B As shown in (a), the injection tube 132 is inserted through the third cavity 165 and exits the outside of the main shaft 120 through the communication hole 134a just before the closed portion 133, and is inserted again through the communication hole 134b into the third cavity 165 inside the main shaft 120. In this state, the silicone tape 129b extends in the radial direction (open state of the injection valve 129).

[0105] In the open state of the injection valve 129, the injection tube 132 is connected to the injection hole 131 located in the spacer 150 through the third lumen 165. Therefore, when the saline solution S is injected through the injection tube 132, the saline solution S passes through the third lumen 165 and enters the space in the spacer 150 through the injection hole 131 to expand the balloon 152. As the balloon 152 expands, the e-PTFE layer 153 also expands.

[0106] When the injection of the saline solution S into the spacer 150 is completed, the injection tube 132 is withdrawn to the outside and retrieved. When the injection tube 132 is withdrawn to the outside and retrieved, the injection tube 132 is withdrawn from the silicone band 129b, so that the silicone band 129b shrinks, as shown in FIG. Figure 4B This makes the silicone tape 129b come into close contact with the outer surface of the main shaft 120, closes the communication holes 134a and 134b (the closed state of the injection valve 129), and prevents the injected saline solution S from escaping to the outside.

[0107] As described above, when the injection valve 129 is disposed at the proximal end portion of the main shaft 120, it is advantageous in that the injection tube 132 does not need to be inserted into the injection hole 131 in the spacer 150. In addition, the silicone tape 129b does not necessarily have to be disposed on the outside of the main shaft 120, but may be disposed on the outside of the upper link portion 510a of the link portion 510 described below.

[0108] also, Figure 5A , Figure 5B and Figure 5C is another embodiment of a transcatheter device 100 that utilizes an injection valve 129 disposed within a proximal portion of the main shaft 120 . Figure 5B yes Figure 5A An enlarged view of the injection valve 129, Figure 5C is along Figure 5B In addition, Figure 5B (a) and Figure 5C (a) shows the open state of the injection valve 129, Figure 5B (b) and Figure 5C (b) shows the closed state of the injection valve 129.

[0109] The injection valve 129 is formed of a cylindrical silicone body 129c having elasticity. The silicone body 129c is disposed inside the main shaft 120 around the proximal end portion of the main shaft 120. The silicone body 129c has a cross-sectional size capable of covering the third cavity 165 in an expanded state. Since the silicone body 129c has elasticity, the silicone body 129c can fill the third cavity 165 in an expanded state, so that the third cavity 165 is in a closed state, and in a contracted state, the third cavity 165 is in an open state. In addition, the silicone body 129c does not necessarily have to be disposed inside the main shaft 120, and can be disposed inside the upper link portion 510a of the link portion 510 described below.

[0110] like Figure 5A As shown, the main shaft 120 has an injection hole 131 formed therein, which communicates with the third lumen 165 and the inner space of the spacer 150. That is, the third lumen 165 of the main shaft 120 extends from the proximal end portion of the main shaft 120 to the injection hole 131.

[0111] like Figure 5B (a) and Figure 5C As shown in (a), when the injection tube 132 is inserted through the third lumen 165, the silicone body 129c contracts, resulting in an open state, and the injection tube 132 can pass through (open state of the injection valve 129). When the saline solution S is injected through the injection tube 132 in this open state, the saline solution S is injected into the inner space of the spacer 150 through the third lumen 165 and the injection hole 131 to expand the balloon 152.

[0112] When the injection is complete and the syringe 132 is withdrawn, Figure 5B (b) and Figure 5C As shown in (b), the silicone body 129c expands, resulting in a closed state in which the third chamber 165 is blocked (the closed state of the injection valve 129). Since the saline solution S in the balloon 152 does not escape in this closed state, the balloon 152 is maintained in an expanded state with a predetermined volume by the filled saline solution S.

[0113] At the same time, reference Figure 5A and 5B , shows a link 510, wherein an upper link 510a is provided on the transcatheter device 100, and a lower link 510b is provided at the upper end of a pusher 520 of a deployment catheter (not shown), and they are stuck to each other. The upper link 510a and the lower link 510b are formed with channels 513a and 513b for inserting the injection tube 132 along the length direction. When the upper link 510a and the lower link 510b are linked, the channels 513a and 513b are connected, and the channels 513a and 513b are communicated with the third cavity 165.

