Bonding device with a positioning system

Abstract

An implantable prosthesis and delivery system for treating tricuspid valve regurgitation (TVR). The system is configured to be pre-loaded into a percutaneous delivery system. The system includes a self-expanding fixation stent with an attachable and positionable junction member. The stent is implanted in the inferior vena cava near the right atrium and is connected to the junction member by a steering tube and a multi-directional coupler and gimbal assembly. The junction member is manufactured from a porous or semi-porous material formed on a wire frame and is optionally configured with a curvature that matches the valve leaflets prior to implantation. Upon deployment, the junction member self-aligns, self-expands, and takes shape over several cardiac cycles to conform to the patient's TV defect and provides a mating surface to the native valve leaflets to reduce TVR.

Description

Technical Field

[0001] The present invention generally relates to medical procedures and devices for repairing damaged or diseased valves, and more particularly to a tricuspid valve prosthesis having a delivery system that enables accurate positioning and placement during implantation and deployment to effectively provide a highly efficient junction surface in the treatment of tricuspid regurgitation (TR) in diverse patient anatomical structures.

Background Art

[0002] The tricuspid valve (TV) includes a plurality of arrangements of native tissue valve leaflets and corresponding surrounding tissue rings (valve annulus) within the right heart structure. The inferior vena cava (IVC) returns deoxygenated blood to the right atrium (RA), after which the blood flows through the TV into the right ventricle (RV), and ultimately to the lungs for reoxygenation. In TVR, the tricuspid valve between the right atrium and the right ventricle does not close properly after the blood is pumped from the right atrium into the right ventricle. Inappropriate coaptation between the native valve leaflets (anterior leaflet, posterior leaflet, septal leaflet) can occur due to several causes, including dilation of the TV annulus, structural damage to the chordae tendineae, and defects in the papillary muscles. As a result of inappropriate coaptation, high ventricular systolic pressure during ventricular systole causes blood to flow retrograde from the right ventricle into the right atrium.

[0003] Designing a medical device that effectively reduces TR in patients is a difficult challenge. When pharmacological interventions such as diuretics or vasodilators are not effective, currently, the following two main solutions remain: (1) a mechanical solution that remodels the shape and size of the TV annulus to force the valve leaflets to adhere tightly for coaptation, which increases the risk to the delicate tissue, and (2) the insertion of a "gap closing" device that prevents or reduces TR within the TV by coaptation with the native valve leaflets.

[0004] The design presented in this application is directed to the latter type of solution, where a novel and improved prosthesis, i.e., a joining device, is securely fixed to the IVC and easily positioned within the TV valve leaflet using a novel delivery system that enables multi-directional positioning and placement of the joining device at the optimal location within the TV. The delivery system of the present invention and the joining prosthesis it delivers are characterized by freedom of movement in multiple axes, allowing unobstructed contact with the native leaflet, thereby enabling the avoidance of the occurrence of new TR.

Summary of the Invention

[0005] In its most essential aspect, the present invention is an implantable prosthesis and delivery system for treating TVR. The prosthesis is configured to be pre-loaded onto a percutaneous, coaxial, over-the-wire type delivery system. This includes a self-expanding fixation stent with an attached positionable joining member, which is referred to herein as a joining sail.

[0006] The stent is implanted in the inferior vena cava adjacent to the right atrium and is connected to the joining sail by a steering tube. The joining sail is manufactured from a porous or semi-porous material and is configured to closely conform to the patient's anatomical structure and the morphological type of the TVR being treated (e.g., leaflet damage, annulus dilation, or pattern of right heart remodeling) prior to implantation and deployment. The joining sail self-aligns within the TV over several cardiac cycles during deployment, absorbs blood, isolates the absorbed blood from the turbulent blood flow, allows the amount of absorbed blood to coagulate and undergo mechanical deformation under contact with the leaflet, thereby ultimately filling the gap of the junction to be addressed and assuming a size and shape that provides a joining surface to the native TV leaflet, thus conforming to the valve defect of the patient.

