Transcatheter device for treating tricuspid regurgitation - Patent Application 20070229933

Abstract

A transcatheter device for treating tricuspid regurgitation. The transcatheter device includes a main shaft, a proximal portion, a distal tail portion, and a spacer body attached to the main shaft and positioned between the proximal portion and the distal tail portion. 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 the shaft and moves through the spacer body. A joint assembly including the transcatheter device and a method for treating tricuspid regurgitation using the transcatheter device are also disclosed.

Description

[Technical field]

[0001] The present invention relates to the treatment of tricuspid regurgitation through the use of a transcatheter device. [Background technology]

[0002] Heart valve regurgitation (leakage from a heart valve) occurs when a heart valve does not close properly. One example is tricuspid regurgitation, which is usually 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, resulting in regurgitation. Previously, repairing heart valves required open-chest surgery with cardiopulmonary bypass. In recent years, various catheter-based techniques for valve repair have been introduced. These catheter-based procedures do not require an open chest or the use of cardiopulmonary bypass. There is a need for further advances in catheter-based treatments for tricuspid regurgitation. Summary of the Invention

[0003] Transcatheter Device: In one aspect, the invention is a transcatheter device comprising a main shaft, a proximal portion, a distal tail portion, and a spacer body attached to the main shaft and located between the proximal portion and the distal tail portion. 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 the shaft and the shaft moves through the spacer body. The proximal portion of the transcatheter device surrounds a proximal segment of the main shaft. This can alternatively be expressed as the proximal segment of the main shaft comprising the proximal portion of the transcatheter device. The distal tail of the transcatheter device surrounds a distal segment of the main shaft. This can alternatively be expressed as the distal segment of the main shaft comprising the distal tail of the transcatheter device.

[0004] The shaft comprises a lumen and opening(s) for receiving a guidewire therein. There can be an opening for the lumen at the distal tip of the shaft (at the distal tail portion). There can also be a proximal opening located at the proximal portion of the transcatheter device. In embodiments where the transcatheter device comprises 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 shaft that couples to the intravascular anchor.

[0005] The total length of the mandrel can range from 50 to 175 cm in length. The mandrel can be constructed in any suitable manner. For example, the mandrel can be made of a metal wire core (e.g., stainless steel or Nitinol alloy) that is then covered with a polymeric material. For example, the metal wire core can be covered with a thermoplastic polyurethane braid or a polytetrafluoroethylene (PTFE) covering. The metal wire core can extend through the entire length of the mandrel. However, in some embodiments, the metal wire core ends before reaching the tip of the distal tail (or the distal tip of the mandrel). For example, the metal wire core can end at a location that is within 0.5 to 4 cm of the distal tip.

[0006] Distal Tail. The distal tail may have any suitable length to provide adequate anchorage within the pulmonary artery. In some embodiments, the length of the distal tail is between 10 and 40 cm long, and in some cases between 15 and 30 cm long. The distal tail may have a pigtail or rounded tip to blunt the tip and reduce trauma as it travels into the pulmonary artery. In some embodiments, the distal tail has one or more bends. The bend(s) may have an internal angle in the range of 80 to 140 degrees. The bend(s) may be located in any suitable location on the distal tail. In some embodiments, the bends are located at a distance of 0.25 to 3.5 cm from the spacer body.

[0007] The distal tail may have a non-constant diameter over its length. In some embodiments, the distal tail comprises a proximal segment and a distal segment. The proximal segment may encompass 10-60% of the total length of the distal tail. The distal segment may have a smaller diameter than the proximal segment. This difference may have various reasons, such as the proximal segment having more or thicker armor or covering 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 comprise any coils, loops, or stents.

[0008] The distal tail can be designed to have a streamlined shape. In some embodiments, the distal tail is a thin, elongated cylindrical shape (with or without a lumen) without protruding features such as hooks, wires, rings, ridges, etc. This may be useful to prevent thrombus formation or erosion of the distal tail into the wall of the pulmonary artery.

[0009] In some embodiments, the distal segment is more flexible than the proximal segment. In some cases, the proximal segment comprises a metal braid, but the distal segment does not. The distal segment can be made of a polymeric material that is softer than the proximal segment. The distal segment can have a smaller diameter than the proximal segment. In some cases, the length of the distal segment is less than the length of the proximal segment. The length of the distal segment can be between 2 and 7 cm long. The length of the proximal segment can be between 7 and 15 cm long. In some cases, the proximal segment comprises 35-65% of the total length of the distal tail.

[0010] The proximal segment can have a different size than 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 size of the proximal segment. For example, the distal segment can have a diameter of 2-5 mm, while the proximal segment can have a diameter of 3-6 mm.

[0011] In some cases, the distal tail further comprises a central segment between the proximal and distal segments. The central segment is more flexible than the proximal segment but stiffer than the distal segment. In some cases, the length of the central segment is less than the length of the proximal segment. For example, the length of the central segment can be between 2 and 7 cm long.

[0012] Spacer body. The spacer body is attached to the main shaft. The spacer body is made to have a size or shape suitable for providing a coaptation surface for the leaflets of a 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., an ovular, cylindrical shape with tapered or conical ends, etc.). In some embodiments, the spacer body has a non-linear shape (e.g., a curved or boot shape). In a non-linear spacer body, the spacer body can have a bend with an internal angle in the range of 80-140°.

[0013] Another design parameter is the length of the spacer body. For example, the length of the spacer body can be 4-13 cm, and in some cases, 5-9 cm. If the spacer body has a non-linear shape, 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 on a transverse cross-sectional plane perpendicular to the longitudinal axis. In some embodiments, the widest width of the spacer body on this transverse cross-sectional plane is in the range of 0.5-3.5 cm, and in some cases, in the range of 0.5-2.5 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 on the widest axis is greater than the width of the spacer body on the cross axis on the transverse plane (i.e., non-circular or asymmetric cross-section).

[0014] The spacer body may have any suitable structure, such as a balloon (e.g., fluid, foam, or air filled), basket, mesh, strut (e.g., like a stent), framework, skeleton, scaffold, etc. If desired, a surface for the spacer body may be provided in any suitable manner, such as a skin, shell, casing, or membrane. The spacer body may be made of any suitable material, such as plastic, metal, or combinations thereof. The spacer body may have one or more openings to allow blood flow therethrough. There may be a gap between the spacer body (at one of its ends) and the main shaft to allow blood flow therethrough. These openings or gaps may be useful in preventing thrombus formation, as blood may easily flow through the spacer body.

[0015] In some embodiments, the spacer body comprises one or more side appendages. These may be located on the sides of the spacer body. The side appendages can be any type of thin, flexible structure that facilitates the function of the spacer body as a barrier to blood flow across the gap in the leaflets of the tricuspid valve. Examples of side appendages include wings, flaps, shrouds, drapes, hems, free edges, tags, etc. The side appendages have a widened configuration (for ventricular systole) and a narrowed configuration (for ventricular diastole).

[0016] The widened configuration of the side appendages is triggered by the direction of blood flow and can be caused to widen, extend, expand, dilate, fold, open, etc. The narrowed configuration of the side appendages is triggered by the opposite direction of blood flow and can be caused to fold, retract, collapse, contract, close, etc.

[0017] The side appendages should be wide enough to reduce the gap between the leaflets of the tricuspid valve or to help stabilize the spacer body across the tricuspid valve. In some embodiments, the width of the side appendages is 0.3-5.0 cm, and in some cases, 0.5-3.5 cm. The width is measured as the widest distance of the side appendage from the spacer body in a direction perpendicular to the transverse axis of the spacer body.

[0018] 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.

[0019] The side appendages should be thin enough to compliantly respond to blood flow across the tricuspid valve. In some embodiments, the side appendages have a thickness of 0.2-10 mm, and in some cases, 0.3-6 mm. The thickness is measured along a transverse axis of the spacer body that is perpendicular to the longitudinal axes of the side appendages and the spacer body.

[0020] The side appendages can have any suitable shape. In some embodiments, the side appendages have a non-flat shape with a three-dimensional curvature that gives the side appendage an inner (concave) and an outer (convex) shape. Having this non-flat shape can be useful to improve response to blood flow across the tricuspid valve.

[0021] Proximal Section. The proximal section of the transcatheter device comprises a proximal segment of the main shaft. The proximal segment can be a proximal continuation of the main shaft. The proximal section of the transcatheter device can have any suitable length to provide intravascular access or sufficient fixation within the vena cava. In some embodiments, the overall length of the proximal section ranges from 10 to 60 cm in length. In embodiments where the proximal section includes an intravascular anchor, this measurement includes the length of the intravascular anchor. In situations where the intravascular anchor does not have a linear shape (e.g., a coil), this refers to the length measured along the longitudinal axis.

[0022] In some embodiments, the proximal segment of the main shaft has one or more bends. The bend(s) can have an internal angle in the range of 80-140°. The bend(s) can be located at any suitable location on the proximal segment of the main shaft. In some embodiments, there are bends located at a distance of 0.25-5.5 cm from the spacer body. The proximal segment can also have a bend (wider than the bend). In some embodiments, the proximal segment has two separate bends and a bend between the two bends. The length of the proximal segment can be in the range of 3-15 cm in length.

[0023] Intravascular anchor. In some embodiments, the proximal portion comprises an intravascular anchor. Examples of intravascular anchors include a spiral coil and an expandable stent. In some embodiments, the intravascular anchor is a spiral coil. The spiral coil can have at least two spirals. The intravascular anchor can have any suitable width for anchoring in a vena cava. In some embodiments, the widest width of the intravascular anchor ranges from 2 to 7 cm in width. The length of the intravascular anchor can range from 4 to 11 cm in length (measured straight on the longitudinal axis). In situations where the intravascular anchor does not have a linear shape (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., as in a helical coil), this length is measured in a naturally coiled configuration. In alternative embodiments of the invention, the transcatheter device comprises either an intravascular anchor or a distal tail, but not both.

[0024] 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 on the proximal segment of the shaft (proximal to the spacer body) and a second radiopaque located on 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.

[0025] Junction Assembly: In another aspect, the present invention is a junction assembly for treating tricuspid regurgitation. The assembly comprises a transcatheter device of the present invention. The assembly further comprises a guidewire that travels through the lumen of the main shaft. In some embodiments, the assembly further comprises a movable delivery sheath that can cover the spacer body or the intravascular anchor. The sheath can be advanced to cover the spacer body or the intravascular anchor. Alternatively, the spacer body can be retracted to remove the spacer body or the intravascular anchor from the cover. In some embodiments, the assembly further comprises a deployment catheter. The deployment catheter is of sufficient length to deploy the transcatheter device in the patient's heart. For example, the deployment catheter can be 50-150 cm in length.

[0026] 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 can be assembled or used in the manner described herein.

