Transcatheter Devices

Abstract

The transcatheter device includes a main shaft having a proximal portion, an intermediate portion, and a distal portion, the main shaft having a first lumen for inserting a guide wire, a second lumen for inserting a nitinol wire, and a third lumen for inserting an infusion tube formed therein, a distal tail including a distal portion of the main shaft, and a spacer body attached to the intermediate portion located between the distal and proximal portions of the main shaft, the proximal portion of the main shaft including a proximal section and an intravascular anchor connected to the proximal section, the spacer body being configured to be contractible or expandable and to expand to a predetermined configuration in the absence of external forces from the environment, and a balloon configured to cover the mesh structure to maintain a sealing state and whose size is controlled according to the amount of saline injected into its internal space.

Description

[Technical Field]

[0001]

[0001] The present invention relates to transcatheter devices for treating tricuspid regurgitation. [Background technology]

[0002] Heart valve regurgitation (leakage through a heart valve) occurs when a heart valve does not close properly. One example is tricuspid regurgitation, which is typically caused by changes in the geometric configuration of the right ventricle, papillary muscles, and tricuspid annulus. These geometric changes result in incomplete coaptation of the valve leaflets during ventricular systole, leading to regurgitation. In the past, repairing heart valves required open-heart surgery with cardiopulmonary bypass. In recent years, various catheter-based techniques for valve repair have been 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: In one aspect, the present invention is a transcatheter device comprising a main shaft, a proximal portion, a distal tail, and a spacer body attached to the main shaft and located between the proximal portion and the distal tail. The transcatheter device can be used to treat tricuspid regurgitation in a patient's heart. All or a portion of the transcatheter device is supported by the main shaft. The spacer body is attached to a shaft that travels through the spacer body. The proximal portion of the transcatheter device includes a proximal section of the main shaft. This can alternatively be expressed as the proximal section of the main shaft including the proximal portion of the transcatheter device. The distal tail of the transcatheter device includes a distal section of the main shaft. This can alternatively be expressed as the distal section of the main shaft including the distal tail of the transcatheter device.

[0005]

[0005] The main shaft includes a lumen and opening(s) for passage of a guidewire. The opening for the lumen can be at the distal tip (distal tail) of the main shaft. There can also be a proximal opening located in the proximal portion of the transcatheter device. In embodiments where the transcatheter device includes an intravascular anchor, this proximal opening for the lumen can be located between the spacer body and the intravascular anchor. For example, the opening can be located at the proximal end of the main shaft that joins to the intravascular anchor.

[0006] The total length of the main shaft can range from 50 to 175 cm. The main shaft can be constructed in any suitable manner. For example, the main shaft can be made of a metal wire core (e.g., stainless steel or Nitinol alloy) and then coated with a polymeric material. For example, the metal wire core can be coated with a thermoplastic polyurethane braid or a polytetrafluoroethylene (PTFE) coating. The metal wire core can extend through the entire length of the main shaft. However, in some embodiments, the metal wire core terminates before reaching the tip of the distal tail (or the distal tip of the main shaft). For example, the metal wire core can terminate within 0.5 to 4 cm of the distal tip.

[0007] Distal Tail: The distal tail may have any suitable length for adequate anchoring within the pulmonary artery. In some embodiments, the distal tail is 10 to 40 cm long, and in some cases, 15 to 30 cm long. The distal tail may have a pigtail or rounded tip to smooth the tip and reduce trauma as it travels into the pulmonary artery. In some embodiments, the distal tail has one or more bends. The bends may have an internal angle ranging from 80° to 140°. The bends may be positioned at any suitable location on the distal tail. In some embodiments, the bends are positioned 0.25 to 3.5 cm from the spacer body.

[0008] The distal tail may not have a constant diameter along its length. In some embodiments, the distal tail includes a proximal section and a distal section. The proximal section may encompass 10-60% of the total length of the distal tail. The distal section may have a smaller diameter than the proximal section. This difference may have various reasons, such as, for example, the proximal section having more or thicker sheathing or coating than the distal section. The distal section may be more flexible than the proximal section of the distal tail. In some embodiments, the distal tail does not include a coil, loop, or stent.

[0009] The distal tail can be designed to be streamlined. In some embodiments, the distal tail is an elongated cylindrical shape (with or without a lumen) without protruding features, such as a hook, wire, ring, or ridge. This can be useful in preventing thrombus formation or erosion of the distal tail into the wall of the pulmonary artery.

[0010] In some embodiments, the distal section is more flexible than the proximal section. In some cases, the proximal section includes a metal braid, but the distal section does not include a metal braid. The distal section can include a polymeric material that is softer than the proximal section. The distal section can have a smaller diameter than the proximal section. In some cases, the length of the distal section is shorter than the length of the proximal section. The length of the distal section can be between 2 and 7 cm. The length of the proximal section can be between 7 and 15 cm. In some cases, the proximal section comprises 35 to 65% of the total length of the distal tail.

[0011] The proximal section can have different dimensions than the distal section. In some cases, the distal section has a smaller diameter than the proximal section. In some cases, the diameter of the distal section is 45-85% of the diameter of the proximal section. For example, the distal section can have a diameter of 2-5 mm and the proximal section can have a diameter of 3-6 mm.

[0012]

[0012] In some cases, the distal tail further includes an intermediate section between the proximal and distal sections. The intermediate section is more flexible than the proximal section but more rigid than the distal section. In some cases, the length of the intermediate section is less than the length of the proximal section. The length of the intermediate section can be between 2 and 7 cm.

[0013]

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

[0014] Another design parameter is the length of the spacer body. For example, the spacer body may be 4 to 13 cm long, or in some cases, 5 to 9 cm long. If the spacer body is nonlinear, this length is represented by the distance traveled along the longitudinal axis of the spacer body. The width of the spacer body can be measured in a cross-section perpendicular to the longitudinal axis. In some embodiments, the widest width of the spacer body in this cross-section is within the range of 0.5 to 3.5 cm, or in some cases, within the range of 0.5 to 2.5 cm. The spacer body may have a relaxed contracted configuration and an elongated configuration. In this situation, the above measurements of the spacer body are taken in the relaxed configuration. In some embodiments, the width of the spacer body at its widest axis is greater than the width of the spacer body at the intersecting axis of the cross-section (i.e., a noncircular or asymmetric cross-section).