[0007] The main component of the prosthesis system is the junction seal. In an embodiment, the junction seal can be manufactured from a medical-grade surgical fabric stitched to a wire frame and is attached to the steering tube in a non-removable manner. The sail frame covered with the fabric extends to the tricuspid valve (TV) and provides a junction structure for the native TV valve leaflets. Materials other than surgical fabric can also be employed, including some porous, semi-porous, and even non-porous materials such as fabrics or polymer barriers. Some types of medical-grade open cell foams can also be employed, including polyurethane foam (PU), reticulated polyurethane, polytetrafluoroethylene (PTFE), and the like.

[0008] In an embodiment, a coupler connects the junction member (junction seal) to the steering tube in a non-removable manner, enables multi-axial rotational movement of the sail, and enables self-alignment with the native valve leaflet junction line and commissures. The steering tube itself is an adjustable member that rotates the junction seal towards the TV to assist in positioning the junction seal within the native TV annulus in response to a tensioning input (i.e., tightening of the internal structure). The steering tube is connected to the handle of the delivery system and enables positioning of the junction seal.

[0009] The anchor securely locks the position of the adjusted steering tube during the implantation procedure and is disengaged to enable removal of the delivery system. The stent is positioned in the IVC near the junction of the right atrium (RA) and the IVC and provides fixation of the junction prosthesis.

[0010] Intentional control inputs during the implantation procedure are made via the handle of the delivery system, which provides multiple functions during the preparation and implantation of the prosthesis of the present invention. The handle of the control system enables precise controlled implantation of the prosthesis and, if necessary, complete retrieval of the prosthesis.

[0011] The flush port within the handle facilitates flushing the system with heparinized saline and removing all air from the inner catheter and prosthesis.

[0012] The sheath dial on the control handle retracts the outer sheath upon rotation, gradually exposing the prosthesis and stent.

[0013] The drip line for heparinized saline passing through the handle of the control system promotes non - coagulation of the adjustment mechanism during prosthesis delivery, and the stent release button prevents accidental release of the prosthesis until pressed by preventing the outer sheath from being fully retracted.

[0014] The tension knob at the proximal end of the handle adjusts the amount of tension applied to the prosthesis upon rotation, and the release button disengages the delivery system from the prosthesis.

Brief Description of the Drawings

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Best Mode for Carrying Out the Invention

[0029] First, referring to FIG. 1, the junction device delivery system 10 of the present invention is best understood in the context of the prosthesis it is configured to deliver, as described herein. Thus, the description herein first includes an explanation of the TV prosthesis 100, which is referred to herein as the junction seal and is positioned and arranged by the delivery system. FIG. 1 shows that in an embodiment, the junction seal 100 includes a nitinol wire 102 of an internal 3D shape that is at least partially surrounded and covered by various porous and non - porous materials 104. This includes a proximal intermediate portion 106 between the nitinol wires. The junction seal 100 extends somewhat towards the center of the TV to provide a junction surface for the native TV leaflet.

[0030] At the proximal intermediate portion of the engagement sail, a gimbal / coupler subassembly 200 connects the engagement sail 100 to the nitinol steering tube subassembly 300. The gimbal 202 connects the coupler 204 to the engagement sail 100 and provides multi-axial rotation of the engagement sail within the TV valve ring relative to the coupler 204. The coupler 204 includes a proximal portion 204a and a distal portion 204b and captures the gimbal in such a way that the gimbal has degrees of freedom of rotation and swivel movement relative to the coupler. The coupler is connected to the distal end 300a of the steering tube by a pin 300b. Also, the nitinol wire frame 102 of the engagement sail 100 is connected to the distal end of the gimbal shaft 202a of the gimbal by a coupling clamp 202b.

[0031] The steering tube 300 and associated tension rod subassembly 500 are attached to the stent 400 and the delivery system handle and provide adjustable multi-axial positioning of the engagement sail 100. By applying tension and / or rotation to the steering tube subassembly within the stent 400, the engagement sail is positioned and aligned with the TV valve ring and engages the native TV valve leaflets to treat various anatomical structures. The IVC stent 400 is composed of nitinol and is positioned in the IVC near the junction of the right atrium (RA) and the IVC and provides fixation of the tricuspid valve prosthesis within the IVC. Note that the antithrombotic cover of the steering tube 300 is not shown.