[0027] Method of Treatment: In another aspect, the invention is a method of treating a defective tricuspid valve in a patient using the transcatheter device of the invention. The transcatheter device is implanted with the distal tail in the pulmonary artery and the spacer body across the tricuspid valve. The transcatheter device is inserted into an inlet vein such as the femoral vein, subclavian vein, or jugular vein. The transcatheter device is advanced further 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 advanced further towards the pulmonary artery. The distal tail is advanced into the pulmonary artery. This can be the left or right pulmonary artery.

[0028] The distal tail serves to help anchor the transcatheter device. As such, the distal tail may 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 cm into the pulmonary artery, and in some cases, at least 15 cm. In some embodiments, the distal tail is advanced beyond a first branch of the pulmonary artery, in some cases beyond a second branch of the pulmonary artery, and in some cases beyond a third branch of the pulmonary artery. Proper placement of the distal tail may include a radiopaque marker and be confirmed by x-ray imaging to view the radiopaque marker. In some embodiments, the distal tail is not embedded into cardiac tissue.

[0029] The spacer body should be properly positioned between the leaflets of the tricuspid valve. Such proper placement can be confirmed by external imaging, such as an x-ray or echocardiogram. In some embodiments, the spacer body is positioned to abut against the supravalicular ridge of the heart. Such abutment against the supravalicular ridge can occur at a location within the distal half of the spacer body. The tricuspid valve has a tricuspid annulus and there is an annular plane defined for 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°) to the annular plane. This oblique angle can range from 15-75°.

[0030] In embodiments in which the spacer body comprises a side appendage, the method may further include widening the side appendage during ventricular systole and narrowing the side appendage during ventricular diastole. In the widened configuration, the side appendage may be positioned between the leaflets of the tricuspid valve to fill a gap present therein. In situations in which the side appendage has a non-flat shape, the inner side (concave) is oriented to face toward the right ventricle.

[0031] In embodiments where the transcatheter device further comprises an intravascular anchor at its proximal portion, the intravascular anchor is anchored 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 advanced further 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 advanced further towards the pulmonary artery. The guidewire is inserted into the guidewire lumen of the transcatheter device, and the transcatheter device is advanced over the guidewire.

[0032] Deployment. The 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 intravascular anchor. During deployment, the delivery sheath is retracted rearward. Retraction of the transcatheter device's delivery sheath and components to unsheath can be part of the implantation process. In embodiments where the spacer body is self-expanding, such unsheathing can cause the spacer body to self-expand outwardly to form a larger interface. In embodiments where the transcatheter device includes an intravascular anchor having an expandable configuration, unsheathing can cause the anchor to expand outwardly to remain within the vena cava.

[0033] In some embodiments, the deployment assembly is not disassembled immediately after the procedure is completed. The clinician may wish to perform 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's body along with the transcatheter device. During the short trial period, tricuspid valve function is monitored (e.g., by echocardiogram). If the transcatheter device demonstrates effectiveness during this trial period, the deployment assembly is removed, but the catheter device remains in place. If the trial period shows ineffective results, the transcatheter device can be easily removed by leaving the deployment assembly still in place. The trial period can be any suitable short period. For example, the trial period can be for a period ranging from 12 to 48 hours after insertion.

[0034] Retrieval. After implantation, the transcatheter device can be removed if desired. This can be done by grasping the intravascular anchor (e.g., the spiral coil at the proximal tip of the anchor) and withdrawing the transcatheter device for removal from the patient's body. For example, this can be done by threading a snare catheter into the entry vein, advancing the snare catheter towards the spiral coil, grasping the spiral coil, removing the snare catheter, and withdrawing the transcatheter device from the entry vein. [Brief description of the drawings]

[0035] [Figure 1] FIG. 1 illustrates an example of a transcatheter device for treating tricuspid regurgitation. [Diagram 2] FIG. 1 shows the transcatheter device alone in an extended and stretched configuration. [Diagram 3] FIG. 1 shows the left lung with visualization of the pulmonary arterial tree. [Figure 4A] FIG. 1 illustrates a transcatheter device as implanted in a patient's heart. [Figure 4B] FIG. 1 illustrates a transcatheter device as implanted in a patient's heart. [Figure 5A] FIG. 2 is a further detailed view of the transcatheter device. [Figure 5B] FIG. 2 is a further detailed view of the transcatheter device. [Figure 6A] FIG. 1 illustrates another exemplary embodiment of a transcatheter device. [Figure 6B] FIG. 1 illustrates another exemplary embodiment of a transcatheter device. [Figure 6C] FIG. 1 illustrates another exemplary embodiment of a transcatheter device. [Figure 7A] FIG. 13 shows a close-up view of the distal end of the spacer body and the distal sleeve. [Figure 7B] FIG. 13 shows a close-up view of the distal end of the spacer body and the distal sleeve. [Figure 8A] FIG. 13 is a close up view of an embodiment in which the spacer body has openings to allow blood flow therethrough. [Figure 8B] FIG. 13 is a close up view of an embodiment in which the spacer body has openings to allow blood flow therethrough. [Figure 9A] FIG. 13 is an additional view of the transcatheter device. [Figure 9B] FIG. 13 is an additional view of the transcatheter device. [Figure 9C] FIG. 13 is an additional view of the transcatheter device. [Figure 10A] FIG. 1 illustrates how a transcatheter device is deployed using a delivery sheath. [Figure 10B] FIG. 1 illustrates how a transcatheter device is deployed using a delivery sheath. [Figure 10C] FIG. 1 illustrates how a transcatheter device is deployed using a delivery sheath. [Figure 11A] FIG. 1 is a schematic diagram showing a profile view of a defective tricuspid valve. [Figure 11B] FIG. 1 is a schematic diagram showing a profile view of a defective tricuspid valve. [Figure 12] 1A-1D are similar schematic diagrams for different embodiments. [Figure 13A]FIG. 2 is another illustration of a transcatheter device as implanted in a patient's heart. [Figure 13B] FIG. 2 is another illustration of a transcatheter device as implanted in a patient's heart. [Figure 13C] FIG. 2 is another illustration of a transcatheter device as implanted in a patient's heart. [Figure 13D] FIG. 2 is another illustration of a transcatheter device as implanted in a patient's heart. [Figure 14A] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 14B] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 15A] 1A-1C are various perspective views of another embodiment of a transcatheter device. [Figure 15B] 1A-1C are various perspective views of another embodiment of a transcatheter device. [Figure 15C] 1A-1C are various perspective views of another embodiment of a transcatheter device. [Figure 16A] 1A-1C are various perspective views of another embodiment of a transcatheter device. [Figure 16B] 1A-1C are various perspective views of another embodiment of a transcatheter device. [Figure 17] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 18A] 1A-1C illustrate how a transcatheter device of the present invention can be positioned in a patient's heart. [Figure 18B] 1A-1C illustrate how a transcatheter device of the present invention can be positioned in a patient's heart. [Figure 19A] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 19B] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 19C] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 19D] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 19E] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 19F] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 19G] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 19H] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 19K] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 20A] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 20B] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 20C] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 20D] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 20E] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 21A] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 21B] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 21C] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 21D] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 21E] 1A-1D are various views of another embodiment of a transcatheter device. [Figure 21F] FIG. 1 shows a transcatheter device implanted in the heart. [Figure 21G] FIG. 1 shows a transcatheter device implanted in the heart. [Fig. 21H] FIG. 1 shows a transcatheter device implanted in the heart. [Figure 22A] 13A-13C illustrate how a spacer body on a transcatheter device can be "self-centering" within the tricuspid valve. [Figure 22B]13A-13C illustrate how a spacer body on a transcatheter device can be "self-centering" within the tricuspid valve. [Figure 23A] FIG. 2 is another view of the delivery assembly. [Figure 23B] FIG. 2 is another view of the delivery assembly. [Figure 24A] 2A-2C are various views of a spacer body; [Figure 24B] 2A-2C are various views of a spacer body; [Figure 24C] 2A-2C are various views of a spacer body; [Figure 24D] 2A-2C are various views of a spacer body; [Figure 24E] 2A-2C are various views of a spacer body; [Figure 24F] 2A-2C are various views of a spacer body; [Figure 24G] 2A-2C are various views of a spacer body; [Figure 25A] 13A-13C show different embodiments of the distal tail. [Figure 25B] 13A-13C show different embodiments of the distal tail. [Figure 25C] 13A-13C show different embodiments of the distal tail. [Figure 26] 13A-13C show an alternative embodiment of a transcatheter device lacking a spiral coil in the proximal portion. [Figure 27] FIG. 1 illustrates dimensional parameters of a transcatheter device. [Figure 28A] FIG. 1 illustrates certain dimensions of a transcatheter device. [Figure 28B] FIG. 1 illustrates certain dimensions of a transcatheter device. [Figure 28C] FIG. 1 illustrates certain dimensions of a transcatheter device. [Figure 29A] FIG. 13 illustrates further specific dimensions of the transcatheter device. [Figure 29B] FIG. 13 illustrates further specific dimensions of the transcatheter device. [Figure 29C] FIG. 13 illustrates further specific dimensions of the transcatheter device. [Figure 30A]FIG. 1 illustrates dimensional parameters of a transcatheter device. [Figure 30B] FIG. 1 illustrates dimensional parameters of a transcatheter device. [Diagram 31] 13A-13C show an alternative embodiment of a transcatheter device lacking a spiral coil in the proximal portion. [Figure 32A] FIG. 1 illustrates dimensional parameters of a transcatheter device. [Figure 32B] FIG. 1 illustrates dimensional parameters of a transcatheter device. [Figure 33A] FIG. 1 illustrates a delivery catheter for a transcatheter device. [Figure 33B] FIG. 1 illustrates a delivery catheter for a transcatheter device. [Figure 33C] FIG. 1 illustrates a delivery catheter for a transcatheter device. [Figure 34A] FIG. 1 illustrates another exemplary embodiment of a transcatheter device. [Figure 34B] FIG. 1 illustrates another exemplary embodiment of a transcatheter device. [Figure 34C] FIG. 1 illustrates another exemplary embodiment of a transcatheter device. [Figure 35A] FIG. 13 illustrates further specific dimensions of the transcatheter device. [Figure 35B] FIG. 13 illustrates further specific dimensions of the transcatheter device. [Figure 36A] FIG. 1 shows a prototype of a transcatheter device. [Figure 36B] FIG. 1 shows a prototype of a transcatheter device. [Figure 36C] FIG. 1 shows a prototype of a transcatheter device. [Figure 37A] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 37B] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 37C] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 37D] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 38A] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 38B] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 38C] FIG. 1 illustrates another embodiment of a transcatheter device. [Figure 39] 13A-13C show how wings can act to improve the coaptation of the spacer body to the tricuspid valve leaflets. [Figure 40A] 13A-13C show how wings can act to improve the coaptation of the spacer body to the tricuspid valve leaflets. [Figure 40B] 13A-13C show how wings can act to improve the coaptation of the spacer body to the tricuspid valve leaflets. [Figure 41A] FIG. 13 illustrates how the wings fold inward. [Figure 41B] FIG. 13 illustrates how the wings fold inward. [Figure 42A] FIG. 13 is a schematic diagram showing possible dimensions of the spacer body and wings. [Figure 42B] FIG. 13 is a schematic diagram showing possible dimensions of the spacer body and wings. [Figure 42C] FIG. 13 is a schematic diagram showing possible dimensions of the spacer body and wings. [Diagram 43] 13A-13C show another example of a transcatheter device having wings on the spacer body. [Figure 44A] FIG. 13 shows another example of a transcatheter device having multiple small winglets on the spacer body. [Figure 44B] FIG. 13 shows another example of a transcatheter device having multiple small winglets on the spacer body. [Figure 44C] FIG. 13 shows another example of a transcatheter device having multiple small winglets on the spacer body. [Figure 45A] 13A-13C show another example of a transcatheter device having a different design for the spacer body. [Figure 45B] 13A-13C show another example of a transcatheter device having a different design for the spacer body. [Figure 45C] 13A-13C show another example of a transcatheter device having a different design for the spacer body. [Diagram 46] FIG. 1 is a perspective view of a transcatheter device showing a spacer body in a deployed configuration. [Figure 47A] FIG. 1 is an illustration of a tricuspid valve shown as a schematic model from a side view with a spacer body installed therein. [Figure 47B] FIG. 1 is an illustration of a tricuspid valve shown as a schematic model from a side view with a spacer body installed therein. [Figure 48A] 13A-13C show another example of a wing design that can be used on the spacer body. [Figure 48B] 13A-13C show another example of a wing design that can be used on the spacer body. [Figure 49A] 13A-13C show another example of a transcatheter device having a shroud on the spacer body. [Figure 49B] 13A-13C show another example of a transcatheter device having a shroud on the spacer body. [Figure 50A] FIG. 1 illustrates another example of a transcatheter device. [Figure 50B] FIG. 1 illustrates another example of a transcatheter device. [Figure 50C] FIG. 1 illustrates another example of a transcatheter device. [Figure 51A] FIG. 2 shows a cross section of the main shaft of the transcatheter device. [Figure 51B] FIG. 2 shows a cross section of the main shaft of the transcatheter device. [Figure 52] FIG. 13 shows an alternative design for the proximal segment of the main shaft. [Figure 53A] FIG. 1 illustrates the overall stem shape of an exemplary transcatheter device. [Figure 53B] FIG. 1 illustrates the overall stem shape of an exemplary transcatheter device. [Figure 53C] FIG. 1 illustrates the overall stem shape of an exemplary transcatheter device. [Fig. 53D] FIG. 1 illustrates the overall stem shape of an exemplary transcatheter device. [Figure 53E]FIG. 1 illustrates the overall stem shape of an exemplary transcatheter device. [Figure 54A] 13A-13C show different designs of overall stem shape. [Figure 54B] 13A-13C show different designs of overall stem shape. [Fig. 54C] 13A-13C show different designs of overall stem shape. [Fig. 54D] 13A-13C show different designs of overall stem shape. [Figure 54E] 13A-13C show different designs of overall stem shape. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS To aid in understanding the present invention, reference is made to the accompanying drawings, which show, by way of illustration, specific embodiments in which the invention may be practiced. The drawings herein are not necessarily made to scale or to actual proportions. For example, the length and width of components may be adjusted to fit the page size.