[0015] The spacer body can have any suitable structure, such as a balloon (e.g., fluid-, foam-, or air-filled), basket, mesh, strut (e.g., stent-like), framework, skeleton, or framework. If desired, the surface of the spacer body may be provided in any suitable manner, such as with a skin, shell, envelope, or membrane. The spacer body may be made of any suitable material, such as plastic, metal, or a combination thereof. The spacer body may have one or more openings that allow blood to flow therethrough. Between the spacer body (at one of its ends) and the main shaft, there may be a gap that allows blood to flow. These openings or gaps allow blood to flow easily through the spacer body, which may be useful in preventing thrombus formation.

[0016] In some embodiments, the spacer body includes one or more side appendages. These may be located laterally of the spacer body. The side appendages may be any type of thin, flexible structure that enhances the spacer body's function as a barrier to blood flow across the gap between the tricuspid valve leaflets. Examples of side appendages include wings, flaps, shrouds, drapes, skirts, free edges, tags, and the like. The side appendages have an expanded configuration (for ventricular systole) and a narrow configuration (for ventricular diastole).

[0017] The expanded configuration of the side appendages is guided by the direction of blood flow and can be accomplished in any suitable manner, such as unfolding, expanding, widening, inflating, collapsing, opening, etc. The narrowed configuration of the side appendages is guided by the other direction of blood flow and can be accomplished in any suitable manner, such as collapsing, retracting, retracting, contracting, closing, etc.

[0018] The lateral attachments should be wide enough to reduce the gap between the tricuspid valve leaflets or to help stabilize the spacer body across the tricuspid valve. In some embodiments, the width of the lateral attachments is 0.3 to 5.0 cm, and in some cases, 0.5 to 3.5 cm. The width is measured as the widest distance of the lateral attachment from the spacer body in a direction perpendicular to the transverse axis of the spacer body.

[0019] The length of the side appendages may be less than the length of the spacer body. In some embodiments, the length of the side appendages is between 2 and 9 cm, and in some cases, between 4 and 7 cm. The length is the longest length measured along the longitudinal axis of the spacer body.

[0020] The side appendages should be thin enough to flexibly respond to blood flow across the tricuspid valve. In some embodiments, the thickness of the side appendages is between 0.2 and 10 mm, and in some cases, between 0.3 and 6 mm. The thickness is measured along the transverse axis of the spacer body, which is perpendicular to the longitudinal axis of the side appendages and the spacer body.

[0021] The side appendages can have any suitable shape. In some embodiments, the side appendages are three-dimensionally curved, non-planar shapes that provide an inside (concave) and an outside (convex) surface to the side appendages. Having this non-planar shape can be useful for improving response to blood flow across the tricuspid valve.

[0022] Proximal Portion: The proximal portion of the transcatheter device includes the proximal section of the main shaft. The proximal section can be a proximal continuation of the main shaft. The proximal portion of the transcatheter device can have any suitable length for adequate anchoring within intravascular access or the vena cava. In some embodiments, the overall length of the proximal portion ranges from 10 to 60 cm. In embodiments where the proximal portion includes an intravascular anchor, this measurement includes the length of the intravascular anchor. In situations where the intravascular anchor is not linear (e.g., is a coil), this length 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 bends can have an internal angle ranging from 80° to 140°. The bends can be located at any suitable location on the proximal section of the main shaft. In some embodiments, there is a bend located at a distance of 0.25 to 5.5 cm from the spacer body. The proximal section can also have a curved portion (wider than the 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 range from 3 to 15 cm.

[0024] Intravascular anchor: In some embodiments, the proximal portion includes an intravascular anchor. Examples of intravascular anchors include a helical coil and an expandable stent. In some embodiments, the intravascular anchor is a helical coil. The helical coil can have at least two helices. The intravascular anchor can have any suitable width for anchoring in a vena cava. In some embodiments, the widest width of the intravascular anchor is within a range of 2-7 cm. The length of the intravascular anchor can be within a range of 4-11 cm (measured linearly on its longitudinal axis). In situations where the intravascular anchor is not linear (e.g., a coil), this length refers to the length measured along the longitudinal axis. In situations where the intravascular anchor has a flexible configuration (e.g., in the case of a helical coil), this length is measured in its naturally coiled configuration. In alternative embodiments of the present invention, the transcatheter device includes either 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., fluoroscopy). In some embodiments of the transcatheter device, there is a first radiopaque marker located in the proximal section of the main shaft (proximal to the spacer body) and a second radiopaque marker located in the distal tail (distal to the spacer body). The first radiopaque marker can be located within 2 cm of the proximal end of the spacer body. The second radiopaque marker can be located within 2 cm of the distal end of the spacer body.

[0026]

[0026] Junction Assembly: In another aspect, the present invention is a junction assembly for treating tricuspid regurgitation. The assembly comprises the transcatheter device of the present invention. The assembly further comprises a guidewire traveling through the lumen of the main shaft. In some embodiments, the assembly further comprises a movable delivery sheath capable of covering the spacer body or the intravascular anchor. The sheath can be advanced to cover the spacer body or the intravascular anchor, or the spacer body can be retracted to expose the spacer body or the intravascular anchor. In some embodiments, the assembly further comprises a deployment catheter. The deployment catheter is of sufficient length to deploy the transcatheter device within a patient's heart. For example, the deployment catheter can be 50 to 150 cm in length.

[0027] Coaptation Kit: In another aspect, the present invention is 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 may be assembled or used in the methods described herein.

[0028]

[0028] Method of Treatment: In another aspect, the present invention is a method of treating a defective tricuspid valve in a patient using the transcatheter device of the present invention. The transcatheter device is implanted with the distal tail positioned within the pulmonary artery and the spacer body positioned across the tricuspid valve. The transcatheter device is inserted into an inlet vein, such as the femoral, subclavian, or jugular vein. The transcatheter device is further advanced into the vena cava (inferior or superior). The transcatheter device is advanced 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 toward the pulmonary artery. The distal tail is advanced into the pulmonary artery, which may be the left or right pulmonary artery.

[0029] The distal tail functions to assist in anchoring the transcatheter device. Thus, the distal tail may extend into the pulmonary artery a sufficient distance to perform this function. In some embodiments, the distal tail extends into the pulmonary artery a distance of at least 10 cm, and in some cases at least 15 cm. In some embodiments, the distal tail advances past the first branching point of the pulmonary artery, in some cases past the second branching point of the pulmonary artery, and in some cases past the third branching point of the pulmonary artery. Proper positioning of the distal tail can be confirmed by radiopaque markers and x-ray imaging to view the radiopaque markers. In some embodiments, the distal tail is not implanted into cardiac tissue.