[0114] The injection tube 132 passes through the lower link 510b and the upper link 510a and is inserted into the third lumen 165 of the transcatheter device 100. The link state of the upper link 510a and the lower link 510b is maintained by the injection tube 132 passing through the upper link 510a and the lower link 510b, so that the transcatheter device 100 is connected to the pusher 520 of the deployment catheter. In the case where the transcatheter device 100 is connected to the pusher 520 of the deployment catheter, the operator can push the transcatheter device 100 through the pusher 520 to advance the transcatheter device 100 to the desired position.

[0115] In addition, when the injection tube 132 is withdrawn from the upper link 510a and the lower link 510b, the link state of the upper link 510a and the lower link 510b is released, thereby releasing the connection between the transcatheter device 100 and the pusher 520 of the deployment catheter. The operator can deploy the transcatheter device 100 at a desired position, and after injecting a saline solution through the injection tube 132, the operator can release the link between the upper link 510a and the lower link 510b by withdrawing the injection tube 132, and then withdraw the pusher 520 of the deployment catheter and the lower link 510b separated from the upper link 510a.

[0116] A concave portion 511 is formed on the upper link 510a, and a convex portion 512 is formed on the lower link 510b, and the convex portion 512 is caught on the concave portion 511. The upper link 510a and the lower link 510b are linked by the concave portion 511 of the upper link 510a and the convex portion 512 of the lower link 510b being engaged and caught. In the structure in which the upper link 510a and the lower link 510b are caught with each other, the upper link 510a may form a convex portion, and the lower link 510b may form a concave portion, or other configurations may be used.

[0117] At the same time, when the upper link 510a and the lower link 510b are linked, each surface of the concave portion 511 and the convex portion 512 contacting each other is an inclined surface inclined relative to the length direction. Therefore, the upper link 510a and the lower link 510b are easier to be stuck and separated.

[0118] In addition, the lower end of the upper link 510a has a curved edge 514. When the lower link 510b is retrieved in a separated state, the lower end of the upper link 510a hits the blood vessel, but the curved edge 514 does not cause blood vessel trauma.

[0119] In addition, when the transcatheter device 100 is withdrawn from the body and retrieved, it is necessary to withdraw the saline solution S from the spacer 150 to shrink the spacer 150. In this case, a needle with a sharp tip wrapped in a delivery sheath can be brought close to the outside of the spacer 150, and then the needle can be exposed from the delivery sheath to make a hole in the balloon 152 and the e-PTFE layer 153 of the spacer 150, allowing the saline solution S to be discharged from the spacer 150 through the hole.

[0120] The above description and examples are intended only to illustrate the present invention and are not intended to limit the scope of the claims. The various aspects and embodiments disclosed in the present invention may be considered alone or in combination with other aspects, embodiments and modifications of the present invention. In addition, unless otherwise specified, the steps of the method of the present invention are not limited to any particular order of execution. Modifications to the disclosed embodiments that include the concepts and essence of the present invention may be accomplished by those skilled in the art, and these modifications are included within the scope of the present invention.

[0121] In this specification, any use of the word "or" is intended to be inclusive, and unless the context clearly dictates otherwise, 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 a combination of A, B, and C.

[0122] Description of reference numerals:

[0123] 100, 100': Transcatheter Devices

[0124] 120: Spindle

[0125] 122: Distal tail

[0126] 124: Remote segment

[0127] 126: Middle section

[0128] 128: Proximal segment

[0129] 129: Injection valve

[0130] 129a, 129b: Silicone tape

[0131] 129c: Silicone

[0132] 131: Injection hole

[0133] 132: Injection tube

[0134] 140: Proximal segment of the spindle

[0135] 141: Insertion

[0136] 142: First bend

[0137] 143, 143': Connecting part

[0138] 144: Second bending section

[0139] 148: Intravascular Anchors

[0140] 150: Spacer

[0141] 151: Network structure

[0142] 152: Balloon

[0143] 153: e-PTFE layer

[0144] 160: Jacket

[0145] 161: e-PTFE layer

[0146] 162: First cavity

[0147] 163: Second cavity

[0148] 164: Nickel-titanium alloy core wire

[0149] 165: The third cavity

[0150] 510: Link Department

[0151] 510a: Upper link

[0152] 510b: Downlink

[0153] R1: First curvature

[0154] R2: Second curvature

[0155] IVC: inferior vena cava

[0156] RV: right ventricle

[0157] RA: right atrium

[0158] PA: pulmonary artery

[0159] CTI: isthmus of the tricuspid valve of the inferior vena cava

[0160] TV: Tricuspid valve

[0161] TVA: tricuspid annulus

[0162] SC: supraventricular ridge.