[0037] FIG. 1 illustrates an example of a transcatheter device for reducing tricuspid regurgitation. Shown is a transcatheter device 100 implanted in a patient's heart. The transcatheter device 100 has a distal tail 160 and a proximal section 20. Between the distal tail 160 and the proximal section 20 is a spacer body 120. The proximal section 20 of the transcatheter device 100 includes a spiral coil 146. The spacer body 120 serves to provide improved coaptation of the tricuspid valve leaflets, thereby reducing valve regurgitation. The spiral coil 146 serves to remain inside the inferior vena cava (IVC) to form an anchor for maintaining a desired position of the spacer body 120 across the tricuspid valve. The distal tail 160 also serves to remain within the pulmonary artery (PA) to form an anchor for maintaining a desired position of the spacer body 120 across the tricuspid valve.

[0038] 2 shows the transcatheter device 100 alone in an extended, stretched configuration. The transcatheter device 100 comprises a main axis 180 that traverses the spacer body 120 and encircles the proximal portion 20 of the transcatheter device 100, and a distal tail 160 of the transcatheter device 100. In this exemplary embodiment, the spacer body 120 has a shape that is symmetrical on both the longitudinal and lateral axes. The shape resembles a football with a gentle longitudinal curvature and an enlarged midsection.

[0039] The main shaft 180 has a lumen through which a guidewire 190 travels. The main shaft 180 has a proximal opening where the lumen begins and a distal opening where the lumen terminates. For implantation of the transcatheter device 100, the guidewire 190 is inserted into the femoral vein and advanced through the inferior vena cava, into the right atrium of the heart, across the tricuspid valve, into the right ventricle, and then into the pulmonary artery.

[0040] Once the guidewire 190 is in place, the transcatheter device 100 is advanced over the guidewire 190 by inserting the guidewire 190 through the proximal opening of the shaft 180, through the lumen of the shaft 180, and out the distal opening. Moving along the guidewire 190, the transcatheter device 100 is advanced through the inferior vena cava, from within the right atrium of the heart, across the tricuspid valve, into the right ventricle, and then into the pulmonary artery. When the transcatheter device 100 is fully implanted, the spiral coil 146 rests inside the inferior vena cava, the distal tail 160 rests within the pulmonary artery, and the spacer body 120 rests across the tricuspid valve. The distal tail 160 may further include a radiopaque marker band sized 1 mm from the distal tip, as visible under fluoroscopy. Distal tail 160 is made of a Nitinol wire core reinforced with Pellethane 55D (a medical grade thermoplastic polyurethane elastomer) braid.

[0041] Distal Tail: In this exemplary embodiment, the distal tail 160 of the transcatheter device 100 is advanced over the guidewire 190 and extended into the pulmonary artery to act as an anchor as shown in Figures 1 and 3. In Figure 1, the distal tail 160 extends into the left pulmonary artery 300, past the first branch 302, past the second branch 304, and past the third branch 306. Similarly, Figure 3 shows a left lung 320 with the pulmonary artery tree visualized. Shown here is the left pulmonary artery main trunk 322 and branch arteries 302, 304, and 306. The distal tail 160 of the transcatheter device 100 enters the pulmonary artery main trunk 322 and extends into the left pulmonary artery main trunk 322, past the first branch 302, past the second branch 304, and past the third branch 306.

[0042] Here, the distal tail 160 is not embedded into the tissue of the pulmonary artery. Instead, the distal tail 160 is trapped in the pulmonary artery as it is entangled by the naturally tortuous anatomy of the pulmonary artery tree. The dashed circles indicate multiple contact points along the path of the distal tail 160 through the pulmonary artery. The distal tail 160 becomes entangled within the pulmonary artery at these multiple contact points. Thus, the distal tail 160 acts as an anchor to resist being pulled retrogradely and to prevent the transcatheter device 100 from being pulled away from the placement of the spacer body 120 across the tricuspid valve.

[0043] Alternative embodiments of the transcatheter device 100 may have only one anchoring member. The device can either have a spiral coil 146 for anchoring in the inferior vena cava, or can have a distal tail 160 for anchoring in the pulmonary artery. In another alternative embodiment of the transcatheter device 100, the distal tail 160 is relatively short and extends only into the pulmonary trunk (left or right), but does not extend beyond the first branch artery.

[0044] Systole and Diastole: Figures 4A and 4B show the transcatheter device of Figure 2 implanted in a patient's heart 290 (cutaway view) with the spacer body 120 positioned across the leaking tricuspid valve. The right atrium (RA) and right ventricle (RV) are labeled. In Figure 4A, the heart 290 is in the systolic contraction portion of the cardiac cycle with the tricuspid valve in a closed conformation. As seen here, the leaflets 292 of the tricuspid valve are pressed (coapted) against the spacer body 120. This reduces regurgitation of the leaking tricuspid valve. Figure 4B shows the tricuspid valve in the diastolic relaxation portion of the cardiac cycle. As seen here, the leaflets 292 of the tricuspid valve are pressed away from the spacer body 120 to allow blood to flow around the spacer body. This allows blood to flow from the right atrium into the right ventricle to replenish blood for the next pumping cycle.

[0045] 13A-13D show another illustration of the transcatheter device of FIG. 2 implanted in a patient's heart 290 (cross-section) with the spacer body 120 positioned across the leaking tricuspid valve. FIGs. 13A and 13B show the heart in systole with the tricuspid valve leaflets 292 closed around the spacer body 120. FIGs. 13C and 13D show the heart in diastole with the tricuspid valve leaflets 292 in an open position. The tricuspid valve leaflets 292 spread apart away from the spacer body 120 to allow blood to flow around the spacer body 120.

[0046] 5A and 5B show more detailed views of the transcatheter device 100 of FIG. 1 above. FIG. 5A shows that the spacer body 120 comprises two sleeves, a proximal sleeve 128a and a distal sleeve 128b. The line MM shows the two sleeves together. The two sleeves can be moved relative to each other, such as apart or pushed together. For the purpose of definition, the transcatheter device 100 can be considered to have a distal tail 160, a spacer body 120, and a proximal portion 20. FIG. 5B shows the transcatheter device 100 in a longitudinal cross-sectional view, clearly showing some of the internal features. As can be seen here, the transcatheter device 100 comprises a main shaft 180. The distal tail 160 can be considered to be the distal segment 86 of the main shaft 180. The spacer body 120 is attached to the central portion 82 of the main shaft 180 in a coaxial arrangement. The proximal end 182a of the spacer body 120 is fixed to the shaft 180, while the distal end 182b is slidable on the shaft 180, allowing the distal sleeve 128b to be slidable towards or away from the proximal sleeve 128a. Alternatively, both the proximal and distal ends 182a, 182b of the spacer body 120 may be slidable on the shaft 180, allowing both the proximal and distal sleeves 128a, 128b to be slidable back and forth relative to each other.

[0047] The proximal section 20 of the transcatheter device 100 can be thought of as being further divided into a proximal segment 84 of the main shaft 180, to which is attached the spiral coil 146. Length L1, which is the length of the spacer body 120, is 5 cm. Length L2, which is the length of the proximal segment 84 of the main shaft 180, is 9 cm. Length L3, is the length of the distal tail 160 (and distal portion 86 of the main shaft 180). The inner diameter of the distal end 182, as indicated by the twin arrows D1, is 3.3 mm.