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

[0031] In embodiments in which the spacer body includes side appendages, the method can further include expanding the side appendages during ventricular systole and narrowing the side appendages during ventricular diastole. In the expanded configuration, the side appendages can be positioned between the leaflets of the tricuspid valve to occlude the gaps therein. In situations in which the side appendages have a non-flat shape, the inner (concave) surface is oriented to face the right ventricle.

[0032] In an embodiment in which a balloon is provided on the spacer body, after the spacer body is properly positioned between the leaflets of the tricuspid valve, saline or air may be injected into the spacer body to expand and maintain the balloon. In this case, the amount of saline or air injected may be adjusted so that the spacer body has a predetermined size and volume to match the size of the regurgitation space in the tricuspid valve.

[0033]

[0033] In embodiments where the transcatheter device further comprises an intravascular anchor in its proximal portion, the intravascular anchor is housed in the vena cava (inferior or superior). 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 or superior). The guidewire is advanced through the right atrium of the heart, across the tricuspid valve, and into the right ventricle of the heart. The guidewire is further advanced toward the pulmonary artery. The guidewire is inserted into the guidewire lumen of the transcatheter device, and the transcatheter device is advanced over the guidewire.

[0034] The deployment transcatheter device can be deployed using a delivery sheath and a deployment catheter. During insertion, the delivery sheath can be moved over the spacer body and, in related embodiments, over the endovascular anchor. During deployment, the delivery sheath is retracted rearward. Retraction of the delivery sheath and desheathing of the transcatheter device components can be part of the implantation process. In embodiments where the spacer body is self-expanding, this desheathing allows the spacer body to self-expand outward to provide a larger interface. In embodiments where the transcatheter device includes an endovascular anchor having an expandable configuration, desheathing allows the anchor to expand outward and remain within the vena cava.

[0035] In some embodiments, the deployment assembly is not disassembled immediately after the procedure is complete. The clinician may wish to conduct a short trial period to confirm the effectiveness of the device. During this short trial period, one or more components of the delivery assembly (deployment catheter, delivery sheath, or guidewire) can be retained in the patient along with the transcatheter device. Tricuspid valve function is monitored (e.g., by echocardiogram) during the short trial period. If the transcatheter device demonstrates effectiveness during this trial period, the deployment assembly is removed, but the transcatheter device remains in place. If the trial period demonstrates ineffective results, the deployment assembly is left stationary in place, allowing for easy removal of the transcatheter device. The trial period can be any suitable short period. For example, the trial period can be within the range of 12 to 48 hours after insertion.

[0036] Retrieval: Once implanted, the transcatheter device can be removed if desired. This can be done by grasping the intravascular anchor (e.g., the helical coil at its proximal tip) and withdrawing the transcatheter device for removal from the patient's body. For example, this can be done by inserting a snare catheter through the entry vein, advancing the snare catheter toward the helical coil, grasping the helical coil, removing the snare catheter, and withdrawing the transcatheter device from the entry vein.

[0037] In embodiments in which the spacer body includes a balloon, the spacer body must be deflated by evacuating saline or air from the spacer body prior to retrieval. In this case, a sharp-tipped needle encased in a delivery sheath can be advanced to the exterior of the spacer body, and then exposed from the delivery sheath to puncture the balloon of the spacer body, allowing saline to exit the spacer body through the hole.

[0038] As described above, the present invention can be effectively applied to catheter treatment of tricuspid regurgitation. [Brief explanation of the drawings]

[0039] [Figure 1A] FIG. 1 illustrates an example of a transcatheter device for treating tricuspid regurgitation. [Figure 1B] FIG. 1B shows the main shaft and distal tail of the transcatheter device of FIG. 1A. [Figure 1C] FIG. 1B is a cross-sectional view taken along the line EE′ of FIG. 1A, showing a cross-section of the main shaft of the transcatheter device. [Figure 1D] 1D are cross-sectional views of the distal tail of FIG. 1C, where (a) is a cross-sectional view taken along line II', (b) is a cross-sectional view taken along line II', and (c) is a cross-sectional view taken along line III'. [Figure 1E] FIG. 10 illustrates another example of a transcatheter device for treating tricuspid regurgitation. [Figure 1F] FIG. 1F shows the main shaft and distal tail of the transcatheter device of FIG. 1E. [Figure 2A] FIG. 10 shows a spacer body with a balloon covering a mesh structure. [Figure 2B] FIG. 10 shows a spacer body with an e-PTEF layer covering a balloon. [Figure 2C] FIG. 2C is a cross-sectional view taken along line AA' in (b) of FIG. 2B. [Figure 3A] FIG. 1 shows an example of a transcatheter device with an injection valve mounted within the spacer body. [Figure 3B] FIG. 3B is an enlarged view of the portion of FIG. 3A where the injection valve is attached. [Figure 3C] 3C is a cross-sectional view taken along line DD' of FIG. 3B, showing the injection valve in an open state and a closed state. [Figure 3D] 3D is a cross-sectional view taken along line BB' of FIG. 3C, showing the injection valve in an open state and a closed state. [Figure 4A] FIG. 1 illustrates an embodiment of a transcatheter device in which an injection valve is attached to the proximal portion of the main shaft. [Figure 4B] 4B is an enlarged view of the portion of FIG. 4A where the injection valve is attached, showing the injection valve in an open state and a closed state. [Figure 5A] 10A-10C show another embodiment of a transcatheter device with an injection valve attached to the proximal portion of the main shaft. [Figure 5B] 5B is an enlarged view of the portion of FIG. 5A where the injection valve is attached, showing the injection valve in an open state and a closed state. [Figure 5C] 5C is a cross-sectional view taken along line CC' of FIG. 5B, showing the injection valve in an open state and a closed state. [Figure 6] FIG. 1 illustrates a transcatheter device positioned within the heart. DETAILED DESCRIPTION OF THE INVENTION

[0040]

[0058] To facilitate an understanding of the present invention, reference is made to the accompanying drawings, which show, by way of example, specific embodiments in which the present invention may be practiced. The drawings herein are not necessarily made to scale or to actual proportions. For example, the length and width of components may be adjusted to accommodate page size. In the following, the terms "distal" and "proximal" are used with "distal" referring to a location further away from the operator and "proximal" referring to a location closer to the operator.