[0032] The major components of the delivery system are shown in FIGS. 2 and 4 - 13. Looking ahead to further disclosure (see the description related to FIGS. 13A - 13C below), and referring here to both FIGS. 2 and 13A - 13C, the system includes a prosthesis delivery system handle 600 at its proximal end, and the prosthesis delivery system handle 600 provides a plurality of functions during the preparation and implantation of the tricuspid valve prosthesis, and provides a controlled implantation that allows for retrieval if necessary. The control handle includes a tension knob 602, a release knob 604, and a guide wire lumen and luer lock 606. A flush port 608 allows the system to be flushed with heparinized saline to remove all air from the inner catheter and prosthesis. A sheath dial 610 is operatively connected to the delivery sheath and, when rotated, draws in the outer sheath, gradually exposing the engagement prosthesis. A drip line 612 for heparinized saline promotes non - coagulation of the adjustment mechanism during prosthesis delivery. A stent release button 614 prevents accidental release of the prosthesis until pressed by preventing the outer sheath from being fully retracted. The tension dial knob 602 adjusts the amount of tension applied to the prosthesis when rotated, and the release knob button 604 disconnects the delivery system from the prosthesis.

[0033] The TR patient population includes many anatomical structure variations beyond basic dimensions such as IVC diameter and TV annulus size. The orientation of the IVC inlet (IVC inlet surface), and the distance to and the orientation of the TV annulus (TV annulus surface) pose additional challenges in the positioning of the engagement sail. However, the orientation and position of the engagement sail within the 3D volumes of the RA and TV annulus are important for successful reduction of TR. Therefore, additional prosthesis and delivery system functions are needed to ensure that the engagement prosthesis and delivery system of the present invention can treat the anatomical structures of a wide range of TR patient populations.

[0034] The novel system shown next provides the required functions by features and functions that enable the joining prosthesis and delivery system of the present invention to treat a more diverse range of anatomic structures of TR patients. Each of these functions provides advantages either individually or in combination. In particular, some novel aspects of the coaptation sail 100, gimbal 202, and coupler 204 are common to the inventors of the present invention and are disclosed in the above-mentioned co-pending international patent application entitled "Coaptation Device", which was filed simultaneously with the present invention, and the entire disclosure is incorporated herein by reference.

[0035] The elements of the prosthesis and delivery system included in this disclosure mainly include, as main components: (1) a novel gimbal design manufactured from a medical-grade suitable material such as polyetheretherketone (PEEK), stainless steel, titanium, etc.; (2) a steering tube (multi-axis adjustable and manufactured from materials such as nitinol, PEEK, etc.); (3) a stent design for attaching the steering tube, also manufactured from the same material; and (4) a tensioning rod subassembly manufactured from PEEK, stainless steel, titanium, polyimide, etc.

[0036] The gimbal 202 connects the coupler 204 to the coaptation sail 100 and enables multi-axis movement of the coupler with respect to the coaptation sail. The ability of the coaptation sail to self-align within the TV valve annulus ensures that it does not interfere with the native leaflets and cause an increase in TR, but instead increases the coaptation of the native leaflets by self-aligning to the coaptation junction. Some figures of the gimbal and coupler assembly are shown in FIGS. 3A - 3C to illustrate the design elements. Porous and non-porous cover materials including the central portion between nitinol wires or porous and non-porous covers between the outer layer and nitinol wires are not shown.

[0037] Figures 3A - 3C are perspective views showing the gimbal 202 including the Nitinol wire 102 and the steering tube 300 attached to the coupler 204. The exploded view of FIG. 3B shows the different components of the assembly including the gimbal 202 and the coupler 204. Note the angled tab 301 at the distal end 301b of the Nitinol steering tube 300. During sheath accommodation of the prosthesis (bonded sail), the tab 301 is generally aligned with the axis of the steering tube, but bends inward to the position shown when exposed from the sheath. This is due to the spring characteristics of the tab material.

[0038] The cross - sectional view of FIG. 3C shows the attachment of the steering tube 300 to the coupler 204 via the pin 300a. Note that the gimbals are respectively housed, captured, and extend through the proximal and distal portions 204a, 204b of the coupler.

[0039] The purpose of the steering tube 300 is to position the bonded sail 100 relative to the TV valve ring. The multi - axis adjustability, bending in multiple planes, and rotation with respect to the stent of this design collectively enable fine - tuning of the position of the bonded sail relative to the patient's anatomical structure.