[0048] 7A and 7B show close-up views of the distal end 182b and distal sleeve 128b of the spacer body 120 shown in FIGS. 5A and 5B. As described above, the spacer body 120 is attached to the shaft 180 with the proximal end 182a fixed to the shaft 180. However, the distal end 182b of the spacer body 120 is not fixed to the shaft 180. Instead, the distal end 182b is slidable on the shaft 180. Thus, the distal sleeve 128b can slide back and forth relative to the proximal sleeve 128a. The shaft 180 has a lumen 184. The pair of arrows D1 indicate the inner diameter at the distal end 182b of the spacer body 120. FIG. 7B shows a cross-section of the spacer body 120. The sleeve is made of ePTFE membrane 22. There is also a small gap 130 between the distal end 182b of the spacer body 120 and the main shaft 180, through which blood can flow.

[0049] Croissant Bun Shape: Figures 6A-6C show another exemplary embodiment of a transcatheter device. Figure 6B shows a spacer body 210 having a shape similar to a croissant. The outer surface of the spacer body 210 is provided by a sleeve made of ePTFE (expanded polytetrafluoroethylene) membrane 212. Figure 6A shows an inner frame 124 supporting the sleeve 212 below. The inner frame 124 is a mesh of flexible metal wires. These wires are a Nitinol alloy that gives the inner frame 124 sufficient rigidity to maintain the croissant shape in an expanded configuration, but also sufficient flexibility to allow it to collapse inside a vascular delivery sheath. Figure 6C shows how the spacer body 210 can be deployed in the tricuspid valve. For reference, the distal end 214 and the proximal end 218 of the spacer body 210 are shown. Due to the croissant shape of the spacer body, the distal portion of the spacer body 210 (towards the distal end 214) is positioned behind (below) the septal and anterior leaflets 30, 32 of the tricuspid valve, while the proximal portion of the spacer body 210 (towards the proximal end 218) is positioned above (above) the posterior leaflet 34 of the tricuspid valve.

[0050] Spacer Body Openings: Figures 8A and 8B show close-up views of an embodiment in which the spacer body has openings that allow blood to flow through. Figure 8A shows a spacer body 200 with a distal end 204 and a proximal end 202. The spacer body 200 is attached to a shaft 206. At the distal end 204, there is a small gap between the spacer body 200 and the shaft 206. There is also a small hole 60 in the sleeve 208 that covers the spacer body 200. This allows blood to flow into the gap at the distal end 204, through the spacer body 200, and out the hole 60 in the sleeve 208, as shown by the dashed arrows. This shows the direction of blood flow during systole. The direction of blood flow may be opposite or different during diastole.

[0051] 8B shows an alternative embodiment of the spacer body. In this embodiment, the spacer body 210 has a distal end 214 and a proximal end 212. The spacer body 210 is attached to a shaft 216. At the distal end 214, there is a small gap between the spacer body 210 and the shaft 216. The spacer body 210 has a sleeve 218 on only the distal half. There is no proximal sleeve exposing the underlying wire mesh frame 219. Thus, as shown by the dashed arrows, this allows blood to flow into the gap at the distal end 214, through the spacer body 210, and out of the wire frame 219 at the proximal portion because there is no covering sleeve, i.e., the proximal sleeve is omitted and only the distal sleeve is present. Also, in use, the amount of blood flow through the spacer body 210 can be adjusted by moving the sleeve 218 (advancing forward or retracting backward) to adjust the size of the opening. This indicates the direction of blood flow during systole. The direction of blood flow may be reversed or different during diastole.

[0052] Main shaft and spiral coil: Figures 9A-9C show additional views of the transcatheter device 100 of Figure 2. Figure 9A shows a condensed side view of the transcatheter device 100. For better visibility, the spacer body has been omitted and the main shaft 180 is shown in a condensed view. The main shaft 180 is made of a Nitinol alloy core wire reinforced with Pellethene 55D (a medical grade thermoplastic polyurethane elastomer) braid. The main shaft 180 has a distal end 450 and a proximal end 452. At the tip of the distal end 450, the shaft 180 has a distal end opening 454. At the proximal end 452, the shaft 180 has a proximal opening 456. The total length of the main shaft 180 is about 30 cm. Similarly, this is the same as the distance between the distal opening 454 and the proximal opening 456 of the main shaft 180. The spiral segment 146 has a length of approximately 7 cm (in the relaxed position, measured along the longitudinal axis, not the travel length). The spiral member 146 is coaxial with the longitudinal axis of the main shaft 180.

[0053] FIG. 9B shows a close-up view of the proximal end 452 of the shaft 180 alone, without the spiral segment 146. The proximal opening 456 is visible here. This view also shows that the proximal end 452 of the shaft 180 has a rounded tip 458 adjacent the proximal opening 456. This view also shows the lumen 453 of the shaft 180. The guidewire 190 (see FIG. 2) travels through this lumen 453. The guidewire 190 has a diameter of about 0.035 inches. The rounded tip 458 can make insertion of the guidewire easier. The spiral coil 146 is made of a 0.019 inch Nitinol wire core that is covered with Pellethene 55D (a medical grade thermoplastic polyurethane elastomer). In this example, the spiral coil 146 has three complete spirals. Alternatively, the spiral member 146 may be replaced by a stent-type structure depending on the particular anatomy of the patient. Figure 9C shows an axial end view of the spiral coil 146, where "C" represents the center of the spiral.

[0054] Deployment Procedure: FIGS. 10A-10C show how the transcatheter device 100 is deployed using a delivery sheath 460. The various components are shown in a condensed view. A 0.035 inch guidewire 190 is inserted into the entry vein and advanced along the path to be taken by the transcatheter device. Out of the entry vein, the proximal end of the guidewire 190 is inserted into the lumen of the transcatheter device at the distal opening 454 at the tip of the distal tail 160. The transcatheter device is slid forward over the guidewire 190. The guidewire 190 exits the transcatheter device at a proximal opening 456 in the proximal segment 84 of the main shaft 180. The proximal end of the guidewire 190 is inserted into the lumen of the deployment catheter 462, and the deployment catheter 462 is slid forward over the guidewire 190. The distal tip of the deployment catheter 462 approaches the proximal segment 84 of the main shaft 180 but does not enter the proximal opening 456. As shown in Figure 10A, the transcatheter device along with the deployment catheter 462 is inserted into the delivery sheath 460. Constrained inside the delivery sheath 460, the spiral coil 146 is compressed so that it extends along the longitudinal axis.

[0055] Pushing forward using the deployment catheter 462, the combined assembly is advanced along the path of the guidewire 190, into the right atrium, across the tricuspid valve, and into the right ventricle. The distal tail 160 is advanced into the pulmonary artery. The spacer body 120 is adjusted to a desired position across the tricuspid valve, while the spiral coil 146 is inside the inferior vena cava. FIG. 10B shows that when the transcatheter device is ready to be secured in place, the delivery sheath 460 is retracted so that the distal end 466 is behind the spacer body 120 (unsheathed). When the delivery sheath 460 is retracted so that the distal end 466 is behind the spiral coil 146, the spiral coil 146 is expanded and secured inside the inferior vena cava. Proper placement of the spacer body 120 and the spiral coil 146 can be confirmed by imaging (e.g., fluoroscopy or echocardiogram). 10C, delivery sheath 460 may now be fully retracted and removed. Upon completing the procedure, guidewire 190 and deployment catheter 462 are also fully retracted and removed.

[0056] 23A and 23B show another view of the delivery assembly. FIG. 23A shows a transcatheter device having a spacer body 120, a distal tail 160, a guidewire 190, a proximal shaft segment 84, and a spiral coil 146. The delivery system includes a delivery sheath 460 and a deployment catheter 462. The delivery sheath 460 covers the spiral coil 146 and the proximal shaft segment 84, thereby compressing the spiral coil 146 into a narrow extended configuration. However, the spacer body 120 is not covered by the delivery sheath 460. As such, the spacer body 120 is shown in an expanded state. FIG. 23B shows the delivery sheath 460 advanced forward over the spacer body 120, thereby compressing the spacer body 120 into a narrow configuration. This allows for easier manipulation of the transcatheter device into the target site.

[0057] Oblique placement: Figures 11A and 11B are schematic diagrams showing a profile view of a defective tricuspid valve. The pulmonary artery (PA), right atrium (RA), right ventricle (RV), and inferior vena cava (IVC) are shown. Figure 11A shows that the tricuspid leaflets 470 / 472 lack sufficient coaptation, thereby creating a regurgitant orifice (RO). The tricuspid valve has a tricuspid annulus in which an annular plane can be defined. The annular plane is along the X-axis of the tricuspid annulus and perpendicular to the Y-axis of the tricuspid annulus. Figure 11B shows a transcatheter device implanted in the heart. The transcatheter device includes a spacer body 474 that crosses the tricuspid valve, a distal tail 478 that extends into the pulmonary artery, and a proximal portion 476 that extends into the inferior vena cava.

[0058] It can be seen that the spacer body 474 provides a docking surface for the tricuspid leaflets 470 / 472. It can also be seen that the spacer body 474 is disposed at an oblique angle relative to the annular plane. Due to this oblique angle, the spacer body 474 is disposed behind the septum and anterior leaflet 470, but in front of the posterior leaflet 472. There are various degrees of oblique angle for the spacer body to accommodate anatomical differences between patients. This may depend on the width of the tricuspid annular isthmus in different patients, which may range from 3-5 cm in width. In patients with a relatively short tricuspid annular isthmus, a relatively shallow angle may be ideal to better accommodate the limited space of the short tricuspid annular isthmus. Additionally, having a preformed L-shaped bend at the proximal portion of the transcatheter device may better accommodate the constrained space of the short tricuspid annular isthmus. In patients with a relatively long tricuspid annular isthmus, a relatively steeper oblique may be ideal. 12 shows a similar schematic diagram for a different embodiment, where the spacer body 474 is aligned coaxially with the Y axis and perpendicular to the annular plane.

[0059] 14A and 14B show another embodiment of a transcatheter device. In this embodiment, the transcatheter device 300 has a distal tail 302, a spacer body 320, and a proximal section 328. The distal tail 302 has a bend 304. The proximal section 328 comprises a proximal segment 314 of the main shaft and a spiral coil 306. The proximal segment 314 of the main shaft of the transcatheter device 300 has two bends 318 / 324 and a curve 322. The location and angle of the bends 318 / 324 and the shape of the curve 322 may depend on the individual anatomy of the patient. The spiral coil 306 has a pigtail 308. For this embodiment, a proximal opening 310 and a distal opening 312 of the spacer body 304 are shown. Experimental work done in a porcine model of tricuspid valve defect showed that having a fenestrated opening 310 (distal) and an outflow opening 312 (distal) provided better neotissue coverage compared to the non-fenestrated spacer body design shown in FIG. 6B.