[0041]

[0059] 1A illustrates one embodiment of a transcatheter device 100. In this embodiment, the transcatheter device 100 includes a distal tail 122, a spacer body 150, a proximal section 140 of the main shaft 120, and an endovascular anchor 148. Additionally, a connection 510 is provided between the proximal section 140 of the main shaft 120 and the endovascular anchor 148 to connect the transcatheter device 100 to a deployment catheter (not shown). The endovascular anchor 148 consists of a helical coil wrapped around a metal wire.

[0042]

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

[0043]

[0061] 1A and 1B, the distal tail 122 has at least three sections with varying degrees of flexibility. The three sections are a distal section 124, an intermediate section 126, and a proximal section 128. The three sections are the distal section 124, the intermediate section 126, and the proximal section 128. The distal section 124 has a curved shape with a constant anchor curvature R0. The anchor curvature R0 is approximately 110 mm.

[0044]

[0062] Furthermore, the distal section 124 of the distal tail 122 is more flexible than the intermediate section 126 and the proximal section 128. The proximal section 128 of the distal tail 122 is more rigid than the intermediate section 126 and the distal section 124. The flexibility of the distal tail 122 increases distally along the longitudinal direction of the curved shape of the distal tail 122, thereby allowing the distal tail 122 to easily bend to conform to the configuration of the pulmonary artery (PA) when inserted into the PA, causing less trauma to the PA.

[0045]

[0063] 1D , the intermediate section 126 and the distal section 124 of the distal tail 122 have a jacket 160 with a first lumen 162 formed inside the jacket 160 for guiding a guidewire. Additionally, a nitinol core wire 164 is not present within the jacket 160 of the intermediate section 126 or the jacket 160 of the distal section 124 of the distal tail 122. The jacket 160 of the intermediate section 126 of the distal tail 122 is made of Pellethan 55D (grade 55 on the Shore D hardness scale), and the jacket 160 of the distal section 124 of the distal tail 122 is made of Pellethan 90A (grade 90 on the Shore A hardness scale). The Pellethan 55D material is harder than the Pellethan 90A material. The diameters of the intermediate 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 jacket 160 of the intermediate section 126 and the jacket 160 of the distal section 124 of the distal tail 122 are surrounded by an e-PTFE layer 161. Pellethan is a trade name for a thermoplastic polyurethane elastomer commonly used in medical devices.

[0046]

[0064] The proximal section 128 of the distal tail 122 consists of a first proximal section 128a and a second proximal section 128b. Both the first proximal section 128a and the second proximal section 128a have a jacket 160 made of Pellethan and an e-PTFE layer 161 surrounding the jacket 160. Inside the jacket 160, a first lumen 162 for guiding a guidewire is formed, and a second lumen 163 is formed through which a Nitinol core wire 164 is inserted. The jacket 160 of the first proximal section 128a is made of Pellethan 55D (grade 55 on the Shore D hardness scale), and the jacket 160 of the second proximal section 128b is made of Pellethan 75D (grade 75 on the Shore D hardness scale). Pellethan 75D is harder than Pellethan 55D. The diameter of the proximal section 128 is approximately 3 mm.

[0047]

[0065] As described above, the distal tail 122 has a configuration that increases in flexibility distally along the length of the curved shape, i.e., second proximal section 128b (nitinol wire + Pellethane 75D jacket) > first proximal section 128a (nitinol wire + Pellethane 55D jacket) > intermediate section 126 (Pellethane 55D jacket) > distal section 124 (Pellethane 90A jacket).

[0048]

[0066] The total length of the distal tail 122 is approximately 15 cm. The length of the distal section 124 is approximately 2.5 cm. The length of the intermediate section 126 is approximately 2.5 cm. The first proximal section 128a and the second proximal section 128b of the proximal section 128 are each approximately 5 cm in length.

[0049]

[0067] The main shaft 120 of the transcatheter device 100 refers to the configuration through which the nitinol wire 164 is inserted to support the transcatheter device 100, and for ease of explanation, may be described as having a proximal portion, an intermediate portion, and a distal portion.

[0050]

[0068] 1A and 1B from the proximal section 140 to the proximal section 128 of the distal tail 122. The proximal section of the main shaft 120 may be the section corresponding to the proximal section 140, the intermediate section of the main shaft 120 may be the section between the proximal and distal sections to which the spacer body 150 is attached, and the distal section of the main shaft 120 may be the section corresponding to the proximal section 128 of the distal tail 122. An intravascular anchor 148 is connected to the proximal section of the main shaft 120.

[0051]

[0069] A first lumen 162 for inserting a guidewire, a second lumen 163 for inserting a nitinol core wire 164, and a third lumen 165 for inserting an injection tube 132 are formed to extend longitudinally within the main shaft 120. However, the third lumen 165 for inserting the injection tube 132 is formed only from the proximal section 140 to a point where an injection valve 129, described below, is located.

[0052]

[0070] As shown in Fig. 6, the proximal section 140 of the main shaft 120 is connected to the upper end of the intravascular anchor 148 at a point offset from the center of the inferior vena cava (IVC) toward the right ventricle (RA). As shown in Figs. 1A and 1B, the proximal section 140 of the main shaft 120 is composed of an insertion section 141, a first bending section 142, a connecting section 143, and a second bending section 144.

[0053]

[0071] Specifically, the insertion section 141 has a linear shape and is inserted perpendicularly into the inferior vena cava (IVC), and its lower end is connected to an intravascular anchor 148. The insertion section 141 may be disposed in contact with the inner surface of the inferior vena cava (IVC) on the right ventricle (RA) side. The first bent section 142 extends from the upper end of the insertion section 141 toward the tricuspid valve (TV) side so as to bend at a first curvature R1. The second bent section 144 extends from the middle of the main axis 120 toward the inferior vena cava (IVC) side so as to bend at a second curvature R2. The connection section 143 connects the first bent section 142 and the second bent section 144 and extends along the transisthmus of the inferior vena cava (CTI) between the inferior vena cava (IVC) and the tricuspid annulus (TVA).