[0040] The schematic views of FIGS. 4A - 4C show some of the orientations of one steering system at various amounts of bending and rotation. Note that the bending of the steering tube is the result of rotating the threaded insert (which interacts with the tension rod sub - assembly) so as to increase the tension in the tensioning member that effectively shortens one side (the side where material is removed) of the steering tube to create curvature. The material of the steering tube is typically Nitinol, but other materials (such as PEEK, stainless steel, etc.) are also suitable.

[0041] One configuration of the steering system subassembly is shown assembled in FIG. 5. FIGS. 9 and 11 are cross-sectional views of the steering configuration of FIG. 5 and further include details of the tensioning rod subassembly coupled to the steering rod subassembly.

[0042] FIG. 6 is a top perspective view showing components including the steering system and the tensioning rod subassembly, where it shows how the tensioning member 501 (i.e., the suture) wraps around the suture pin 502 (i.e., the anchor pin). Note that when the threaded part 504 rotates to create tension, little or no moment is applied to the tensioning member 501 and there is no counter torque for unscrewing, so the axial load on the threaded part substantially locks it in place.

[0043] The individual components shown in FIGS. 5 - 12 and their respective functions are the steering tube 300 as described above. It should be understood that based on the (as - cut) pattern (and additional cross - through pins), bending can occur in several different directions. The serrated collar 302 is fixed to the steering tube 300 using the cross - through pin 303, thereby providing serrations at the inboard / proximal end, which locks the rotational angle of the steering tube with respect to the serrated stent collar 304 having serrations that interlock with the serrations of the serrated collar. Thereby, the bending direction is provided via the tensioning member passing under the cross - through pin (see particularly FIG. 9). The serrated stent collar 304 attaches the steering tube 300 to the stent 400 while allowing rotation of the steering tube with respect to the stent.

[0044] The compression spring 306 provides a spring force that engages the teeth of the serrated collar 302 with the teeth of the serrated distal (first) stent collar 304 while allowing manual rotation of the steering tube relative to the stent. In an embodiment, the compression spring 306 may be internal to the steering tube to provide a locking spring force (not shown).

[0045] Although the use of a serrated collar is shown, other embodiments may include a collet that provides a higher angular rotation resolution, or an arrangement of cross pins and grooved collars, etc. In other embodiments (also not shown), compression of the spring, rotation of the steering tube, and locking of the rotation angle via delivery system handle control may be enabled.

[0046] The ring collar 308 is also attached to the steering tube using a transverse pin 305 and opposes the spring force of the compression spring 306. The proximal (second) stent collar 310 is attached to the steering tube and allows rotation and translation of the steering tube relative to the stent.

[0047] The tension rod subassembly 500 provides a secure connection between the prosthesis and the delivery system handle to transmit a rotational (torque) force to the steering tube via a tension rod, thereby adjusting the tension against bending of the steering tube.

[0048] The tensioning rod subassembly shown in FIGS. 7A - 7C is shown in three views: an isometric assembly view, an exploded perspective view, and a cross-sectional perspective view.

[0049] The individual components shown and their respective functions include a suture pin 502 (FIG. 7B) secured to the threaded tensioner 504 and connected to the tensioning member 501. The threaded tensioner 504 component adjusts the tension of the tensioning member when screwed into or out of the screw insert 312 to provide flexion to the steering tube 300. The ball wire 506 is combined with the threaded tensioner 504 using a ball expansion 506a at the distal end of the ball wire, which is captured between formed recesses 504a and 510a at the proximal end of the threaded tensioner and the distal end 510a of the tension interlock 510 surrounded by the tension collar 508, providing a contact point that locks into place to provide a torqueable assembly while allowing disconnection when the tension interlock 510 translates away from the threaded tensioner 504. The ball wire is connected at its proximal end to a release button 604 within the delivery system (see FIGS. 2 and 13A - 13C). The tensioner collar 508 is secured to cover the proximal end 504a of the threaded tensioner 504 and the distal end 510a of the tension interlock 510. The threaded tension interlock 510 is secured to the tension tube 514 and the torsion tube 514.

[0050] The radiopaque band 512 is secured over the tension tube 514 and provides fluoroscopic imaging assistance in evaluating the relative position of the threaded tensioner 504 within the screw insert 312. The tension tube 514 is secured to the tension interlock 510 and connected to a tension knob 602 within the delivery system.