[0060] 16A and 16B show close-up views of different designs of the proximal shaft segment. Shown in this figure is a spacer body 360 (partial view) and the proximal portion of the transcatheter device. The proximal portion comprises a proximal shaft segment 374 and a spiral coil 372 (partial view). The proximal shaft segment has two bends 366 and 368, but no curves.

[0061] 15A-15C show various views of another embodiment of a transcatheter device. FIG. 15A shows a perspective view, FIG. 15B shows a longitudinal cross-sectional view, and FIG. 15C shows a proximal end view. In this embodiment, the distal tail 332 of the transcatheter device 330 has a straight configuration (no bends). This transcatheter device 330 also has a main axis with a proximal segment 344, which is short and has a straight configuration. Also shown is a spacer body 340 and a spiral coil 346. The spacer body 340 has a generally cylindrical shape with a conical end. The spacer body 340 has a proximal opening 342 and a distal opening 346 to allow blood flow through the spacer body. In an alternative embodiment, the spacer body 340 has only one such opening, either the proximal opening 342 or the distal opening 346.

[0062] As shown in FIG. 15B, the spacer body 340 comprises a wire mesh scaffold 560 that is covered with an ePTFE membrane to provide an outer surface. This wire mesh scaffold 560 gives the spacer body 340 the ability to collapse or expand during the deployment procedure. FIG. 15C shows an end view of the wire mesh scaffold 560. The mandrel 559 of the transcatheter device has a lumen 566 for inserting a guidewire. At the distal end of the spacer body 340, there is a sleeve gap 568 from the mandrel 559. The distal end of the spacer body 340 is not affixed to the mandrel 559 at this sleeve gap 568 so that the distal end of the spacer body 340 can slide over the mandrel 559. The mandrel 559 is made of a nitinol core wire 562 covered with a polyurethane sheath and reinforced with a wire braid 564.

[0063] 17 shows another embodiment of a transcatheter device. In this embodiment, the distal tail 382 of the transcatheter device 380 has a bend 384. The proximal segment 386 of the shaft has a single bend 388. A spiral coil 392 is attached to the proximal segment 386 of the shaft. The spiral coil 392 also has a pigtail 393. The spacer body 390 has a boot shape with a curve 394 at the proximal end. The spacer body 390 also has a proximal opening 396 and a distal opening 398.

[0064] 18A and 18B show how the transcatheter device of the present invention can be positioned in a patient's heart. In FIG. 19A, the transcatheter device 400 has a football-shaped spacer body 402 with a distal tail 404 and a spiral coil 406. The patient's heart is shown in cross section with the tricuspid and pulmonary valves 410. As can be seen in this view, the spacer body 402 is positioned across the tricuspid valve and the distal tail 404 travels across the pulmonary valve 410 into the right pulmonary artery. Note that the distal tail 404 has a bend 412 that facilitates directing the tail into the right pulmonary artery. The distal portion of the spacer body 402 abuts against the supraventricular ridge 408.

[0065] In Figure 18B, the transcatheter device 420 has a boot-shaped spacer body 422 with a distal tail 424 and a spiral coil 426. The patient's heart is shown in cross section with the tricuspid and pulmonary valves 410. As seen in this view, the spacer body 422 is positioned across the tricuspid valve and the distal tail 424 travels across the pulmonary valve 410 into the right pulmonary artery. Note that the distal tail 424 has a bend 426 that facilitates pointing the tail into the right pulmonary artery. Note also that the boot-shaped spacer body 422 facilitates abutment against the supraventricular ridge 408.

[0066] 19A-19H and 19K show various views of an embodiment of a transcatheter device. FIG. 19A shows a side view and FIG. 19B shows a cutaway view of a longitudinal section. FIG. 19C shows a side view at a different rotation. FIG. 19D shows a proximal end view. The transcatheter device has a spacer body 480, a spiral coil 486, and a distal tail 484. The spiral coil 486 has a hook 492 for recapturing the transcatheter device if it needs to be withdrawn. The spacer body 480 has a generally cylindrical shape with a conical end. The spacer body 480 has a proximal opening 483 and a distal opening 485 to allow blood flow through the spacer body. The distal tail 484 has a bend 506.

[0067] At the proximal portion of the transcatheter device, there is a proximal segment 482 of the main axis 490. This proximal segment 482 has several contour features. The proximal segment has two bends 502 / 504. Between the bends 502 and 504 is a curved segment 500 which may have a curvature of 80-120° depending on the particular anatomy of the patient. This curved segment 500 brings the spacer body 480 closer to the supraventricular crest of the heart. The location of the bends 502 / 504 and the dimensions of the curved segment 500 may vary depending on the particular anatomy of the patient.

[0068] FIG. 19B (cross section) shows that the spacer body 480 comprises a wire mesh scaffold 496 that is covered with an ePTFE membrane to provide an outer surface. This wire mesh scaffold 496 gives the spacer body 480 the ability to collapse or expand during the deployment procedure. FIG. 19E shows an end view of the wire mesh scaffold 496. The mandrel 490 has a lumen 488 for inserting a guidewire. At the distal end of the spacer body 480 is a sleeve gap 508 from the mandrel 490. The distal end of the spacer body 480 is not affixed to the mandrel 490 at this sleeve gap 508 so that the distal end of the spacer body 480 can slide over the mandrel 490. The mandrel 490 is made of a nitinol core wire 497 reinforced with a polyurethane braid 495.

[0069] 19F-19H and 19K show a transcatheter device implanted in the heart with a path that travels from the inferior vena cava into the right atrium (RA), then across the tricuspid valve into the right ventricle (RV), touching the superior ventricular ridge 505, and through the pulmonary valve 507 into the right pulmonary artery (PA). This path through the heart allows the transcatheter device to remain in a stable position and to resist forward and backward movement despite the beating of the heart. Additionally, this path allows the transcatheter device to be flexible in terms of lateral movement, allowing the device to "self-center" in position as described below.

[0070] FIG. 19F shows the heart in systole with the tricuspid leaflets 503 closed around the spacer body 480. FIG. 19G shows the heart in diastole with the tricuspid leaflets 503 in an open position. The tricuspid leaflets 503 are spread apart away from the spacer body 480 to allow blood flow around the spacer body 480. It can be seen that the L-shaped bend 506 in the distal tail 484 helps to bring the distal portion of the spacer body 480 closer to the ventricular ridge 505. This bend 506 also directs the distal tail 484 into the right pulmonary artery (instead of the left pulmonary artery). It can also be seen that the contour features of the proximal segment 482 help to keep the spacer body 480 at an oblique angle to the annular plane of the tricuspid valve. FIG. 19H shows a close-up view. FIG. 19K shows a close-up view of an alternative design of the proximal segment 512 having a more gently curved shape.

[0071] 20A-20E show various views of another embodiment of a transcatheter device. FIG. 20A shows a cross-sectional view, FIG. 20B shows a side view, FIG. 20C shows a top view, and FIG. 20D shows a proximal end view. The transcatheter device has a spacer body 510, a spiral coil 517, and a distal tail 514. The spacer body 510 has a generally cylindrical shape with a conical end. The spacer body 510 has a proximal opening 513 and a distal opening 515 to allow blood flow through the spacer body. The distal tail 514 has a bend 516.

[0072] At the proximal portion of the transcatheter device is a proximal segment 512 of a main shaft 519. This proximal segment 512 has two bends 522 / 524. The location and angle of the bends 522 / 524 may vary depending on the particular anatomy of the patient. The spacer body 510 comprises a wire mesh scaffold that is covered with an ePTFE membrane to provide an outer surface. This wire mesh scaffold gives the spacer body 510 the ability to collapse or expand during the deployment procedure. FIG. 20E shows an end view of the wire mesh scaffold 526. The main shaft 519 has a lumen 528 for inserting a guidewire. At the distal end of the spacer body 510 is a sleeve gap 528 from the main shaft 519. The distal end of the spacer body 510 is not affixed to the main shaft 519 at this sleeve gap 518 so that the distal end of the spacer body 510 is slidable on the main shaft 519. The main shaft 519 is made of a Nitinol core wire 517 reinforced with a polyurethane braid 525 .

[0073] 21A-21E show various views of another embodiment of a transcatheter device. FIG. 21A shows a side view and FIG. 21B shows a longitudinal cross-sectional cutaway view. FIG. 21C shows a side view at a different rotation. FIG. 21D shows a proximal end view. The transcatheter device has a spacer body 530, a spiral coil 537, and a distal tail 534. The spacer body 530 has a boot shape with a 90° curved proximal portion 531. The spacer body 530 has a proximal opening 533 and a distal opening 535 to allow blood flow through the spacer body. The distal tail 536 has a bend 536.

[0074] At the proximal portion of the transcatheter device is a proximal segment 532 of a mandrel 539. The proximal segment 532 has a 90° outward bend 542. The spacer body 530 includes a wire mesh scaffold 546 that is covered with an ePTFE membrane to provide an outer surface. The wire mesh scaffold 546 gives the spacer body 530 the ability to collapse or expand during the deployment procedure. FIG. 21E shows an end view of the wire mesh scaffold 546. The mandrel 539 has a lumen 548 for inserting a guidewire. At the distal end of the spacer body 530 is a sleeve gap 538 from the mandrel 539. The distal end of the spacer body 530 is not affixed to the mandrel 539 at the sleeve gap 538 so that the distal end of the spacer body 530 can slide over the mandrel 539. The mandrel 539 is made of a nitinol core wire 547 reinforced with a polyurethane braid 545.

[0075] 21F-21H show a transcatheter device implanted in the heart, with a pathway from the inferior vena cava into the right atrium (RA), across the tricuspid valve into the right ventricle (RV), touching the ventricular ridge 505, and traveling through the pulmonary valve 507 into the right pulmonary artery (PA). FIG. 21F shows the heart in systole with the tricuspid valve leaflets 503 closed around the spacer body 530. FIG. 21G shows the heart in diastole with the tricuspid valve leaflets 503 in an open position. The tricuspid valve leaflets 503 are spread apart away from the spacer body 530 to allow blood flow around the spacer body 530. It can be seen that the bend 536 in the distal tail 534 helps bring the distal portion of the spacer body 530 closer to the ventricular ridge 505. This bend 536 also directs the distal tail 534 into the right pulmonary artery (instead of the left pulmonary artery).

[0076] It can also be seen that the contour features of the proximal segment 532 and the boot-shaped curve 531 at the proximal portion of the spacer body 530 help to keep the spacer body 530 at an oblique angle relative to the annular plane of the tricuspid valve. Figure 21H is a close-up view of the distal portion of the spacer body 530 abutting against the supraventricular ridge 505. It can also be seen that the bend 531 in the boot-shaped spacer body 530 abuts against the tricuspid annulus-inferior vena cava isthmus.