Claims

1. A transcatheter device comprising: a main shaft including a proximal portion, a middle portion and a distal portion, and having a first lumen for inserting a guide wire, a second lumen for inserting a nickel-titanium alloy wire and a third lumen for inserting an injection tube formed therein; a distal tail comprising a distal portion of the main shaft; as well as a spacer mounted on the intermediate portion, the intermediate portion being located between the distal portion and the proximal portion of the main shaft, wherein the proximal portion of the main shaft comprises a proximal segment and an intravascular anchor connected to the proximal segment, and Wherein, the spacer comprises: a mesh structure configured to be contractible or expandable and expand to have a predetermined configuration in the absence of external forces from the environment; and The balloon is configured to cover the mesh structure to maintain a closed state, and the size of the balloon is controlled according to the amount of saline solution injected into the inner space thereof.

2. The transcatheter device of claim 1, wherein: The spacer also includes an e-PTFE layer configured to cover the balloon.

3. The transcatheter device of claim 1, wherein: The main shaft further includes an injection hole configured to connect the third cavity with the inner space of the spacer, and an injection valve configured to open and close the communication between the third cavity and the injection hole by inserting or withdrawing the injection tube.

4. The transcatheter device of claim 3, wherein: The injection valve includes a silicone band disposed on an outer side of the main shaft inside the spacer.

5. The transcatheter device of claim 3, wherein: The injection valve includes a silicone band disposed outside the main shaft in the proximal end portion of the main shaft.

6. The transcatheter device of claim 3, wherein: The injection valve includes a silicone body disposed inside the main shaft in the proximal end portion of the main shaft.

7. The transcatheter device according to any one of claims 1 to 6, wherein: In the proximal portion of the main shaft, the proximal section comprises: an insertion portion, inserted into the inferior vena cava (IVC) and connected to the intravascular anchor; a first curved portion extending curvedly from an upper end of the insertion portion toward a tricuspid valve (TV) side with a first curvature R1; A second curved portion extending curvedly from the middle portion of the main shaft toward the inferior vena cava (IVC) side with a second curvature R2; A connecting portion is configured to connect the first curved portion to the second curved portion and extends along the tricuspid isthmus (CTI) of the inferior vena cava (IVC) and the tricuspid valve (TV).

8. The transcatheter device of claim 7, wherein: The horizontal length L1 of the proximal segment in the proximal portion of the main shaft has a range covering the isthmus of the inferior vena cava tricuspid annulus (CTI) between the inferior vena cava (IVC) and the tricuspid valve (TV).

9. The transcatheter device of claim 8, wherein: The horizontal length L1 of the proximal section is in the range of 30 to 70 mm.

10. The transcatheter device of claim 8, wherein: The extension length L2 of the connecting portion of the proximal section is in the range of 30 to 50 mm.

11. The transcatheter device of claim 7, wherein: An inner angle α of the first curved portion is in the range of 80° to 120°.

12. The transcatheter device of claim 7, wherein: An inner angle α of the second curved portion is in the range of 80° to 120°.

13. A joint assembly comprising: The transcatheter device according to claim 1; a guidewire configured to be moved through the first lumen of the main shaft; a delivery sheath movable to cover the spacer and the intravascular anchor; as well as A deployment catheter is configured for intravascular deployment of the transcatheter device.

14. The joint assembly of claim 13, comprising: an upper link disposed on a proximal portion of the main shaft of the transcatheter device; The lower link, connected to the pusher of the deployment catheter, can be snapped or separated from the upper link, Wherein, the channel through which the injection tube passes is connected to the upper link part and the lower link part which are in a linked state.

15. A method of treating tricuspid regurgitation in a patient's heart using the transcatheter device of claim 1, the method comprising: inserting the transcatheter device into a femoral vein; advancing the transcatheter device through the inferior vena cava; advancing the transcatheter device through the right atrium of the heart; advancing the transcatheter device across the tricuspid valve into the right ventricle of the heart; advancing the transcatheter device toward a pulmonary artery; advancing the distal tail into the pulmonary artery a distance of at least 10 centimeters; positioning the spacer between the leaflets of the tricuspid valve; fixing the intravascular anchor in the inferior vena cava; A saline solution is injected into the spacer, and the amount of the injected saline solution is adjusted so that the spacer has a predetermined size and volume.

16. The method according to claim 15, further comprising: When retrieving the transcatheter device, a needle with a sharp tip is brought close to the outside of the spacer to form a hole in the spacer, thereby draining the saline solution filled in the spacer.

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