[0054]

[0072] As shown in FIG. 6, the connecting portion 143 has a shape that mimics the configuration of the isthmus of the inferior vena cava (CTI) between the inferior vena cava (IVC) and the tricuspid annulus (TVA). Specifically, as shown in FIGS. 1A and 1B, the connecting portion 141 may have an upward slope from the first bend portion 142 to the second bend portion 144. The transcatheter device 100 having the upwardly sloping connecting portion 143 may preferably be applied to a heart in which the isthmus of the inferior vena cava (CTI) has an upward slope due to the low inferior vena cava (IVC) and the high tricuspid annulus (TVA). The interior angle α of the first bend portion 142 is in the range of 80° to 120°. The interior angle β of the second bend portion 144 is in the range of 80° to 120°.

[0055]

[0073] The main shaft 120 having the proximal section 140 is capable of elastic deformation about a second bend 144 and about a first bend 142 of the proximal section 140 .

[0056]

[0074] The position of the attached transcatheter device 100 may change depending on the movement of the heart during relaxation and contraction. In particular, when the right ventricle (RV) contracts, the intermediate and distal portions are pushed toward the right ventricle (RV). As a result, the intermediate and distal portions may deform in the direction of arrow A in FIG. 6 around the second bent portion 144, and in the direction of arrow A in FIG. 6 around the first bent portion 142.

[0057]

[0075] As described above, the intermediate and distal portions of the transcatheter device 100 are capable of elastic deformation around the second bend 144 of the proximal section 41 and also around the first bend 142 of the proximal section 41. Therefore, even in this case, a restoring force is generated that pushes the intermediate and distal portions in the direction of arrow B, which is opposite to the direction of arrow A. As a result, the distal tail 122, including the distal portion, is tightly attached within the pulmonary artery (PA), and further, the point where the distal and intermediate portions contact each other may be tightly attached to the supraventricular ridge (SUV) (see FIG. 6 ). As a result, the transcatheter device 100 and the spacer 120 can be stably held in a desired position against the movement of the heart, particularly during cardiac contraction.

[0058]

[0076] Furthermore, the first curvature R1 of the first bent portion 142 and the second curvature R2 of the second bent portion 144 are determined by the configuration of the heart at the corresponding portions, and may be the same or different. However, if the first curvature R1 of the first bent portion 142 and the second curvature R2 of the second bent portion 144 are the same, manufacturing is easier.

[0059]

[0077] On the other hand, the horizontal length L1 of the proximal section 140 of the main shaft 120, i.e., the length L1 between the first bend 142 and the second bend 144, is preferably in a range covering the inferior vena cava inter-isthmus (CTI). In this embodiment, the horizontal length L1 of the proximal section 41 is in a range of 30 to 70 mm. In addition, the longitudinal extension length L2 of the connecting portion 143 located between the first bend 142 and the second bend 144 is in a range of 30 to 50 mm.

[0060]

[0078] 1A , showing a cross-sectional view of the main shaft of the transcatheter device. As shown in FIG. 1C, the proximal section 140 of the main shaft 120 has a jacket 160 made of Pellethane 90A (grade 90 on the Shore A hardness scale) and an e-PTFE layer 161 surrounding the jacket 160, with a first lumen 162 formed inside the jacket 160 to guide a guidewire. The diameter D1 of the proximal section 140 of the main shaft 120 is approximately 3 mm.

[0061]

[0079] Additionally, the proximal section 140 of the main shaft 120 has a second lumen 163 formed therein into which a nitinol core wire 164 is inserted to provide structural support to the main shaft 120 along its entire length. The nitinol core wire 164 extends to the proximal section 128 of the distal tail 122, providing the distal tail 122 with a preformed curved shape. The main shaft 120 also has a third lumen 165 formed therein into which the infusion tube 132, described below, is inserted.

[0062]

[0080] 1C and 1D(c), the proximal section 140 of the main shaft 120 has a similar structure and material composition to the proximal section 128 of the distal tail 122, except that the proximal section 140 has the lumen 165 of the infusion tube formed therein. Thus, the proximal section 128 of the distal tail 122 and the proximal section 140 of the main shaft 120 have similar strength.

[0063]

[0081] The transcatheter device 100 has a series of radiopaque markers. The proximal section 140 of the main shaft has a radiopaque strip (not shown). The distal tail 122 has a series of radiopaque bands. Additionally, the distal tail 122 has a radiopaque band at its tip.

[0064]

[0082] Fig. 1E is a diagram showing another example of a transcatheter device for treating tricuspid regurgitation, and Fig. 1F is a diagram showing the main shaft and distal tail of the transcatheter device of Fig. 1E. The transcatheter device 100' shown in Figs. 1E and 1F is identical to the transcatheter device 100 shown in Figs. 1A to 1D except for the configuration of the connection portion 143' formed by the proximal section 140 of the main shaft 120.

[0065]

[0083] 1A to 1D, the connecting portion 143 of the transcatheter device 100 slopes upward from the first bend 142 to the second bend 144, whereas the connecting portion 143' of the transcatheter device 100' shown in FIGS. 1E and 1F slopes downward from the first bend 142 to the second bend 144. The transcatheter device 100 having the connecting portion 143' with a downward slope may preferably be applied to a heart in which the isthmus of the inferior vena cava (CTI) slopes downward due to the high inferior vena cava (IVC) and the low tricuspid annulus (TVA). The interior angle α of the first bend 142 is in the range of 80° to 120°, and the interior angle β of the second bend 144 is in the range of 80° to 120°. Furthermore, the longitudinal extension length L2 of the connecting portion 143' located between the first bent portion 142 and the second bent portion 144 is in the range of 30 to 50 mm.

[0066]

[0084] Meanwhile, the main shaft 120, the distal tail 122, and the intravascular anchor 148 are all surrounded by a constant-thickness e-PTFE layer 161 made of e-PTFE. As shown in Figures 1A, 1B, 1E, and 1F, the e-PTFE layer 161 extends a constant distance from the tip of the distal tail 122 to form a circularly rolled tip 125. That is, because the tip 125 protrudes beyond the tip of the distal section 124 of the distal tail 122 and is made solely of an e-PTFE layer and is circularly rolled, the tip 125 will not injure the pulmonary artery (PA) even if it comes into contact with the PA when inserted into the pulmonary artery (PA).