[0077] FIG. 24A shows a side view of the spacer body 530 with a partial perspective showing the internal wire mesh framework. FIG. 24B shows a close-up perspective view of the proximal end 539 of the spacer body 530 showing the internal wire mesh framework. FIG. 24C shows a close-up perspective view of the middle portion of the spacer body 530 showing the internal wire mesh framework. FIG. 24D shows a close-up view of the proximal end 539 of the spacer body 530 covered with an ePTFE membrane as a sleeve. FIG. 24E shows a close-up view of the proximal opening 533 of the spacer body 530 where the internal wire mesh framework can be seen. FIG. 24F shows a close-up view of the distal opening 535 at the distal end 537 of the spacer body 530 where the internal wire mesh framework can be seen. FIG. 24G shows an end view of the wire mesh framework for the spacer body 530.

[0078] Self-centering: Figures 22A and 22B show how the spacer body on the transcatheter device can "self-center" within the tricuspid valve. Figure 22A shows a transcatheter device with a spacer body 570, a proximal segment of the main shaft 572, and a distal tail 576. The location of the ventricular ridge is indicated by a dashed circle. The distal tail 576 has a bend 574 that facilitates placement of the spacer body against the ventricular ridge. The anterior, septal, and posterior leaflets are labeled. A marginal view of the tricuspid annulus is also shown. As seen in Figure 22A, it is flexible for lateral movement relative to the posterior leaflet. Figure 22B shows how the distal portion of the spacer body 570 abuts against the ventricular ridge. Pulsatile pressure in the pulsating right ventricle repeatedly pushes the spacer body 570 to wobble in anterior-to-posterior (AP) movement. As can be seen here, in such an arrangement, the supraventricular ridge acts as a wall preventing anterior-posterior (AP) movement of the spacer body 570 between the anterior and septal leaflets.

[0079] Experimental studies in pigs have shown that the spacer body uses the supraventricular ridge as a robust buttress against systolic pressure during right ventricular contraction, as visualized by echocardiography. Thus, the entire transcatheter device design conforms to the internal cardiac and vascular anatomy to prevent excessive migration.

[0080] Distal Tail: Figures 25A-C show different embodiments of the distal tail. Figure 25A shows a distal tail 580 with a bend 582. The distal tail 580 extends from the distal end 584 of the spacer body. Figure 25B shows an alternative embodiment in which the distal tail 580 has a distal section 587 that is a bare Nitinol wire and a proximal section 586 that is a Nitinol wire with a covering sheath (e.g., ePTFE coating or Pellethen 55D braid). Figure 25C shows a close-up view of the distal segment 587 in which the Nitinol wire has a rounded tip 588. This rounded tip 588 blunts the tip of the Nitinol wire to reduce trauma as it travels into the pulmonary artery.

[0081] 26 illustrates an alternative embodiment of a transcatheter device lacking a spiral coil in the proximal portion. This transcatheter device 595 includes a boot-shaped spacer body 590, a shaft 592, a distal tail 596, a guidewire 598, and a proximal segment 594 of the shaft 592. The boot-shaped spacer body 590 has a curved portion 591.

[0082] FIG. 27 shows the dimensional parameters of the transcatheter device 595. L1 is the length of the distal tail 596. L2 is the length of the main axis 592 that surrounds the straight portion of the spacer body 590. L3 is the length of the main axis that surrounds the curved portion 591 of the spacer body 590. L4 is the length of the proximal segment 594 of the main axis 592. By way of example, L1 can be 20-25 cm long, L2 can be 6-9 cm long, L3 can be 2-3.5 cm long, and L4 can be 90-120 cm long. A1 is the internal angle of the bend 599a in the main axis 592 that turns into the distal tail 596. A2 is the internal angle of the bend 599b at the bend in the boot-shaped spacer body 590. The angles A1 and A2 can be in the range of 80-120°. A3 is the interior angle of bend 599c in major axis 592 which turns into proximal segment 594.

[0083] 28A-C show specific dimensions of the transcatheter device 595. FIG. 28A shows the distal tail 596 which is a Nitinol wire core reinforced with Pellethen braid. The distal tail 596 has a sheathed section 602 which is covered with an ePTFE covering and an unsheathed section 604 which does not have an ePTFE covering. The distal tail 596 has a length L1 which is about 20 cm. The unsheathed section 606 has a length L2 which is about 10 cm. The sheathed section 602 has an outer diameter D2 of about 2.83 mm. The unsheathed section 604 has an outer diameter D1 of about 2.57 mm. The proximal segment 594 has a length L3 which is about 90 cm.

[0084] FIG. 28B shows a cross-sectional view of the proximal segment 594 at line G shown in FIG. 28A. As can be seen, the proximal segment 594 has an outer diameter D3 of 2.43 mm. The proximal segment 594 also includes a lumen having an inner diameter D4 of 0.99 mm. FIG. 28C shows a cross-sectional view of the distal tail 596 at line H shown in FIG. 28A. The distal tail 596 is made of an embedded Nitinol core wire having an outer diameter D8 of 0.48 mm. The core wire is reinforced with a Pellethene braid to create an outer diameter D7 of 2.17 mm. The Pellethene braid is further coated with ePTFE to create a total outer diameter D5 of 2.57 mm. The distal tail 596 also includes a lumen having an inner diameter D6 of 0.99 mm.

[0085] 29A-C show more specific dimensions of the transcatheter device 595. FIG. 29A shows the main shaft 592 without the spacer body 590. The inside angle of the bend 601 in the main shaft 592 that turns into the distal tail 596 is 120°. This bend 601 has a radius of curvature of 10 mm. The outside angle of the bend 603 in the boot-shaped spacer body 590 that turns into the proximal segment 594 is 240°. The inside angle of the bend 605 in the main shaft 592 that turns into the proximal segment 594 is 135°. This bend 605 has a radius of curvature of 5 mm.

[0086] FIG. 29B shows various lengths of a transcatheter device 595 with a spacer body 590 attached to a mandrel 592. Length S1 represents the straight portion of the spacer body 590 in an unextended configuration and is 6 cm long. The distal end of the spacer body 590 slides forward on the mandrel 592 when compressed outward inside the delivery sheath. Length S2 represents the bent arm portion of the spacer body 590 in an unextended configuration and is 2.5 cm long. FIG. 29C shows a cross section of the spacer body 590 along line A in FIG. 29B. This view shows the inner wire frame 600, the Nitinol wire core 606, the polymer braid 608 around the wire core 606, and the lumen 610 for the guidewire. The outer diameter (OD) of the spacer body 590 (when the wire mesh 600 is relaxed) ranges from 9 to 19 mm wide.

[0087] FIG. 30A shows the dimensional parameters of the transcatheter device of FIG. 29A and FIG. 29B. L1 is the length of the distal tail 514. L2 is the length of the main axis 519 surrounding the spacer body 510. L3 is the length of the proximal segment 512 between the first bend 524 and the second bend 522. L4 is the length of the proximal segment 512 of the main axis 519 after the second bend 522. FIG. 30B shows a close-up schematic diagram of the spacer body 510. The length H1 of the spacer body 510 is in the range of 5-7 cm. The length D1 is the distance between the distal end of the spacer body 510 and the bend 516 in the distal tail 514. The length D2 is the distance between the proximal end of the spacer body 510 and the bend 524 in the proximal segment 514.

[0088] FIG. 31 shows an alternative embodiment of a transcatheter device lacking a proximal spiral coil. The transcatheter device 630 includes a spacer body 635, a main shaft 638, a distal tail 634, and a proximal segment 636 of the main shaft 638. FIG. 32A shows dimensional parameters of the transcatheter device 630. L1 is the length of the distal tail 634. By way of example, L1 has a length in the range of 20-25 cm. L2 is the length of the proximal segment 636 of the main shaft 638. By way of example, L2 has a length in the range of 90-120 cm. Each of these lengths represents a length along the longitudinal axis (as opposed to the axis of movement). FIG. 32B shows a close-up view of a schematic diagram of the spacer body 635. The bend 633 is a bend in the main shaft 638 that turns towards the distal tail 634. By way of example, the angle at the bend 633 has a range of 80-120°. The length H1 of the spacer body 635 is in the range of 5-7 cm. The length D1 is the distance between the distal end of the spacer body 635 and the bend 633 in the distal tail 634.

[0089] Delivery Catheter: Figures 33A-C show a delivery catheter for a transcatheter device. Figure 33A shows a side view of a transcatheter device placed in a delivery catheter 700. Visible here are the spacer body 710 and distal tail 712 of the transcatheter device. The delivery catheter 700 comprises a shaft 702. At the proximal end, the delivery catheter 700 has a main port 706 and a stylet 704. Figure 33B shows a close-up side view of the proximal end of the delivery catheter 700. Length L1 represents the 60 cm length of the shaft 702. The overall length of the delivery catheter 700 (including the ports) is approximately 670 mm. Figure 33C shows a cross-sectional view of the delivery catheter 700. The outer diameter of the delivery catheter is approximately 5.7 mm. Also shown is an accessory port 708.

[0090] 34A-34C show another exemplary embodiment of a transcatheter device. FIG. 34A shows a transcatheter device 730 with a balloon-type boot-shaped spacer body 732, a distal tail 734, and a proximal segment of the main shaft 740. The distal tail 734 has a bend 738. The distal tail 734 has a distal segment 736 (2 cm long) that is not supported by a Nitinol core wire. That is, the Nitinol core wire ends before reaching the distal tip of the distal tail 734. The absence of Nitinol wire at the distal section may be useful to have more flexibility for the distal tail 734 so that it can advance further into the pulmonary artery tree. The internal angle at the bend 738 is 120°. The spacer body 732 has a bend 744 to give the spacer body 732 a curved shape. The internal angle at the bend 744 is 120°. There is a bend 742 where the main axis turns towards the proximal segment 740. The included angle at bend 742 is 110°. The spacer body 732 is designed as an inflatable balloon.

[0091] Also shown in Figure 34A is a delivery catheter 700 for deploying the transcatheter device 730 into the patient's heart. Figure 34B shows a cross-sectional view of the delivery catheter 700 at line G in Figure 34A. It shows a lumen for a guidewire with an inner diameter D1 (0.99 mm) and an air supply port 746 through which the balloon of the spacer body 732 is inflated and deflated. The outer diameter (D2) of the delivery catheter 700 is 2.43 mm. Figure 34C shows a cross-sectional view of the distal tail 734 along line H, which has a Nitinol wire core with a diameter (D5) of 0.48 mm. It also has a guidewire lumen with a diameter (D3) of 0.99 mm. A Pellesen braid around the Nitinol wire gives it a diameter (D4) of 2.17 mm. There is also a thin ePTFE covering around the Pellesen braid.