[0051] The individual parts of the interlock assembly are shown side by side in Figure 10. In this figure, the separated parts are shown, but the final assembly is actually coaxial. Here, also, the tension interlock 510 is rotated 180 degrees to show the end feature that captures the ball end 506a of the ball wire 506. As described above, the expanded spherical end of the ball wire 506 fits into the pocket at the end of the threaded tensioner 504, and when the tension interlock 510 is positioned over the circular end and, together with the tensioner collar 508, is positioned over all the parts at the junction, the ball wire is fully captured. Both the threaded tensioner 504 and the tension interlock 510 have a "D" shaped end and, when joined together, fit into the tensioner collar 508. This interlock assembly provides a contact point that locks into place to provide a torqueable assembly while allowing for disconnection when the tension interlock 510 translates away from the threaded tensioner 504 in a parallel manner.

[0052] In this configuration, the "ball wire captured in the pocket" is described, but this is not limiting, and as an alternative, an L-shaped wire end may be mentioned, which fits either into an L-shaped pocket on either side of the D-shaped end or into a slot with a hole at the end for the L-shaped wire end. In each alternative, the tensioner collar will need to restrain the connection until disconnection is desired.

[0053] Cross-sectional views of the steering system and the tensioning rod subassembly are shown in FIGS. 9 and 11. Note that the path of the tensioning member (i.e., suture, etc.) in this configuration goes from the distal end 516, passes under the intermediate point 518, reaches the proximal return portion 520, and then returns to 516 along the same path. A typical assembly method involves looping the tensioning member around the pin 520 and passing it through a protective lubricated tube (i.e., FEP, PTFE, etc.) that is tied at 516 while passing under the transverse pin 518. The protective lubricated tube (not shown) prevents damage to the tensioning member from the inner edge of the steering tube 300 during flexion or natural prosthesis movement in a clinical environment. Additional transverse pins can be distributed along the length of the steering tube to create additional turning points, and the additional pivot points, in combination with various laser cut patterns, provide flexion of the multi-directional steering tube.

[0054] The path of the tensioning member over / under or from one side to the other of each transverse pin can vary depending on the desired flexion. Additional guides can be placed on the transverse pins to control the path of the tensioning member. Additional tensioning members can be connected to these transverse pins to allow various amounts of force to be applied to different sections of the steering tube via the use of coaxial or non-coaxial threaded inserts and tensioning rod configurations (not shown).

[0055] In the attachment of the threaded insert to the steering tube, the steering tube has a "T" shaped feature that interlocks with the threaded insert to provide fixation without fixtures or adhesives.

[0056] As can be seen in FIGS. 9-10, the stent 400 is configured to be attached to a steering tube. The serrated stent collars 304 and 310 each include two pins that pass through the collar into aligned holes 402, 404 (see FIG. 10) within the stent for attachment of the steering tube to the stent. The gap in the stent struts between the holes allows an integral stent collar to be securely captured by the stent struts.

[0057] A single coaxial tensioning rod subassembly is shown in FIG. 11. As can be surmised thus far, the purpose of the tensioning rod subassembly is to adjust the flexion of the steering tube, fix the tension force once positioned, and then cut from the prosthesis upon completion of the implantation procedure. The tensioning rod subassembly is detailed in each of FIGS. 7A-9, 11-12. The connection between the steering system subassembly and the tensioning rod subassembly is achieved via a threaded insert 312 that is attached to the steering tube and threaded to threadably connect with the threaded tensioner 504.

[0058] The proximal end of the delivery system associated with the tensioning rod subassembly is shown in FIGS. 13A-13C. Note the delivery system handle 600, the tension knob 602, the release knob 604, and the guide wire lumen and luer lock 606. The cross-sectional view (FIG. 13B) shows how the components are structurally and operationally related and how the compression spring inside the tension knob 602 applies a spring force and keeps the interlock assembly connected. A side set screw 605 is included for safety to ensure that the two components remain connected. When ready to cut, the side set screw is loosened to allow the tension knob 602 to be pulled in for cutting from the prosthesis.