[0067]

[0085] 2A and 2C are diagrams illustrating an example of a spacer body 150 in detail. Also, (a) and (b) of FIG. 2A are diagrams illustrating the spacer body 150 in a state where it is not filled with saline and a state where it is filled with saline, respectively. The spacer body 150 has a distal end 151a, a proximal end 151b, and a mesh structure 151 made of wire. A main shaft 120 penetrates the spacer body 150. One side of the distal end 151a and the proximal end 151b of the main shaft 120 is fixedly attached to the main shaft 120, and the other side is not fixedly attached to the main shaft 120 and is movable in the axial direction relative to the main shaft 120. In this embodiment, the proximal end 151b of the spacer body 150 is fixed, and the distal end 151b is movable.

[0068]

[0086] The mesh structure 151 is made of a shape memory alloy or the like, and maintains a predetermined expanded configuration in the absence of an external force. Alternatively, the mesh structure 151 may contract when an external force is applied, in which case the other side that is not fixed to the main shaft 120 may move along the main shaft 120. The mesh structure 151 may contract or expand during the deployment process.

[0069]

[0087] 2A, the spacer body 150 has a balloon 152 having a distal end 152a and a proximal end 152b. Both the distal end 152a and the proximal end 152b of the balloon 152 are fixedly attached to the main shaft 120. The balloon 152 is formed as a sealed structure that covers the mesh structure 151. The sealed internal space of the balloon 152 may be filled with saline solution S.

[0070]

[0088] 2A(a), even when the internal space of the balloon 152 is not filled with saline solution S, the balloon 152 may maintain its shape to some extent due to the mesh structure 151 located inside the balloon 152. Furthermore, as shown in FIG. 2A(b), when the internal space of the balloon 152 is filled with saline solution S, the balloon 152 expands, and the mesh structure 151 expands accordingly.

[0071]

[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 has a shape in which, in an expanded state, the right ventricle (RV) side is larger than the right atrium (RA) side relative to the main axis 120.

[0072]

[0090] The volume of the spacer body 150 may be adjusted according to the amount of saline solution S injected into the balloon 152. Therefore, the size of the spacer body 150 may be adjusted according to the size of the regurgitation space where tricuspid regurgitation occurs. In this way, if the spacer body 150 does not fit the size of the regurgitation space, the operator only needs to adjust the amount of saline solution S injected, and there is no need to retrieve it. Furthermore, the inside of the balloon 152 may be filled with air instead of saline solution S.

[0073]

[0091] 2B is a diagram showing another example of the spacer body 150, and (a) and (b) of FIG. 2B respectively show the spacer body 150 in a state where it is not filled with saline and a state where it is filled with saline. The spacer body 150 shown in FIG. 2B further includes an e-PTFE layer 153 formed to cover the balloon 152 compared to the spacer body 150 shown in FIG. 2A. The e-PTFE layer 153 is formed to expand together with the balloon 152 as the balloon 152 is inflated by the supply of saline. Like the balloon 152, 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).

[0074]

[0092] 2C is a cross-sectional view of the spacer body 150 taken along line A-A' in FIG. 2B(b). When the spacer body 150 expands within the tricuspid valve, the balloon 152 and the e-PTFE layer 153 are formed to cover the expanded mesh structure 151.

[0075]

[0093] 3A and 3B are diagrams showing injection valve 129 and injection tube 132, Fig. 3B is an enlarged view of injection valve 129 in Fig. 3A, Fig. 3C is a D-D' cross-sectional view of injection valve 129 in Fig. 3B, and Fig. 3d is a B-B' cross-sectional view of injection valve 129 in Fig. 3C. Also, Fig. 3C(a) and Fig. 3D(a) show a state in which injection tube 132b is inserted and injection valve 129 is open, and Fig. 3C(b) and Fig. 3D(b) show a state in which injection tube 132b is removed and injection valve 129 is closed.

[0076]

[0094] The injection valve 129 is formed of an elastic silicone band 129a that surrounds the outside of the main shaft 120. The injection tube 132 may be inserted between the silicone band 129a and the main shaft 120.

[0077]

[0095] An injection hole 131 is formed in main shaft 120, which connects third lumen 165 with the internal space of spacer body 150. Silicon band 129a covers injection hole 131. Injection tube 132 may pass through injection hole 131.

[0078]

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

[0079]

[0097] When the tip of injection tube 132 is exposed to the internal space of spacer body 150, silicone band 129a is extended radially by injection tube 132, and injection valve 129 is in an open state (see (a) of FIG. 3C and (a) of FIG. 3D). In this open state, when saline solution S is injected into the internal space of spacer body 150 via injection tube 132, balloon 152 expands. As balloon 152 expands, e-PTFE layer 153 also expands.

[0080]

[0098] When the injection of saline solution S through injection tube 132 is completed and injection tube 132 is removed and collected, silicone band 129a contracts and adheres tightly to the outer surface of main shaft 120. As a result, injection hole 131 is blocked by silicone band 129a, and third lumen 165 is closed with injection valve 129 closed (see (d) of FIG. 3C and (d) of FIG. 3D).

[0081]

[0099] When the injection valve 129 is in a closed state, the interior of the spacer body 150 is filled with saline solution S, and the spacer body 150 has a predetermined pressure, which allows the silicone band 129a to come into more firm and intimate contact with the outer surface of the main shaft 120. This more reliably prevents the saline solution S filled inside the spacer body 150 from leaking from the third lumen 165.

[0082]

[0100] Next, Figure 4A shows one embodiment of a transcatheter device having an injection valve attached to the proximal portion of the main shaft, and Figure 4B is an enlarged view of the portion of Figure 4A where the injection valve is attached, showing the injection valve in an open state (Figure 4B(a)) and a closed state (Figure 4B(b)).

[0083]

[0101] 4A and 4B, injection valve 129 is formed from an elastic silicone band 129b that is wrapped around a point on the proximal portion of main shaft 120. Main shaft 120 is formed with injection hole 131 that communicates third lumen 165 with the interior space of spacer body 150. That is, third lumen 165 of main shaft 120 extends from the proximal portion of main shaft 120 to injection hole 131.

[0084]

[0102] Further, a blocking portion 133 that blocks a portion of third lumen 165 is provided in the proximal portion of main shaft 120. Communication holes 134a and 134b are formed at both ends of blocking portion 133, which connect third lumen 165 to the outside of main shaft 120 and through which injection tube 132 passes.

[0085]

[0103] Silicon band 129b of injection valve 129 has a lengthwise dimension sufficient to cover closing portion 133 and communication holes 134a and 134b, and is capable of closing communication holes 134a and 134b when contracted.