[0092] 35A and 35B show further specific dimensions of the transcatheter device 730. The travel length of the bend 738 in the distal tail 734 is about 10 mm. The travel length of the bend 744 in the proximal segment 740 of the main shaft is about 5 mm. FIG. 35A shows the balloon-type spacer body 732 in an uninflated configuration. FIG. 35B shows the balloon-type spacer body 732 in an inflated configuration. It can be seen that the width of the spacer body 732 has expanded after inflation. For spacer bodies supported by an expandable internal scaffold, FIG. 35A and 35B can alternatively show the spacer body in a constrained and relaxed configuration, respectively.

[0093] FIG. 36A shows a prototype of a transcatheter device 730 with the spacer body 732 inflated and the guidewire 190 inserted. FIG. 36B shows a cross-sectional view along line B of FIG. 36B. Seen here is the main shaft 760 with a main lumen for the guidewire. There is also an accessory channel 762 for supplying air or saline to the balloon-type spacer body 732. The air or saline flows through holes 768 in the main shaft 760 to inflate / deflate the balloon-type spacer body 732. FIG. 36C shows a cross-sectional view along line A of FIG. 35B. Seen here is the main shaft 760 with the main lumen 758 and accessory channel 762. There is also a Nitinol wire core 764 for rigid support of the main shaft 760.

[0094] 37A-37D show another embodiment of a transcatheter device. These illustrations show a transcatheter device 140 placed in a patient's heart. The inferior vena cava 150, superior vena cava 151, right atrium 152, coronary sinus 153, right ventricle 154, pulmonary valve 155, ventricular ridge 156, main trunk of pulmonary artery 157, and two branches of pulmonary artery 158 are shown. FIG. 37A shows the transcatheter device 140 being deployed through a delivery sheath 149. The spacer body 142 and the spiral coil 144 are held inside the delivery sheath 149. Constrained inside the delivery sheath 149, the spiral coil 144 is in a compressed configuration extending outwardly along the longitudinal axis. Note that the spacer body 142 includes a small barbed hook 148 at its distal end, which is held in a retracted position by the delivery sheath 149.

[0095] The distal tail 146 extends out of the delivery sheath 149 and across the pulmonary valve 155 into the main pulmonary artery 157. It is noted that the distal tail 146 does not extend into the pulmonary artery branch 158. By having the hook 148, the distal tail 146 can be relatively short in length. For example, the length of the distal tail 146 can range from 5-25 cm in length, and in some cases from 5-15 cm in length. FIG. 37B shows the hook 148 deployed. As the delivery sheath 149 is retracted rearward, the hook 148 emerges and springs out in a pre-biased, protruding configuration.

[0096] The spring-like force of the hook 148 may be sufficient to embed the hook 148 into the ventricular ridge 156. The spacer body 142 may also be pulled back slightly to aid in embedding the hook 148 into the ventricular ridge 156. Thus, the distal portion of the spacer body 142 is secured near the ventricular ridge 156. This improves the stability of the spacer body 142 in the correct position relative to the tricuspid valve. In FIG. 37C, the delivery sheath 149 is fully retracted so that the spiral coil 144 expands outward and remains within the inferior vena cava 150. FIG. 37C also shows the orientation of the hook 148, which is positioned opposite the distal hole 141, but on the same side as the proximal hole 143 and toward the boot of the spacer body 142.

[0097] 37D illustrates how the transcatheter device can then be removed by a retrieval procedure. Note that this is for an alternative transcatheter device design without the hook 148 described above. This requires the use of a snare catheter 686 having a snare loop 688. The snare catheter 686 is inserted into the femoral vein and advanced under fluoroscopic guidance up towards the inferior vena cava 150. The snare catheter 686 is manipulated so that the snare loop 688 captures the distal end of the spiral coil 144. The snare catheter 686 is then removed, removing the entire transcatheter device 140 outside of the patient's body.

[0098] 38A-38C show another example of a transcatheter device for treating a defective tricuspid valve. The transcatheter device 800 has a distal tail 806 and a proximal section 820. Between the distal tail 806 and the proximal section 820 is a spacer body 802 having wings 804. The proximal section 820 of the transcatheter device 800 comprises a spiral coil 812. A main shaft 810 surrounds the proximal section 820 of the transcatheter device 800 through the spacer body 802 and the distal tail 806 of the transcatheter device 800. As seen in FIG. 38A (bottom view), there is a small distal opening 808. As seen in FIG. 38B (side view), there is a bend 816 at the proximal section 820 of the main shaft 810 and a bend 818 at the distal tail 806. As can be seen in FIG. 38C (top view), the spacer body 802 has a larger proximal opening 814 .

[0099] In this exemplary embodiment, the spacer body 802 has a cylindrical boot shape. The spacer body 802 also has a pair of wings 804, which serve to improve the coupling of the spacer body 802 to the tricuspid valve leaflets. Figures 39, 40A, 40B, 41A and 41B show how this works. Figure 39 shows the spacer body 530 of Figure 22A across a tricuspid valve 840 having three leaflets. The mitral valve 824, the pulmonary valve 828 and the aortic valve 826 are also shown. In the tricuspid valve 840, the spacer body 530 provides good coaptation with the leaflets 822. However, there is still a gap 825 between the two sides of the leaflets 822 that allows regurgitation to persist.

[0100] 40A and 40B show how the wings 804 help close these gaps 825. FIG. 40A shows the tricuspid valve 840 in a closed configuration during ventricular systole. Pressure from the right ventricle causes the wings 804 to open into a spread configuration. In this configuration, the wings 804 act to reduce the gaps 825 between the leaflets 822, thereby improving the coupling of the spacer body 802 to the leaflets 822. FIG. 40B is an axial end view of the spacer body 802 alone with the wings 804 in a spread configuration.

[0101] 41A and 41B show how the wings 804 fold inward. During ventricular diastole, the tricuspid valve 840 opens, allowing blood to flow from the right atrium into the right ventricle. This blood flow causes the wings 804 to fold inward into a compact configuration, thereby reducing interference that the wings 804 may cause to this flow of blood into the right ventricle. FIG. 41B is an isolated axial end view of the spacer body 802 with the wings 804 in a folded configuration.

[0102] 42A-C are schematic diagrams showing possible dimensions of the spacer body and wings. As seen in FIG. 42A (top view), the width of the wings is wide enough to reduce the gap between the tricuspid valve leaflets. In some embodiments, the width W1 of the wings 804 is 0.1-3.5 cm, and in some cases, 0.5-2.5 cm. As seen in FIG. 42B (side, edge view), the length of the wings 804 is less than the length of the spacer body 802. In some embodiments, the length L5 of the wings 804 (measured as the longest length along the longitudinal axis of the spacer body 802) is 2-9 cm, and in some cases, 3-6 cm. As seen in FIG. 42C (axial end view), the thickness of the wings 804 is less than the thickness of the spacer body 802. In some embodiments, the thickness of the wings 804 (measured along a transverse axis T perpendicular to the longitudinal axis of the wings and spacer body) is 0.5-10 mm, and in some cases, 0.5-6 mm.

[0103] 43 shows another example of a transcatheter device with wings on the spacer body. The transcatheter device 850 has a distal tail 856 and a proximal section 858. Between the distal tail 856 and the proximal section 858 is a spacer body 842. Here, the spacer body 842 has an hourglass shape with a narrow waist 844 near the center. At this waist 844 are two wings 846. The proximal section 858 of the transcatheter device 850 includes a proximal segment 852 of a main shaft, and a spiral coil 854. A proximal opening 848 is also shown in the spacer body 842.

[0104] 44A-C show another example of a transcatheter device with multiple small winglets in the spacer body. The transcatheter device 860 includes a main shaft with a distal tail 866 and a proximal segment 870. Between the distal tail 866 and the proximal segment 870 is a spacer body 862. Here, the spacer body 862 has three small winglets 864 on each side for a total of six winglets 864. As shown in FIG. 44A (bottom view), the transcatheter device 860 includes a spiral coil 872 and a distal hole 868 in the spacer body 862. As shown in FIG. 44B (top view), the spacer body 862 also has a proximal hole 874. FIG. 44C is a side view of the transcatheter device 860 showing two bends in the main shaft.

[0105] 45A-C show another example of a transcatheter device with different designs of the spacer body. The transcatheter device 880 includes a main shaft with a spiral coil 888, a distal tail 886, and a proximal segment 884. Between the distal tail 886 and the proximal segment 884 is a spacer body 882. Here, the spacer body 882 is designed to work in a parachute-like fashion. FIG. 45A is a top view of the transcatheter device 880 showing an overhead view of the canopy 890 relative to the spacer body 882. FIG. 45B is a bottom view showing a bottom view of the canopy 890. Shown here are multiple strings 892 attached to the perimeter of the canopy 890. FIG. 45C is a side view of the transcatheter device 880 showing how the strings 892 and tethers 894 are attached. At one end, the strings 892 are attached to the perimeter of the canopy 890 and at the other end to the tip of the tether 894. Tether 894 is attached to the main shaft.

[0106] 46 is a perspective view of a transcatheter device 880 showing a spacer body 882 in a deployed configuration. A canopy 890 is shown here swollen in an expanded configuration. The canopy 890 shape is held together by a string 892 attached to a tether 894.

[0107] 47A and 47B are illustrations of a tricuspid valve shown as a schematic model from a side view. Shown here is a spacer body 882 of a transcatheter device 880 in operation when placed in the tricuspid valve. FIG. 47A shows the tricuspid valve in a closed configuration during ventricular systole, when ventricular pressure is in the direction of arrow F1. This fluid pressure causes the canopy 890 to swell and open, abutting against the leaflets 822 and coapting the spacer body 882 to the tricuspid valve. The shape of the canopy 890 is maintained by a string 892 attached to a tether 894 attached to a main shaft 896 of the transcatheter device 880. In FIG. 47B, arrow F2 shows blood flow from the right atrium into the right ventricle during ventricular diastole. This blood flow causes the canopy 890 to collapse inwardly into a compact configuration, thereby reducing interference that the canopy 890 may cause to this flow of blood into the right ventricle.

[0108] Figures 48A and 48B show another example of a wing design that can be used for the spacer body. Figure 48A is a perspective view of a wing 900 alone. The wing 900 has a boat shape with a convex outer side 902 and a concave inner side 904. Grid lines have been added to better illustrate the three-dimensional shape. Figure 48B is a cross-sectional view of a transcatheter device with a spacer body 906 and a boat-shaped wing 900. This view helps to explain the curvature of the wing 900 with a convex outer side 902 and a concave inner side 904. In practical use, the inner side 904 faces towards the right ventricle. This shape can be useful to improve the flapping response of the wing 900 to the flow of blood.