[0059] The enlarged view (Figure 13C) shows a white ring visual indicator 607 that provides a reference point for the applied tension. An additional delivery system handle configuration (not shown) includes a plurality of dials for causing rotation and / or bending of the steering tube, a lever for locking or unlocking the position of the junction device, and other control and actuation mechanisms for the multi-directional movement of the junction device to ensure very precise positioning and placement within the TV. The implantation procedure using the junction device and its delivery system is similar to other transcatheter procedures that use fluoroscopy and echogenic visualization and includes the following steps.

[0060] First, access the femoral vein and perform an anatomical structure and TVR assessment. Next, prepare the junction prosthesis, enclose it in the sheath, and confirm the preparation of the system. Insert the cardiac guidewire from the distal tip of the control handle (i.e., the nose cone) and pass it to the exit of the proximal luer lock near the release knob. Then, connect the heparinized saline pressurized bag to the side stopcock of the delivery system handle and set the pressure of the bag appropriately to ensure that a small flow passes through the sheath tip. Load the prosthesis into the percutaneous delivery system (in the embodiment, a 0.035-inch (0.89 mm) nitrex / nitinol / stainless steel guidewire-compatible system).

[0061] Next, the physician / operator advances the junction prosthesis and its control mechanism over the guidewire through the access site into the right atrium using image guidance. The physician / surgeon then observes the radiopaque nose cone and the outer sheath tip marker using fluoroscopy.

[0062] To deploy the engagement prosthesis, fix the delivery handle to the surface with pins and rotate the sheath dial clockwise. As a result, the tip of the outer sheath is drawn in and the sail is gradually exposed into the right atrium. During this time, the outer sheath slides through the introducer sheath. Stop rotating the sheath dial when the engagement sail and the steering tube are fully exposed from the sheath. At this point, evaluate the position of the engagement sail relative to the TV valve annulus and its interaction with the native valve leaflets.

[0063] The sail is repositioned, if necessary to obtain optimal results, by any of the following: (1) advancing, retracting, or rotating the entire prosthesis system; (2) further rotating the sheath dial clockwise to expose the prosthesis more; or (3) rotating the tension knob counterclockwise to bend the distal portion of the stent. Take great care that this action is only performed when the stent is exposed.

[0064] Subsequently, changes in regurgitation and valve function are evaluated by echocardiography (ICE, TTE).

[0065] Deployment of the prosthesis: To deploy the prosthesis, the physician / operator carefully rotates the sheath dial 610 clockwise until it stops while maintaining the position of the distal edge of the stent within the IVC, exposing the stent. Note that the stent remains constrained at its proximal end within the sheath and the stent is crimped within the IVC during expansion.

[0066] Using the hex wrench included in the sterile preparation kit, the operator carefully loosens the set screw 605 that connects the tension knob 602 to the release button 604. To cut the delivery system from the stent, the operator performs a light pushing / pulling action with the tension knob and the release button (the tension knob provides the pull and the release button provides the push). Observe the result carefully and confirm the cut by carefully pulling the tension knob away from the handle 600 together with the release button.

[0067] To completely release the stent within the IVC, continuously press the release button on the delivery system handle and subsequently rotate (clockwise) the sheath dial until the stent is fully expanded within the IVC.

[0068] Note that, if appropriate for the situation, the order of some steps may be reversed.

[0069] Next, the operator must confirm that the delivery system is completely detached from the prosthesis by gently advancing / retracting the delivery system.

[0070] Subsequently, rotate the sheath dial (counterclockwise) to advance the sheath to the nose cone.

[0071] Finally, remove the guide wire before releasing the stent, and the guide wire is removed from the prosthesis system that is now positioned and left in place here.

[0072] Figure 14 is a very schematic cross-sectional view of the joined sail 108 aligned and deployed within the TV and the fixed stent 400 within the IVC. These two components are connected by the steering tube 300, and all are according to an embodiment of the present invention.

[0073] The above description is directed to preferred embodiments of the present invention, including the best mode contemplated by the inventor for carrying out the present invention as presently planned. However, these do not cover, or even begin to cover, possible alternative embodiments, whether found in substantially equivalent alternative structures or substantially equivalent alternative operations, or both. The embodiments are, instead, presented and described for illustrative purposes, while it will be understood by those skilled in the art that these are not intended to limit the present invention to the exact structures, dimensional relationships, and operations shown and described. Those skilled in the art will readily conceive of various modifications, alternative structures, changes, and equivalents that can be suitably adopted without departing from the true spirit and scope of the present invention. Such changes may include alternative materials, components, structural arrangements, sizes, shapes, forms, functions, operating characteristics, alternative orders of method steps, and the like. Accordingly, the above description and illustration should not be construed as limiting the scope of the present invention, which is defined by the appended claims.