[0086]

[0104] 4B(a), injection tube 132 is inserted into third lumen 165, passes through communication hole 134a just before blocking portion 133 to the outside of main shaft 120, and then passes through communication hole 134b again to be inserted into third lumen 165 on the inside of main shaft 120. In this state (when injection valve 129 is open), silicone band 129b extends radially.

[0087]

[0105] When injection valve 129 is in an open state, injection tube 132 communicates with injection hole 131 located in spacer body 150 via third lumen 165. Therefore, when saline solution S is injected from injection tube 132, the saline solution S passes through third lumen 165 and enters the space within spacer body 150 through injection hole 131, causing balloon 152 to expand. As balloon 152 expands, e-PTFE layer 153 also expands.

[0088]

[0106] When the injection of saline solution S into spacer body 150 is completed, injection tube 132 is removed and collected. When injection tube 132 is removed and collected, injection tube 132 is removed from silicone band 129a, and silicone band 129a contracts, as shown in (b) of FIG. 4B. This causes silicone band 129a to adhere tightly to the outer surface of main shaft 120, blocking communication holes 134a and 134b (injection valve 129 is closed), and preventing the injected saline solution S from leaking out.

[0089]

[0107] Providing injection valve 129 in the proximal portion of main shaft 120 in this manner has the advantage that injection tube 132 does not need to be inserted all the way to injection hole 131 inside spacer body 150. Furthermore, silicone band 129b does not necessarily need to be provided on the outside of main shaft 120, and may be provided on the outside of upper connecting portion 510a of connecting portion 510, which will be described later.

[0090]

[0108] 5A, 5B, and 5C show another embodiment of the transcatheter device 100 using an injection valve 129 disposed within the proximal portion of the main shaft 120. FIG. 5B is an enlarged view of the injection valve 129 of FIG. 5A, and FIG. 5C is a cross-sectional view taken along the line C-C' of FIG. 5B. Also, FIGS. 5B(a) and 5C(a) show the injection valve 129 in an open state, and FIGS. 5B(b) and 5C(b) show the injection valve 129 in a closed state.

[0091]

[0109] Injection valve 129 is formed of a cylindrical elastic silicon body 129c. Silicon body 129c is provided inside main shaft 120 near the proximal portion of main shaft 120. Silicon body 129c has a cross-sectional dimension that allows it to cover third lumen 165 in the extended state. Because silicon body 129c is elastic, silicon body 129c may fill third lumen 165 in the extended state, closing third lumen 165, and open third lumen 165 in the contracted state. Silicon body 129c does not necessarily have to be provided inside main shaft 120, but may also be provided inside upper connecting portion 510a of connecting portion 510, which will be described later.

[0092]

[0110] 5A, main shaft 120 is formed with injection hole 131 that communicates third lumen 165 with the interior space of spacer body 150. That is, third lumen 165 of main shaft 120 extends from the proximal portion of main shaft 120 to injection hole 131.

[0093]

[0111] 5B(a) and 5C(a), when injection tube 132 is inserted into third lumen 165, silicone body 129C contracts and enters an open state (open state of injection valve 129) that allows injection tube 132 to pass through. When saline solution S is injected through injection tube 132 in this open state, saline solution S is injected into the internal space of spacer body 150 via third lumen 165 and injection hole 131, and balloon 152 expands.

[0094]

[0112] 5B(b) and 5C(b), when the injection is completed and the injection tube 132 is removed, the silicone body 129c expands, and the third lumen 165 is closed (the injection valve 129 is closed). In this closed state, the saline solution S in the balloon 152 does not leak out, and the balloon 152 maintains the expanded state of a predetermined volume with the saline solution S filled therein.

[0095]

[0113] 5A and 5B , a connecting portion 510 is shown having an upper connecting portion 510a provided on the transcatheter device 100 and a lower connecting portion 510b provided on the upper end of a plunger 520 of a deployment catheter (not shown), which are hooked together. Passages 513a, 513b into which the injection tube 132 is inserted along the longitudinal direction are formed in the upper connecting portion 510a and the lower connecting portion 510b. When the upper connecting portion 510a and the lower connecting portion 510b are connected, the passages 513a, 513b are connected, and these passages 513a, 513b communicate with the third lumen 165.

[0096]

[0114] The injection tube 132 passes through the lower connecting portion 510b and the upper connecting portion 510a and is inserted into the third lumen 165 of the transcatheter device 100. The state in which the upper connecting portion 510a and the lower connecting portion 510b are connected is maintained by the injection tube 132 passing through the upper connecting portion 510a and the lower connecting portion 510b, thereby connecting the transcatheter device 100 and the pusher 520 of the deployment catheter. With the transcatheter device 100 and the pusher 520 of the deployment catheter connected, the operator may push the transcatheter device 100 via the pusher 520 to advance the transcatheter device 100 to a desired position.

[0097]

[0115] Furthermore, when the injection tube 132 is removed from the upper connecting part 510a and the lower connecting part 510b, the connected state of the upper connecting part 510a and the lower connecting part 510b is released, and the transcatheter device 100 is disconnected from the plunger 520 of the deployment catheter. After the operator can deploy the transcatheter device 100 at a desired position and inject saline through the injection tube 132, the operator may release the connection between the upper connecting part 510a and the lower connecting part 510b by removing the injection tube 132, and then remove the plunger 520 of the deployment catheter and the lower connecting part 510b that have been separated from the upper connecting part 510a.

[0098]

[0116] A recess 511 is formed in upper connecting portion 510a, and a protrusion 512 that hooks into recess 511 is formed in lower connecting portion 510b. Upper connecting portion 510a and lower connecting portion 510b are connected by recess 511 of upper connecting portion 510a engaging with and hooking onto protrusion 512 of lower connecting portion 510b. In the case of a structure in which upper connecting portion 510a and lower connecting portion 510b hook together, a protrusion may be formed in upper connecting portion 510a and a recess may be formed in lower connecting portion 510b, or other configurations may be used.

[0099]

[0117] Meanwhile, the surfaces of recessed portion 511 and protruding portion 512, which come into contact with each other when upper connecting portion 510a and lower connecting portion 510b are connected, are inclined with respect to the length direction, which makes it easy for upper connecting portion 510a and lower connecting portion 510b to be caught and separated.