[0109] 49A and 49B show another example of a transcatheter device with a shroud on the spacer body. The transcatheter device is shown in the context of an artificial silicone plastic model 111 of a human heart. FIG. 49A shows a bottom view (from inside the artificial right ventricle) of a transcatheter device with a distal tail 916 and a spacer body 910. The main hull 912 of the spacer body 910 is housed within a shroud 914. The shroud 914 has edge flaps 915 that act in a manner similar to the wings described above, and have open and closed configurations. The shroud 914 also has an inherent curvature that improves the flapping response of the edge flaps 915 to the flow of blood. FIG. 49B shows a top view (from inside the artificial right atrium) of a transcatheter device with a proximal segment 918 of the main axis. As can be seen, the inside of the shroud 914 faces the right ventricle.

[0110] 50A-50C show another embodiment of a transcatheter device. In this embodiment, the transcatheter device 620 has a distal tail 622, a spacer body 650, a main shaft proximal segment 656, and a spiral coil 658. As shown in FIG. 50A (side view), the distal tail 622 has three segments with different flexibility characteristics: a distal segment 624, a central segment 626, and a proximal segment 628. The distal segment 624 is more flexible than both the central segment 626 and the proximal segment 628. In addition, the central segment 626 is more flexible than the proximal segment 628. That is, the proximal segment 628 is stiffer than both the central segment 626 and the distal segment 624. The preformed (pre-biased) curved shape of the distal tail 622, along with the progressively increasing flexibility of the distal tail 622 along its length, reduces trauma to the pulmonary artery. This reduces the risk of damage to the pulmonary artery.

[0111] The total length of the distal tail 622 is approximately 20 cm. The distal segment 624 is approximately 5 cm long. The central segment 626 is approximately 5 cm long. The proximal segment 628 is approximately 10 cm long. The proximal shaft segment 656 is approximately 5 cm long. Note also that the proximal shaft segment 656 has a rounded gooseneck curve 657 to connect with the spacer body 650.

[0112] Figures 50B (perspective view) and 50C (rear view) show a spacer body 650 having a proximal opening 654 and a distal opening 652 that allow blood flow through the spacer body 650. Also shown on the transcatheter device are a series of radiopaque markers. There is a radiopaque strip 670 on the proximal segment 656 of the main shaft. There is also a series of radiopaque bands (672, 674, 676) on the distal tail 622. There is also a radiopaque band 678 at the tip of the distal tail 622.

[0113] 51A and 51B show cross-sectional views of the shaft of the transcatheter device 620. FIG. 51A shows the distal segment 624, which includes a jacket 660 made of Pellethene 90A (grade 90 on the Shore A hardness scale) and a lumen 662 that is lined with ePTFE. The diameter D8 of the distal segment 624 is approximately 3 mm. Pellethene is a brand of thermoplastic polyurethane elastomer designed for use in medical devices. There is also a Nitinol core wire 664 for structural support that runs the length of the shaft of the transcatheter device 620. The Nitinol core wire 664 provides a preformed curved shape to the distal tail 622. The central segment 626 has the same construction, but the jacket is made of Pellethene 55D (grade 55 on the Shore D hardness scale) for the jacket. The Pellethene 55D material is harder than the Pellethene 90A material used in the distal segment 624. The diameter of the central segment 626 is approximately 3 mm.

[0114] FIG. 51B shows the proximal segment 628, which includes a jacket 666 made of Pellethen 77D (grade 77 on the Shore D hardness scale) and a lumen 662 that is lined with ePTFE. The Pellethen 77D material is harder than the Pellethen 55D used in the central segment 626. To provide extra stiffness, the proximal segment 628 is covered with a sheath of stainless steel braid 668. The proximal segment 628 is approximately 4 mm in diameter. A Nitinol core wire 664 runs through the proximal segment 628. The mandrel proximal segment 656 also has a similar construction and material composition. Thus, the proximal segment 628 and the mandrel proximal segment 656 have similar stiffness.

[0115] Figure 52 shows an alternative design for the proximal segment of the shaft, where the proximal shaft segment 682 has a sharp right angle curve 684 connecting to the spacer body 680, as opposed to the rounded gooseneck curve 657 for the design shown in Figure 50A. Also shown here is a spiral coil 686.

[0116] 53A and 53B show the overall shape of the stem of a transcatheter device. The overall stem comprises a main shaft and a distal tail. The main shaft comprises a proximal segment and a spacer. Sasse The proximal segment has an intravascular anchor attached. The proximal segment is a spacer. segment Leads to. Space Sasse Attached to the main shaft is the spacer body. Continuing from the main shaft is the distal tail.

[0117] FIG. 53A shows the overall trunk shape 440 with a main axis including a proximal segment 442 and a spacer segment 444. The trunk 440 further includes a distal tail 446. The proximal segment 442 includes only a single bend 443 with a corner-turning shape. More information on the possible characteristics of this bend 443 is explained in the summary section above under the heading "Proximal Section". The spacer segment 444 and the distal tail 446 form an overall C-shape. As shown in FIG. 53C and FIG. 53D, the overall C-shape is designed to encompass the path along the pulmonary artery, the RV ventricular crest, the tricuspid valve, and the right atrium, and then towards the IVC. The RV ventricular crest, which is the outer wall of the ascending aorta, anatomically provides a sturdy buttress for this encompassing function of the device.

[0118] The distal segment of the distal tail 446 has a longitudinal axis 447. The initial straight section 441 of the proximal segment of the main shaft has a longitudinal axis 448. FIG. 53B shows an angle α between the longitudinal axis 447 and the longitudinal axis 448, where α is in the range of 20-60°. Thus, the distal segment of the distal tail 446 can point in a direction that is within 20-60° of the direction of the initial straight section 441 of the proximal segment 442.

[0119] 53C and 53E show angle α2 between longitudinal axis 447A and longitudinal axis 448B, where α2 is in the range of 0 to 15°.

[0120] FIG. 54A shows a different overall stem shape 550 with two bends 553 and 559 in a curved goose neck shape of the main shaft. These two bends occur in the proximal segment 552 of the main shaft and in the spacer segment 554. In this design, the bends 553 and 559 create a smoothly curved S-shape in the main shaft. The first bend 553 has a curvature in one direction (downward), while the second bend 559 has a curvature in a different direction, i.e., generally the opposite direction (upward). The first bend 553 encompasses a length in the main shaft ranging from 1-5 cm. The second bend 555 encompasses a length in the main shaft ranging from 1-5 cm. FIG. 54B shows the angle β between the longitudinal axis 557 and the longitudinal axis 558, where β is in the range of 20-60°. Thus, the distal segment of the distal tail 556 can point in a direction that is within 20-60° of the direction of the initial straight section 551 of the proximal segment 552.

[0121] As shown in Figures 54A and 54D, the entire C-shape is designed to encompass the pulmonary artery, the RV ventricular ridge, the tricuspid valve, along the right atrium, and then towards the IVC. The RV ventricular ridge, the outer wall of the ascending aorta, anatomically provides a sturdy buttress for this encompassing function of the device. Figures 54C and 54E show the angle β2 between the longitudinal axis 557A and the longitudinal axis 557B, where β2 is in the range of 0-15°.

[0122] Experimental Testing: A prototype of the transcatheter device was tested in a porcine model of tricuspid valve defect and efficacy was assessed by echocardiogram imaging of the defective tricuspid valve. Before treatment, echocardiograms showed severe tricuspid regurgitation rating grade V-VI. The transcatheter device was implanted and the spacer body was positioned across the tricuspid valve. Echocardiogram images were taken 6 weeks after implantation and showed a reduction in tricuspid regurgitation rating grade II.

[0123] Experiments were also performed to test the retrieval of the transcatheter device in a swine model of tricuspid valve defect. A prototype transcatheter device was implanted across the tricuspid valve. Retrieval was performed at three time points: (group 1) immediately after safe placement of the transcatheter device, (group 2) 2 weeks after implantation, and (group 3) 4 weeks after implantation. In each case, retrieval was attempted with a conventional catheter snare system. The retrieval procedure was performed by grasping the proximal tip of the spiral coil of the transcatheter device, removing the snare system, and withdrawing the entire transcatheter device from the entry vein. In groups 1 and 2 (immediately and 2 weeks later), the transcatheter device was successfully removed without any issues. Postprocedure echocardiograms confirmed the absence of any abnormalities caused by the implantation of the transcatheter device and the subsequent trauma caused by its removal. However, in group 3 (after 4 weeks), retrieval was not possible due to strong attachment of the spiral coil to the inferior vena cava. This indicates that the spiral coil functions successfully as a secure anchor within the inferior vena cava.

[0124] The descriptions and examples provided herein are intended to merely illustrate the invention and are not intended to be limiting. Each of the disclosed aspects and embodiments of the invention may be considered individually or in combination with other aspects, embodiments, and variations of the invention. In addition, unless otherwise specified, the steps of the methods of the invention are not limited to a particular order of performance. Modifications of the disclosed embodiments that incorporate the spirit and substance of the invention may occur to those skilled in the art, and such modifications are within the scope of the invention.

[0125] Any use of the word "or" herein is intended to be inclusive and is equivalent to the term "and / or," unless the context clearly dictates otherwise. Thus, for example, the term "A or B" means A or B, or both A and B. Similarly, for example, the term "A, B, or C" means A, B, or C, or any combination thereof.

Claims

1. The main axis and a proximal portion comprising a proximal segment of the main shaft and an intravascular anchor, the proximal portion having a single bend such that the proximal segment has a single curvature; a distal tail comprising a distal segment of the main shaft; a spacer body attached to a spacer segment of the main shaft and located between the proximal segment and the distal tail of the main shaft; A transcatheter device, wherein the distal tail and the spacer segment have a C-shape configured to encompass a path along the pulmonary artery, the superior ridge of the right ventricle, the tricuspid valve, and the right atrium, and then toward the inferior vena cava.

2. The transcatheter device of claim 1 , wherein the spacer body has a non-linear shape.

3. The transcatheter device of claim 1 , wherein the distal tail comprises a bend.

4. The transcatheter device of claim 1 , wherein the distal tail comprises a proximal segment and a distal segment, the distal segment of the distal tail having a narrower diameter than the proximal segment of the distal tail.

5. The transcatheter device of claim 1 , wherein the spacer body has a length in the range of 4 to 13 cm.

6. The transcatheter device of claim 1 , wherein the intravascular anchor is a spiral coil.

7. The transcatheter device of claim 6 , wherein the intravascular anchor has at least two spirals.

8. 10. The transcatheter device of claim 1 , wherein the shaft comprises a lumen; a guidewire moving through the lumen of the shaft; a removable delivery sheath covering the spacer body and the intravascular anchor; a deployment catheter for intravascular deployment of the transcatheter device.

9. an entrance opening in the shaft at a location between the intravascular anchor and the spacer body, and an exit opening in the shaft at a tip of the distal tail; the lumen of the shaft extends from the inlet opening to the outlet opening; The transcatheter device assembly of claim 8 , wherein the guidewire travels through the lumen from the entrance opening to the exit opening.

Images