Claims

1. A system for treating tricuspid valve regurgitation (TVR), comprising: a stent configured for placement within the inferior vena cava (IVC) near its junction with the right atrium (RA); a swivel device connected to the stent; a junction member connected to the swivel device, the junction member being configured for percutaneous delivery to the RA for deployment within the tricuspid valve (TV) annulus; a steering system including a steering tube having a proximal end and a distal end, the steering tube being interposed between the stent and the swivel device, the steering system being configured to enable multi-directional positioning and placement of the junction member before and after the stent is placed within the IVC; a control handle for use by an operator to percutaneously guide the stent into the IVC and the junction member into the RA, and to provide an input to the steering system during the prosthesis implantation procedure; when the stent is placed within the IVC and the junction member is positioned within the RA, the swivel device enables the junction member to automatically rotate relative to the TV annulus to optimize the junction with the native valve leaflets, and the control handle enables the operator to bend and rotate the steering tube to finely position the junction member relative to the TV.

2. The system of claim 1, wherein the swivel device is a coupler / gimbal assembly.

3. The coupler / gimbal assembly includes a proximal portion pivotally connected to the distal end of the steering tube, a coupler having a distal portion pivotally connected to the proximal portion and having a cylindrical through-passage, a head captured between the proximal and distal portions of the coupler, and a gimbal having a cylindrical shaft inserted through the through-passage, the gimbal shaft having a distal end configured to be attached to the junction member.

4. The system of claim 3, wherein the head of the gimbal and the distal portion of the coupler are configured to enable the gimbal to pivot and rotate relative to the coupler. **Claim 5** The system of claim 4, wherein the coupler / gimbal assembly is configured to provide a multi-axis rotation of the joining member relative to the coupler within the TV valve ring. **Claim 6** The system of claim 1, wherein the steering tube remains in a predetermined arrangement even after deployment of the joining member and connects the stent and the swivel device. **Claim 7** The system of claim 6, wherein the stent is connected to the steering tube by at least two stent collars that lock the rotation of the steering tube but selectively permit manual rotation of the steering tube by the operator during the placement procedure. **Claim 8** The system of claim 1, wherein the steering tube is operatively connected to the control handle. **Claim 9** The system of claim 8, wherein the steering tube and the control handle are collectively configured to enable control input by the operator via the control handle to bend and rotate the steering tube after the stent is fixed within the IVC. **Claim 10** The system of claim 9, wherein the bending of the steering tube is controlled by a pattern at the time of cutting in manufacturing and one or more transverse pins disposed within the steering tube. **Claim 11** The system of claim 10, wherein the steering tube includes a plurality of transverse pins, a tensioning member is passed around the plurality of transverse pins and is operatively connected to the control handle, whereby an input to the tensioning member via the control handle induces bending of the steering tube. **Claim 12** The system of claim 11, including a first transverse pin at a proximal portion of the steering tube, a second transverse pin distal to the first transverse pin, and an eyelet at the distal end of the steering tube, wherein the tensioning member is connected internally by the eyelet and an input that pulls the tensioning member bends the steering tube. **Claim 13** A tension tube sub-assembly that is slidably disposed at the proximal end of the steering tube and is threadably connected to a tensioning rod sub-assembly interposed between the steering tube and the control handle, the tensioning rod sub-assembly including a tension tube connected to the control handle, further including a steering sub-assembly, The first transverse pin is disposed within the steering tube sub-assembly, whereby an operator input that pulls the tension tube transmits a pulling force to the steering tube sub-assembly, thereby causing a bend in the steering tube. The system according to claim 12.

14. Further including an angled tab made of a shape memory alloy and disposed at the distal end of the steering tube, during sheath accommodation of the joint member and the coupler / gimbal assembly, the angled tab generally aligns with the axis of the steering tube, and then, by exposing the coupler / gimbal assembly from the sheath, the angled tab is enabled to bend inwardly by the spring characteristics of the material of the angled tab. The system according to claim 1.

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