[0100]

[0118] Furthermore, the lower end of upper connecting part 510a has curved edge 514. When lower connecting part 510b is retrieved in a separated state, the lower end of upper connecting part 510a comes into contact with a blood vessel, but since edge 514 is curved, no trauma to the blood vessel is caused.

[0101]

[0119] Furthermore, when the transcatheter device 100 is withdrawn from the body and retrieved, the saline solution S inside the spacer body 150 needs to be extracted from the spacer body 150 in order to contract the spacer body 150. In this case, a needle with a sharp tip enclosed in a delivery sheath can be brought close to the outside of the spacer body 150, and then the needle can be exposed from the delivery sheath to puncture a hole in the balloon 152 and the e-PTFE layer 153 of the spacer body 150, allowing the saline solution S to be expelled from the spacer body 150 through the hole.

[0102]

[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. Each of the disclosed aspects and embodiments of the present invention may be considered individually or in combination with other aspects, embodiments, and modifications of the present invention. Furthermore, unless otherwise specified, the steps of the methods of the present invention are not limited to any particular order of execution. Modifications to the disclosed embodiments, which incorporate the concept and essence of the present invention, may be accomplished by those skilled in the art, and such modifications are within the scope of the present invention.

[0103]

[0121] As used herein, unless the context clearly dictates otherwise, the use of the word "or" is intended to be inclusive and is equivalent to the term "and / or." Thus, for example, the term "A or B" means A, or B, or both A and B. Similarly, for example, the term "A, B, or C" means A, or B, or C, or a combination of A, B, and C. [Explanation of symbols]

[0104] 100, 100' transcatheter device 120 spindle 122 distal tail 124 Distal compartment 126 Middle Section 128 Proximal compartment 129 Injection valve 129a, 129b Silicone band 129c Silicone Body 131 Injection hole 132 Injection tube 140 Proximal division of the main axis 141 Insertion section 142 1st bending part 143, 143' connection 144 2nd bending part 148 Intravascular anchor 150 Spacer body 151 Mesh Structure 152 Balloon 153 e-PTFE layer 160 Jacket 161 e-PTFE layer 162 1st lumen 163 Second lumen 164 Nitinol core wire 165 Third lumen 510 Connection section 510a Upper connection part 510b Lower connection R1 1st curvature R2 2nd curvature IVC inferior vena cava RV right ventricle RA right atrium PA pulmonary artery CTI IVC isthmus TV Tricuspid valve TVA tricuspid annulus SC Murokami Ryo

Claims

1. a main shaft including a proximal portion, an intermediate portion, and a distal portion, the main shaft having a first lumen formed therein for inserting a guide wire, a second lumen for inserting a nitinol wire, and a third lumen for inserting an infusion tube; a distal tail including a distal portion of the main shaft; a spacer body attached to the intermediate portion of the main shaft located between the distal and proximal portions; A transcatheter device comprising: the proximal portion of the main shaft comprising a proximal segment and an intravascular anchor connected to the proximal segment; The spacer body is a mesh structure configured to be contractible or expandable and configured to expand to a predetermined configuration in the absence of external environmental forces; a balloon configured to cover the mesh structure to maintain a sealed state and to control the size according to the amount of physiological saline injected into the internal space thereof; Equipped with Transcatheter devices.

2. The transcatheter device of claim 1 , wherein the spacer body further comprises an e-PTFE layer configured to cover the balloon.

3. 2. The transcatheter device of claim 1, wherein the main shaft further comprises an injection hole configured to connect the third lumen to an interior space of the spacer body, and an injection valve configured to open and close communication between the third lumen and the injection hole by inserting or removing the injection tube.

4. The transcatheter device of claim 3 , wherein the injection valve comprises a silicone band disposed inside the spacer body and outside the main shaft.

5. The transcatheter device of claim 3 , wherein the injection valve comprises a silicone band disposed on the exterior of the shaft at the proximal portion of the shaft.

6. The transcatheter device of claim 3 , wherein the injection valve comprises a body of silicone disposed inside the shaft at the proximal portion of the shaft.

7. At the proximal portion of the main shaft, the proximal section comprises: an insertion portion that is inserted into the inferior vena cava (IVC) and connected to the intravascular anchor; a first bending portion extending from an upper end of the insertion portion toward a tricuspid valve (TV) side so as to bend at a first curvature R1; a second bending portion extending from the intermediate portion of the main axis toward the inferior vena cava (IVC) side so as to bend at a second curvature R2; a connection portion configured to connect the first bend portion to the second bend portion and extending along an isthmus of the inferior vena cava (CTI) between the inferior vena cava (IVC) and the tricuspid valve (TV); The transcatheter device according to any one of claims 1 to 6, comprising:

8. 8. The transcatheter device of claim 7, wherein the horizontal length L1 of the proximal section at the proximal portion of the main axis has a range covering the isthmus of the inferior vena cava (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 according to claim 8, wherein the extension length L2 of the connection portion of the proximal section is in the range of 30 to 50 mm.

11. The transcatheter device according to claim 7, wherein the interior angle α of the first bend portion is in the range of 80° to 120°.

12. The transcatheter device according to claim 7, wherein the interior angle α of the second bend portion is in the range of 80° to 120°.

13. The transcatheter device of claim 1; the guidewire configured to travel through the first lumen of the main shaft; a delivery sheath movable over the spacer body and the intravascular anchor; a deployment catheter configured for intravascular deployment of the transcatheter device; A joint assembly comprising:

14. an upper connector provided at the proximal portion of the main shaft of the transcatheter device; a lower connecting portion connected to a plunger of the deployment catheter and capable of being hooked onto the upper connecting portion or separated from the upper connecting portion; Equipped with a passage through which the injection pipe passes communicates with the upper connecting portion and the lower connecting portion which are in a connected state; The joint assembly of claim 13.

15. 10. A method of treating tricuspid regurgitation in a patient's heart using the transcatheter device of claim 1, 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 cm; positioning the spacer body between the leaflets of the tricuspid valve; receiving the intravascular anchor within the inferior vena cava; injecting saline into the spacer body and adjusting the amount of saline injected so that the spacer body has a predetermined size and volume; A method comprising:

16. When withdrawing the transcatheter device, a needle having a sharp tip is brought close to the outside of the spacer body to form a hole in the spacer body, thereby withdrawing the saline solution filled in the spacer body.

16. The method of claim 15, further comprising:

Images